Understanding Pharmaceutical Recalls, Key Players, and Their Roles

Pharmaceutical Recalls

The United States Pharmacists defines a recall as “an action executed by a manufacturer at any time to remove a defective or harmful drug product from the market when the drug is discovered to be in violation of laws and regulations administered by the FDA.”

According to a publication by StatPearls, FDA recalls have widespread implications on the healthcare system, including an extensive financial burden. On average, the FDA recalls one clinically significant drug per month in the US. Despite common misconceptions, market withdrawals cannot be mandated by the FDA directly. Instead, the FDA typically will request that a company issues a recall. Assuming the manufacturer refuses, the FDA can pursue legal action to prevent the product from remaining on the market.

Researchers in StatPearls explained, “This legal action is pursued via the Food, Drug, and Cosmetic Act. An injunction is issued to halt further manufacture or distribution. The FDA can directly and unilaterally demand the removal of medical devices, but it cannot do the same for medications. However, both medical devices and medications are typically recalled by the manufacturers voluntarily. The FDA issues drug recalls — more precisely thought of as requests for drug recalls — through the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).”

Reasons for a drug recall can vary dramatically from mislabeling to contamination and adverse side effects. There are two pathways of FDA recall, voluntary and legally mandated. The vast majority of FDA recalls are voluntary by manufacturers after identifying an issue or a concern or after the FDA raises a concern. The US Pharmacist notes that the FDA’s primary role in the procedure is to supervise the recall strategy and confirm that it is in line with expectations.

Classifications

There are three classes of recalls, class I, II, or III, with class I considered the most dangerous and life-threatening. Class I recalls are issued for products that can cause severe, irreversible, adverse side effects or death. Class II recalls are indicated for product errors that can cause reversible side effects or have a small probability of adverse events. Finally, class III recalls are usually issued for concerns that are not harmful such as packaging issues. Many may even refer to class III recalls as benign, emphasizing that they are often given for the sake of caution rather than for any adverse effects.

Health Hazard Evaluation

According to the FDA, the organization often uses a health hazard evaluation (HHE) to classify a recall as class I, II, or III. An HHE considers many factors, including the following:

• current disease or injury caused by the product
• the impact of existing conditions on the severity of the health hazard
• how the adverse effects impact various populations — such as children, elderly patients, and so on
• the severity of the hazard
• the probability of the hazard occurring
• the long- and short-term consequences

Key Players and Their Roles

Many vital stakeholders have legal, ethical, and professional obligations to report issues that could result in a recall. In addition, once a recall is initiated, these key players have additional commitments throughout the process. The FDA, manufacturers, pharmacists, and other healthcare professionals are key players.

The FDA

As previously mentioned, the FDA does not have the authority to force a recall — outside of taking legal action. However, the prominent roles of the FDA in the recall process involve monitoring, including initiating voluntary and non-voluntary recalls, formalizing the recall, identifying the recall strategy, classifying the recall, notifying healthcare professionals and the public, auditing the recall, and determining when to terminate the recall.

While the FDA’s leading roles include supervising or monitoring the recall, it may intervene with regulatory action in cases where the manufacturer refuses a recall or the FDA determines that a manufacturer is not effectively implementing recall procedures.

According to the FDA Regulatory Procedures Manual, “FDA-regulated firms may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, as statutorily mandated or as ordered by FDA.”

Manufacturers

The next critical player in the recall process is the manufacturers, who often initiate a voluntary recall. Voluntary recalls or recalls initiated by the manufacturer — commonly referred to as firm-initiated recalls — can be based on any reason or circumstance.

In the case of a firm-initiated recall, the FDA requires that the firm shares the product identity, the reason for removal, a risk evaluation, the number of products produced or the period of production, the number of products distributed, distribution information, recall communications, recall strategy, and the main point of contact.

Recall Strategy

The recall strategy is multifaceted, as many considerations and components play a role. Determining a recall strategy begins with a review of the HHE, among other evaluations. The plan should address multiple aspects of the recall, such as the depth of recall, public warnings, and efficacy checks.

The depth of recall determines whether the recall includes choosing whether the recall hazard warrants recall at the consumer, retail, or wholesale level. Public warnings, used to inform others of the recall, can be issued to the general public via national or general news media, or they can be given through specialized news outlets for healthcare professionals. The type of public warning typically depends on the severity of outcomes, recall depth, and additional factors.

Finally, the recall strategy will also include effectiveness checks to confirm that all the appropriate parties have been notified of the recall.

Pharmacists

Community and clinical pharmacists are encouraged based on ethical and professional responsibility — while often not required by law — to report any adverse reactions to the FDA.

Additionally, they may be encouraged to educate and inform patients about recalls; however, manufacturers often notify consumers of recalls. Despite knowledge of a recall reaching most patients relatively quickly, pharmacists — like many other healthcare providers — are responsible for answering questions about recalls and alleviating patient concerns.

Pharmacists are also responsible for advising patients on how to move forward after a recall. Depending on the recall classification or cause, pharmacists may have varying advice. For class III recalls that would not impact the medication or device quality and efficacy, pharmacists may advise patients to continue taking the drug but closely monitor updates. More severe recalls will warrant discontinuing medications; however, pharmacists can often provide insight on where to obtain medicines from another manufacturer. Pharmacists are strongly urged to communicate with a patient’s primary care provider — or other medication prescribers — to discuss alternative options and processes.

Below is a graphic from the US Pharmacist outlining ideal pharmacist roles throughout a drug recall.