Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
State 	 Pharmacy  Boards  Oversight  of 
Patient  Counsebng  Laws 
JUNE  GIBBS  BROWN 
Inspector  General 
August 1997 
OEI-01-97-00040  OFFICE  OF INSPECTOR  GENERAL 
The mission  of the Office of Inspector  General  (OIG), as mandated  by Public Law 95-452,  is to 
protect  the integrity  of the Department  of Health and Human  Services programs  as well as the 
health and welfare  of beneficiaries  served by them.  This statutory  mission  is carried  out through  a 
nationwide  program  of audits,  investigations,  evaluations,  sanctions,  and fraud  alerts.  The 
Inspector  General  informs  the Secretary  of program  and management  problems  and recommends 
legislative,  regulatory,  and operational  approaches  to correct them. 
OFFICE  OF EVALUATION  AND INSPECTIONS 
The OIGs Office of Evaluation  and Inspections  (OEI) conducts  short-term  management  and 
program  evaluations  (called inspections)  that focus on issues of concern  to the Department,  the 
Congress,  and the public.  The inspection  reports  provide  findings  and recommendations  on the 
efficiency,  vulnerability,  and effectiveness  of departmental  programs. 
OEIs Boston Regional  Office prepared  this report  under  the direction  of Mark R. Yessian,  Ph.D., 
Regional  Inspector  General.  Principal  OEI staff included: 
Boston Region  Headauarters 
Kenneth  Price  Jennifer  Antic0 
Elise Stein 
To obtain a copy of this report,  contact the Boston Regional  Office by telephone  at 
(617) 5651050  or by fax at (617) 565-3751.  Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
State 	 Pharmacy  Boards  Oversight  of 
Patient  Counseling  Laws 
JUNE  GIBBS  BROWN 
Inspector  General 
August 1997 
OEI-01-97-00040  EXECUTIVE  SUMMARY 
PURPOSE 
To assess State pharmacy  boards  oversight  of State patient  counseling  laws. 
BACKGROUND 
-ICATION  AS A NATIONAL PROBLEM 

Adverse  drug reactions  associated  with the misuse of prescription  drugs are widespread. 
They  reduce  the quality  of health  care received  by millions  of people.  They  also add as 
much as $100 billion  a year to health  care costs. 
Pharmacists  can help address  this problem--by  serving  as a last line of defense  to identify 
and correct  prescription  errors  and by providing  patients  with oral and written  information 
to improve  their  understanding  and use of prescription  drugs.  This patient  education  role 
has been of longstanding  interest  to The Food and Drug Administration  (FDA) and is 
central  to a public-private  prescription  information  program  recently  approved  by the 
Secretary  of the Department  of Health  and Human  Services  (HHS). 
STATE PATIENT COUNSELING LAWS HAVE QUESTIONABLE EFFECTS 

In  1990, Congress  required  that pharmacists  offer  to counsel  Medicaid  beneficiaries  who 
present  prescriptions  and that States establish  counseling  standards.  Nearly  all States 
responded  by passing  patient  counseling  laws that extend  to all patients,  not just  Medicaid 
beneficiaries.  They  look  to State pharmacy  boards  to oversee  compliance  with the laws. 
Recent  survey  results  suggest that the offer  to counsel  often  is not extended.  Worse  yet, 
investigations  conducted  by  shoppers  pretending  to be patients  reveal  that pharmacists 
often  fail to warn patients  about drug interactions  that could be harmful  or even fatal. 
Our inquiry,  based primarily  on a survey  of State pharmacy  boards,  focuses  on the 
performance  of the boards  in ensuring  compliance  with patient  counseling  laws. 
FINDINGS 
Statephamtacy boards have played an active role in explaining and urging pharmacist 
compliance withStatepatient counseling laws. 
During  the past year,  38 of 46 responding  boards  conducted  educational  efforts  directed  to 
pharmacists. 
The boards  have carried  out three  major types of educational  activities.  They  include:  (1) 
the distribution  of newsletters,  (2) the presentation  of information  at professional 
association  meetings,  and (3) the provision  of information  during  inspection  visits. 
1  However, the boards enforcement of the counseling laws has been minimal. 
They  have  made little  use of  shopping  visits,  whereby  board  representatives  pose as 
patients  to assess compliance  with counseling  requirements.  In the past year,  only  17 of 
46 responding  boards  made such visits.  Generally,  they were made only  to pharmacies 
against  which  a complaint  had been lodged. 
They  have relied  on inspection  visits as the major  means of enforcement.  Such visits  are 
conducted  with widely  varying  degrees  of frequency.  At best they  offer  limited 
opportunities  for assessing  the extent and adequacy  of counseling. 
They  have taken  few final,  formal  disciplinary  actions  involving  violations  of patient 
counseling  laws.  Of the 354 actions  taken during  the past year by 23 reporting  boards, 
208 (59 percent)  were in just  3 States. 
The boards identified major obstaclesto the successful implementationof patient 
counseling ikws. 
ECONOMICS OFPHARMACY  PRACTICE.  About three-fourths  of the boards 

noted  as a major  obstacle  the limited  reimbursement  for counseling 

services;  about one-half  noted the lack of pharmacy  owners  commitment  to 

counseling.  Workload  pressures  on pharmacists  often  too great  to allow  for 

routine  counseling. 

IJMITED PATIENT DEMAND.  About 60 percent  of the boards  underscored 

the lack of patient  knowledge  about the patient  counseling  requirements. 

Patients  often reluctant  to spend the additional  time counseling  would 

require. 

LACK OF RESOURCESFOR ENFORCEMENT.  Cited by close  to one-half  of 

the boards  as a major  obstacle.  Insufficient  staff support,  especially  for 

labor  intensive  shopping  investigations.  Complaints  about  having 

responsibility  for enforcing  Federal  Medicaid  counseling  requirements 

without  additional  funding. 

RECOMMENDATIONS 
The HHS Secretary  and the FDA are committed  to a public-private  prescription 
information  program  that by the year 2000 will result  in at least 75 percent  of the 
individuals  receiving  new prescriptions  being given  useful patient  written  information. 
The Health  Care Financing  Administration  (HCFA) is committed  to Federal-State  efforts 
that will result  in full adherence  to Medicaid  patient  counseling  requirements. 
Pharmacy  boards,  through  their oversight  efforts,  have a vital  role in ensuring  that 
progress  is made in providing  individuals  with useful written  and oral  information.  Our 
review  indicates  that there  is much room  for progress  in State oversight  efforts  and that 
11  major obstacles  impede  the integration  of counseling  into pharmacy  practice.  We offer 
two sets of recommendations  intended  to address this situation--one  to FDA,  the other  to 
HCFA. 
The FDA should collaboratewithStatepharmacy boards to collect survey data on the 
usefulness of writteninformation offered to patients receiving new prescriptions. 
Pharmacy  boards,  in concert  with FDA,  could conduct  shopping  efforts  to a sample of 
pharmacies  to determine  the extent and type of information  being  offered  to patients.  A 
joint  effort  of this kind would  help FDA carry  out its responsibility  to measure  progress 
being  made in offering  useful  written  information  to patients.  At the same time,  it 
would  facilitate  State board  oversight  of counseling  law provisions  governing  the provision 
of both oral and written  information. 
The HCFA shouldfacilitate State efforts to enforce the Medicaid patient counseling 
mandate. 
Working  in partnership  with the States and the above-noted  HHS agencies,  HCFA  could 
take the following  initiatives: 
DEVELOP AND ASSESSSTATE PROGRESS TOWARD  A PATIENT COUNSELJNG 
PERFORMANCE  OFUECTIVE. This  objective  could resemble  the year  2~ 
objective  noted above.  The States annual  drug utilization  review  reports 
could  reflect  progress  made in meeting  it. 
DEVELOP GUIDELINESON STATE OVERSIGHT OF THE FEDERAL PATIENT 
COUNSELING MANDATE.  Such guidelines,  incorporating  best practices 
currently  being  carried  out by the States,  could  help State boards  in 
developing  cost-effective  enforcement  approaches. 
COMMENTS  ON THE DRAFT  REPORT 
Within  the Department,  we solicited  and received  comments  on the draft  report  from 
FDA,  HCFA,  the Health  Resources  and Services  Administration  (HRSA),  and the 
Assistant  Secretary  for Planning  and Evaluation  (ASPE).  From  external  organizations,  we 
requested  and received  comments  from the National  Association  of Boards of Pharmacy, 
the Citizens  Advocacy  Center,  Public  Citizens  Health  Research  Group,  the American 
Pharmaceutical  Association,  the National  Association  of Chain  Drug  Stores,  the National 
Community  Pharmacists  Association,  and the American  Society  of Health-System 
Pharmacists.  We include  the complete  text of comments  in appendix  C.  Below we 
summarize  the major  thrust of the comments  on our recommendations  and,  in italics,  offer 
our responses.  We made a number  of minor  edits in the report  in response  to comments. 
.. . 
111  FDA,HCFA,HRSA, AND ASPE COMMENTS 

The FDA,  HCFA,  and ASPE concurred  with our recommendations.  In our drafi report, 
we suggested that one initiativethatHCFA could take infacilitatingState efforts to 
enforce the Medicaidpatient counseling mandatewouldbe to facilitatethe convening of a 
nationalsymposiumon oral counseling by pharmacists.n In thisfinal report, we have 
eliminatedthatsuggestion because pharmacy associationshave decided to sponsor such a 
symposiumin September 1997.  We stillsuggest, however, thatHCFA pay careful 
attentionto the issues raised in the symposiumand that it exert leadership in examining 
and even showcasingconstructivewaysof addressing the major obstacles to patient 
counseling thatwe ident@ed in this report. 
The HRSA did not comment  specifically  on the recommendations,  but it noted  that the 
draft  report  made it appear  that it was the responsibility  of the State pharmacy  boards  to 
enforce  the Federal  Medicaid  patient  counseling  requirement.  We modifiedthe 
introductorytext to clan3  thatStatestypicallyhave relied upon the boards as the 
enforcement armfor both Federal and Statecounseling laws. 
EXTERNAL ORGANIZATIONS COMMENTS 

These  comments  serve as an important  complement  to our report.  They  add useful 
perspective,  especially  with respect to the obstacles  to patient  counseling.  The 
associations  tend to emphasize  the need for Federal  initiatives  to address  these obstacles 
(especially  with respect  to the economics  of pharmacy  practice)  while  more generally 
expressing  their concern  about any broadening  of the Federal  role.  The consumer-based 
organizations  call for stronger  Federal  action  in ensuring  that patients  are adequately 
informed.  We are sensitiveto the scope of the obstacles inhibitingoral counseling by 
pharmacistsand to the primary role of Stategovernmentin enforcing existing counseling 
laws. At the same time, we must reemphasizethatour survey reveals that the enforcement 
of Federal and Stateoral counseling lawshas been minimal. It is vital, we believe, for 
both levels of governmentto give greater attentionto the implementationof these laws and 
to suppon  shoppingand other techniquestowardthat end. 
iv  TABLE  OF  CONTENTS 
PAGE 

EXECUTIVESUMMARY 

INTRODUCTION  ........................................... 

FINDINGS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...4 

Boards  Active  in Conducting  Educational  Outreach  . . . . . . . . . . . . . . . . . . . .  4 

Boards  Enforcement  of Counseling  Laws is Minimal  . . . . . . . . . . . . . . . . . .  5 

Boards Identify  Major  Obstacles  to Patient  Counseling  Laws  . . . . . . . . . . . . . .  6 

RECOMMENDATIONS  ......................................g 

CO~~MENTS~N~EDRAFTREPORT  ..,......................  10 

APPENDICES 

A:  Survey  of State Pharmacy  Boards  .............................  A-l 

B: The MedGuide  Effort  ....................................  .B-1 

C:  Complete  Comments  on the Draft  Report  .........................  C-l 
D: Endnotes  ............................................  D-l  INTRODUCTION 

PURPOSE 
To assess State pharmacy  boards  oversight  of State patient  counseling  laws. 
BACKGROUND 
Mismedication  as a National Problem 
Mismedication  is a major  national  problem.  It contributes  to adverse  drug reactions  that 
severely  impact  the quality  of health  care received  by millions  of persons,  particularly  the 
elderly.  It also adds greatly  to health  care costs.  Costs associated  with the waste in 
misused drugs and the results  of not receiving  intended  therapy  have been estimated  to 
account  for as much as $100 billion  a ~ear.~ 
Patient  failure  to comply  with a prescribed  drug regimen  is one factor  responsible  for this 
problem.  Studies have  shown that noncompliance  rates average  between  30 and 50 
percent.3  But there  are also other  important  contributing  factors,  such as the inadequate 
prescribing  and dispensing  of drugs.4 
Pharmacists  as Counselors 
In hospitals  and nursing  homes,  pharmacists,  working  collaboratively  with physicians, 

have long played  important  clinical  roles.  In community  pharmacies,  the barriers  to such 

roles  have been imposing  and the practice  of clinical  pharmacy  has been less 

pronounced.  But with the advances  in computer  technology  and software,  community 

pharmacists  have ready  access to drug product  information  that can be helpful  to patients. 

In many cases,  they also have access to patient  profile  information  that can help guide 

pharmacist  counseling  of patients. 

Thus,  pharmacists  are in a key position  to help address  the mismedication  problem  noted 

above.  In one sense,  they  can serve as a last line of defense,  to identify  and correct  any 

prescription  errors  at the point  of dispensing.  In another,  they can act in a proactive 

manner  as a part of the patient  care team to foster better patient  understanding  and use of 

prescription  drugs. 6  Such a role is in accord  with the Food and Drug  Administrations 

longstanding  efforts  to increase  patient  information  about prescription  drugs.  It is also in 

accord  with the prescription  information  action  plan recently  developed  by a broadly  based 

task force and approved  by the Department  of Health  and Human  Services  (see appendix 

A). 
 State Patient Counseling  Laws 
In  1990, Congress  underscored  the counseling  role of pharmacists  by including  it as one 
of the components  of the Drug Utilization  Review  requirements  it incorporated  into  the 
Medicaid  program.  It stipulated  that pharmacists  must offer  to counsel  each Medicaid 
beneficiary  who presents  a prescription  and that State governments  must establish 
standards  for the counseling  of these individuals.7 
Nearly  all States responded  by enacting 
patient  counseling  laws that applied  not  STATE  PATIENT  COUNSELING  LAWS 
only  to Medicaid  beneficiaries,  but to all 
consumers.  The scope of the laws is  States 
Delivery 
limited.  For instance,  in most States an 
Offer  must be made  verbally  17 
offer  to counsel  can be extended  in a 
Counseling,  when  performed,  must 
written  form  handed  to the patient  by a  be face-to-face  by pharmacist  46 
pharmacy  technician.  Nevertheless,  the  Scope 
Inclusive  of all ambulatory  patients  42 
laws have  served  to heighten  the 
Inclusive  of refills  17 
professional  roles  and responsibilities  of 
Content 
community  pharmacists.  The States 
Mandate  patient  profiles  43 
typically  have given  the responsibility  of  Mandate  minimum  set of information  9 
enforcing  the laws to State Boards of 
Source: Derived from information compikd  by the National 
Pharmacy,  the entities  responsible  for 
Associatioo  of Boards of Fhannacy, 1996. 
licensing  and,  where  necessary, 
disciplining  pharmacists. 
Questionable  Effects  of the Laws 
The actual effects  of the laws in fostering  useful patient  counseling  remains  questionable. 
For  instance,  a July  1994 survey  conducted  by the National  Association  of Boards of 
Pharmacy  indicated  that patients  reported  offers  to counsel  only  38 percent  of the time.8 
Another  survey  conducted  at about the same time by the New York City  Office  of the 
Public  Advocate  found that only  42 percent  of independent  community  pharmacists  and 27 
percent  of chain  pharmacists  extended  offers  to counsel.9 
One of the most troubling  and widely  publicized  signs that the laws may not be having  the 
intended  effect  was provided  in August  1996 in a national  news magazine  under a cover 
story entitled:  Danger  at the Drugstore:  Pharmacists  are your  last defense  against  risky 
drug interactions.  Too  many are blowing  it.l  The  story  was based on the efforts  of 
reporters  who posed as consumers  seeking  to fill combinations  of prescriptions  which 
would be dangerous  or even deadly  if taken together.  In the 245 pharmacies  visited  in 7 
cities,  more than one-half  of the pharmacists  failed  to warn  the reporters/consumers  of the 
risks associated  with  mixing  the drugs.  A similar  study conducted  earlier  in the District 
of Columbia  by researchers  at Georgetown  University  Medical  Center  found  that more 
than 30 percent  of the pharmacists  filled  the prescriptions  without  any warning. 
2 
 This Inquiry 
This inquiry  focuses on the role of State pharmacy  boards  in overseeing  compliance  with 
State patient  counseling  laws.  It is based on the premise  that effective  oversight  can help 
foster  the intent  of the laws.  It sets forth  the extent and nature  of the boards  educational 
and enforcement  efforts,  and closes  with a review  of what board  officials  regard  as major 
obstacles  to successful  implementation  of the laws. 
The information  we present  comes from three  sources.  The primary  source is a survey 
we conducted  of all State pharmacy  boards  in the country.  We administered  the survey 
from November  1996 through  January  1997. We sent questionnaires  to 51 boardsI  and 
received  responses  from 46 of them,  representing  a response  rate of 90 percent.  (The 
survey  results  appear  in appendix  A). I3 The  second  source is telephone  interviews  with 
board  officials  in  12 to  15 States.  Typically,  we initiated  these interviews  to obtain  some 
elaboration  on information  provided  on a returned  questionnaire.  Finally,  mainly  for 
context,  we draw on a review  of pertinent  reports  and literature  concerning  patient 
counseling  by pharmacists  and concerning  problems  associated  with  misuse of prescription 
drugs. 
We conducted  this inspection  in accordance  with the Quality  Standards  for Inspections 
issued by the Presidents  Council  on Integrity  and Efficiency. 
3 
 FINDINGS 

State pharmacy  boards  have played an active role in explaining and urging 
pharmacist  compliance  with State patient counseling laws. 
b 	 During  the past year,  38 of 46 responding  boards  (83 percent)  have conducted 
educational  efforts  intended  to help pharmacists  understand  or carry  out the laws. 
Among  these 38 boards,  28 have carried  out three  or more different  types of 
b 	
educational  efforts.  Typically,  they have involved  the preparation  and distribution 
of newsletters  and other written  materials,  the presentation  of information  at 
professional  association  meetings,  and the provision  of information  during 
pharmacy  inspection  visits. 
This  educational  thrust of the boards  is most apparent  in the newsletters  which  they 
typically  send to all pharmacists  in their  States.  Through  these newsletters  they  explain 
the key elements  of the counseling  law and remind  pharmacists  of the importance  of 
counseling  and how they  might overcome  some of the barriers  associated  with  it.  A 
particularly  notable  example  of such educational  outreach  was an issue of the California 
boards  newsletter.  Drawing  on information  from the California  Pharmacists  Association 
and the California  Society  of Health  System Pharmacists,  it spelled out how pharmacists 
in seven different  settings  have implemented  pharmaceutical  care by emphasizing  patient 
counseling  and pain  management. l4 
Through  appearances  at professional  association  meetings,  the boards  get out the same 
message in a more personal  way,  with opportunity  for give and take.  The Texas board 
was particularly  active  in this regard,  having  made during  the past year  29 presentations 
that reached  4,000  pharmacists.  The Virginia  board  held four public  forums  that 
addressed  how pharmacists  workloads  affect  their ability  to comply  with counseling 
requirements  and to prevent  dispensing  errors.  The Arizona  board  developed  and 
provided  for continuing  education  credit  at professional  meetings  a live  2 to 3 hour 
program  specifically  aimed  at preventing  dispensing  errors  through  patient  counseling. 
Even  more personal  and direct  are the face-to-face  exchanges  that pharmacy  inspectors 
and pharmacists  engage  in during  the course  of board  inspections  of individual 
pharmacies.16  During  these inspections,  boards  are primarily  focused  on compliance,  but 
at least with respect  to the counseling  law they also tend to be attentive  to the educational 
opportunity  afforded  by their  visit.  They  reinforce  the intent  of the counseling  law, 
answer  questions  concerning  it, and sometimes  leave informational  materials. 
In contrast  to the above  efforts  directed  to pharmacists,  boards  have devoted  much less 
attention  to educating  patients  about the counseling  laws.  Of 46 responding  boards,  only 
11 (24 percent)  undertook  any  such initiatives  during  the past year.17  However,  some 
notable  efforts  have been made and more are being  developed.  The New York,  Texas 
4  and California  boards  have prepared  information  brochures  directed  to consumers.  The 
Nevada board  produced  a series of public  service  announcements.  The Louisiana,  Ohio, 
and other  boards  are preparing  informational  postings  on the Internet.  And the 
Massachusetts  board,  at this writing,  is preparing  a guideline  that will require  all 
pharmacies  to post a sign informing  consumers  of their  right  to counseling. 
The boards  enforcement  of the counseling laws has been minimal. 
They  have  made little  use of shopping  visits,  whereby  representatives  of 
b 	
pharmacy  boards  pose as patients  to assess compliance  with counseling 
requirements.  During  the past year,  only  17 of 46 responding  boards  (37 percent) 
made such visits--generally  only  to pharmacies  against  which  a complaint  had been 
lodged. 
Shopping  visits  to pharmacies  are an excellent  enforcement  tool to determine  if and how 
well pharmacists  are counseling  patients.  The Georgetown  Medical  School,  as we noted 
earlier,  used this approach  to help draw attention  to the fact that pharmacists  often  do not 
provide  a sufficient  front  line  of protection  for patients.  The pharmacy  boards,  however, 
make little  use of this mechanism.  Most do not use it at all;  most of the others,  do so 
sparingly.  In a few cases,  legal concerns  about entrapment  seem to inhibit  its use.  Much 
more often,  the limited  resources  available  to the board  serve as the restraint.  Shopping  is 
a labor-intensive  activity  that can be quite costly  if used on other  than a highly  selective 
basis. la 
Thus,  even among  the  17 boards  citing  some recent  experience  with  shopping,  only  a few 
have used the technique  in a proactive  manner,  randomly  visiting  pharmacies  in the State. 
And even in those cases,  relatively  few pharmacies  were visited.  Shopping,  to the 
limited  extent  it is practiced  by the boards,  is used essentially  as a tool  of investigation  of 
pharmacies  that are the focus of special concern.2o 
b 	 Boards have relied  on inspection  visits  as the primary  means of enforcing  patient 
counseling  laws.  Such visits are conducted  with widely  varying  degrees  of 
frequency  among  the states and even at best offer  limited  opportunities  for 
assessing  the extent and adequacy  of counseling. 
During  these visits,  inspectors  must examine  many different  elements  associated  with the 
practice  of pharmacy. 21 They  include,  among  other  things,  the adequacy  of the facility 
itself,  of the records  and record-keeping  procedures,  of the prescription  drug inventory,  of 
the compounding  practices,  and of interactions  with patients.  The latter  involves  some 
tangible  elements  that can be examined,  such as the physical  area  set aside  for counseling 
or the type of written  material  distributed.  But the dynamics  of offering  to counsel  and 
then actually  counseling  are much less conducive  to assessment.  Pharmacy  inspections  are 
usually  unannounced,  but we are told that once the inspectors  appear  on site, pharmacy 
staff tend to be well aware of their presence.  Accordingly,  one board  official  noted: 
Some of the best counseling  in our State goes on when the inspectors  are around. 
5 
 How often the inspectors  are around  in any particular  pharmacy  varies  greatly  from  State-
to-State.  Among  46 reporting  boards,  8 (all among  the least populated  States) indicated 
that during  the past year  they had conducted  site visits  to all of the pharmacies  in their 
State.  On the other  hand,  7 reported  conducting  no such visits  and 8 (most among  the 
most heavily  populated  States) reported  visits to less than 50 percent  of the pharmacies. 
b 	 They  have taken  few final,  formal  disciplinary  actions  involving  violations  of 
patient  counseling  laws.  Of the 354 actions  taken during  the past year by 23 
reporting  boards,  208 (59 percent)  were in just  3 States. 
Pharmacy  board  officials,  as we will  note below,  recognize  the substantial  constraints  that 

limit  the potential  effectiveness  of the patient  counseling  laws.  Some also appear  to 

believe  that too punitive  an approach  to enforcement  could be counterproductive. 

