|Patient Medication Information (2008 – 2011)
- European Medicines Agency Improves Package Leaflets (July 2011) - The European Medicines Agency has updated the template for package leaflets for human medicines, to make the information easier for patients to understand and to include new sections on medicines' benefits and their uses in children. The Agency introduced these changes to contribute towards the safe and effective use of medicines. They address the feedback from five years of user testing and from a range of stakeholders, including patient and consumer groups, national medicines regulatory agencies, the pharmaceutical industry and academics. This feedback included concerns that the package leaflet needed to be more readable with fewer rigid standard statements, and that patients needed more information on the benefits that medicines can bring and on their uses in children. Click here for details
- In December 2008, FDA released its final assessment of private sector activities to achieve the goals of the Action Plan for the Provision of Useful Prescription medicine Information. The assessment, Expert and Consumer Evaluation of Consumer Medication Information, 2008, was conducted by the University of Florida College of Pharmacy. Click here for details
- In May 2010, FDA released a proposed plan for an Experimental Study of Standardized Patient Information Prototypes. The study (to occur in 2011) is designed to test different ways of presenting information about prescription drugs to patients who have obtained a prescription. The information used will be based on a fictitious medication for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Data collection will occur via computer at training and testing facilities with orientation and debriefing conducted by interviewers. Participants will include adults who have been diagnosed with one of the conditions the fictitious drug treats. Participants will be prescreened to obtain a reasonable representation of health literacy, including those who score at the lower end of the scale. Questionnaire measures will include open- and closed-ended questions. Extensive pre-testing of materials and stimuli will be conducted to refine the experimental stimuli and dependent measures and to ensure the stimuli meet minimum communication requirements and are delivering expected messages. Click here for details
- Through a cooperative agreement, the Brookings Institution, Engelberg Center for Health Care Reform, is working in collaboration with the Food and Drug Administration (FDA) to convene three workshops (July 2010 – February 2011) to discuss optimizing, implementing, and evaluating adoption of a single standard medication information document. Two of the meetings (July 2010 and February 2011) will be expert workshops involving a small group of subject matter experts charged with the task of exploring focused topics, while one meeting (October 2010) was a large public workshop to solicit perspectives from all relevant stakeholders (federal agencies, pharmacies, health care plans, pharmacy benefit managers, manufacturers, CMI publishers, providers, hospitals, patients, and consumers). Each of these three workshops will focus on a different aspect of PMI: Click here for details
June 12-13, 2007 -- FDA Public Hearing on Medication Guides and Risk Communication
The U.S. Food and Drug Administration (FDA) convened a two-day public hearing (June 12-13, 2007) to hear specific feedback on the development, distribution, comprehensibility, and accessibility of Medication Guides, which include FDA-approved information, and are required to be distributed to patients in order to convey drug risk information. FDA officials heard testimony from a member of Congress and 40 individuals representing academia, consumers and consumer groups, the pharmaceutical industry, healthcare professional groups, practicing physicians, and pharmacists as well as pharmacy organizations. Click here for a summary of the meeting, prepared by FDA.
NCPIE Weighs In
Ray Bullman, NCPIE’s Executive Vice President, encouraged FDA to enable pharmacies that wish to generate Medication Guides electronically to do so and be recognized as in compliance with the Medication Guide regulation despite the inability of some current-generation pharmacy systems to produce documents that conform to Medication Guide design specifications. Additionally, Bullman concurred with the recommendation that Medication Guides be shortened, and that FDA collaborate with stakeholders in developing and promoting a broad-based medicine risk communication plan that builds on progress that has been made by the private and public sectors to date. Click here for NCPIE’s comments.
December 1, 2006 -- FDA Publishes Results of Latest Survey: Minimal Progress Toward 2010 Medication Counseling Goals
Since 1982, the U.S. Food and Drug Administration (FDA) has conducted eight national telephone surveys to determine the percentage of consumers who receive oral and written information about their prescription medicine from their doctor's office or pharmacy. The surveys included about 1,000 U.S. consumers who had received a new prescription for themselves or a family member at a retail pharmacy during the previous month. Consumers were asked whether they had been given information in either oral or written form in each of these two health care settings. If they had, they were asked about the type of information - the medicine's use, how much to take, how often to take it, whether it could be refilled, any precautions to take, and possible side effects.
Consumers' reported receipt of information provided orally at the doctor's office has increased slowly since 1992. Reported oral counseling at the pharmacy has been decreasing since 1998. In both locales, a higher percentage of consumers received information about directions for use (i.e., how much medicine to take and how often to take it) than risk-related information (i.e., precautions to take or possible side effects). In 2004, 26% of consumers were told about directions for use and risk information at the doctor's office, while only 6% were told both directions and risk information at the pharmacy.
