U.S. FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

**FOOD AND DRUG ADMINISTRATION**

**NATIONAL TRANSPORTATION SAFETY BOARD**

**JOINT PUBLIC MEETING**

Transportation Safety

and

Potentially Sedating or Impairing Medications

National Transportation Safety Board Headquarters

429 L\'Enfant Plaza

Washington, D.C.

Thursday, November 15, 2001

8:00 a.m.

**BERNARD A. SCHWETZ, D.V.M., Ph.D.**

Acting Principal Deputy Commissioner

Food and Drug Administration

**CAROL CARMODY**

Vice Chairman

National Transportation Safety Board

[Co-Chairs]{.underline}

STEVEN GALSON, M.D., M.P.H.

Deputy Director

Center for Drug Evaluation and Research

Food and Drug Administration

DR. VERNON ELLINGSTAD

Director

Office of Research & Engineering

National Transportation Safety Board

## Technical Panel

[On behalf of the Food and Drug]{.underline}

[Administration]{.underline}:

DR. ROBERT TEMPLE

Director

Office of Medical Policy & Office of Drug

Evaluation I

[On behalf of the Food and Drug]{.underline}

[Administration]{.underline}:

DR. ROBERT MEYER

Director

Division of Pulmonary and Allergy Drug

Products

DR. CHARLES GANLEY

Director

Division of Over-the-Counter Drug Products

DR. RUSSELL KATZ

Director

Division of Neuropharmacological Drug

Products

DR. THOMAS LAUGHREN

Supervisory Medical Officer

Division of Neuropharmacological Drug

Products

DR. PAUL ANDREASON

Medical Officer

Division of Neuropharmacological Drug

Products

[On behalf of the National Transportation]{.underline}

[Safety Board]{.underline}:

DR. MITCHELL GARBER

Medical Officer

Office of Research & Engineering

DR. MARGARET SWEENEY

Transportation Research Analyst

Safety Studies Division

Office of Research & Engineering

MR. PETE KOTOWSKI

Motor Carrier Specialist

Office of Highway Safety

MR. RAFAEL MARSHALL

Project Manager

Office of Highway Safety

[Invited Parties]{.underline}

[Advocacy Groups]{.underline}

KAREN TARNEY

Citizens Against Drug Impaired Drivers

[Industry]{.underline}

TODD SPENCER

Owner-Operator Independent Drivers

CORRINE RUSSELL

Consumer Healthcare Products Association

WILLIAM MAHORNEY

American Bus Association

NORM LITTLER

United Motor Coach Association

TOM FAULKNER

Air Transport Association

BILL BRADLEY

Consumer Healthcare Products Association

[Operator Unions]{.underline}

KAREN HEAD

Legislative Council

CAPTAIN RANDY POPIEL

Allied Pilots Association

[Government]{.underline}

ROBERT M. CLARKE

DR. FREDERICK TILTON

[Professional]{.underline}

RICHARD GELULA

National Sleep Foundation

DARREL DROBNICH

National Sleep Foundation

### A G E N D A

[AGENDA ITEM]{.underline}: [PAGE]{.underline}:

Administrative Announcements and Opening 328

Remarks

Witness Panel V - Education 329

Kenneth Edgell

Office of the Secretary of Transportation

Office of Drug and Alcohol Policy and

Compliance

Washington, D.C.

Natalie Hartenbaum, M.D., M.P.H.

Occumedix

Maple Glen, PA

Allen Parmet, M.D., M.P.H.

Midwest Occupational Medicine

Kansas City, Missouri

Questions from Technical Panel/Parties 346

and Discussion

Witness Panel VI - International 428

Jenny Bergin

Pharmacist Consultant

National Secretariat of the Pharmacy Guild

Australia

Asbjorg S. Christophersen, Ph.D.

Associate Director

National Institute of Forensic Toxicology

Norway

Dr. Johann J. de Gier

Ultrecht Institute for Pharmaceutical Science

The Netherlands

Questions from Technical Panel and Discussion 459

### A G E N D A

[AGENDA ITEM]{.underline}: [PAGE]{.underline}:

[Afternoon Session]{.underline}

Witness Panel VII - Warning Labels 495

Ruth Day, Ph.D.

Duke University

Durham, North Carolina

R. William Soller

Senior Vice President and Director,

Science and Technology

Consumer Healthcare Products Association

Washington, D.C.

Bert Spilker, Ph.D., M.D.

Pharmaceutical Research and Manufacturers

of America

Washington, D.C.

Michael Wogalter, Ph.D.

North Carolina State University

Raleigh, North Carolina

Questions from Technical Panel/Parties 521

and Discussion

Adjournment

#  P R O C E E D I N G S

8:06 a.m.

Administrative Announcements and Opening Remarks DR. ELLINGSTAD: Welcome
back. We\'re off schedule already. I\'m sure we\'ll make up for
that.We\'ll have three panels today. A couple of announcements first.

Again, as \-- as yesterday, questions from the audience may be given to
one of the staff members who\'s \-- who have the index cards, and if you
get that \-- give \-- give those questions to them we will ask that at
the conclusion of the round of \-- of questioning.

We also will \-- have scheduled a 1:00 audience discussion session as we
had yesterday for those who have \-- have preregistered to make some
remarks. At the moment no one has \-- has registered for that, and
essentially, anybody that wishes to do so should do that by the time of
the first break. What is likely to happen is that we will move up the
start of our afternoon panel to 1:00. So, we \-- we possibly will \--
will be able to exceed the schedule that we have printed up here.

Are there \-- you have, Steve?

DR. GALSON: Just very quickly. The reason this meeting is running so
smoothly is because of a lot of hard work of \-- of \-- and planning and
also running the mechanics of the room, and I just want to acknowledge
the hard work and assistance of those folks. From FDA, Lee Lemley and
Anne Henig, who are standing in the back. From NTSB, Carolyn Dargan and
Mary Jones. I\'m not quite sure where they are but they\'re around. And
then, helping us in the room is Antione Downs and Will Scholochenko.
Thank you very much. Doing a great job.

DR. ELLINGSTAD: Thank you. We\'ll begin this morning with our Education
Panel. And our first panelist is Dr. Natalie Hartenbaum from Occumedix
in Maple Glen, Pennsylvania.

Dr. Hartenbaum?

Witness Panel V - Education

DR. HARTENBAUM: Thank you for inviting me \-- that better? Okay. Sorry
about that. Didn\'t sound like it was vibrating yet.

While I\'m primarily going to address educating operators, I think it\'s
equally important to look that we have to also educate healthcare
providers, and this is not just the medical examiners that work for the
companies but also the treating providers. While companies are aware
that they do have a requirement to educate their operators, they do so
in many different ways. I\'ve spoken with several of my colleagues in
occupational medicine, both in the corporate and private practice
setting, to get a sense of what the different organizations are doing.
I\'ve also practiced in private practice and served as medical director
of a Class 1 railroad, so I\'m going to primarily address commercial
highway driving and rail.

Many of the companies will advise their operators to talk to their
treating providers and read labels, which is a nice start. Some of them
will also tell them to have their providers or have the employees
themselves talk to the companies\' medical professionals to discuss the
side effects of medications. This may work well in some cases but it
doesn\'t work very well when we\'re dealing with over-the-counter
medications where there are no medical professionals involved in the
prescribing.

Some of the drivers may actually go ahead, take the medication insert,
read it, pulling up their reading glasses first if they need to, and
look for the great words that say, \"Use caution when driving motor
vehicle or operating machinery.\" These operators will indeed use
caution. They will be careful. They will work more slowly. But they are
still impaired. Evidence has shown that they cannot always adequately
assess the degree of impairment these medications may cause.

Some companies do require that individuals in safety-sensitive
operations provide information from their healthcare professional that
the medication they\'re using is safe, medication they\'re using will
not impair their operations. And what they will do is some companies
will also ask that the medical examiners for that company interview and
instruct.

For the rail industry, the only individuals required to have regular
contact with health professionals are locomotive engineers. This occurs
only once every three years and they\'re only required to address
vision, hearing, and color vision.

For highway, the new medical examination reporting form requires the
examiner to discuss with the driver the potential hazards of
medications, both prescription and over-the-counter. But here again, the
only thing the examiner can do is advise them to talk to their treating
provider and read warning labels.

With very few exceptions commercial driving, the only \-- there are very
few specific limitations on medications. They are not supposed to be
using any medication which is impairing or may be habit-forming.
However, if they have a health professional who is prescribing a
medication and states they are not impaired, they can continue to work
in commercial operations.

Many examiners and many companies attempt to get this information from
the treating provider and may give questionnaires similar to the one in
the binder containing questions such as these. The treating professional
looks at the patient \-- their patient they want to keep happy and says,
\"Are you having side effects?\" What does the driver or operator say?
\"No, I\'m not.\" He knows if he answers he\'s having problems he\'ll be
pulled from service. The healthcare professional says, \"Okay. Fine.
You\'re safe to drive,\" signs off the form, it goes back to the
company. The company\'s medical examiner has no option but tries to
challenge or question this medical professional. The response that they
often get is, \"I know this patient longer than you have and he\'s
better now than he\'s been for the past five years not on the
medication,\" not understanding the full implications of this partially
incomplete assessment and the impairment that this medication may cause.

There are some guidance available for commercial driver medical
examiners. In conference reports prepared by \-- they were conferences
sponsored by the Federal Highway Administration. These, however,
predated the ADA. So, even though it contains recommendations on both
classes of medications and specific medications, examiners for companies
who try to prohibit this are challenged because they need to do an
individualized assessment on each driver.

Some of the companies will have information such as the FDA does have a
nice pamphlet called \"Over-the-Counter Medications and Flying,\" maybe
you shouldn\'t. There are also information prepared by \--
pharmaceutical companies who try to reach out to the healthcare
providers and explain to them the importance of impairing medication
while at work, not just while driving.

The FAA has a bulletin available and the FTA also has a newsletter
available that has in the past covered medication\'s potential
impairment. The FRA and the FMCSA does not at this point have a vehicle
for this. Labeling is one start but it\'s just as important to make
certain that the health professionals, the healthcare professionals,
understand the importance of a complete assessment and how impairing and
how dangerous some of these medications can be.

DR. ELLINGSTAD: Thank you. Dr. Garber has reminded me that I\'ve
neglected to make the obligatory fire safety announcement. And in the
event of an emergency such as a fire, the building fire alarm will
activate and a voice message will instruct persons to vacate the
building. If that happens, you should proceed to the nearest exit. There
are emergency exits up in the front here on either side of the platform
and at the back of the room. Sorry for having neglected that, intruding
into the program.

Our next panelist is Dr. Allen Parmet, Midwest Occupational Medicine,
Kansas City, Missouri.

Dr. Parmet?

DR. PARMET: Thank you for inviting me.

My background is about 25 years in the military medicine and about 10
years in private practice. The last six years I was medical director for
an American Airline company, which was a not-for-profit company. It
wasn\'t on purpose. Just kind of worked out that way. But back in
private practice now.

I am a pilot and before I started all this I was actually an air traffic
controller for the military, so I\'ve been in this business a long time.

Our point of view from aviation is very similar. I\'ll have to preface
my remarks by saying I totally agree with what Dr. Hartenbaum has said
and want to build a few things with regard to aviation.

Our pilots and air traffic controllers are regulated and we have the FAA
to rely on and often to blame. When we need somebody to blame, we\'re
very happy to have them there because it gives us the opportunity to
say, \"You can\'t take any medications without approval.\" That\'s a
blanket statement. Nothing. And at least in my company, our rule was
that any medication taken must be reported to the company medical
director and I personally reviewed all the reports that were submitted
and had to approve somebody to return to work. I won\'t say that
everybody actually did that, but that was the rule and it was enforced
if somebody was found not to be compliant with it.

But across the board, the only regulations that really apply are to the
pilots and air traffic controllers. We have other safety-sensitive
personnel as well, including our mechanics, our flight attendants, and
security people. And we certainly don\'t need a mechanic who is sedated
and forgets to screw the bolts that hold the tail plane on. We don\'t
need a security person who falls asleep and allows a few pieces of
cutlery to go through the X-ray machine. So, our \-- our needs are quite
broad here.

And we can\'t use accidents as the end point because those events are so
rare as to not give us a good statistical evaluation. We have to be able
to evaluate cognitive impairment by a means less than that.

We also have to evaluate it over a very broad screen. We of course
don\'t \-- in \-- general commercial aviation don\'t \-- don\'t have any
60-year-old \-- 61-year-old pilots, but we do know that \-- that aging
affects the results of some of these medications, so we have to look at
that as well.

The other thing is the environment we operate in is not quite the same.
Most of us operate at cabin altitudes equivalent to about 8000 feet.
That\'s about 550 millimeters of barometric pressure and the oxygen
levels have dropped from a normal \-- the 160 millimeters down to 110.
This hypoxia affects and magnifies the effect of any sedating
medications. You put in at end of flight, long day, fatigue after a \--
a maximum mission is basically equivalent to having about two drinks of
alcohol. We \-- when we add in any sedation from any medication, you get
a sedagistic effect.

So, we\'ve had company policies that work. We can try to educate
individual practitioners. It\'s very difficult to do that because the
individual practitioner is the advocate of the patient and will
absolutely never tell their patients, \"You can\'t do what you want to
do.\" And I\'ve seen extremes in this.

It \-- really, to give you an example, I \-- I had a recent case where a
driver literally ran into a parked vehicle that had warning lights and a
flagman, and the driver was taking prescription amounts of codeine and
diphenhydramine and also had a blood alcohol of .18 and at the time his
personal physician evaluated him had a blood alcohol level of .18. And
his provider testified in court that that man was not impaired.

When you have these situations where the individual provider clearly is
such an advocate for the patient, we\'re never going to see anybody say
that there is no impairment unless they\'re independent, and they have
to be independent to be able to \-- to base it because otherwise we\'re
\-- we\'re winning individual freedom with no collective responsibility.
And if we don\'t regulate this we\'re going to legislate \-- we\'re
going to litigate it. The lawyers are going to say who will be
responsible and who\'s going to end up paying the bills, and that could
be individual practitioners.

What we\'d like to have is strong guidance. One could create a list. The
\-- the FAA has \-- has already, as you\'ve seen, Dr. Hartenbaum
presented, a \-- a pamphlet that is a very strong advisory for aviators.
And it works if everybody reads it. But getting that pamphlet is not
universal. Ideally, we\'d like to have every single person aware of
every medication they take and, even more ideally, the interaction
between medications, which is much more difficult and in many cases
remains unknown.

So, we\'re faced with a lot of dilemmas here and it\'s not an easy \--
easy situation to \-- to come to the ultimate conclusion of what is
safe, what can you go safely and work with, what can you not, and what
are individual variations. So, it\'s a tough problem. I don\'t have the
absolute solutions for you.

DR. ELLINGSTAD: Thank you, Dr. Parmet.

Our third panelist is Mr. Kenneth Edgell with the Office of the
Secretary of Transportation and the Office of Drug and Alcohol Policy
and Compliance.

Mr. Edgell?

MR. EDGELL: Dr. Ellingstad, Dr. Galson, members of the panel, thank you
for inviting me here.

I \--

(Pause)

MR. EDGELL: Okay. Back on track. I am going to take the next few minutes
\-- I hope I can get through it in five or 10 \-- to introduce this
mountain of information that I have here on \-- on the table and leave
it with you and offer it as an example of DOT\'s contribution in the
education area.

Safety is DOT\'s number one objective. It is \-- we refer to it as our
\"North Star.\" DOT shares the concern of the NTSB and the FDA regarding
the complications that can arise if caution is not exercised when any
prescription medication and some over-the-counter medications are used.
During the last decade DOT has issued extensive drug and alcohol
regulations together with guidance and specific education and training
requirements. The transportation industry itself has addressed the need
for caution when using prescription and over-the-counter medicine.

DOT continually addresses this issue with periodic notices to the
industry and with a wide range of educational and training efforts to
those with safety-sensitive jobs and those \--

DR. ELLINGSTAD: Could you pull the microphone a little closer?

MR. EDGELL: Oh, I\'m sorry.

DOT continually addresses these issues with periodic notices to the
industry and a wide range of educational and training efforts to those
with safety-sensitive jobs, to those \-- and to those physicians who are
tasked with ensuring the medical qualifications. I\'d like to go through
some slides to point out some of the actions taken by each one of our
operating administrations.

(Slide)

MR. EDGELL: The Federal Motor Carrier Safety Administration develops and
periodically publishes easy-to-understand guidance documents and videos
that advise medical providers and operators on the hazards of \--
hazards of using medications while responsible for operating commercial
motor vehicles.

As an example, Federal Motor Carrier Administration has developed an
educational video that targets the motor coach industry. This video
addresses the use of prescription and over-the-counter meds in
relationship to fatigue.

Motor Carriers is working in partnership with the American Trucking
Association on a train-the-trainer program for their Wellness Program
which targets commercial drivers called \"Getting in Gear.\" This
program will address, among other issues, the use of over-the-counter
medicine, prescription meds as possible hazards when operating a
commercial motor vehicle.

The \-- over 350 physicians, medical examiners involved in determining
medical qualification for drivers have been trained by the American
College of Occupational and Environmental Medicine and more physicians,
approximately 3000, have purchased the DOT \"Medical Examination
Guidebook.\"

Motor Carriers has traditionally relied upon the medical community to
advise drivers about the proper use of \-- medications, both
prescription and non-prescription.

(Slide)

MR. EDGELL: Federal Transit Administration has been very active in
providing training for public transit agencies and their contractors the
past two years. 13 fatigue classes, 15 substance abuse classes, eight
drug and alcohol seminars, 13 seminars are planned for 2002. Special
emphasis has been placed on education for both management and employees
about the safe use of all medications, including over-the-counter drugs.
All of the major transit systems have incorporated over-the-counter and
prescriptive meds into their policies and driver training orientations.

(Slide)

MR. EDGELL: The Federal Rail has issued a safety advisory on the
recommended practices for safe use of prescription and over-the-counter
meds by safety-sensitive railroad employees. That initiative involved
into the Federal Rail publishing and distributing a compliance and
enforcement manual which established the program standard for
prescription and over-counter medication use. Federal Rails has also
provided numerous presentations and classes to railroad labor and
management leaders which underscore the seriousness of their training
efforts.

(Slide)

MR. EDGELL: And as a follow-up to the \-- the DOT\'s complete commitment
to safety, when Lamar Allen, who was a panelist before you yesterday,
does a railroad inspection tomorrow, I can assure you that he will look
carefully at the railroad to determine that their policy that they have
is fully implemented in this area of concern.

(Slide)

MR. EDGELL: Federal Aviation has published information for airmen which
addresses the dangers associated with the use of specific
over-the-counter drugs as well as the dangers associated with the use of
prescriptive medications. Examples include the \"Aeronautical
Information Manual\" developed for civil aviation pilots which devotes
an entire chapter to the medical facts for pilots; the \"Medical
Handbook for Pilots,\" which contains a chapter \"Drugs and Flying;\"
and from the \"Medical Facts for Pilots\" a brochure entitled
\"Over-the-Counter Medications and Flying.\"

In addition, the FAA has developed information specific for the aviation
\-- for their aviation medical examiners. These include quarterly
publications from the Federal air surgeon and the medical bulletin,
which contains relevant articles and technical reports on the effects of
medications and flying. A series of presentations has been developed by
the Civil Aeronautical \-- Aero Medical Institute. These are known as
CAMI\'s aviation \-- courses. CAMI has also developed the basic and beam
aviation medical \-- examiners\' seminars which are conducted across the
country and two self-administered training courses.

(Slide)

MR. EDGELL: U.S. Coast Guard has the Motion Marine Personnel Physical
Examination Report. This is a report \-- this is a form that
standardizes the physical examination of all holders of Coast
Guard-issued licenses and merchant mariner documents. This form is used
for navigation and vessel inspection circular, which specifies \--
specifically addresses dosage, purpose, and side effects of medication.

The Coast Guard has embarked on a new crew alertness campaign. The
Research and Development Center has been working with the maritime
industry in generating interest and awareness of crew alertness and crew
endurance management. This system was designed to allow company
management and crew members to use objective methods to constantly
improve the work plan, the safety, and the personnel endurance.

(Slide)

MR. EDGELL: National Highway Traffic Safety Administration is involved
now in the large truck crash study with the Federal Motor Carrier Safety
Administration. This study is to determine the causes of serious truck
crashes so that most \-- so that the most effective measures \--
countermeasures to reduce the occurrence and the severity of the large
truck crashes will be implemented. The study will determine the causes
of serious large truck crashes and the part of the assessment includes
significant information related to the use of prescription and
over-counter medications, asking about 41 different prescriptions and 15
over-the-counter medications. Data will be collected on a voluntary
basis but not from the standpoint of toxicological testing by the
National Automotive Sampling System and law enforcement at 24 sites
across the country.

This is a four-year effort, 250 of a planned 1000 accidents results have
been collected to date and a final draft report and preliminary results
should be available in 2003.

(Slide)

MR. EDGELL: The DOT strongly supports clear, consistent, meaningful,
easily recognizable warning labels on prescription drugs and
over-the-counter medications. Such a meaningful label would be helpful
as a tool as a constant reminder of the side effects of medication. A
meaningful warning label would be an excellent memory jogger for all of
those involved in transportation.

The DOT\'s position is that we believe that the underlying medical
condition for which these listed medications are taken is of utmost
concern; that individual reactions to medications vary, creating a
case-by-case determination; that drug interactions are another highly
confounding concern that, again, leads to a case-by-case evaluation due
to beliefs that the solution is very complicated but it centers around a
system of continual education of all the key safety components, the DOT
medical examiners, and the DOT safety-sensitive employees. Thank you.

DR. ELLINGSTAD: Thank you.

Questions from Technical Panel/Parties and Discussion

DR. ELLINGSTAD: We\'ll turn to the Technical Panel. Lead-off questions
from Dr. Garber.

DR. GARBER: Thank you. Thank you all for \-- for being here and thank
you for your presentations.

I\'d like to start out with a couple of points of clarification from Mr.
Edgell, if I may. The training, the American College of Occupational and
Environment \-- Environmental Medicine training that \-- that you listed
under the FMCSA actions, is that DOT-sponsored? Does the DOT pay for
that?

MR. EDGELL: No, not to my knowledge.

DR. GARBER: Okay. And \--

MR. EDGELL: \-- that\'s one-day training. That is \-- would be paid for
by those participating.

DR. GARBER: Does the DOT in any way fund that training?

MR. EDGELL: Not to my knowledge.

DR. GARBER: Okay. Does the DOT publish a book that goes along with that
training?

MR. EDGELL: I\'m not sure.

DR. GARBER: Okay. So, in spite of the fact that this is an FMCSA-listed
activity, the FMCSA in fact does not have any role in providing that
training?

MR. EDGELL: I\'m actually not sure what the Federal Motor Carrier Safety
Administration\'s role is in the administration of that training, if
they participate in the training. They could very well. The Department
of Transportation, and I\'m speaking of other types of training or
perhaps this is an analogy to be made here, we train medical review
officers.

DR. GARBER: Right. No, I\'m sorry \--

MR. EDGELL: Now, \--

DR. GARBER: \-- I guess \-- I guess the question really was to that
specific issue of the \-- of the training provided by the FMCSA.

MR. EDGELL: They \-- they \-- they \-- they could participate in that
with staff members. I personally do not know. I can find that out for
you \--

DR. GARBER: Does \--

MR. EDGELL: \-- and give you that information.

DR. GARBER: \-- I know that Dr. Hartenbaum is a member of the American
College of Occupational Medicine and also the \-- the \-- the editor of
the text used, I believe, in that training. Can you comment on that, Dr.
Hartenbaum?

DR. HARTENBAUM: Actually, there are several pieces. First of all, the
textbook is not through ACOM. It\'s not through the American College of
Occupational Medicine. It was an independent book put out, really, as a
result of the negotiator rule-making committing merging the exam and the
licensing process.

We recognize that information was available but it was not easily
accessible. You had to all the agency and request the conference
reports. What we did at the time was we took the conference reports and
basically summarized them. We included information on the medications as
it was listed in the conference reports, which were recommendations. It
also included recommendations for an FHWA-, at the time, accepted and
trained psychiatrist to evaluate the use of any of the psychiatric
medications.

So, the book came out of the conference reports. They were
recommendations. They had no regulatory force and could not really be
held to a standard.

Of course, this came a couple years later. It is fully run by ACOM \--
ACOM members. We did have a member from the FHWA speak several years
ago, just talking about the regulatory issues.

What we\'ve tended to present, again, are recommendations, regulations,
and guidance material where any exists. Much of it is many years old.
Our examiners continually tell us that they really can\'t enforce many
of the recommendations on medications because it\'s a matter of opinion.
These are recommendations. They\'re not codified. There\'s no supporting
material available and there have been numerous lawsuits filed against
companies and examiners that say, \"I\'m sorry. I can\'t qualify you
while you\'re on Xanax or while you\'re on Adivan.\" And they go back
and they get the treating professional to fill out a questionnaire and
he says, \"He\'s safe to drive. He\'s fine to drive.\"

ACOM would welcome an opportunity to work with the agency to get this
sanctioned information. Right now it is independent and partially
opinion.

DR. GARBER: Okay. And just, again, so \-- so that I\'m \-- I\'m very
clear on this. And this is something that is independent of the DOT,
this \-- this guidance and these courses? Okay.

MR. EDGELL: But if I could add here, these courses in training the
medical examiners would no doubt rely heavily on the DOT-published
regulations, such as 391 which covers the medical examination criteria
and the support information, the question and answers, additional
guidance that is published to go along with 391.

And all of this is available on the DOT Web site. There\'s a very
elaborate Federal Motor Carrier Safety Administration home page with
this information spelled out categorically. And I would think that \--
that the Motor Carriers would work very closely with ACOM or any
organization to try to train to be in \-- in a cooperative partnership.
I just can\'t imagine anything else.

DR. GARBER: Which \-- which actually brings me to my next question. Dr.
Hartenbaum, do you believe that the guidance that is available that Mr.
Edgell just described on the Web site and through other DOT sources,
regulatory or official guidance sources, is adequate for the average
commercial vehicle operator, commercial truck driver in particular, out
on the \-- out on the roads? Are they able to make a determination with
the resources they have available as to whether a medication should or
should not be used by them?

DR. HARTENBAUM: What the first \-- is do medical examiners know the
information is even out there? We\'ve trained 350. There are thousands
of individuals who can do these exams, from physicians, both M.D.s and
D.O.s, nurse practitioners, P.A.s, and in some states chiropractors can
medically qualify a driver as being able to drive. That includes
evaluating the medication. So, first of all, we\'re not even coming
close to reaching the \-- the examiners.

Secondly, the information is incredibly vague. The recommendation on \--
is very clear and it says that Elavil should not be used. But that\'s
not codified. If an examiner or company says, \"I\'m sorry but you\'re
on Elavil. I can\'t qualify you,\" there have been and there will
continue to be lawsuits because these are not codified or officially \--
recently updated regulations. They come from conference reports that are
about 10 years old and that is where we\'re getting our resources from.

We are with the second edition of the book, with the new recourses,
we\'re trying to pull from medical literature but it\'s still
recommendation and that\'s only reaching a very small percentage of the
examiners.

DR. GARBER: And with regard then again to the drivers themselves, would
\-- would you suggest that \-- that a large percentage or a small
percentage of them is in reach of this information?

DR. HARTENBAUM: That\'d be a very small percentage. If there was a
brochure or pamphlet available similar to what the FAA has produced,
that could be distributed either through the companies or through the
examiners. That would probably be a good starting point.

DR. GARBER: Thank you. And Dr. Parmet, sort of a similar question. Is
the \-- is the guidance that is provided by the FAA currently effective
in reaching the entire pilot community? And again here, I recognize that
a lot of your experience has been in the commercial air carrier
operations where there \-- where there\'s often a physician such as
yourself supervising. But in air taxi operations or commuter operations
where there may not be as \-- as robust a medical program, do you feel
that those pilots are getting the official and \-- and necessary
information to make the appropriate decisions?

DR. PARMET: I think initially the information\'s available. And when
we\'re dealing with pilots we have a different group of people who are
more interested in what\'s going on because the tolerances are so much
tighter. Certainly, at the fundamental level of the medical examiner we
have a very different environment. We only have about 7000 aviation
medical examiners in the country. You cannot just pick up and do a
physical. You must go through a mandatory 40-hour training course from
the FAA. You not only \-- having done this, every exam you do is
reviewed by the FAA. Your \-- everything you do is tracked by the FAA.
You must have continuing education and document that in the FAA courses.

There is no way that any medical exam in contact with the medical
community through the FAA is done without FAA information, sponsored
oversight, and continuous training. The FAA provides us with a
newsletter that comes out on a periodic basis. So, medical examinations
have continuous input from the FAA with advice to the medical examiner
and we pass that on to our pilots.

And at the commercial level it works extremely well. At general aviation
it\'s much less so and a lot of it\'s relied on their private
organizations, particularly AOPA and EAA, which are very helpful and
they work closely with the FAA on that issue.

In between are air taxi, some charter operations, and what we \-- we
like to call Agro Americans out in my part of the world, crop dusters
and agricultural aircraft. And a lot of these folks, even if you gave
them the information, wouldn\'t pay any attention. So, it\'s \-- these
are sort of our \-- our equivalent to independent operators from the
truck drivers.

But the information is \-- is much more readily available. There are FAA
publications that are \-- that are reasonably good. I\'d like to see
more detail and better labeling on the issue, but we\'re in a much
better situation on the aviation community than \-- than the other
agencies are.

DR. GARBER: Thank you. I think those are all my questions for now.

DR. LAUGHREN: I want to try and contrast this with \-- with the \-- the
program late in the day yesterday when the military was talking about
their approach to \-- to controlling medications. So \-- just so I can
understand exactly how it happens in commercial transportation in this
country, for example, a commercial truck driver is having problems
sleeping, so goes to his physician and gets prescribed a medication.
Does that have to be cleared with \-- say if it\'s a \-- if it\'s a
large company, large trucking company. Does that have to be cleared with
the medical examiner at the company?

DR. HARTENBAUM: In the majority of companies, no. Some large companies
may require reporting. Most of them do not. Most of them leave it just
to the \-- talk to your doctor and discuss it.

DR. LAUGHREN: Okay. How about in \-- in commercial air? Would \-- if a
pilot is prescribed a hypnotic, would that have to be cleared with \--
with the medical examiner in the company?

DR. PARMET: Well, the answer is individual companies might have a policy
yes or not, but absolutely every pilot would be knowledgeable that if
they\'re on a prescription medication that must be reported to the FAA
before they\'re cleared to return to service. And most commercial air
operators would tell any \-- any pilot if you have newly prescribed
medication you are not cleared to fly and not cleared to return to duty
until you have \-- and blessed by the FAA or you\'re no longer requiring
that medication.

DR. LAUGHREN: Okay. So \-- so, \--

DR. PARMET: We fail safe, basically.

DR. LAUGHREN: Okay. So, it would have to be cleared by \-- by someone
presumably following FAA policies about that. Then, my question is, what
\-- what are those policies? Do you have \-- do you have lists of \-- of
hypnotics that are acceptable or not acceptable in the same sense that
the military might \-- might have those?

DR. PARMET: For most of the hypnotics the blanket answer\'s no. They\'re
\-- none of them are accepted.

DR. LAUGHREN: Even a very short half-life one would not be acceptable?

DR. PARMET: Yeah. In \-- in general, they\'re \-- and I could be
corrected because I can see that Federal air surgeon has a
representative, but in general, no, they\'re not permitted. If somebody
is not actively flying and needs to take something, they cannot fly for
at least 24 hours so that the effects of that are worn off before they
return to duty.

DR. LAUGHREN: Well, it sound \-- it sounds like that\'s an even more
severe policy than is applied in the military. I mean as I \-- if I
understood it yesterday, very short half-life hypnotics were considered
acceptable. I think the term was \"bottle to throttle time\" four hours
or something like that. So, it sounds like it\'s \-- it\'s even a more
strict policy than in the military.

DR. PARMET: Well, the military is mission-driven. And if they want
somebody to get their rest right now they tell them to get their rest
right now. And when I was in the military we would prescribe what we
called \"no-go pills.\" We would give you a medication to put you to
sleep now and then when we wanted you awake we would give you a
medication to make you alert, even to the point of prescribing
amphetamines. And we know short-term that this is safe. But we also had
much higher acceptable level of risk in military aviation. There\'s
people shooting at you.

In civil aviation, you don\'t have to go. We can get somebody else to do
your job, so we don\'t have to accept that risk. We can bring in a
back-up pilot to fly that flight. Why should \-- why should we accept
the risk that somebody may be compromised in their cognitive ability?

DR. LAUGHREN: I guess the only difficulty then is that if \-- if the \--
if the consequence of taking a hypnotic to a pilot is that he or she
won\'t fly and if they, you know, they feel they need that, then it
might encourage deception.

DR. PARMET: This is true, and this does happen. And I \-- you know,
I\'ve had informal conversations with the Pilots Union physicians and
they\'re aware of it. And the pilots are aware of it. We haven\'t quite
figured out how to get around it yet.

DR. LAUGHREN: I guess the only other point I wanted to come back to \--
this is for Dr. Hartenbaum. I had \-- had the sense from what you were
saying is that \-- that one severe limitation on \-- on what kind of
education you can provide is the information available on drugs and in
particular the fact that it\'s hard to distinguish among drugs based on
\-- on, for example, prescription labeling, that \-- that the
information is often somewhat vague. It encourages caution but doesn\'t
really make the kinds of distinctions that might be \-- might be useful
to an examiner in making recommendations about, you know, one drug
versus another for any particular class of drug.

DR. HARTENBAUM: Most of the examiners are seeing the driver for one time
over two year exposure. The person who is prescribing are the treating
professionals. And when you go back and say, \"Is this person having
side effects? Are they safe on this medication?\" invariably the
treating will say, \"He\'s fine. He\'s not having side effects.\" So,
until there\'s a list that says, \"These are not permitted\" \-- right
now the \-- FMCSA prohibits the use of insulin and medications for
seizures if you\'re driving a truck. And we still have neurologists and
endocrinologists who keep writing, \"Okay to go back to work. Safe to
drive,\" yet he\'s on insulin. But we don\'t have the same kind of force
behind saying, \"He is on Elavil. He really isn\'t safe to drive.\"
\"No, he\'s my patient. I know him. He\'s better now than he\'s ever
been.\" And the companies will try and deny that and we\'ll end up in
court.

MR. EDGELL: One of the things I would like to add on your first
statement, just to point out that it is a requirement of any driver \--
and \-- and drivers, that\'s the \-- the largest portion of the
transportation industry. 7 and a half million, we estimate, out of the 8
and a half million safety-sensitive employees regulated by the
Department of Transportation. Those drivers are required to any time
they go to a physician are \-- and have medication prescribed are
required to tell that physician, \"I\'m a driver,\" so that the
physician can provide the proper warnings with any medication.

And maybe it\'s \-- the defense \-- being somewhat defensive or \-- or
just naive in this area, but I would like to think that these individual
providers are more than advocates of the patient in doing these
physicals, that they are advocates of safety. That\'s their purpose in
this. And \-- and we are having faith in that system.

DR. GALSON: Your colleagues next to you are shaking their heads.

DR. HARTENBAUM: I\'d like to respond on that one. There\'s really two
different \--

MR. EDGELL: They are the physicians. I\'m not.

DR. HARTENBAUM: There\'s really two different examiners we\'re referring
to. One is the medical examiner that the company may send the individual
to, and that contact is only once every two years. The other is the
prescribing physician, who actually may end up being the examining
physician because some companies allow a driver to go to their own
personal physician, who generally doesn\'t even \--

We have found in occupational medicine that we frequently get
return-to-work notes. \"Can return to work.\" But he\'s having
passing-out episodes. \"Do you know he works at heights?\" \"Oh, I
didn\'t know that.\" \"I started him on insulin. He had a seizure last
month. He\'s fine to go back to work.\" \"Do you have any idea what he
does for a living?\" or even ask what the person\'s job is? And doctors
prescribe the sedating medications. I\'m not sure why they would
prescribe it without thinking that they\'re driving a car or just
working around with other equipment at home.

So, I think too often physicians just really don\'t think about the
potential side effects of their medications or what the person does for
a living.

DR. TEMPLE: Mr. Edgell, you just \-- before I get to my main question,
you said that drivers are required to tell their treating physician
their \-- what their job is. What does that actually mean? How are they
required \-- what if they violate \-- is it a law?

MR. EDGELL: It is \-- it is a \-- requirement of DOT regulation for
motor carriers and it is to be conveyed to the driver by the employer
that if you go to a physician that you tell that physician that you are
a driver when they\'re prescribing any medication in the interest of
safety. And that is to be conveyed by the employer to the driver, and we
write our rules addressing the employer as well as the driver.

Also, companies are authorized to have policies that if you\'re on
prescription medication it\'s the company\'s \-- is the \-- is
authorized to know that \-- stated that most companies do not have those
policies in place. I would think that the large companies do. They have
a greater appreciation for litigation liability. But we are a small
business industry.

DR. TEMPLE: Well, one of the things people ask us more and more at FDA
is whether we know how our various risk management programs are actually
working. We have all kinds of labeling and advice and if it was followed
everything would probably be perfect. But we know that people don\'t
follow it.

Really, for all of you, do we have any idea how much transmission of
knowledge and then \-- and then appropriate performance there is?
There\'s \-- it sounds like there\'s masses of literature that give all
good advice people would need if they became aware. Do we have any idea
what the penetrance of that is? Do most people know? And if they do
know, do they say, \"Oh, well, I just \-- I\'ve got a cold. I\'m going
to take that stuff\"? Any \-- I mean these are susceptible to surveys
and sampling. Is there any of that?

DR. HARTENBAUM: I guess just even looking at some of the accident
reports that\'s come through the NTSB where operators at all commercial
modes have been found to have things like Benadryl in their system.

As far as reporting to your personal physician, I\'m not sure that even
makes a real difference. We had an accident in New Orleans a couple
years ago where every treating physician knew he was a bus driver. It
was on every hospital admission, it was on every hospital form, every
physician encounter, and yet they kept releasing him back to work
despite medical problems and despite medications.

So, I think educating the healthcare provider has to be an important
part of this process. We can\'t just stop educating the employee because
they\'ll go back and talk to their doctor and the doctor will say, \"Oh,
I guess you\'re fine.\"

DR. TEMPLE: But it \-- it would be possible, for example, to conduct a
survey among practitioners, wherever the people who are doing this, to
learn about the level of consciousness of those things. I mean those are
all expensive and I understand why things don\'t get done, but there
isn\'t \-- nobody\'s tried to do that sort of thing, I take it?

DR. PARMET: Well, \--

DR. HARTENBAUM: I\'m sure the College \-- the American College of
Occupational Medicine would be thrilled to work with the FDA in \--

DR. TEMPLE: DOT \--

DR. HARTENBAUM: Whoever wants to work with us.

(Laughter)

DR. HARTENBAUM: We\'d love to get the grant.

DR. PARMET: Well, let me \-- let me say, the FAA has actually been doing
this because they have a much tighter control as well as investigating
all the fatal accidents, and they\'ve got a continuing surveillance both
by FAA and NTSB together. And they have the statistical data. I mean
when you look at that end point, rare as it is, you find that between 25
and 35 percent of fatal accidents have some sort of drug on board at
time of the accident. Some of these drugs are prescription drugs that
are prescribed and approved by FAA. It\'s just a survey that\'s been
done. But it\'s \-- some of them, about 15 percent, are over-the-counter
drugs. And a small percentage are controlled substances that it was
illegal to fly with under the DOT 5.

So, we \-- we know it\'s out there even in a organization and a group of
\-- of pilots who are aware of the risk. They\'re much more aware,
they\'re much better educated on the average than the other agencies.
They\'re much better controlled. The examiners are all trained, which
you cannot say in the other agencies, except the Coast Guard is working
on theirs.

But certainly, the DOT examiners of \-- of commercial drivers, I would
say the majority of them have had no training whatsoever. They\'re just
told to do the physical, and they don\'t have to be a physician, they
don\'t have any training, and there is no feedback as to whether
they\'ve done the job correctly or not. I can\'t tell you how many
drivers\' physicals I may have failed somebody on and the individual go
down the street and have someone else do it and pass them for egregious
conditions.

DR. ELLINGSTAD: Could I interrupt? To follow up on that point, we \--
we\'ve got representatives of all of the transportation modes here and
we\'re participating and we\'re sort of pretending that we have
equivalent kinds of systems going on. But we\'re certainly hearing of
substantial differences in terms of the kinds of infrastructure both to
monitor and regulate operators as well as to provide education and
training and information.

Perhaps it would be helpful, maybe starting with Mr. Edgell, if you
could just explain for us what the infrastructure is with \-- in each of
the \-- the modes with respect to the \-- the medical examiner, you
know, cadre and what \-- what role they have with respect to operators
either to monitor what they\'re \-- they\'re taking or to \-- to deliver
this kind of information?

MR. EDGELL: The \-- starting with the Federal Motor Carrier Safety
Administration drivers, the drivers are the safety-sensitive position.
And they are required, if they\'re driving interstate, to have a
physical to determine their medical qualifications for driving.

DR. ELLINGSTAD: Who delivers the physical, and does FMCSA license or \--
or otherwise \--

MR. EDGELL: They \--

DR. ELLINGSTAD: \-- certify these examiners?

MR. EDGELL: They \-- the Motor Carriers allows the states to determine
the \-- who \-- who a medical examiner may be: physicians, some places
physician\'s assistants, nurse practitioners, and at this point or not
even chiropractors if they\'re allowed to do physicals in that \-- in
that state.

The intrastate drivers, most of the states have incorporated the
requirements of the regulation that I mentioned, 391, for their state
commercial motor vehicle operators. Aviation has specific physical
requirements that have been discussed on the regular basis, periodic
basis, one to two years, some three years.

The transit industry does not have specific requirements for physicals.
However, most of the transit operators are strongly influenced by Motor
Carriers and by the rail industry and have incorporated those same
physical requirements in their transit operations \-- all of the major
transit systems have physical requirements \-- medical qualifications
for their operators.

And the maritime industry has medical qualifications for anyone with
documents, issued licenses and merchant mariner documents.

DR. ELLINGSTAD: One follow-up. I assume from what I\'ve heard that
someone could probably produce a list of all of the FAA-certified
medical examiners by this afternoon if we asked. Could the same thing be
done for any of the other modes?

DR. HARTENBAUM: No.

MR. EDGELL: No, I don\'t believe so.

DR. HARTENBAUM: No. There\'s no way you can do it for highway, and you
can\'t do it in rail, either. It can also take a little bit for transit.
I know transit right now \-- a large number of transit operators are
covered either under FRA or FMCSA requirements. And the companies that
have those requirements are meeting them.

For their operators who do not fall under one of those two agencies,
there are often \-- maybe some similar exam but not always, not
requirement. For highway, the examiner can be anyone who is licensed by
a state to do an exam. There is no formal training requirement. The
examiner is expected by regulation to be aware and knowledgeable of
regulations and training and \-- regulations and additional material.

There was an informal study done about six years ago asking occupational
physicians if they were even aware of the conference reports or the
advisory criteria that was available and a significant portion of them
said they had no clue it even existed.

There was also a study done in the midwest with eight states where they
were looking at every single examination done, and over half of them had
errors made and these were examiners that knew they were being reviewed.

For rail, the company can \-- can have the exam done by any examiner
they choose. And it\'s only \-- locomotive engineers are required to be
examined and it\'s only vision, hearing, and color vision.

DR. ELLINGSTAD: Thank you. I\'m sorry, Dr. Temple.

DR. TEMPLE: No, that was very instructive, actually. I think I\'m \--
I\'m done.

DR. SWEENEY: I have a question for probably Mr. Edgell. What has DOT
done for non-commercial drivers in terms of informing them about the
dangers of medications?

MR. EDGELL: Non-commercial drivers?

DR. SWEENEY: Yes.

MR. EDGELL: Taxi cabs? Private autos?

DR. SWEENEY: Passenger cars, yeah.

MR. EDGELL: Passenger cars? I really can\'t address that question. I
mean we have not \-- we participated with this \-- with the City of New
York when they had some questions regarding drug testing their \-- their
taxi drivers, but on \-- on request we will provide information. But
specifically providing information to private drivers, I\'m not aware of
anything specific that we \-- anything targeted that we have in \-- in
the Department.

DR. SWEENEY: And yesterday \-- for any of the panel members here,
yesterday we heard in the late afternoon about the expanding role of
pharmacists in counseling patients who come in for prescription
medications. Have any of the modes worked in the \-- with the pharmacy
industry?

DR. HARTENBAUM: I know that at least one pharmaceutical company has been
working with the American College of Occupational Medicine trying to
make sure that the op docs know about the sedating versus non-sedating
antihistamines. But not directly working with the pharmacists.

DR. GARBER: I\'ve just got one point of clarification. There \-- there
is \-- is there in fact any list, either permissible medications or
non-permitted medications, that an operator could access if they wanted
it that is approved by the DOT? In fact, does \-- does the DOT publish
any list of either approved or non-approved medications that an operator
could use either in conjunction with their physician or \-- or on their
own to determine whether a medication should or should not be used?

MR. EDGELL: We do not have an approved list.

DR. GARBER: And again, just as a point of clarification, I know Dr.
Parmet indicated that certain hypnotics would not be permitted for 24
hours, but my impression is that that was more of a guidance either
provided to the medical examiners or something that the company provided
rather than FAA guidance, is that correct?

DR. PARMET: For \-- for general purposes that\'s correct. The FAA does
have an internal list that they use with their air traffic controllers,
but in theory \-- not supposed to be using.

DR. GARBER: Okay. And then, just \-- I really \-- I know that I\'ve \--
I\'ve probably been a bit harsh in my questioning, Mr. Edgell, but I did
want to point out and \-- and perhaps give you the opportunity to point
out how \-- how much leeway does the DOT actually have in enforcing any
rules that it would \-- might require with regard to medications? I mean
how would the DOT in fact be able to enforce any rules were they to put
them in place that were specific to specific medications?

MR. EDGELL: Well, enforcement is certainly a big concern with the
Department of Transportation because we have so many companies, so many
employees. In the motor carrier industry alone you\'re talking hundreds
of thousands of employers, millions of employees. It \-- it would be
quite \-- quite difficult because the enforcement is only \-- it\'s most
effective when done at the company\'s \-- at the employer\'s principle
place of business. And the resources are \-- are a problem.

DR. GARBER: Thank you. I think that\'s all we\'ve got for now from the
Technical Panel.

DR. ELLINGSTAD: Thank you.

This morning I think we\'ll start with the Transportation Industry
group.

DR. FAULKNER: Tom Faulkner, ATA. I have a question from colleagues here
for Dr. Hartenbaum. Is it your position that all medical providers
performing DOT medical examinations be trained, certified, and/or
registered on an approved DOT list similar to what the FAA has?

DR. HARTENBAUM: That\'s a difficult question. My personal opinion is,
yes, there should be some mandatory information dissemination, mandatory
requirement that they demonstrate that they understand the questions.

There was a committee formed several years back and we\'ve been waiting
the past three years I guess now for a rule-making where the question of
should there be certified examiners. One group proposed certified
examiners similar to the FAA system. One group \-- one party of this
committee said, \"We\'ll sign a form that we\'ll do the exams right,\"
which clearly they\'re already signing the form, they\'re still not
doing it right. And the third group recommended giving the information
out and answering a series of questions and answers to demonstrate
understanding.

Part of the problem with certifying is that there are not absolutes.
Intentionally, a lot of these are left to the discretion of the
examiner. There is not a pass-defer type system as there is in the FAA.
An AME can examine an individual and say, \"You don\'t meet these
criteria. I defer you,\" and that goes to the regional flight surgeon
and it goes up the ladder for review.

In highway, the medical examiner, whoever that might be, whether they
have the information or not, has the final answer. There is no appeal.
There is no further up-the-ladder to go. So, my concern with certifying
is how do you test an absolute yes-no answer when there is no absolute
yes-no answer? You have to look at each individual basis.

Do I feel there should be mandatory training? I do there \-- do feel
there should be some mandatory training of some sort. Does it need to be
for the FAA? No. We would love to work cooperatively with, you know, the
agency on these courses.

DR. FAULKNER: Another question. We will be hearing from the
International group, but for instance, in France they have by mandate so
many doctors per so many employees, a pretty tight ratio. And as we
heard yesterday with the military, one flight surgeon will be serving,
you know, maybe 100 pilots along with the other personnel. In the States
here 7500 AMEs, or aviation medical examiners, to half a million pilots.

What\'s the panel\'s thought about something similar to what they have
in other countries where you have a mandatory number of physicians,
maybe increase the number of AMEs to be more \-- better resource or
accessible to employees in the transportation industry?

DR. HARTENBAUM: \-- doing commercial driver exams?

DR. FAULKNER: No, I \-- well, that\'s another thing is to have a, maybe,
combined specialist that, you know, we\'ve heard here a maritime ground
transportation \-- commercial driver\'s license, aviation. Individuals
that know the very limits and the training in that and have that safety
responsibility rather than \-- I mean they\'re still patient advocates,
obviously, but again, the \-- the public good, shall we say, in mind as
well.

DR. HARTENBAUM: That\'s probably not a bad step but I think you could do
it a simpler way by making certain that examiners \-- there are
sufficient examiners and they\'re sufficiently provided the information.

DR. PARMET: If I can address that \-- I was part of one of the pilot
programs about seven years ago. And we trained all the individuals in
the State of Missouri who were going to do DOT driver examinations. We
got organized, we trained everybody in a series of seminars. It wasn\'t
nearly as extensive as \-- as the FAA, but we weren\'t dealing with the
same demanding environment of altitude and acceleration. And we were
also dealing with people who were fairly experienced already. We
certified the people in short order.

I think we greatly improved the awareness and the quality of the
examinations done. For the first time people began to get feedback on
the examinations they were doing. Somebody was looking at their product
and giving them a grade. Because right now there is nothing done. For
the majority of these examinations under DOT commercial drivers there is
absolutely no feedback. You don\'t know if you\'re doing a good job or a
bad job. You may be the best, you may be the worst, and you have no
idea. And I think it\'s very feasible to do that and we\'ve proved it.

So, I \-- I actually support something parallel to the FAA system. I
think that would be an excellent idea. It would promote safety. It\'s
going to cost, but it would promote safety.

MR. EDGELL: We certainly \-- if I could comment on that, the advocates
of safety are also advocates of training. If we get to establish a \-- a
way to get this information to the physicians in a better way I think
the Department would certainly promote that idea. We do have guidelines
that have been put out that I mentioned. The Motor Carrier industry has
developed a physical examination form that we certainly want to have in
the hands of all of those examiners doing these physicals and a better
way to get that information out.

We certainly \-- I think what I hear is that we need to do more and the
needs are very broad \-- tremendous amount of individuals \-- it\'s a
huge problem. Huge, huge issue.

DR. FAULKNER: Last question, actually, is \-- it\'s from the \-- since I
gotcha, Mr. Edgell, comment. Any plans on the horizon to change the DOT
5 drugs tested for?

MR. EDGELL: They\'re at the \-- at OMDCP, the Office of Management and
Drug Control Policy and Health and Human Services Drug Testing Advisory
Board, there has been a lot of attention lately made to the ecstasy
drug. And that is \-- has been proposed in some guidance \-- some
efforts by the Drug Testing Advisory Board on their \-- on their
guidance for alternative specimens to add that drug. But the protocols
are not developed. It would be an amphetamine class and that is the only
thing \-- and I\'m not saying we\'re going to do this. I\'m just saying
that that \-- that is the one that\'s making its way towards the stove
and could be a possible addition to the amphetamine class of drugs.
That\'s the only one that I\'m aware of.

That is \-- if we did that, it would \-- sometime in the near future,
two, three years probably.

DR. FAULKNER: Final question. This is more, really, for the panel. What
about \-- there\'s been approaches from some people or employees in
particular saying when it comes to labeling perhaps putting
\"DOT-prohibited drug.\" Your thoughts on that?

MR. EDGELL: The idea of a list, a tremendous amount of medications,
these medications, the condition is more important than the medication
you\'re taking. The physicians yesterday were talking about it. Can I
produce a list that is \-- is totally safe? And one physician says, yes,
probably \-- only problem in one in a thousand. One in a thousand with 8
and a half million people still gets you a pretty large number that
could be potentially problematic.

Everyone said that, well, you have to have a caveat here that taking it
at the proper dosage because if you\'re using it incorrectly \-- and
then the \-- the cross reaction with other medications you might be
taking. So, once again, you ask tough questions.

DR. PARMET: I \-- I\'d like to think that would be a great idea, but the
\-- there are some \-- some medications that even at minimal dose would
not be safe. The problem is that you say \"no go\" and the assumption is
that that \-- if that\'s not on the label everything else is okay.

DR. HARTENBAUM: I think having a list of at least some absolute \"no's\"
would provide some start, a way of getting around this for both
examiners and for providers. I used the example of Elavil earlier. It
was recommended Elavil should not be permitted but it\'s recommended. We
know Elavil is significantly \-- its effects last for a \-- really, for
a long time. If we had something that said that these are absolutely
nots and these are to be reviewed, it would give the companies and the
examiners something to stand on.

DR. PARMET: You could in fact have a prohibited label, a mandatory \"you
gotta check before you can do this,\" and then this is generally okay.
Although I \-- I can tell you in my workers\' compensation practice I
have a lot of people who tell me they can\'t possibly work if I put them
on ibuprofen. It puts them right to sleep. Now, if they\'re taking it
for a headache it\'s okay but not with a work-related injury.
Everybody\'s individual.

(Pause)

MR. SPENCER: I\'m Todd Spencer with the Owner-Operator and Drivers
Association. And I\'m not going to contend or \-- that I\'m going to
speak for anybody else at the table, but yesterday I had \-- I had real
difficulty with the sedating effects of this particular meeting.

Now, this morning \--

(Laughter)

MR. SPENCER: \-- I\'ve had no such condition. I felt the arrows several
times and I think now and then somebody really needs to speak up and
say, well, wait a minute, let\'s get with the real world.

Clearly, I think the best we can hope for from this meeting is some
guidance about what is acceptable and what\'s not. Largely everything
else is a gray area. It\'s important, I think, for us to realize the
people that we\'re working with.

Now, in \-- for example, I don\'t know very many people of any
occupation and doing anything that aren\'t aware that things like
Benadryl and other over-the-counter cold remedies or \-- or drugs for
allergies can make you \-- can make you drowsy. It doesn\'t make any
difference what they are. Most people know those things already whether
they\'re truck drivers or pilots, and I cannot imagine any scenario
where pilots or truck drivers or other operators of equipment aren\'t
especially aware and keen on those particular issues. And those are \--
any kind of over-the-counter stuff you\'re only going to take as a last
resort if \-- if \-- because the symptoms of the problem are going to
create more of a safety problem than the condition that might result
from taking an over-the-counter medication.

Now, in regard to \-- so you\'re not going to do that unless you \--
unless you really have no other options, and then you\'re aware of those
things.

In my experience in commercial trucking, oftentimes \-- oftentimes
doctors are going to be conscientious. If it\'s your personal physician,
then he\'s going to know something about you. And yes, he\'s going to be
your advocate but he\'s also going to be \-- he\'s also doesn\'t want
you to die. Now, that\'s going to be a personal physician. So, he\'s
going to tell you straight in terms of \-- in terms of what effects any
kind of a prescription medication might have on you. He\'s going to
provide you the information.

Now \-- but not all doctors are going to be equal when it comes to this.
We hear \-- there are instances where there are company physicians with
motor carriers. Now, the way the motor carrier industry works is that
\-- is that they need \-- they need drivers. The \-- the biggest segment
of trucking is the truckload carrier industry and this is the segment
that goes through drivers like oats to a horse.

A hundred percent turnover is the industry norm. Now, do I think a
company\'s medical doctor is going to necessarily be more conscientious
about things like that? Not a chance if they\'ve got a truck that needs
a driver. Not a chance. They\'ll send him down the road.

Now, in the practical world, in the \-- in the practical world, we have
anywhere from 5 to 7 and a half to 10 million commercial drivers. I
don\'t care whether the driver works for a small company or the biggest
company in the world. None of those drivers are going to report to the
company that they\'re taking medications. They\'re not going to do it
and there\'s absolutely no power on this earth that would make them, no
law we could pass. It\'s simply not going to happen.

We need to provide better education to truck drivers and perhaps to
pilots and some others. Right now there\'s no formal education of any
kind, not in driving or anything like that required, for truck drivers.
None whatsoever. And unless \-- unless it\'s mandated there \-- there
won\'t ever be any real meaningful training that truck drivers get.
There won\'t be any.

There are opportunities, as I said previously. Many \-- most people are
aware of side effects that are common with some substances but not all.
In the trucking industry what we\'ve seen over the past decade is a
tremendous growth in immigrant drivers operating trucks. Many don\'t
speak English. I\'m thinking they don\'t speak English and I\'m thinking
they would be at a real disadvantage in any of these types of things
because I\'m not aware of any over-the-counter substances that basically
come with different languages on the label. Maybe there are some, but I
suspect we have problems there that could be addressed. I\'m not exactly
sure how we do them.

Now, is \-- and I know there are \-- I would agree that there should be
substances that should be simply \"yes\" \-- \"yes\" or clearly \"no.\"
But in other instances I think drivers can safely drive with
over-the-counter medications and \-- and many \-- many, many, many have
done it for years.

Now, probably to underscore my comment about how trucking works, a few
months ago there was a driver that took a truck into the capital in
California. Now, in retrospect, I kind of wish that driver had have had
some Elavil in his blood because maybe he wouldn\'t have made that
decision. But \-- but that\'s basically the way trucking works. Thank
you.

DR. ELLINGSTAD: Was there a question embedded in there, Todd?

(Laughter)

DR. HARTENBAUM: If there was I\'d like to make a comment on that.

DR. ELLINGSTAD: I \-- I am glad that \-- that we aroused you a little
bit. I \-- I despaired of surviving an entire public meeting without a
word from Todd Spencer.

(Laughter)

MR. SPENCER: Actually, I need to add one more just to set the record
straight.

(Laughter)

MR. SPENCER: I mean it\'s important that you have an accurate picture of
the real world if you\'re going to be talking about policies that are
going to have any meaningful impact. Dr. Parmet suggested a while ago
that independents could somehow be some special problems. Now, I
understand the term \"independent\" covers lots and lots of different
areas. The particular organization that I\'m here representing are \--
is made up of individuals that own \-- that own and drive their own
trucks. They do this for a living and most do it for careers. In terms
of frequency of accidents and severity of accidents, they are the best
and safest drivers on the road today. So, I\'m hoping that wasn\'t the
\"independents\" that you might have been suggesting.

DR. ELLINGSTAD: Well, we don\'t want to cast dispersions on the crop
dusters that he was talking about either, so we\'ll move on to the
unions.

DR. PARMET: That\'s the highest risk activity you can do, so they
naturally have more accidents.

DR. ELLINGSTAD: The union table?

CAPTAIN POPIEL: Pretty hard to follow that speech.

(Laughter)

CAPTAIN POPIEL: Randy Popiel, APA.

(Pause)

CAPTAIN POPIEL: \-- the FAA actually has a \-- a very strict tolerance
on \-- on hypnotics and depressants. And I guess it\'s curious to me as
to why the DOT wouldn\'t follow through with \-- with something like
that, something as to their strict policy with \-- with any operator of
any \-- of any motor vehicle. I think in commercial aviation the \-- the
grounding time is \-- is more than the magnitude of the depressant \--
certain depressants that have been prescribed to an aviator are in the
\-- in the area of \-- of three to six months away from the \-- of the
cockpit of an aircraft.

Any idea why \-- why the severity or the \-- the concern doesn\'t follow
through into DOT\'s enforcement of \-- of other activities, other
drivers?

DR. PARMET: Well, I think in terms of use of antidepressant medications
the question is less the medication than the underlying disease, both of
which have to be addressed for safety. So, with regard to a minimum of
six months \-- and in fact right now the FAA will not approve somebody
returning to flight duty who\'s taking an antidepressant medication. If
they stop the medication and \-- as most of these mental health problems
do resolve, we can return to some \-- I will have to say for our other
safety-sensitive people a lot of them do work on antidepressant
medications. About 25 percent of my flight attendants are taking some
sort of psychoactive drug and we are aware of the process of reviewing
if there is a safety impact.

But again, we\'re looking more in those cases to the underlying disease
process, not the use of medication. The \-- the comments earlier were a
short-term grounding if somebody was using a medication on a one-time or
two-time basis for sleep or some acute problem. It\'s \-- it\'s not \--
not really a disease going on, it\'s simply a situation that is \-- is
going to pass in a day or two.

CAPTAIN POPIEL: In the \-- in general aviation and also commercial
aviation there are mandatory disclosures either on a \-- depending on
which area you\'re operating in, mandatory physicals at \-- at six
months or a year, depending on \-- on what your \-- your position is in
the aircraft and up to two years in general aviation between \-- between
physicals. And on each one of those the FAA requires a mandatory
disclosure of doctors visits and medications being prescribed. Is there
any \-- is there any follow-up policy with \-- with the other industries
that require mandatory \-- mandatory disclosures?

DR. HARTENBAUM: For rail, no. For highway, the exams are at least every
two years and the new form does include a space for any physician
you\'ve seen, any medications you\'re taking. So, that\'s there.

The \-- the driver is required to sign that the information they\'ve
provided is accurate and true. So, that\'s, I guess, the closest you can
come to a mandatory. But it\'s two years.

If a person starts on the medication during that two-year period there
is no flag to pick that up. And you know, the ideal waiting period,
talking about a period of time until you adjust to the medication and
develop a tolerance to the side effects, there\'s nothing to really
educate the drivers that they shouldn\'t drive until they develop a
tolerance or have gotten used to side effects.

MR. EDGELL: The form used in maritime also has similar questions \--
past \--

CAPTAIN POPIEL: In both \-- in both commercial and transportation
operators are international drivers and operators held to the same
standards as far as disclosures? Is that a question you can answer?

DR. HARTENBAUM: I can answer for highway. There\'s been agreements both
with Canada and with Mexico through NAFTA that we will accept their
statement that their drivers are medically qualified. Canada has a
rather interesting system with a very detailed book put out, essentially
approved by the government, on medical conditions and what\'s qualified
and what\'s not qualified. Very detailed.

Mexico, we\'re really not quite sure what they have. But the U.S. has
signed an agreement that we\'ll accept their medical qualification.

CAPTAIN POPIEL: Same hold true with aviation?

DR. PARMET: With aviation we have a requirement that anyone that flies a
commercial aircraft into U.S. air space must meet U.S. FAA requirements.
And we participate with ICAO, the International Civil Aviation
Organization, whose regulations are similar \-- tougher than FAA. FAA\'s
actually one of the more liberal organizations in having carefully
evaluated pilots for use of chronic problems and chronic medications and
permitting them to return to flying. But they have the largest database
in the world as well, so I think their \-- their decision on that is
sound. The aviation community internationally is close to \--

MR. EDGELL: Just to add one thing that of the \-- with the exception of
just a handful of Mexican employers \-- carriers, while they do enter
the United States they are limited to the travel within the commercial
zones \-- U.S.-Mexico border. We\'re still in the process of \-- of
working that issue for \--

DR. ELLINGSTAD: Thank you. Now we\'ll go to the pharmaceutical industry.

MS. RUSSELL: I\'m Corinne with the Consumer Healthcare Products
Association. I have two questions aimed at any or all of the panelists.
Are you aware that the over-the-counter drug manufacturers have an
extensive and ongoing consumer education program aimed at all consumers?
And as consumers we know there are many drivers who are drivers, and
this campaign is aimed to provide important guides for safe medicine
use. And continuing with that same question, I \-- I wanted to know if
you\'re aware of an organization called the Council on Family Health,
which is a consumer education foundation funded by industry that has
averaged over 194 million impressions with print, broadcast, and
Internet materials designed to educate people about consumer proper
medicine use. And CHPA, our association, has distributed over 6 and a
half million copies of various publications, again, about safe medicine
use over the last three decades or so. That\'s one question.

And the other is, what suggestions do any of you have for the OTC
industry about groups we can work with to further get out messages that
would specifically help the transportation industry? Because we do
partner often with Food and Drug Administration, with a host of consumer
groups, minority groups, senior citizen groups, et cetera. So, we\'d
like your suggestions.

DR. HARTENBAUM: I think the first issue is that we\'re dealing with a
different population. I had not heard of the second organization you
mentioned. I\'m aware of OTC, information that\'s out there. It
recommends don\'t operate machinery, don\'t drive until you know how
this affects you. The problem is, is the individual has that choice. I
can say, \"Okay. I have a cold. I\'m not going to go drive today or I\'m
going to drive from here to the supermarket.\"

With commercial drivers, we\'re dealing with those who need to show up
at work or they\'re going to get disciplined or they\'re going to lose
their pay or are driving 10 hours, according to our service regulations.
So, the amount of driving they\'ll do is different.