Whatever  the rationales,  the data we collected  indicate  that in most States the boards  have 

taken  few if any final,  formal  disciplinary  actions  against  pharmacists  for reasons  that 

relate  at least in part to violations  of patient  counseling  laws.  Further,  of the actions 

taken,  only  a small percent  have involved  anything  other  than a fine or reprimand. 

A number  of boards  note that while  they invoke  few if any  formal  disciplinary  actions  that 

concern  counseling,  they  do take informal  actions,  which  serve as warnings  to pharmacists 

who they  found were not sufficiently  attentive  to patient  counseling.  Such warnings, 

board  officials  note,  can be an effective  way of reminding  the pharmacists  and the 

pharmacy  managers  of the intent  of these laws. 

The Boards  identified  major  obstacles to the successful  implementation  of patient 
counseling  laws. 
Economics of Pharmacy Practice.  The most significant  obstacles,  according  to the 
boards,  is the economic  reality  of pharmacy  practice  in environments  where  payers  are 
squeezing  operating  margins  and pharmacies  are consolidating,  often  as part of large 
national  chains.  Thus,  about three-fourths  of 44 responding  boards  cited as a major 
obstacle  the limited  reimbursement  for counseling  services  and about one-half  of 45 
boards  - the lack of owners  commitment  to counseling.22  Making  a point  reiterated  by 
many of his colleagues  in other  States,  one board official  said:  Staffing  in corporate 
pharmacies  is simply  insufficient  to allow  routine  counseling.   The workload  pressures  on 
individual  pharmacists  are simply  too great.23 
Limited Patient Demand.  The demand  side, boards  emphasized,  must not be overlooked. 
About  60 percent  of 45 responding  boards  underscored  that a major  obstacle  was a lack of 
patient  knowledge  about the counseling  requirement;  about one-half  stressed  the lack of a 
suitable physical  area for counseling  as a major  impediment. 
In their  comments  to us, boards  surfaced  two other,  perhaps  more basic  factors  inhibiting 
patient  demand.  One is that many patients  tend to overlook  the vital  importance  of drug 
information  and just  assume that their physicians  and pharmacists  will  not allow  anything 
bad to happen  to them.  Another  related  factor  is that patients  do not want to spend the 
6  extra  time that counseling  entails.  The entire  counseling  process,  said one board 
official,  is new and not within  what most patients  consider  traditional  practice.  Even 
when asked,  they will refuse. ~4 Of course,  the relatively  limited  educational  outreach 
efforts  of boards  (and other  entities)  do little  to change  this patient  perspective. 
Lack of Resources for  Enforcement.  Finally,  boards  stressed  that insufficient  resources 
are a major  factor  impeding  their  enforcement  of patient  counseling  efforts.  Close  to one-
half of 45 responding  boards  identified  it as a major  obstacle.25  They  stress that they 
have insufficient  staff to engage  in the long and tedious  process  of identifying  those 
pharmacists  and pharmacies  that are not complying  with the counseling  laws and,  where 
necessary,  accumulating  enough  evidence  to serve as the basis for disciplinary  action. 
One particularly  irksome  concern  to some boards  is that without  any additional  funding 
they are expected  by the State Medicaid  agency  to serve as the chief  entity  responsible  for 
enforcing  the Federal  counseling  requirement  directed  to Medicaid  beneficiaries.  Boards 
note that while  the Medicaid  agency  gets Federal  reimbursement  for a share of their  costs, 
none of that reimbursement  gets passed on to them. 
On the other  hand,  a few officials  noted developments  that may contribute  to increased 
interest  attention  to counseling,  One is the acceleration  of automation  efforts  that can free 
up more pharmacist  time for counseling.  Another  is the threat  imposed  by large 
malpractice  settlements  in cases involving  drug dispensing  errors.26 
7 
 RECOMMENDATIONS 

There  is a substantial  Federal  interest  in effective  implementation  and enforcement  of 
patient  counseling  laws.  The HHS Secretary  and the FDA are committed  to public-private 
efforts  that will  result by the year 2000 in at least 75 percent  of the individuals  receiving 
new prescriptions  being  given  useful written  information.  The HCFA  is committed  to 
Federal-State  efforts  that will result  in fulfilling  the intent  of the Medicaid  patient 
counseling  requirements  established  by Congress. 
At the State level,  the pharmacy  boards  serve as the main body  responsible  for overseeing 
pharmacists  compliance  with the Federal  and State patient  counseling  laws.  Our review 
indicates  that there  is much room  for improvement  in State oversight  efforts  and that there 
are major  obstacles  to the full-fledged  integration  of patient  counseling  into pharmacy 
practice.  We offer  two sets of recommendations  intended  to help address  this situation. 
One is directed  to the FDA;  the other  to HCFA.  They  follow: 
The FDA should collaboratewithStatepharmacy boards to collect survey d&a on the 
usefulness of writteninformation offered to individualsreceiving new prescriptions. 
The FDA is completing  a survey  assessing  the extent  to which  patients  are being  given 
written  information  when receiving  new prescriptions.  To assess the  usefulness  of the 
information  being  offered,  it will be conducting  another  survey.  This  survey  effort  offers 
a prime  opportunity  for the FDA and pharmacy  boards  to work collaboratively  to foster 
mutual interests  in patient  counseling. 
In particular,  we suggest that a number  of boards,  working  in concert  with FDA,  conduct 
shopping  efforts  to a sample of pharmacies  to determine  the extent and type of 
counseling  being  offered  to patients.  In conducting  these visits,  the boards  could  obtain 
information  that would help them ensure compliance  with their  States own patient 
counseling  laws and at the same time collect  and send to FDA the written  information  that 
pharmacists  provided  to the  shopper.   The FDA could  then assess the usefulness  of this 
information  in accord  with the criteria  established  in the prescription  information  action 
plan  approved  by the HHS Secretary  (see appendix  B). 
The prospects  for a successful  cooperative  effort  of this kind would appear  to be good. 
Pharmacy  boards  have already  been working  with FDA in helping  to enforce  FDA 
regulations.  Moreover,  many board  officials  have been commissioned  by FDA.  This 
entitles  them with access to communications  and information  that would  otherwise  be 
considered  confidential. 
8 
 The HCFA should facilitate  State effoortsto enforce  the Medicaidpatient counseling 
mandate. 
The lead role  in carrying  out this mandate is with the States.  But given  the partnership 
nature  of the Medicaid  program,  HCFA,  the above-noted  HHS agencies,  and the State 
governments  (including  State Medicaid  agencies  and State pharmacy  boards  or their 
national  federation)  should work  together  cooperatively  in fostering  their  common  interest 
in patient  counseling.  Toward  that end,  we suggest two initiatives  which  HCFA  could 
undertake: 
Develop and assess Stateprogress towarda patient counseling petionnance  objective. 
Ideally,  this objective  would closely  parallel  the performance  objective  which  the 

Secretary  has already  endorsed  calling  for 75 percent  of patients  by the year  2ooO to 

receive  useful written  information  and which  the FDA is monitoring.  (Given  the nature  of 

the Federal  mandate,  however,  it probably  should address  oral as well as written 

information.)  The HCFA  could amend its Drug Utilization  Review  annual  report 

instructions  to State Medicaid  agencies  to require  State updates,  based on survey  data,  of 

progress  being  made in meeting  the objective.  At present,  those instructions  are much 

more general. 

Develop guidelines on State oversight of the Federal patient counseling mandate.  The 

authorizing  statute calls upon the States to develop  standards  for counseling  individuals. 

Federal  guidelines  governing  how States ensure  enforcement  of the standards  could 

facilitate  State progress  in meeting  them.  If based on input from  and best practices 

currently  being  carried  out by the States,  these guidelines  could be of considerable  value 

to State pharmacy  boards  as they consider  how to carry  out their  enforcement  efforts  in 

the most cost-effective  manner  possible. 

9 
 COMMENTS  ON  THE  DRAFT  REPORT 

Within  the Department,  we solicited  and received  comments  on the draft  report  from 
FDA,  HCFA,  the Health  Resources  and Services  Administration  (HRSA),  and the 
Assistant  Secretary  for Planning  and Evaluation  (ASPE).  From  external  organizations,  we 
requested  and received  comments  from the National  Association  of Boards of Pharmacy, 
the Citizens  Advocacy  Center,  Public  Citizens  Health  Research  Group,  the American 
Pharmaceutical  Association,  the National  Association  of Chain  Drug Stores,  the National 
Community  Pharmacists  Association,  and the American  Society  of Health-System 
Pharmacists.  We include  the complete  text of comments  in appendix  B.  Below we 
summarize  the major  thrust of the comments  on our recommendations  and,  in italics,  offer 
our responses.  We made a number  of minor  edits in the report  in response  to the 
comments. 
FDA,  HCFA,  HRSA,  AND ASPE COMMENTS 
The FDA,  HCFA,  and ASPE concurred  with our recommendations.  In our dra@report, 
we suggested that one initiativethatHCFA could take infacilitatingState eflorts to 
enforce the Medicaidpatient counseling mandatewouldbe to facilitatethe convening of a 
nationalsymposiumon oral counseling by pharmacists.n In thisfinal report, we have 
eliminatedthatsuggestion because pharmacy associationshave decided to sponsor such a 
symposiumin September 1997.  We stillsuggest, however, thatHCFA pay care@1 
attentionto the issues raised in the symposiumand that it exert leadership in examining 
and even showcasingconstructivewaysof addressing the major obstacles to patient 
counseling that we ident$ed in this report.28 
The HRSA did not comment  specifically  on the recommendations,  but it did note that the 
draft  report  made it appear  that it was the responsibility  of State pharmacy  boards  to 
enforce  Federal  Medicaid  statutes.  We modiJed our introductorydiscussionto make it 
clear that Statestypicallyhave chosen to rely on the boards as their enforcement arm. 
Further, in both the draft andj?nal report our discussionconcerning the lack of resources 
for enforcement addresses State board concerns that StateMedicaid agencies look to them 
to enforce the Federal patient counseling law withoutsharing any of the Federal finds 
they receive under the Medicaidprogram. 
EXTERNAL  ORGANIZATIONS  COMMENTS 
These  comments  serve as an important  complement  to our report.  They  add useful 
perspective,  especially  with respect  to the obstacles  to patient  counseling.  The 
associations  tend to emphasize  the need for Federal  initiatives  to address  these obstacles 
(especially  with respect  to the economics  of pharmacy  practice)  while  more generally 
expressing  their  concern  about any broadening  of the Federal  role.  The consumer-based 
organizations  call  for stronger  Federal  action  in ensuring  that patients  are adequately 
10  informed  We are sensitiveto the scope of the obstacles inhibitingoral counseling by 
pharmacistsand to the primary role of Stategovernmentin enforcing existing counseling 
laws. At the same time, we must reemphasizethatour survey reveals thatthe enforcement 
of Federal and Stateoral counseling lawshas been minimal. It is vital, we believe, for 
both levels of governmentto give greater attentionto the implementationof these laws and 
to support shoppingand other techniques towardthat end. 
11 
 APPENDIX  A 
SURVEY  OF STATE  PHARMACY  BOARDS 
Response  Rate to the Survey 
Number  of States Surveyed*  51 
Number  of Responses  46 
Response  Rate  90% 
*Includes  the District  of Columbia 
Nonrespondents  were:  the District  of Columbia, 
Kansas,  Maine,  Michigan  and  South  Carolina. 
Survey Questions  and Responses 
In your view, how informeddo pharmaciststend to be of their obligationsunder your 
Statespatient counseling requirement? 
Number 
Percent
of States 
Well  Informed  24  53 
Very Well Informed  11  24 
1rry  Informed  1  tr  1  z. 
Percentages  may  not  total  to  100 due  to rounding. 
Withinthe past year, has your Board conducted any educationaleflorts intendedto help 
pharmacistsunderstandand/or carry out the Statespatient counseling requirements? 
Number 
Percent 
of States 
Yes  38  83 
No  8  17 
Total  46  100 
A-l  If yes, please check (and briefly explain) any offollowing educationaleaorts that apply. 
Number  of States  Percent  of 
Undertaking  Effort  States 
Made information  available  at on site inspections  33  89 
Mailed  information  to pharmacists  31  84 
Made information  available  at professional 
association  meetings 
I
Conducted  other  educational  efforts  I  9  I  24 
Issued media announcements  6  16 
Mailed  information  to patients  5  14 
Made information  available  on the Internet  3  8 
I
Total  Number  of Efforts  Reported  117 
1 N States  Responding  =  37 (Multiple  responses  permitted.) 
I Number  of Educational  Methods  Undertaken  by States to Help Pharmacists 
Understand  and/or  Carry  Out Patient  Counseling  Requirements 
I 
Number  of Methods  Number  of States  Percent  of States 
1  2  5 
2  7  19 
3  18  49 
4 or more  10  27 
I
Total 
1 Percentages  may  not  add  to 100 due  to rounding. 
I 
A-2 
 Does your Statehave any continuingeducationrequirementsspectjkally intendedto help 
pharmacistsconductpatient counseling? 
Number 
Percent
of States 
No  43  94 
Yes  3  7 
I
Total 
Withinthe past year, has your Board conducted any shopping eflorts, whereby individuals 
pose as patientsto assess compliancewithpatient counseling requirements? 
Number 
Percent
of States 
No  29  63 
Yes  17  37 
Withinthe past year, has your Board conductedsite visitsof pharmacies to assess their 
compliance withStatepharmacy laws (includingpatient counseling requirements)? 
Number 
Percent
of States 
Yes  39  85 
No  7  15 
A-3 
 If yes, about whatpercent of pharmacies in the Statehas your Board visited? 
Number  of  Mean 
Median  Minimum  Maximum
States 
37  71%  80%  10%  100% 
Has your Board conducted other types of proactive enforcement eflorts to assess 
compliance withpatient counseling requirements? 
Number  of 
Percent
States 
No  29  63 
Yes  17  37 
I
Total 
Whatis the most recent year for whichyour Board has compiled statisticsconcerning 
complaintsand disciplinaryactivities? 
Number 
Percent
of States 
1996  19  54 
1995  15  43 
1994  1  3 
Total  35  100 
Years  reported  were  a combination  of CY,  FY,  and 

YTD. 

Percentages  may  not  add  to  100 due  to rounding. 

A-4 
 For  that year, please provide  the following: 
A) Number of Complaintsof Any Type Made to the PharmacyBoard: 
Number  of 
Mean  Median  Minimum  Maximum
States 
30  269  106  6  1576 
B) Number of ComplaintsInvolvingPossible Violationsof PatientCounseling 
Requirements: 
Number  of 
Mean  Median  Minimum  Maximum
States 
20  22  12  0  119 
Whatwouldyou say is the primary source of complaintsinvolvingpossible violationsof 
patient counseling requirements? 
IConsumers  I  28  I  76 
I I  I 
Law Enforcement  3 
I
Pharmacists 
I
Percentages  may  not  add  to  100 due  to rounding. 
For the prior year, please completethefollowing: 
A) Number of Complaintsof any Type Made to the PharmacyBoard: 
Number  of 
Mean  Median  Minimum  Maximum
States 
28  228  89  0  1236 
A-5 
 B) Number of ComplaintsInvolvingPossible Violationsof PatientCounseling 
Requirements: 
Number  of 
MeaIl  Median  Minimum  Maximum
States 
21  15  8  0  84 
For the most recent year for whichyour Board compiled statisticsconcerning complaints 
and disciplinaryactivities,please provide thefollowing: 
A) 	 Number offlnal, formal disciplinaryactionstaken againstlicensed pharmaciststhat 
were based at least in part onfailure to adhere to patient counseling requirements. 
Number  of 
Mean  Median  Minimum  Maximum
States 
34  7  3  0  80 
B) 	 Please indicatethe number of such actionsthathave resulted in revocations, 
suspensions,fines,  reprimands, or other disciplinaryactions. 
Number 
Percent
of Actions 
Fines  176  50 
Reprimands  129  36 
Other  24  7 
Suspensions  16  5 
Revocations  9  3 
Total  354  100 
Number  of States  responding  =  23 
Percentages  may  not  add  to  100 due  to rounding. 
A-6 
 Please indicatehow much of an obstacle each of thefollowing represents to e$ective 
enforcement of patient counseling requirements: 
Very
Not  an  Minor  Moderate  Significant 
Categories  Ranked  by  States  Significant  Totals 
Obstacle  Obstacle  Obstacle  Obstacle 
Obstacle 
(lG%) 
Complexity  of the law 
(4:) 
Higher  priority  enforcement 
 (Iii%) 
issues  for the board  (167%) 

Opposition  from  professional 
 (Z%) 
community  (2&j 

(lCt%) 
Lack  of resources 
(136%) 
Limited  complaints/referrals  to  (lit%) 
the board  (219%) 
Percentages  may  not add to 100 due to rounding. 
Please indicatehow much of an obstacle each of thefollowing represents to pharmacist 
compliance to patient counSelingrequirements: 
Very 
Not an  Minor  Moderate  Significant 
Categories  Ranked  by  States  Significant  Total 
Obstacle  Obstacle  Obstacle  Obstacle 
Obstacle 
Lack  of commitment  from 

pharmacy  owners/management  (9:) 
 (A%)  (2&j  (4&  (I:%) 
Underutilization  of supportive 

personnel  in pharmacies  (136%) 
 (2o9%)  (&)  (209%)  (4:) 
Limited  reimbursement  for 

counseling  services  (2%) 
 (9:)  (lZ%)  (3&j  (46) 
Inadequate  computer  software 
(167%)  (4:)  (2F%)  (7;)  Vh 
Insufficient  counseling  skills  of 

pharmacists  (167%) 
 (7;)  (00) 
Percentages  may  not add to 100 due to rounding. 
A-7 
 Please indicatehow much of an obstacle each of thefollowing represents to patients who 
wish to receive pharmacist counseling: 
Very
Not an  Minor  Moderate  Significant 
Categories  Ranked  by  States  Significant  Total 
Obstacle  Obstacle  Obstacle  Obstacle 
Obstacle 
Lack  of patient  knowledge 
10  6 
about  the counseling 
(4;)  (li%)  (22 %)  (4%)  (13 %)  (lZ%) 
requirement 
Lack  of pharmacist  availability 
(21%)  (136%)  (456)  (4%)  (4:)  (HE%) 
Prescription  area  not 
conducive  to communication 
between  patients  and  the  (0:)  (136%)  (3Z)  (4:)  (136%)  (2%) 
pharmacist 
Insufficient  patient  access  to 
basic  prescription  drug 
(9:)  (32)  (4&  (167%)  (0:)  (lCZ%) 
information 
Percentages  may  not add to  100 due to rounding. 
A-8 
 APPENDIX  B 

