Ask The Pharmacist: Understanding the Different Types of Drug Recalls
Spencer Sherman, Pharm.D.
Clinical Pharmacist, Pharmacy Solutions
What are the different types of drug recalls?
Drugs can be withdrawn from the market for a number of reasons, ranging from minor labeling errors to the potential risk of severe health consequences. The process behind these recalls are diverse but essential for safeguarding public health. Recalls are classified based on the severity of the threat posed and can be either conducted voluntarily by the pharmaceutical company or enforced by the Food and Drug Administration (FDA).
Pharmaceutical companies may initiate a preemptive withdrawal of affected drugs, known as a voluntary recall, upon identifying a problem. This action underscores a company’s legal and ethical duty to prevent harm to consumers. For instance, in May 2023, Family Dollar voluntarily recalled specific lot numbers for their brand of Advil after it was found that the drugs were stored at unsafe temperatures during distribution, demonstrating the company's responsibility to protect public health.
However, not all recalls are initiated by the drug manufacturers themselves. The FDA plays a pivotal regulatory role in protecting public health, enforcing recalls when deemed necessary. Upon receiving a report of a drug issue, the FDA performs a health hazard evaluation, considering factors such as the number of reported illnesses or injuries, the severity of potential adverse effects and the likelihood of harm. Following this assessment, the recall is classified into one of three categories:
Class I: Represents the most critical recall level, designated for situations where a drug poses a significant risk of serious health issues or death. Class I recalls typically garner extensive media coverage.
Class II: This category is for recalls where there is a potential for temporary or medically reversible adverse health effects, but the probability of serious consequences is low.
Class III: The least severe category, indicating situations that are unlikely to lead to adverse health effects.
The FDA outlines the necessary actions in their recall announcements, including instructions for patient contact regarding returns or replacements. Patients are usually advised to communicate directly with the manufacturer. The recall classification dictates the percentage of affected patients that need to be notified, a task that can be undertaken by the dispensing pharmacy, the manufacturer or an external party.
The urgency of the recall often determines whether replacements are offered. Typically, manufacturers are responsible for providing these replacements. If not, the dispensing pharmacy may step in to facilitate the replacement process and later seek reimbursement from the pharmaceutical company. This ensures patients maintain access to essential medications without incurring the cost of the recall.
Whether initiated voluntarily by manufacturers or enforced by the FDA, recalls are a testament to the joint efforts to prioritize and safeguard public health.
Enlyte Pharmacy Solutions monitors drug recalls and when a recall impacts our clients, we strive to provide them with valuable information in a timely manner. If you have questions or concerns regarding drug recall information, please contact your Account Manager.
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References:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts