The communication of risks and benefits of prescription medications is crucial for patients to make informed decisions about their health. A recent clinical trial compared a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an updated version developed by researchers at the University of Pittsburgh. The study, published in JAMA Network Open, used the drug mifepristone as an example to highlight the importance of clear and informative medication information.
Lead author Tamar Krishnamurti, Ph.D., emphasized the need for medication handouts to include not only directions for use and safety information but also the quantification of a drug’s risks and benefits. The FDA’s proposed patient medication information handout was found to be lacking in providing detailed information about the benefits of the medication, the likelihood of common side effects, and how the medication works in the body.
The researchers developed a Decision Critical Patient Medication Information (PMI) that addressed these shortcomings by explaining how mifepristone works, how effective it is, and the frequency of side effects. In a study involving 330 female participants, the Decision Critical PMI was found to be more readable and comprehensible compared to the FDA’s PMI and a vendor’s five-page medication guide. Participants also rated the Decision Critical PMI as more supportive of decision-making and providing clearer drug use directions.
The study’s findings suggest that transparent communication about the uncertainty of medication effects and providing patients with numerical data to evaluate the strength of evidence are essential for effective risk communication. The researchers hope that their findings will influence changes to the FDA’s requirements for patient medication information handouts, making them more informative and useful for patients.
Krishnamurti also emphasized the importance of user testing for public-facing drug information, suggesting that pharmaceutical companies should be required to test the messaging in their PMIs to ensure patients can read and understand the materials effectively. By improving the communication of medication risks and benefits, patients can make more informed decisions about their healthcare.
For more information, the study titled “Public Understanding of Risk and Benefit of Mifepristone” can be found in JAMA Network Open. This research was conducted by the University of Pittsburgh.