THE  MEDGUIDE  EFFORT 
For about 30 years.  the Food  and Drug Administration  (FDA) has sought to enable 
consumers  to receive  more and better  information  about the prescription  drugs they use. 
Its first  such effort  was a requirement  that written  information  be provided  that made clear 
the dangers  associated  with certain  inhalation  products.  Toward  the end of the next 
decade,  it proposed  a rule that would have required  drug manufacturers  to include  patient 
package  inserts  for  10 classes of drugs.  In  1982, the FDA withdrew  the proposed 
regulation  in response  to concerns  about over-regulation. 
Throughout  the  1980s and into the  1990s  FDA continued  to stress the importance  of 
consumer  education,  particularly  through  the issuance  of written  materials  that were 
distributed  with the drugs and made clear  the best ways to take a drug and any  side effects 
associated  with it.  It conducted  a number  of surveys  of patients  assessing  how often  they 
were provided  such information  about their prescription  drugs. 
By the mid-1990s,  FDA  found that the rate at which  such information  was being  provided 
had increased.  But it felt that the progress  was not nearly  fast or thorough  enough,  given 
the continued  high  incidence  of adverse  drug events and patient  noncompliance  with 
prescribed  drug regimens.  Further,  continued  advancement  in computer  technology,  it 
felt,  made the provision  of consumer  information  more efficient  and economical  than it 
would  have been a decade  or two ago. 
Thus,  in August  1995, it once again proposed  a rule entitled,  Prescription  Drug 
Labeling:  Medication  Guide Requirements.  Widely  cited as the MedGuide 
requirements,  they called  for manufacturers  to produce  written  product  inserts  for certain 
categories  of drugs posing  particular  dangers,  encouraged  the preparation  and distribution 
of written  information  for all drugs,  and established  performance  standards  for both the 
distribution  and quality  of written  information. 
As the performance  standard  for distribution,  FDA proposed  using the pertinent  goal 
already  established  by the Public  Health  Service  in the Healthy  People  2000  set of 
performance  goals.  The goal set forth  is that by the Year 2000 at least 75 percent  of the 
people  receiving  new prescriptions  would be given  useful written  patient  information.  For 
the Year 2006,  the goal is 95 percent. 
As the performance  standard  for determining  what is useful  information,  FDA identified 
7 components  which  must be satisfactory.  They  are:  scientific  accuracy,  consistency  with 
a standard  format,  nonpromotional  tone and content,  specificity,  comprehensiveness, 
understandable  language,  and legibility. 
B-l  In August  1996, Congress,  as part of the FDA appropriations  bill,  included  a provision 
giving  private  sector groups  120 days to assess the effectiveness  of current  private-sector 
approaches  used to provide  oral  and written  information  to consumers  and to submit to 
the HHS Secretary  an alternative  to FDAs Medguide  plan.  If an alternative  plan  that was 
acceptable  to the Secretary  was not produced,  then FDA would be authorized  to proceed 
in carrying  out its MedGuide  requirements. 
The Secretary  appointed  the Keystone  Group,  a private  firm,  to appoint  and develop  a 
steering  committee  comprised  of diverse  interests.  The 34 member  Committee  met on 
numerous  occasions  and produced  its action  plan in December  1996.  In January  1997, the 
Secretary  approved  the plan,  which  essentially  looks to the private  sector to foster 
progress  in providing  more and better  written  information  about prescription  drugs to the 
public.  It sets forth  the performance  target that action  plan will  result  in the distribution 
of useful  information  to 75 percent  of individuals  receiving  new prescriptions  by the year 
2000 and to 95 percent  by the year  2006.  In determining  the kind of information  that 
would be regarded  as useful,  it supplants FDAs 7 criteria  with  11 distinct  components. 
With  respect  to oral  counseling,  the plan  makes three  recommendations.  The  first is that 
State pharmacy  boards  continue  their efforts  to assess the quality  of oral counseling 
provided  by pharmacists  in all settings in which prescription  medicines  are provided  to 
ambulatory  patients  This assessment,  it adds,  should include  the nature  and 
effectiveness  of the  offer to counsel  made to the patient. 
The second  recommendation  is that  a National  Symposium  on Oral Counseling  by 
Pharmacists  about Prescription  Medicines  be convened  in  1997 by pharmacists  groups, 
including  NABP  [the National  Association  of Boards of Pharmacy].  . . The purpose  of 
this conference  would be to assess the effectiveness  of current  oral  counseling  guidelines 
. . .  and to assist State boards  of pharmacy  and NABP in enforcing  existing  guidelines 
and developing  new guidelines,  if necessary,  for oral counseling. 
Finally,  the third  recommendation  is that FDA  should continue  to conduct  periodic 
consumer  surveys  to determine  whether  consumers  are receiving  oral  counseling  when 
they obtain  their prescription  medications.   It adds that for oral  counseling  the 
appropriate  mechanism  to assess the quality  of the information. being  provided  to 
consumers  by pharmacists,  as well as the offer  to counsel,  should be developed  by 
individual  State boards  of pharmacy..  .  
B-2 
 APPENDIX  C 
COMPLETE  COMMENTS  ON DRAFT  REPORT 
In this appendix,  we present  in full the comments  we received  on the draft report. 
C-l  Public Health Service 

Food and Drug AdminIstration 

Memorandum 
From:  Deputy Commissioner for Management and Systems 
Subject: 	 FDA Responseto OKi  Draft Repott: State Pharmacy Boards Oversight of Patient 
Counseling  Laws, OEM-9790040 
To: 	 June Gibbs Brown, Inspector General 
Department of Health and Human Services 
We have revlewed the OIC  Draft Report: State Phirmacy  Boards Oversight of Patient 
Counseling  Laws, and offer the following  comments: 
I For over thirty  years, FDA has sought to enable consumers to receive more and better 
* 	
information  about the prescription drugs they use. We have recently conducted  the fifth in 
a series of surveys of both oral and written  information  being given to consumers with  their 
prescription  medications,  Our latest survey indicales that the level of verbal counseling  is 
still very low and although written  information being given to consumers has increased, 
only  6770 of patients reported receiving  wrltten  information from their pharmacists. 
We strong/y agree with your proposal to have the Food and Drug Administration 
collaborate  with state pharmacy bpards by collecting data about the usefulness of written 
information  offered to patients by pharmacists,  FDA could then assessthe usefulness of 
this information  In accord with the criteria established in the Prescription Information 
Action  Plan developed  by a divorse steering committee made up of health professionals, 
consumers, patient advocacy groups, drug information vendors and the pharmaceutical 
industry.  This Plan was accepted by the Secretary on January 13, 1997.  This joint  effort 
would  help FDA carry out its responsibility to measure progress being made in offering 
useful written information to patients. 
FDA is committed  to the public-private  sector efforts in Healthy People 2000 where the 
.  objective  is that at least 75% of individuals  receiving new prescriptions be given useful, 
written  information.  FDA will  continue to facilitate both oral and written  information 
giveri to consumers by health professionals.  Our Office of External Affairs has ongoing 
efforts to help make consumers and health professionals aware of the importance of this 
information.  One of the new initiatives in this area is focused on providing  information  to  . 

women and encouraging this population to begin a dialogue with their health care 
professionalsabout medications,  Page 2 -June Gibbs Brown, IG 
We agree with the premise of your Draft Report that encouraging health care professionals 
to improve th&r  communications  with consumers about prescription medicines will 
Improve health outcomes and reduce pieventable, medications-related  problems.  We also 
encourage activities to Increase consumer undarstanding and awareness of the benefits and 
availability  of written  prescription medicine information,  and the importance of oral 
communication  between health care professionals and patients. 
--  DATE: 
AUG-4  l9m 
TO:  June GibbsBrowa  , 
InspeotorGenetnl 
FROM: 
SUBJECT:  Office of ImpectorGeneral(OIG)DraftReport:%ate  PharmacyBoards 
Oversight of PatientCounselingLaws, (OEI-Ol-97+0040) 
We reviewed the above-referencedreportwhichassessesstate pharmacyboards 
oversight of patient counselinglaws. 
Our deeailedcomments on the reportiecotmcndatiotu arc attachedfor your 
consideration. Thmk you for the opportunityto review on this sport. 
andcomment
Attnchment 
. 
. 
.  . 
..  Comments_otfhe HealthCareFinan&!  tHCFAl.on 
gffh  of boector  GeneraltOJO\ DraftRSQ@Z 
State Ph- BoardsOversirrhotf PatientCOUllSW   Laws: 
[OEI-01-97-00040~ 
OIG Recowdation 
The Food and Dnq Admhistrati~n(FDA) shouldcollaboratewith state pharmacy boards 
to collect surveydataon the usefulness of writteninfomation of&redto patients 
receiving new prescriptions. 
We defer to FDA for commentson specificinitiatives. 
DIG Recwen  datioq  . 
HCFA should assist with state effortsto edorcc the Medicaidpatient counseling 
mandate. 
JI;ICFARespons 
We concur. WCbelievethere is an urgencyin addressingthe problemsstates are having 
in their efforts to monitorcomplianceof the OmnibusBudgetReconciliationAcr of 1990 
(OBRA 1990)patientcounselingmat&c.  Problemssuch as lack of resources,reliance 
cmsporadic pharmacy board inspectionvisits, and the lack of cmsumer educationon 
their right to be counseled,have hamperedthe effectiveaess of the pharmacyboard&ate 
Medicaid agency &ersight of patientcounseling laws.   
a 
\ 
&iditional cw  em  on Q&$xmted  Initiatives: 
OIG lpjtiative #l 
Develop and hsesr  s@teProg&  Towarda PatientCounseiingPerformanceObjective 
. 
We concur. HCFA is conmimd to assistingstates.in fully adhexingto Medicaidpaticnt 
cpun~elir~ngquirements, and meeting  that objectiveby year 2000. By doingso, atleast 
percerit of individualsreceivingnew prescriptionswill be giveuuseful patient written 
75 
infinmation. We mustrecognize&is objective  is not mentionedin the OERA 1990 law, 
nor is it mentioned in XCFA regulations. Starescan only be encouragedto use the  9 
II 
. . 
objective as a yardstick to improvethe effectivenessof patient counselingeach year, 
HCFAwill assist states by amendingthe Dmg UtilizationReview(DUR)Annual Report 
insttmions  to coUectmore specificinformationregarditnhgec om
 pliance.monitoring
efforts that have beenpetformed and how effectivethese effortshave been  Questions 
concen&g tbc progressof each state in tnonito~& compliance,m well as the level of 
compliancein the phermrcies with the counselingrequiremeats,will be includedin 
future repon iastructions. This informationwill be &ared with states tn HCFAs 
Medicaid DURNewsletter. 
Sincemany Medicaidk&iciaries  read poorly and/ormay XIOuZnderstandthe need 
enoughto&e  time reading driigi&fmatioq  it is crucialto have on! counseling 
stmdards as weI]. Mso, since most repeatMedicaiddrugusers are elderly and/or 
chronically ill or disabled,hop&@  high oral standards8re at-b&abledue to a 
traditionallymore cooperativeclienteleand t&fact  that constantmedicationis a viial 
part of thtirdaily routine. CounseIingthese individualsare tht top priority. 
. .  .
OK I@attve #2 
Develop ouidttincs on Stae Oversightof the FederalPatient CounselingMandate 
J-XFAResnonse 
We concur.  HCFAis committedto Federal-statepamship.  Therefore,WCwill solicit 
input fhm states on the practicesthey find most effective,and distributethis information 
to all pharmacy boards. 
OS3kliti8tive##a  . 
Facilitate the Conveniq of a NationaiSymposiumon Oral Counselingby Pharmacists  . 
We ccmm.  AlthoughFederal leadershipis necessaryin facilitatingthis meeting, 
Congrosshat not sppropriatedthe rescues  necessaryto lead this ndcawr. 
Nevertheless,HCFAis Attrycommittedto assistingstate uversightof the counseling 
requirements,ad  thereby improvingthe quality of care of MedicaidPatients. WC 
believe includingthe activitiesdescribedabovewill assist us in accomplishingthis 
oiijectivc~  .. 
. 
,  *  . 
AUG  I  5  1997 
TO8  InspectorGeneral,DHHS 

FROM:  Acting DeputyA' inistr&tor 

$" 

SUBJECTt Office  of Insp 
PharmaoyBoar  ent  Counseling  Laws/ 
(CIN:  OEI-Ol-
In responseto an  inform  st f-orcommentson the subject 

report,  we  are  providing  commentsas listedbelow. 

This report walginformal 
 ded to HRSA on July 10, 1997, 

HRSA appreciatesthe oppo 
subject  draft  report.The 
informationon a subject 
importantfor health aare  ofessionalato communicate  with 
patientsabout prescripti  medicationsto improveoutcomesand 
reducemedicationmisadve 
One issue that wae not ad 
 ssed in the reportthat may serve as 

a barrierto counselingp
 ents is the need to improvethe 

communicationskillsof p 

addressedis the age, gen 

that exist in providing 

The  OIC may want to consi  the following  published  refiources  as 
referencesfor inalusfon  the draft report8 
Manasse HR  Jr. Medic  on use in an imperfectworld. 1: drug 

z&adventuring as an  sue of publicpolicy. Am J Hosp 

Pharm, 1989:46:.92 
Manasse HR Jr. Medic 
driig  misadventuri 
Pharm, 1989:46:1 
JohnsonJA, Bootman  Drug-RelatedMorbidityand 

Mortality,  Arch Int  'Med/vol155, Ott 9, 1995. 1949-1956. 

With regard to the chai  bility,the premises of the 

report are plausiblefr  1 perspeotivs,but they look 

odd from  the  perspectiv  in a State government, The 

draft text presumestha  lear duty of State pharmacy 

boards to enforce Feder  There is no dire& 
 ..  

. i 

.. 
Page 2 - InspeatorGeneral,DHHS 

duty to do so.  Instead,there is an indirsot  ahain of 
responsibilitythat must be effectivelytransmittedfrom HCFA and 
a State Medicaidagency t4  that Gtate'spharmao board.  The 
draft  report  should  prob alarify this, plaoxng the 
responsibility  on  the  sta  Medioaidagencyto deputiseand fund 
the  phamacy  board to per  rm the requisitetasks  with  respect to 
pharmacycounseling. The  this reportmight discussthe 
relativemerits of  hazd.1  forcement"versus soft "educatio!P 
e for the subsequentdiscussionsof 
nter-professionalpolicy controversy 
dnotea 6 and 28 explainsthe softer 
f*
 
 by  most boards;this report should 
sy in the backgroundexplanations, 
on pages  four  throughseven, the text 
sent occurathrough,"shopping 

T,.poseas patientsto assess 

ints,particularlyregarding 

nt, shouldbe more fully 

sumes that such lrshopping'iBs
 

cost-effectivein combati 
 minor quasi-violationslike failurs-

Endnote18 might profit&blybe ' 

on, and the existinganecdote 

sumes that HCFA counseling 

regulationsshouldtake 
 igh p	 riorityamong enforcement 
activities. 
 hould reflectState pharmacy 
boards' con 
 of drug storage,abuse of drugs, 
are more dangerousproblemsthat 
e for  saaraeenforcement 
..  	 TThhee  nnaattiioonnaall  ssyymmppoossiiuumm pprroo  oosseedd  oonn  ppaaggee  nniinnee  wwoouulldd  
bbee   bbeesstt  
ccoonnvv88nnee..ddbb yy  HHCCFFAA  aanndd  FFDDAA,,  ccssaawwiinngg oonn  tthhee  ppeerrssppeeccttiivveessoo ff  tthhee  
ootthheerr  aaggeenncciieess mmeennttiioonneedd,,  
IItt  wwoouulldd  aallssoo  bbee  hheellppffuull ttcclltt hhee  rreeaaddeerr  iiff   aann   eexxttrraacctt   ooff   tthhee  
rreelleevvaanntt ppoorrttiioonnss ooff  ooBBRRAA  33999900  ((SSeeaa,, 44440011((gg))((zz))))ww eerree   aattttaacchheedd..  
I 
 Page 3 - InspectorGenerai,DHHS 

Page i ExecutiveSummary,Baakground,states They also add as 

muah as  $100  million  a  ye  to health care co8ta.e Page 1, 
Introduction,Eaokground, t
ates  Wosts associatedwith the waste 
in misused drugs and the 
 its of not receivingintended 
therapy  have  be  to acaountfor as much as  $100 
billion a year."  llion appearsto be the correct 
figure,  so the.$lO  n the ExecutiveSummarymay need 

to be correctedif they a  referringto the same cost figure. 

Containedin the findings  pages six and seven of the report 
are differentnumbersfor  e respondingboards (i.e.,45,  and  . 
44 
'1  46).  It is unclear as to ich number is oorrect. 
* 
Page  8,  paragraph  1  state  "'TheHHS Secretaryand the FDA are 
committedto public-priva  effortsthat will result  by  the year 
2000  in at least 75 peroe  of the individualsreceivingnew 
prescriptionsbei  ful  written information."Healthy 
People  2000  obj  1 counselingas well by  its 
objective12.8 "Increase  at least75 percentof the proportion 
of people who receiveuse  1 informationverbally  and  in  writing 
for new presorip  esaribersand dispensers,~A~lthough 
the Keystone gro  me  to a consensus,the steering 
committee"did  e v	 ery importantrole  that oral . 
counseling  will  ving the goals of this Plan.11It is 
unclear  if  the  r only written informationor if 
oral counselin 

On page 0, paragraph5, li ? 7  referenceis made to a,
ll..,presorfptioinnformati  actionplan approvedby the I-MS 
I 
Seoretary (seeAppendixA)4IThe AppendixA in the draft I have 
ie a collectionof statists:a1tablestitled lqSurveyof State 
PharmacyBoards,,'and no IIf: InformationAction Plan" 
:eSCription 
. 	 is attached. If  AppendixE  Yl?heMedguideEffort,"is intended, 

the text should so state.  kf so, furtherediting is indicated, 

as  that  text  is somewhatur :learand the lVcriteriaalntd
  the 
concretenessof an "Action ?lan  are  not obviousin it.  If not, 
the real Action Plan that t >e authorshad.inmind 
should-be 
attached and properly aitei  The appropriatecorrectionshould 

be made in Endnote 6 as we1 i. 
 . 
Page4 - h8peatOr Cm&a;,  DHHS 

0 

Staffquestionamay be  referred  to MiahaelKerbstih the Division 
of  Grantsand ProcurementNanagementon 443-5256. 

v
ThomasG. Morford 

* 
co:  Mr. Comigan, W/attachment 

. M	 r. Ge&ifig,k/6ttachn\ent 
Mr.  Clark,w/attachment
Dr. Paavola,w/attachment
Dr. Robimon, w/.attamoent 

Dr. Mahoney;w/a'ktakant

Dr. Snyder,w/attiachnmt
  

.3 
 National  Association  of  Boards  of  Pharmacy 
700 Busse Highway    Pad Ridge, IL 60068 
    Fax: 347/696-0124 
July 18.1997 
. 
June Gibbs Brown 
Inspector General 

Office of Inspector General 

Department of Health & Human Services  *-

Washington, DC  20201 

RE: 	 Draft I.nspcctioa Report State Pharmacy  Boards Oversight  of Patient 
Counseling  Laws 
Dear Ms. Brown: 
The National Association of Boards of Pharmady (NABP) represents the state boards of 
pharmacy in all jurisdictions  of the United States, Guam, Virgin Islands, Puerto Rico, 
nine provinces of Canada, three states in Australia, and New Zealand.  NABP assists its 
member boards in developing, implementing, and enforcing uniform standards for the . 
purpose of protecting the public health. 
The NAJ3Pcompliments the Office of the Ins@xztorGeneral for researching this critical 
patient care area and concurs, in general, with tht findings and subsequent   
recommendations.  The state boards of pharmacy and NABP also agree with the Office of 
the Inspector Generals assertion that plikrmacistscan help to reduce adverse drug 
reactions and the misuse of prescription drugs by providing patients with oral and 
written information. 
Studies conducted by NABP confirm the finding that too many patients, for many of the 
reasons noted in the report, are not being counseled about their prescription medications. 
We believe that counseling is a necessary responsibility of the pharmacist; a 
responsibility  of the individual pharmacist, who must be competent and willing to 
counsel, and employer, who must provide the resources and support, to provide 
counseling  to patients.  June Gibbs Brown 
July 18,1997 
Page 2 
SPECIFICCOMMENI$ 
. 

