Updated drug information Handout exceeded FDA’s version in the clinical trial

A clinical study in which a hand-out of one page medication is presented by the US Food and Drug Administration (FDA) with an updated version developed by researchers from the University of Pittsburgh who quantifying the risk and benefits of a medicine showed that The latter was informative and patients helped and patients helped. Feel better rested to make decisions.

Published in Jama Network OpenThe study, which used the Mifepriston drug as an example, emphasizes the importance of communicating risks and benefits of prescribed medicines – and the size of those risks and benefits.

“The proposed hand -out of the FDA -proposed trade in the patient is good: it is concise and it is simple,” said chief author Tamar Krishnamurti, Ph.D., university teacher at the General Internal Medicine Division on the Pitt School of Medicine and Magee -Womens Research Institute.

“But nuances lack risks and assumes that a patient knows all the benefits of a medicine. Our study shows that this complexity can be explained in an easy -to -understand way, which can support people in making better -informed decisions About their health. “

Currently, guides are provided for the patient’s medication Certain circumstances Such as for drugs with serious risks or where product information can prevent serious adverse effects. But because these hand – outs do not have standardized format, they can be long – often four or five pages – and unclear.

To help patients use drugs safer and more effectively, the FDA Recently presented A new information about the patient’s medication (PMI) hand-out of one page For all prescription drugs that are used in an outpatient setting that clearly contains instructions for use, safety information, warnings and common side effects.

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

“The FDA can assume that when patients pick up their medicines, the benefits of the medicine are clearly communicated by their provider, but if someone trusts a PMI to help them make a decision, this information must be included,” said Krishnamurti .

“It is also important to tell people about the size of risks and benefits of a medication, so that they know how likely something is to happen, not just that it is possible.”

According to Krishnamurti, PMIs must also contain a mechanistic explanation about how the drug works, so that patients can understand what is happening in their bodies.

Focus on Mifepriston-that is used in combination with another medicine called Misoprostol to end pregnancies that are less than 10 weeks of its developed Krishnamurti and her team a so-called decision-critical PMI that is similar to the PMI of the FDA, but explains How the medicine works, how often it is effective and how often side effects occur. Instead of stating that fever and headache are common side effects, it indicates that 48% of patients experience a fever and experience 43% headache.

To test the effectiveness of different communication about Mifepristone, the researchers recruited 330 female participants through an online survey. After being randomly assigned to the Drug seller of five -page medication guideThe PMI of the FDA or the decision -critical PMI, participants were tested for their knowledge about the medicine and answered questions about the usefulness of the information.

Participants assessed both the FDA and the decision -critical PMIs as a higher readability compared to the seller’s hand -out. The decision critical PMI scored better than the other two communication in terms of understanding, to support decision -making and instructions for drug use.

“Our findings support other evidence that being transparent about uncertainty and giving people the number of evaluating the power of evidence about a medication itself is the best practice for risk communication,” said Krishnamurti.

“Our hope is that these findings inform the changes in the final requirements of the FDA for the proposed PMI, which could be an incredibly useful communication for patients, especially for medicines that can be subject to popular wrong information.”

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

“The proposed regulation will tell suppliers what topics they should deal with in the PMI, but there is no requirement to test on how well people read or understand the materials,” she explained. “User tests must be a requirement for information about all medicines.”