The information provided includes, \"Be careful.\" And the drivers are
being careful. The problem is there\'s difficulty in recognizing the
level of impairment and in essentially multi-tasking. You can
concentrate on one activity. But if you have a car coming at you from
the right, another one coming from the left, and they\'re walking across
in front of you, you may not have that reaction time to respond
appropriately. And the exposure time and the potential hazards are very
different from the private drivers that\'s into commercial driving.

As far as organizations, I can give you, \"Gee, I can suggest.\"
Probably afterwards would be \--

MR. EDGELL: The \-- specifically as \-- since we are mainly talking
about the Federal Motor Carrier Safety Administration, a good point of
contact within Motor Carriers would be the Physical Requirements branch.

Also, it sounds like that just physicians in general would be an
excellent place to start to provide this information since they \-- they
are what we are relying on \-- who we are relying on for safety of \--
of the drivers.

MS. RUSSELL: Thank you very much.

DR. ELLINGSTAD: Thank you. Next we\'ll move to the Professional Sleep
group.

MR. GELULA: Thank you. I have a question first for Dr. Hartenbaum and
then Dr. Parmet, and it\'s the same question. At this hearing yesterday
the Delaware deputy attorney general cited an egregious example of a
failure to adhere to established trucking hours of service rules
resulting in that case in a catastrophic collision. And I\'m wondering
if you would explain the hours of service work rules for commercial
drivers and, Dr. Parmet, for pilots and then address how such work rules
would create drowsiness and sleepiness for many, if not most workers and
interact with sedating medications?

DR. HARTENBAUM: Okay. They\'re very detailed. It\'s basically \-- I\'d
might defer from \-- details, but they can operate 10 hours without a
rest period. And I believe they have to have eight hours \-- it\'s 60
hours a certain number of days, 70 hours other days. There was a new
hours of service rule proposed \-- it\'s been put on kind of indefinite
hold \-- which was more based on giving them adequate rest areas and
looking at some of the studies to see people don\'t rest during their
time off.

MR. GELULA: But those work rules have not been implemented. The existing
work rules, as you said, 10 hours on, eight hours off, and then 10 hours
on and eight hours off. So, there \-- isn\'t there a circadian effect
there?

DR. HARTENBAUM: Absolutely. There\'s a maximum number of hours you can
put in over a seven-day period. But getting yourself regular sleep when
it\'s required is definitely a problem.

MR. GELULA: How would that react \-- relate to sedating medication?

DR. HARTENBAUM: Certainly not helping.

MR. GELULA: And \-- and for pilots, could you also explain, Dr. Parmet,
the distinction between flying time and duty time?

DR. PARMET: We clock them in when they \-- they actually push back, so
that\'s when their flight time begins. They do have an 80-hour work
month. But they may put in 160 hours to get their 80 hours because
they\'re going to show up, report for duty, and brief their flight,
pre-flight the aircraft. If there\'s a delay there\'s going to be more
\-- more time before they actually push back and start the clock. They
will have a limited duty day and we forecast a particular flight \-- run
a flight crew out we have to put a second crew on board the aircraft so
that one crew takes off and the other crew lands. They have mandatory
rest periods.

We work very hard in the commercial industry to make sure where people
are staying is adequate, quiet so they do get good rest. We \-- hotels
to make sure that we get our \-- our people appropriate rest.

In the air taxi operations, however, the rules are considerably looser
and you\'ll find that somebody\'s \-- may put in two or three hours in
the morning and then be back in the afternoon and put in three or four
more hours the same day. Certainly, there\'s \-- teeing is an issue
here.

Circadian synchrony, or jet lag some people call it, is \-- is a major
problem because when we\'re trying to have someone operate when their
body clock says sleep, your performance goes down. And as I mentioned
earlier, that can be the same as having several drinks of alcohol. When
you add any sedation whatsoever to that from a medication, even one that
someone is well adapted to, as we mentioned, \-- which people typically
don\'t have sedation after a week or two on that medication. Put them
into a situation where they\'re fatigued because of duty time, working,
and they\'re out of their daily body synchrony, now you have a
synergistic effect and it all adds up to create an unsafe situation.

We try by scheduling to avoid that in commercial airlines. We work
pretty hard \-- we\'re not there yet \-- working \-- our pilots\' unions
are trying to make sure we work on it.

MR. DROBNICH: One quick question. You did a pretty good job of covering
all the different modes but what I didn\'t hear a lot about was light
rail and bus operators, which concerns me very greatly. Can you describe
any educational efforts aimed at transit operators or are they covered
by any rules or regulations from Department of Transportation?

DR. HARTENBAUM: Light rail are generally covered under the FRA, so
they\'d be under those regulations.

The buses are often CDL holders and will fall under the FMCSA standards.
The ones that are not covered of the FTA are the subway operators. And
it really \-- I noted the FTA has put out both a \-- has a newsletter
that goes out to the examiners and several companies have gotten
together and they do have questionnaires that are sent to the employees
asking them to fill out by the treating physician, \"Are you safe or are
you not safe?\" So, we\'re kind of back to the same question as before.

MR. DROBNICH: Does the FTA have any rules or regulations covering Metro
rail drivers or bus operators?

DR. HARTENBAUM: Rail and \-- under highway. The \-- there was a letter
issued \-- you know, I have the least knowledge about FTA or FAA. There
was a letter issued by the secretary about two years ago reminding
transit companies that they need to educate their operators. I do
believe that most of them have now standardized the form and do educate
their operators.

MR. DROBNICH: Is the panel aware of any educational efforts towards
transit operators on this issue?

MR. EDGELL: Transit has over the past two years run a number of training
operations on fatigue classes, substance abuse classes, drug and alcohol
seminars. And they\'ve continued to plan for those in the future as
well. And Doctor\'s correct that transit is very much influenced by the
rail industry or the motor carrier industry because of the obvious
association \-- your large transit operators, say, in total are very
aware of the medication issues, as I mentioned before, and have those in
\-- in driving training orientations.

DR. ELLINGSTAD: Thank you. We\'ll go to the Government group. Mr.
Clarke?

MR. CLARKE: If I can \-- let me just clarify on that last point before I
get into my questions. The FTA does not have statutory authority to
issue safety regulations for the transit authority. What they do have
statutory authority for is to require that transit authorities as a
condition of \-- of being funded by FTA for capital programs have safety
programs in place. But our authority to approve or disapprove those
plans is tenuous, and so I think the answer to the question, \"Do we
have direct control over \-- over transit operations,\" we at the
Federal level, the answer is \"no.\" But we certainly work very closely
with transit operators to help them do the right thing. And I think the
point that\'s being made here is that they are conscientious and
responsible.

MR. DROBNICH: Just to follow up on that, has the FTA given guidance in
this area to the transit authority?

MR. CLARKE: Well, I think Mr. Edgell pointed out that there\'s been a
series of classes and training exercises done in which this is part \--
this issue is part of that subject.

Let me go on to some of my questions. Dr. Hartenbaum, there was some
back and forth earlier on about FMCSA\'s role in \-- in your \-- and
ACOM\'s activities in training. Can you explain further whether or not
\-- it\'s my understanding that they have had some more than small
amount of involvement and cooperation with you folks on that work, is
that \-- is that not true? In terms of guidance or support or
coordination?

DR. HARTENBAUM: No.

MR. CLARKE: No? You\'ve had no contact with them at all?

DR. HARTENBAUM: No. We\'ve had contact. We\'ve actually had much more
earlier on where we did have someone from FMCSA speak one of the
lectures \-- two of the lectures much earlier. We actually asked \-- we
discussed the possibility of working more closely and were kind of told
that the agency couldn\'t sanction one training program over another. We
also have a newsletter that\'s put out through ACOM which we have \-- I
sent an open invitation to the FMCSA and also the NTSB to submit
articles. And you know, they\'ve had the time to answer specific
questions when they\'ve been posed.

But no, the \-- is not overseeing it, it is not reviewed, it is not
sanctioned by the FMCSA. The information we present is primarily from
their regulations and their conference reports although the conference
reports are many years old.

MR. CLARKE: Are you familiar with FMCSA\'s waiver program for disability
folks?

DR. HARTENBAUM: Well, there\'s the skill forms evaluation certificate,
which used to be \-- orthopedic waiver program. And yes, I also am aware
of what used to be the waiver program for vision and diabetes. It was
then changed after being challenged to an exemption program. I know
there was a \"Federal Register\" announcement about two or three, maybe
six months ago concerning the option of exempting insulin-requiring
diabetics. I believe at this time there\'s only exemption or waiver
programs that are under consideration.

MR. CLARKE: And there\'s a testing program associated with that, too, is
that \--

DR. HARTENBAUM: The only testing program is for the skill performance
evaluation certificate, former orthopedic, requires a road test.

MR. CLARKE: Is it your \-- is it your sense that that\'s an involved
process?

DR. HARTENBAUM: Yeah, that is an involved process. The processing of the
vision waiver, which is the only waiver currently being \-- vision
exemption. The wording was changed in 1998 \-- required an
ophthalmologist to say the person is safe and that their vision hasn\'t
changed.

MR. CLARKE: Does this go before some kind of board or \--

DR. HARTENBAUM: It\'s published in the \"Federal Register.\" There is a
required public comment period for this exemption.

MR. CLARKE: Would you see the same kind of thing evolving if this was to
expand to kind of \-- in fact, he was talking about here. In other
words, folks looking for waivers and \--

DR. HARTENBAUM: I think the program could exist and would be very well
\-- well based if there was a decent review mechanism in place.
Unfortunately, the individual who\'s saying that he is safe is the
person\'s treating physician.

MR. CLARKE: Right.

DR. HARTENBAUM: The waiver program in the FAA has individuals who are
trained and understand flight. They understand the medical conditions
that occur in flight. Right now what the FMCSA does for their waiver
programs is they put it back to the treating provider. You know, I\'ve
\--

MR. CLARKE: But still, I\'m talking procedural. What \-- what is \--
what is the process involved in attempting to get one of these things in
terms of due process and \-- and amount of time spent to do all this?

DR. HARTENBAUM: There\'s two different pieces. First is the orthopedic
piece where the motor carrier or the individual can submit to a state or
regional director of the FMCSA that they\'re, first of all, otherwise
medically qualified, what their orthopedic limitation is, how long
they\'ve had, what kind of vehicle they\'re operating, how long, and all
the details that go along with that. They then undergo a road test.

MR. CLARKE: So it\'s an involved process?

DR. HARTENBAUM: That\'s an involved process. The other waiver program or
exception program is vision and there they submit an application to the
Federal agency, who gathers information including their safety record,
and gets information from an ophthalmologist about their vision, about
whether it\'s stable or not.

MR. CLARKE: Any sense as to how many folks total might be involved in
both these, then?

DR. HARTENBAUM: Yeah. There\'s probably about 400 in vision exemption
right now and \-- better number on that. There are also a number,
probably about 1500 who have been in the original waiver program for
vision and I think about 200 may still be floating out there who have
been in the insulin \--

MR. CLARKE: Would you like to venture a guess as to how that process
might work? Because the number was 3 million or 4 million or so.

DR. HARTENBAUM: I think at \--

MR. CLARKE: Attempting to get those kinds of waivers.

DR. HARTENBAUM: I think it would be overwhelmed, the system. But I think
that even the way it works right now I have concern about, you know,
there\'s \-- put the information out. On one hand, there\'s a report
that just came out sponsored by the \-- the FHWI that the vision
requirement is necessary and in fact to recommend that the field of
vision be expanded to include a vertical requirement, not just a
horizontal field of vision as it now exists. Yet, we\'re \-- they\'re
granting exemptions \--

MR. CLARKE: I guess my question goes to the process, not the \-- not the
criteria.

DR. HARTENBAUM: The process \-- I think there needs to be a better
medical body that reviews this than just the person \-- personal
physician.

MR. CLARKE: But \-- but in your opinion, how would that work if the
numbers were on the order of millions?

DR. HARTENBAUM: It wouldn\'t work.

MR. CLARKE: So, how would you \-- how would you suggest, then, if
something like that \--

DR. HARTENBAUM: I think you would need a system similar to the FAA where
there is a group that is dedicated to looking at the waivers and has
sufficient staffing and funding \--

MR. CLARKE: And how many \--

DR. HARTENBAUM: \-- and expertise.

MR. CLARKE: \-- how many folks do you think that would take?

DR. HARTENBAUM: I couldn\'t begin to \--

MR. CLARKE: Do you want to guess?

DR. HARTENBAUM: How many does the FAA use? Multiply it by a factor of
\--

DR. PARMET: Well, \--

DR. HARTENBAUM: \-- 10.

DR. PARMET: \-- right \-- right now I think the FAA has about six
full-time physicians. Is that right, Doctor \-- down at \-- down at CAMI
who review 7000 field examiners. You would probably need some \--

MR. CLARKE: And that\'s for a population of how many \-- how many \--

DR. PARMET: We \-- we have around 600,000 pilots.

MR. CLARKE: How many commercial?

DR. PARMET: Commercial, I think it\'s around 150,000. I\'m \-- it\'s in
that area.

MR. CLARKE: So, we\'re talking a population of 100-, 150,000 commercial
operators?

DR. PARMET: Right. You would have to proportionally be on the same
ratio. If you have enough people, your process will work properly. But
that\'s what it requires, enough people to properly access, review, and
analyze each individual case.

MR. CLARKE: So, we\'re talking hundreds of thousands of \-- of field
examiners, the equivalents of AMEs \--

DR. PARMET: Right \-- right now you have no clue as to how many
examiners you have. It\'s theoretically every licensed exam \--

MR. CLARKE: Physician.

DR. PARMET: \-- P.A. in several states. You know, you\'re talking
millions. You have no idea who \--who\'s out there.

MR. CLARKE: No, but I mean in the system \--

DR. PARMET: And no idea \--

MR. CLARKE: \-- in the system that\'s been suggested here, do you want
to hazard a guess as to what the scope might be as it relates to the
commercial driving population?

DR. PARMET: It \-- it would be proportionately large. You\'d probably
need around 100,000 examiners.

MR. CLARKE: Or more.

DR. PARMET: It\'s \-- possibly, yeah. It\'s \-- it\'s doable.

MR. CLARKE: And a review mechanism associated with reviewing what \--
what those \--

DR. PARMET: That \-- that\'s right. You\'d have to meet proportionally
that kind of training system set up to do it. But you could do it. It\'s
not impossible.

MR. CLARKE: No, no. I\'m not suggesting it\'s impossible.

DR. PARMET: Been working for the FAA since 1926.

MR. CLARKE: Are you suggesting, then, that \-- that you think in \-- in
\-- in your opinion that some system like that \-- of that magnitude is
\-- is \-- is practical and warranted?

DR. PARMET: I \-- I think it\'s warranted. I think it would be
practical. It\'s \-- if you do it computer-based, which is how we do it
with the FAA, 99 percent of the routine physicals are absolutely
standard and they\'re reviewed on a computer base compared to published
regulations. And you know the person meets the standard. When they
don\'t, then they require review.

DR. HARTENBAUM: One comment on published standards. The published
standards for pilots is much more detailed than for highway. The cardiac
one for \-- for highway states that they can\'t have cardiac
insufficiency \-- I forget the exact wording right now. I should know
that \-- or any other medical condition likely to result in loss of
consciousness, syncope, or congestive heart failure. But it doesn\'t
give guidance as the FAA\'s does on how long they need to be \-- after
an MI, what\'s required after a heart attack, whether they can have a
pacemaker or not, what kind of \-- they can have. So, the specifics \--

MR. CLARKE: As a \--

DR. HARTENBAUM: \-- of the regulations are very different.

MR. CLARKE: \-- as a practical matter, all of that, if it were to be
done, would have to be done in a rule-making process.

DR. HARTENBAUM: That would be correct.

MR. CLARKE: And \-- and all of it would have to be subject to the
scrutiny of \-- of the rule-making process in excruciating detail on
every aspect of every guideline.

Is it \-- do you have any sense as to whether or not the new Motor
Carrier form has helped at all in terms of highlight \-- or heightening
doctors\' awareness of the need to be sensitive to this issue?

DR. HARTENBAUM: The issue in general or just sedating medications?

MR. CLARKE: Medication.

DR. HARTENBAUM: I think it has made them more aware, those that read it.
We know a lot of them don\'t read it, especially the ones who do one or
two a year. They are instructed to discuss with the driver. But even
just discussing it doesn\'t always solve the problem because the drivers
don\'t understand how much impairment they may have and the treating
providers don\'t understand.

MR. CLARKE: So, in your \--

DR. HARTENBAUM: I think there\'s improvement. Do I think it solved the
problem? No.

MR. CLARKE: But there has been improvement?

DR. HARTENBAUM: Some.

MR. CLARKE: Thank you.

DR. ELLINGSTAD: And finally, we turn to the Evidence group.

MS. TARNEY: Two questions for Mr. Edgell. What do you know about
training of pharmacists and physicians during their professional
schooling, if any, on the issues of driving and medications?

MR. EDGELL: I really can\'t comment on that at all. I have very limited
knowledge. Physicians might be better to address that question.

DR. HARTENBAUM: I\'ll handle that one. Not very much at all. I gave \--
rounds at a hospital recently. Not even looking at commercial drivers
but just reminding them that there are medical standards for private
drivers and a significant physician \-- significant proportion of
practicing physicians weren\'t even aware that there were medical
standards for private drivers. They weren\'t aware that \-- I live in
Pennsylvania \-- that Pennsylvania has a mandatory reporting law. So,
these are practicing physicians.

In private \-- in medical schools they\'re not taught at all.

MS. TARNEY: Is the DOT working with the AMA,the American Medical
Association, for general physician education?

MR. EDGELL: Specifically, I\'m not \-- I \-- once again, I\'m not able
to comment on that specifically.

MS. TARNEY: We have two questions for Dr. Hartenbaum. Along with your
talking about generating a \-- you\'d like to see a list of \-- of drugs
generated that are absolutely on a unsafe list, would it also make sense
to you to have your examiners trained on the issue of impairment and not
rely totally on medications so that variations can be included \--
individual variations can be included?

DR. HARTENBAUM: I would love to see examiners properly trained on
impairment, on medical conditions, on prognosis, on understanding that
if a person has a small heart attack they\'re not necessarily safe to go
back to work one week later because that small heart attack may extend
out, become a large heart attack. So, there\'s a lot of education that
needs to be done.

But what\'s important is we need to have support \-- companies and the
examiners need support to make a decision and not constantly be
challenged, as we\'re seeing right now.

MS. TARNEY: In the courts?

DR. HARTENBAUM: Yes.

MS. TARNEY: Another question for Dr. Hartenbaum. Are you aware that the
Australian truck drivers operate without any limiting hours of service
and that surveys have shown that up to 25 percent of them use
amphetamines to stay alert and to keep driving? Could you describe some
of the psychomotor degradation and cognitive impairment that can result
when drivers operate trucks for very long consecutive hours and are
actively using drugs to stay awake?

DR. HARTENBAUM: No.

(Laughter)

DR. HARTENBAUM: It\'s not a good combination, but I am not a
psychopharmacologist. So, I \-- I was aware that Australia did not have
hours of service regulations. I was not aware that that many of them
operate with enhancing medications.

MS. TARNEY: Do you think there\'s that many in \-- in this country? I
hear rumors all the time that there\'s that many and more using
amphetamines.

DR. HARTENBAUM: There may be. We have run into a problem where providers
will prescribe ritalin for drivers who have, quote, \"ADD\" to help them
stay alert while they\'re driving. You know, we do have to talk about
the underlying condition, if they truly have ADD. Again, there\'s
medical \-- medical literature out there that drive \-- individuals with
ADD don\'t drive safely. However, the physicians swear that they\'re
safer because they\'re on the amphetamine.

So, you know, it\'s really the information and getting it out there and
having support to make these decisions.

MS. TARNEY: Thank you.

DR. ELLINGSTAD: Thank you.

I believe we have a couple of questions from the audience. Dr. Galson?

DR. GALSON: Let me just start with a question of my own. In the air
transport sector, how are sedating antihistamines treated with regard to
their stature on these lists?

DR. PARMET: All sedating antihistamines are not \--

DR. GALSON: If some \--

DR. PARMET: \-- are not \-- sedating antihistamines are not approved.
The so-called \"non-sedating antihistamines\" must go through a trial
period and then we can submit the individuals for approval to be
chronically on them, keeping in mind that about six percent of people
are sedated by the \-- the non-sedators because they don\'t have the
enzyme in the brain that actually pumps the \-- the drug back out.

DR. GALSON: Great. Okay. From the audience, if medical examiners will be
required to be certified, what would be the impact on the number of
medical examiners that would be willing to continue conducting exams?
This is for anyone on the panel.

DR. HARTENBAUM: Well, I think that\'s been a concern all along is that
the number of examiners will go down. I think we\'re now seeing with the
medical review officers as they\'re now required to be trained and pass
an exam that the numbers will drop off. So, I think the \-- the number
will go down. There also is concern that as the number goes down, the
cost may go up both because of the cost of training and the decreased
access, supply and demand economics.

DR. PARMET: When we did the pilot program in Missouri we had a whole lot
of \-- that\'s a technical term, \"whole lot\" \-- of \-- of educational
programs to certify people. We went all around the state and made it as
convenient as we could. We maybe had a drop-off at 20 percent of folks
but there was no increase in cost because we went out of our way to make
sure that everybody who wanted to take the training could go through it.

Yeah, there would be an impact but that\'s \-- that\'s the effect of
every regulation we do. We have to \-- have to weigh the \-- the cost of
the benefit.

DR. GALSON: Okay. This is a \-- specifically for Dr. Parmet. If \-- if a
pilot flies with a company without a treating medical \-- and is
prescribed a medication not recommended for flight, what mechanism is
there for forcing the individual to report to his AME or company or FAA?

DR. PARMET: Well, the individual\'s required by Federal Air Regulations
to report that. And the treating \-- if the treating physician\'s in the
AME, then the AME knows that that has to be reported. But just like with
drivers or any other agency, if the treating physician is not the
medical examiner they may not report it. They may not even know. So, we
\-- we, as everybody else, have to rely on the individual pilot or
driver to report and basically ground themselves in those situations.

DR. GALSON: And the follow-up to that, isn\'t it true that many of these
drug uses are never reported?

DR. PARMET: Absolutely.

DR. GALSON: And then the last one, isn\'t it true that this reporting is
largely voluntary? And I think you\'ve already answered that.

DR. PARMET: That\'s correct.

DR. GALSON: That\'s it.

DR. ELLINGSTAD: Okay. I think we have a couple more from the Technical
Panel. Dr. Garber?

DR. GARBER: Yeah. Just one \-- one distinction that I\'d like to draw
would be the \-- we spent a fair amount of time discussing certification
of examiners or \-- or examiner systems. And obviously, that could
conceivably play an important role in regulating medication use by
operators, particularly for chronic conditions. But I do want to draw a
distinction. What about for the acute conditions? The \-- many of our
drivers, many of our pilots will be using, say, a benzoanasapine as
prescribed for muscle relaxant properties or other central nervous
system acting medications for that. For an intermittent problem that
they may have they may be using the over-the-counter substances for
intermittent problems that they have.

Even if you do have a \-- a \-- a large systematic program by which an
individual has intermittent contact with aviation medical examiners or
other certifying officials, how do you get to that issue? How do you get
to the issue of the intermittent use of various medications, hypnotics
for sleep aids, variety of different things that we \-- that we commonly
see prescribed and commonly see used by \-- by people out in the
community that would not be listed as a medication that they were
currently using?

DR. HARTENBAUM: One way of doing that, the FAA\'s pamphlet,
informational booklets that are given to AMEs to give to their pilots.
Having something similar prepared to be given to commercial drivers.
Just kind of a little bit of an education piece. Will it stop them all
the time? No. Will it at least make them stop and think? Yes.

DR. PARMET: With regard to the individual practitioners, we\'re talking
about every single licensed provider in the country and how do you get
that information to them? One might have to actually change the labeling
within the \"Physician\'s Desk Reference,\" which is probably on every
provider\'s desk in the country since it\'s provided to us for free.
That\'s \-- that\'s the best way I \-- I buy that book.

But if it actually had a label on each drug that says, \"This may not be
used by a commercial pilot without approval by the FAA,\" \"This should
not be operated in commercial vehicles,\" kind of a labeling issue on
that end. That brings awareness to the individual providers who may not
even know that their \-- their patient happens to operate hazardous
equipment.

DR. GARBER: And \-- and one \-- one question related. For the medical
certification system, we\'ve been discussing either an FAA-type system
or a system in which, essentially, every licensed practitioner can \--
can allow or certify operator. Presumably, there are variations in
between these two systems. And I thought I heard Dr. Parmet discuss a
system in Missouri which was somewhere in between and did or did not
have Federal funds or Federal requirements attached to that? Perhaps you
could elucidate a little bit more on how that worked and whether that
sort of system might be useful in conveying medical information \--
medication information to operators?

DR. PARMET: That \-- that was a pilot program under the aegis of DOT.
So, the state was educating every physician. In Missouri it\'s only
physicians and nurse practitioners can complete the DOT form for
drivers. And that was just a pilot program under one year.

And we \-- we actually modeled it on the FAA system using a new form
that required the driver to fill out everything they were taking,
including medications, and then sign it under penalty, which didn\'t
exist in the regular commercial driver\'s market.

DR. GARBER: If \-- would \-- in your opinion, would the system that was
initiated as a pilot program in Missouri at that time be as unwieldy for
handling as many commercial drivers as the system that would be proposed
that would be a Federally centralized system from the \-- from the \--
from a FAA-type perspective?

DR. PARMET: I think it has the same issues because it had to be managed
at the state level. And the state Department of Transportation was
having the same issues with \-- with manpower as well as trying to be
consistent. And you\'ve got every jurisdiction in the country.

So, I\'m not sure you would get uniformity at \-- at the state level.
Certainly don\'t have it now. It would certainly improve the system in
terms of education, and drugs and sedation were addressed in that
program.

DR. HARTENBAUM: With the negotiation of that rule-making committee, one
of the concepts was to make a system not quite as unwieldy as the FAA
system where all the information is, first of all, updated and,
secondly, sent to all examiners that you\'re not on the approved
examiner list, you just don\'t do it. And I would also provide a
mechanism that when there\'s new drug information available that could
be sent to the examiners and then relayed to the drivers when they show
up at their exams. Kind of a cross breed between the way it is and the
way FAA has it.

DR. PARMET: I\'m not sure the FAA system is unwieldy, but it\'s \--
it\'s more structured. It does respond. When we have a problem we get
good response out of it, so I \-- I wouldn\'t say they\'re unwieldy.
They\'re a highly structured system and it\'s been in place for over 75
years, so it knows what it\'s doing. And our \-- our regulations are \--
that we operate under are straightforward. I\'ve got three pages of
guidance for cardiac conditions, not three sentences.

DR. GARBER: Thank you. And I believe Dr. Sweeney has a question as well.

DR. SWEENEY: Earlier the question was asked about the feasibility of a
\"DOT-prohibited\" label. What about the alternative of a
\"DOT-approved\" label? Your opinions on that?

DR. HARTENBAUM: That would probably work just as well. Yeah, then you
would address what do you do about medications that are not on that
list? There would need to be a mechanism to review those as they come
along.

MR. EDGELL: I think any list would certainly be a formidable task. The
review, the development, the updating. Certainly a formidable task.

DR. GALSON: But it exists already for the FAA and the military has a
list, so what \-- why is that such a large endeavor?

MR. EDGELL: I was not here yesterday so I did not hear the military list
and I think even when you were talking about it a moment ago you had
some issues with it. The \-- I\'m \-- the \-- for the DOT to prepare
this list.

DR. ELLINGSTAD: Mr. Clarke asked some questions about the staffing
requirements to \-- to hire all of these physicians and supervise them.
If we\'re try \-- if we\'re talking about some kind of a magnitude
estimate of the task, what would it take to do that particular task of
creating such lists? And I guess we probably should have asked our Air
Force and Navy folks in terms of what their investment was. Do you have
something to suggest in terms of \-- of how big that \-- that project
would be?

DR. HARTENBAUM: First you start with what exists. You take the military
list, you take the FAA not officially sanctioned list. You review it,
you add to it, it \-- that probably is somewhat more workable than the
whole certification and review process for everything else. So, I think
it\'s workable.

DR. TILTON: I have a comment that there is no FAA list, so I \--

DR. ELLINGSTAD: Excuse me. Please identify yourself?

DR. TILTON: I\'m Dr. Tilton. I\'m the Deputy Federal Air Surgeon.

There is no FAA list, and \-- and Dr. Parmet said there\'s an
unsanctioned list which I \-- I would say is a very loose definition
because what I think he\'s talking about is the fact that we don\'t
allow hypnotics and we don\'t allow a lot of categories of things. But
there\'s no list of medications that we have either written or unwritten
or sanctioned. So, I just want to make sure that we understand there is
no list, and I agree with what Dr. \-- Mr. Edgell said about the \-- the
difficulty of developing that list, number one, maintaining it, number
two, and also, coming back to what we\'re really concerned about, is the
underlying condition.

If you had an approved list, someone might say, \"Okay. I can take
Medication X,\" when in fact they shouldn\'t be taking Medication X
because of the side effects they might have, number one, and also
because the underlying condition they have, number two, would preclude
them from safely operating whatever vehicle it is they\'re operating.

DR. PARMET: I think you do have a list you use with your air traffic
control unit, which is not quite the same thing.

DR. TILTON: Well, I guess if we do I\'m not aware of it, so. The air
traffic control process is managed and \-- and we actually, in my mind,
we don\'t have an approved sanctioned list for air traffic controllers
as well. But we would include them in the same way we would include
pilots, which would be they\'re effectively controlling airplanes. And
so, the list of kinds of things that we would prevent them from working
with would be the same things: hypnotics and anything that would sedate
and anything that would be psychoactive.

DR. ELLINGSTAD: Did you have another comment, Dr. Hartenbaum?

DR. HARTENBAUM: If we could get a \-- even a list like that that was
official in commercial drivers that we take out of the recommendations
from the conference report and say, \"These are officially recommended
as not to be used without detailed review,\" it would help the examiner
because a lot of them don\'t even know what to do with that list. They
\-- 10 years old.

DR. ELLINGSTAD: Thank you. Are there any \--

MR. CLARKE: Can I make a comment? Can I make a comment, Doctor?

DR. ELLINGSTAD: Okay.

MR. CLARKE: There\'s been a lot of discussion about recommending and
requiring, and just to clarify, in the context of \-- of sanctioned
programs, regulated programs like pilots and locomotive engineers and so
forth there are no such things as recommendations. You either have a
rule or you don\'t. You can \-- and I learned this long ago from my
lawyers, that if you want to put out a recommendation, they would say,
put out a rule.

So, I think we have to be clear that \-- that you can\'t deal with
recommendations here in the context of official DOT-recommended lists.
It\'s either a rule that would allow or prohibit or not. And therefore,
I think we \-- we have to be mindful of what all that entails to get
such an official prohibition or approval in place. I think that\'s some
of the distinctions that we\'re trying to draw here. Recommendations,
trade associations, professional societies, the AME, for example, can
make all kinds of recommendations about best practices and \-- and
professionally recommended ways of doing things, but officially
sanctioned and prohibiting is a very different issue.

DR. GALSON: Just \--

DR. HARTENBAUM: I \--

DR. GALSON: \-- just a quick comment. Sorry.

The Food and Drug Administration and I believe lots of other Federal
regulatory agencies make recommendations that don\'t have the weight of
law. So, there are officially sanctioned guidances or recommendations
that the Federal regulatory agencies make. They wouldn\'t have the force
of prohibiting but they can be used as guidances by industry and other
groups, and that\'s fairly common Federal regulatory practice.

DR. HARTENBAUM: The conference reports I refer to are \-- were sponsored
by the FHWA and it does say, \"These are not officially sanctioned
recommendations.\" But they are what the medical examiner tries to use
to give some guidance to these very vague regulatory pieces. And because
they\'re only recommendations from a conference that hasn\'t been
sanctioned, they really don\'t carry any weight and that is very
frustrating.

MR. CLARKE: Right. But that goes to the next step you talked about:
people then looking for official ability to go back to work or not go
back to work or prohibiting people from going to work.

DR. HARTENBAUM: The examiner\'s looking for guidance, whatever way we
can get it. And the \-- the guidance from the conference reports are
many years old. And anyone who tries to stand behind them and say,
\"This is what the recommendations from this group of specialists \--
representatives suggest we do\" are challenged. So, the examiners try to
follow it but are really given a hard time.

DR. ELLINGSTAD: Okay. Anything else from the Tech Panel?

(No response)

DR. ELLINGSTAD: Okay. I\'d like to thank the panel very much. Any effort
here that keeps Todd awake all morning is \-- is \--

(Laughter)

DR. ELLINGSTAD: \-- certainly worthwhile.

We will reconvene at 10:30 for our International Panel.