FINDINGS 
SIote pharmucy  boards have played  an ktive  role in explaining  ahd urging pharmackt 
compliance  with State patient  counseling  laws. 
The report accurately notes the efforts of the state boards of pharmacy to educate 
pharmacists, through a number of methods and avenues, about patient counseli  laws 
and urge their compliance with these laws. The efforts of the boards in this area were 
exceptional and clearly demonstrated that state boards of pharmacy perform meaningful 
functions  beyond  licensing  and discipline. 
State boards, through NABP, did develop the Patient BiIl of Rights (Attachment A) to 
educate patients about their rights under the new counseling laws. Although we agree 
with the reports conclusion that these efforts were less than those expended to educate 
pharmacists, the reason for such disparity is clearly resources and not an unwilliigness  to 
.
doso. 
Xhe boar&  ertfarcement  of the counseling  laws has been minimal. 
Although the actual disciplinary actions taken by state boards of pharmacy for failing to 
provide counseling may seem low, the activity of the boards of pharmacy to ensure that 
patients are counseled is significant,  As noted in the report, a number of boards of 
phaunacy use in.formaIconferences or written warnings to increase the compliance of 
phaqmacists with state counseling laws/rules. These activities often do not result in a 
formal discipliiary  action, such as the revocation  or suspension  of a pharmacists  license. 
Data from NABPs Disciplinary Clearinghouse indicate that the state boards  of pharmacy 
are taking  action  in situations  where counseling  is not occurring  or medication  errors 
could have been prevented  if counseling was provided and more actions than noted in 
previous years.  We agree with the finding of the report that more effort needs to be 
devoted to this area and the use of shoppers increased,  June Gibbs Brown 
July 18,1997 
Page 3 
The report accurately identifies a major obstacle which impedes the ability of state boards 
of pharmacy to be more effective .in enforcing counseling laws - tiding.  This factor is, 
in NABPs opinion, the single most limiting obstacle. We cannot emphasize enough the 
importance of state governments and Federal agencies providing additional resources to 
the state boards of phatmacy to enforce counseling laws properly and thereby, better 
protect the public health and welfare.  Without adequate and additional funding, the state 
boards of pharmacy arc restricted to.a reactive regulatory stance and limited to 
responding to complaints or taking actions when violations occur and patients injured or 
inappropriately served. 
RECOMMENDATIONS 
The FDA should  cokborate  with State pharmacy  boa&  to collect survey data on the 
usefulness  of written information  offered toindividualr  receiving new prescriptions. 
NABP strongly supports this recommendation.  Through the NABP, the state boards of. 
pharmacy have worked collaboratively with the FDA on a number of projects and 
enforcement initiatives.  We believe that a cooperative partnership which recognizes the 
separate authority of the state boards of pharmacy and FDA and creates a collective 
regulatory synergy will improve the enforcement of counseling laws and patient care:  June Gibbs Bro& 
JuIy 18.1997 
Page 4 
The HCFA  should/crcifitate  Stale effom  b  enformthe  Medicaidpatient  comsefing 
mandatk 
Develop  and assess State progress  toward a patient  counseling performance 
objective.  . 
Although NABP agrees that a performance objective needs to be established and 
recognizes that HCFA bears responsibility for the Drug Utilization Review 
provisions of the Medicaid program, we would urge that any such 
recommendation recognize the authority of the state boards of pharmacy and the 
reports recommendation be revised to extol HCFA to develop a pefiormance 
objective in concert with the state boards of pharmacy. NABP would be glad to 
assist in this regard and help to represent the state boards of pharmacy. 
Develop guidelines  on State oversight  of ihe Federal patient  counseling  . 

mandate. 
NABP does not agree that Federal standards for ensuring enforcement will 
necessarily assist states. If the guidelines are not developed iu conjunction with 
the states and do not include Federal funding, the states will be faced with 
additional requirements and no means to sati@  them. The problems with lack of 
enforcement noted in this report will be further exacerbated. The state boards 
should set the standards and adopt these standards as a national, uniform Policy as 
they have done so with other requirements and patient care standards. This can be 
accomplished through the collective efforts of the states and NABP. The 
standards for enforcement once developed, could then be recognized by HCFA 
and additional funding from HCFA provided to the states to ensure that the 
standards can be implemented. 
Facilitate  the convening  of a nakonai  symposium  on oral counseling  by 
 	
pharmacists.   
NABP stronglysupports this recommendation.  June Gibbs B&n 
July 18,1997 
Page 5 
Thank you for the opportunity to comment on this report. If we can be of any tkther 
assistance to you, please do not hesitate to call upon me. 
.  _.
RespectfUy  yours, 
NATIONAL ASSOCIATION OF 
T 
-5 
Executive Dircctor!Secre&q 
Attachment A:  Pharmacy Patients Bill of Rights  -..  --.  -. 
Attachment  A  , 
.- Pharmacy  Patiexxt's 

EWLL  OF  RIGHTS 
PREAMBLE 
IN  ACIWOWLEDGMEii  OF an 1ncreasIngly infdrmed  and cost-conscious  public,  and  with  spe$lc 
Seferencc to the proliferation  and complexity  of drug therapy.  Pharmacists have  recognized  the need for : 
Pharmacy Patients Bill of Rights. To reinforce their commitment  to protect the health and well-being  of the1 
xxients.  Phzmncists  wed  a common reference  to describe their covenantal  relationship  with  the public.  II 
rcugnidon  of the publics tight to freedom of choice and the Pharmacists professional  fehrlonship  with thei 
,atients, tbls document  delineates:  1) the patients rights and rtiponsibilities  with  respect  to appropriate  drug 
herapy.  and  2) the patients  responsibilities  and  Pharmacists riehrs  with  respect  to the quality  ofseenrice 
>tovided.  Such a charter  is setforthwith  and shall be knownas  the Pharmacy  Patients Bill of Rights. 
PATIENT  RltGHTS/PH~RMACISTS  RESPOLbIBILITIES 
hztiunts  have  tba dgbt  to expect  tbefrpbawnacfst  to: 
1. Be professionally  competent  and adhere  to accepted  standards of pharmacy  practice. 
1. Treat  them  with  dignity,  consistent with  profesbional  standards for all patients,  regardless of manner  oi 
%tyment.  race, sex, age. nationality,  religion,  disability.  or other  discriminatory  factors. 
3. hct in their best interest when  maklng  phatmaceurical  care decisions. 
4. Serve as their rdvoate  for appropriate  drug thenpy  and to make  reasonable  efforts to recommend 
alternative  choices in coordination  with  the patlenw  other health  care providers. 
3. Wtintain  their medical, records, keeping  them  confidential.  using them routinely  to maximize  their care 
And making  them available  to the patient  for review  upon  request. 
6. Provide  counseling,  using the methods  appropriate  to the patients  physlcal,  psychosocial  and intellec
.
tual stm.ls. 
7. Have  their prescriptions  dispensed  and pharmacy  services provided  at a pharmacy  of their choice  In 
an atmosphere  which  allows  for confidenclal  communication  and in an environment  which  is privat& 
properly  lighted,  well  ventilated  and clean. 
8. Monitor  drug therapy  within  their medical  regimen  forsafety and efficacy  and make  reasonable  effotu 
to detect  and prevent  drug allergies,  adverne reactions,  contraindications  or inappropriate  dosage.   
9. Monitor  their compliance  and proper  drug use and institute  remedial  interventions  when  necessary. 
10.  Prominently  post the Pharmacy  Pattents Bill qf Rights. 
PATIENT  RESPONSIBILITItiS/P~ARMACISTS  RIGHTS 
III orderJ3wpbarntacfsts  to meet  rhifr  responsfbilfttes  co pdfenta  as setforrb  t 
tbfs  Pharmacy  Patien;s  Biff of Rtghts,apatients  are  responsible  for= 
1, Provfding  the peison;rl demographlcs,  rhedical  history and payment ,mechanism  including  thttd patty 
payor  lnformatlon  necessary for Pharmacists to lndlviduallze  care, the method  of its provision  and its 
reimbursement. 
2. Implementing  the drug therapy  regimen  conscientiously  and reporting  their  clinical  response  ;o their 
pharmacist,  especially  untoward  reactions and any changes in their health status and medical  care, 
3. Cooperating  with  the pharmacist  and authorizingtheir physician  or other  health care practitioner  to 
release  the medical  infotmationtiecessaryfor the pharmacist  to practice  responsibly. 
I 
.  .  .  .s  .
llllll 
citizenAdvocacy  Center
.* 
A lhining,  Research,and SupportNetworkfor Publtc 
Memberaof lZeu1t.htkm  Regrclatorycrnd  Governing  Boa&a
June 12, 1997 
Ms. June GibbsBrown 

InspectorGeneral 

Departmentof Healthand HumanServices . 

Wash&ton, DC 20201 

Dear InspectorGeneralBrown: 

Thankyou for askingfor our comment8on your draftreport, StatePharmacy 
BoardsOversightof PatientCounselingLaws, The CitizenAdvocacyCenter (CAC)is 
a 501 (c) (3) trainingand supportcenterfor publicmemberswho8erveon statehealth 
licensingboards, includingboard8 of pharmacy, CACparticipatedas a memberof the 
SteeringCommitteefor the CollaborativeDevelopmentof a Long-RangeActionPlan for 
the Provisionof UsefulPrescriptionMedicineInformationthat submittedits ActionPlan 
to SecretaryShalalain December1996. CACtook a leadrole in promotingthe need for 
more and better oral cowlseling, In a February26, 1997letterto SecretaryShalala,CAC 
stated, Certainlywithregard to pharmaoy,t&ereis plentyof legi8lationalreadyon the 
books in the form of OBRA1990requirements(underHCFAjurisdictio&nd lawsin 
over 40 state8(understatepharmacyboardjurisdiction)requirmgpharmaciststo offer to 
counselpatients. However,the actualdeliveryof oral counselingneedsto be improved. 
The new OIGreport reinforceswhatmanybelievedto be the case-that state 
patientcounselinglawsare not working. Whilerecognizingthat the  board8face 
state 
major obstacle8to the successfulimplement&ionof patientcounselinglaw8(lackof   
resourcesfor enforcement,economicsof pharmacypractice,andlimitedpatientdemand), 
the report also finds-thattheboardsenforcementof the counselinglawshave been 
minimal. This findingcannotandniustnot be ignored. In three shortparagraphs,the 
report pinpoint8the problemof poor enforcement,as follows: 
They havemadelittleuse of  shoppingvisits, wherebyboardrepresentativespose a8 
patientsto assesscompliancewithcounselingrequirements. In the past year, only 17 of 
46 re8pondingboard8madesuchvisits. Generally,they weremadeonly to pharmacies 
againstwhicha complainthad been lodged, 
1424SixteenthStreet,NW0Suite1059WashingtonD,C20096 
PHONEi(202) 462.1174 FAX (202) 2656664  They have relied on inspectionvisits as the majormeaneof enforcement.Suchvisit8are 
conductedwith widelyvarying degreesof frequency. At best they offer limited 
Opportuniti&$orassessingthe extentand adequacyof counseiing. 
They have taken fewfinal , formaldisciplinaryactionsinvolvingviolation8of patient 
coweiing  hW8.  Of the 354 action8takenduringthe paatyear by 23 reportingboards, 
208 (59 pent)  were in just 3 stfites. 
That bring8 u8 to the recommendations.We agreewitheachof the 4 
recommendation8in the report - ono addre8Sed to FDA, the other 3 to HCPA. WC 
believe, however,there is a needfor a fifth recommendation- one addressedto the state 
boardsof pharmacy. Sucha recommendationsshouldstatebhmtlythat while them is a 
goodunderstandingof the diff~cultictshe stateboards,facein enforcingpatient 
counselinglaws, that cannotbe used as an excusefor lax enforcement.Unenforcedlaws 
breed a contemptfor governmentthat eats awayat the fabricof our society. Legislatures 
in 46 stateshave determinedin their wisdomthat citizensneedto receivegoodoffersto 
be counseled,andwhenthey acceptsuchoffers-toreceivehigh qualitycounseling. They 
have directedthe boardsof pharmacyto see to it that theselaws are enforced. All the 
sympathyand understandingin the world. concerningthe diffculties the boards face 
I 
f-*  enforcingthese lawscannotexplainaway the abysmalrecordto date. A strong  statement 
to this effect in the final report wouldbe appropriate. CAChas madeoverturesto the 
NationalAssociationof Boardsof Pharmacyto help bring aboutbetter enforcement,and 
we havebeen pleasedwith the positiveresponseof NABP. ButNABPis not the 
enforcementagency, The state boards,individually,mustbe held accountable. A 
statementto that effectby the OIGwmouldbe mostwelcome.  
Da  I t4)A .  Swankin,  Esq,
esident
2  Buytn Up  CongressWarch  Critical Mats  Global Trade Watch  -Health Rescarch Group  Litigvion &up 
Jogn Uaybmok.  President 
Public Citizens Health Research Groups Comments On: 
State Pharmacy Boards Oversight of Patient Counseling  Laws (OEI-01-97-00040) 
Submitted - June 19.1997 
Publics  Citizens Health Research Gmup sincerely  appreciates the opportunity  it 
has been given to comment on this topic of vital inkrest  to the health of prescriptlon  drug 
consumers. 
Since 1972, Public Citizens Health Research Group has been promoting research-
based, system-wide changes in health care policy as well as advocating for the appropriate 
prescribing  and use  of prcsoriptian drugs.  The Health Research Group teMles  before 
Congress  and  petitions  the  Food and  Drug Administration  (FDA)  on  issues  such  as 
banning  or relabeling  of drugs and the misleading advertising of prescription  And non-
prescription  drugs  by  their  manufacturers.  Our  publications  help  consumers  make 
informed decisions  about the health care they receive and the drugs they are prescribed. 
This  draft report identifies mismedication,  a term with no known definition,  as a 
major  national  problem and promotes the irrational notion that failure of consumers  to 
always be compliant (obedient) with their physicians prescribed drug regimens is a major 
factor  contributing  to adverse drug reactions.  This ambiguous articulation  has led to an 
erroneousanalysis and to unprqductivc recommendations that do not address the urgency 
or the seriousnessof the most pressing problem faced daily by millions of .prescription drug 
~WMWWW- ~E~w~LWII~drug Induced injury. 
The focus of this draft report is improving consumer access to useful prescription 
drug information1 by effective implementation and enforcement  of existing laws requiring 
pharmacists to counsel consumers about their prescriptions.  it is Public Citizens view, as 
a member  of the steering committee responsible for developing the Acfhn  Plan for the 
Pm&ion  of U&id  Prescription Medicine lnfomationZ  (The Action Plan), that because of 
the  small proportion  of consumers  receiving oral counseling  about  the  risk& of their 
prescriptions and the dooumented inconsistent and unreliable performance by pharmacists 
in warning  of potentially  fatal drug interactions, oral counseling cannot be considered  a 
priority  for consumers.  if remains our view that written information meeting The Action 
Plan guidelines  is the only source of accurate, consistent, comprehensive,  and objective 
Ralph Npdcr, Fuundcr 
IGOO20rh Sttcct NW  Washingwn, DC 20009-1001 -(202)  58&1000 
 
-+3- Q  Pmcdnnm%lw?sC  information that-a majority of consumersmay receive in the foreseeable  future about the 
risks of their prescriptions  and how to protect themselves  from potential harm. 
AM  77 years of waiting consumers still have no reliable source of objective information 
about the risks of prescriptlon drugs, how to recognize adverse effects and what steps to 
take should an adverse reaction appear.  Written drug information Is the essential  safety 
net that consumem urgently need to protect themselves from the inappropriate prescribing 
and dispensing  of prescription drugs. 
Wewill concentrate the remainder of our comments on (I) the preventable problems 
facing prescription  drug consumers: (2) pharmacisls as counselorsy(3) the distribution  of 
oral  and  written  information  in .pharrnacles;  and (4) who  is the  last line of defense  in 
protecting  consumers from preventable drug induced injury?  Our recommendations  will 
urge  the  Health  Care  Financing  Administration  (HCFA)  to  require  that  Medicaid 
beneficiaries receive useful written prescription drug Information meeting the guidelines  of 
The Action  Plan.  To ensure effective impiemendion  there must be strong independent 
oversight and quality assurance by the.FDA. 
PREVtNTABLE  DRUG INDUCED INJURY: A NATIONAL  PROBLEM 
This  reports  use of the term mismedication  has obscured  the true nature  of the 
problem  faced  daily  by prescription  drug consumers,  the  preventable  causes  of drug 
induced injury; the adverse drug reactions resulting from inappropriate prescribing*16ea7nd 
the improper dispensing&Oof prescriptions.  Compounding these risks is the distribution  of 
inadequate,*  sometimes dangerous written drug information  by pharmacists. 
By citing the failure of consumers to be compliant (obedient)  to their physicians 
prescribed  drug regimens as a major coritributing cause of adverse drug reactions,  this 
report has blamed the victims and has failed to grasp the dimension  of the public health 
problem facing  prescription drug consumers.  In the absence of useful prescription  drug 
information,  the present situation faced by consumers, to promote consumer  obedience 
is irrational and potentially dangerous.* 
The pharmaceutical industry has numerous opportunities to promote the use, over 
use, inappropriate  use, and potential benefits of prescription drugs by spending  millions 
of dollars  advertising  to doctors,  pharmaclsls,  and increasingly  in direct to  consumer 
advertising.  Drug industry backed promotion of consumer c6mpliance without ensuring 
consumer access to useful drug information only serves the interests of corporate  sates, 
not the publics health.  Citation 27 in this draft report illustrates precisely why there is an 
urgenf need for accurate, consistent,  comprehensive, and objective drug information  for 
consumers  meeting the guidelines of The Actiorl Plan.  The vldeo tape referred to in this 
citation and its accompanying printed materials were distributed to members of The Action 
Plan steering  committee by the American Pharmaceutical Association.  These  materials 
were funded by a major drug company, Pfizer Incorporated, and over promote consumer 
-2- compliance  while  minimizing  the  communication  of risk information  to consumers  by 
pharmacists.  Public Citizen finds it disturbing that citation 27 suggests this video tape be 
used as a training vehicle in a national symposium on oral counseling  for pharmacists. 
PHARMACISTS  AS COUNSELORS 
Public Citizen recognizes the ability and dedication  of the many pharmacists  who 
dally contrIbute to high quality health care by counseling consumers about the risks of their 
drugs.  We also recognjze the key role that pharmacists can play in reducing the incidence 
of preventable  drug induced injury by providing cunsumers with Useful drug information. 
However,  we  doubt  the  commitment  of  the  owners  and  managers  of  pharmacies, 
particularly  large,  corporate  chain  pharmacies  in providing  a workplace  environment, 
including  adequate  staffing,  to  allow  pharmacists  to  counsel  consumers  about  their 
prescription drugs. In this report, 23 of the 45reporting  State Boards of Pharmacy  (51%) 
cited the lack of coinmitmcnt from pharmacy owrle&management  as a significant  or very 
significant  obstacle to pharmacist compliance with consumer counseling  laws. 
The  34  of 45  reporting  State  Boards  (71%) that felt limited  reimbursement  for 
counseling services was a significant or very significant obstacle to pharmacist compliance 
with  counseling  laws  batter  reflects  the  level  of  commitment  of  pharmacy  owners, 
managers,  corporations  and  the  trade  groups  representing  their  interests.  In  the 
deliberations  that created The Action Plan the commitment of the pharmacy trade groups 
representing  the interests of pharmacy owners and corporations was to reimbursement, 
no oversight, and no effective enforcement of the plan, not in contributing to a solution  for 
a serious  public health problem.  If there were a professional F;ommltment by pharmacy 
trade groups, then consumers would have had access to useful written drug information 
17 years ago. 
Public  Citizen has little confidence  that the community pharmacists  dedicatgd  to 
providing quality care to prescription drug consumers will be allowed to do so in the current 
market driven environment for health care. 
THE UlSlRlBUTlON  OF ORAL AND WRI-I-I-EN INFORMATION  IN PHARMACIES 
This  report  documents  the  minimal  effects  of  the  1990  Omnibus  Budget 
Reconciliation Act (OBRA 90) and subsequently  enacted state laws to ensure consumer 
access to useful drug information by requiring pharmacists to offer to counsel  consumers 
about  their  prescriptions,  Results  of  FDA  conducted  national  telephone  surveys  of 
randomly  selected  prescription drug consumers between q982 and I 99613substantiates 
this finding. 
Pharmacist oral counseling to consumers concerning side effects (adverse effects) 
Increased  approximately  three  fold between  1982 and  1996, from eight  percent  to 23 
-3- percent respectively.  During this same period oral information about a drugs precautions 
increased  two  fold,  from  13 percent  in  1982 to  26  percent  in  1996.  However,  the 
distribution of written Information in any form, regardless of quality, increased over four fold 
from 16 percent in 1982 to 71 percent in 1996.  This figure of 71 percent approaches  the 
goal of 75 percent mandated by The Action Plan,  Only about one-quarkr otConSUmelS 
are receiving  any  oral information that could  aid in reducing their chances  of avoiding 
preventable  drug induced injury while almost threequarters  of consumers  are receiving 
wriierl  informatlon,  though of doubtful quality. 
At the present  rate Public Citizen estimates it will take pharmacists  over 40 years 
to provide the same proportion of consumers with oral information about the precautions 
(26%) and side effects (23%) of their drugs as those receiving written information  in 1996 
(71%).  We view It as highly unlikely that the.extent  of oral counseling  in pharmacies  will 
adequately  address  the problem of preventable drug induced injury in the foreseeable 
T-
future. 
Because  pharmacists  can now distribute some form of written  information  to 71 
permnt  ot prescription drug consumer?, and consumers have already absorbed  this cost 
through higher prescription prices, responsible public health policy dictates that HCFA must 
make its highest  priority improving the poor quality of the information  that is now being 
distributed by pharmacists and ensuring that IO0 percent of Medicaid beneficiaries receive 
useful written drug information meeting the guidelines of The Action Plan for the Revision 
of Useful Prescrlpfion  Mecfieine lnfomtafion as soon as possible. 
WHO IS THE LAST LINE OF DEFENSE? 
This question was prophetically answered by John Gans, Execufiie  Vice Presidient 
of the American  Phartiaceutical  Association when he was quoated  in the troubling U.S. 
News & World Report investigation, Danger at the Drugstore8, that patients  have little 
choice but to look out for themselves and that You have to manage your own care.  Until 
a rational system of health care is adopted in the U.S., in the current chaosof  competing 
corporations,  health care consumers are the last line of defense against preventable  drug 
induced  InJury.  .. 
This  draft  report  cites two widely  publicized  studies** showing  the  extent  that 
pharmacists  warn  consumers  of possibly fatal drug interactions.  In the survey  of 245 
pharmacies  in seven  cities,  more than  one-half  of the  pharmacists  failed  to warn  of 
potentially  serious  drug interactions.b  A similar survey conducted  in Washington  DC by 
researchers  from the  Georgetown  University Medical Center found  that  more than  30 
percent of pharmacists filled prescriptions,for two potentially fat-4 interacting dtIJgs without 
any warning.  Clearly, the logic of consumer noncompliance with prescribed regimens as 
a cause  of adverse  drug reactions is fallacious.  If the pea@? participating  in these  two 
studies  had been actual prescription drug consumers and had been compliant  with the 
4- directions writ&  on their prescription containers the results may have been catastrophic. 
The Georgetown University study9 used prescriptions for terfenadine (Seldane) and 
erythromycin to assess the extent that pharmacists warn consumers of possibley fatal drug 
interactions.  Of the 10 pairs of prescript&s  filled without comment by chain pharmacies, 
nine were accompanied by written information,  Six of these nine suggested checking with 
the doctor if terfenadine and eMtir0mycir-t were prescribed togethst. while three contained 
the  general  statement,  Report  any other drugs you take or diseases  you  have.  The 
written information distributed by these nine pharmacists lacked the contextual information 
nerzssary  to adequately  warn consumers of the seriousness  of ,taKrngterfenadine  with 
erythromycin  and  thus  is dangerous.  Distributing  written  information  that  does  not 
adequately warn of a potentially life threatening risk can only be crxxidered  as professional 
dereliction  by these pharmacists. 
1 
RECOMMENDATlONS 
The  first  recommendation  of  this draft  report  that  State  Roar&  of  Pharmacy 
collaborate  with the FDA by collecting written information distributed to prescription drug 
consumers  for quality  evaluation  by the agency  is pointless.  The  FDA is required  to 
evaluate If the distribution  and quality goals for us&~1 written drug Information mandated 
by The Action  Plan are achieved by 2000. 
Given the Department of Health and Human Services (DHHS) and the FDAs stated 
commitment to ensure that consumers will receive useful prescription drug information we 
can find little purpose for the second recommendation, other than oral counseling must be 
addressed,  because of its ill advised inclusion in the legislation4 establishing the process 
that  created  The Action  Plan,  OBRA 90 was enacted  seven years ago to address the 
issue  of oral  counseling  and  has  had minimal effect.  When enacted,  this  legisl&tion 
required  that all Medicaid recipients receive an offer to counsel, and subsequently  most 
states  required  that all oonsumers also receive an offer to counsel by pharmacists.  By 
lowering the performance objective of 100.percent established in OBRA 90 to parallel the 
distribution objectives for written information inThe Action Plan, 75 percent by 2000, and 
extending  a deadline that is already four years old to 2000 is tacit acknowledgment  of the 
failure of OBRA 90 to provide consumers with useful drug information. 
Following a recommendation made in The Actlon Plan, this draft report recommends 
the convening of a national symposium on oral counseling by pharmacists to be facilitated 
by HWA.  However, HCFA need not follow recommendations that are unlikely to produce 
a productive  result.  The obstacles to consumer counseling are well understood,  but the 
issue  for  consumers  has  remained  for  the  past  17 years  access  to  useful  written 
prescription  drug information.  Public Citizen recommends the following actions be taken by HCFA: 
1. 	 Require  that  all Medicaid  beneficiaries  receive  useful written  prescription  drug 
information meeting the agreed upon guldelines of The Action Plan with each new 
and refill prescription. 
2. 	 Establish a deadline of January 7998 for meeting the distribution requirement.  This 
would be one year after commercial information vendors agreed to The Action Plan 
guidelines  for useful written drug information. 
3. 	 Guarantee, strong independent  oversight and quality assurance by the FDA.  This 
would include giving the agency authoFityto remove written information not meeting 
The  Action  Plan  guidelines  from distribution  and fining  pharmacy  owners  and 
corporations  for  distributing  written  information  not  meeting  The  Action  Plan 
-1 
guidelines. 
Sincerely, 

Larry D. Sasich,  Pharm.D., M.P.H., FASHP 

Research Analyst, 

Public Citiien  Health Research Group. 

