FDA Drug Recall Process

On average, 4500 drugs and medical devices are pulled from shelves across the United States each year, because of product recalls.

Drugs can be recalled, because of a variety of reasons, including issues involving drug contamination, safety, changes in potency, or mislabeling. Although recalls aim to protect the public from potentially harmful products, for some of these drugs, more than 100 million prescriptions have been issued prior to being withdrawn from the market. As the world of health care continues to see an increasing trend in the number of both OTC and prescription drug recalls, it is imperative that pharmacists familiarize themselves with the FDA recall process.

By definition, a drug recall is the action taken by a manufacturer to remove a defective or harmful drug product from the market after discovering that the drug is in violation of laws and regulations administered by the FDA. It is important to note that a recall is a voluntary action taken by a pharmaceutical company. Although the FDA can request that a drug regulated by the agency be recalled, the decision is ultimately left in the hands of the manufacturer. Recently, Democratic Rep. Rosa DeLauro of Connecticut reintroduced the Recall Unsafe Drug Act in the House. If passed, this would grant the FDA mandatory drug recall power over manufacturers. The FDA’s role in the recall process focuses on assessing the appropriateness of the recall, classifying the recall, and overseeing a company’s response and strategy. There are 3 ways to classify a recall: class I, II, or III. A class I recall is related to a product whose use could result in death or serious harm to the patient. Although a class II recall is not as severe as class I, there is still a notable risk and threat to the patient. Class III recalls are the least likely to cause adverse events in patients but violate the FDA’s labeling or manufacturing laws, leaving the drug unfit for the market.

After a drug recall has been initiated, the pharmacy may be contacted by a variety of sources, including boards of pharmacy, compounding pharmacies, drug manufacturers and wholesalers, outsourcing facilities, the state health department, and even the FDA. Only if the drug is considered widely distributed will the FDA heavily use social media platforms to provide the public with continuous information and updates regarding the recall. Unfortunately, these announcements may go unnoticed or may not be fully understood by the public. Thus, following the announcement of a recall, pharmacists should help notify all affected personnel, including patients, pharmacy staff members, and prescribers. Additionally, all automated dispensing cabinets, floor-stock inventory, and medication storage areas should be inspected to ensure that the recalled product is removed and properly disposed of per the instructions of the notice. To demonstrate compliance, pharmacies should document all recall activities. Information regarding actions taken and the dates should be documented.

With the growing number of drug recalls, pharmacists can expect to see an increase in questions from concerned patients about the nature of the recall and how it may affect them and their medications. Recently, popular medications, such as ranitidine (Zantac), a medication used to treat acid reflux, and specific lots and manufacturers of the generic version of angiotensin receptor blockers, medications used to treat hypertension, have been recalled. As more patients continue to be affected by drug recalls, the fear of non-adherence and poorly managed disease states increases. Therefore, it is crucial that pharmacists remain educated and informed regarding the latest drug recalls to best assist patients. Resources such as the FDA’s free recall notification subscription services and website, are valuable tools to help keep pharmacists ready to answer patient questions. Pharmacists can help patients confirm if their medications have been affected and what the appropriate course of action is. Although some medications may be safe for patients to stop immediately, abruptly stopping others could be life-threatening. Counsel patients individually regarding the status of the medication in question.

Drug recalls have been on an alarming rise over the last several years.
Between January 2013 and October 2018, pharmaceutical companies across the world recalled about 8000 medications, and the number will likely continue to increase, according to a Kaiser Health News report.

As more widely used medications are recalled, up to 81 % of consumers in the United States have been affected. As key health care providers, pharmacists can help keep patients alert and informed regarding the latest drug recalls, while mitigating potential compromises to patient care. Thus, pharmacists should strive to frequently monitor for new drug recalls and review the FDA’s drug recall process.

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