Developing Optimal Patient Medication Information

Washington, we have a problem. Patients continue to receive prescription medication information, which they often misunderstand or ignore. According to a study about patient medication information (PMI) conducted for the Food and Drug Administration (FDA), 94% of surveyed consumers reported receiving PMIs with their new prescriptions. However, only 75% of the postprescription documents met the minimum FDA criteria for usefulness. Only half of the PMIs met criteria for directions on how to monitor medications and what actions to take when side effects or other problems occurred.¹

Medication information is generated by several different sources: health providers, pharmacists, and manufacturers. As any patient or consumer knows, these written handouts vary in readability and content, depending on the source. Typically, the text is in a small font size with narrow margins and utilizes words that most people would have difficulty understanding. John Coster, Senior Vice President of Government Affairs with the National Community Pharmacists Association, succinctly put it this way: "What's not read is not used, and what's not used is not acted on."²

The FDA, with the assistance of the Brookings Institution, has pulled together patient advocates, communications experts, healthcare providers, and industry representatives to try to develop, implement, and evaluate a single, standardized medication information template. This uniform format would replace the varying layout styles of patient package inserts, current PMIs, and medication guides.³

From the patient perspective, an optimal PMI leaflet should provide the best information that individuals can use to make the most informed decisions about their drugs. Patients have told the National Health Council in repeated focus group meetings that they want access to full information about risks associated with prescription drugs. But when and how that information is presented also must be taken into consideration.

We must find the right balance between the courage to present all of the facts and the compassion to consider the impact of too much information presented at the wrong time. Some patients told us they became cautious or fearful about continuing to take a medication when they learned about new possible adverse effects, even though they had not experienced these effects.

Focus group members did not say they want all of the information all of the time. What they want is access to information in a way that meets their personal needs. That could mean information in another language. It could mean a handout printed in large type or supplemented with additional details on the Internet. People with chronic diseases and disabilities want information that is personalized, customized, and individualized.

Interestingly, a focus group the National Health Council convened back in 2006 to discuss drug safety issues suggested making medication information accessible in the familiar "nutrition facts" format that is found on food packages.

The participants in the FDA and Brookings Institution project agree that paper-based information remains necessary and is not likely to disappear. But we need to marry the final uniform PMI with new technology and provide people with the ability to ask questions, particularly in this interactive Web 2.0 world. Patients want to be respected as valuable participants on the healthcare team. They want to be listened to and understood.

The National Health Council conducted an unscientific online survey in October involving just over 230 patients. The majority of respondents (53%) said they want their medication information in writing and on the Web. Only 4% want their information in writing with a toll-free phone number for asking questions. Twenty-eight percent want their written information to come with both a Web address and a toll-free number. We did not ask about mobile applications. However, research has shown that these applications could play an important role in providing timely healthcare and medication information.⁴

Although I have focused on the recipients of medication information, I recognize that those who provide this information also have concerns. The PMI leaflets distributed by pharmacies are typically generated electronically as part of the dispensing process. The content is determined by a small number of private vendors who sell drug information materials to pharmacy outlets. The formatting then is determined by the pharmacies. As a result, PMI leaflets from different pharmacies can have very different content and appearance.1 Some pharmacies are limited by their in-house equipment and cannot print in color or include images of a pill in a PMI.²

The FDA has created 3 PMI prototypes, and the Office of Management and Budget is expected by June 2011 to approve an FDA request to test them with patients. But the dialogue to create feasible solutions for delivering higher-quality medication information is not over. At an October 2010 public meeting, Rachel Behrman, Director of the FDA's Office of Medical Policy, Center for Drug Evaluation and Research, said, "How (PMI) is generated, who generates it, how it is distributed, and how we measure success--all are things we need to think about. One can see a terrific public-private partnership with various working groups addressing these issues."²

To learn more about the project, visit the Brookings Institution's Web site at www.brookings.edu/ health/Projects/PMI.aspx. As this article was being written, the FDA was scheduled to submit its study to the Federal Register and provide a 60-day public comment period. To review the report, visit www. regulations.gov and enter docket number FDA- 2010-N-0184 in the keyword field.

Address correspondence to: Myrl Weinberg, CAE, President, National Health Council, 1730 M St NW, Ste 500, Washington, DC 20036-4561. E-mail: mweinberg@nhcouncil.org.

References1. Kimberlin CL, Winterstein AG. Expert and Consumer Evaluation of Consumer Medication Information 2008. Final Report to the US Department of Health and Human Services and the Food and Drug Administration. November 4, 2008. http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/ RiskCommunicationAdvisoryCommittee/UCM117149. pdf. Accessed November 1, 2010.

2. Brookings Institution. Ensuring Access to Effective Patient Medication Information. Meeting transcript. October 12, 2010. http://www.brookings.edu/~/media/Files/ events/2010/1012_patient_medication_information/ Transcript.pdf. Accessed November 1, 2010.

3. Brookings Institution. The Science of Communicating Medication Information to Consumers. Expert workshop. July, 2010. http://www.brookings.edu/~/ media/Files/events/2010/0721_CMI/CMI%20Expert%20 Workshop%20summary_20101007% 20EW.pdf. Accessed November 1, 2010.

4. Centers for Disease Control and Prevention, CDC Mobile Health Coalition. Benefits of mobile applications. http:// www.cdc.gov/MobileHealth/benefits.html. Accessed November 1, 2010.

Published in Oncology & Biotech News. January 2011.