(Brief recess)

Witness Panel VI - International

DR. GALSON: Let\'s get started. Like to start with our sixth panel here,
International, and give a special thanks to this crew that has traveled
tremendously long distances to come give us the benefit of their
expertise and input.

The first speaker is going to be Jennifer Bergin, who is a pharmacist
consultant at the Pharmacy Guild of Australia. Thank you.

MS. BERGIN: Dr. Galson, Dr. Ellingstad, members of the panel, thank you
very much for inviting me here.

(Slide)

MS. BERGIN: What I\'m going to do today is give you an overview of \--
overview of the professional and regulatory partnership that exists in
Australia.

(Slide)

MS. BERGIN: Okay. Just by way of background, the \-- approximately 25
percent of drivers \-- of the 3400 drivers killed in Australia in road
accidents \-- yesterday one of the other speakers referred to Olaf
Drummer\'s work. We \-- we have evidence that shows that \-- goodness.
25 percent have drugs in their system and of those people, 15 percent
had cannabis, 13.4 had psychotropics, 4 to 4.4 percent had opiates, 3.8
percent had stimulants, 3.6 percent had benzodiazepines, and about 8
percent had both drug and alcohol in their system.

It\'s interesting to note that most cyclists had a higher instance of
cannabis, some 17 to 20 percent, and as already mentioned this morning,
truck drivers had \-- had an incidence of 20 percent of stimulants.
These \-- these figures are similarly demonstrated in the seriously
injured category.

And also, we have a \-- a regulatory system that involves subsidizing
medicines called \"Pharmaceutical Benefit Scheme.\" And that largely
determines how frequently a drug is prescribed because it is subsidized.
And of the 250 frequently prescribed drugs, 25 percent are either known
or suspected of being capable of impairing users\' driver skills. And we
have 120 drugs that are actually \-- that actually require sedative
warnings.

(Slide)

MS. BERGIN: The regulatory framework includes two main categories. The
\"Prescription Only\" system is governed by therapeutic goods orders
under the regulations and they require warning statements. As I said
earlier, in the standard for the uniform scheduling of drugs and poisons
there\'s an appendix with 120 drugs and pharmacists are required by law
to label these with sedative warnings.

(Slide)

MS. BERGIN: In the Non-Prescription area we have two categories of
drugs: Schedule 2 and Schedule 3. The \-- these are known as
\"Pharmacist Only\" medicines or \"Pharmacy\" medicines. In this
category as a \-- as a restriction to the licensing or the registration
of the product the manufacturer has to include the warning statements on
the packaging.

(Slide)

MS. BERGIN: In the Professional Framework we have a publication called
the \"Australian Pharmaceutical Formulary Handbook,\" commonly known as
the \"APF.\" In that book the counseling notes.

(Slide)

MS. BERGIN: There are 153 drugs that are listed as an instruction to
pharmacists as to what \-- what additional information to add to the
counseling and also dispensing process.

So, if you can on that slide, there are lots of numbers and letters, and
so something with a Warning 1 or a Warning 12 would indicate to the
pharmacist that a stated warning statement would be required. We will go
back to that in a minute.

These take the \-- these take the \-- SUSDP, the standard warning
statements, of which there are three, a little further because they add
drugs like antihypertensives and hypoglemics, drugs that may cause
dizziness and lightheadedness or \-- particularly in the early part of
dosing or where the doses change, the pharmacists would use their
discretion and add those \-- add those \-- not, no \-- sorry. Not
discretion. They would add the warning segment but they would also
discuss with the person what would be the most appropriate label for \--
depending on the person\'s intended use.

(Slide)

MS. BERGIN: The other link is that the \-- the warning statements that
are in the \-- that are in the regulatory framework have been taken up
by companies who produce these \-- these \-- these three stickers. Now,
they don\'t quite match the warning statements of the SUSDP. The one on
the right is a new statement, the use where the medication is a \--
hypnotic and for nighttime use. But the \-- these are produced by a
company called Fieldlies.

Now, Mr. Fieldlies came to the United States 30 years ago and saw some
warning \-- warning labels here and he went back and he negotiated with
the professional organizations, and as a result we now have these \--
they\'re stick-on labels that the pharmacist adds to the dispensing
label.

Now, what they do is processes that the SUSDP has produced \-- so
that\'s the regulatory framework. The professional framework is then
produced and then the company who produces the stickied-up labels adds
the colored statements. So, the one that I\'ve decided is green, it will
be in the next edition, the 18th edition of the APF. It\'s just being
produced. The SUSDP. This is a new warning statement, Warning Statement
90, and so that was only just decided recently and it will be in the
next \-- the next production run of sticky labels.

(Slide)

MS. BERGIN: Okay. Now, the other link is the dispensing software. As you
can see \-- this is a screen dump from Winifred, which is a dispense \--
dispensing software. All pharmacists in Australia use dispensing
software. You can see on the \-- the left-hand side \-- what would you
call it? \"Aide de memoire\" or something like that, but also a shortcut
key for the pharmacist.

So, these are all the warning statements that apply to carbamazepine.
And if a pharmacist wants to type in L12 or any of those other little
shortcut keys on the left-hand side there, that will also appear on the
dispensing label. And the person may \-- the pharmacist may also then
add the \-- those little colored labels as well. So, there are sort of
two \-- two ways that you can add the label or you may want to have
both.

(Slide)

MS. BERGIN: Okay. We also have professional standards and guidelines and
other mechanisms to reinforce this activity. The Quality Care Program
was introduced in 1998 and it\'s a whole series of professional
standards that leads \-- that eventually leads to the pharmacist
becoming accredited. They are externally assessed against these
standards. So, there is a dispensing standard and there is a \-- a
counseling standard.

The dispensing standard requires that the \-- that the pharmacist adds
the caution and advisory labels every time they dispense.

The other thing that we have to reinforce these are things called shelf
talkers. Now, I\'ll have to hold these up. They\'re not on my
presentation.

So, these are three shelf talkers that are sedating antihistamines,
antihistamines for motion sickness, and antihistamines for use as sleep
aids. Now, these are placed near the products. As I said earlier, we
have \-- we have either prescription or we have two categories of
over-the-counter medications. The anti \-- the antihistamines are both
\-- there are some in the Schedule 3 category and there are some in the
Schedule 2 category. But where does the \-- medications are physically
placed within the pharmacy? These \-- these little cards are placed and
the consumer can look at them and look at the questions. And it says,
\"Are you driving or operating machinery?\" So, it\'s a little check to
the consumer to say, you know, \"Why do I need to ask \-- you know, I
must ask why that\'s important\" when they\'re still selecting.

But the \-- the other part is that the \-- the professional framework
has what\'s called the S23 standards. So, the pharmacists \-- required
to take part in the supply of an S3 medication and an S2 medication
where \-- where warranted. And we\'ve had this training program all
around the country and in one of the states of Australia every pharmacy
has now been through a behavioral modification change program where
they\'ve had a \-- a \-- a mystery shopper come in and report their
behavior against these standards.

(Slide)

MS. BERGIN: Okay. The other thing we have is consumer hand-out
information, and here I\'ve given you an extract from temazapam. These
\-- this is a hand-out that comes with the dispensed medication. They
are produced \-- and they\'re currently being modified and
performance-tested to be easily \-- more easily being able to \-- to be
read and understood. But \-- and they\'re given out with the medication.
They are different from the product information, so that in particular,
I\'ve just given you the extract there from the one for temazapam.

(Slide)

MS. BERGIN: Okay. The other thing that we have in the pharmacy is the
pharmacists\' self-care fact card. That should have a link to \--

(Pause)

MS. BERGIN: This is \-- this is part of the pharmacy self-care program.
Now, not all pharmacies have these. About \-- about 40 percent have
them. And what it is is a fact card about medicines and driving that the
pharmacist can add either in talking to the person and counseling them
when they give out the medication or in response to a request for a
consumer about information about medicines and driving.

(Slide)

MS. BERGIN: And lastly, the way forward. We do have a multicultural
society in Australia and, as was mentioned yesterday, not everybody has
the level of understanding, can read to the level that these labels
require. So, there has been some research that has been done in
Australia to \-- to indicate that not everybody has a full understanding
from the labels. So, we don\'t really accept that labeling is the only
way to go.

So, we \-- we really do encourage the pharmacists\' intervention in
talking to people and helping them to understand. Some of the dispensing
systems have language other \-- languages other than English and in the
guidelines pharmacists can add those labels to \-- to the \-- to the
dispensed product. But we certainly see the use of picturegrams being
used in the future and a colleague of mine suggested something like the
one I have on the screen.

The Victorian \-- the State of Victoria has been very proactive in this
area. They \-- they are advocating increased education and public
awareness, and they have also developed a \-- an assessment tool for
practitioners which covers both medications and conditions. There are 30
checkpoints in the \-- in this quite comprehensive document. They now
have the power to test if they believe a driver is impaired and they
test my understanding is over 100 medications. So, they don\'t just
stick to the sedating medications. There are over 100 medications they
can test for.

So, we would certainly like to see a greater public awareness. And a lot
of my colleagues certainly in the Pharmaceutical Society and in \--
members of the Pharmacy Guild work with organizations. It\'s not
uncommon to see people doing driver education programs to do with
medication. There is also another standard to do with health promotion
and there are \-- so this is not an uncommon activity. I thank you.

DR. GALSON: Thank you very much.

Our next speaker is going to be Johann de Gier, who\'s from the Ultrecht
Institute for Pharmaceutical Science in the Netherlands.

DR. de GIER: Thank you very much for inviting me to speak here today.
It\'s on, is it? Yeah.

(Slide)

DR. de GIER: Well, in the Netherlands we have had experience, I think,
for over 25 years now in the field of drugs and driving, and we really
take care of patients \-- at least that\'s what we intend to at the
School of Pharmacy in the Netherlands, especially since we all know that
about 10 percent of the drivers, at least in the European countries on
the average, is taking regularly some kind of psychotropic medication.

In the Netherlands we have had an \-- a very longstanding tradition of
affixing labels \-- warning labels such as was just shown in the
Australian example, and I will come back to that later in order to give
you some feedback on the experience and evaluation of its use.

(Slide)

DR. de GIER: What I would like to do now is, first of all, to present
you the most recent example of an international effort to implement what
\-- what we all have heard yesterday, the present knowledge out of
experimental and epidemiological research in order to get the
prescribers and the dispensers more active in this whole field.

What \-- what I would like to do also is remind you that the report that
I will present here, at least the recommendations of this report, they
can be downloaded from this Web site of ICADTS. ICADTS, as you all know,
the International Council on Alcohol, Drugs, and Traffic Safety, is an
independent non-profit body whose goal is to reduce mortality and
morbidity brought about by the misuse of alcohol and drugs, licit and
illicit, by operators of vehicles in all modes of transportation. This
organization was founded 50 years ago in Stockholm.

The working group that is \-- actually was busy on the prescribing and
dispensing guidelines was established in 1997 at the ICADTS conference
in \-- there was a \-- specifically, the chairman of the Victorian Road
Safety Parliamentary Committee who actually challenged the \-- the
scientists of the \-- in the \-- in the room and said, \"Well, you all
disagree,\" like we have seen meetings like this yesterday and in other
parts of the worlds as well. But what is now really the next step to go
forward in order to be more practical?

So, this \-- this ICADTS working group started with 13 experts from
eight countries, most of them out of Europe. We actually decided to go
for a multidisciplinary approach because I think that the change of
behavior of all the healthcare professionals is \-- is our first
priority target now and see how they can be involved but still also
reminding you that sharing responsibilities and \-- is, I think, the
next issue, is how to achieve partnership with pharmaceutical industry,
with drug regulatory agencies, health educators, and all those who have
a responsibility, not in the least also to mention the patient.

So, I would like to give you the brief presentation of the report\'s
recommendation and I\'m of course most willing to respond to your
questions afterwards.

(Slide)

DR. de GIER: I think the first recommendation deals with the regulatory
authorities, the drug regulatory authorities. I think that implementing
warning systems that are effective is \-- is one of the priorities that
we would like to stress. There is, I must say, hard \-- hardly defined
any studies that evaluate the effectiveness of affixing warning labels.
And hopefully this afternoon you will hear more about this by midday.

(Slide)

DR. de GIER: There is some research in the Netherlands. I said we have
started this \-- this implementation in the early \'70s but we found out
that if the physician was not stressing anything or the pharmacist was
not stressing anything in addition to what was on the label and
specifically the label, \"This drug can influence or might impair your
driving performance\" doesn\'t tell the patient much if there is no
backup information from the professional to \-- to point this out.

The red label, the one that probably also was in the \-- in the
Australian scheme that actually forbid the patient to drive, has hardly
been used by the Dutch prescribers. And if you go into a Dutch pharmacy
these days, they probably cannot show you the label anymore. This was
just done by not using it.

Since the computer systems in the Netherlands and \-- and also like in
Australia took over most of the labeling processing of the information
by dispensing labels, the information is now on the dispensing label.
So, the \-- I think half of the pharmacists in the Netherlands do not
use those yellow stickers or yellow labels anymore because they say,
\"Well, the information is there. Now I don\'t forget to use it because
the computer has taken care of it,\" so it\'s an improvement on that
side. But it is not as alerting as it was in the \-- in the early days.

(Slide)

DR. de GIER: In Norway, and probably you will explain a little bit more,
the Red Triangle system was introduced in 1981 and later on in 1983 in
all the Nordic countries. And \-- but also here, hard to say how
effective it was. In 1987 there was an evaluation in Sweden that
actually explained that three years after the implementation that 50
percent of the patients receiving a medication with a red triangle on
the medication box did not really understand the meaning of it. They
thought it was something that indicated poison or that it was to keep it
out of reach of children. So, there was not an understanding that all
the patients understood what was going on.

And also in the Netherlands we looked at that and we found out that
one-third of the patients receiving that yellow sticker actually took
any action, which means not drive at all, drive less, or in some
situations also stopped taking the medication, which of course is not
the right thing to do if you are treating some kind of a disease.

(Slide)

DR. de GIER: So, what we would like to do is just focus on the \-- the
responsibility here with drug regulatory authorities, and I think that
one of the ways we could actually go a step forward is to actually use
the three tier categorization system, which I will declare in more
detail a little bit later, because this is what we know at the moment
based on \-- on \-- on experimental work and also based on the consensus
among experts in the field who did this kind of research for more than
25 years at the moment.

We also should improve the structure to assist the drug \-- drug
manufacturers in drug testing because most of the research that has been
submitted to the drug regulatory authorities as we have seen it,
especially years ago, was not right useful in order to get some \-- some
\-- some kind of a categorization system installed. That was also one of
the reasons that ICADTS in 1991 presented another report with guidelines
how to do a proper drug testing with respect to impairing properties of
the medication.

The final thing we would like to \-- to put forward here is the
establishment of an \-- an independent center for maintaining the drug
characterization system. Since its introduction we have seen initiatives
in Germany by the Pharmacists Association, in Belgium by the National
Road Traffic Safety Institute, also permission by the government to do
so, and most recently, last month in Spain by the Minister of Transport.
They came up with a \-- translated list of these original three tier
categorization system. The only ones that really did an update on the
original list were the Belgians but the others just translated this. But
I \-- I still think that there is a need to go forward here.

(Slide)

DR. de GIER: Well, this is about the categorization system as it was
introduced in 1991 by a group of experts. This was actually a consensus
survey with more than 50 experts all over the world at that time
involved in this kind of research. And what we did was we actually
assessed categorization according to these three scheme \--
three-category scheme by looking at about 600 drug names and different
doses. We looked at the acute and the agronic administration to see how
that might affect the \-- the categorization and also to look for the
time after intake of \-- specifically for the hypnotics where the
residual effects of course are most important for the patient.

The \-- the comparison with alcohol came in late. It was not the
original scheme with the comparison with alcohol, and you have seen
examples yesterday presented by Jim O\'Hanlon who showed the
experimental work where he used higher blood alcohol concentrations to
compare with tests being indicated in this sheet here.

What the \-- the status at that time was that it was adopted by the
European Drug Regulatory Agency as a note for guidance and only for all
new chemical entities. So, all the new medicines that were introduced as
of the 1st of January \'92, should have the \-- at least have an
opportunity to \-- to come up with a categorization in this scheme. But
since the Note for Guidance also allowed the pharmaceutical companies to
ignore this and to come up with a pharmaco-dynamic profile with a long
list of the reported adverse direct reactions, most of the drug
companies actually choose for that \-- that option.

And I have done a review, a survey, afterwards, five years after this
implementation. I found out that actually no regulatory authority
demanded this kind of information from the pharmaceutical companies.
There were several reasons for it. First of all, of course, there are no
guidelines on \-- on \-- for allowing the categorization. There was
discussion on how \-- difficulties \-- descriptions, actually, were to
apply even though we later on developed the scheme with the comparison
with alcohol.

I think one of the basic issues in Europe at that time also was the
priority that was given to a completely other type of problem with drugs
and pregnancy. In that field there were categorizations and \-- and code
systems developed and people had some problems with it. And I think that
that was also one reason that they didn\'t want another topic to go into
the same kind of problems again. That would also be one of the reasons.

(Slide)

DR. de GIER: One problem that the European harmonization in this field
actually caused was that they did decide to come up with class
descriptions of impairment of driving behavior for \-- for example, for
all the benzos they came up with one same type of information, ignoring
the possibilities and also having no opportunity to distinguish between
the various benzodiazepines, as we have seen yesterday, from
experimental work. I think that\'s a step backwards after doing research
in 25 years in this field that the harmonization process in this
particular area of drug regulation takes the other direction in not
allowing you to give the difference between the different drugs.

(Slide)

DR. de GIER: Well, this has been shown yesterday. I will skip it. But
this allows you also to see that these \-- there\'s a risk ratios coming
out from some of the epidemiological surveys show that not all the
benzos are similar. Of course, they have a \-- an increased risk but
comparable to BAC levels of alcohol. But this kind of information you
completely lose if you have one standardized sentence in the package
insert which for all the benzos the same.

(Slide)

DR. de GIER: One of these studies by Garbone shows very clearly that if
you look at the different dose levels that were actually defined
according to the British National Formulary, low dose, intermediate
dose, and high dose, that there is an increased risk for benzo users to
be involved in a road traffic accident. And if you look at the \-- the
risk on the right-hand side, low bottom right, you also understand that
this is about what you can achieve if you take alcohol in a blood
alcohol concentration out to the legal limit in this country, .08, which
of course is far more higher than the legal limit in most European
countries where we have .05. So, the definition of impairment is
slightly different, I think, if you compared it with alcohol.

(Slide)

DR. de GIER: Specifically for the professional organizations of
physicians and pharmacists, we would like to have the report, as I
indicated earlier, to be implemented in their professional activities
and also encourage the membership to dispense the least impairing or
safe medication if available. Of course, even if you have a safe or a
relatively safe drug, there always will be a individual response, so
specifically for the first week or two specific guidance should be given
to the \-- the patient. And therefore, we also come up with \-- with
more information than you normally can find in your package insert in
order to give some more guidance and some more tools to the patient how
to detect this kind of impairment.

Also, we would like to utilize information and communication technology
for implementing these guidelines. We have developed a program, computer
program, for pharmacies and general practitioners in the Netherlands
where if they select the worst impairing hypnotic like, for example,
florazepine, the system pops up with a decision support tool which
actually allows them to select the least impairing one in the same
class. This has all been supported by the users of the system. It\'s not
mandatory. There is no \-- no government that takes care of that, but
the professionals themselves selected this kind of approach based on the
categorization system.

(Slide)

DR. de GIER: Well, with respect to the responsibilities in
transportation safety and public health, I think that even the existing
systems but also if we would like to follow the Nordic countries by
introducing the red triangle, we still need to have a good evaluation
before and after implementation of the effect of this kind of warning
system and we\'re still lacking that.

I think that there is a need to increase the knowledge regarding the
relative risks of being involved in accidents by users of this type of
medication. The research yesterday, the epidemiological research
actually allows you to come up with \-- with class \-- direct class
relative risk estimates, so all the different \-- you can see in
experimental work, if you would like to have that confirmed by
pharmaco-epidemiological surveys, you probably need a lot more database
\-- extensive database than most of the research that has been done
until today can show. But possibilities are available and I think that
we should use them.

There is also a discussion going in the Netherlands and also in other
countries like Belgium, Sweden, and Germany where they just a couple of
years ago in 1991 introduced a new traffic law where it was \-- a zero
tolerance approach for illicit drugs. But knowing that this is only one
to two percent of the driving populations that regularly take this type
of illicit drugs and knowing that 10 percent is probably taking
psychotropic medication, there needs to be something else also for that
\-- that population at risk.

So, the discussion in the task force in the Netherlands is now not to
combine driving with benzodiazepines being used specifically, as the
benzodiazepines are all half-life drugs, and also to look at the high
levels of short half-life benzodiazepines. And the discussion now is
whether this should be implemented in a law or that we first have to,
again, try to do the prevention approach.

(Slide)

DR. de GIER: We also would like to have an encouragement of healthcare
professionals to implement these guidelines with or without information
technology. And this also should be looked upon in the \-- in the sense
of media campaigns, which of course are also very difficult to evaluate
if you do not know the baseline, if you do not know the effects of other
modes of information transfer.

DR. GALSON: Dr. de Gier, it\'s just a time. If you could try to finish
up?

DR. de GIER: Yes. I \-- I will \--

DR. GALSON: Thanks.

DR. de GIER: \-- close down with my last two ones.

(Slide)

DR. de GIER: The driving licensing authorities, I think, have been
struggling a lot with this type of information, and also they ask for
their \-- the list of drugs and their categorization system. The
European guidelines so far have not established what is a high dose not
compatible with driving but it\'s stated that way.

And finally, the research and education as has been given before. I
think we probably should think of presenting the categorization system
on the Internet and try to find people to respond to that and hopefully
this will improve the situation in the future. Thank you very much.

DR. GALSON: Thanks a lot.

Our last speaker is Dr. Asbjorg Christophersen \-- I hope I\'ve
pronounced that right \-- from the National Institute of Forensic
Toxicology in Norway. Thank you for being here.

MS. CHRISTOPHERSEN: Okay. Thank you very much for inviting me to this
seminar.

(Slide)

MS. CHRISTOPHERSEN: And first, I\'ll try to give a short overview of the
drugged driving situation in Norway, including some general information
on medicinal psychoactive drugs and accident risk.

(Slide)

MS. CHRISTOPHERSEN: The first picture, I think we have the goal \-- flew
very fast because this stuff was \-- topic was covered very well by the
speakers yesterday. However, this is a figure or a table which is a
summary based on a large number of studies on psychomotor tests and
driving tests. This was published last year in \"Forensics and Science
Review.\"

And this again show that benzodiazepines has very high risks and also
the cyclic antidepressant and sedative and antihistamines, obits, and
also the stimulants have \-- considerable risk and to some summaries for
accidents.

(Slide)

MS. CHRISTOPHERSEN: Go through this very fast.

Okay. And then I will go through an \-- to the Norwegian situation. And
then, first, the Norwegian Road Traffic Act showing that if this is not
allowed to drive under the influence of alcohol and the BAC limit is
0.02, which was lowered this year, and it\'s also not allowed to drive
under the influence of other intoxication or narcotic drugs, which also
including psychoactive medicine and drugs.

(Slide)

MS. CHRISTOPHERSEN: The next pictures gives a very short overview of the
handling of drugged driving cases in Norway. First, the drivers are
stopped by the police and mainly due to an accident, reckless, or
dangerous driving. The police make some private investigation by the \--
at the roadside used during a DRE investigation and an alcohol test. If
drugs are suspected, blood and drug samples are collected and at the
same time a clinical examination are performed by physicians. The
samples are sent to our institute, and these are standard \-- and
analyzed by a standard analytic program covering the most frequently
used illegal drugs and also medicinal drugs. And after the report is
sent back to the police, there is done a primary evaluation based on the
analytical research and the clinical examination if this person was
impaired or not.

And again, the police may also ask for an expert witness statement
before the case end up in court.

(Slide)

MS. CHRISTOPHERSEN: The next picture gives an overview of the drug \--
drunken and drugged driving situation in Norway for the last 15 to 20
years and which is shown \-- shown or illustrated on the blue bars,
there has been a decrease of drunken driving but at the same time this
has been an \-- an increase of drugged driving cases. And to \-- to the
end of 19 \-- in the \'90s, drugged driving cases was at the same level
as drunken driving cases, or between 4500 to 5000 cases in a year from a
population of 4.3 million inhabitants.

(Slide)

MS. CHRISTOPHERSEN: The next picture shows an overview of the most
frequently detected drugs, with THC and amphetamines on the top, and
then followed by some benzodiazepines.

(Slide)

MS. CHRISTOPHERSEN: On the next picture it is focused on the \-- on the
medicinal drugs where you will see that benzodiazepine and
fluronitrazepine is the most frequently detected drug, followed by
codeine and some other benzodiazepines, and also some muscle relaxants,
but these drugs are detected not so frequently compared to diazepines to
nitrazepines.

We have also performed some accident studies both of phantom accident
and also in \-- accident drivers. And these studies show that
benzodiazepines after alcohol was the most frequently detected drugs. It
also including both \-- antidepressant and also sedating antihistamine
in the studies but these drugs were not detected at all.

(Slide)

MS. CHRISTOPHERSEN: Who are these drivers? They are most oftenly a man
between 20 to 25 years old misusing illegal drugs and also psychoactive
drugs and often at high doses. They are frequent multi-drug users and
they have also frequently been arrested earlier for drunken or drugged
driving. And also, this driver has a very high mortality rate.

(Slide)

MS. CHRISTOPHERSEN: There are also some available information about
medicinal drugs and traffic risk which has been developed in Norway. As
has been mentioned earlier, the drug passage \-- packages for
psychotropic drugs has a red triangle systems. The practice for two
years ago approximately was introduced package insert systems for all
drugs with rather \-- red triangle marks. There are information
brochures at the pharmacies which should be distributed to the patients
and oral information should also by given \-- be given by the
prescribing physicians and also the pharmacist, but however, this could
be done much better.

There are also special literature available in Norwegian drug handbook
system for physicians and pharmacists. And at last, there are lessons
and courses are offered for physicians and pharmacy student at the
university.

(Slide)

MS. CHRISTOPHERSEN: There you see an example of the red triangle system
which has been in Norway \-- used in Norway for about 20 years. And this
red triangle is \-- means that \-- which is also in the Habsburg system
and this information should also be given by the physicians or the
pharmacists that for the first time when you start to use this drug you
should not drive at all for the first \-- first two to four weeks before
you \-- you can \-- you know your reaction on these drugs. And when you
continue on to use these drugs, you should never drive for the first two
to four hours after you have taken the drugs.

(Slide)

MS. CHRISTOPHERSEN: And at last, there are also some special guidelines
for keeping driving license. First, drivers misusing \-- it has been
documented that a driver misuse alcohol, illegal drugs, or high doses
psychoactive and medicinal drugs, he should not be or she \-- he or she
should not be allowed to keep their driving license.

Another thing, we have also a narcotic drug law which also include both
illegal drugs and psychoactive prescribed drugs, but if the person use
this drug without any prescription. And if the persons are sentenced
according to the Drug Use Law, it could also be decided by the court
that this person should not keep their driving license because he is \--
can be a risk for traffic safety.

And at last, there are special guidelines for patients on methadone
treatment programs or other substitution programs. Thank you.

DR. GALSON: Thank you very much.

Questions from Technical Panel and Discussion

DR. GALSON: We\'ll move now to the panel \-- the questions from the
Technical Panel. NTSB, do you want to start? Tom, want to start?

DR. LAUGHREN: Is it on now? I\'ll start with \-- with Dr. Bergin, but
the other panelists should feel free to jump in as well.

I have a question about this red triangle. I was listening to each of
you and looking at your slides. It \-- it appeared to me that the
triangle might have different meanings in different countries. As I
understood Australia, what the red triangle means is that patients
should be aware that the drug may be sedating and they should not drive
if it affects them but that does obviously give them the option to
drive, whereas in Norway, as I understood it, the red triangle means
don\'t drive if you\'re taking the drug. And I wasn\'t clear on what it
means in \-- in the rest of Europe.

So, could you \-- could you clarify what that \-- what it does mean?

MS. BERGIN: I think your interpretation is correct that the patients do
have the option to drive. It\'s \-- of the three labels, Label 1 would
be considered the \-- the highest warning level, I suppose. The Label 12
is used with a range of medications but including the antihypertensives
and the hypoglycemics and it is not as serious. So, I suppose the red
triangle is an indication of the severity of the \-- the warning, but
yeah, you\'re quite correct. It \-- we\'re just saying to people if
affected don\'t drive.

Let me just refer to some notes here. I \--

(Pause)

MS. BERGIN: The assessment tool that is used by mainly doctors but some
\-- but also occupational therapists, their assessment tool with
medication is divided into categories of drugs, and in the, say,
antihistamines, they \-- they recommend that the non-sedating
antihistamines be used. In the sedative hypnotics they advise people not
to drive while being stabilized. So, their advice is that the chronic
long-term use of these drugs does impair ability to drive and all
patients should be cautioned and they should be asked not to drive while
being stabilized. So, that\'s the assessment tool for a driving license.

DR. LAUGHREN: Okay. But that\'s \-- that\'s separate from the product
labeling. The product labeling, as I understand it, the strongest
warning for any drug is that \-- see how it affects you and then decide
whether or not you can drive?

MS. BERGIN: Yes. In the labeling process. But in the course of talking
to the person I think that the advice might be given not to drive,
particularly in the early stages of the therapy.

DR. TEMPLE: How does the triangle and the conversation interact? Does
the triangle carry the implication you should talk to your doctor about
it? How do those two systems dovetail?

MS. BERGIN: Yeah. I don\'t think the triangle is really used as a tool,
I \-- I\'d have to say, impact. Pharmacist is just aware of which drugs
have the sedating or impairing properties and they talk to people
without particular reference to the red triangle. But they certainly
refer them back to their \-- to their doctor.

DR. LAUGHREN: Is it different in \-- in Norway? Does the red triangle
have a different meaning in Norway?

MS. CHRISTOPHERSEN: Is it on? Yes. Yes, I think it\'s a bit different
from what\'s in Australia. But of course, the patient is \-- is
responsible itself. But information should be given by the doctors and
also a brochure should be delivered by the pharmacist and recommend that
you should not drive for the first two to four weeks when you use this
drug. But of course \-- and if this patient is arrested by the police
and it can be documented that you are impaired with a combination of
analyses, what you detect in blood and also a clinical examination, the
drive \-- this driver can lose his driving license if it\'s proved that
it \-- he or she was impaired.

DR. TEMPLE: Impaired or \-- or using?

MS. CHRISTOPHERSEN: Impaired.

DR. TEMPLE: And that\'s because what triggers the examination in the
first place is the observation by somebody that person seemed to be
behaving in an impaired way?

MS. CHRISTOPHERSEN: If it was \-- if it can be proven for the court and
the court accepted that this patient or this person was impaired.

DR. TEMPLE: Does that actually happen other than out with \-- I mean
does that happen with alcohol \-- other than with alcohol or abused
drugs? I mean have you actually had \--

MS. CHRISTOPHERSEN: Oh, yeah.

DR. TEMPLE: \-- some \--

MS. CHRISTOPHERSEN: Yes, many times. Many times.

DR. TEMPLE: For \-- for using a sedating antihistamine or a
benzodiazepine?

MS. CHRISTOPHERSEN: Yes. If it has been proven for the court that this
patient was impaired or influenced.

DR. LAUGHREN: Then I had a question for Dr. de Gier about the \-- the
three tier system. On face it\'s very attractive to have that way of
categorizing drugs, just as it would be very attractive to have a list
of drugs that \-- that could be used or could not be used in someone
who\'s going to drive.

As always, the devil\'s in the details, and how do you propose to
actually categorize drugs? On \-- on what basis? And is there any
agreement in Europe on, you know, what kind of experimental data should
go into that, what kind of epidemiologic data, and have drugs in Europe
been categorized using this three tier system?

DR. de GIER: Well, the \-- the system has been developed based on the
\-- actually, the discrepancies that existed for the dichotomous systems
like we have in the Netherlands for many years. And also, the red
triangle is kind of \-- in the system.

As long as you do not take into account dosage that has been prescribed
for \-- and/or the formulation of the drug, it could be very difficult
to use only the \-- the drug name on the list. So, I think the system
allows you at least to have that kind of specific categorization of the
impairing drug included.

The categorization system has been supported by the experts in that \--
in that survey that we did in 1991. And we \-- we looked at specific
expertise among these experts, and if there were five or more experts
responding to a specific drug name, dose, and/or formulation and no more
than \-- 15 percent of them were in disagreement with what the outcome
of those five experts or more experts were, then we \-- we call it an
agreement and a consensus. This was based on the knowledge we have in
the \-- in the period of the \'80s. It has not \-- not been updated ever
since.

