The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence.
The proposed “Patient Medication Information” guide would be an FDA-approved, one-page document that includes the necessary information for patients to understand the drug product and how to use it. The document would include the drug/biological product name, side effects, directions for use, safety information, and a concise summary of indications and uses. Since all documents would have a standardised format and content requirements, the FDA expects this new model to reduce repetitive information and lessen costs for drug and biologics manufacturers. This is a departure from the current method, where patients receive one or more types of written information for prescription drugs and certain biological products, depending on the prescribed drug.
The agency describes the current system as “confusing, conflicting, incomplete, or repetitive”, based on study data. Due to this, patients often take their medications incorrectly, or stop taking them entirely, which causes further harm. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.
The US Centers for Disease Control and Prevention (CDC) names “understanding when and how often to take medications” as one of the main factors causing medicine non-adherence. According to a 2018 study, nonadherence is especially an issue in the case of chronic illness where patients may be expected to take medications at least once daily. The CDC considers a population as medicine adherent if “80% of people have access to their medications for at least 80% of days in a defined study period”. Thus, according to the World Health Organisation, adherence is particularly low in people with chronic diseases in developed countries, only reaching 40%–60%.
In its statement, the FDA cited research that says medication nonadherence can cause almost 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 US deaths annually. The agency also aims to prevent misinformation and disinformation with this clearer form of patient communication. FDA will accept public comments on the proposed changes for 180 days after 30 May, after which the proposed guide will be reviewed to make a final rule.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData