USP Label Standards Update
&
FDA Patient Medication Information (PMI) Update
Ray Bullman, Executive Vice President
National Council on Patient
Information and Education
USP Label Update

Medication misuse results in over 1 million ADE/yr (IOM
2007)

The patient’s best source (and often only source) of
information is the Rx container label.

While written information and oral consultations may
sometimes be available, the Rx container label must be
able to fulfill the professional obligations of physicians and
pharmacists to give the patient all the information needed
to understand how to safely use the medication.
USP Label Update

Determine optimal prescription label content and format
to promote safe medication use by critically reviewing
factors that promote or distract from patient
understanding of prescription medication instructions

Create universal prescription label standards for
format/appearance and content/language

Co-chairs: Gerald McEvoy, Pharm D; ASHP, Joanne
Schwartzberg, MD, AMA
Recommendations for Universal Standards

Advisory panel with 4 subcommittees studied the issues.

Recommendations for prescription container labeling
approved and posted on the USP website in November,
2009.

Proposed General Chapter <17> Prescription Container
Labeling drafted and published in USP Pharmacopeial
Forum 37(1) January-February 2010
Universal standards - Principles

Organizing the prescription label in a patientcentered manner

Patient-directed information must be organized in a
way that best reflects how most patients seek out and
understand medication instructions.

Prescription container labeling should feature only the
most important patient information needed for safe and
effective understanding and use
Universal standards: Format/Readability

Patient-directed instructions

Should be at the top of the label; the patient’s name,
drug name and directions for use (i.e., specific
dosage/usage/administration instructions) should be
displayed with greatest prominence.

Other less critical but important content (e.g.,
pharmacy name and phone number, prescriber name,
fill date, refill information, expiration date,
prescription number, drug quantity, product description,
and evidence-based auxiliary information) should not
supersede critical patient information.
Universal standards: Format/Readability

Improving readability

Critical information for patients must appear on
the prescription label in an uncondensed, simple,
familiar, minimum 12-point font that is in sentence
case.

Use numeric rather than alphabetical characters

Use horizontal text

Minimize need to turn container
Universal Standards: Format/Readability

Optimize typography:

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
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Use high contrast print (black print on white
background),
Use simple, familiar fonts with sufficient space
within letters and between letters, use effective
fonts such as serif (e.g., Times Roman) or san serif
(e.g., Arial),
Use large print 12-14 point font for critical
information and do not use smaller than 10 point
font for important information).
Bolding, highlighting with light color only, reserve
for critical information.
Universal Standards: Format/Readability

Optimize white space
 Use
adequate space between lines of text
(25-30%);
 Use
white space to distinguish sections on
the label such as directions for use vs.
pharmacy information)
Universal Standards: Language/Content

Simplifying language

Language on the label should be clear, simplified,
concise, familiar and used in a standardized manner.

Only common terms and sentences should be used.
Use of unfamiliar words (including Latin terms) and
unclarified medical jargon should be avoided.

Whenever available and appropriate to the patient
context, standardized patient-centered translations
of common prescribing directions to patients (SIG)
should be used.
Universal Standards: Language/Content

Use explicit text to describe dosage/interval
instructions

Instructions for use must clearly separate the dose
from the dosage interval, so as to explicitly convey
the number of dosage units to be taken and the
timing of such.

Instructions for use should contain numeric rather
than alphabetic characters for numbers (For example,
“ Take 2 tablets in the morning and 2 tablets in the
evening” rather than “Take two tablets twice daily”).
Universal Standards: Language/Content
Chapter also addresses:

Limited English Proficiency
 Prescription container labeling should be provided in an
individual’s preferred language, if a high-quality translation
process has been used.

Including the purpose for use
 Patient preferences in sharing such information on the label
must be paramount consideration.


Confidentiality and FDA approval for intended use (e.g., labeled
vs. off-label use) will limit inclusion of indications on Rx
container labels.
Current evidence supports inclusion of purpose-for-use language
in clear, simple terms (e.g. for high blood pressure versus
hypertension).
Universal Standards: Language/Content
Chapter also addresses:

Auxiliary information
 Auxiliary information on the prescription container label should
be minimized and should be limited to evidence-based critical
information regarding safe use.
Public Comments Received – Next Steps

More than 150 comments from various organizations &
individuals received at USP during 90 day comment
period.

All comments received are being reviewed and will be
considered by the Prescription Container Labeling
Expert Panel for possible revision of the Chapter.

Recent acetaminophen issues (e.g., NCPDP
recommendations) sent to the Panel and will be
considered for inclusion in the prescription container
labeling standard during this revision.
Part II – PMI Update
FDA Patient Medicine Information (PMI)
Relevant Chronology
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1996 – 2006 – 10-Year Keystone Action Plan by private sector
Dec. 2008 - FDA final assessment of PMI
Feb. 2009 – FDA Risk Communications AC Meeting (single doc. sol)
Sept. 2009 – FDA public workshop (elements of useful PMI; prototypes
introduced)
May 2010 – FDA releases plan for consumer testing of
PMI prototypes (Fed. Register)
July 2010 – 1st of 3 Brookings Institution/FDA) Meetings (Workshop on
prototype design, assessment and distribution)
Sept. 2010 (FDA Public Hearing – design / distribution of PMI)
Oct. 2010 -2nd of 3 BI/FDA Meetings (ensuring access to PMI)
Feb. 2011 – Final BI/FDA Meeting (prototype testing)
Sept. 2011 – FDA receives OMP clearance to proceed with consumer
prototype testing
FDA hopes to have data available – ???
Patient Medication Information (PMI) Update
FDA plan: develop, consumer test & require a singleDocument, manufacturer-prepared prescription
medicine information (PMI) sheet developed under
FDA guidance for all Rxs
 New
document intended to replace current
Consumer Medicine Information (CMI) & Medication
Guides
 Two
prototypes for consumer testing
 FDA’s
pilot testing plan okayed by OMB this month
Patient Medication Information Needs

Consumers need to receive clear, actionable patient
medication information in order to use prescription
medication safely and effectively.

The information provided needs to be accurate,
balanced and delivered in a consistent and easily
understood format.

The information needs to be available when the patient
receives a prescription.
Current System

Patient Package Inserts (PPI)
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Medication Guides (MG)
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Developed by manufacturers, approved by FDA, and dispensed with
specific products (e.g., oral contraceptives, estrogen-containing
products)
Manufacturers can voluntarily submit other PPI to FDA for approval
but distribution not mandated by regulation
For medications that “pose a serious and significant public health
concern”
Developed by manufacturers, approved by FDA, and mandated
distribution to patients each time medication is dispensed
Consumer Medication Information (CMI)


Developed by organizations other than a drug manufacturer
Voluntarily distributed to consumers by pharmacies
FDA’s Concern: Why do we need PMI?

Under the current system, patients receive several types of information
developed by different sources that may be duplicative, incomplete, or
difficult to read and understand.

Patients may not be receiving federally mandated Medication Guides from
the pharmacy.

2008 Evaluation of Consumer Medication Information (CMI):
 94% consumers received information with new prescriptions
 75% met the criteria for usefulness
 Demonstrating the PMI need is not being met

Based on above issues, recommendations from FDA’s Risk Communication
Advisory Committee, and additional stakeholder input, FDA sees merit in
adopting use of a single document standardized with respect to content
and format, surveillance and submission, and enforcement.
A New Paradigm: The Single-Document Solution

Clear actionable information that allows a patient to use
their Rx medication safely & effectively.

Single document solution that provides Rx medication risk
and benefit information in an accurate and balanced form
delivered in a consistent and easily understood format.

Provided when a patient receives an Rx medication with
the intent that the information be used to take
medications properly once the patient has gone home.

Purpose is to aid patients who have already received a
prescription. PMI is not a replacement for patient
counseling.
The Future of Patient Medicine Information

FDA is considering new regulation to:

Require all prescription drugs have a single PMI
document

Sources of information in PMI – FDA approved
professional labeling

Set standards for the content and format

Define evaluation criteria

Require manufacturers to consumer-test

Manufacturers must submit PMI to an electronic
central repository
The Future of Patient Medicine Information

Recent PMI Activities
 Part 15 Public Hearing on Sept. 2010 for input on a new
framework for development & distribution of PMI.
 Stakeholders provided recommendations on content, format
& strategies for creating, distributing & evaluating PMI
effectiveness.

On Oct. 12, 2010, Brookings Institute hosted public forum to
discuss strategies for ensuring that patients have access to
effective PMI.

On Feb. 23, 2011, Brookings Institute hosted small expert PMI
workshop that summarized challenges expressed in above
Brookings meetings & considered how best to design pilot
studies for the distribution of PMI.
The Future of Patient Medicine Information

FDA Next steps:
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Future meetings with stakeholders
Consumer testing of single-document PMI prototypes
Identify and assess mechanisms to ensure PMI
distribution through pilots.
Standardization of content and format
Evaluation and testing to ensure PMI meets standards
Identify and assess mechanisms to ensure PMI
distribution
FDA Proposed Consumer Testing to
Evaluate Prototypes
Design includes three parts:
1.
Live pretest: small sample of in-person testing (n =
180)
2.
Internet with hard copy prototype: patients receive
one of the prototypes in the mail and answer questions
via the Internet (n = 900)
3.
Internet with electronic prototype: patients have an
electronic copy of the prototype and answer questions
via the Internet (n = 200)
Critical Process Issues
Key process areas that need to be defined:

How to enforce pharmacy distribution?

A central repository needs to be selected before data
standards can be determined.

FDA study needs to be completed before content and
format can be established.

Distribution pilots need to be performed before
distribution can be established.

All of the aforementioned activities need to be addressed
prior to the creation of new regulations for PMI.
Future PMI Considerations

Although there is no evidence on optimal page length, FDA
firmly stated that PMI must stay within the single-sided onepage limit.

Decision based on concern of non-adherence to page limits
from past experience, such as with MedGuides, where
manufacturers exceeded specified page limits.

There are, however, several variable elements that might
influence success of PMI, such as: order in which information
presented, font choice, and font size -- all of which must be
tested with patients to determine the best mix of elements.
Future PMI Considerations
(BI/FDA #1 – July 2010)

Paper-based PMI remains necessary and is not likely to
disappear in the foreseeable future. However, several
offered long-term visions for integrating technology with
PMI distribution (e.g., patient portals and smart phones)

E-mailing PMI to patients seems to be the most realistic
next step in the integration of PMI and technology.
Anticipated this distribution method having minimal effect
on format & content of paper-based PMI

Note: e-mail distribution presents additional considerations, such
as an opt-in requirement, concerns about security of information,
& patient privacy
Prototype Examples (2)
Bubble
Drug Facts Style
FDA Contact Information

If you have any questions for the FDA’s Office of
Medical Policy regarding PMI, email PMI@fda.hhs.gov.

FDA OMP Contacts:
 Bryon Pearsall: bryon.pearsall@fda.hhs.gov
 Denise Hinton: denise.hinton@fda.hhs.gov

Richardae Araojo: richardae.araojo@fda.hhs.gov
NCPIE Contact Information
Ray Bullman
National Council on Patient
Information and Education (NCPIE)
200-A Monroe Street, Suite 212
Rockville, MD 20850
bullman@ncpie.info
(301) 340-3940 – telephone