As I explained earlier, the Belgian police did for their support of
their introduction of the new traffic law in 1999 did a exercise to
cover the Belgian market within the place and that is what I can \-- I
can explain as the \-- the latest development.

The drug regulatory agencies, as I explained in the Note for Guidance,
also offered you opportunity not to use the categorization system. And
also, they indicated that for \-- entities this would apply if possible.
And since 1992 \-- and I did a survey, an experience that no \-- no
example of a categorization application of the system in the specific
\-- entity market authorization was \-- was discovered. So far, no one
has really used it.

DR. LAUGHREN: What about the factor \-- in addition to dose, what about
the factor of time? You might imagine that a drug like \-- like zaleplon
within the first couple of hours would \-- would have a \-- you know,
might have a severe categorization but at eight hours might \-- might
have no effect.

DR. de GIER: That\'s true, and that\'s \-- that\'s also the reason why
Dr. O\'Hanlon yesterday explained this with this particular type of
medication. There is an extension to the categorization system that you
indicate to the \-- the time after \-- after intake of the medication.
And that is an extension as it\'s been used. And also the \-- the
possibility to indicate whether they use an acute drug situation or a
chronic drug situation.

So, these \-- these type of extensions are possible.

DR. TEMPLE: The \-- for the places that have red triangles now, who
decides whether a drug gets one or not? You may have explained this and
I may have missed it, but in Australia how is that determined? It looks
like it\'s on but it looked like a \-- oh, no, that was the other\--
that was the \-- it looks like it was on the unit of use package.
Somebody must have decided that it goes on there. Who does that?

MS. BERGIN: That red triangle is only on the labels produced by the
company that produced \-- produces a range of labels. It\'s their
decision, I think, in consultation with the Pharmaceutical Society to
put that red triangle.

The regulatory framework only list the 120 drugs that have to have the
warning statements either on the packaging or by the pharmacist. So, \--

DR. TEMPLE: This is part of the drug approval system in Australia?

MS. BERGIN: Yes, yes, yes.

DR. TEMPLE: And it\'s \-- and it\'s specifically a recommendation for
the bottle, is that right? This \-- this isn\'t \-- this isn\'t the
packing \--

MS. BERGIN: It depends whether it\'s a prescription or \-- Schedule 4
\-- no, I shouldn\'t say \"prescription.\" Schedule 4 or Schedule 8 or a
Schedule 2 or Schedule 3. So, Schedule 2 and Schedule 3 is the
over-the-counter \-- are the over-the-counter categories. They have to
have it on the packaging. The other two have to have it when it\'s
dispensed, so they have to have it on \-- on place by the pharmacist.

DR. TEMPLE: Okay. But that is determined by the regulatory authority?

MS. BERGIN: Yes.

DR. TEMPLE: And is that also true in the Netherlands?

DR. de GIER: In the Netherlands the yellow sticker or the label was
introduced in 1973 by the National Association of Pharmacists and the
National Association of General Practitioners. And this was not a
regulation that was just a voluntary system. And as I said, it\'s been
actually diminished its use by the introduction of computerization in
pharmacy.

DR. TEMPLE: And \-- and has there \-- are \-- is there discussion with
the regulatory authority about it? Do they interact and decide together
or is it completely independent?

DR. de GIER: Well, in the situation at this moment I think that there is
a discussion how we can implement a new system if you would like to do
that. We look very carefully at the evaluations from the Nordic
countries. The red triangle is \-- is an attractive one but still it\'s
not an improvement if it\'s still a dichotomous system. If you cannot
differentiate for dosage for time after intake for chronic and acute
situation, it probably is not an improvement.

DR. TEMPLE: So, you think it\'s not optimal because of that. So, you \--
are you thinking some text in the little box or something?

DR. de GIER: Well, it was a surprise to see that some of the regulatory
authorities who was \-- I was talking to who said, well, actually, the
information from the industry is there because probably for liability
issues they need to have all those long lists of the first direct
reactions stated there. But to give a \-- a warning level with a
categorization indication in itself could help the people leading that
put some reference over that type of information.

And a quick reference, of course, is to see how in bearing it should be
and if you compare it with blood alcohol concentrations that people are
most aware of.

DR. TEMPLE: Some of the information in boxes, does it come from
standardized tests? Is every potentially sedating drug in any given
country or in Europe subjected, for example, all the time to a driving
test like we heard about yesterday or I guess simulation isn\'t widely
available so that couldn\'t be it. Do they all have that? Is that where
the linkage to a particular blood alcohol concentration comes from?
Where \-- how do those numbers get created?

DR. de GIER: As far as we have received the attention, I think, from the
industry as Dr. O\'Hanlon expressed at yesterday, all the new
antidepressants, all the hypnotics, all the antihistamines that are
entering the market are probably taken to a schedule where you also look
at driving tests or over-the-road driving tests as we have established
that in the Netherlands \-- I know a company who recently indicated that
they did not have that driving test achieved in their approach and they
were considering this because as a result of that we do not pay any
priority attention to this kind of drug if there is no information on
the type of a driving test that is available. That\'s not used.

I think that in the situation in the Netherlands where it is the
professional group physicians and pharmacists who decide in particular
on how to use the warning label that they can decide whether \-- whether
or not this will be a drug to be mentioned as an alternative to a
situation where the older drugs are sedate or heat-bearing.

DR. TEMPLE: Would \-- would \-- would the \-- going through Dr.
O\'Hanlon\'s or his \-- or his successors\' system become a de facto
requirement for a drug in the Netherlands as a regulatory matter?

DR. de GIER: Well, it \-- in Europe at this time the \-- the regulatory
system is centralized as much as possible by the \-- in London. And as
Dr. O\'Hanlon indicated, the driving test has been approved as a
reliable tool for this kind of testing. And I think this is probably a
matter of time in order to get this accomplished.

DR. LAUGHREN: Could I come back to Australia for a moment? Again, as I
understand it, here in Australia the red triangle is a regulatory
requirement as opposed to the Netherlands. It\'s part of the regulatory
process as opposed to an independent group.

MS. BERGIN: I don\'t believe so.

DR. LAUGHREN: Oh, oh. It\'s \-- it\'s not?

MS. BERGIN: No.

DR. LAUGHREN: Okay. Well, that \--

MS. BERGIN: No.

DR. LAUGHREN: \-- that\'s \--

MS. BERGIN: Appendix K, I think, in the SUSDP, which is the Standard of
Uniform Scheduling of Drugs and Poisons, lists the drugs that have to
have the warning statement 39, 40, or 90.

DR. LAUGHREN: Which is \-- which is sedation?

MS. BERGIN: Or to aid sleep. The new one is 90.

DR. LAUGHREN: Okay.

MS. BERGIN: That\'s only been introduced in the last few months.

DR. LAUGHREN: Okay. So, the red triangle is basically voluntary wherever
it is?

MS. BERGIN: Yes. In fact, there\'s only one company that produces the
labels that the pharmacists use to affix to the packaging when they put
the dispensing label on, and so all pharmacies have these \-- these
warning \-- these range of labels \--

DR. LAUGHREN: And the \--

MS. BERGIN: \-- and they\'re the \-- they\'re the ones they use.

DR. LAUGHREN: And the basis for the decision to use a red triangle as
opposed to some lesser warning is \-- is what?

MS. BERGIN: Well, it\'s the \-- as \-- I suppose I still have a level of
cognitive impairment because I have sleep deprivation in getting here.
But \-- and I know I was nervous when I first started so I apologize for
that.

DR. LAUGHREN: Don\'t drive.

(Laughter)

MS. BERGIN: No, I won\'t. What happens is after the SUSDP, after the
scheduling process this Appendix K is produced. Then the Pharmaceutical
Society produces the instructions to pharmacists, I suppose, the
counseling notes. And then the company that produces the labels, then
they follow on and produce the labels.

Now, the professional organizations go further than the regulatory
process and add other drugs to the list where they think the warning
statements should be, and they \-- they add \-- they have a sub-category
of the label 12 where it \-- they believe it\'s only important in \-- in
change \-- in the initial part of treatment or in changes of dose. So,
that \-- that\'s the link between the regulatory process and what ends
up in the dispensing systems and also the labels that are affixed to the
\-- to the products.

DR. TEMPLE: Are there \-- I can imagine why one might believe they\'d
have an effect, but are there actual studies that suggest that people
pay particular attention to red triangles or yellow boxes or any of
these things as opposed to just words? Has that actually been looked at
or compared?

MS. BERGIN: Not to my knowledge, so \-- but only \-- the evidence, I
guess, that we have is the anecdotal evidence in the interactions
between \-- because this is such a high level of intervention and
discussion when these products are dispensed or supplied, I\'d say that
the feedback is that there is a level of understanding. Whether that
translates into a change of behavior I am unable to say. But certainly,
there\'s a pretty good attempt to make sure that there\'s an
understanding.

DR. TEMPLE: Would you know from surveys or, you know, sending shoppers
in that there usually is a discussion of the effects on, say, driving
with the pharmacist when they go get either a prescription or an
over-the-counter drug? Do those interchanges actually take place as you
hope they would?

MS. BERGIN: Certainly, the feedback from the S23 Standards Project that
has been going on for the last year or so indicates that that level of
\-- there is a high level now of interaction that is going on. I guess
the difference is a lot of yesterday focused on sedating antihistamines
and \-- but in Australia the non-sedating antihistamines are available
over-the-counter. And so, part of that interaction would be if there was
a request for a particular product would be a discussion with the person
on those factors that might make \-- you know, what are they going to
use it for, what have they used before, and \-- and \-- and steering
them towards a non-sedating medicine.

DR. TEMPLE: But you \-- how do you know those things occur? What \-- it
sounds like \-- they\'re obviously good things. How do you know that
they occur? Anecdotes or people tell you or you send shoppers through or
\--

MS. BERGIN: The \-- the \-- the S23 Standards Project had a mystery
shopper.

DR. TEMPLE: Uh huh.

MS. BERGIN: Yeah. So, what they did was they sent in \-- first of all,
they sent in a facilitator to explain that the project was going on and
to make \-- increase the awareness of the standards. And then later on
they \-- they sent in a mystery shopper who tapes the experience. And
so, then they \-- they \-- they measured, I guess, the baseline behavior
and then the \-- after \-- with the mystery shopper behavior. So, they
had a reasonable awareness of that \-- a good awareness now because, as
I said, in one state every pharmacy has met the standards.

That\'s not to state \-- to say that there is an interaction \-- every
man, woman, and child in Australia visits their pharmacy 14 times. I\'m
not confident to say that there would be a pharmacist intervention in
every visit, but I think we\'re getting to a better level of
intervention.

DR. TEMPLE: Is the report \-- is what you just described in one of the
things that\'s included in the \--

MS. BERGIN: No, it isn\'t. And I would \-- I\'m not \-- when I talk
about that high level of intervention they \-- I know that they were
talking about analgesics. I just can\'t remember whether the \-- one of
the product groups they targeted was antihistamines.

DR. TEMPLE: Actually, anything that describes an assessment of an
intervention or an assessment of a program would be of interest to us.

MS. BERGIN: I can certainly get \-- that project is just winding up and
will finish in February, so I can certainly get \-- get you the final
report when it\'s available.

DR. GALSON: Okay. Unless there are any pressing questions from the
Technical Panel, I think we\'ll move on to the parties. Start with the
Government table. Are there any comments from this group?

MR. CLARKE: I don\'t have any questions.

DR. GALSON: Okay. Advocacy table?

(Pause)

DR. GALSON: While they\'re thinking about it, in the Professional table?
You guys?

MR. DROBNICH: Just a quick question for Dr. de Gier. Obviously, you\'ve
had a lot of experience with these issues. Having heard what you\'ve
heard over the last two days, what are the one or two things you really
think the government or the professional groups should focus on to
tackle this problem? Should it be media education first, campaigns
first, or should it be professional education?

DR. de GIER: I think that one priority should be given to the
educational part of it and specifically for physicians and pharmacists.
The discussion yesterday was also on the movement of pharmaceutical care
and that\'ll \-- at least and also in other European countries this is
catching up, which means that there is a \-- more attention to the needs
with respect to the \-- the drug use and the problems that they may
cause for the patient.

I think that by having that approach established you can also start
thinking of a better warning system, but as long as it is not an
improvement of what we already have, I would not recommend to use that.
At least in our government, the discussion is on that if we start only
by switching from the yellow label to the red triangle this will not
really help. If it is not a safety system or a different \-- approach in
that respect.

Furthermore, I think that the \-- the prescribing and dispensing
guidelines, as long as they are here, if they are being adopted by the
professional \-- health professionals, then the next step will be how to
apply these. And I think that what we have seen with all this new
development, like pharmaceutical care practice standards and guidelines
in \-- in \-- in the medical and the pharmaceutical field, that as long
as this is not being implemented into any practice in a computerization
it will not be applied as easily as it is intended to be.

So, I think information and communication technology will push this
forward as long as we can first of all adopt this. And the information
campaigns as they are being developed or will be developed, they will
support on each of these specific areas, so as well in the professional
as in the patient and the public field.

DR. GALSON: Advocacy Group, question?

MS. TARNEY: We have two questions. In the ICADTS Dispensing Guidelines
under Number 4 and Number 8 they generally refer to the physician and
the \-- the pharmacist having some \-- some interaction and having the
patient return to the pharmacist. In this country it would seem that the
patients if there\'s a problem with the drug or there\'s a question that
they generally go back to the physician and not the pharmacist. Is that
\-- does it really show itself differently in the Netherlands or in
Europe? And who has the regulatory authority over those pharmacists to
follow up?

DR. de GIER: Well, there is a change in the reimbursement system for
pharmacists in the Netherlands, which means that they should provide \--
approve of their documentation system, of their \-- the use of practice
guidelines and standards and protocols as they do, for example, with
asthmatic patients who have their instructions by first-time use of the
aerosols and other treatments. If they can show that they can do that
\-- do that practice by following the protocol and also document this
intervention, they get a better reimbursement scheme for their \-- for
their activities.

The reason for referring patients back to the pharmacy is based on what
in the Netherlands has been established as a pharmacotherapeutic review
committee concept of a local scale that the pharmacist and the
prescribing physicians together decide on a sort of formulary, what type
of medication should be used in specific medical situations. And these
are all based on the accepted medical standards in the professional
groups, so the government is very keen on having this kind of discussion
going because it\'s \-- it turns out to be, at least in the Netherlands,
that this will lower the cost in medication, the total healthcare costs
proportionately. And I think that this will allow the pharmacist and the
patient also to \-- to collaborate in a more professional way.

MS. TARNEY: So, your physician has let go of a little control?

DR. de GIER: Excuse me?

MS. TARNEY: Your physician is \-- has let go of a little bit of control,
then?

DR. de GIER: Yeah. Well, the situation, as I said, that the insurance
companies actually make the contracts with the pharmacists and the
physicians and they can also require to use protocols, to use
documentation systems in order to \-- to control the drug bill.

MS. TARNEY: And we have one other question. What kind of mass media
campaign was done in any of the countries on these labels so that people
really understood what \-- what they meant? And do they identify with
the intended use of the labels?

MS. BERGIN: I\'m aware of one campaign in 1995 where there was a mass
media campaign which was just \-- judged to be successful, and the
assessment, however, was made by the pharmacies on the number of people
who came in to discuss their \-- sedating medication or the medication
that may affect driving performance as a result of the campaign. To my
knowledge, it didn\'t address the level of understanding.

I\'m only aware of one study which has looked into a person\'s ability
to understand and label in general and, certainly, that recommendation
from that report was that a lot of people \-- sorry, I can\'t remember
the percentage \-- require someone to assist them in interpretation of
medicine\'s information so that in a certain level of reading ability, I
suppose, and understanding.

DR. GALSON: Did you want to add something, Doctor?

MS. CHRISTOPHERSEN: Is it on? Yes.

In Norway the mass media or the newspapers and television very often
focus on \-- on the drugs and driving, showing that this is an
increasing problem and also give information on what the special drugs
\-- medicine drugs which may affect your driving. So, I think that many
people, hopefully, are aware of this problem. So, in this case, they are
also doing a good job.

DR. GALSON: Okay. Industry table? The Transport?

MR. BRADLEY: No.

DR. GALSON: No questions? Consumer Healthcare?

DR. PARMET: No questions at this time.

DR. GALSON: Okay. Union?

CAPTAIN POPIEL: No.

DR. GALSON: Okay. Circling back to the Technical Panel, are there any
questions that you wanted \-- go ahead. Okay.

MS. BERGIN: Excuse me. Could I just add something else to that last
question?

DR. GALSON: Certainly.

MS. BERGIN: One of the things that has happened in Australia, it\'s a
government-funded system. Because there was, I guess, skepticism by
medical practitioners about the information provided by drug companies
there was a call for unbiased, evidence-based material for physicians,
doctors. And so, the government has set up a \-- a system called
Divisions of General Practice, and so there are 123 geographical areas
in Australia that have \-- it\'s an infrastructure where general
practice sort of manages public health programs and other \-- other
activities and \-- including computerization of the profession.

But one of the major activities is called the National Prescribing
Service. And they are \-- they \-- they have some \-- they have
facilitators in each of those divisions that is linked to the National
Prescribing Service and they provide information on \-- this unbiased,
evidence-based information that the \-- they\'re an independent drug
rep, I suppose. They go out and do practice visits and provide this
information or they may hold education sessions within a division. And
they have targets within their division to reach, you know, reach the
number of general practitioners in their division. And that\'s proven to
be very, very successful. They\'ve only been in operation a couple of
years, so I guess it\'s another medium \-- I guess it\'s another mass
media sort of approach to drug information for it.

And the other thing that we are doing which may help is we\'ve just
launched a program called Home Medicines Review, which is a
collaborative medication review. The doctor refers the person formally.
Any member of the healthcare \-- healthcare team can trigger you, but
the doctor formally refers the person to the pharmacy of their choice.
And the pharmacist goes out and conducts home medicines review. And so,
they are able to see what \-- the complete range of medication the
person is taking, what problems they have, and how \-- what problems
they have in taking it, including the complementary medicines. And also,
what we are seeing is in increasing the sedating medications and \-- and
medications that are level \-- labeled 12 contributing to falls and
that\'s a focus in \-- in Australia at the moment in \-- to decrease the
number of falls that are related to medication.

And so, I think that system will be \-- also be very effective in
increasing the awareness about drugs and driving.

DR. TILTON: Could I make a clarification for the record? This is Dr.
Tilton over here.

DR. GALSON: Certainly.

DR. TILTON: Going back to our previous session, the elusive list that
was referred to. Actually, about three years ago a list was developed
and it was developed in conjunction with our Air Traffic Controllers
Union because they asked for some direction on what kind of medications
we might consider that if they were on they wouldn\'t be allowed to
control traffic. So, in conjunction with the union and the negotiated
process we developed a list which is not exhaustive. It\'s not used and
it\'s not reported to be \-- to them that if they\'re on a medication or
not on this medication that they will or will not be allowed to control
traffic. It\'s a list that informs them that probably if they\'re taking
such a medication they\'ll not be allowed to control traffic and it
could be temporary or permanent depending on the condition.

It\'s not exhaustive. It is not used \-- it\'s only updated once a year
per the negotiated union agreement, and we do not put medications on or
off that list during the year. If something were new to appear on the
market we wouldn\'t go back and update that list, so nobody\'s in charge
of the list other than every year we update it. And we do not use it in
conjunction with any of our pilots. So, there is \-- there is a document
out there that we use but it is not \-- it\'s not a list that we refer
to when we\'re doing our certification process.

DR. GALSON: Thank you for that clarification.

Is there more points of \--

DR. LAUGHREN: Yeah. One more question. And this \-- this is for
Australia or \-- or the other panelists could respond, too.

This is a question about the number of \-- of warning labels that might
appear on a prescription bottle and \-- and the effect that that might
have on, I suppose, in a sense desensitizing patients to warning labels
and therefore decreasing the impact. Has that been a problem in
Australia?

MS. BERGIN: Well, as it hasn\'t been evaluated I \-- I can\'t really
give you a definitive answer. I think most pharmacists would \-- in the
list I have in the kit you can see things like \"swallow whole\" or
\"take after food\" would be in the text but the warning statements,
generally they would use the colored labels. Some of them might put it
on and have both, but \-- so, you would probably not see more than one
or perhaps an \-- an additional expiry date label or something like
that.

So, I think they do \-- they are \-- they are aware of information
overload, I suppose, and \-- and that people just don\'t see things
after they become used to them, so I think that there would be selective
use. But as it hasn\'t been evaluated I can\'t say for sure.

DR. LAUGHREN: Thank you.

DR. de GIER: The \-- the Netherlands discussion went on \-- after
introducing the computerization 20 years ago, at that time we were
applying different colors and different shapes of stickers and labels.
And it was decided by the \-- by the pharmacists that they would like to
have the \-- the most important ones on the dispensing label printed by
the computer so that it will not be a \-- a manually tasked \-- manual
task for the person \-- person in the pharmacy to do. And ever since, as
I said, this has been used with great enthusiasm and \-- and people
don\'t like to \-- to stick labels anymore.

DR. TEMPLE: Whether we\'re talking about a triangle or a sticker or
whatever, would people be entitled to assume that if a drug doesn\'t
have one it\'s okay in this respect? Which really involves mostly a
question of whether you\'ve gone back to look at the older drugs that
may have not been \-- may not have been subjected to driving tests and
so on. Would \-- would \-- would that be what you\'d expect people to
assume? No sticker, no triangle, no problem?

DR. de GIER: Well, the \-- the information with the older drugs is \--
is, as I said, not being tested as \-- as extensively as with the new
ones. But on the other hand, that the \-- the Netherlands at least, the
local formulary committees and following these practice standards of the
medical and pharmaceutical professional organizations, they don\'t pay
attention to the older drugs anymore. They actually go for the safer
ones in this respect.

As soon as you take the next step, legislation, and you would like to
have traffic \-- traffic law developed with some kind of a list of
drugs, then of course the \-- the risk might be that people who do not
see the name of the drug on a particular list that has been regulated by
traffic law, they probably would look for an alternative with \-- with a
drug which has a constituent that is not on the list. And that
discussion is \-- is being taken up by the task force that I was
referring to. So, we \-- we identified the problem and they\'re still
working on how to improve this situation.

DR. TEMPLE: So, ideally at least, any system like this should try to be
comprehensive and go back as well as forward or \--

DR. de GIER: Exactly.

DR. TEMPLE: \-- or it would be misleading?

DR. de GIER: That\'s correct.

MS. CHRISTOPHERSEN: Could I address that statement? I think that based
on some interview investigation in Norway it\'s a change between the
older generation of the pharmacists to the younger one. It\'s maybe that
it\'s based on better education but the younger one are more aware of
their \-- that they are responsible to give information to the patient.
I\'m hopeful also that drug package inserts with written care
information would also \-- will improve the situation.

DR. GALSON: Okay. I think we\'ve got \-- we have a question from the
public, so let\'s do that and then we\'ll come back.

DR. ELLINGSTAD: One question for Ms. Bergin. How is the consumer to
determine whether or not they are affected by a medication? Doesn\'t
your labeling imply that it is okay to drive if you don\'t feel sleepy?

MS. BERGIN: Yes. The Warning 12 talks about mental alertness. I mean as
we heard \-- well, as we\'ve heard from a lot of speakers, people may
not be aware that their driving is impaired. So, I \-- I accept the
point that there is \-- it appears that we are saying that you \-- you
only shouldn\'t drive after you self-assess that you have a level of
impairment.

I\'m not answering this very well but, yeah, I \-- I \-- there\'s not
that link that you \--

DR. ELLINGSTAD: I think the point is, is there any instruction given to
the \-- the consumer themselves to make that determination?

MS. BERGIN: On how they know that \--

DR. ELLINGSTAD: Right.

MS. BERGIN: Only in the discussion, I guess, between the pharmacist and
the \-- and the person. I mean, certainly, the fact card recommends that
\-- that they should take alternatives like a taxi or a friend. But I
suppose after a period of stabilization of medication, then \-- then I
guess we \-- we are relying on that \-- their own subjective assessment
of their ability.

DR. ELLINGSTAD: Thank you.

DR. TEMPLE: Of course, that\'s \-- that\'s an interesting question
because, as we heard yesterday, people can have impairment on the
simulation test and not feel sleepy, not feel impaired, and in fact they
can even have decreased sleep latency and not feel sleepy, all of which
makes you wonder about how well people can assess their own abilities.

MS. BERGIN: However, in speaking to colleagues before I came over here
who have worked more in the \-- the testing field and \-- they made the
comment that people adjust their driving habits and in fact may be
adjusting to the more cautious or safe zone when they drive because they
know they\'re on medication. I think we\'ve seen in the relative risks
studies that those that are on cannabis have \-- tends to have a lower
relative risk. And it \-- my \-- one of my colleagues made the comment
that if you are anxious perhaps you are better on an anxieolytic than
\-- and driving than if you are not.

So, it\'s a multi-factorial \--

DR. TEMPLE: Right.

MS. BERGIN: Yes, so \-- system and, certainly, I mean I accept that
through courses that were given yesterday, but it\'s \-- it\'s not an
\-- it\'s not as simple, you know, how you \-- it\'s multifactorial.

DR. GALSON: One more question.

MR. MARSHALL: There was a little mention yesterday about drug
recognition experts in the United States, and I was just wondering what
sort of training do law enforcement get to recognize drug impairments or
things such as that?

MS. CHRISTOPHERSEN: In Norway all of this is implemented in the
education for the police officers. And it\'s also from post-education
courses offered for the traffic police. So, I think, yeah, at the moment
very many in Norwegian Traffic Police has these special courses. But the
Drug Recognition Expert Program, they use, it\'s something similar to
what they have in United States, and I\'ve seen \-- lots of things have
been taken. For the \-- but it\'s something more simple than \-- simpler
than it is in \-- in United States because if drugs are suspected then
there \-- we will follow by a clinical examination performed by a
physician. So, the investigation they do at the road is not so many
different tests as in \-- I know it is for the program in United States.

DR. GALSON: Okay. Any other pressing questions from the Technical Panel?

DR. GARBER: Just briefly, and \-- and maybe this panel can\'t \-- can\'t
fully answer the question. But is there any specialized guidance
provided to commercial vehicle operators separate from what\'s provided
to the general public in \-- in the organizations from countries that
you represent?

MS. BERGIN: The \-- only in the area of the assessment tool that I
mentioned, the fitness to drive. There are two levels. One is for more
of the general public and then there is a commercial assessment tool
that\'s at a high level.

DR. de GIER: Similar in \-- I think there is, according to European
guidelines. This is all over the European countries. It\'s a similar
thing.

MS. CHRISTOPHERSEN: Same in \-- in Norway.

MS. BERGIN: I mean what was referred to earlier that was the use of
stimulants, it\'s certainly a major problem in Australia in that
pseudoephedrine is available as a Schedule 2 medicine and certainly
pharmacists are applying a much greater level of scrutiny in the supply
of that product. That\'s my \-- but I think the people who are buying it
for \-- well, for both diversion and also inappropriate use know the
correct answers to all the questions anyway.

DR. GALSON: Okay. I think we\'ll end this session now. Thank you very
much, witnesses. Very informative.

I do want to make an announcement about the scheduling. We were
scheduled to have lunch now and then have an open audience discussion at
one. However, no one has registered for that session. So, we\'ll break
for an hour and start with Session VII after lunch, and we have been in
touch with all the witnesses. I think all but one is already here and
that one\'s going to come early. So, we will aim to start in an hour on
the next panel. Thanks.

(Whereupon, at 11:58 a.m., the meeting was adjourned for lunch, to
reconvene at 1:00 p.m., the same day.)

A F T E R N O O N S E S S I O N

1:03 p.m.

DR. ELLINGSTAD: Okay. Let\'s get started. We have some new faces at the
Technical Panel table, so why don\'t those people introduce themselves?

DR. GANLEY: Charlie Ganley from the Division of Over-the-Counter Drugs,
FDA.

DR. TEMPLE: Bob Temple, also FDA. Director of the Office of Medical
Policy.

DR. SWEENEY: Meg Sweeney, National Transportation Safety Board, Safety
Studies Division.

MR. MARSHALL: Rafael Marshall. I\'m with the Office of Highway Safety.

DR. ELLINGSTAD: Okay. Thanks.

Witness Panel VII - Warning Labels

DR. ELLINGSTAD: We\'ll start now with our final panel for the meeting.
And this panel will discuss warning labels. We\'ll start with Dr.
Michael Wogalter from North Carolina State University.

Dr. Wogalter?

MR. WOGALTER: Thank you.

I\'m Mike Wogalter. I\'m from North Carolina State University, part of
the Ergonomics Program there, Cognitive Ergonomics. And I\'ve been doing
research on warnings some 15 years or so.

And it\'s hard \-- it\'s hard to distill a lot of research that has been
done. There are books that have been written on the topic. I brought a
few. This is \"Warnings and Risk Communication.\" It has a \-- several
\-- many chapters on warnings and various studies. And also, there\'s
collections books of various articles. These two books contain
approximately 120 research articles, empirical experiments, and so
forth.

In the five minutes that I\'ve been allocated I\'m just going to gloss
over some things, try to introduce you to the area. Thought I\'d
introduce the very first thing that is probably a safety principle,
engineering principle, and it\'s a hazard control hierarchy which
basically says that if you\'ve got a hazard, first of all, you have to
determine that there is a hazard. And then, if you\'re able to, you try
to design out the hazards. You try to eliminate the hazard, and that\'s
\-- that\'s probably the best strategy.

If you can\'t do that, then you try to guard against the hazard in some
way to prevent people from getting to the hazard or getting near the
hazard.

Then finally, if you can\'t do those things well then you warn and you
try to warn as best you can. The problem is that warnings are not 100
percent reliable. And so, the best you can probably do is try to
maximize effectiveness.

And there\'s a bunch of methodologies out there now across the last 15
years that one could use to evaluate warnings. That includes subjective
studies where you compare different warning labels. There\'s latency
studies, reaction time studies where you try to find out how long it
takes for them to find a warning label. There\'s comprehension types of
studies; after you\'ve exposed them to the label what did they get out
of it, what \-- do they remember it? You could ask them about attitudes
and beliefs and so forth.

There is a \-- a national standard. American National Standards
Institute over in Arlington area, I think, has a Z535 standard, and you
probably have seen similar kinds of warnings on machinery and so forth.
It has the warnings with a triangle, exclamation point with the
\"danger,\" \"warning,\" \"caution\" header with \-- in different
colors. It also specifies certain things that go into warnings, and that
includes stating what the hazard is, describing the hazard, telling
people what to do to avoid the hazard, and the consequences of what
would happen if they fail to comply with that hazard.

They also recommend certain kinds of format, things like bullet points
and putting it in outline format. That is, not putting it in continuous
text, giving it a certain amount of white spacing and so forth. They
also recommend if it\'s possible to use a pictorial symbol, one that
would reach 85 percent comprehension in a test and have no more than
five percent critical confusions. And by critical confusion, what that
is is an interpretation perhaps opposite of what it\'s intended or at
least a very wrong interpretation that could lead to some problems. You
can\'t have more than five percent.

I thought the \-- just the remainder of my five minutes is to show you
an information processing. It\'s kind of a \-- a combination. I call it
the Chip Model.

Let\'s get that up there. I \-- I \-- I spent lots of money to get
prepared here.

(Slide)

MR. WOGALTER: It\'s \-- I call it the Chip Model and it\'s described \--
each one of these stages is \-- has a chapter in here that goes through
the research regarding it. And it\'s kind of a sequential model, but
you\'ll see that there\'s looping-backs and feedback loops.

Well, the first stage is the source. And that\'s who it\'s \-- the
warning is coming from. And some research has suggested that if it\'s,
for example, government warning on alcohol. That \-- that \-- that
actually seems to lend more credibility to that warning, or surgeon
generals as opposed to just, you know, no \-- no source there.

The next is the channel. And warnings is a fairly broad area. It
doesn\'t just include labeling. It\'s \-- we had some things on
education and pamphlets, mass communications such as advertisements,
commercials. There\'s indirect warnings where someone \-- for example, a
physician may receive a warning and relay it to a patient. So, there\'s
many different \-- also auditory warnings, another way.

So, all \-- if you have a warning hopefully it gets delivered to the
receiver, and you can see that it\'s a communication \-- a simple one,
source-channel-receiver, but inside the \-- in the receiver there\'s
certain processes that must go on if you expect the warning to have some
effectiveness.

And by effectiveness, there\'s three basic ideas or what\'s the purpose
of the warnings. One is to inform. Another one is to facilitate
compliance, compliance behavior. And then, sometimes also it\'s added
that it should be a reminder if you already know that information.

