From: Hobson,Gerry [ghobson@multum.com]
Sent: Monday, June 30, 2003 7:04 PM
To: Bechtel, Christine
Subject: Request for Oral Presentation

Christine Bechtel
Center for Drug Evaluation and Research (HFD-006)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Ms. Bechtel,

Please accept this electronic mail as notice that I plan to make an oral
presentation of approximately 15 minutes duration at the public meeting on
Current Status of Useful Written Prescription Drug Information for
Consumers.  Here is my written statement addressing questions 1, 2, and 3.

	1.	What steps is the private sector taking to improve the
usefulness of the written information patients receive with prescription
drugs and to meet the Year 2006 goal?

		Cerner Multum, Inc. has been producing patient education
leaflets (PEL) since 1998, designed to be compliant with MedGuide 1996.  The
leaflets created by Cerner Multum are created by pharmacists, reviewed by
outside experts in clinical practice, and are continuously updated using
resources such as new package information and MedWatch alerts. 
		PBMs, hospital systems, retail pharmacies, and Internet
sites use the Cerner Multum leaflets.

		The key features included in the Cerner Multum leaflets are:
			*	All FDA approved indications, 
			*	Full Text - comprehensive descriptions of
medicines and their effects subdivided into specific sections with distinct
section headers,
			*	Easy to read - formatted to include distinct
sections, minimum 10 pt. Text, adequate spacing between sections, use of
limited bold text, minimum 6th grade comprehension, include the phonetic
pronunciation of the drug entity
			*	The use of pictograms/illustrative patient
instructions
			*	Age-specific (pediatric/geriatric)
information and precautions
			*	Renal and liver precautions
			*	Gender-specific precautions
			*	English and Spanish versions

		The leaflets are available in multiple formats including
print and web-enabled.  They are generally one to two legal size pages in
length.  Detailed systems have been developed to assure that the leaflets
fully comply with the template, guidelines, and format of the MedGuide
recommendations.  The creation of the leaflets adheres to explicit writing
guidelines.

		The leaflet layout sample:
		Generic Drug
		Pronunciation
		Brand Names
		What is the most important information I should know about
_____? (name of drug)
		A summary section containing critical aspects of proper use,
significant warnings, precautions, and/or contraindications, serious adverse
reactions, and potential safety hazards.

		What is (name of drug)?
		A section that identifies a drug product's indications for
use, what class the drug is in and how the drug works.
		Off-label used (FDA unapproved indications) are tagged
separately to allow the institution to decide whether these should be
printed).
		Also, a statement that "Medicines are sometimes prescribed
for purposes other than those listed in a Medication Guide" is included.

Who should not take (name of drug)
		Information on circumstances under which the drug product
should not be used for its labeled indication (its contraindications), and
information from the package insert regarding precautions (conditions or
circumstances that may require cautious use of the medication, dosage
adjustment or special monitoring).
		Information related to use of the medication during
pregnancy or breast-feeding is also included in this section.
		Specific warnings or concerns regarding use of the
medication in geriatric or pediatric populations also appears in this
section.

How should I take (name of drug)
Information on the proper use of the drug product, including:
A statement stressing the importance of adhering to the dosing instructions.
		A statement or statements describing special instructions on
how to prepare and/or administer the drug product.
		A description of the recommended storage of the drug.

What should I do if I miss a dose of (name of drug)?
		A statement of what the patient should do if he/she misses
taking a scheduled dose of the drug product.

What should I do if I overdose?
		Information on what the patient should do in case of an
overdose of the drug product and the possible symptoms of an overdose.

What should I avoid while taking (name of drug)
		A statement or statements that identify activities (such as
driving or sunbathing), and drugs, foods, or other substances (such as
tobacco or alcohol) that the patient should avoid, including why they should
be avoided.

What are the possible side effects of (name of drug)?
		A statement of the possible serious side effects that
require immediate medical attention followed by a list of those side
effects.
		A statements indicating less serious side effects that may
occur (generally, those that occur frequently) and that the patient should
discuss them with their provider at a convenient time, followed by a list of
those side effects.
		A statement that tolerance to or dependence on the drug
product may occur (if applicable).
		Also included is a statement that side effects other than
the ones listed may occur and patient should contact their healthcare
provider with questions.

What other drugs will interact with this drug?
		Statements describing other drugs that will interact with
the index drug and how this may affect the prescribed treatment.
		Also included is a statement that side effects other than
the ones listed may occur and patient should contact their healthcare
provider with questions.

Where can I get more information?
		Example: Your pharmacist has additional information about
(this drug) written for health professionals that you may read.

What do the pills look like?
		Statements describing how the medication is available (i.e.,
over-the-counter or prescription) and common brand names for the drug.  We
include a description of shape, color, and dose form for each strength of
the medication available (for the most common brand products).  A statement
such as "Formulations other than those listed may also be available.  Ask
your pharmacist any questions you have about this medication, especially if
it is new to you."

Final (optional)
		A statement that the drug product not be used for other
conditions or given to other persons and should be kept out of the reach of
children..
	
Date
		The date of the most recent revision of the Medication guide
placed immediately after the last section.

Disclaimer
Reviewed by outside experts.

		The leaflets are continuously updated using resources such
as new package information and MedWatch alerts.


	2.	What barriers exist for the private sector to meet the Year
2006 goal, and what plans exist to overcome these barriers?

		Cerner Multum has the resources in intellectual property and
technology to meet the Year 2006 goal.  Where we see the greatest challenge
is in meeting the demands of the different dispensing pharmacies, since not
all have the technology resources to retrieve electronically the latest
published PEL on a timely manner.  Other costly challenges will occur in
trying to incorporate the leaflets into the IT systems/workflow used in the
dispensing of prescriptions at each pharmacy.  The increase in costs will
occur at both sides, the vendor (here, Cerner Multum) of the patient
medication leaflet modifying the final document to the specific requirements
of each particular pharmacy and at the dispensing pharmacy as mentioned
above.  Workflow issues must be addressed.  Even the most useful
presentation of patient medical information will only meet the goal if the
workflow processes provide for an efficient mechanism of delivery.  

	3.	What should the role of FDA be in assuring full
implementation of the Action Plan to meet the Year 2006 goal?

		FDA should encourage independent entities, e.g., publishers
of healthcare information having no conflict of interest to provide
unbiased, well-researched, informative, and complete patient education
information.  Independent publishers of medical information will provide a
mechanism for consistent presentation and format of patient medication
information across multiple therapeutic classes of drugs.

		FDA should encourage pharmacy providers to implement the
technology and resources necessary for fulfillment of the Year 2006 goal.


Regards,
Gerry

Gerry Hobson, RPh
Research Manager
Cerner Multum
3200 Cherry Creek Drive
Suite 300
Denver, CO  80209
phone: 303.282.2057
fax:	816.936.9057
ghobson@cerner.com