|
FDA to Require New Patient-Friendly Medication Guides For all Drugs
(Thursday, June 1, 2023) Patients cannot read the fine print, called package insert (PI), accompanying their prescription drugs, leading to medication errors which in turn results in treatment failures and other serious consequences for the patients. To address that, FDA is proposing a new rule to require simplified drug information, called “Patient Medication Information (PMI)” for all prescription drugs and biologics dispensed to patients for use in outpatient settings. The PMI will be required initially only for the new drugs and biologics approved by the FDA, and over time would be required for all prescription products. The package inserts are highly technical and contain detailed information that is not directly relevant to the use of the prescribed drugs by the patients. The PI was originally intended primarily for the physicians and prescribers, hence contains information relevant for their prescription decisions. For many years private parties have used Consumer Medication Information (CMI) to help the patients, which are distributed along with the prescription drug at the pharmacy. FDA even has a guidance document with recommendations for creating the CMI, but the CMI is not standardized and varies across different organizations or individuals creating them. Hence, CMIs need improvement, which is what PMIs intends to do. The goal of the proposed PMI rule is to create a one-page document that provides clear and useful information to the patient about their prescription drug. The PMI would include a concise summary of the uses of the prescription product, key safety and side effect information, and instructions for use. The proposed rule will standardize the format and content of the PMI. The PMI will use visual elements to ease finding information quickly. The proposed requirements are based on extensive research by FDA on the various formats available currently and discussions with stakeholders. The PMI would be included in the market approval applications (NDA, BLA, ANDA and BsLA) for new and generic drugs, biologics and biosimilars. PMI would also be required for blood and blood components intended for transfusion in outpatient settings. The PMIs would be provided to the patients primarily as a printed document along with each prescription, but pharmacies would be allowed to also provide electronic copy of the PMI to the patients upon request. FDA would also store the PMI on its website. In about 5 years from the final rule, the PMI would eliminate the need for Medical Guides currently required for high-risk products such as those with REMS. This is a much-needed rule and has wide support from all stakeholders. Comments to the proposed rule can be submitted till 27 November 2023 and the expected finalization by the end of 2024. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
