Transcript Enhancing Written Information from the Pharmacy: An Update

Enhancing Written Information from the
Pharmacy: An Update on MedGuides &
Consumer Medicine Information (CMI)
National Association of Chain Drug Stores
2006 Pharmacy & Technology Conference
San Diego, CA
July 28, 2006
William Ray Bullman
Executive Vice President
National Council on Patient Information and Education
Bethesda, MD
Why so Much Emphasis on Written
Prescription Information?
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FDA regulation
High risk medications (e.g., Vioxx)
New IOM report – Preventing Medication Errors
CMI “usefulness” survey in 2007
Challenges with MedGuides
Many types of written prescription information
FDA Regulation of Prescription
Medicine information
• What the FDA regulates?
– Professional labeling and promotional
materials, including direct-to-consumer (DTC)
advertising
• What the FDA does NOT regulate
– Websites with medication information
– Consumer books (excluding some references)
Types of Written Information in
Pharmacies
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Package Insert (PI)
Consumer Medicine Information (CMI)
Medication Guides (“MedGuides”)
Patient Information Sheets (PIS)
Patient Package Insert (PPI)
Package Insert (PI)
• To gain marketing approval, manufacturers must have
“official labeling” for its product approved by FDA. This
includes both the label on container & “package insert” or
“PI” which contains detailed information about indications,
warnings, precautions, side effects, dosage,
administration, and clinical pharmacology. PI also referred
to as “professional labeling” because it is written
primarily for physician & pharmacist.
• With only a few exceptions, PI does NOT have to be
given to patients because it is highly technical & not
expected to be understood by average consumer.
However, consumers can easily obtain PI via the PDR or
by asking pharmacist or manufacturer for a copy.
An Aside on PIs
• November 2005 -- FDA, in collaboration with National
Library of Medicine (NLM) and NIH, launched “DailyMed,
an interagency online health information clearinghouse.
• “DailyMed” requires manufacturers to submit prescription
drug label information to FDA in a new electronic format.
This information can be accessed through the National
Library of Medicine at http://dailymed.nlm.nih.gov
• Currently includes 521 approved prescription drugs.
Medication Guides (MedGuides)
• FDA has authority to require that FDA-approved labeling
also include specific information for the patient under
circumstances where the drug is considered to have
significant safety issues that puts patient or public health
at risk.
• Under such a circumstance, FDA-approved written
information for patients, called a “Medication Guide,”
must be given to pt. when the drug is dispensed. For
example, antidepressants & NSAIDs now require that an
FDA-approved Medication Guide be dispensed with
those prescription drugs.
• MedGuides primarily emphasize “risks” as opposed to
“benefits.”
Consumer Medicine Information (CMI)
• Unlike Europe, where patient information leaflets are
highly regulated, only a few Rx drugs dispensed in the
U.S. require FDA-approved written information for
patients (primarily aforementioned Medication Guides).
• Federal law (P.L. 104-180) in the U.S. requires that new
Rxs be dispensed with written CMI). The law further
requires that content & format of CMIs must be “useful”
for patients, as defined by criteria developed by a multistakeholder committee – the Keystone Committee a
decade ago.
Consumer Medicine Information (CMI)
• The content and format of each written consumer
medication information sheet, i.e., a CMI leaflet, that is
dispensed by a pharmacist with a prescription is usually
developed by private companies. While these leaflets
are based on FDA-approved labeling, their specific
content and format are not subject to FDA approval.
• However, FDA has authority to evaluate these
pharmacist-delivered CMIs for “usefulness.” If the
private sector fails to meet the goals of the Keystone
Committee by 2006, the FDA has the authority to
regulate the content and format of all future written
information dispensed to patients with prescription drugs.
Patient Information Sheets (PIS)
• FDA in 2005 proposed a new Web page called “Drug
Watch,” on which it would post emerging “safety alerts.”
As part of this now revised initiative, the FDA links new
safety alerts to what is called a “Patient Information
Sheet” (PIS).
• PIS are prepared by FDA and, like MedGuides, the focus
of PIS is on risk information.
For example of PIS for Gabitril  see
www.fda.gov/cder/drug/infopage/tiagabine/default.htm.
Patient Information Sheets (PIS)
• FDA has not disclosed plans for dissemination of its
Patient Information Sheets. Currently, PIS exist solely
on the FDA’s Web site and, unlike private sector CMI
leaflets, PIS are not disseminated through community
pharmacies.
• Healthcare professionals are encouraged by FDA to
download and provide PIS to consumers.
Patient Package Insert
• For some prescription medicines, FDA approves
manufacturer-prepared patient materials to
instruct patients about the safe use of the
product.
• These materials may be given to patients by
their health care provider or pharmacist.
• Considered part of FDA-regulated product
labeling.
CMI – Where it Stands (August 2006)
• 1996 Keystone Action Plan set 10-yr. timeframe for
meeting specific target goals for formulation /
dissemination of “Useful” CMI. FDA empowered to
evaluate progress made by private sector:
– By end of 2000: 75% of new Rxs convey with CMI
that meets Action Plan criteria for content &
design/layout and readability
– By end of 2006: 95% of new Rxs convey with CMI
that meets Action Plan criteria for content &
design/layout and readability
CMI – Where it Stands (August 2006)
• FDA’s interim assessment (reported July ‘03) found:
– CMI distribution @ 89% (> 75% target)
– CMI content/quality @ 50% -55% (< 75% target)
• Considerable concern voiced about how FDA contractor
performed initial assessment (particularly by ASHP) &
how final (’07) assessment will be conducted.
CMI – Where it Stands (August 2006)
• FDA released Final Guidance on Useful CMI
July 17, 2006
• FDA’s Final Guidance silent on how Agency will
conduct final (2007) assessment, although likely
it will be conducted like initial assessment
(hidden shoppers; 4 Rxs; CMI collected &
evaluated by panels of pharmacy experts &
consumers)
What We Know About the
2007 CMI Assessment
• FDA silent (but considering) expanding final
assessment to include mail order CMI.
• Action Plan will remain basis for FDA’s
assessment; CMI Guidance will be used “to
elucidate.”
• Although encouraged to publish details about
assessment for public comment (after collection
of CMI in the field), FDA not excited about this
approach.