Updated drug information handout outdoes FDA’s version

(Press-News.org) A clinical trial comparing 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 that quantifies a drug’s risk and benefits showed that the latter was more informative and helped patients feel better equipped to make decisions.

Published today in JAMA Network Open, the study, which used the drug mifepristone as an example, highlights the importance of communicating risks and benefits of prescription medications – and the size of those risks and benefits.

“The FDA’s proposed patient medication information handout gets a lot of things right: it’s succinct and it’s simple,” said lead author Tamar Krishnamurti, Ph.D., associate professor in the Division of General Internal Medicine at the Pitt School of Medicine and Magee-Womens Research Institute. “But it’s missing nuances about risks and assumes that a patient already knows a drug’s benefits. Our study shows that this complexity can be explained in an easy-to-understand way, which can support people in making more informed decisions about their health.”

Currently, patient medication guides are provided under certain circumstances such as for drugs with serious risks or where product information could prevent serious adverse effects. But because these handouts do not have a standardized format, they can be lengthy — often four or five pages long — and unclear.

To help patients use medications more safely and effectively, the FDA recently proposed a new patient medication information (PMI) one-page handout for all prescription drugs used in an outpatient setting that clearly lays out directions for use, safety information, warnings and common side effects.

But there are no requirements to list the benefits of the medication, to quantify how effective it is or how often common side effects occur, or to explain how the medication works.

“The FDA may be assuming that when patients pick up their drugs, the benefits of the medication will have already been clearly communicated to them by their provider, but if someone is relying on a PMI to help them make a decision, this information should be included,” said Krishnamurti. “It’s also important to tell people about the size of risks and benefits of a medication, so that they know how likely something is to occur, not just that it’s possible.”

According to Krishnamurti, PMIs should also include a mechanistic explanation of how the drug works so that patients can understand what is happening in their body.

Focusing on mifepristone — which is used in combination with another drug called misoprostol to end pregnancies that are less than 10 weeks along — Krishnamurti and her team developed a so-called Decision Critical PMI that is similar to the FDA’s PMI but explains how the drug works, how often it is effective and how often side effects occur. For example, instead of stating that fever and headache are common side effects, it specifies that 48% of patients experience fever and 43% experience headache.

To test the effectiveness of different communications about mifepristone, the researchers recruited 330 female participants via an online survey. After being randomly assigned to view the drug vendor’s five-page medication guide, the FDA’s PMI or the Decision Critical PMI, participants were tested on their knowledge about the drug and answered questions about the usefulness of the information.

Participants rated both the FDA and Decision Critical PMIs as having higher readability compared with the vendor’s handout. The Decision Critical PMI scored better than the other two communications in terms of comprehension, supporting decision making and drug use directions.

“Our findings support other evidence that being transparent about uncertainty and giving people the numbers to evaluate the strength of evidence about a medication themselves is best practice for risk communication,” said Krishnamurti. “Our hope is that these findings inform changes to the FDA’s final requirements for the proposed PMI, which could be an incredibly useful communication for patients, particularly for drugs that may be subject to popular misinformation.”

According to Krishnamurti, the FDA’s proposal does not currently require pharmaceutical companies to test the messaging in their PMIs.

“The proposed regulation will tell vendors what topics they need to cover in the PMI, but there is no requirement for testing for how well people read or understand the materials,” she explained. “User testing should be a requirement for public-facing information on all drugs.”

Other authors on the study were Gianna White, M.S., Barry Dewitt, Ph.D., and Baruch Fischhoff, Ph.D., all of Carnegie Mellon University; and Elizabeth Mosley, Ph.D., M.P.H., of Pitt.

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