So, basically, with the attention, you need to make it noticeable.
There\'s lots of clutter out in the environment. On labels there\'s lot
of information. You need to have it stand out. There\'s things like
color, bigger print, pictorial symbols, and so forth that would enhance
the likelihood that someone would see it.

Then also, in the attention part is there\'s attention maintenance. So,
after you\'ve captured attention, how do you hold attention there so
that they actually read it? Well, you have to have, like, good
legibility. And legibility is \-- is important because a lot of folks
don\'t have great vision, presbyopia. And if you have four point font
there a lot of people are not going to be able to read that. You need it
a certain level above that.

You\'ve got to make it kind of interesting. Some of the white spacing
and \-- will help maintain attention. Think comprehension real briefly.
The warning has to provide information. It should be \-- the research
suggests that it should be explicit. It shouldn\'t be just general
warning, \"This may be bad for your health\" or \"bad for driving\" or
whatever. Generally, the more explicit, the better.

With pictorial symbols you have to make sure that they understand it and
don\'t misinterpret the pictorial symbols, and it\'s hard to design with
pictorial symbols. It\'s not as easy as one might think.

Then, after that, so you\'ve captured attention, you got to
comprehension, then you may want to change attitudes and beliefs if
they\'re wrong. For example, people may believe that over-the-counter
drugs are safe. Well, how are you going to convince them that there may
be some harm there or you may need to give a strident message, a firm
message. It may come back to the source, giving it from a credible
source and so forth.

And then lastly, your motivation. There\'s various factors that affect
that whether it\'s low cost of compliance, whether it\'s easy to do. If
it\'s very difficult to do or something is getting in the way people are
not likely to comply. Whether they\'re under time stress. That hurts
compliance. And whether they\'re social modeling, whether they can see
other people complying effectively.

And lastly \-- well, I\'ll \-- I\'ll hold off. I do have some example
pictorial symbols but I\'ll wait until, maybe, after Ruth Day gives some
of her presentation. That\'s all with me.

DR. ELLINGSTAD: Thank you.

Our next panelist is Dr. Ruth Day from Duke University.

DR. DAY: Good afternoon. I can have the first slide.

I\'d like to begin by telling you I do research on the cognitive
accessibility of drug information. And by cognitive accessibility, I
mean the ease with which both providers and patients can find,
understand, remember, and use drug information and do so in an efficient
and accurate manner.

Our research examines drug information from many sources, from the PBR
and pharmacy leaflets to TV ads, Internet Web sites, and packaging. I\'m
hoping our first slide comes up because it cues the topic for today and
has an interesting pictogram on it.

I may pause for a moment.

(Pause)

(Slide)

DR. DAY: Ah ha. Thank you.

So, today I\'m going to begin by focusing on pictograms and ask whether
they can help. And the first question we want to ask is what kind of
help would that be? Well, we\'d certainly want them to enhance cognition
processes such as pattern recognition, comprehension, memory,
problem-solving, and decision-making but ultimately we would like to be
able to change behavior. So, when a person is taking a drug they might
reconsider whether they should drive. When they must drive, they might
reconsider whether they ought to take a certain medication and
ultimately improve driving safety.

(Slide)

DR. DAY: In order to examine how we might study this problem, I\'d like
to take a look at one of the experiments that we\'ve conducted, and here
is the packaging for the antihistamine Benadryl. Very well-known one.
The top of the display is the front of the package and the bottom of the
display is the back.

There\'s a terrific amount of information here. In order for you to see
it better I\'ve enlarged it in the next slide.

(Slide)

DR. DAY: And I might ask you, where is the warning and what does it say?
For most people, it takes a long time to find it, the warning about
driving and perhaps they don\'t find it at all. In order to enhance the
chances that people will take away the information that there may be
some problem driving while on this medication, we\'ve created a
variation on this display using this pictogram.

(Slide)

DR. DAY: This pictogram comes from the pictogram library of the U.S.
Pharmacopeia. It\'s part of one of their pictograms. It\'s a very strong
pictogram. It doesn\'t say, \"Use caution.\" It essentially is
communicating, \"Do not.\"

In order to determine the effect of this pictogram on cognition we did
an experiment where some people saw the previous display, the packaging
without the pictogram, and the other half on a random basis saw the same
thing with a pictogram embedded.

Now, there are many locations where you could put this pictogram. For
this particular experiment we put it up top, large \-- in large size,
and right by the drug name to really make it stand out, so we\'ve been
quite heavy-handed here.

The procedure was a study test paradigm. During the study phase people
were actually comparing packaging for two drugs in the same category in
order to ostensibly determine which one they would buy. And then,
afterwards in the test phase we asked many different kinds of questions
and one of which was about warnings, what are some of the warnings for
this medication. And the results were that the people who had the
pictogram added did do better. They did three times better in terms of
their ability to report that perhaps driving was not a good thing to do
while using this medication. Well, that\'s the good news. A threefold
increase in performance.

The bad news is shown on the next display, \--

(Slide)

DR. DAY: \-- which shows that almost no one got it anyway. So, the \--
it\'s well below 10 percent overall.

So, we might ask why? Why aren\'t people picking up this information?
One answer is, of course, potentially information overload. But we asked
about other things on this packaging. For example, we asked what are
some potential side effects? The next display shows that people did
quite well.

(Slide)

DR. DAY: On average, half the people reported that drowsiness could
occur and it didn\'t matter whether they got the pictogram or not. So,
they got this information from the packaging.

But did they really? Perhaps they got it from somewhere else, namely
prior knowledge. In other studies we have asked people what are some
possible side effects that can occur when you take medications in
general? And as you can see, drowsiness is the most often reported
likely side effect. It\'s twice as great as any of the others, and so
people have general prior knowledge that drowsiness can come from taking
medications.

By the way, many of the other things that came to mind are also not good
for driving, such as dizziness, et cetera.

So, people don\'t seem to be making this causal link that they have
prior knowledge about drowsiness. They may pick up some of it when they
read the packaging, but they don\'t then make the link about driving.

So now, why is performance so poor? Why don\'t they get this warning in
\-- in \-- in a \-- in a good way? Well, there are a lot of other
potential factors, and I think by going back and looking at the warning
section again, and I\'ve just blown it up and given it more favorable
thought and so on so that you can see it.

(Slide)

DR. DAY: It is still a big block of text. A big block of text makes it
hard to search, find, understand, remember, and use information. In
order to enhance the exact same information here, the next slide shows
how we can pull this information out and chunk it.

(Slide)

DR. DAY: Chunking involves just separating each chunk from the next
chunk in a variety of different techniques that you can see on the
display. There\'s a terrific amount of research that shows that when
information is chunked people are much better at being able to remember,
learn it, and use it later.

Another cognitive principle beyond chunking is coding. An easy way to
describe this is that if you can put a name to it then you might be able
to remember it more readily. So, the next display takes the exact same
information of the previous slide and chunks it and codes it, both
giving it a name and doing it in color.

(Slide)

DR. DAY: I\'m not recommending we should go to displays like this. I\'m
using this as an analytical tool today.

And when you look at this slide, you\'ll see that there\'s a lot of
jumping around of topics. So, you start out in the beginning with side
effects, go to contraindications, then more side effects, then more
actions, warning interaction, contraindications, storage, and overdose,
which leads to another cognitive principle, and that is clustering \--
put together which goes together in terms of the semantic or meaning
basis.

So, we would recommend that a variety of cognitive principles be taken
into account in analyzing current materials and designing new materials,
principles such as chunking, coding, clustering.

(Slide)

DR. DAY: By the way, we have done a lot of work with the pictograms
themselves. And as you can see here, the first choice that you \-- you
need to consider, one of the first ones, is whether the \-- the
pictograms are information-sparse or information-rich. That is to say,
do they have a lot of intrinsic meaning in and of themselves? There are
advantages and disadvantages to both types.

(Slide)

DR. DAY: Information-sparse pictograms are harder to learn but \-- and
they have less intrinsic meaning so they can be misunderstood. And
different people can take away different meanings, as we heard in some
of the discussions this morning. On the other hand, they can then be
applied to a wider category of things, different types of warnings, not
just the driving while medicated.

(Slide)

DR. DAY: The information-rich pictograms contain the meaning within it
more readily and the top one has done very well in our test. They
actually combine with other things in the U.S. Pharmacopeia pictogram
library. For example, the middle one shows the causal link. You take the
drug, you get sleepy, therefore don\'t drive. In some of our testing we
find that when people first see the top of this pictogram they think the
person is laughing or screaming or smelling one\'s own breath. I mean
the interpretations are quite remarkable. Over time with a little bit of
education hopefully this will go away. Far less education with these
pictograms than with the information-sparse ones.

(Slide)

DR. DAY: Final issue is who\'s going to be designing the pictograms?
Well, of course the experts will. I would love to give the job over to
Mike Wogalter here and he\'ll get you a good pictogram. But we still
have to take into account the prior knowledge of the people who are
going to be using these, the general public.

And so, what we did was to give people what the current language is in
the packaging, which is \"Use caution when operating a motor vehicle or
operating machinery\" and ask them to design a pictogram. Could be a
rough sketch. Drawing ability didn\'t count. And people did this and
this display shows you the percent of times that different semantic
components were included. Just about everybody has a car and the
cross-out. And so, those are the two basic elements that need to be in
the pictogram as far as just everyday consumers go.

A lot of them want to have a person and steering and some intention of
driving in it rather than just interpreting it that if you\'re in a car
you might get seasick or not feel well if you\'re taking a medication.

There are a variety of other things they put in. Machinery, we had a lot
of buzz saws and other kinds of things but there was no consensus. So,
when there\'s no consensus for how to represent a semantic component
it\'s probably not a good idea to include it.

The last thing I\'ll mention on this slide is only a quarter of the
people did anything about indicating that causality, the causality which
goes from take the medication, maybe get side effects, maybe get
impaired, back to the fact of driving.

(Slide)

DR. DAY: So, in conclusion, let\'s step back here \-- oh, this \-- this
slide just shows that we\'ve done work with a variety of other kinds of
drugs, both OTC and prescription for allergies and other types of
indications.

The last display comes back to this whole issue that we want to enhance
cognition and behavior about the drawing \-- driving and warning. In
order to do so, we need to take a lot of approaches. I was distressed
this morning when people said, \"Well, we tried this and it sort of
worked and then it fell off. We tried that, it didn\'t work.\"
Pictograms are going to work in and of themselves but also in the wider
context of the entire information.

So, there are a lot of issues to be addressed about what pictograms,
should they be information-rich or sparse, where do you put them, et
cetera, et cetera. But at the same time we have to take into account the
linguistic information that\'s being presented as well. Chunking and
coding and various kinds of language structures are important to take
into account as well. And when you put together both linguistic and
pictorial information about the same warning, that really enhances the
chance that many more different people are going to get it and the
people are going to have the information enhanced with both types of
representation.

So, to conclude, there are many cognitive principles that are
well-rounded and empirical studies that have gone on for the last 40 to
50 years. These principles work. Let\'s use them. Let\'s use them to
analyze the existing materials and test the consequences for cognition
and action. Then let\'s go into the redesign phase and let\'s redesign
using these principles to enhance cognition and action, then retest. Let
us test the consequences before we then put them out in the public view
and only then begin the efforts on education programs. Thank you.

DR. ELLINGSTAD: Thank you, Dr. Day.

Our next panelist is Dr. Soller from the Consumer Healthcare Products
Association.

DR. SOLLER: Could we go back one slide?

(Pause)

(Slide)

DR. SOLLER: Thank you. Good afternoon. I\'m Dr. Bill Soller with the
Consumer Healthcare Products Association.

My comments focus on OTC drug labeling, the OTC drowsiness warning, the
new OTC drug facts label, public education, and a brief comment by way
of conclusion.

Yesterday I presented this overhead which represented the summary of our
AER postmarking surveillance analysis. Over this 10-year period \'91 to
2000 there were 23 serious AERs with antihistamines as primary or
secondary suspect drugs and with an accident term in any field of the
AER no more than four per year and about 850 million OTC packages for
adults alone sold over this particular period. And it\'s on this
background that I make my comments.

The current OTC label has specific components that are arranged in a
standardized flow of information, including active ingredients, uses,
warnings. Within warnings, absolute contraindications, relative
contraindications, in-use precautions, directions, other information,
inactive ingredients, and questions.

I say the \"current label.\" This is the current drug facts label
format.

The important point to glean from this is that all of this information
is important and it should be presented in a consumer-friendly way that
has low to no potential for interrupting the standard flow of medical
information, particularly in the warning section.

(Slide)

DR. SOLLER: This is an example of the drowsiness warning for OTC
antihistamines. \"When using this product marked drowsiness may occur.
Avoid alcoholic drinks. Alcohol, sedatives, and tranquilizers may
increase the drowsiness. Use caution when driving a motor vehicle or
operating machinery. And excitability may occur, especially in
children.\"

(Slide)

DR. SOLLER: And here we have the pre- and post-drug facts labeling. I
think you can see there\'s quite a difference. The presentation we just
saw did a study on the old drug facts label, the one on the left. And
the new drug facts label has an outline format; the use of bullets to
chunk information; the information is clustered; prominent, consistent
placing of the drowsiness warning. I don\'t have a pointer here, but if
you go down about halfway on the label you\'ll see \"When using this
particular product.\" And it\'s a consistent, standardized, rational
flow of medical information starting from the top and moving down that
would be replicated across all OTC products, all categories, thereby
having an educational component to the consumer as they\'re using many
different OTC products.

Most antihistamine-containing products have already been relabeled with
this new drug facts format with full compliance May 16th, 2002.

(Slide)

DR. SOLLER: Given the lack of data to demonstrate that OTC labeling
should be changed, the focus here should be on the core public
educational message \"Read the label, read the entire OTC label.\" The
new drug facts box allows a renewed emphasis on this core message in an
attractive way, noting, for example, more prominent and consistently
placed warnings. Awareness and education about the need to read and heed
the entire OTC label should target operators and consumers, and CHPA has
traditionally partnered with outside groups and governments to promote
this core message as noted by our Vice President of Public Affairs
Corinne Russell this morning.

(Slide)

DR. SOLLER: Now, in relation to pictograms and symbols, this matter was
thoroughly and publicly reviewed during the development of the final
rule on drug facts labeling that took place over many years. FDA found
that pictograms and symbols may be used voluntarily in addition to
required warning language but, and I quote, \"A symbol or pictogram that
directs attention away from the required information or one that is
ambiguous or can be misunderstood by consumers may render the products
to be misbranded.\"

Pictograms and symbols are unproven in any in-use situation for OTC
medicines that we\'re aware of, particularly as it would relate to the
drowsiness label as it might affect accidents. They are potentially open
to misinterpretations. Study \-- studies supporting their ability to
clearly communicate are, in our opinion, at best mixed. A number of
studies show very poor understanding. Others show that \-- or another
shows that an illiterate population did not achieve understanding
equivalent to a literate person reading the label. Another reports an
ability to improve the communication of the pictogram but leaves
unanswered the question whether the pictogram translates to real world
views and benefit in a nationally representative population.

And with misinterpretation can come misuse and potential misbranding,
and in our view this is an important limitation even in a small
percentage of cases.

Pictograms and symbols would crowd the limited \-- the label, limiting
the amount of white space and space without wording and therefore make
it less attractive, less readable, less consumer-friendly. They would
work against the \"read the label\" message by potentially interfering
with the flow of information in the drug facts label by distracting the
reader to start at an icon if it were placed midway in the drug facts
label rather than at the top of the label.

And I think potentially they would in fact represent a way for a reader
to speed-read the label. This is particularly important because you have
to ask the question, \"Where would you stop?\" Which is more important:
a drug interaction label, a pregnancy label, \"Keep away from
children,\" driving, diabetes, the list goes on and on. And the
potential of having multiple icons and then using that to speed-read \--
changes to label I think detracts from the basic message of \"Read the
entire OTC label.\"

(Slide)

DR. SOLLER: In conclusion, OTC antihistamines have a demonstrated
history of safe and effective use when used according to label
directions. They are appropriately and adequately labeled. Pictograms
and symbols are unproven in any in-use situation for OTC medicines that
we\'re aware of. The issue is read and heed the entire OTC label. CHPA
believes that it\'s important to maintain an ongoing program of consumer
education on the importance of reading the label. Thank you very much.

DR. ELLINGSTAD: Thank you, Dr. Soller.

Our final panelist is Dr. Bert Spilker with the Pharmaceutical Research
and Manufacturers of America.

DR. SPILKER: Good afternoon. I\'m Dr. Bert Spilker of \-- as you just
heard, and in regard to the subject for this panel\'s focus I wish to
make four points.

First, all investigational prescription drugs are thoroughly evaluated
for ADRs by the sponsors that are developing them. One of the most
commonly reported ADRs is drowsiness, and this often finds its way into
the label of products across many different therapeutic classes.

Two, drowsiness is a subjective measure and is not always correlated
with performance impairment in clinical studies. It is often very
difficult to know if drowsiness is drug-related, related to the
underlying disease for which a product is prescribed, or related to
other factors.

Three, the sponsor\'s evaluation of drowsiness may include testing of
drugs versus placebo, different doses of a drug to evaluate those
relationships, and drug versus active agents from the same class with an
incidence of drowsiness. Statistically it\'s different from placebo if
applicable.

Any adverse event occurring at a rate greater than a pre-defined
threshold which is usually on the order of .5 percent or one percent or
any adverse event of clinical significance or any adverse drug reactions
that occur during clinical development will be placed in the drug\'s
labeling. All data are evaluated by the FDA and are supported by
adequate and well-designed clinical studies. When clinical trials
document the drowsiness due to a drug as statistically significantly
greater than placebo, it may require a label precaution.

Lastly, current FDA-approved label language is adequate to present this
information to the physicians and to patients. Warnings and product
labels currently exist to alert prescribing physicians to the potential
hazards of vehicle operation while using medications that can cause
drowsiness. These safety warnings are communicated to subjects when
physicians prescribe to their patients. Patient package inserts when
provided reflect these warnings in easily understood language for the
public.

Pharmacists are already required in many states to attach a peel-off
label on the pill bottle mentioning when a drug may cause drowsiness and
also to avoid using with alcohol or other depressants. In addition, many
pharmacies hand out patient information leaflets informing patients of
safety-related information when purchasing their medication.

In summary, there currently exist ample opportunities for physicians and
patients to be informed about a product safety profile. We recommend
that there not be any changes to FDA\'s current practice of label design
for prescription drug products.

Thank you for this opportunity to make these comments, and we\'d say
that copies of this text are available on the desk outside.

DR. ELLINGSTAD: Thank you.

Questions from Technical Panel/Parties and Discussion

DR. ELLINGSTAD: We\'ll turn to the Technical Panel, and I believe our
first questioner will be Dr. Ganley.

DR. GANLEY: Thank you for the presentations. They were very good.

I\'m going to \-- I have a bias towards OTC products right now so I\'m
going to sort of focus on \-- on that right now. Oftentimes we see label
comprehension studies that suggest that there\'s a comprehension of a
certain warning, yet when an actual use study is done the actual
behavior of the individual is not predicted by that label comprehension.
And I can give you an example. Two years ago we looked at a muscle
relaxant and it was reviewed in front of an advisory committee and there
was data presented there where comprehension of \-- not to drive if
using this product was in the 95 percent range. Yet, in the actual use
study 50 percent of people used the product and went out and drove.

And so, I guess the \-- the issue for me is does a pictogram actually
just highlight something for a patient to see? Does it help them
comprehend it better? Or does it help change behavior? Because we\'re
really interested in changing behavior here because I think whether you
use words and, you know, in the chunks now that Dr. Day had presented,
which I think is sort of how our \-- our new labeling format is
presented. You know, the issue is how do we change behavior? What \--
what information do we have to include in there to change behavior?

MR. WOGALTER: Well, if you remember the Chip Model that I mentioned
earlier, there was comprehension as an earlier stage and later there was
behavior. You still had to go through attitudes and beliefs and
motivation which could, if they don\'t believe that it\'s hazardous or
it\'s too difficult to read the label, then you\'re going to get the
possible decrease in \-- in behavioral change. They may understand it
when you show it to them but in actual use they may not believe the
information or that it\'s for somebody else, not them. That\'s the
problem.

The other thing about the pictogram, there\'s several different uses of
the pictogram possibly. The one that\'s usually attributed to it is the
comprehension aspect of it, but there\'s also the attention-getting
aspect. That is, that it will draw your attention to that pictogram even
if you don\'t understand it \-- what it is. People are kind of curious
about that and of course you don\'t want them to make an error in what
it means, okay, so you have to look for the critical confusions.

The other aspect of pictograms is the reminder aspect, that if they do
know the information just by a quick glance they can get that
information.

DR. DAY: I would like to add something about the high level in
comprehension studies. I\'ve seen quite a few comprehension studies
which have a high percent comprehension score and when you look at the
methods I don\'t think that\'s necessarily what you can conclude. In
some research that we did sponsored by the U.S. Pharmacopeia we did a
levels of processing approach in looking at people\'s understanding of
pictograms and other information in the pharmacy leaflets and things
that go in the bags. And you can ask a general question, \"What does
this mean?\" or \"Did you see any\" and \"What were they about?\" and so
on. And as you get deeper and deeper, you find that maybe people don\'t
really understand.

So, what is being taken as a comprehension score? And I think one of the
best techniques is using what we call a problem-solving scenario task
where you say \-- say you\'re taking this medication and such and such
happens. Is it all right to continue to use this drug? And half of the
examples or scenarios you give, the answer should be \"yes\" and half
should be \"no.\" You mix them all in so you\'re not just asking, \"Is
it okay to drive with this drug?\" And when you do that you see that
comprehension scores often go way down.

So, I think we have to take a multiple level approach to understanding
what these comprehension scores mean in the first place.

DR. SOLLER: This is Dr. Soller. I have three comments, Dr. Ganley. The
first is that this may be drug-specific, and that\'s one thing to always
consider, that the effects seen and how people are behaving to a
particular warning may be impacted by the \-- sort of the intrinsic
toxicity of the drug itself and how they\'re using it. And I would guess
that some of those answers would come out in the \-- new study in terms
of perhaps some of the compliance measures that will come out. So, sort
of that said.

The second is, of course, and you know perhaps better than anybody in
this room, that the label comprehension study and the actual use studies
iterative process and there\'s always the potential to make the label
better, test it again, and see if you can refine and get a better
behavioral intervention that you\'d hoped for.

And my third comment is the \-- I think the importance of perspective
here to step back. It\'s something that we\'ve tried to share in terms
of our comments and our thinking in this area, and that is that we are
here in the very narrow focus of transportation. And when we sort of
step up and we consider other special interest groups, people that are
interested in accidental child ingestions, people that are interested in
the effects of drugs on pregnancy, the issue of don\'t mix drugs, and on
and on, you ask which is most important that we\'re going to put on the
particular label. Or are we going to emphasize the basicness as you\'re
reading the entire label and then use educational programs to have
perhaps \-- particular different parts of that basic message.

DR. TEMPLE: I guess even if you thought that the best thing is for
people to read the entire label, it still seems likely that some
presentations might be better than others.

I guess the first question I have is there seems to be at least a little
bit of a contradiction. Dr. Day showed some evidence that pictograms
have a little bit of effect. It wasn\'t very large and it was after all
a very small pictogram. You could have made it much bigger. And it
wasn\'t reproduced down among \-- down in the text to sort of link the
two. One can think of various ways of seeing if pictograms could work
\-- could work better.

But, Bill, you seem to think that there was really just no hope that
there was any likelihood they work, so I guess I\'m curious whether
people think this is something to be explored more if you had a
particular part of the label you wanted to draw attention to. Of course
you want everybody to read it all, but you still might want \-- you
still might want to emphasize one part.

DR. SOLLER: Well, \--

DR. TEMPLE: I take your point that every group will want to emphasize
the part that\'s of interest.

DR. SOLLER: Yeah. And I think we fought about this. We\'ve fought about
this for many years during the development of the final rule on drug
facts labeling and there was a thorough discussion of this. And I think
that FDA netted out with the right kind of policy letting it be
voluntary but noting that it was misinterpretation, you\'re open to
misbranding. That makes sense. So, given that and then stepping back and
saying what are we really trying to achieve as the new drug facts
labeling is rolled out? We are taking the broader view and, yes, we are
saying that in the context of pictograms this may not be the best kind
of approach for this particular situation and for various reasons that I
gave.

There\'s another study that shows that you can refine the symbol and
come up with somewhat greater comprehension than was shown by Dr. Day,
but that still leaves you with the question of how that translates out
in a multicultural society and whether it\'s universal.

Another study has shown that if you really focus in on the cultural
differences that people have and make your pictogram defined in that
context your comprehension goes way up and the question is how do you
translate that over here and in a multicultural society? And so, looking
at what you \-- what you have in terms of the outline format where you
have the ability to \-- for people to scan the label, if you\'re looking
for memory the outline format of being able to scan through and get a
quick re-recognition of what\'s important exists in the drug facts
labeling. And that\'s an important feature of it.

The ability to use educational efforts, particularly with an industry
that is interested in doing even more, is an opportunity to highlight
drug facts labeling and even pulse different messages within that,
within the basic one of \"read the entire label.\"

DR. TEMPLE: I don\'t think anybody\'s suggesting that you have pictogram
and no text or have text and no pictogram. It\'s the question of whether
combinations of those things are worth exploring to see if you can do
better. You wouldn\'t say that that isn\'t worth thinking about. What I
understand is you\'re saying don\'t do it until you have a good idea
whether it works.

DR. SOLLER: Well, I think \--

DR. TEMPLE: Right?

DR. SOLLER: \-- it\'s important to have a data-driven approach to
labeling and you\'ve heard me say that on other occasions, so \--

DR. TEMPLE: Okay. But that \-- does that include the possibility that a
pictogram might be shown to be useful in a particular area or \-- or do
you think it\'s a settled issue?

DR. SOLLER: Well, I wouldn\'t necessarily exclude the potential that we
can do even better on labeling. I mean we may find \-- you take almost
any category of OTC medicines and as new information emerges I think
it\'s important to think about what we\'re doing. And I know you are
involved in doing that on a daily basis and \-- and that\'s something
that happens on the OTC arena as well.

But I do say and I do think that you have done, you as an agency have
done a very thorough examine \-- examination of this. There hasn\'t been
any new information that really has come forward that would change the
considerations that you already had and I think that the policy that you
have for the voluntary use with the proviso vis-a-vis misinterpretation
and misbranding has set the right arc for what we know now.

DR. DAY: I have a comment about the data that you referred to. Not many
people reported the driving warning. Keep in mind what the nature of the
cognitive task was. People were given two packages and told to look at
them to decide which they would buy. And they could take as much time as
they wanted to and some \-- one \-- one experiment and another they were
limited to a certain amount of time. Didn\'t make any difference. Those
were the data I showed you.

However, if the task is take a look at these packages so that you\'ll be
able to take this medication in a safe and effective way, then things do
go up and that\'s a major point I would like to make in all the studies
that a review \-- that are cognitive or any sort at all. What is the
nature of the task that people are being asked to do? And people get in
information in different ways, and then the way you ask for it to come
out can determine what you get.

And just one other point. In the displays that I showed it was the old
labeling for OTC medications for antihistamines. We are also doing
studies on the new labeling so we will have empirical evidence of the
extent to which those are enhancing \-- this and other information.
There weren\'t enough data available in order to present that today.

DR. TEMPLE: Do you have data in order and how it matters? I mean you
can\'t help but notice that in the label that was shown the first things
mentioned is that children get excited on Benadryl. Not exactly the most
important thing to know, you might think.

DR. DAY: That\'s true on this one \--

DR. TEMPLE: I mean I guess you could argue that, but it doesn\'t seem to
be.

DR. DAY: That\'s true in this one, not in clortrimaton and other things.
But Dr. Wogalter has done a lot of research on the order of information.

MR. WOGALTER: Yes. We\'ve published a number of studies looking at
prioritization of different label components. As it turns out, there is
an article in the \"Drug Information Journal\" that looks at what \--
what \-- what order of the different sections might be in different
scenarios. For example, when you first purchase the product, if you\'re
giving it to someone else, and pretty \-- and we used different
populations: older adults and students and so forth.

Basically, what the results were were very close to the new drug facts
label. The real exception to it was that regular folks were not that
interested in the active ingredients being first and they had it later
down in the label, but pretty much the rest of the components were
ordered in multiple different scenarios.

DR. TEMPLE: What about within a paragraph of text? There\'s a single
paragraph that talks about five different things. It takes a little
while to get to the sleepiness part.

MR. WOGALTER: Yes.

DR. TEMPLE: Could that \-- could that interfere with understanding if
that\'s important? I mean everybody runs off and worries about giving it
to their children first and they forget that they\'re supposed to worry
about driving.

DR. SOLLER: Just \-- go ahead.

MR. WOGALTER: Well, you could \-- that\'s true. I mean if you read a lot
of instruction \-- I mean a lot of warning materials, gives some really
obvious things up front. And that leads to people saying, \"Well, I
already know this stuff.\" And so, whenever you have something further
down even in the section or in any kind of text, you\'re going to get
less likely that they\'re going to get to that section. So, you could
prioritize within that section, I suppose.

DR. TEMPLE: I should say I\'m not offering judgement here. We happen to
be focusing on sleepiness now and maybe that\'s not what we were doing
then. I\'m just wondering about whether if one wanted to focus more on
sleepiness one would think about rearranging the order.

MR. WOGALTER: Yeah. No, I understand.

DR. TEMPLE: And not intended as a nasty comment.

DR. SOLLER: Didn\'t take it and didn\'t think you needed a disclaimer.
But my comment really reflects on the discussion, the very depths of
discussion that we had with FDA. And we had a difference from an
industry standpoint than FDA wanting to have directions higher in the
label than it is. And in fact, we were \-- even within our own group we
were debating whether that should be.

But the basic order in terms of actives, uses, the question was
directions or warnings. And warnings and directions I think also was
engaged in a concept of whether this should be the consumer driving what
they think they ought to have or whether there should be a medical
overlay in terms of helping the consumer access the right information
first. And part of the reason the active ingredient was \-- was first
was in relation to the brand name and ensuring that consumers understood
the differences and what impactors were there.

Use is next. What do you use it for? And now that you\'re thinking you
might use it, your first self-selection, the question being are there
any absolute contraindications, \"Do not use.\" Are there any relative
contraindications? \"Ask a physician before using.\" And then in-use
precautions, and that\'s the standardized order for the warning section.
I\'ll return to that in a minute.

And then, pregnancy and breast-feeding split out separately. And then
directions, which you\'ve gone through all of that in your
self-selection. Then you move to the directions, and that makes sense as
you asked for order.

Now, as it relates to drowsiness, for the antihistamine
single-ingredient labeling, for example,

\"When using this product marked drowsiness may occur,\" and that occurs
within a sub-box within the overall drug facts box, so it is prominent.
It\'s more \--

DR. TEMPLE: Well, but it\'s \--

DR. SOLLER: \-- it\'s more conspicuous.

DR. TEMPLE: But it\'s late in the sub-box.

DR. SOLLER: Well, \--

DR. TEMPLE: It\'s not the first thing in the sub-box. That\'s really all
I\'m asking about. I wasn\'t \--

DR. SOLLER: That would be \-- yeah.

DR. TEMPLE: \-- trying to restructure the whole label.

DR. SOLLER: Yeah. And I \-- and I think that\'s important to think
whether you put drowsiness, and I\'ll return to that if I may by way of
putting this whole thing into perspective, or whether you think about
that it\'s important that a person ask a doctor before they use it if
they have glaucoma and trouble urinating due to an enlarged prostate or
a breathing problem such as emphysema or chronic bronchitis. That\'s a
medical judgement. And the judgement was made during the discussion in a
fair amount of discussion on that that you want to put the contact with
the doctor for a medical condition like that first.

And I \-- I would add by way of perspective, and I was reflecting on
this over lunch with my colleague Bill Bradley, and that is that we\'re
\-- we\'re dealing with about 100,000 crashes per year on drowsy
driving. I\'m not suggesting to minimize any one of those crashes.
Don\'t misunderstand. Our understanding of the tremendous impact that
that \-- that that can have on a family. That\'s about 1.6 percent of
the total 6 million or so police-reported crashes. Fatigue is the
primary factor in all of this. Time of day is the most consistent factor
with a peak that\'s right after midnight, another mid-afternoon. This is
all off the Web page. With a feeling that the human circadian rhythm is
the plain underlying factor as we\'re thinking about drowsiness.

Fatalities from drowsy driving is about 3.6 percent of all fatal
crashes, and if you look at the NITSA prevalent study, you\'re dealing
with alcohol over 51 percent prevalence. Antihistamines are about .6
percent prevalence. That very low involvement I think in terms of
crashes overall is supportive of the AER survey we were seeing.

