A recent clinical trial conducted at the University of Pittsburgh compared a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an updated version developed by researchers. The study focused on the drug mifepristone and aimed to assess the effectiveness of different communication strategies in conveying the risks and benefits of prescription medications.
Published in JAMA Network Open, the study revealed that the updated medication handout, known as the Decision Critical PMI, was more informative and helped patients feel more equipped to make decisions about their health. This handout quantified the risks and benefits of the drug, providing detailed information on how the medication works, its effectiveness, and the frequency of common side effects.
The FDA’s proposed patient medication information handout, while concise and simple, was found to lack nuances about risks and benefits. It also did not include information on the benefits of the medication, the likelihood of common side effects, or a mechanistic explanation of how the drug works. The study emphasized the importance of providing patients with comprehensive and easy-to-understand information to support informed decision-making.
Currently, patient medication guides provided by the FDA can be lengthy and unclear, leading to potential confusion among patients. The proposed one-page handout aims to streamline the information provided to patients, focusing on directions for use, safety information, warnings, and common side effects. However, there are no requirements to list the benefits of the medication, quantify its effectiveness, or explain how it works.
The study participants, who were randomly assigned to view different medication handouts, rated the Decision Critical PMI as having higher readability and comprehension compared to the FDA’s handout. The updated handout was found to be more effective in supporting decision-making and providing clear drug use directions.
The researchers hope that these findings will inform changes to the FDA’s final requirements for the proposed patient medication information handout. They recommend that pharmaceutical companies should test the messaging in their handouts to ensure that patients can read and understand the information effectively. Transparent communication about the uncertainties and risks associated with medications is crucial for empowering patients to make informed decisions about their health.
In conclusion, the study highlights the importance of clear and comprehensive communication of risks and benefits in patient medication information handouts. By providing patients with detailed information on the effectiveness of medications, the likelihood of side effects, and how the drugs work, healthcare providers can better support patients in managing their health.