.  ENDNOTES  . . 
1.Throughout  our comments we will define useful prescription drug information as 
information  that enables the consumer to use the drug properly and appropriately, 
receive the maximum benefit, and avoid harm BSdefined in the Action Plan for the 
Provision  of Useful Prescription Medicine Information presented to Donna E. Shalala, 
Secretary  of the Department of Health and Human Sertices,  December 1996. 
2. Action  Plan for the Provision of Useful Prescription Medicine Information, presented 
to Donna E. Shalala,  Secretary of the Department of Health and Human Services by 
the Steering  Committee for the Collaborative Development of a Long-Range  Action 
Plan for the Provision of Useful Prescription Medicine Information, December 1998. 
3. Department  of Health and Human Services, Food and Drug Adminisjration. 
Prescription  drugs: patient package inserts requirements and draft guideline  patient 
package  inserts. federal  RegisterVol.  45 No. 179, September 12,1980,  page 60754. 
4. Avom J, Chen M, Hartley R. Scientific versus commercial sources of influence on the 
prescribing  behavior of physicians.  American Journal of Mecflcine 1982;73:4-8. 
5. Willoox SM, Himmelslein  DU. Woolhandler S. inappropriate drug prescribing for the 
community-dwelling  elderly. Journal of the American Medical Association  ?994;272: 
292-296. 
6. Carlson AM, Morris LS. Coprescriptlon of terfenadine and erythromycin  or 
ketoconazole:  an assessment of potential hah.  Journal of the American 
Pharmaceutical  Association  1996:NS36:263-269  and Thompson  D, Oster G. Use of, 
terfenadine  and contraindicateddrugs. Journalof fhe Am&can  Medical Associafion 
1996;275:1339-1341.  . 
7. Moore TJ. Deadly Medicine, New York: Simon & Schuster;  7995. 
8. Headden  S, Lenzy T, Kostyu P, Roebuck K,Locke L, Burgower Hordern B. et 31. 
Danger at the drugstore.  U.S. News & WorjcfRepoti, August 26,1996. 
. 
9. CavutO NJ, Woosley  RL, Sale M. Pharmacies and prevention of potentially  fatal drug 
Interactions.  Journal  of fhe American  Medical Associafion  1996; 275:1086[letter]. 
10. Sasich  LD, Wolfe SM. Deficiencies in patient information leaflets concerning 
gastroi@testinal complications  of nonsteroidal anti-inflammatory  drugs. Journal of 
General  Internal  Medicine  1997;12(suppl  1):79[abstract], and Department of Health and 
t-luman Servlces,  Food and Drug Administration. Prescription Drug Product Labeling; 
Medication  Guide Requirements,  Proposed rule. Federal Register Vol. 60, No. 164, 
August  24.1995.  pages 44193 and 44104. 
-7- 1I.  Public Citizen obtajned drug information leaflets from a Washington  DC pharmacy 
in late 1996 containing  dangerous  FDA disapproved-unapproved  use information.  A 
leaflet for short-acting  nifedipine capsules (Adalat, Procardia) contained  use information 
for hypertension.  The use of short-acting nifedipine capsules to treat hypertensive 
emergencies  was disapproved by the FDA in 1985.  Current approved labeling for this 
drug warns in bold type that this form of nifedipine should not be used to treat 
hypertension  for safety reasons,  A leaflet for bromocriptine (Parlodel) contained 
information  on the use of this drug to stop breast milk production in new mothers who 
choose  not to breast-feed,  The use of bromocriptine for this purpose was disapproved 
by the FDA because of heart attacks and strokes in young mothers. 
12. Wynne  HA, Long A. Patient awareness of the adverse effects of non-steroidal  anti-
inflammatory  drugs (NSAlDs). f3f#s!1 Journal of Clinical Phamtacology  1QQ6:42:25% 
256. 
13. Morris LA, Tabak ER, Gondek K. Counseling patients about prescribed medication: 
1Zyear  trends.  Medical Care 1997 (in press). 
14. Agriculture,  Rural Development,  Food and Drug Adminisfration,  and Relafed 
Agencies  Appropriations  Ad,  1997, PL 104-I 80 (August 6, 1996), fitle  VI, Section 601, 
Effective Medication  Guides.  American  2215 Ccnstitution  Avenue. NW 

Pharmaceuticat  Washmyton, DC 20037-2985  The National  Professional 

Association  (202) 628-44 10  Fax (202) 783-235 1  Society of Pt7arrnacists 

--  -
August 6,1997 

The Honorable June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

5250 Wilbur J. Cohen Building 

330 Independence Avenue, S.Wi 

Washington, D.C. 20201   

Dear Ms. Brown: 

Thank you for the opportunity to comment on the draft report, State Pharmucy Boar& 

Oversighzof Patient CounselingLaws (OEI-Ol-9740040). 

This report is remarkably timely.  The past year has seen an unprecedented surge in the 

attention given by the Congress, the Secret  of Health and Human Services, the 

pharmacy profession, pharmacy store owners, and consumers themselves to the important 

problem of improving drug information provided to consumers.  Your report is likely to 

contribute significantly to greater understanding of the need to solve this problem, and of 

the barriers that must be overcome before consumers can be assured of routinely receiving 

essential diug information from pharmacists. 

Mismedication  as a National  Problem.  The report does a fine job of citing several key 

studies documenting the human and financial cost of suboptimal prescribing, dispensing, 

and patient adherence to their prescribed drug regimen.  While it is customary to cite the 

most recent studies to establish the nature and extent of a social problem, this approach 

may inadvertently lead policymakers to believe this problem has been only recently realized 

by health services researchers.  Nothing could be further from the truth. 

In fact, the great morbidity and mortality associated with poorly-managed pharmacotherapy 

has been documented in numerous studies for many years.  For example, eight years to the 

day prior to the publication in Archives of Inter&  Medicine of the paper entitled Drug-

Related Morbidity and Mortality by Johnson and Bootman, which reported the estimate of 

an expert pharmacist panel,  JAMA published a similar estimate by an expert medical 

school panel entitled Assuring the Quality of Health Care for Older Persons.  The JAMA 

authors placed the adverse effects of drugs among the top five greatest priorities for 

quality improvement in care of the elderly - along with four of the greatest sources of 

morbidity and mortality in our society: congestive heart failure, hypertension, pneumonia, 

and breast cancer. 

Citing some of this older research will help to establish the grim reality that public and 

private policy may fairly be criticized as producing much more talk lbarl action toward a 

solution.  An annotated bibliography of severa  such studies is provided as an attachment. 
 Pharmacists  as Counselors.  One of the bright spots in this otherwise dismal picture of 
persistent preventable morbidity and mortality has been the dramatically improved 
performance of pharmacists in providing drug information to consumers.  These 
educational services are a promising part of any effort to reduce the human and fiscal cost 
of mismanaged drug therapy.  The pharmacists contribution goes far beyond the written 
handouts discussed in the recommendations section of draft report. 
Surveys performed at several intervals over the past fifteen years have shown direct 
pharmacist counseling of consumers has improved from 20 percent in an FDA survey 
conducted in 1982 (Federal Register, Volume 50, No. 164, page 44191) to 51 percent of 
consumers responding to the National E%armacyConsumers Survey, conducted by the 
American Pharmaceutical Association (APhA) in 1996. 
The draft report is correct in its contention that these services, when provided, are 
valuable.  Some readers of your report may not be aware of the evidentiary basis for this 
assertion, and for this reason we suggest that the report add numerous other citations to 
studies that confirm the effectiveness of the pharmacist as a source of drug therapy patient 
education and management.  A brief annotated bibliography of  several recent studies is 
attached for your reference and use.  Copies of these articles are available upon request. 
Board Enforcement  of Counseling Laws.  Use of the shopping technique is a 
potentially powerful tool for identifying inadequate counseling practices.  The advantage of 
this approach is that it can discover directly the experience of the typical consumer who 
receives products and services in a pharmacy., if such shoppers are not identifiable as 
such. 
Shoppers utilized for this purpose tiust be well-trained in counseling techniques, and 
must be well-supervised, to ensure validity and equity in their findings.  A critically 
important aspect of such training should be in assessing the workplace circumstances of 
pharmacist employees, who may simply be unable to counsel given the level of staffing and 
the volume of dispensing they are required to perform by their employer.  For these 
reasons, it may be helpful for State pharmacy boards to have a best practices model to 
inform  their efforts in making wise use of this quality monitoring tool.  APhA has been 
collaborating with the National Association of State Boards of Pharmacy (NABP) and 
appropriate physician and consumer organizations to cosponsor a conference to debate and 
develop guidelines, such as a model oral counseling assessment mechanism, and would 
urge the OIG and the Department to provide financial support for this conference. 
Finally, APhA believes it makes sense, given the scant resources of pharmacy boards, to 
reserve such resource-intensive methods as shopping for investigating pharmacies and 
pharmacists about which complaints h.avebeen filed relating to the quality of counseling 
services. 
2  Regulatory pressure on pharmacies and pharmacists to increase patient counseling may 
produce some small incremental reallocation of resources to improve pharmacist 
counseling.  But it would be a mistake to expect a crack down on pharmacists or store 
owners to produce many benefits for the public because margins in the retail sector of 
pharmacy are extremely thin and getting thinner for reasons beyond the control of the 
pharmacist and many store owners.  Already, financial pressures have forced 
approximately a thousand indep&dent retail pharmacies to be sold or closed each year in 
the early 1990s. even without the additional pressure of a call by regulators to reassign 
pharmacists to counseling duties: 
These realities are so broadly accepted as to be reflected not only in comments from store 
owners and pharmacists but, as the draft report indicates, in comments from most 
pharmacy regulators, who understand that the disincentives for counseling are formidable. 
What is needed is a concerted effort by those representing all stakeholders to convince 
payors, consumers, and store owners of the value of counseling services.  The draft report 
can play a stronger role in awakening public policymakers to these realities of the 
marketplace. 
Barriers to Patient  Counseiing.  The OIG report correctly identifies the three major 
barriers impeding full implementation of section 4401(g) of the Omnibus Budget 
Reconciliation Act of 1990 (OBRA 90). 
Relative imnortance of the Barriers Identified bv the OIG.  In presenting these, we believe 
it makes the most sense to present these in order of the frequency with which they were 
mentioned by the State pharmacy board officials surveyed by the OIG: 
(1)  Economics of Pharmacy Practice (cited by about 75 % of respondents); 
(2)  Limited Patient Demand (cited by about 60%); and 
(3)  Lack of Resources for Enforcement (cited by just SO%,despite the direct incentive 
to emphasize this problem which might be ascribed to State board officials). 
This sequence more accurately reflects State officials awareness of the fundamental 
diseconomies dominating todays  marketplace which punish, rather than reward, 
pharmacists for patient counseling activities.  State officials understand that it would be 
both inequitable and ineffective to attempt to reverse these powerful economic disincentives 
solely by imposing ever greater financial or other civil penalties.  patlent Demand.  APhAs 1996 National Pharmacy Consumer Survey assessed the views 
of a random sample of over 980 consumers who reported at least one visit to a pharmacy in 
the preceding six months.  The survey validates to some extent the State board officials 
perception that there is limited consumer demand for pharmacist counseling services, but 
paints a somewhat more complex picture.  Consider the following evidence from the 
survey: 
The most important reason given by cousumers for choosing their pharmacy is 
 	
convenience (37% of respondents) - specifically, how close the pharmacy is to home 
or work (33%):  This is more than twice the percentage identifying either price 
(18%) or service (16%) as the reason for their choice of pharmacy. 
Results from this survey revealed that between 76% and 93% of consumers believe that 
 	
their needs for most dispensing-related services are already being met by their 
pharmacist.  This high level of satisfaction with-the current level of pharmacists 
service indicates consumers believe pharmacists are already providing essential 
counseling services when these are needed, and may feel no need to ask for what is not 
already being provided. 
The survey does provide some evidence that about 20% of pharmacy consumers desire 
 	
more contact with their pharmacist to discuss their prescription drug therapy, but 
significant barriers interfere with their obtaining these services: 
b  Nearly half of those expressing a desire to have greater access to their pharmacist 
are daunted by the perception that the pharmacist is too busy to speak with them. 
Over one-third of consumers have difficulty distinguishing pharmacist(s) from other 
pharmacy personnel.  I 
Finally, the services consumers most often report theyd like to receive from the 
pharmacist are the services least likely to be performed at the time of dispensing: 
About 70 percent of consumers want the pharmacist (1) to remind customers by 
mail or telephone that it is time to have a prescription refdled, and (2) call to find 
out how the prescription is working.  This  suggests the greatest unmet demand for 
pharmacist counseling services are those which are provided to the consumer while 
they are not in the pharmacy. 
Relatively few consumers are willing to pay the entire cost of enhanced counseling 
 	
services out of pocket, suggesting that these services will not be used at an optimal 
level by the consumer until the expense is covered by health plans in the same manner 
as other health care services; 
4  The National Pharmacy Consumers Survey does supply evidence that most cousumers are 
open to a more intensive level of service from their pharmacist.  Over two-thirds of 
consumers would view somewhat favorably or very favorably a new, higher level of 
service in which the pharmacist would provide more counseling before and after the filling 
of prescriptions, as well as engage in greater interaction with their physician to facilitate 
any needed adjustments to their drug regimen.  Fully 31% of pharmacy consumers 
expressed a willingness to switch pharmacies to gain access to this higher level of service, 
if there was no cost to the consumer. 
Economic_Barriers.  The report accurately depicts the dilemma of 
pharmacists and their employers in the current marketplace.  There are two major 
economic barriers standing in the way of consumers receiving more and better counseliug 
from their pharmacist.  Both are the result of drug pmducf  reimbursement reductions that 
are squeezing pharmacist counseling services out of the pharmacy.  These barriers deserve 
more explanation in the report, even though it is unlikely that the market will embrace 
higher drug product reimbursement as a solution.  -
In the past, pharmacists were able to finance patient counseling activities from the margin 
they received from selling pharmaceuticals.  Demands from within the profession and from 
the Federal and State governments for greater pharmacist counseling have coincided with 
the increasing domination of the market by third party payors, who have been increasingly 
successful in demanding drug product discounts from pharmacists.  By 1995, a senior Blue 
Cross/Blue Shield Association official was able to report that reduced reimbursement to 
pharmacies accounted for fully 60% of all savings achieved by the Association in managing 
the drug benefits offered through the Federal Employees Health Benefits Program 
(FEHBP). 
Such reimbursement reductions inevitably spur changes in pharmacy practice.  In a market 
dominated by slim and declining margins, pharmacies that can dispense more prescriptions 
per hour are economically advantaged over those which cannot.  Pharmacies where 
pharmacist employees spend time on non-revenue generating counseling of patients can 
only expect to benefit if patients select that pharmacy on the basis of service - which the 
draft report has correctly identified as an area of soft consumer demand. 
One remedy for this situation would be for private and public sector payors, such as the 
Federal and State governments - through the FEHBP, State employee, Medicare, and 
Medicaid programs - to pay for some or all pharmaceutical care services.  Data from the 
Washington State Medicaid Drug Use Review demonstration project show that paying 
pharmacists for counseling activities easily pays for itself out of drug product costs alone 
if payment is tied to documented, clinically necessary changes in drug therapy which have 
been suggested to the physician by the pharmacist.  Additional savings from reduced 
morbidity and mortality may reasonably be expected, though that demonstration project 
was not designed to capture evidence of such savings from reduced health care utilization.  A large controlled study done by the University of-Southern California and Kaiser 
Permanente (publication pending) found that either of two different models of pharmacist 
counseling significantly reduce hospitalizations compared to the control group.  The two 
models of pharmacist counseling were the OBRA 90 counseling model and Kaiser 
Permanent&s own counseling program, in which pharmacists are instructed to focus 
wunseling  efforts on high risk drug products and related patient populations. 
Patients who received OBRA 90 counseling services from Kaiser pharmacists were 
interviewed for the USC/Kaiser study about the frequency of wunselii  they received. 
These patients reported receiving OBRA 90 counseling interventions at over twice the 
rate of patients served in community pharmacies during the course of the study.  It appears 
that these Kaiser pharmacists, serving under the same legal obligations as their professional 
colleagues in community pharmacies,  provided a substantlally higher level of service. 
Why?  The most likely explanation for this is that Kaiser pharmacists enjoyed a significant 
infusion of resources in the form of more technicians and management encouragement and 
support for counseling.  Financial incentives support effective counseling by Kaiser and its 
employee pharmacists, inasmuch as staff receive bonuses if their efforts result in reduced 
preventable health care utilization. 
The existence or absence of financial incentives for pharmacy owners and pharmacists has 
a powerful impact on whether certain pharmacy practice innovations produce more 
counseling service, or simply result in reduced professional staffing.  For example, the 
draft report suggests that increased use of technicians, as well as automation of the 
dispensing aspect of pharmacy practice, can theoretically free up the pharmacist to provide 
counseling services.  This is certainly true, however, if the owner of the pharmacy does not 
realize revenue from the services of the pharmacist, the owner has an incentive to replace 
the pharmacist with automation and/or technicians and pocket the savings, rather than 
continue to pay the pharmacist to provide unpaid drug therapy management to consumers. 
A related barrier deserving mention and follow up study is that some State pharmacy 
boards limit, by regulation, the USCof technicians that might be used to free up the 
pharmacist for counseling services. 
Additional Studies on Economic Barriers.  Several studies confirm the impression of the 
State pharmacy board executives surveyed by the OIG that there are significant economic 
barriers to pharmacists spending time with patients.  These studies should be cited in the 
report: 
Barnes et al, in a 1996 survey of 400 pharmacists published in The Annals of 
 	
Phamcotherupy  found that the most significant barriers to implementation of the 
6  OBRA 90 patient counseling requirements were (1) excessive workload; (2) lack of 
financial compensation; (3) patients attitudes (e.g.,  lack of interest in counseiing). 
Rupp et al, in a 1992 study published in Medical Cure, documented that there is a 
 	
statistically significant inverse relationship between greater volume of prescriptions 
dispensed and the amount of pharmacist .oversight and counseling of those 
prescriptions.  The authors noted in this study: 
this fmding suggests that pharmacists willingness or ability to intervene in 
problematic new prescription orders decreases as the volume of prescriptions they 
dispense per hour increases.  
According to the May 8, 1995 issue of Forbes magazine, the growing power of 
 
[insurance plans] to dictate the price of prescription drugs has slashed retail pharmacy 
gross margins to 25%) from 35% in 1989.  Thats $5.5 billion carved right out of 
operating profits.  Declining per unit profits create a powerful incentive for pharmacy 
owners to increase volume and improve the productivity of their employee pharmacists 
in performing those activities for which the store receives revenue.  Thii directly 
affects the time available for counseling. 
Results from the 1996 APhA National Pharmacy Consumers Survey indicate that 
 	
nearly 60% of those desirjng greater access to their pharmacist reported that these 
health professionals appear COObusy to talk with them. 
Additional Recommendations Regarding Federal Govetnment Action.  The draft report 
properly notes that there is a substantial Federal interest in improving the quantity and 
quality of pharmacist counseling of consumers.  The draft recommendations fall short of 
addressing the key economic incentives discussed in the body of the report, however. 
APhA has several additional recommendations to suggest, described below. 
(a) Federal Costs Associated with Drug-related Morbiditv & Mortality.  An important 
Federal interest which is not mentioned is the cost of s&optimal drug therapy which is 
charged to Medicare, Medicaid, FEHBP, CHAMPUS and other insurance or health plan 
arrangements sponsored or financed by the Federal Government.  Although the report 
mentions the scientific and clinical literature (in&ding  estimates from FDA) which 
estimate substantial costs associated with preventable drug-related morbidity and mortality, 
these costs should be projected to the large patient populations covered under these health 
care programs, even if these estimates are only based on the approximate drug utilization of 
these populations. 
7  (b) Economic Incentives to Counsel are Annronriate and Timelv.  APhA believes the OIG 
report should recommend that fee for service programs, beginning with those operated or 
funded by the Federal Government, provide financial incentives for these services as well. 
These payments couid be conditioned on documentation that a prescriber has accepted a 
clinically-relevant drug therapy change recommended by a pharmacist.  Such a program 
could be put into place today, using existing electronic claims coding standards.  The entire 
objective of such a program should be to reduce drug-related morbidity and mortality in 
key populations of interest to the Federal Government, such as  older Americans. 
(c)  Oral CounselinP Obiectives bf the Secretarv.  The draft report discusses the,HHS 
Secretarys support for increased distribution of written information to pharmaceutical 
consumers.  It is important to note that the Secretary has for several years embraced the 
Health People 2000 goals, which were updated in 1995 to call for -
[Objective 12.81 Increase to at least 75 percent the proportion of people who 
receive useful information verbdy  and in writingfor new prescriptions from 
prescribers or dispensers.   [emphasis supplied] 
APhA believes this report will help encourage pharmacy boards, consumers, pharmacy 
owners and pharmacists to begin an unprecedented cooperative effort to enhance the quality 
and frequency of pharmacist service received by the public.  Once again, thank you for 
your consideration of the views of Americas pharmacy profession. 
\L9l(n  A. Gans, PharmD 
Executive Vice President 
Enclosures 
JAGldgs 
8  American  2215  Constitution  Avenue.  NW 

Pharmaceutical  Washinglon,  DC 20037-29%  The National  Professional 

Association  (202) 628-4410  Fax (202)  783-2351  Sociefy  of Pharmacists 
OLDER  AMERICANS  NEED PHARMACEUTICAL  CARE SERVICES 
PROBLEM:  Preventable  drug related problems  inflict  substantial  morbidity  and 
mortality,  costing  Medicare,  employers,  and  health  insurers  biIIions every year. 
Drug-Elated  morbidity  and  mortality  are  estimated  to cost  $77  bihion  in the 
US.  each year.  -- Archives  of Internal  Medicine,  October  1995. 
Adverse  drug  events  are  among  the  top  five  greatest  and  most  preventable 
threats  to  the  health  of  elderly  Americans,  after  Congestive  Heart  Failure, 
Breast Cancer,  Hypertension,  & Pneumonia.  -- JAMA,  October  1987. 
Twenty-eight  percent  of  hospitalizations  of  elderly  Americans  are  due  to 
noncompliance  with drug  therapy  (1 I %) and  adverse  drug  reactions  (17%).  -- 
Archives  of Internal  Medicine,  April  1.990. 
Patient compliance  with drug therapy  deteriorates  as the number  of drugs  taken 
by the patient  increases.  Because  25%  of the elderly  use three  or more  drugs 
daily,  the elderly  are particularly  at risk.  -- The Gerontologist,  March  1994. 
Of elderly  patients  taking  three  or more  chronic  prescription  drugs,  over  one-
third are re-hospitalized  within six months  of discharge  from a hospital.  Twenty 
percent  of readmissions  are due to drug  problems,  principally  undertreatment, 
noncompliance,  and adverse  drug reactions.  -- Medical  Care,  October  1991. 
32,000  senior  citizens  each  year  suffer  hip  fractures  from  falls  caused  by 
adverse drug  events.  - New England  Journal  of Medicine,  February  1987. 
The inappropriate  use of prescription  drugs  is a potential  health  problem  that is 
particularly  acute for the elderly.  The U.S.  General Accounting  Office analyzed 
1992 Medicare  data and found  that about  5.25  million  of  noninstitutionalized 
elderly  Medicare  enrollees  used  at  least  one  drug  identified  as  generally 
unsuitable  for elderly  patients  given  that safer drugs  exist.  - GAO,  July  1995. 
In an average  year,  32,800  people  die from  pneumococcal  disease  and 20,000 
die from  influenza-almost  all elderly.  Medicare  spends  as much  as $1 billion 
for treatment  of influenza-associated  diseases  each year.  Seventy-three  percent 
of the elderly  have never  been immunized  for pneurnococcal  pneumonia;  49% 
of the elderly  have not been  vaccinated  against  infIuenz.a.  -- GAO,  June  1995. 
Infhrenza  vaccination  reduced  hospitalization  costs  an average  of $117 for each 
of the 41,418  elderly  people  immumzed  during  a three year period. - The New 
England  Journal  of Medicine,  September  1994. 
PROBLEM:  Perverse incentives.  Until pharmacists  are paid for pharmaceutical  care, 
their livelihood  depends  on faster dispensing  of prescriptions,  making  it uneconomical 
for them  to spend  time  with patients  & physicians  solving  drug  therapy  problems.  .-
2 
PHARMACEUTICAL  CARE IMPROVES PATIENT CARE AND OUTCOMES 
0 	 Pharmacist teaching and monitoring  of drug therapy in a group of African-
American asthma patients reduced emergency department (ED) visits by over 
70% and hospitalizations by 80%) compared with no significant reduction in ED 
visits and a 50% reduction in hospitalizations in a control group receiving usual 
care from local physicians.   [Kelso TM, et al, Am Jml of Med Sciences, June 
lf=l 
0 	 Asthma  patients  who  are  high  users  of  hospital  emergency  departments 
experienced an 80% decline in ED visits after ongoing pharmacist counseling. 
[Pauley TR, et al, Annals of Pharmacotherapy, Jan 19951 
0 	 Geriatric consumers, who account for about 30% of drug use in the U.S., were 
able  to  reduce the  number  of  drugs  taken  and achieve  significantly  better 
compliance with their drug regimen after counseling by pharmacists, with no 
increase in costs.  [Lipton HI,, and Bird JA, Gerontologist, March 19941. 
0 	 Ambulatory patients used significantly fewer health services, saving over $640 
a year in health costs per individual, as a result of comprehensive pharmacist 
counseling,  [Borgsdorf LR, et al, Am Jrnl of Hosp Pharm, March 19941. 
0 	 Community pharmacists counseling patients identified and resolved problem 
drug therapy in  -2%  of new prescription orders, with about 28% of these 
judged capable of causing patient.ham  if the pharmacist had not intervened. 
[Rupp MT, et al, Medical Care, Ott  19921. 
0 	 Physicians  accepted about  83% of  pharmacists  recommendations for  drug 
therapy changes in an ambulatory care clinic.  For 80% of recommendations, 
improvement or  resolution  of  a  patients  disease  state  occurred.  cost 
reductions were noted.  [Lobas NH, et al, Am Jml of Hosp Pharm, July 19921. 
0 	 Medicare would realize net savings of $280,000, 139 hospitalizations, and 63 
deaths per 100,000 errrollees each year if it paid pharmacists to advise enrollees 
to be vaccinated for influenza, according to an estimate based on an experiment 
in North ~Carolina. [Grabenstein JD, et al, Medical Care June 1992.1 
0 	 The addition of a clinical pharmacist to a hospital-based geriatric clinic reduced 
the number of medications associated with an adverse drug reaction by 42%, 
and produced  direct  cost  savings  of  $54/patient,  in  the  first  six  months. 
(Phillips SL, Carr-Lopez SM.  Am Jrnl of Hosp Pharm, May 19901 
0 	 Hypertensive patients who received pharmacist counseling were more compliant 
with their treatment, and achieved better blood pressure control, than a control 
group.  [McKenney JM, et al, Circulation,  Nov.  1973; McKenrtey JM, et al,  .- 3
Contemp Pharm Pratt,  Fall 19781_ 
0 	 Relative to a control group, diabetic patients who received pharmaceutical care 
were more compliant in keeping clinic appointments, made fewer medication 
errors,  saw symptoms improve in 5 of 8 variables measured, and had a lower 
incidence of.hospital admissions and medical contacts.  [Sczupak CA, Conrad 
WF, Am Jml of Hosp Phaxm, Nov 19771.  National  Association  of Chain  Drug  Stores 
Thomas  &I. Ryan  . . 
Chairmnn  of the Board 
Ronald  L. Ziegler 
President  & CEO 
June 30,1997 

The Honorable  June Gibbs Brown 

Inspector  General 

United States Department  of Health and Human Services 

Room 5250 Cohen Building 

Washington,  DC  20201 

RE: OEI-0 l-97-00040 

Dear Ms. Brown: 

f
f 
On behalf  of the National  Association  of Chain Drug Stores (NACDS),  I am pleased to 

include the attached document which provides our perspectives  on the drat? report,  State 

Pharmacy Boards  Oversighis of Patient  Counse&g  Laws. n We appreciate  the 

opportunity  to comment  on this draft report. 

NACDS membership  consists of more than 130 retail chain community  pharmacy 

companies.  Collectively,  chain community pharmacy  accounts for the largest component 

of pharmacy  practice with over 86,000 pharmacists.  Chain community  pharmacy  is 

comprised  of 18,500 traditional  chain drug stores, over 6,000 supermarket  pharmacies 

and nearly  5,000 mass merchant pharmacies.  The NACDS membership  base operates 

nearly  30,000  retail community pharmacies with annual  sales totaling  over $110 billion  in 

prescription  drugs,  over-the-counter  (OTC) medications  and health and beauty aids 

(HBA).  Chain operated community  retail pharmacies  fill approximately  6(! percent of the 

more than 2.5 billion  prescriptions  dispensed annuahy  in the United States. 

Thank  you for the opportunity  to comment on this report.  Please call on us if we can 

provide  any additional  information  to your office about this or other issues. 

Sincerely, 

Officer 
413 North  Lee  Street,  P.0. Box 1417-D49,  Alexandria,  Virginia  22313-1480  Phone:  703-549-3001  Edx 703-836-4869  COMMENTS  OF THE NATIONAL ASSOCIATION  OF CHAIN DRUG STORES 

DRAFT REPORT 

STATE PHAkpvlACY BOARDS OVERSIGHT  OF PATIENT  COUNSELING  LAWS 

General Overview 
Consumers of prescription medications are entitled to a meaningfui offer to be counseled, 
consistent with state law. Interaction with the pharmacist should help consumers better 
understand how to take their medications. 
NACDS also believes that consumers are entitled to receive comprehensive written information 
about their prescription medications that reinforces and supplements the oral information 
provided to the consumer by health professionals. Such written information can also serve as a 
reference source for the consumer during the course of prescription use. 
The OIG report clearly identifies current issues relating to state board of pharmacy enforcement 
of patient counseling laws. However, NACDS believes that the report describes the situation as 
a glass half empty rather than a glass half full. While there are clearly strides to be made in 
improving the quality and quantity of oral counseling, FDAs own data illustrate the progress 
that has been made to.date by pharmacists in providing oral counseling to consumers. 
While the oral counseling provisions were included in Medicaid legislation enacted in 1990,the 
law required that these provisions take effect January 1,1993.  Since that time, consistent and 
appreciable strides have been made in improving the quantity and quality of oral counseling.  In 
fact, FDA reported that 32 percent of consumers reported that they received oral counseling in 
1992, which increased to 42 percent in 1994and 47 percent in 1996. 
Therefore, substantial progress in complying with oral counseling laws has already been made by 
pharmacy in just three short years, in spite of multiple challenges to the development of this 
practice. As with any significant and substantive change in the practice of a health professional, 
a period of adjustment must be expected by all parties involved, including consumers. 
Moreover, the success of oral counseling depends upon a complex dynamic of multiple factors in 
the health care system working well together. These include boards of pharmacy, pharmacists, 
consumers, pharmacy benefit managers (PBMs),and other thii  parties, all of whom have a 
vested interest in its success, and all of whom have to contribute to making it successful. 
The practice, economic and social barriers and challenges that must be addressed to increase 
m&.ningful oral counseling by pharmacistsare described below. 
. 
ce m:  Many state boards impose outdated and antiquated practice requirements on 
pharmacies, requirements that shift pharmacistsfocus to prescription dispensing rather than 
consumer interaction.  That is, many state boards impose unrealistic technician-to-pharmacist 
ratios, and some states require that only pharmacistsperform non-judgmental tasks that could be 
performed by well-trained technical personnel. NACDS is working to revise these antiquated 
and outdated practice acts so that pharmacistscan spend more time with consumers on such 
National Association of Chain Drug Stores 
June 27.1997 
Page 1  activities as oral counseling. This movement will also be facilitated by the evolution of 
automated pharmacy dispensing systems. 
An additional practice barrier is the fact that pharmacists are often unaware of the intended use 
of the prescription medication, or the patients diagnosis. Knowledge of the prescribers 
intended use of the drug would facilitate the interaction between the pharmacist and the 
consumer, especially when the drug is being used for an off-label use. 
To facilitate and encourage oral counseling, many chain pharmacies are restructuring their 
prescription departments to provide a private area for the consumerto talk with the pharmacist 
about the medication. 
.
B~hallenges:  We concur with the draft reports fmding that a significant obstacle to 
providing oral counseling is the economics of pharmacy practice, where, according to the report, 
payers are squeezing operating margins. When OBRA 90 was enacted, no additional 
provisions for payment were provided to states to defray pharmacists costs of providing 
counseling to Medicaid recipients, essentiaily resulting in an unfunded mandate on pharmacists 
and the states. 
As the report also indicates, OBRA 90 vested the enforcement of these new laws with the states 
without providing for additional resources. In addition, most states extended the counseling 
requirements to non-Medicaid recipients, meaning that the unfunded mandate was extended in 
most states to all pharmacy consumers, not just Medicaid recipients. 
At this point, almost 70 percent of all prescriptions are paid for by third party plans. These plans 
are paying pharmacies less per prescription, not more, and are squeezingpharmacy margins.  In 
almost all cases, third-party plan reimbursement, including Medicaid, does not even compensate 
pharmacies adequately for the cost of filling the prescription, much less for providing 
counseling. 
In 1991, before the pharmacy counseling provisions were implemented, HCFA found that the 
average cost of dispensing a Medicaid prescription was about $5.50. This amount did not 
include the cost of counseling. In its final rule implementing the patient counseling guidelines, 
HCFA itself indicated that the cost of a counseling session was about $2.50-$3.00. 
When the HCFA-estimated additional costs of counseling are addedto the cost of providing the 
prescription, it increases the cost of dispensing to, on average $838.50 per prescription, well 
below the current average per-prescription Medicaid payment to pharmacies. At this point, 
Medicaids average dispensing fee per prescription has declined by 14.4%in 1996 inflation-
adjusted dollars from $4.93 in 1991to $4.22 today. This underscoresthe economic challenge to 
the provision of oral counseling by community retail pharmacies. 
Consumer Cu:  Consumers need to better-understandand appreciate the value of the 
pharmacist in helping them manage their medications. Physicians and other health care 
professionals also have to sensitize consumersto the need to obtain as much information about 
their medications as possible, including through oral communications. 
National Associatioonf Chain Drug Stores 
June 27,1997 
Page 2  Consumers can also help their own cause by demanding that their health benefit plans cover the 
cost of pharmacists providing oral counseling as a part of the prescription drug benefit. 
Unfortunately, third party prescription benefit plans continue to focus on reducing 
reimbursement for the product cost. 
Instead, health benefit plans and PBMs should adopt reimbursement policies that encourage the 
delivery of pharmacy services which reduce overall drug expenditures through better drug use. 
Community pharmacy is eager to work with consumer and patient advocacy groups  to increase 
consumer demand for oral counseling at local pharmacies. 
Response to OIG Suggestions 
NACDS would like to offer brief comments on the suggestions made by the OIG in its draft 
report relative to methods to improve oral counseling. NACDS is participating with almost 
every other national pharmacy organization in cosponsoring a national symposium on pharmacy 
oral counseling.  The symposium is scheduled to be held this fall, which will help implement 
part of the Action Plan for the Provision of Useful Prescription Medicine Information. 
This plan was developed in lieu of the MedGuide action plan proposed by the FDA. This  . 

upcoming symposium will assess the current array of pharmacy oral counseling guidelines, 
evaluate the need for any refinement to these guidelines, and seek to develop an action plan to 
address many of the challenges to the further provisions of oral counseling as described above. 
NACDS has serious reservations, however, about other recommendations made in the report that 
would prescribe a broader role for the Federal government, notably HCFA and FDA, in setting 
performance objectives for oral counseling.by pharmacists, as well as-Federaloversight of such 
counseling. NACDS believes that the regulation of the practice of pharmacy is the purview of 
the states. Any additional performance objectives-orstandards that are needed, including any 
necessary oversight mechanisms, should be developed by the state boards of pharmacy in 
conjunction with the profession of pharmacy. 
It is important to recognize that, while an increase in the quality and quantity of  counseling 
oral 
is a goal that is desirable and achievable, any further efforts to establish additional standards or 
oversight must be accompanied by an equally-committed and forceful effort to address some of 
the challenges that currently impede the further development of oral counseling. 
uk/govtlfdaloigrptZ! 
National Association  of Chain Drug Stores 

June 27,1997 

Page 3 
 June 13, 1997 
June Gibbs Brown 
Inspector General 
De  artrnentof Health & Human Scrviccs 
Wilbur J, Cohen Building, Suite 5250 
330 Independence Aye,, SW  __ 
Wasbingtoa, D.C. 20201 
Nations1  RI3: Draft inspection report, State Pharmacy Boards Oversi ht 
of Patient Counselmg Laws.  Q$&Z-W~~ 
5  COMMUNITY 
PHARMACISTS 
Association 
Dear Inspector General, June Gibbs Brbwn: 
We agree with your basic premise that effective oversight can help foster the 
intent of the federal and statt  atient counseling laws. We commend your 
office for doing this study anB  our rccognitlon that proper use of mcdicino is 
a major  ublic policy Issue, d t also agree with your view that  hatznacists 
arc In a Eey role towsprc the appropfiatouse of medication, bo% tllrough 
identifying and correcting prescri tlon errors, and tirough effective 
intcruction wlth patients to foster e Cttcrpatient understanding and UN  qf
mcd)Ane. Incidentally, several studies have documented the cost of 
inappropriate medication well in excess of $100 million a year noted in ybur 
report, (See attached.,Thc?6 Billion DoZlurQueslk) 
The oversfght of the non-Medicaid laws, of course, rests exclusive1 with thp 
state pharmacy boards. Your investigation h,u determined that tic % 
enforcement of the laws has been minimal, We belleve it is pattlculqrly 
important that your investigation o$obstacles to effective pharmacist 
NCPA 
counseling found that the pr@cipIebarrier was limited reimbursemcpt for 
2OfIhngedeld  Road 
counseling service-s.The Prescription Infomlation Actioh Plan ap roved by 
Aknndrla.Vlqinb 
12314.2885  Secretary Sbalala, at page.33,conclu,desthak.third-party payers Pmcluding 
government agencies) should consider the health care and economic benefits 
phone 
they will likely receive due to improved oral and written comxnunkation and 
703.683.8200  *  , 
arc  encouraged to provide paym$nt lp health care professionals for 
rbx  strongly 
703.683.3619 	 providing these services. Your departmenthas a wide range of optibns 
available to help facilitate the removal of this principlebarrier to more effective 
patlenl counseling. 
Another particularly enlightenjng aspect of your investigation isthat 94% of 
the state pharmacy boardsindicated that their stat0had no contlnulng 
education requircqents specifically inlended to help pharmacists conduct 
aticnt counseling; Under thcpmspective drug review provisions of the 1990 
R edicaid amendments,each statesprogmp Is required LOconduct a&c  and 
ongoing educational outreach pro.gra& to educatepractltioncrs, ph,umacists 
I -0,  *.a  \=.  I.  f  4.  a.  *I*..  . .  . .  Brown 
InSpector  General 
Page 
TWO 

June 13, 1997 

and doctors, on  drug therapy problems. We recommend that your 

comnion 
department encourage slate Medicaid progMmsthrough funds made av$labIe 

lo state pharmacist association iddonductthe ieleitant continuing edudatloh
;  .B  I. 
programs.  . 
.-
Considering your finding that lack of patient knowledge about the counseling 

requirement is aIso a major obstacle; 1t would seem that similar Medicaid 

patient education programs would be appropriate. Of course the development 

of state standards called for in the 90 amendments could help achieve these 

and other objectives, 

The planning for the National Symposium on Oral Counseling by pharmacists 

called for in the Secretary Shalalas Prescription Information Action Plan is 

well underway.  In fact, several weeks after the plan approval, we hosted a 

meeting of the CEOs of Qe major national pharmacy organizations where a 

consensus was developed in support of convening the private sector 

sponsored symposium. 

The Center for Drugs and Public Policy has been contracted to assist with the 

symposium, and recently an advisory commitlee met in our offices to help 

assure that consumer, private third-p&ty payor and other intercstcd parties am 

involved both  in the development of the program and participation ?t *the 

s m  oslum which will be held September 19-21 at the Landsdowne 

EYon
  erence Center in Leesburg, Virginia. (SC&eliclosed related ma$~@Is), It 

is pLarlicuIarlyexcitiag tosee all of pharmacy supporting this effort. 

HCFA is encouraged to designate a representative for the Advisory 

Committee and to suggest appropriate individuals to the Center on Drugs and 

Public Policy to participate aethe symposium. It is important, however, to 

note that while support for the symposium by HCFA is important, it is a   

private sector pharmacy Icd initiative 

Incidentally, the purposes of the symposium include an assessment of 

guidelines as noted in your rep&t (see B-2), but are per Secretary Shalakbs 

Prescription Information Action Plan more comprehensive: 

the effectiveness of current oral counseling guidelines relating to 

 
prescription medicines 

identication  of best practices for oral counseliig 

 
sug estions for refincmcnt to current guidelines, if needed, with rcfcrral to 

 
State t oards of pharmacy. 

strategies to reduce the economic, pradice, and social barriersrelating to 

 
provldlng useful oral information about prescription medicines. 
 .  . 
Inspector Genera1Brown 

June 13, 1997 

Page Three 

Regarding the FDA, WCcertainly support their involvement in an assessment 

of the usefulness of written information Provided to patients and would 

encourage a similar assessment of *&en  mformation provided by the boar& 

of pharmacy to  pharmacists.  .-

Again, thank you for the 9  ortunity for community pharmacy to comment 

on this report, and its signupicant findings.  We stand ready to assist your 

department in taking meaningful steps to address the findings. 

