FDA program aims to protect the public against unsafe compounded drugs

Abstract

As part of FDA’s Compounding Incidents Program, pharmacists can share with the agency any identified potential issues with compounded products. The mission of the program is to protect the public from unsafe compounded drugs, and FDA is emphasizing the important role pharmacists play in reporting any adverse events or complaints related to compounding to them. “Pharmacists are in a unique position to learn about issues or concerns associated with compounded products due to close relationships with their patients and communication with providers,” said Shannon N. Glueck, PharmD, RPh, acting branch chief with FDA’s Office of Compounding Quality and Compliance. Compounded drugs serve an important role in fulfilling unmet needs. Four descriptions can be used to decide whether a product is considered to be compounded:▪The provider stated that the medication required customization for patient-specific needs.▪The pharmacy or physician mixed several ingredients to create a product tailored to the needs of the patient.▪The product label states “This is a compounded drug” and that it was produced by an outsourcing facility.▪The manufacturer is listed as a 503B outsourcing facility online. However, these drugs are not approved by FDA and can present potential safety concerns to patients. For example, in 2012, contaminated intrathecal and intra-articular drugs compounded at the New England Compounding Center in Massachusetts resulted in hundreds of cases of fungal meningitis and more than 60 patient deaths. In response to this case, amendments were made to the Federal Food, Drug, and Cosmetic Act as it relates to compounded drugs. FDA has implemented programs such as Compounding Incidents Program aimed at enforcing these provisions. The program tracks, reviews, and addresses adverse events and complaints related to compounded drugs. FDA pharmacists review reports from multiple sources (e.g., FDA’s Adverse Event Reporting System, FDA’s Division of Drug Information, state regulatory authorities, etc.) daily to identify cases related to compounded drugs or compounding firms. “These issues can range from product quality concerns to adverse events or complications from the use of a compounded product,” said Glueck. “What may seem like an individual patient experience could actually be a signal of a larger safety concern.” Once a case is determined to be compounding-related, it is entered into a searchable database and additional research is conducted to further evaluate the case. The case findings are then presented and various actions can be taken to ensure an appropriate response that protects the public from unsafe compounded drugs. “With pharmacists, other health care professionals, and consumers providing information on issues relating to compounded products, FDA can better identify trends, locate the source of the issue through investigation, and take action as necessary,” she said. “However, FDA cannot take action without becoming aware of such issues. The majority of the safety signals investigated by FDA and those posted on the FDA website as Compounding Risk Alerts were identified from reports of potential issues with compounded products. It is these reports from the public that allow FDA to mitigate the safety issue and prevent further patient harm,” said Glueck. FDA’s Human Drug Compounding website (fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding) contains many useful resources related to compounding, including an overview of compounding regulations, links to FDA guidance documents, memoranda of understanding and Federal Register notices, online training programs pertaining to sterile and non-sterile compounding, and more. A recent AJHP article about the Compounding Incidents Program includes helpful tips on how to report an adverse event associated with a compounded drug on FDA’s MedWatch form, such as providing as much detail as possible about the event and selecting the most appropriate product type (with “Compounded” listed as one of the choices). “As pharmacists ourselves, we work hard each and every day at the FDA to assure the safety and quality of compounded products and to protect patients from unsafe and ineffective compounded products,” said Glueck. “We appreciate the pharmacists and other health care professionals who partner with us to help make that happen.”