I think in that context as we\'re thinking about what to do, industry
and FDA, particularly with the drug facts label, has done an awful lot,
an awful lot in taking that paragraph format and putting it into a very
prominent, consistently-placed type of warning within the warning
section. And when you deal with what we had yesterday in terms of the
ambiguities of extrapolating from the controlled trials and the
simulator studies and the questions that we have about pictograms and
whether they translate to changing in-use behavior, I think at this time
our view is that as the drug facts label rolls out, as education is
applied to that, the ability to hit certain specific messages perhaps on
the warnings, that you\'ve got the right kind of balanced approach
already in place to address the issues that we\'ve been talking about
over the last two days.

DR. GANLEY: In the example that you talked about where there\'s an X-out
of a car, does the consumer view an X-out as an absolute
contraindication or a relative contraindication or does there have to be
words attached to that?

DR. DAY: Most people interpret that \"Do not.\" And most people, when I
gave them the \"Use caution\" and they were to draw a pictogram, turned
it into \"Do not.\" Some people did use the caution, the exclamation
point and the yellow triangle, but I think that the \-- I don\'t have a
position on this that we should or should not use pictograms. But if we
were going to use them I think a pictogram should always be directly
linked with the linguistic expression of the same information. And I can
direct you to a paper of mine that goes into that and the whys and
wherefores.

I do want to acknowledge Bill Soller\'s point, though, that too many
pictograms can be distracting and you could have interference effects
and so on, but all of these are empirical questions. We designed studies
to test how many pictograms can a person handle and so on and so forth.
And so, I think there are answers to these questions and I just want to
point out that there\'s a huge body of literature and what\'s called
dual coding theory. If you take some information and show it in both
linguistic and pictorial information, people learn it and remember it
better and they have more retrieval cues at the time of doing something
else, behaving in the real world, whether they should take a medication
or drive, that there will then be a retrieval cue. I saw some picture
with a car and a cross-out, and that will then be more likely to cue
them that this is a problem in this situation.

DR. GANLEY: Even if that \-- the information that\'s attached to it is
different? For example, if \-- as we talked about earlier, some of these
drugs may have a shorter effect than others so it \-- there would have
to be different information as to when you could resume driving, for
example.

DR. DAY: Right. That\'s one problem. Another problem is it doesn\'t
affect everyone in the same way. And so, I can understand that the
pharmaceutical industry might be against having this as an absolute.
It\'s not going to affect some people.

DR. GANLEY: What \-- what about for prescription products where
essentially a consumer is just given a container that has the drug and
they may be given a slip alongside it? And, you know, the examples we
saw earlier today, there was just a red triangle with the standard text
that did not differentiate products. And how do you convey that
information in the prescription setting? Does a package leaflet need to
be attached that further explains that that would also have a red
triangle? How do you accomplish that?

DR. DAY: Well, one way is to have the \-- the pharmacy leaflet stuck in
there. But we\'ve done research on the best ones of those and find that
the cognitive accessibility issues are still there. But we\'ve also
looked at the little auxiliary labels called the stickies that people
put \-- that the pharmacist puts on \-- on the bottle. And I\'ve tracked
the same patient on the same drug, refills in the same pharmacy, and
each time the labels were different across a couple of different drugs.
So, sometimes it\'s without alcohol or with or without food or
drowsiness and driving and there\'s no consistency. And that gets to the
issue of mandatory versus optional use of these auxiliary labels.

Now, some of these software systems now do print out with the actual
label who the person is and the prescriber and so on on the bottle, the
little label that goes with it. But not all software does that, so it\'s
up to the pharmacist to decide. If the phone rings and they\'re in the
middle of getting the drowsy-driving auxiliary label and they answer the
phone, they then may not get that label on.

DR. GANLEY: Is \-- I guess then that would lead me to in the OTC
setting, you know, one of the emphases, as Bill had pointed out, was
this consistency that \-- in terms of location of information. And you
know, if the information isn\'t \-- isn\'t there, is there an assumption
that it\'s okay?

So, I guess one of the questions is should FDA develop a list of
accepted and unaccepted drugs and label all medication whether they can
be used if you\'re going to drive or use heavy machinery?

DR. DAY: Well, I\'ll comment about that and Dr. Wogalter might want to,
also.

Any time you say \"Don\'t\" and you have a list, people interpret
anything else as okay. It\'s not on the list, right? Anytime you say
this is okay they don\'t necessarily to the same extent assume that
things not on the list aren\'t okay. So, we were talking about the lists
the military have and so on and so forth. It\'s not a \-- it\'s \--
it\'s not a \-- a bi-directional thing that works in the same way. that
is to say, when you say \"Don\'t\" people won\'t do that, they\'ll do
everything else. If you say, \"These are okay,\" they don\'t think about
the others not being okay.

So, the \-- the strength of the \-- the warning is not bi-directional.

MR. WOGALTER: It\'s difficult to say whether people are going to
interpret something that \-- that it\'s okay if it lacks something
there. It\'s kind of a gray area.

I have kind of like an anecdote where someone in my department used the
\"Mr. Yuck\" label and put \-- if you know what that is. It\'s the
unhappy face with the \-- the tongue sticking out \-- and put it on all
\-- many of the products under the counter and all \-- all \-- all over
the place, actually, and told their kids, \"This is bad, this is poison,
don\'t touch this,\" and then she brought home some other products and
forgot to put the little label on there. And she comes home one day and
sees that her little boy is spraying pesticides all over the kitchen and
he said, \"Well, it didn\'t have the \"Mr. Yuck\" on it.\" So, you never
know how that\'s going to be interpreted.

One of the things that was brought up is the inserts. That\'s another
place that perhaps you could add some pictorials, explain some
additional things. We have published a paper which may be relevant \-- I
think it is relevant \-- in the \"Drug Information Journal\" where we
looked at inserts where it had eight different kinds of warnings on
there and they either had both pictorials for all eight or they had
pictorials for half of them. They were randomly distributed. Or it was
just a verbal information or nothing. And we gave them \-- at least
those first three conditions for a limited amount of time and had people
look at it.

And what we were really interested in is what happens to the things that
don\'t have a pictorial symbol because you may not have a comprehensible
symbol or something specific enough and will they ignore that
information that doesn\'t have a pictorial? Well, it turns out if it had
a pictorial they do get that information. That\'s the first thing they
start looking at. They\'ll read the instructions right next to it. But
they tend not to pick up the other things that don\'t have pictorial
next to it. Basically, when they had pictorial symbols for everything
they did great. It went very well. And if you ask consumers which would
they prefer, they\'d like to have the pictorial symbols. You just ask
their subjective judgement, but there is a problem that you may not have
a symbol for everything. And they\'re not specific enough.

The car there, is that going to fit a lot of things? You\'re leaving out
perhaps the heavy machinery, whatever the heck that is, and, you know,
can\'t fly a helicopter. It\'s \-- you don\'t know how far they\'re
going to take it. Now, if you had education beforehand it could serve as
a cue or a reminder, \"Oh, yeah, this comes under this auspices of not
being \-- use it while driving or use any other kind of machinery.

So, one possibility is to consider for alternative information to use
pictorial symbols and maybe not have the problem with the misbranding,
maybe if it came out with \-- from other organizations as well. The
pharmaceutical actual product where they may have some problems with
litigation.

DR. TEMPLE: One of the points that Dr. Day made was that pictorial
things should be linked to the text, so maybe that\'s part of the answer
to that.

Can I ask a slightly different question? Do the pictograms have any
potential role as a reminder function? Despite everybody\'s best
efforts, it\'s hard to believe that people are going to re-read an
entire label every time they get a familiar drug. Is it possible that,
and has anybody studied this question actually, that this would be
shorthand reminder of something that was important but that they may
have forgotten? And I guess part of that might be when multiple drugs
have the same brand name, could a pictogram help you tease your way
through the thicket of different ingredients that bear the same class
name?

MR. WOGALTER: I\'ve done some research. It hasn\'t been on
pharmaceuticals. It\'s been on other \-- concerning other products where
we give participants \-- they think they\'re going to use a particular
product and it contains an instruction manual with pictograms and the
text. And if you were to ask them later on, \"Describe all the hazards
associated with this particular product,\" if they have a pictorial \--
a pictogram at test that is serving as a reminder, they do much better
in the hall.

DR. TEMPLE: Any other \--

DR. SOLLER: I \-- I think it\'s possible to generate hypotheses about
what might happen in a situation. I don\'t have anything more to say
about that relative to reminder except to ask whether you would be
reminding persons not to drive a car and then ask what does that mean
for truck. And I think what happens when you\'re looking at pictograms,
you\'re balancing what might be done and certain benefits as you\'re
suggesting perhaps as a reminder against what might be certain
limitations, and I\'ve elaborated those. I won\'t elaborate them again,
but I think the universality is an issue. I think distracting \-- the
experts here, distracting information. Works well when there\'s a
pictogram for a lot of the information. Doesn\'t work well if you only
hit one, focusing only on that and get tired of reading.

So, I think it\'s a matter of balance. I think FDA did the right way.
The evidence balance \-- equation and came up with the right policy.

DR. TEMPLE: A lot of those questions sound potential of study. However
\-- I mean just as an example, you \-- if \-- if the pictogram reminded
you that, \"Oh, yeah, oh, driving,\" then it would remind you that \--
similarly about all driving and you would \-- you would, assuming
reasonable intelligence, be able to realize that it applies both to
driving a truck and a car. So \-- but it doesn\'t sound like there\'s a
whole lot of data yet on whether it can help your mind be \-- of what
you read in detail before. So, let\'s assume everybody\'s going to read
it in full detail. Still might have that function.

DR. SWEENEY: Dr. Wogalter, you mentioned a minute ago the \"Mr. Yuck\"
pictogram. How well recognized are some of these pictograms, the \"Mr.
Yuck\", the biohazard pictogram? How well recognized are these ones?

MR. WOGALTER: Well, it depends on the population. We\'ve tested \"Mr.
Yuck\" over the Spanish-speaking population \-- primarily
Spanish-speaking, very little English, and they had no idea what that
was. And they didn\'t attribute much hazard to it. And I think a lot of
people haven\'t seen that for \-- \"Mr. Yuck\" for quite a long time
now.

As far as for aviation or biohazard or some other things, those are
dealing with abstract concepts, things that are not really visible, and
it\'s very difficult to create a pictogram for something that doesn\'t
have a visual analog. You can make one for washing the hands. You could
show water and a faucet with your hands there, but there\'s a variety of
concepts that \-- that is very difficult. It\'s not likely that they\'ll
get it the first time. If they didn\'t \-- weren\'t able to read the
textual language and they didn\'t have any background training in it,
they\'re not going to know what a biohazard symbol is.

DR. SWEENEY: Well, what is the role of education in developing some
level of comprehension of pictograms?

MR. WOGALTER: Well, I think it\'s \-- it\'s a good idea to have the
education and I \-- I\'ve heard in some countries that they actually
have some video games or a kind of a video game or you can give
something like a coin in an airport and it gives you the pictorial
symbols and you try to guess what it is. And it apparently earns some
money, okay. So, that could be a way to educate folks. I think that\'s
\-- certainly there should be the education.

Let me just mention something about the warning system. The warning
system is a very broad area. It includes the mass media, brochures, you
know, variety of different things, including education that might happen
in school. Each one of them are going to hit a different kind of
population. We shouldn\'t assume that just one method is going to do it
and by itself. I\'ve run across certain situations where people don\'t
get the newspaper or they get it just on the weekends and they don\'t
watch Oprah or some of these other things. If I go into some of these
hazards or \-- you know, they have limited amount of exposure to what we
might say is mass media. And so, you have to hit them in different ways.

DR. SWEENEY: How effective are labels right now for targeting a lower
level population, people who may not have a high literacy rate? How
effective are they for that population?

MR. WOGALTER: Well, I think they\'re improved. I think that the labels
that are coming out, that have been coming out, the drug facts label,
they use simpler language and I don\'t know of anybody who\'s actually
evaluated the language. There apparently is some folks who have looked
at some of the words and gotten some of the grade levels and tried to
simplify it. There is \-- the Spanish-speaking population does not \--
unless they really are frequent words.

DR. SWEENEY: We just completed some studies on grade level analyses for
prescription drugs and I think it\'s unwise to grade level overall
without looking by semantic category. A lot of research in my lab is
about benefits versus risks, within risks specifically side effects,
let\'s say.

In the current TV ads that are running, 30 seconds, 45 seconds, or 60
second ads, we\'ve done a lot of \-- many different kinds of analyses,
one of which is the readability level which also relates to
comprehension on the auditory domain, and the readability level of the
side effects that are given is much higher, something like 10th grade or
11th grade. I think \-- yeah, it\'s 11th grade level whereas for the
benefits it\'s much lower. So, you have to look within semantic
categories within the type of information source, such as TV, Internet,
package inserts, and so forth.

DR. SOLLER: Just a general commentary that when the drug facts label was
developed industry and FDA independently brought in literacy experts to
consult on that. Part of the final rule included what is called the
interchangeability of terms with the idea of trying to go to simpler
words, those with fewer syllables. And quite a lot was done. Very
specific wording is part of that final regulation, all to help bring the
\-- the level of under \-- well, the ability of the label to communicate
to the individuals with a lower understanding of language.

DR. SWEENEY: Have there been any studies done comparing the
effectiveness of a warning label versus a verbal warning from a
pharmacist or a doctors in terms of behavioral compliance?

DR. SOLLER: I\'m not aware of any.

MR. WOGALTER: I\'m not aware either, at least as specifically as you\'ve
stated it. There are studies that have looked at auditory \-- speech
versus the printed information. And it depends on what the information
is. If it\'s a complicated message, a long message, then that\'s better
communicated via print as opposed \-- and if it\'s a short message, easy
to grasp, then the verbal \-- the speech version is \-- is sometimes
found to be better.

DR. SPILKER: In terms of the question you asked, there are so may
factors, even for a single pharmacist or a single physician, that I\'d
be very suspect about the data that they generate, just want to ask a
lot of questions. For example, a physician or for that matter a
pharmacist who\'s in a hurry is going to communicate differently than
when they have enough time. If they have some personal interest, if they
know the person they\'re talking to, if they\'re more empathetic, you
know, I mean we can go on and on.

And so, to \-- your question is a good one but I\'d be \-- I\'m not
aware of studies and I may be giving you one of the reasons why it\'s
not easy to do that, because there are so many factors involved.

DR. DAY: Also, the extent to which pharmacists actually counsel is an
interesting question. We heard yesterday about national boards of
pharmacy having this be something that all pharmacists have to do and
when a patient declines counseling they have to sign, \"I decline
counseling.\" But in fact, that part of the information is way at the
top of the page. It\'s often on a clipboard, so the clip is over what
that says there, and so people sign their name and the date, whatever it
is. Most people believe they just signed, \"I picked up this drug,\" and
they don\'t know it\'s anything about counseling.

I stand in pharmacies and watch the extent to which pharmacists talk to
patients. It\'s not very frequent.

DR. SWEENEY: One last question for me and then Dr. Marshall has a
couple. Are there any companies manufacturing over-the-counter products
that are using or contemplating using the voluntary pictograms?

DR. SOLLER: I\'m not aware of a relation to the drugs that we\'ve been
talking about at this meeting.

MR. MARSHALL: During the session we\'ve mentioned the Spanish-speaking
population several times, and I was just wondering if you could tell us
what sort of studies have been done on the cross-cultural effectiveness
of warning symbols or \--

MR. WOGALTER: Well, there really isn\'t that much on the topic. We\'ve
done a few because I\'ve had some graduate students who were interested
in that. We do have a recent grant that has \-- but it\'s dealing with
agromedicine and farmers and communicating things in Spanish or other
means to migrant workers. We\'ve done just \-- I mentioned some
pictograms earlier. They were just simplistic pictographs, and we asked
them how hazardous these pictograms connote to you? They were kind of
general pictograms: skull, the triangle-exclamation point symbol, and
\"Mr. Yuck\" and so forth.

It turns out that the skull is recognized as being a hazard symbol but
there is, I guess, another kind of anecdote that\'s described in a book
that is kind of a reading book in human factors where they use the skull
and crossbones. And the United States had put some skull and crossbones
on some grain that was sent to, actually, Iraq to the Kurds and it had
mercury. It was red-dyed. They weren\'t supposed to eat it. That was the
idea, just for planting. And they discovered that they did eat it \--
eat that because there were some droughts and things like that. And they
asked them, you know, \"What \-- what about this skull and crossbones?
Didn\'t you know what that was?\" And they just said, \"Well, it just
seemed like a nice American symbol.\" They had no idea what that was.
It\'s just like a logo.

And so, there is the problem with the \-- in other cultures. There have
been things like face memory and things like that. It\'s sometimes
difficult to cross the cultures. Now, there may be more in Europe
because ISO, the International Standards Organization, vice versa, the
name, they do require for the testing of their pictograms three
countries, three cultures to find that the pictograms are acceptable.

MR. MARSHALL: Another \-- Dr. Day, do you have anything to add to that?

DR. DAY: No.

MR. MARSHALL: Another sub-population that the Safety Board is interested
in is the older driver population since there is a growing number of
older commercial drivers. And there\'s been a lot of research,
obviously, showing that there\'s perceptual and cognitive changes that
are associated with aging. I was wondering if there was anything that we
can do or that needs to be done to make drug \-- drug labels more
comprehensible to this population?

MR. WOGALTER: I recently presented a paper at the Human Factors and
Ergonomic Society in October and we looked at over-the-counter drugs and
some different formats. It\'s kind of the older format that were out
there. And we looked at size of print, white spacing. We looked at
whether extended labels \-- that is, fold-out labels so there would be
some more information put on it. And we did a couple of different tests.
One was subjective impressions, \"Which do you like better?\" And we
also did a comprehension type of study where we handed the \-- these
containers that were manipulated on these dimensions.

And when the print was something like four point font or so we handed it
to them. A lot of the older adults couldn\'t get a thing out of it. We
even gave them questionnaires and they could look at the label and they
were not able to get anything out of it. If it was seven point font,
then they were able to get information out of it and you have a larger
size there. So, you do have to be concerned about the size.

I think in the new labels there is more of a minimum size, around six or
something like that, or at least that\'s the recommendation, which may
be okay.

DR. SOLLER: That\'s right. There\'s a six point \-- I don\'t know any
studies that would specifically address an in-use situation a pictogram
on an OTC label. There are studies \-- where a co-worker looked at the
lower literacy people and how \-- on a variety of pictograms. Found a
fair amount of miscomprehension.

But one of the things to think about that was \-- hadn\'t really thought
about it over the last two days, but dealing with the issue of
pictograms, type, size, font, et cetera remind me of this. And that is
that as you take these pictograms and start reducing them and you have a
complicated picture that you\'re trying to convey in that, I think there
is an issue that would relate to how easy it is to discern what is
actually going on in that pictogram if you have \-- and how low you can
go. And that does impact, of course, then how large you want to make it,
thereby impacting white space, amount of information that\'s not on the
label, and believe it or not, that\'s extremely important in order to
make people want to read the label. It\'s a lot \-- you\'re more
attracted to the diagram on the right side of the slide I showed than
the one that\'s just one big, big paragraph. That looks daunting.

So, these are important issues when you start filling it up with a large
pictogram so it\'s not going to be \-- soon you\'re at a label where \--
level where it\'s understood and you still have some of these other
acuity issues.

MR. MARSHALL: So, were any focus groups or any field tests used to
create the drug facts label that involved these sub-populations?

DR. SOLLER: There were studies that were done by FDA and there have been
label comprehension studies and in-use studies with the label
comprehension format \-- the format that was developed through a label
comprehension study that have been part of our \-- switch applications
that FDA\'s reviewed. I think in this room perhaps Charlie has seen more
than anybody else in terms of those types of studies.

DR. ELLINGSTAD: Okay. Thank you.

Before we go to the \-- the panels, most of this discussion has \-- has
focused on sort of a uni-dimensional, textual kinds of messages. A
little bit of Dr. Day\'s discussions of pictograms sort of hinted at
using more than one dimension but particularly redundant or partially
redundant codes. Would any of you care to comment on that? And
particularly, I\'d be interested to know whether there has been any kind
of a systematic examination of the benefits of \-- of redundant coding,
either fully or partially redundant coding? Start with Dr. Day.

DR. DAY: Oh, there\'s a lot of research outside of this content domain.
So, if you repeat something more than once, learning and memory go way
up. Repetition effects. There\'s hundreds of experiments on this.

The idea of having alternative representations of the same information
is a powerful tool as well. And the tool coding theory I mentioned
before, having linguistic and pictorial information, was developed by
Allen Pavio, and there\'s hundreds of studies on that.

My own research has looked at alternative representations of the same
information in a variety of content domains, and within the drug domain
just the extent which people know what the side effects are after they
read one of the pharmacy leaflets or the PDR, there\'s a tremendous
information overload. So, in some of the drugs you might have as many as
52 side effects listed even on just the little in-the-bag pharmacy
leaflet. And what we do is we ask people afterwards about how many side
effects were on that leaflet? And they\'ll say, oh, about seven, and
there were 52.

So, over and beyond knowing what they are, they\'re not picking up on
what the information is. But if we take and then ask them to re-recall
what they are, they can\'t remember many. But if we use more and more
sensitive tests, they can pick \-- we seem to pick up some information.
But if we take and go away from the traditional ways of displaying the
information and display it more spatially \-- there is a series of fans
and tree diagrams that people have never seen. They\'re unusual. But we
can increase the ability of people to not only learn and remember but to
know what to do if they got a side effect by 80 percent. And so, that
essentially means a decrease by 80 percent of errors that people will
make if they get a side effect: going to the ER when they shouldn\'t or
not seeking medical \-- medical attention when they should.

And these effects occur in providers and professionals as well as
patients. So, we study doctors and pharmacists and providers as well.
And although their overall performance is higher, they have more prior
knowledge, the differential effects of alternative ways to display the
same information is very powerful. Everyone benefits from some kinds of
displays as opposed to others, which tells us something about the way
that mental processes and cognition in general works.

So, yes, repetition. Yes to multiply ways to show information. But not
all ways are good ways.

MR. WOGALTER: I agree with Dr. Day. There is quite a bit of research on
multiple modalities. When you give them voice and print or pictorial and
print, basically what the results say is that if you have both it\'s
better. And it depends on the experiment which one of the individual,
whether voice or print or pictorial of print, is better when you compare
the single modality.

Also, on \-- in the ANSI standards that I mentioned earlier, which are
kind of a broad standard not necessarily for pharmaceuticals, they \--
they include some redundant cues in their warnings. For example, the
word \"caution\" is supposed to have a yellow background, so that\'s an
extra thing. Or \"danger\" has a red background. So, that\'s just extra
cues.

And people may miss one modality, as we know, and \-- and pick up on
another, so they may get information from their doctor but not read the
label or not \-- because they\'re sick or what \-- the doctor doesn\'t
give the information the way they understand. They might \-- from the
labels. Generally, more is better.

DR. ELLINGSTAD: Dr. Soller, in any of the work that you have done have
you considered redundant coding? The color example is a good one in that
other contexts, in displaying cockpit information or whatever, that kind
of \-- of redundancy within the \-- the visual mode has been effective.
Have you looked at it in this context?

DR. SOLLER: I\'m not recalling \-- I don\'t believe there were specific
comments suggesting \-- from outside parties that suggest that during
the development of the drug facts label.

I would come at it from this standpoint, if I might. There are \--
there\'s information that is suggested that there might be benefits on
one side. We\'re aware of those. We look at how the drug facts label was
developed and we consider that there are more disadvantages than
benefits to pictograms in this area. And on coloring, it would be a
similar sort of distracting mode. For example, if you had the warning
section in yellow and I think there \-- I think Giant, for example, did
that for a number of years until the drug facts labeling came through.
That is a \-- that\'s something that draws your attention right to the
warnings.

In terms of how we think how people should select the products, making
sure that they don\'t cross dose, take the ingredient that contains one
ingredient, picking up another product and taking that product that has
the same ingredient, it\'s important to have the first actives first.
Uses. That\'s how they\'re selecting. And then to go through the
warnings. So, we think that there\'s a sequential \-- I\'ll call it
\"coding\" \-- but a sequential acquisition of information that should
be done. Putting colors or pictograms within the warning section we
think would be distracting and take away from \--

DR. ELLINGSTAD: Okay. But that\'s not based on empirical data? From what
I\'m hearing, this is a judgement that \-- that someone has exercised
that it\'s not based on some empirical findings. Is that \--

DR. SOLLER: In terms of \--

DR. ELLINGSTAD: \-- a proper \--

DR. SOLLER: \-- deciding what the order of information should be, that
\-- I\'m trying to think back in terms of the studies that FDA did in
terms of different ordering. I believe that there is studies \-- I think
it was called Study A that was part of the drug facts rule that looked
at different ordering of information. So, there is some empirical
information that would support that.

Now, relative to the coloring, no, I\'m not aware of any. That yellow
box, for example \--

DR. ELLINGSTAD: Dr. Spilker, are you aware of any?

DR. SPILKER: You would not find these, that I\'m aware of, with
prescription drugs. I think that \-- I\'m sure there may be some
exceptions, but really, I\'m not aware of colors being used.

DR. ELLINGSTAD: Thank you.

We\'ll go to the parties. Let\'s start with the Pharmaceutical Industry
group.

MR. BRADLEY: I\'m Bill Bradley with the Consumer Healthcare Products
Association.

I thought it was very interesting that both Dr. Wogalter and Dr. Day
made recommendations that have now been included in the new drug facts
labels, such as chunking, bullet points, and so forth that do increase
comprehension and make labels easier to read.

I don\'t know how to turn this into a question. Dr. Day\'s presentation
seemed to show that consumers are most alert about drowsiness as a side
effect and that may have something to do with the sometimes
discrepancies we\'ve seen in theoretically how things like
antihistamines should perform and how they actually do, which they seem
in actual life to perform much better than they would in theory. Do you
have any comments on that?

DR. DAY: The study that I reported did not classify medications by OTC,
prescription, or any indications. That study was very general. It was
embedded in questions about a wide variety of products. And for that
particular \-- what are some common side effects of medications. And I
think it did say prescription medications. And we have studies in the
works now which do say \"over-the-counter medications\" and \"safe or
antihistamines\" and \-- or \"anti-depression drugs\" and so on, so
we\'ll know a little bit better. But that\'s just what is off the top of
the head when you ask them about side effects and medications in the
same sentence.

MR. BRADLEY: Thank you.

DR. ELLINGSTAD: Thank you.

The Professional group?

MR. DROBNICH: Yes. I just have a \-- a basic comment. I want to clarify
the statistic that was thrown out from NITSA. I guess if I had a warning
label it\'d be warning \"Don\'t cite NITSA statistics about drowsy
driving.\"

I want to clarify that. When NITSA did that study there was 10 states
that did not even have fatigue on the police accident report forms. So,
if you look at international studies and at population surveys such as
the National Sea Foundation\'s, five of the last six consecutive years
50 percent of Americans surveyed said that they\'ve driven drowsy in the
past year. One-fifth have actually dosed off at the wheel. And 23
percent said that they actually know someone who\'s had a crash in their
lifetime due to falling asleep at the wheel.

Now, with that said, we still don\'t know what medications is part of
that \-- that drowsiness or fatigue or drowsy driving.

But if you look at international studies, 10 to 20 percent of the crash
problem has been attributed to drowsiness.

So, I just wanted to make the point is if you\'re going to use the
statistics as a consideration when prioritizing what goes up on the
label make sure that we have all the \-- all the information.

DR. SOLLER: Oh, I \-- I take your point. I\'m \-- when I started off
with the umbrella I was funneling down, and I could \-- relative to the
point I was trying to make and what we understand in terms of
contribution of antihistamines based on the epidemiologic studies.

I would still stand by my point and take your clarification relative to
the broad statistic \-- gets us into that discussion.

MR. DROBNICH: Right. Absolutely. We have no idea, really, that I know of
of studies showing how much sedating medications are part of that drowsy
driving problem.

The \-- the caveat to that is we know about two-thirds of Americans
don\'t get proper sleep. So, if you imagine the interaction between
sedating medications and underlying sleep debts, it\'s a much larger
problem. It\'s like people walking around if they drank two beers a day
and then take a sedating medication. And we do know that when people
take medications it\'s often because of a cold or a chronic illness that
may be contributing to an already sleepy state.

DR. ELLINGSTAD: Thank you.

Let\'s go to the Union group.

MS. HEAD: No questions.

DR. ELLINGSTAD: And the Transportation Industry?

PARTICIPANT: No questions.

DR. ELLINGSTAD: The Advocacy group?

MS. TARNEY: The first question\'s for Dr. Soller. Are you aware that
highway authorities have moved strongly to the use of symbols and signs
in lieu of word messages for many sign legends because of improved
driver comprehension and with no adverse liability impacts on state
departments of transportation?

DR. SOLLER: Yeah. The issue of something like \"stop,\" which is sort of
an all or none. I could see where moving to a legend and as we have that
in terms of what becomes a necessary shorthand and a very quick
information acquisition moment is an important thing to do. But where
you have the label and the ability to read the label and take the time
to read the label as you should we think there should be full conveyance
of information and that the message should be, \"Read the entire
label.\" That\'s a very important public health message to be sure that
we don\'t short-circuit.

MS. TARNEY: Our experience in \-- in \-- the kinds of questions that we
get on our Web site often relate to questions regarding the side effects
of medication, particularly on driving. And often that information is on
the label already, which leads me to believe that people don\'t take the
time to \-- to read a whole label or the picture of a mother shopping
with a couple of kids and she\'s trying to decide which over-the-counter
medication to pick, and I think what she\'s looking for is a quick
reference to the kinds of questions she might have. \"Will this impair
me?\" And I\'d like somebody to address those kinds of issues.

DR. SPILKER: I\'d make one comment on that, although this is not just
for prescription drugs. And that is that the individual variability is
so enormous and we heard, which I totally agree with, that if any of us
are sleepy or sleep-deprived for a number of hours, that\'s going to
influence our reactions. Possibly, if you\'re taking other drugs, if
you\'ve just had a full meal, if you\'ve had some alcohol, depending
upon your mood, it can go on and on. For one individual let alone a lot
of others, yes, it would be nice to be able to do that, but these are
medically less feasible than we would wish for.

MS. TARNEY: I think we\'re trying to breach a wide gap between what is
\-- what is medically sound and what the non-medically-educated public
will often want to look for and think is sufficient to keep them safe.

DR. SPILKER: Well, no, there is another issue we haven\'t brought up
which really relates to the gap you\'re talking about, and that\'s
liability. For the companies to go out and say, \"Well, you know,
really, this product hardly ever causes it,\" and this and that,
drowsiness, so let\'s just say this is fine or let\'s go the other way.
I think you get to the point that companies have to be concerned about
liability issues and that does enter into this in different ways, I mean
not just one way. And it\'s unfortunate, but I think that\'s one way \--
one reason why companies are certainly going to be less willing to be
crystal clear as you would like to see or the consumer would like to see
when they shop for a product and they\'re picking up two things.

So, when the FDA is class labeling and the FDA has certain types of
organization for data, we in the industry think that that\'s \-- creates
more or less a level playing field. It protects us as well as I think
providing, Bill said, enough information so that when someone reads it
they can get the information they need. Unfortunately, as you rightfully
say, people want a real quick way to get the information.

MS. TARNEY: What happens to the liability issue, like, for instance, use
the example of somebody\'s gone to the emergency room and the physician
may say, \"Go to the drug store and buy some Benadryl.\" And so now
they\'ve had a referral from a medical authority and they\'re not going
to bother to read the label. What happens to the liability issue in that
case?

DR. SPILKER: I think it kind of depends upon what happens \--

MS. TARNEY: Well, assuming \--

DR. SPILKER: \-- situation.

MS. TARNEY: \-- that it\'s not a good outcome.

DR. SPILKER: Well, of course. I mean \-- well, I shouldn\'t say \"of
course.\" Benadryl may be the right product and maybe that person is
being driven to the pharmacy by their spouse or someone else, they get
the Benadryl, and it really doesn\'t work as the physician intended.

MS. TARNEY: I guess I\'m assuming that they did their own driving.

I\'d like to ask one further question. Often people comprehend or see
when they say \"Do not operate with heavy machinery,\" they see that as
a forklift or a tractor and they don\'t separate that out to a motor
vehicle. Is there any objection or recommendation to adding \"motor
vehicle\" to \"heavy machinery\"?

DR. SOLLER: If I could comment on that, that was a discussion within the
development of the final monograph for OTC antihistamines. And I believe
the first recommendation in that development was to use \"heavy
machinery\" and it was FDA\'s determination that it should be
\"machinery\" and \"motor vehicle\" does appear in the label.

