Performance Improvement 2008. How do Consumers Perceive the Food and Drug Administration's Early Risk Information on Drug Products?


For this study, the Center for Drug Evaluation and Research (CDER) gathered data from patients about the effectiveness of communication and overall usefulness of CDER´s patient information hand outs. Researchers conducted eight focus groups to explore how patients want to learn about newly discovered drug side effects. CDER´s major vehicle for communicating drug product safety information to healthcare practitioners has been the product´s approved labeling, a lengthy document containing extensive detail about the research supporting approval, as well as instructions to assure safe and effective use.

The focus groups discussed patients´ understanding of drug side effects, how patients get information about new drug side effects, and patients´ opinions about FDA´s role in notifying the public about new side effects. Participants discussed and reacted to four examples of current information about medicines that FDA has on its web site. The main qualifying criterion for participation in these focus groups was that each participant should currently use or have used a prescription medication in the past 6 months.

Focus group members indicated that many consumers stopped taking a drug due to an adverse event before talking to their physicians. Several participants understood the possibility of long-term adverse consequences from taking a drug long-term. The majority of participants considered physicians and pharmacists to be the most trustworthy sources. When prompted, participants said they trusted the FDA. Some suggested that FDA safety news should be sent out through TV and newspapers. It appears that consumers do some sort of risk/benefit decision-making concerning drug products. When participants were asked, "What does ´safe drug´ mean to you?" most agreed that it meant there was no chance of death or serious and/or permanent side effects. Participants found the sample Patient Information Sheets to be informative, used clear and understandable language, contained comprehensive information, and were clearly formatted. Participants preferred information in Public Health Advisories in bullet points and most liked bolded font but thought the most important information, e.g., the safety issue and ways to minimize harm should be listed first in any Public Health Advisory information. Participants concluded the Health Care Professional sheet was helpful and included enough information for a healthcare provider to start a discussion with a patient. The participants appreciated the way information was organized, the sequence in which information was provided and its clarity and conciseness.

Report Title: Consumer Perception of FDAs Early Risk Information on Drug Products. Report may be obtained from Federal Contact
Agency Sponsor:
FDA, Food and Drug Administration
Federal Contact:
Mary Mease, 301-443-5576
OMR Team

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"PerformanceImprovement2008.pdf" (pdf, 1.29Mb)

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