The Department of Health and Human Services' Healthy People 2010 for the Nation include specific objectives to increase the percentage of patients who receive both oral and written prescription medicine information. The FDA is the designated lead agency for tracking progress toward meeting specific Medical Product Safety goals, including:
- Objective 17-4: Increase to 95% the proportion of patients receiving information that meets guidelines for usefulness when their new prescriptions are dispensed.
- Objective 17-5: Increase to 95% the proportion of patients who receive verbal counseling from prescribers and pharmacists on the appropriate use and potential risks of medications.
HHS has recently posted its mid-course review of Healthy People 2010 Objectives for the Nation. Click here for the pdf version of the mid-course assessment of progress on the above two medication communication objectives.
July 18, 2006 -- FDA Publishes Final Guidance for Useful Written Consumer Medication Information (CMI)
NCPIE Comments on FDA Draft Guidance on Useful CMI...
On May 25, 2005, the Food and Drug Administration (FDA) released a draft guidance document on Useful Consumer Medication Information (CMI). The 60-day comment period on the CMI draft guidance ended on July 25, 2005. Click here for a pdf version of the FDA's draft guidance document. Click here for the Federal Register announcement (May 26, 2005, Docket No. 2005D-0169), providing background provided by FDA. For a copy of NCPIE's comments to the Docket, Click here. Attachment A accompanying NCPIE's comments is a draft of the comprehensive Guide for Assessing the Usefulness of Consumer Medicine Information prepared by the NCPIE CMI criteria committee and submitted to FDA for its input in September 2004. Release of this Guide by NCPIE has been on hold since Sept. 2004 awaiting feedback from FDA. A final version of the Guide will be posted here as soon as possible. Check back here for details.
NCPIE Comments on FDA Drug Safety Plan
Click here for NCPIE’s comments on FDA’s Draft Guidance for Industry on the Food and Drug Administration’s "Drug Watch" for Emerging Drug Safety Information (Federal Register, May 10, 2005, Volume 70, Number 89, pages 24606-24607).
NCPIE Presents CMI Session @ ASAP Conference.
Click here for details and presentation slide.
NCPIE Presents CMI Session @ Food & Drug Law Institute Conference
NCPIE organized a breakout session on Consumer Medicine Information (CMI) and related drug information issues for the 48th Annual Conference of the Food and Drug Law Institute (FDLI). The session, entitled, "Prescription Drug Information for Consumers and Healthcare Professionals." Participants in the session included: Ray Bullman, NCPIE Executive Vice President; Paul J. Seligman, MD, MPH, Director, Office of Pharmacoepidemiology and Statistical Science, CDER, FDA; Alan Goldhammer, Ph.D., Associate Vice President, Pharmaceutical Research and Manufacturers of America; and Susan J. Winckler, R.Ph., J.D., Vice President, Policy and Communications, and Staff Council, American Pharmacists Association.
Click below for slide presentations:
"Bullman - CMI Initiative"
|"Seligman - FDA Perspective"
|"Goldhammer - Industry Perspective"
|"Winckler - From the Pharmacists' Perspective"
Your Written Medicine Information is Important" -- public service print ads (PSAs) for consumer publications. Help spread the word about the value of written medicine information. Place these ads on your web site, in your newsletters, magazines, and local newspapers. Contact NCPIE to request pdf files. Available in two sizes:
"Quarter page PSA"
|"One column PSA"
"Click here for NCPIE's 2004 "Talk about Prescriptions" Month materials,
Your Medicine Information is Important: Read It and Heed It."
Click here for "The Benefits or Written Consumer Medicine Information."
For information about joining NCPIE’s CMI
Initiative, please e-mail Ray Bullman at
|NCPIE CMI Initiative Stakeholders’ Meeting, March 2004
CMI March 2004 Agenda
As convener of the CMI Initiative, the National Council on Patient
Information and Education organized a CMI Stakeholders’ Meeting
on March 8, 2004 in Washington, DC. The CMI Criteria, Education,
and Implementation Committees – which have been meeting
regularly via teleconference since early 2004 – reported on progress
to date and developed work plans for 2004-2006. Three dozen attendees,
representing 25 different CMI stakeholder organizations (including the FDA
and the VA), participated on March 8. The CMI
Committees’ action plans are below:
Criteria Committee Action Plan
- Communicate (in writing) to FDA concerns
about year 2000 CMI assessment, including
the need for the approved P.I. to be the
threshold for compliance with CMI guidelines.
[NOTE: This was completed in mid-March.]
- Slate for April 2004 a follow-up meeting with
FDA to obtain feedback on above document.
- Create a CMI Universal Assessment Tool for
use by drug information publishers and,
ultimately, other stakeholders.
- Determine process for development
- Identify and secure funding to hire experts
and/or to compensate Criteria Cmte.
volunteers who work on this Tool
- Complete Tool by Summer 2004
- Refine, as necessary, based on FDA’s anticipated guidance document (Fall ’04)
Education Committee Work Plan
- For each CMI stakeholder, identify key messages and action steps
- Diagram process of CMI development, including where breakdowns occur, and what each stakeholder can do along the way to bolster success.
- Recommend to CMI Implementation Committee a pilot project that would assess differently-formatted CMI leaflets’ impact (1) on pharmacists’ work flow, and (2) on consumers’ appropriate use of their medicines.
Implementation Committee Action Plan
- Draft letter to chain drug CEOs identifying
steps they can take to provide more useful
CMI; include brief overview of CMI survey
conducted by the American Society for
Automation in Pharmacy (Feb. 2004)
- Draft letter to pharmacy system integrators
relaying overview of the same survey results,
and encouraging them to formulate / test
- Coordinate with the FDA:
- Development of “points to consider” guidance
- Criteria Cmte.’s written comments on assessment
of criteria and sub-criteria, and follow-up meeting
- Weighting / scoring of CMI
- Development of Keystone-compliant CMI prototypes
- Develop and conduct a survey of pharmacy “hardware”
capacity for re-formatted CMI
- Reach out directly to consumers re: CMI; e.g., prepare
an article for AARP’s “Bulletin”
Please check this page often for further CMI developments.
NCPIE Press Release on CMI, July 31, 2003
Statement on CMI from FDA Commissioner, July 31, 2003
FDA Public CMI Meeting, July 2003
NOTE: What follows is a brief summary; please click on
highlighted hotlinks throughout this page for more details.
A federal law enacted in 1996 (P.L. 104-180) set specific
targets for the distribution of useful oral and written
prescription information. The first target was 75% of
people receiving new prescriptions in 2000, rising to
95% by 2006. Efforts to date, and evaluation of progress,
have focused on written prescription information distributed
at community pharmacies although the law’s original scope
is much broader.
In late 1996, as instructed in the law, a diverse group of
prescription information stakeholders (including many
NCPIE coalition members) collaborated to develop a long-range
plan to meet the 2000 and 2006 goals. This
“Action Plan for the Provision of Useful Prescription Medicine Information”
was approved by then-HHS Secretary Donna Shalala in 1997.
One component of this Action Plan identified characteristics
of “useful” medicine information.
Action Plan Appendix G - Specific Language & Format Guidelines for Useful CMI
Sample #1 of Useful CMI
Sample #2 of Useful CMI
Sample #3 of Useful CMI
The extent to which community pharmacy-distributed medicine
leaflets met these characteristics for usefulness formed the
basis of FDA’s first national evaluation of progress toward
meeting the 2000 goals. Research conducted for the FDA by
Professor Bonnie Svarstad, Ph.D., School of Pharmacy,
University of Wisconsin, found that the distribution rate stood
at 89%, but the leaflets’ usefulness was only about 50%.
Click here for a
“Talk Paper” FDA issued on this research in
Meanwhile, the FDA carried out its new statutory authority to
issue FDA-approved “Medication Guides” for certain prescription
medicines and biologics that “pose a serious and significant
health public health concern.” A description of “Patient
Labeling and Risk Communication,” including a list of
Medication Guides issued since July 2003, is available from
FDA’s Office of Drug Safety.
An important distinction is that “Medication
Guides” are approved by the FDA for a very limited number
of medicines, while pharmacy-distributed medicine leaflets
are usually produced by independent drug information
At a July 2002 FDA Drug Safety and Risk Management
Advisory Committee meeting, the FDA was urged to take
a more active role in advising and encouraging the private
sector to meet the 2006 goals.
|FDA Public CMI Meeting, July 2003
In June 2003, the FDA issued a Federal Register notice
announcing that a public meeting on the current status of
useful written medicine information for consumers – now
referred to as consumer medicine information (CMI) –
would be held in Washington, DC on July 31.
Click here to read the
4-page notice, which incorporates detailed chronology of CMI activities since the 1970’s.
Click here for the
final agenda for this July 31 meeting.
A statement on CMI from FDA Commissioner Mark McClellan, M.D.
is available here.
At this meeting, the National Council on Patient Information
and Education outlined its role as convener and catalyst
for the private sector’s efforts to meet the Year 2006 CMI
goals. Click here for our press release.
NCPIE representatives made five presentations explaining the
goals, structure and process of this CMI Initiative, which
involves three committees. NCPIE’s PowerPoint presentations
can be viewed by clicking on the links below.
NCPIE’s Ray Bullman Interviewed on CMI in Computer Talk Magazine
Comments on FDA’s Proposed Patient Patient Information Survey due March 29, 2004
National Surveys of Prescription Medicine Information Received by Consumers (FDA, 1992-2000)
Drug Topics article (18 Aug. 2003) on FDA Public Meeting
“Evaluation of Written Prescription Information Provided in Community Pharmacies: A Study in
Eight States,” Journal of the American Pharmaceutical Association, Vol. 43, No. 3 (May/June
2003),B. Svarstad, et. al.
U.S. Pharmacopeia issues Guidelines for Written Prescription Drug Information (14 Jan. 2003)