DR. DAY: And I\'d like to add to that that as long as the word
\"driving\" is there the first thing that comes to people\'s mind is a
car, and I don\'t think you need to specify that. So, you can leave in
the \"machinery\" to then occlude everything else.

DR. SPILKER: But I personally react exactly as you do to the word
\"heavy machinery.\" I like the word \"machinery\" and take the
\"heavy\" out.

DR. SOLLER: That\'s \-- that\'s where it is.

MR. WOGALTER: I think that part of the problem is getting people to read
the labels, particularly for OTC drugs. I \-- I think that a lot of
folks think that after seeing advertisements and the fact that they can
get it without a prescription, they just generally think that they\'re
safe. And we \-- we\'re now in the transition from what I consider to be
pretty bad labels on lots of products into much better labels. And I
think that now when they\'re more attractive we may get some more people
to read it.

There is a down side with standardizing these labels, is that, at least
in psychology, you have the habituation phenomenon where they may be
looking at some labels for one kind of drug or a few kinds of drugs and
then they come upon one that is still an over-the-counter drug but looks
the same, basically, and then decide not to read it, it\'s safe. So, it
\-- it\'s \-- there \-- there are certainly benefits in being able to
locate the information, it\'s easier to read, but I kind of am worried
that there is going to be some situations where people said, \"Well, you
know, it\'s the same old label and I don\'t need to look at it any
further.\"

DR. SOLLER: I do have a question for you. We\'ve done surveys over quite
a number of years and typically people report that they do have a very
high \-- majority of people report that they do read the label before
using the product the first time. I wasn\'t quite sure in your comment
on downsizing \-- did I hear that?

MR. WOGALTER: Down side.

DR. SOLLER: Down side? I\'m sorry. I misunderstood. I beg your pardon.

But I think that is an opportunity that the drug facts label offers in
terms of the kind of educational programs that can help them present
this more attractive label in a way that is conveying that message \--

DR. ELLINGSTAD: And the Government group?

MR. CLARKE: I just have one quick question. In either prescription or
over-the-counter drugs, are any \-- any of these warning labels under
any circumstances say, \"Do not take,\" for example, pregnant or any \--
any set of \--

DR. SPILKER: I believe that that\'s the distinction between precaution
or warning and contraindication. Contraindication by its definition
means \"do not,\" and then it\'s usually \"Do not take if you are,\" for
example, pregnant. But you have a \-- the way to think of this, quite
frankly, is just as a simple hierarchy. So, you go from the
contraindications and precautions \-- warnings first, thank you, and
then precautions, and then adverse reactions. And so, that\'s the way
the physician certainly will look at this.

But in terms of the professional labeling, if you have labeling for
patients they will not use those words in general but a pharmacist in
those companies that make it up will say, \"Do not take if you,\" bum
bum bum, and then give some other \-- through some other English words
try to convey the distinction between something that\'s a stronger
warning or a precaution and something that\'s been a reported side
effect.

DR. SOLLER: If I \-- oh, go ahead.

DR. DAY: I was going to say, and in some cases you will see \"Do not
take if you are,\" blah blah blah blah blah blah, \"without consulting
your doctor first.\" And so, sometimes people will say \-- if you read
the first part you toss it back on the shelf or get it home and then not
take it. So, sometimes there\'s a warning that starts out one way and
goes another way. And Johann de Gier from this morning has some examples
of \-- of those where within the same warning it\'s strong one way and
then it takes it back later. So, I don\'t know \--

MR. CLARKE: I mean even that \-- even that sometimes can be better than
\-- than careful.

DR. DAY: Right. Exercise caution. By the way, some of the people in our
studies when it says, \"Use caution,\" they did not think it meant \"Do
not.\" They were going to do it anyway but they were going to be more
careful. And you know what people do when they pay alcohol, they want to
be more careful, they\'ll drive more slowly. Too slowly sometimes.

MR. CLARKE: Dr. Soller?

DR. SOLLER: Yeah, I just \-- I had a brief comment. The OTC review began
in 1972. That is some 30 years ago. And there is a huge information base
and experience and policy base within the many \"Federal Register\"
publications that came out of that.

An important aspect here is you think about what is behind the drug
facts label is that the basic warning policy is that OTC warnings should
be scientifically documented, clinically significant, and important for
the safe and effective use of the product by the consumer as a base. And
then as that has developed over the years to have a science base for
what would go into the warning section, we now have the drug facts label
that begins with, you know, in a kind of standardized way the absolute
contraindication \"Do not use.\" And there are \"Do not use\" warnings
\-- immediately come to mind right now and it doesn\'t matter, but \--
specifics.

The second one is the relative contraindication, which is ask a doctor
or ask a pharmacist before use if \-- and there\'s a drug interaction
section that basically is along those lines.

And then the next piece is in-use precautions, which typically will have
embedded in there what might be emergent signs and symptoms as a
person\'s taking care \--

So, there\'s a very \--

MR. CLARKE: So, there is a \-- there is a category, though, of \--

DR. SOLLER: Oh, yes. There\'s a category and there\'s also a \-- what I
wanted to share was that there is a very \-- very strong policy base for
how warnings are developed and put onto OTC labels.

MR. CLARKE: And I guess there\'s a hierarchy of concerns as to whether
or not it goes in the \"Do not take\" or the advisory or the warning \--

DR. SOLLER: Based on the science and in \-- yeah.

MR. CLARKE: Thank you.

DR. ELLINGSTAD: We had another question from the Professional group?

MR. GELULA: Yes, thank you. For the panel, I\'m curious. Is there any
research about the effect of warning labels when a consumer or patient
is uninsured, which is a condition of many non-unionized commercial
drivers, and they may not be able to afford the optimal medications such
as a non-sedating antihistamine? Will they heed or ignore the warning
label?

MR. WOGALTER: I don\'t know of any research on that topic.

DR. SOLLER: I agree with Dr. Wogalter.

DR. DAY: As do I.

(Laughter)

DR. ELLINGSTAD: Thank you.

This has been a very efficient panel and you\'ll notice that we\'re a
bit ahead of schedule. We do have a number of questions from the
audience which Dr. Galson will \-- will give to the panel in just a
second, but what I would like to do is \-- is alert the \-- the various
groups at the tables here that we will have an opportunity for a very
brief comment. It doesn\'t need to be lengthy, unbridled sort of a
thing, but we will be able to \-- to make a pass through all of the
groups before we adjourn, and if you have anything that you would like
to say you\'ll have a few minutes to do that.

So, we\'ll \-- we will \-- you can be thinking about that while Dr.
Galson gives the \-- the questions from the audience.

DR. GALSON: Okay. The first one to the panel is, have studies shown that
people ignore the \"Use caution while driving\" if they don\'t feel
drowsy? We sort of touched on this but is there anything more you want
to say?

DR. SPILKER: I want to comment about that, that many times whether
you\'re taking prescription or over-the-counter products people have
very simple mechanisms for avoiding drowsiness while they\'re driving.
And that is they can speak with their spouse or someone else in the car,
turn up the radio, sing, do all sorts of things to overcome or, you
know, just be, you know, thinking about different problems, working it
out. I think everyone has their own methods. But these methods I\'ve
noted anecdotally and \-- with a number of people are ways to overcome
them.

DR. GALSON: Any other responses to that?

DR. SOLLER: You asked for studies? I\'m not aware of studies.

MR. WOGALTER: There\'s a general principal in the warnings research that
if people perceive that the information is irrelevant to them they\'ll
just skip over it.

DR. GALSON: Okay. The next question is sort of \-- it\'s two parts.
I\'ll read them both. The first is, do consumers read the entire label?
We sort of touched on that. The second part is, after hearing
yesterday\'s presentations on the disconnection between drowsiness and
impairment do you think the need to find a way to explain this to the
consumer \-- in an upcoming label suggests that if you don\'t feel
drowsy you won\'t be impaired?

DR. DAY: In many of the things that I reported today we just don\'t find
that people have that causal link. Now, if you specifically ask them
about it, ask them to reason it through, they would probably come to it,
but it\'s very low in the cognitive deck. It\'s not at the top of the
deck and they don\'t pull it out and substantiate it in everyday life.

DR. SOLLER: I answered that in part earlier but I would also say based
on how we track our postmarking surveillance of our products and as we
look forward to the promise of the new drug facts label, we think we\'re
on target.

MR. WOGALTER: The first part of the question dealt with reading the
entire label and just \-- just a comment. Teaching at a university I
have students come to my office and say, \"I studied this material, I
read the material,\" and they get a D. And so, when people \-- if you
were to get from a survey, \"Did you \-- do you read the entire label?\"
it may not be an accurate assessment of whether they got the information
out of it.

DR. SOLLER: Just a comment. The experience with label comprehension and
actual risk studies that would put that label on study into actual use
has been part of the \-- improvement process for \-- in the \'90s. And
at least as far as I know, the experience with those products has been
extremely good and I think that\'s \-- that label. And the playoff on
that is the development of the drug facts label for all products.

DR. DAY: I\'d like to just comment that our XOTC switch process required
the comprehension of \-- is really wonderful. It\'s very nice to have
that. I do think there are some drugs that haven\'t made it to the
switch and it\'s partly because of whether people really understand the
information. That may not be the fault of the format, however, as
opposed to complexity of some of the drugs and what a consumer needs to
understand about his or her own age and other health conditions in order
to make the decision. So, not all drugs that have tried to go through
the process \-- prescription and OTC have made it partly based on
comprehension. It wasn\'t necessarily related to \--

DR. GALSON: Okay. Next question is addressed to Dr. Spilker in
particular, and it says, does the package insert report the extent to
which performance deficits have been found in \-- psychomotor studies or
the extent to which abnormalities have been demonstrated on
physiological studies such as sleep studies? The FDA folks may be
wanting to answer that.

DR. SPILKER: That\'s what I was going to say, that I\'m sure the FDA
group here would be in a wonderful position to chime in.

I think the first part of the answer has to do with the clinical
significance of those studies. Keep in mind when a pharmaceutical
product is tested during its investigational clinical trials, there are
often up to 100 \-- the average is supposed to be 68 clinical trials.
Many, many endpoints measured, many tests, parameters measured, and
there are often, for a variety of reasons, clinical \-- well, sorry,
statistically significant differences found between, say, one drug and
placebo or active drug control or usual therapy.

And the question for both the company and the FDA is which of those
differences are clinically significant and therefore are deemed
important enough and relevant enough to be put in the label? I would
imagine that for the most part in terms of the specific question there
would be concurrence between FDA and the pharmaceutical manufacturer. I
would imagine that when there were differences of opinion these would be
discussed and an agreement reached and then when \-- so the answer
really is when it is relevant this information would be put in the
package label.

Having said that and having read many package labels, I would say it is
not very common that this specific information that the member who asked
the question posed does make it to the label, and the conclusion would
be that any differences would have been considered minor, mild, or not
clinically significant if they\'re not present.

DR. GALSON: FDA want to add anything to that?

DR. TEMPLE: Only that while some labeling sometimes has the \-- the
qualitative statement about what the result was, say in effect on sleep
latency, Sonata for example has statements that the next day nothing
could be found on the following test. We\'ve never actually put real
numbers in like how much degree of impairment was largely because we
don\'t think it would be easy to interpret. If \-- if there ever were
something that were readily interpretable I suppose we\'d be willing to
use it.

We actually haven\'t so far put in the results of driving tests. Again,
with apologies to Dr. O\'Hanlon, but the \-- because we weren\'t sure
that told you more than the fact that the drug \-- that the drug makes
you sleepy. I\'m not totally sure that\'s true but that has been the
position up to now.

DR. GALSON: Okay. Next question is about a specific kind of label. Dr.
O\'Hanlon showed pie charts that indicate the time course of sedation.
Does the panel feel that this would be helpful to prescribers and
consumers? These were pie charts, three colors. Red was one to four
hours, yellow five to eight hours, green nine to 12 hours.

DR. DAY: I regret I wasn\'t here and didn\'t see it, but I think the
coloring in and of itself is probably not the way to do it. If there
would be a pie chart or anything else with an arrow and differential
length of the arrow, that might be more effective. So, there might be
some pictorial way to do it but I don\'t think color would do it. More
color we put in for more different reasons and so on, it just gets
confusing. But if you had, like, a full day as your circle and you had
the arrow just went a little bit versus one that went a long way, that
would probably be more \--

DR. SPILKER: I\'d like to comment that I don\'t think that a pictograph
is the way to go with this. But I commented yesterday I think that this
is important information if it is obtained and it is relevant to put in
the label so that people understand what is the expected range of
duration of effect on driving or other symptoms when they\'re deemed
relevant. I think his data were quite important.

DR. SOLLER: Just a comment. I remember that they had red and green, if
I\'m remembering the circle, and I would just ask, you know, I hadn\'t
thought about this before but you\'ve got color blindness to consider
yet again. And so, you know, some of these things seem like good ideas
and then you kind of delve in and they eventually have limitations.

DR. GALSON: And the last question is driving and heavy machinery was
mentioned on warnings. Was any thought put into operating aircraft
and/or operating boats? We sort of talked about that.

DR. SPILKER: I would assume aircraft and boats come under the category
of the machinery, heavy machinery. I think perhaps another term could be
found involving transportation. I mean I think that\'ll be confusing too
unless one can \-- you have to draw the line somewhere. And if people
say, \"Well, I know I\'m not going to operate a forklift, I\'m just
going to take out my F16 today, so\" \--

(Laughter)

DR. SPILKER: I mean you have to hope that people are wise enough to
realize that even taking out a recreation boat with a motor does count
as machinery.

DR. GALSON: Any other comments on that?

DR. SOLLER: I agree. I don\'t know that I would have done the
F16-forklift analogy, but I \--

(Laughter)

DR. DAY: I agree for a slightly different reason. If you put \"heavy
machinery\" in then people might not think of chain saws because
they\'re not heavy. So, I think just \"machinery\" without any
adjectives.

DR. GALSON: Okay. That\'s it for the questions.

DR. ELLINGSTAD: Thank you.

The Technical Panel, do you have any more? Last chance.

DR. TEMPLE: Okay. Just \-- just one. This has come up before. A lot of
labeling says use \-- you know, \"Use caution if you\'re operating heavy
machinery.\" We have collectively here reached the conclusion that
that\'s meaningless gibberish. I wonder what you all think about that?
We \-- we can\'t figure out what a person\'s supposed to take from that.
Do \-- does it mean do it carefully, think about doing it, and we\'re
fully resolved not to use that terminology anymore. I just wondered what
you thought.

DR. DAY: The answer to your answer is yes, people take all of those
possible meanings.

DR. TEMPLE: Which means it\'s meaningless gibberish, as I suggested?

DR. DAY: Not necessarily meaningless gibberish but differentially
meaningful with lots of interpretations and behaviors. So, therefore,
let\'s try to narrow the \--

DR. TEMPLE: I\'ll buy your correction but it doesn\'t transmit very
well. That\'s really \--

DR. SOLLER: Well, I \-- I\'d make the comment, if I could, that \"use
caution\" has been used in other product categories. It\'s used in the
\-- to separate dermatitis, eczema, monograph. It\'s used with the OTC
stimulants, caffeine for example. The allergy, anti-emetic. So, it\'s
used in a lot of different categories.

DR. TEMPLE: Is it clear what it means in each of those cases?

DR. SOLLER: And \-- and I think that from the standpoint of looking at
how the label is constructed where it says when using this product that
you are potentially going to get this particular side effect, it may
occur in terms of how this was constructed and how this was thought
through. And then, in a separate section that says \"use caution,\" I
think when you put that together that there is a reasonable expectation
that the consumer is going to do the right thing.

And we looked at that. We considered that and put that in relation to
the evidence that is at hand to suggest that maybe this is not working.
And I don\'t think we have it. So, we conclude that we think the label
as it was constructed has been doing a pretty good job. We\'ll actually
do a better job with drug facts labeling.

DR. TEMPLE: I guess I think you\'re posing a different question. Whether
this is as big a risk as some people think it is is worth discussing but
if we can\'t tell whether it means \-- think about getting someone to
drive you or pinch yourself a lot or open the window and sing a lot or
\-- or whatever those mechanisms, which I can assert do not work because
I have a lot of trouble at three in the afternoon and those things
don\'t help me at all.

DR. SOLLER: Well, I can tell you \--

DR. TEMPLE: I think if you can\'t figure out which of those things it
is, it\'s not communicating very well.

DR. SOLLER: Well, I can tell you I think it does. And I think it does
because you\'re informing the consumer that marked drowsiness may occur.
And if that occurs \-- so use caution when driving motor vehicle or
using machinery if that occurs. The very implied meaning is stop what
you\'re doing or decide that you\'re not going to do it to begin with.

DR. TEMPLE: But \-- but in some ways that\'s \-- that\'s the point. It
could say, \"If you\'re very drowsy, don\'t,\" which would be one
intelligent possibility, leaving aside the question of whether you do
get appropriately drowsy as a signal. It could also mean do it \-- be
unusually careful with this F16 while you\'re using it, whatever that
means. Drive it slow.

DR. SPILKER: Well, I have a \--

DR. TEMPLE: Go extra high.

DR. SPILKER: I have a possibly slightly different take on this. I do
agree with you that it does not convey much information. I think when
you look at it the biggest problem is the word \"heavy\" in terms of
heavy machinery, but why not say what you really mean? What we mean is
the risk of accidents may be greater when you\'re taking this drug and
you can describe what kind of accidents. But if you say something to
that effect, you know, people understand \-- that\'s \-- that\'s the
message, isn\'t it?

DR. TEMPLE: Well, that would leave the person free to decide how much
they\'re willing to accept and \--

DR. SPILKER: Exactly.

DR. TEMPLE: \-- accidents, which at least makes sense. But \"use
caution,\" \--

DR. SPILKER: Well, I mean \--

DR. TEMPLE: Obviously, people can disagree on this.

DR. SOLLER: Yeah, and I stated the view that as we put this together
with the experience in terms of the post-marketing surveillance and the
idea that it is even better placed, provided my opinion in terms of
thinking that it\'s doing the job.

MR. WOGALTER: I think it\'s an empirical question. I think that you need
to give that original statement, see what people are coming up with. If
it isn\'t what you intended, then try some more explicit statements.

DR. TEMPLE: I think we use it because we don\'t quite know what we
intended. We\'re somewhere between saying, \"Oh, really? Find someone
else to drive you there,\" and you know, \"Pinch yourself a lot.\" And
we haven\'t really thought about it enough yet, but I\'m sure we will.

DR. SPILKER: Well, I hope that when you \--

DR. TEMPLE: With Bill\'s help.

DR. SPILKER: I hope when you think about it you consider at least saying
what it is we all need, which is that the risk of accidents may be
higher when you are operating machineries.

DR. TEMPLE: That has clarity.

MR. MARSHALL: Yesterday we \-- we discussed several drugs that have
caused or result in multi-fold increases in risk if taken and if the
person drove afterwards. So, the question comes up is there any labeling
on any drug that actually says, \"Do not drive\"? Would you know of any
of them?

DR. SOLLER: Yes, I think there\'s prescription drugs. I don\'t have them
off hand, but as I recall going through the PDR that I remember seeing
that. But I don\'t \-- I can\'t \-- you have that information?

DR. SPILKER: I don\'t mean to be facetious and I don\'t mean it that
way, but if you are having IV barbiturates or others, you know,
obviously you\'re not going to be driving. And I think that there are a
lot of things that, you know, it\'s not necessary to say it because
people are not taking it. I defer to FDA to say if any traditional \--
for example, if you\'re taking heavy sedatives or barbiturates, I mean
do barbiturates say this?

DR. TEMPLE: We don\'t think they \-- there\'s anything that says that
absolutely, but we\'re not sure. We \-- we don\'t know of any.

DR. ELLINGSTAD: Any final questions from the Tech Panel?

(No response)

DR. ELLINGSTAD: Okay. What we\'ll do now is \-- is go and \-- and
provide an opportunity for each of the party groups to make any brief
closing comment that they would care to make. Let\'s start with the
Advocacy group.

MR. DONALDSON: I\'m sure this is just a minor note struck in the
symphony that we\'ve heard for the past few days, but I just wanted to
confirm Dr. Temple\'s remark and I\'m probably almost certainly stealing
the thunder from Darrel Drobnich over at the National Sleep Foundation.
Pinching yourself, screaming at your spouse or friend in the car,
opening the window, turning up the radio has an extremely fleeting
alerting effect and drowsiness returns very, very quickly. And the only
way to cure drowsiness is sleep, and unfortunately, a lot of people do
it behind the wheel.

DR. ELLINGSTAD: Thank you.

Government group?

MS. TARNEY: I would \--

DR. ELLINGSTAD: Oh, I\'m sorry.

MS. TARNEY: I would like to make a recommendation that we do some
further research and the combination of a written label with a pictogram
with finding what the pictogram would be. I think there are \-- still
are a number of people that will not, cannot, and don\'t take the time
to read a label or just are unable to. I think something \-- even if a
pictogram is not an ideal solution and I take the points that were made
here this afternoon, I think something is better than nothing for some
of those folks.

DR. ELLINGSTAD: Thank you.

The Government group, any concluding comments?

MR. CLARKE: First off, I\'d like to commend both the FDA and \-- and the
Board for holding this hearing. This is a \-- obviously been a \-- it\'s
a very complex subject, multifaceted, and not only in terms of
determining when and under what circumstances drugs should or shouldn\'t
be taken but also then what you do about it once you\'ve made that kind
of determination if such a determination can be made definitively.

In the \-- the overall context that we\'ve been discussing this thing
which is the transportation arena, I just might highlight again the fact
that we\'ve been mixing and matching some of our discussions here. There
is \-- transportation is \-- talked around has many aspects starting,
obviously, in terms of modes but also in terms of population size of
folks that we\'re dealing with and most importantly whether they\'re
private or commercial operators. And \-- and also whether or not \-- and
what levels of intervention, governmental intervention if you want to
look at it that way, are available in those contexts.

Clearly, aviation \-- commercial aviation is high on that list in terms
of level of control. It\'s also in terms of commercial air transport
operators of relatively small population, 100,000, thereabouts. We
probably have less than that number, 50- to 100,000, I\'m not exactly
sure, locomotive engineers. We\'re dealing with thousands of transit
operators and \-- and mariners I\'m sure it\'s on that order of
magnitude whereas in the case of commercial motor vehicle operators
we\'re talking 5, 6, 8, 10 million. I\'ve heard different numbers.

The levels of control vary between highly Federal to practically no
Federal in the case of \-- of private motor vehicle operators. There is
no direct Federal control of private vehicle motor operators \-- private
motor vehicle operators.

That\'s \-- so, as we\'re considering this whole issue in total, I think
we need to \-- to keep in mind all those facets about how we would do
anything relative to these various different populations in addition to
the risks that may be associated with them and what those interventions
\-- what appropriate interventions are in each of those cases. Thank
you.

DR. ELLINGSTAD: Thank you, Bob.

The Professional group, final comment?

MR. GELULA: Thank you. I will reiterate and agree that this has been a
great meeting and we thank you all for pulling it together. I think in
many respects it has also demonstrated that we\'re beginning in a lot of
areas to find ways to recognize how drowsiness, whether it\'s caused by
sedate \-- sedating medications or other causes, is a factor in
transportation and is a real concern.

I\'d say from the Sleep Foundation\'s perspective sedating medications
is an important issue but probably secondary to broader acts of omission
rather than commission, such as general sleep deprivation that is
pervasive in our society and has acute patterns in transportation.
Issues of untreated sleep disorders as well as the interaction with
sedating medications.

I\'d say we \-- there may have been something missing from the witnesses
which might have been a scientist with a specialty in sleep to have
introduced the interactive effect of sleep sufficiency versus sleep
deprivation, the effects of sleep disorders, and the effects of
circadian rhythms, particularly on shift \-- shift workers, which is an
endemic pattern in transportation industries.

Another point is \-- that was made that I think was very important is
that there is not always a signal of drowsiness prior to impairment.
That\'s a special concern and why we need appropriate labeling.

We feel that the modal administrations in DOT are at this time all aware
of drowsiness and sleep-related impairment, which given the relatively
short history of \-- of sleep sciences is \-- is a significant advance.
But to date there is not a sufficient priority given to this problem,
resulting in a comprehensive and consistent high priority program.
Education is a key. Labeling would only be part of the solution, so we
need both together.

Finally, we think that labeling must be informed, and one example we
would cite is the benefit \-- potential benefit of short-acting
prescription hypnotic medications for many people in the transportation
industries who have to \-- can only get sleep at times of erratic
scheduling and in very unusual circumstances. Many times trucks with \--
parked by the roadside with \-- I think we have to take those
circumstances into consideration and look at risk benefits and then form
our labeling by them. Thank you.

DR. ELLINGSTAD: Thank you.

And the Pharmaceutical Industry, final comment?

MR. BRADLEY: We represent the manufacturers and distributors of
non-prescription drugs, so our interest in this is on the
over-the-counter drug side and that would be primarily the antihistamine
as it relates to this hearing.

I think that we have seen over the past few days a lot of very
interesting information presented. And certainly, one of the things \--
yesterday we saw one of the panels unanimously agree that
over-the-counter antihistamines did not seem to be much of a problem and
we\'re glad to hear that. We also learned that indeed the Food and Drug
Administration and our industry went in the right direction with the
drug facts box, which makes the label easier to read and makes the
warnings easier to find and makes them easier to comprehend due to the
way that they\'re presented.

We also believe that any action that\'s contemplated further should be
something that is shown to be needed on the basis of the evidence. It
should be driven by data, not by anecdotes, and that anything that would
be decided would be tested. Thank you.

DR. ELLINGSTAD: Thank you.

The Union group?

MS. HEAD: First of all, I just want to thank you all for putting
together this meeting and in particular for inviting transportation
labor to participate in this discussion.

My union represents transit employees and inner city bus operators and I
think it\'s pretty clear that in both those industries there\'s a lot of
confusion and \-- about what is permissible and what \-- what
medications operators are allowed to take and continue operating.

I just want to say that we look forward to working with DOT and the NTSB
and FDA in \-- in taking steps to clarify and come up with some solid
standards as to what it is our members can and cannot \--

DR. ELLINGSTAD: Thank you.

And finally, our Transportation Industry group.

MR. MAHORNEY: I believe we all have short comments, but I\'m Bill
Mahorney with the American Bus Association. I think the things I\'ve
brought out of or at least that have really stuck in my mind the most
out of the last two days is yesterday\'s panel that included the
toxicologist that really indicated that therapeutic doses of
antihistamines and some of these types of things are not necessarily a
problem. Where the problem is is the improper use of some of these
medications. You know, that could be anything from using when you\'re
tired already to mixing them with the wrong kinds of other medications.

So, it seems to me that the way we get the most bang for our buck on
this type of thing is education. And for commercial motor vehicle
drivers, which is the folks \-- what we at this table are concerned
about is our drivers, is twofold in my view. One is educating the
physicians who perform the examinations, whether that be a certification
process, which we support. Maybe not necessarily something that is as
in-depth as the FAA but certainly some type of certification and/or
education program for those doctors that would include this type of
information that they could convey to the drivers when they come in.
Give them some basic information about what types of medications you
should be very careful when you\'re using.

And the other thing is \-- in my view is labeling of the medications
themselves, of the OTC medications. You know, pictograms, of course, you
know, intrigue me quite a bit but I think the bottom line is whatever we
can do to make the label as clear and concise as possible in order to
eliminate any possibility that whoever\'s taking that doesn\'t know what
the side effects could possibly be is the way to go. Thank you. And
thank you for \-- for inviting us here.

MR. LITTLER: Norm Littler with the United Motor Coach Association. And
first of all, I\'d like to thank the NTSB and the FDA for inviting us
here. This is an issue that we\'ve been very concerned with for a number
of years.

And over the last several days I think we\'ve learned a great deal. And
one of the things that comes out to us first and foremost is this is a
question of choice: consumer choice, informed choice versus uninformed
choice. And what we\'re seeing is several problems being highlighted
here, and one is, first of all, the prescribed medications that the
healthcare professional would prescribe and the pharmacist would
dispense. To back up my colleagues\' remarks, education is most
important. Ask the patient what they do. Determine the risks. And from
that point, then you can make the choices as to whether to prescribe a
prescription drug that will best fit in what that person does versus
possibly recommending an over-the-counter drug.

That takes us to the next question and the much more difficult one of
the OTCs. And where you have medication, where you have a situation
where somebody is self-medicating, and when you go into a store to make
that informed decision, labeling is absolutely important. But I think
before that what we \-- what we\'re seeing \-- what I heard yesterday
was the comment relating to television or radio advertising. And in
certain prescription medications now where warnings on adverse side
effects are being made on prescription medications. We see a lot of
advertising for the OTCs but we don\'t see the same level of warnings
going on them. I think that\'s something that we would \-- we would
recommend and we would like to see.

And the other thing, again going back to the media, I think that the \--
the FDA, the Department of Labor, and the Department of Transportation
jointly or individually could take the message out to the public through
the media campaign on the simply message that there are dangers present
or possible risks involved with a range of medications when you\'re
doing certain things, either operating machinery, operating motor
vehicles, or other modes of \-- transportation modes or doing other
things. And this would cross the bounds of transportation into all job
functions or even your private time, personal time.

But I think the message could go out and that could be something that
could be done relatively quickly and fairly easily. And that\'s all I
have. Thank you very much.

MR. SPENCER: I\'ll be real short because I think \-- Todd Spencer,
Owner-Operators \-- I think most of these issues I\'m going to be
covering either have been or will be.

But of course, from our perspective, education has to be the key. For
commercial operators, generally education \-- at least commercial truck
operators, education and training are largely non-existent and that is
something that should be fixed. And of course, when you approach the
subject of education I think a reasonable person should assume that any
\-- any substance you take can have an impact, a safety impact on your
ability to operate that vehicle. And of course, I don\'t \-- there \--
there are lots of things we could do and none of them will be perfect
when it comes to labeling and instructions and things like that, but to
start out knowing that there can be an impact and knowing that you
should be looking for that impact before you take it should be key and
we need to remind people to do that at every opportunity.

And of course, whether we\'re talking about over-the-counter substances
or prescription substances, the \-- the condition we\'re addressing here
is alertness or the lack thereof, and that happens for many, many
reasons. I mean just in recent years we\'ve started becoming aware of
all of these \-- all of these degrees and things are involved in sleep
and things like that, and circadian cycles are going to happen to
everybody every day whether you take substances or not. You need to be
aware of those things and the impact that that can have on at least your
ability to drive a vehicle and I would assume fly a plane and for that
matter sail a boat.

But the key things have to start with education, and I do thank this
committee for holding this hearing because I think it\'s going to be a
benefit.

DR. ELLINGSTAD: Thank you. I\'d like now before we conclude to call on
my colleague Dr. Galson to first of all give us some administrative
information about where we\'re going to be able to find all of the
information that has been assembled and to make any concluding comments
from the point of view of the FDA.

DR. GALSON: Okay. In case folks in the audience or the parties or the
witnesses feel like they haven\'t had the last word and you want to have
\-- communicate more to us, our docket on this issue is going to
continue to be open until December 17th and you can submit written
materials to us up to that date. The information on exactly how to do
that is in the \"Federal Register\" notice. If you need details, talk to
the FDA staff in the back of the room or as you go out at the table.

We\'ve enjoyed this meeting tremendously. I want to thank everybody for
the time you\'ve invested in letting us be aware of your views, and
we\'ll take what we\'ve heard very seriously in \-- in making any policy
decisions in the future on this issue, so for the FDA, thanks a lot.

DR. ELLINGSTAD: Thank you. On behalf of the Safety Board, I\'d like to
extend our thanks to all of the parties who have participated and kept
our \-- our witness panels hopping, to all of the witnesses who have
explored these issues. This is \-- has been very \-- very informative.
To \-- to the \-- those of you that have come and watched the
proceedings and submitted your questions, we also appreciate that.

I\'d particularly like to \-- to thank the folks from both the FDA and
the Safety Board who have served on our Technical Panel and done all of
the \-- the real heavy lifting to get this \-- this whole activity
underway and to \-- and to carry it off. At the risk of \-- of \-- of
bruising any other egos, I \-- I do need to \-- to particularly
acknowledge Mitch Garber for the \-- the efforts that he has made.

Our \-- our support staff, Carolyn and Mary, I appreciate that \-- all
of the work that you\'ve done.

And Steve, appreciate the opportunity to work with you.

Thank you all very much. We will take the information that we\'ve
obtained from these two days. It\'s probably going to take us a little
while to \-- to weigh and examine it, but I think that it will have a
beneficial outcome for transportation safety. Thank you all.

(Whereupon, at 3:27 p.m., the meeting was concluded.)