CXdj 

Enclosures 
 $ 
El 
AMERICAN SOCIETYOF HEALTH-SYSTEPMHARMACISTS  ,. , -.,.
.  Pharmacists41healthsystems helpingp  t uqf  medications  _--
July lo,1997 

Ms. June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

5250 Cohen Building 

330 Independence Avenue, S.W. 

Washington, DC 20201 

RE:  Draft Repoti,  State Pharmacy  Boards Oversight of Patient Counseling  Laws. 
Dear Ms. Brown: 
The American Society of Health-System Pharmacists (ASkP) appreciatesthe opportunity to comment on 
this draft report. ASHYis the 30,000-membernational professional organization that represents phar
macists who practice in hospitals, health maintenance organizations, long-term care facilities, home care 
z  organizations, and other components of health care systems. 
As a long-time proponent of patient counseling, ASHP has a particular interest in the subject matter of 
the draft report. Because of its strong commitment to patient counseling, ASHP has taken an active role 
in supporting this aspect of patient care as part of iti mission to help pharmacists provide pharmaceutical 
care that results in positive patient-care outcomes. In the 197Os,ASHP established Guidelines on 
Pharmacist-ConductedPatient Counseling. These guidelines have been revised and expanded over the 
years, and a copy of the most recent (1996) revision is enclosed. The guidelines indicate AMPS 
commitment to the principle that pharmacists should educate and counsel all patients to the fullest extent 
possible, going beyond the minimum requirements of laws and regulations. Anything less is inconsistent 
with pharmacistsresponsibilities and talents.  . 
Ibe importance of informing consumers about the vital patient care role of pharmacists and expanding 
efforts to preventmedieation emors and other drug-related problems are also prominent portions of our 
1997-1998Leadership Agenda (also enclosed). ASHP has provided input to state boards of pharmacy 
when those boards develop patient-counseling rules. ASHP was represented on the steering cO~i&% 
that developedthe ActionPlanfor the Provision,of UsefirlPrescriptionMedicine Informationthat was 
approved by Secretary Shalala in January of this year. And ASHP is one of the eight organizations 
planning and providing funding for the National Symposium on Oral Counseling that was called for by 
the Action Plan.  I 
We shardd the executive summary of the report with our Board of Directors and leaders of our Afftliated 
State Societies. The comments below are partly a result of the responsesreceived from these members. 
BACKGROUND  SECTION (Pages l-3 of the Draft Report) 
Page 1 of the report states that pharmacists can help patients as a last line of defense, to identify and 
correct prescription errors and in a proactive manner to foster better patient understanding and use of 
prescription drugs;  ASHP encourages the Inspector General to stress pharmacistsproactive and pros
pective abilities for intervention as a vital and productive member of the patient care team. 
?272WlSCONSIN  AVENUE  I  BETHESDA,MD  20814  m  301-657-3000  m  FAX: 301-652-8278  m  www.ashp.org  Ms. June Gibbs Brown 
July 10, 1997 
..
Page 2 
FINDINGS SECTION  (Pages 4-7 of the Draft Report) 
While ASHP is in general agreement with the findings of the inspector General contained in the draft 
report, we would like to bring the following concerns to your attention: 
Although the data used to prepare the draft report came primarily from a survey of state boards of  phar
macy conducted as recently as November 1996to January 1997,we would argue that the information 
from your survey is not completely accurate and up-to-date. For example, a coalition of pharmacy 
groups in Illinois has been working with that statesBoard of Pharmacy to establish rules and regula
tions enhancing pharmaceutical care and patient counseling. In May of this year, the Illinois Board of 
Pharmacy accepted the coalitions recommendations for revising that statesrules for patient counseling. 
Although the state boardsadoption of these recommendations is only the first step in the process of 
establishing better patient counseling rules in Illinois, and implementation of those rules cannot occur 
without the appropriate infrastructure and funding, it is an example of how state pharmacy organizations 
are dealing with the problem. 
Pharmacy organizations in other states have had similar successes. Through the work of  pharmacy   
groups in Texas within the last three months, that state has expanded its counseling requirements to 
include a once-a-year consultation on refills and maintenance medications, but this has not been enforced 
yet due to its recency.  Texas pharmacy groups are currently holding meetings to discuss the affect phar
macistsworking conditions have on their ability to offer counseling.
. 
ASHP applauds these efforts by state pharmacist organizations and state boards of pharmacy to improve 
the dissemination of medication information to patients. We suggest that the Inspector General conduct 
follow-up surveys to determine what recent and on-going efforts have been initiated to solve the prob
lems noted in the draft report. 
Pharmacy  Boards Enforcement  of Counseling  Laws 
ASHP agrees with the finding, noted on page 5 of the draft report, that board of pharmacy enforcement 
of counseling laws has been minimal.. This is due, partly, to differences in how pharmacy boards deal 
with complaints and implement enforcement of state laws and regulations, a factor that the draft report 
does not seem to address. In addition to dierences  in how pharmacy boards implement enforcement of 
pharmacist counseling, there are differences, as noted on page 6 of the draft report, in how punitive 
boards are. Some are-funded solely by the fmes they issue, and these may be more inclined to carry out 
enforcement procedures. 
ASHP believes strongly that implementation and enforcement of pharmacy practice laws and regulations 
should be left up to the individual states, and we recommend that a study or studies be conducted to 
determine what factors, related to state board of pharmacy operations and funding, have a positive 
influence on effective enforcement of counseling laws.  Ms. June Gibbs Brown 

July 10, 1997 

Page 3 

State Boards Identification  of Obstacles to Implementing  Patient  Counseiing  Laws 
Lack of Resourcesfor Enforcement 
ASHP agrees that state boards of pharmacy lack sufficient staff and funding to investigate and enforce 
federal and state counseling requirements. While some state boards are funded by the fines they impose, 
others are not reimbursed for any costs related to the enforcement of counseling requirements, and even 
have limited funding to disseminate educational information about counseling. 
Economicsof PharmacyPractice 
On page 6, the drafI  report  lists  Economics  of Pharmacy  Pqctice  as one  of the obstacles state phar
macy boards identified as impediments to patient counseling. This includes limited reimbursement for 
counseling services and lack of ownerscommitment to counseling. ASHP and its members agree 
with both of these observations. 
In todaysmarketplace, pharmacists are expected to increase the number of prescriptions they till and 
patients they serve while simultaneously cutting costs and, in many cases, staff  This leads to patients 
equating the quality of pharmaceutical care and services with the quick delivery of prescriptions, which 
further lowers the priority of counseling as a service that can and should be provided by pharmacists.  If 
the numbers cited in the draft report are correct - that as much  as $100 billion a year is added to health-
care costs due to patients misusing drugs and not receiving intended therapy - some consideration must 
be given to increasing insurance carriersand other payers (e.g., government) motivation to pay more at 
the pharmacy counseling level to encourage compliance with medication therapy and thereby reduce the 
overall cost of providing health care. 
ASHP has received some interesting comments regarding what the draft report calls lack of owners 
commitment to wunseling.  In Endnote 28 (page C-4), the draft report states that owners and managers 
of pharmacies,particularly large, corporate chainphatmacies, express considerable concern that without 
reimbursement for cognitive services offered by pharmacists, oral counseling could have undesirable 
financial effects on their operations. ASHP members who provided us with comments on the Executive 
Summary of the draft report, while agreeing that areimbursement mechanism should be established for 
cognitive services, noted that a major impediment to proper pharmacist involvement in patient medica
tion education is the attitude of non-pharmacist owners of pharmacies, particularly chain store owners, 
have little interest in promoting counseling activities that may decrease the volume of prescriptions 
who 
dispensed. 
Some ASHP members contend that the reason some state pharmacy boards do not enforce counseling 
laws is because these boards have members who represent certain corporate interests that resist efforts at 
stronger enforcement. They believe that this situation will not change until boards are restructured to 
Some minor corrections  need to be made to the draft report  Page 1 of the report correctly  cites the 
estimatedcosts as S 100 billion a year.  Page i of the Executive  Summary incorrectly  states the cost as %100 million a 
year.  The date of the source for this estimate - an article in the Journal of the American Medical Association - is 
cited incorrectly  in Endnote 2 (page C-1 of the report) as June 2 1, 1996; the article actually appeared in JAM4 on 
June 21, 1995.  Ms. June Gibbs Brown 

July 10, 1997 

Page 4  : 

provide more input from practitioner pharmacists and consumers. One member noted that economic 

reality places an unfair burden on a pharmacist who may choose to question company policy.... Proper 

counseling will not become universal or even widespread until the laws are changed to place sanctions 

on pharmacy owuers who do not require their employed pharmacists to counsel patients. Ihe wnsensus 

is that ways should be found to fine and discipline corporate owners as well as individual pharmacists for 

not complying with patient counseling laws. 

LimitedPatientDemand 
On page 7, the draft report lists Limited Patient Demand as another obstacle identified as an impedi
ment to patient counseling. ASHP believes that this is more of a perception than a reality. Demand 
should not be a barrier to counseling. Federal regulations and state laws require that pharmacists offer to 
counsel patients, not that the patients should ask  Pharmacists are often told by patients that they prefer 
to go to particular pharmacies because of theprinted material the pharmacists provide there. Personal 
discussions with pharmacists could have an even greater impact on patient satisfaction. 
-z
* 
Counseling must be a part of the prescription process and not a separate task performed by the phar
macist. While offering counseling as an extraservice requiring additional time might be discouraging 
to some, our experience indicates that patients will spend the time needed for counseling if it is built into 
the process and is routinely performed. Clearly, patients require oral and written reinforcements to 
assure safe use and compliance with the prescribed drug regimen. 
RECOMMENDATIONS  SECTION (Pages 8-9 of the Draft Report) 
Recommendations  Directed to the Food and Drug Administration 
On page 8, the draft report recommendsthat the FDA collaborate with state boards ofpharmacy to 
collect survey data - particularly through shoppingvisits - to determine the extent and type of wun
seling being offered to patients. While ASHP agrees that shoppingvisits may be helpful indicators of 
the amount of counseling that is provided (or if it is even offered), this is only one approach to fact
fmding, and it is a labor-intensive and costly approach. Other survey methods should be considered, 
such as customer satisfaction surveys, which might be a better indicator of whether the patient has 
received any counseling at all, and whether the patient is pleased with the information provided by the 
pharmacist. Surveys could also be used to examine whether the pharmacy environment is appropriate for 
the interaction between pharmacists and patients, and they could identify and offer suggestionsto correct 
structural deficiencies and proceduresthat can improve the delivery of healthcare information. 
Recommendations  Directed to the Health Care Financing  Administration 
On page 8, the draft report recommends that the HCFA should facilitate State efforts to enforce the 
Medicaid patient counseling mandate. Unfortunately, it is likely that this facilitation .willbe largely 
ineffective unless pharmacists and state boards receive some type of economic incentive to comply with 
the federal mandate. One solution would be for HCFAto ensure that reimbursement for pharmacy 
services be adequate enough to cover counseling. The Inspector Generalsfinal report needs to  Ms. June Gibbs Brown 

July 10, 1997 

Page 5  .* 

address the important issue of how to fund the initiatives it recommends. ASHP suggests,as an initial 

phase, that HHS and HCFA measure the true costs of providing complete medication distribution and 

education, and then assist in developing a plan to make the appropriate resources available. 

On page 9, the draft report recommends that HCFA should play a stimulative role in convening the 

national symposium on oral counseling by pharmacists recommended by the Action Planfor the 

Provisionof UsefulPrescriptionMedicine Informationthat was approved by Secretary Shalala. As 

noted above, ASHP and seven other organizations - the Academy of Managed Care Pharmacy, the 

American Pharmaceutical Association, the American Society of Consultant Pharmacists, the National 

Community Pharmacists Association, the National Association of Boards of Pharmacy, the National 

Association of Chain Drug Stores, and the Pharmaceutical Care Management Association - are spon

soring this symposium under the auspices of the Center on Drugs and Public Policy, University of 

Maryland School of Pharmacy. Most of the constructive work of the symposium, which is scheduled to 

be held on September 19-21,1997, will be conducted through small group workshops that will address 

three major issues: consumers, pharmacy practice, and compensation. The goal of the symposium is to 

develop a wmmon set of specific strategic plans for action that can be implemented by pharmacists to 

provide effective oral counseling to consumers. The sponsoring organizations plan to invite HCFA 

representatives to participate in the symposium on various levels. 

ASHP looks forward to working with the Department of Health and Human Services, the Food and Drug 
Administration, the Heaith Care Financing Administration, and private-sector pharmacy organizations to 
address the concerns raised in the Inspector Generalsdraft report  Our Affiliated State Chapters are 
prepared to work with their boards of pharmacy on this issue. Please call us if you have any questions 
about our comments, and we can discuss a further role that national and state professional pharmacy 
.  organizations may play in ensuring compliance with this important practice issue. 
. 
Sincerely, 
_ .. 
Executive Vice President 
q:\gcs\counsei.bm:sc 
Enclosures 
CC:  Board of Directors  G-103 
ASHPGuidelinesonPhktiaGtXtitiductedPtitiknt 
EducationandCounseling 
Am J Health-Syst Ftwm.  1997: 34~4314 
MHP b&eves these patient eduutionnd  counxl
Providing pharmaceutical axe  entails accepting re lng guidelines are appliable  in all practice sett@s
sponsibUity  for patients  pharmacothenpeudc  out- &@dfng  acute lnpatimt  care, ambulatory are,  home 
comes. Pharmacists  can  contribute  to  positive out- arc,  and long-tam  -whetha  the  sctUngs are 
comes by educating and counAlng  patients to prepare  associated with Integrated health systems or managtd 
and motivate them  to follow their pharmacotherapeu care oganlzafions  or are frestandlng.  Ike  guidelines 
5  tic regimens and monitoring plans. Ihe  purpose of this  may need to be adapted; for example, for use in tele
document  is to help pharmadsts  provide effective p phonecounseiingor  fcucounsellngfamifymcmbersor 
tlent educationand courwling.  are@vas insteaodf prtlcm.Patienctd uattonand
In work@  with individual patienti, patient groups,  cuunsd@usually~atthetlmepresa@lonsare 
families, and caregivers, pharmacists should approach  dispens&utmayal4okprovided&sr#purtesav
cducadon  and  counseling  as interrelated  activities.  ke.lhetechniquesandtheamttntshouldkad@sted 
ASHPbelt- phannadsts  should educate and counsei  tomeathespedfIcneedsd&hepatkntandtocompty 
ail patients  to the extant pordble,  going beyond the  withthepoUdamdfxoc&msofthe~sctting. 
minImum rquhments  of laws and regulations: simply  Inh4thsystems.othetkaithazeteamwmkrs 
offering to counsel  k Inconsistent  with  phaxmadsts  shareInthere3ponsihiUtytoOte8ndcuunsclpa-
rqonsiitles.  In pharmaceutical  care, pharmadsts  tlam  83spedfled In the p8tknU  are  plans. 
should encourage patients to seek education and coun
seling and should eliminate barriers to provUng  it 
Rnmudss  should also seek opportunities to pan&i- Thehumanandeconomicco  nsqueMsofinappco
pate in h&h-system  patlaWctucatlon  programs and to  prlate mzdkatioa  use bavv been the subject of profes
supporttheeduMonaleffor&ofotherhealthareteam  *tiplwc=Jooogrmionrl  -foralorc 
member% phumrdm  should  crollabom  with otha  thantwodeade%-Lackofsuffid~thwmkdgeabout 
health axe team men&as, as rppmprlate, to detemUne  thdrhealthpmbIemsmdmediatbasbonecauseof 
whatspdecinfotmatkmandcumMngarerqulzedin  pucnu  nonadheraKe to uldt lJhmmmhmpeutic 
cadl p8lialt arc  sltuatIon. A cootd&uted effott 8morl&  regimens  and  monttodng  pb  nithout  dquate 
he&h  are  team membQI will enhance patients adha hmwIedge~p8tlalt8  amot  be eecuve  pt.nas  ln 
ence to pharmacotherapeutlc  f@nens,  monitoring of  managingthdrowncaze.Tl2epharmacyprofessionhas 
drug effects, and feedback to the health system.  acceptedfcsponsibUltyforpmvidingpatknt&ucat&n  ASHP  Reports  Patient education and counseling 
and counseling in the context  of pharmaceutical  care to  environment  conducive  to  patient  involvement, 
improve patient adherence  and reduce medication-relat learning,  and  acceptance-one  that  supports  pharma
ed problems.69  cists efforts  to establish  caring relationships  with  pa
Concerns about improper medication use contributed  tients.  Individual  patients, groups, families,  or caregiv
to the provision  in the Omnibus  Budget Reconciliation  ers  should  perceive  the  counseling  environment  as 
Act of 1990 (OBRA90)that mandated an offer to counsel  comfortable,  confidential,  and safe. 
Medicaid  outpatients  about  prescription  medications.  Education  and counseling  are most  effective  when 
Subsequently,  states enacted  legislation  that  generally  conducted  in a room or space that ensures  privacy  and 
extends  the-offer-tcKounse1  requirement  tooutpatients  opportunity  to  engage  in  confidential  communica
not cover&  by Medicaid. Future couit cases may estab tion.  If such  an isolated space is not  available,  a com
lish that pharmacists,  in part because of changing  laws,  mon  area  can be restructured  to maximize  visual  and 
have a public duty to warn patients of adverse effects and  auditory  privacy  from other  patients  or staff.  Patients, 
potential  interactions  of medications. The result could be  including  those  who  are disabled,  should  have  easy 
increased  liability  for pharmacists  who  fail to educate  access  and  seating.  Space and seating  should  be ade
and  counsel their  patients  or who do so incorrectly  or  quate  for  family  members  or caregiven.  The  design 
incomplete1y.*0  and placement  of desks and counters  should  minimize 
barriers  to communication.  Distractions  and  tnterrup 
Pharmacists knowledge and skills  tions  should  be few, so that  patients  and  pharmacists 
In addition to a current  knowledge of pharmacother can have  each  others undivided  attention. 
apy, pharmacists  need to have the knowledge and skills  Thehnvironment  should  be equipped  with  appro
to provide effective and accurate patient  education  and  priate  learning  aids, e.g., graphics, anatomical  models, 
counseling.  They should know about their patients ctd medication  administration  devices,  memory  aids, 
tures, especially health  and illness beliefs, attitudes,  and  written  material,  and audiovisual  resources. 
practices.  They  should  be  aware of  patients  feelings 
toward  the health  system and views of their  own roles  Pharmacist and patient roles 
and responsibilities  for decision-making  and for manag Pharmacists  and  patients  bring  to  education  and 
ing their care.  counseling  sessions  their  own  perceptions  of  their 
Effective, open-ended  questioning  and active listen roles  and  responsibilities.  For the  experience  to  be 
ing are essential  skiils for obtaining  information  from  effective,  the  pharmacist  and patient  need  to come  to 
and sharing information  with patients. Pharmacists have  a common  understanding  about their  respective  roles 
to  adapt  messages to fit patients  language  skills and  and  responsibilities.  It may be necessary  to clarify  for 
primary  languages,  through  the  use of  teaching  aids,  patients  that  pharmacists  have  an  appropriate  and 
interpreters,  or cultural  guides If necessary. Pharmacists  important  role in providing education  and counseling. 
also need to observe and interpret the nonverbal  messag Patients  should  be encouraged  to  be  active  partici
es (e.g., eye contact,  facial expressions, body movements,  pants. 
vocal characteristics)  patients give during education  and  The pharmacists  role is to verify that  patients  have 
counseling  sessions.L2  sufficient  understanding,  knowledge,  and  skill to  fol
Assessing a patients cognitive abilities, learning style,  low  their  pharmacotherapeutic  regimens  and  moni
and sensory and ph$%%l status enables the pharmacist  toring  plans.  Pharmacists  should  also  seek  ways  to 
to adapt information  and educational  methods  to meet  motivate  patients  to learn about their treatment  and to 
the patients needs. A patient  may learn best by hearing  be  active  partners  in their  care.  Patients  role  is  to 
spoken  instructions;  by  seeing  a diagram,  picture,  or  adhere  to their  pharmacotherapeutic  regimens,  moni
model; or by directly handling medications and adminis tor  for  drug  effects,  and  report  their  experiences  to 
tration  devices. A patient  may lack the visual acuity  to  pharmacists  or  other  members  of  their  health  care 
read Iabels on presaiption~~~ntainers,  markings on sy teams.*zls  Optimally,  the patients role should  include 
ringes,  or written  handout  material. A patient  may  be  seeking  information  and  presenting  concerns  that 
unable  to hear oral instructions  or may  lack sufficient  may make  adherence  difficult. 
motor  skills to open  a child-resistant  container.  Depending  on the health systems policies  and pro
Lnaddition to assessing whether patients knowhow to  cedures,  its use of protocols  or clinical  care  plans,  and 
use their  medications,  pharmacists  should  attempt  to  its credentialing  of providers,  pharmacists  may  also 
understand  patients  attitudes  and potential  behaviors  have  disease  management  roles  and  responsibilities 
concerning  medication  use. The  pharmacist  needs  to  for specified  categories of patients.  This expands  phar
determine  whether  a patient  is willing to use a medica macists relationships  with patients  and the  content  of 
tion and whether  he or she intends to do 50.~.~  education  and counseling  sessions. 
Environment  Process steps 
Education  and  counseling  should  take place in an  Steps in the patient  education  and counseling  proc-
432 Am I Health-Syst Pharm  Vol 54 Feb 15 1997  Patient  education  and counseling  ASHP  Retorts 
ess will vary according  to the  health  systems  policies  intended  to  cure  a disease,  eliminate  or  reduce 
and  procedures,  environment,  and  practice  setting.  symptoms,  arrest  or slow  the disease process, or 
Generally,  the  following  steps are,appropriate  for pa prevent the disease or a symptom. 
3. 	me  medications expected onset of action and what 
tients  receiving  new  medications  or returning  for re-
to do if the action does not occur. 
fillsi221: 
4. 	me  medications  route, dosage form, dosage, and 
1.  Establish caring relationships  with  patients  as ap administration  schedule (including duration of ther
propriate  to the practice  setting  and stage in the  apy).
patients health care management.  introduce  your- 5. 	Directions for preparing and using or administering 
self as a pharmacist,  explain  the. purpose  and ex-.  the medication.  This may tnclude adaptation  to fit 
petted  length  of the sessions, and obtain  the  pa patienti  lifestyles or work enviionments.  -
tients agreement  to participate.  Determine  the pa 6. Adion  to be taken in case of a missed dose. 
tients primary spoken language.  7. 	Precautions to be observed during the medications 
2. Assess the  patients  knowledge  about  his or  her  use or administration  and the medications poten
health  problems  and  medications,  physical  and  tial risks in relation to benefits. For injectable med
mental capability  to use the medications  appropri ications and administration  devices, concern about 
ately, and attitude  toward the health  problems and  latex allergy may be discussed. 
medications. Ask open-ended  questions  about each  8. 	Potential common  and severe adverse effects that 
medications purpose and what the patient expects,  may occur,  actions  to prevent  or minimize  their 
and ask the patient  to describe or show how he or  occurrence,  and  actions  to take if they occur,  in
she wilt use the medication.  cluding  notifying  the  prescriber,  pharmacist,  or 
other h-ealth care provider. 
Patients returning  for refill medications  should  be 
9. 	Techniques  for self-monitoring  of the  phannaco
asked to describe or show how they have been using 
therapy. 
their  medications.  They  should  also be asked to 
describe any problems,  concerns,  or uncertainties  10. Potential  drugdrug  (including  nonprescription), 
drug-food,  and  drugdisease  interactions  or con
they are experiencing  with their medications. 
-z 
traindications. 
+-3. Provide information  orally and  use visual aids or 
demonstrations  to fill patients gaps in knowledge  Il. 	 The medications  relationships  to radiologic  and 
laboratory  procedures  (e.g., timing  of doses  and 
and understanding.  Open the medication  contain
ers to show patients  the colors,  sizes, shapes, and  potential  interferences  with  interpretation  of  re
suks). 
markings on oral solids. For oral liquids and inject
ables. show patients the dosage marks on measuring  12. Prescription  refill authorizations  and the  process 
for obtaining  refills. 
devices. Demonstrate  the assembly and use of ad-
13. Instructions  for 24-hour access to a pharmacist. 
ministration devices such as nasal and oral inhalers. 
14. Proper storage of the medication. 
As a supplement  to face-to-face  oral communica
IS. 	Proper disposal  of contaminated  or discontinued 
tion, provide written  handouts  to help the patient 
recall the information.  medications  and used administration  devices. 
16. Any other  information  unique  to  an  individual 
.  If a patient is experiencing  problems with his or her 
patient or medication. 
medications, gather appropriate  data and assess the 
problems.  Then  adjust  the  pharmacotherapeutic  These points are applicable  to both prescription  and 
regimens according  to protocols  or notify  the pre nonprescription  medications.  Pharmacists  should 
scribers.  counsel  patients  in  the  proper  selection  of  nonpre
4. Verify patients  knowledge  and  understanding  of  scription  medications. 
medication  use. Ask patients  to describe  or show 
Additional  content  may be appropriate  when  phar
how they  will use their  medications  and identify 
macists have authorized  responsibilities  in collabora
their effects. Observe patients  medication-use.  ca
tive  disease  management  for  specified  categories  of 
pability and accuracy and attitudes  toward follow
ing their pharmacotherapeutic  regimens and mon patients.  Depending  on the patients  disease manage
itoring plans.  ment  or clinical  care plan,  the  following  may be cov
ered: 
Content 
1. The disease state: whether  it is acute or chronic and 
The content  of an educatioiand  counseling  session  its prevention,  transmission,  progression, and  re
may include the information  listed below,as appropri currence. 
ate  for each  patients  pharmacotherapeutic  regimen  2. 	Expected  effects  of  the  disease on  the  patients 
and  monitoring  plan .6.9.mThe decision  to discuss spe normal dally living. 
3. 	Recognition and monitoring  of disease complica
cific  pharmacotherapeutic  information  with  an indi
tions. 
vidual  patient  must  be  based  on  the  pharmacists 
professional  judgment. 
Documentation 
1. The medications  trade name, generic name, com
Pharmacists should  document  education  and coun
mon synonym,  or other  descriptive  name(s)  and, 
when appropriate,  its therapeutic  class and efficacy.  seling in patients  permanent  medical records  as con
2. 	The  medications  use and  expected  benefits  and  sistent  with  the  patients  care  plans,  the  health  sys
action. This may include whether  the medication  is  tems policies and procedures,  and applicable state and 
Vol 54 Feb 15 1997 Am J Health-Syst Pharm  433  ASHP  Rep0rt.s  Patient  education  and counseling 
federal laws. When pharmacists  do not  have  access to  7. Hepier CD, Strand IA. Opportunitiesand responsibilities  in 
patients  medical  records,  education  and  counseling  pharmaceuticai care. Am I Hosp Pham.  1990; 47:533-U. 
8.  Hatoum KT, Hutchinson  RA, kmbert  5L OBRA90: patient 
may  be documented  .in the  pharmacys  patient  pro- counseling-enhancing  patient  outcomes.  US Phurm.  1993; 
files, on the medication  orderor  prescription  form,  or  180an):76-86. 
on a specially designed counseling  record.  9.  OBRA90: a practical guide to cffccting pharmaceutical  care. 
Washington,  DC: American  Pharmaceutical  Association; 
The pharmacist  should  record  (1) that  counseling 
1994. 
was offered  and was accepted  and provided  or refused  10. LynnNJ,  Kamm RL Avoiding liability problems. Am FVmmr. 
and  (2) the  pharmacists  perceived  level  of  the  pa 1995; NS3S(Dec):14-22. 
tients  understanding?  As:appropriate,  the. .content  11. Henicr RX.BoyceRW. Doescounselingi.FproveCompliance? 
Am Ph&m.  1995;NS3Stkp):l l-2.  -
should be documented  (for example;  counseling  about 
12. Foster SL Smith E5, Seybold MR.Advanced counseling  tech
fooddrug  interactidns).  All documentation  should  be  niques: integratingassessmentand intervention.  Am Phmm. 
safeguarded  to respect patient  confidentiality  and pri 1995: NS3S(Oct):4@8. 
13. 5ond WS, Hussar DA Detection methods and strategies for 
vacy and to comply  with applicable  state  and  federal 
improving  medication compliance. Am I Hasp Phana  1991; 
laws.lO  48:197%38. 
14. Felkey 5G. Adherence screening and monitoring.  Am fhunn. 
19%: NSZfJul):42-51. 
Roferoncos  15. Herrier RN, 5oyce RW. &tabUshing an active patient partner-
1. Smith MC. Socialbarriers to rational drug therapy. Am I Hasp  ship. Am Phann. 1995; NuSMpr):4&57. 
Phum. 1972; 29:121-7.  16. Boyce RW, Herrier RN, Gardner M. Pharmacist-patient  con
2. Prioritiesand approachesfor improvtngprescriptton medi suitation  program, unit  I: an Interactive approach to verify 
dne  use by older Americans. Washington,  DC: National  oatient understandinn.  New York PffzerInc.: 1991. 
Council on Patient Information and Education: 1987.  17. Phamiacist-patient ccksultation  pqram,  unit  II: counseling 
3. 	Manasse HRJr. Medication use in an imperfect wotld: drug  patients  in  challenging  situations.  New York  Pfizer Inc.: 
misadventuring as an issue of public policy, part 1.Am 1Hosp  1993. 

