FDA proposes revamping medication guides that come with prescriptions
By Jen Christensen, CNN
(CNN) — The US Food and Drug Administration proposed Tuesday to add to what you get with your prescription drugs.
The proposed rule would require the prescriptions you get to come with a new kind of single-page medication guide with an easy-to-use set of directions and easy-to-understand safety information, a goal the FDA has been working toward for years.
One study found that nearly 75% of Americans have had trouble taking their medicine as directed. A lot of that is due to cost – people might not be able to afford their medicine, so they don’t take it – but some is due to confusion. They might get more than one kind of written information with their prescription, or the information they receive can be conflicting, incomplete or repetitive, the FDA said.
When people are confused or misinformed about their prescription, there is a good chance they will not take it or will stop taking it, and that can directly hurt their health.
“Research suggests that medication nonadherence can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in our country each year,” the FDA says.
The agency said the new proposal is also meant to help fight the “nation’s crisis with health care misinformation and disinformation.”
If the rule goes into effect, this new Patient Medication Information guide will be required for prescription drugs and certain biological products, including blood and blood components transfused in an outpatient setting.
The one-page guides would offer concise, accessible information in a consistent format. They would include the drug/biologic’s name, a quick summary of its use and indications, safety information, common side effects and directions on how to take it.
The information would be given to people when they pick up prescriptions, offered in an outpatient setting and available online.
The guide would come in lieu of other required instructions and would reduce the current number of other FDA-approved written prescription information requirements.
“Today’s proposed rule is a practical step towards improving the nation’s health,” FDA Commissioner Dr. Robert Califf tweeted. “Our public health mission is to ensure drugs and certain biological products are used safely and effectively, help people feel empowered and confident in their ability to manage their care, and prevent negative health outcomes.”
The FDA is encouraging public comments on the proposed rule. It typically allows 60 days for public comment and will consider these comments as it finalizes the rule.
The-CNN-Wire
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