Pharm. 1989; 4632944.  18. Pharmacist-patienctonsultationprogram,unit III:counseling 

4. 	Manasse  HRJr. Medication use in an Imperfect world: drug  to enhance compliance.NewYorkPfizer  fnc;  1995. 

=  misadventutig  as an issue of public policy, part 2. elm 1Hasp  19. BoyceRW,Herder R?LObtainingand usingpatient data. Am 

-*  Phomr. 1989;46:1141-x.  Phnrm. 1991: NS3l(Jul):6S-70. 

5. JohnsonjA, Bootman JL Drug-related morbidity and mortali 20. Herrier RN, Boyce RW. Communicating  risk to patients. Am 

ty: a cost-f-illness  model. Arch Intan  Med. 1995; 155:1949- Phutm.  1995: NUSfJun):12-4. 

56.  21. APM  special  report: medication  administration  problem 

6. 	Summary of the final repoti of the Scope of Pharmacy Prac solving in ambulatory care. Washington, DC: American Phar

tice Project. Am / HospPhamr. 1994; 51:2179-82.  maceutical Association: 1994. 

---. 
434 Am J Health-Syst  Pharm Voi 54 Feb 15 1997  ASHP  Leadership  Agenda,  1997-98 
Rationale  and  Implementation 
Increase awareness among the public in general and among health-system  decision-makers 
specifically about the vital patient care role of pharmacists. 
Rationale.A new mission for pharmacists-helping  people make the best use of medications-has  been declared, but 
pharmacists need public understanding and support in order to achieve widespread acceptance and recognition  for this 
role.  Decision-makers in heaitlt systems do not fully apprekie  the value of pharmacists in patient care and in the 
continuiq  of care. There is a risk in todays cost-cutting c&ronment  that some health-system  executives may 
compromise the quality of patient care by simply cunailing their employment of pharmacists without seeking ways for 
pharmacists to help improve patient outcomes while lowering costs. 
Implementation.  ASHP has expanded its efforts to increase the general publics awareness of the value of health-
system pharmacists.  An aggressive. proactive public relations program is being developed with the assistance of a 
communications  fmn and with the involvement of affiliated state societies. In 1996-97. ASHP launched a 
communicationcsampaign to increase the awareness of health-system decision-makers  about the vital patient care role 
of pharmacists. One thrust of the campaign. which will continue in 1997-98, is communicating  directly with hcalth
s)stem esecutives  and another is developing tools that individual ASHY members can use to help them demonstrate the 
\rluc  of pharmacists in their practice settings. 
Foster expanded efforts b? health systems to prevent medication  errors 
and other drug-related problems. 
Rationale.The safety of medication use is a growing public concern as reflected by the news media and by the 
scientific and professional literature. In the health-system environment, responsibility for the safety of the medication-
use process is shared by many persons in addition to pharmacists. including physicians. nurses. administrators, various 
technical personnel. and patients. Health systems are not consistently applying proven methods for reducing 
medication errors.-By virtue of their education and training, pharmacists are in a position to lead efforts within health 
systems to assess and improve the safety of medication use. Highly visible activity by health-system  pharmacists on 
this issue will enhance public awareness of the patient care role of pharmacists. 
Implementation.ASHP will build ou its previous work and launch new initiatives lo foster safe medication use in 
health systems. in doing so, it will collaborate with the ASHP Research and Education Foundation and other health 
professions and organizations.  Accelerate  efforts  to help health-system  pharmacists 
setie  patients  across  the continuum  of care. 
Rationale. The ongoing formation of integrated health care delivery systems will require ASHP members to be well 
equipped to serve the needs of patients in all components of integrated systems and to foster continuity of care across 
those components. The demand for health-system pharmacists in certain areas such as ambulatory care may grow 
faster than in acute care, presenting new opportunities for pharmacists to improve patient outcomes. Health systems 
will be giving more atteat+n  to disease prevention and health promotion, activities that are relatively underdeveloped
.  _. 
in pharmacy education and practice. 
Implementation. ASHP will identify and begin development of initiatives to ensure that pharmacists are well 
equipped for their evolving roles in all components of health systems. including ambulatory care, chronic care, long-
term care, disease prevention, and health promotion. These initiatives will cover pharmacy management and leadership 
as well as clinical practice. 
Build  strategic  partnerships  that will advance  the health-system  pharmacists 
role in the medication-use  process. 
. 
Rationale. The providers of health care setvices will continue to consolidate tbrougb the development of integrated 
delivery systems that cover all components of health care. In this environment. ASHY must actively seek new types of 
collaborative relationships that will create opportunities for advancing the health-system pharmacists role in 
= 
*  coordinating the medication-use  process as well as expanding AMPs capacity to serve members. 
Implementation.  AU-P  has identified existing and desirable partnerships (organizational. interdisciplinary.  business) 
that offer strategic possibilities and has determined which offer the best potential for strategic alliances. ASHP is 
systematically pursuing the establishment of strong working relationships with several key groups. The top priorities 
are medical organizations. managed care provider organizations. and standard-setting and performance-measurement 
organizations in health care. 
ASHP  Mission  Statement 
Themission  of ASHP  is to represent-its  members  and to provide  leadership  that 
will enable  pharmacists  in organized  health-care  settings  to 
(1)  extend  pharmaceutical  care focused  on achieving  positive  patient 
outcomes  through  drug therapy; 
(2)  provide  services  that foster the efficacy,  safety,  and cost-effectiveness  of 
drug use; 
(3)  contribute  to programs  and services  that emphasize  the health  needs  of 
the public  and the prevention  of disease;  and 
(4)  promote  pharmacyas  an essential  component  of the health-care  team. 
--Approved  by the ASHP House of Delegates. June 3.1992 
4  APPENDIX  D 
ENDNOTES 
1.  For  studies addressing  the quality  of care impacts associated  with mismedications,  see 

A.J.  Wood  and J.A.  Oates,  Adverse Reactions  to Drugs,  in R. Petersdorf  et al., 

Harrisons Principles of InternalMedicine, 12th ed.  (New York:  McGraw  Hill,  1991), 

373-9;  Stephen  H. Long,  Prescription  Drugs and the Elderly:  Issues and Options, n 

HealthA@irs  158 (Spring II,  1994),  157-74;U.S.  General  Accounting  Office, 

PrescriptionDrugs and the Elderly: Many StillReceive PotentiallyHarm@ Drugs Despite 

Recent Improvements,GAO/HEHS-95-152,  July  1995; Jeffrey  A. Johnson  et al.,  Drug-

Related  Morbidity  and Mortality:  A Cost-of-Illness  Model,  Archives of Internal 

Medicine, 155 (October  9,  1995),  1949-56; Adverse Drug Reactionsin the Elderly: 

Hearing before the Special Committeeon Aging, United  States Senate,  104th Cong.,  2nd 

Sess.,  March  28,  1996; and Robert  McCarthy,  Patient  Compliance:  Strategies  to 

Overcome  a Costly  Problem,  Medical UtilizationManagement24 (July  11, 1996) 14, 5-

8. 

2. 	 This  assessment  was made by Paul Rogers,  chair  of the National  Conference  on 

Prescription  Medicine  Information  and Education.  See FDA Pushes for Prescription 

Drug Information,   Journal of the American Medical Association(273) 23, June 21,  1995, 

1815-16.  The FDA Commissioner  has estimated  that failure  to get consumers  adequate 

information  about prescription  drugs costs about $20 billion  a year  in direct  costs 

associated  with patients  who have not adhered  to a prescribed  drug regimen  and about $80 

billion  in indirect  costs such as those associated  with days lost from work.  See Philip  J. 

Hilts,  F.D.A.  Seeks Clear Information  Inserts  with Prescription  Drugs,  New York 

Times, August 24,  1995, A21. 

3.  On the basis of a review  of 50 studies,  the FDA concluded  that noncompliance  rates 

averaged  from  30 to 50 percent.  See Prescription  Drug Product  Labeling:  Medication 

Guide Requirements;  Proposed  Rule,  Department  of Health  and Human  Services,  Food 

and Drug  Administration,  Federal Register, 21 CFR Part 201, wt al.,  August 24,  1995, 

44186. 

4.  See, for instance,  Timothy  S. Lesar,  et al.,  Factors  Related  to Errors  in Medication 

Prescribing,  Journal of the American Medical Association,(277) 4, January  22129, 1997, 

312-17. 

5. 	 See Office of Inspector  General,  The Clinical  Role of the Community  Pharmacist, 

OEI-01-89-89160,  November  1990. 

6.  The American  Pharmaceutical  Association  and other pharmacy  professional 

organizations  are encouraging  the development  of  pharmaceutical  care  - whereby 

pharmacists  play  an important  role in counseling  patients.  Professional  medical 

associations  support pharmacist  roles in helping  ensure  that patients  understand  and adhere 

D-l  to drug therapy  prescribed  by physicians.  However,  they tend to be wary  of more activist 
roles by community  pharmacists.  This was most apparent  in the minority  report  of the 
American  Medical  Association,  the American  Academy  of Family  Physicians,  and the 
American  College  of Obstetricians  and Gynecologists  to the private-sector  action  plan 
recently  approved  by the Secretary  of Health  and Human  Services  (see appendix  B).  In 
their  comments,  they express  concern  that pharmacy  organizations  have  sought to use the 
action  plan  as a mechanism  to legitimize  the role of the pharmacist  as a primary 
counselor  of patients  about prescription  drugs.  It is,  they add,  the unwavering  view 
of the physician  organizations  that this is inappropriate  as it distorts  the reality  of actual 
practice.  
7.  The Omnibus  Budget Reconciliation  Act of  1990 (P.L.  101-508). 
8.  The National  Association  of Boards of Pharmacy,  Consumer Patient Counseling 
Survey,  1996. 
9. 	 New York City  Office of the Public  Advocate,  Prescription for  Danger:  Drugstore 
Counseling Routinely Ignored,  1996. 
10.  U.S. News and World Report  (121) 8, August 26,  1996, 46-53.  At about the same 
time,  a television  news show ran a major  segment on the same topic. 
11.  Nicholas  John  Cavuto,  et al.,  Letter  to the Editor,  Pharmacies  and Prevention  of 
Potentially  Fatal  Drug Interactions,  Journ.al of the American Medical Association  (275) 
14, April  10, 1996,  1086-7. 
12.  We sent the survey  to the 50 State pharmacy  boards  and the pharmacy  board  of the 
District  of Columbia. 
13.  Three  boards  did not respond  to our survey:  Maine,  Kansas,  and District  of 
Columbia.  Two,  Michigan  and South Carolina,  suggested that we contact  the State 
Medicaid  agency  to discuss enforcement  of the Medicaid  counseling  law.  In those two 
cases,  we did conduct  discussions  with Medicaid  agency  representatives,  but we regarded 
those two States as nonrespondents  for our survey  of pharmacy  boards. 
14.  California  State Board of Pharmacy,  Department  of Consumer  Affairs,  Fall  1995. 
15.  Although  this and other  such outreach  efforts  by boards  would provide  pharmacists 
with opportunities  to obtain  continuing  education  credits,  only  3 of 46 reporting  boards 
indicated  that their  State had a continuing  education  requirement  for pharmacists  that was 
specifically  intended  to help them conduct  patient  counseling. 
16.  During  the past year,  39 of 46 reporting  boards  (85 percent)  conducted  on-site  visits 
of pharmacies.  In these States,  the median percentage  of pharmacies  visited  was 80 
percent. 
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 17.  Our reference  here and throughout  the report  is to boards  responding  to a particular 
question.  Thus,  while  46 boards  responded  to some or all of our survey,  the number 
responding  to any particular  question  varies  slightly. 
18.  One board  official  commented  as follows:  It is virtually  impossible  to make a paper 
case.   Each  disciplinary  action  requires  more than one undercover  shopping  visit  and is 
very  labor  intensive.  This  is a problem  for an agency  that is short on personnel. 
19.  One board  noted that several  shopping  efforts  have been undertaken  in the past year 
and that in almost  all cases pharmacists  are complying  with the OBRA  1990 legislation. 
Two other  boards  were less positive  in describing  their  results.  One noted  an overall 
compliance  rate of 70 percent.  One simply  noted that the results  of shopping  visits  to 
three  dozen pharmacies  were not satisfactory.  He noted  that they found  that 
pharmacists  tend to skip counseling  on patients  they didnt know. 
20. 	 Even  though  the investigation  may involve  shopping,  the complaint/concern  leading 
to it does not necessarily  involve  a possible  counseling  violation. 
21.  Pharmacy  boards  also enforce  patient  counseling  laws through  their  response  to 
complaints.  In our survey,  we asked how often  such complaints  were related  to patient 
counseling.  We present  the responses  in appendix  A.  However,  upon follow-up 
discussions  with a number  of board  officials  we determined  that boards  had widely 
varying  interpretations  of counseling-related;  thus any generalizations  on this matter 
would be suspect.  It may be pertinent  to note though  that among  37 reporting  boards,  28 
(76 percent)  estimated  that consumers  were the primary  source of complaints  involving 
possible  violations  of patient  counseling  requirements. 
22. 	 The economic  barriers  to counseling  were also emphasized  in a prior  Office  of 
Inspector  General  study.  See OEI-89-89160,  The Clinical  Role of the Community 
Pharmacist,  November  1990. 
23. 	 A few officials,  however,  suggested that the attitudes  of pharmacists  also 
contributed  to a lack of counseling. 
24. 	 This  perception  has been documented  in many prior  studies over  many years.  For 
instance,  a 1982 Schering  Laboratory  study found that among  15 possible  reasons  offered 
for choosing  a pharmacy,  consumers  they  surveyed  ranked  the following  as the first 
reason:  Pharmacist  fills prescriptions  promptly.   See Schering  laboratories,  Pharmacist 
Perceptions  vs.  Consumer  Realities:  Updating  the View from Both Sides of the Counter, 
The Schering  Report  IV, Kenilworth,  New Jersey,  1982. 
25.  Here,  and throughout  the text,  we use the term  major  to describe  responses 
identified  by respondents  as significant  or  very  significant. 
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 26. 	 For  instance,  an October  1996 verdict  a South Carolina  case resulted  in a $16 million 

settlement  against  a chain pharmacy  for an improperly  filled prescription  leading  to severe 

brain  damage  for a child.  (Court of Common  Pleas,  York County,  South Carolina. 

Docket  Numbers:  9%CP-46-405  and 95-CP-46-406.) 

27.  The national  health  promotion  and disease prevention  objectives  issued by the 

Department  of Health  and Human  Services  in its report  entitled,  Healthy  People  2oO0, 

calls for a commitment  to written  and oral counseling.  Objective  12.8,  added in  1995, 

states:  Increase  to at least 75 percent  the proportion  of people  who receive  useful 

information  verbally  and in writing  for new prescriptions  from prescribers  and 

dispensers.  

28. 	 Physician  groups,  as we have noted,  express considerable  concern  that oral 

counseling  initiatives  could lead to undesirable  intrusions  into the practice  of medicine. 

Similarly,  owners  and managers  of pharmacies,  particularly  large,  corporate  chain 

pharmacies,  express considerable  concern  that without  reimbursement  for cognitive 

services  offered  by pharmacists,  oral counseling  could have undesirable  financial  effects 

on their  operations.  The HCFA  and pharmacy  associations  could help address  these 

concerns  by showcasing  ways in which pharmacists  and physicians  are working  together  in 

some community  settings.  Similarly,  they could help draw attention  to initiatives  such as 

the one in Wisconsin  where  the Medicaid  program  is reimbursing  pharmacists  for 

pharmaceutical  care  at varied  levels,  depending  on the extent of care being  provided  to 

patients. 

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