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The Food and Drug Administration (FDA) enforces standards for prescription medications, medical devices, and vaccines through the recall process. This process ensures that drugs and other medical products are safe and efficacious. Pharmacists can optimize healthcare outcomes by staying up-to-date on FDA recalls, sharing information with other healthcare professionals, and sharing information with their patients. This activity reviews the procedures and implications of FDA recalls and highlights the responsibility of the interprofessional team in sharing such information. Objectives: Describe the impact of FDA drug recalls on the healthcare system. Describe the different categories of FDA recalls and list examples of each. Explain how pharmacists can access reliable information regarding FDA recalls and contribute to such data. Describe the interprofessional teamwork between pharmacists and physicians managing patients affected by recalled products. Access free multiple choice questions on this topic.

FDA recalls have a significant financial toll on the healthcare system. Clinically important drug recalls occur approximately once per month in the United States. Illustrating the financial cost of recalls, Johnson and Johnson lost approximately $600 million in sales after closing a distribution site due to a recall. Moreover, the toll on human life has been substantial. A striking example is the New England Compounding Center recall of injectable corticosteroids contaminated with fungal strains. The product caused 751 reported cases of fungal meningitis and 64 deaths. Historically, this incident was significant: it triggered a transfer of regulatory authority over compounded products from state pharmacy boards to the FDA.[1] Another infamous recall occurred in 2012 when Pfizer recalled approximately 1 million packs of birth control pills due to incorrect packaging.[2] The top recall causes are incorrect labeling, defective products, and incorrect potency. Common examples of contaminants that cause drug recalls were other drugs, heavy metals, bacteria, or fungi.

Healthcare providers, including pharmacists, must understand their legal and professional responsibilities regarding recalls. Pharmacists are strongly encouraged, but not required by law, to report adverse drug reactions to the FDA. With certain vaccines, however, there is a legal obligation.[15] Providers play a key role in improving public health when they opt to report adverse events. By educating themselves about potential adverse drug effects, monitoring them in patients, and reporting events to the FDA, pharmacists, and physicians protect public health. The scientific vetting process for new drugs is extremely rigorous in the United States; however, the system still relies on physicians to detect adverse reactions that might be undiscovered in clinical trials. Unfortunately, adverse reactions are underreported by clinicians.[15] Drug manufacturers often notify consumers automatically of a recall before pharmacies are notified. Notices are sent to all consumers of the recalled medication without regard to specific batches affected. Thus, pharmacists should be prepared to answer patient questions concerning recalls. By comparing the batch number of a patient’s medication to the batch numbers involved in the recall, pharmacists can identify whether their specific patient’s medication was affected. The best resource for pharmacists to obtain the most current information regarding FDA recalls, including specific batch numbers affected, is the FDA Enforcement Report Index. This resource is free online and is updated weekly.

Drug manufacturers often notify consumers automatically of a recall before pharmacies are notified. Notices are sent to all consumers of the recalled medication without regard to specific batches affected. Thus, pharmacists should be prepared to answer patient questions concerning recalls. By comparing the batch number of a patient’s medication to the batch numbers involved in the recall, pharmacists can identify whether their specific patient’s medication was affected. The best resource for pharmacists to obtain the most current information regarding FDA recalls, including specific batch numbers affected, is the FDA Enforcement Report Index. This resource is free online and is updated weekly. If a patient’s medication is among the affected batches, the pharmacist should learn the reason for the recall. If the recall is due to something benign—for example, the drug container has a defect that does not impact the chemical quality of the medication—the pharmacist should inform the patient of this and counsel them to continue taking the medication as usual. If the recall justifies the patient stopping their medication, the pharmacist can help them obtain their medication from another manufacturer. If a patient’s medication was not among the affected batches, the pharmacist can reassure the patient and counsel the patient to continue taking the medication as usual. This communication is vital because it prevents patients from needlessly stopping their medication. The pharmacist can also share their decision with the patient’s primary care provider to avoid future confusion. Another resource providers can direct their patients to is the FDA Adverse Events Reporting System (FAERS). Consumers, pharmaceutical companies, and providers can all report complaints and adverse events to the FDA Adverse Event Reporting System (FAERS). This FDA maintains FAERS as a free, user-friendly system for online searching by the general public. Thus, it is a useful resource for patients.[1]

If a patient’s medication is among the affected batches, the pharmacist should learn the reason for the recall. If the recall is due to something benign—for example, the drug container has a defect that does not impact the chemical quality of the medication—the pharmacist should inform the patient of this and counsel them to continue taking the medication as usual. If the recall justifies the patient stopping their medication, the pharmacist can help them obtain their medication from another manufacturer. If a patient’s medication was not among the affected batches, the pharmacist can reassure the patient and counsel the patient to continue taking the medication as usual. This communication is vital because it prevents patients from needlessly stopping their medication. The pharmacist can also share their decision with the patient’s primary care provider to avoid future confusion. Another resource providers can direct their patients to is the FDA Adverse Events Reporting System (FAERS). Consumers, pharmaceutical companies, and providers can all report complaints and adverse events to the FDA Adverse Event Reporting System (FAERS). This FDA maintains FAERS as a free, user-friendly system for online searching by the general public. Thus, it is a useful resource for patients.[1] The Recall Alert System is a mechanism designed for the FDA to communicate with providers regarding recalls, but it frequently fails to do so. For 20% of Class I recalls (the most severe category of recalls), the FDA failed to utilize the Recall Alert System or MedWatch in one study. Rather than an exhaustive list of all available recall information, MedWatch is a summary of severe reactions that a provider would not anticipate based solely on current labeling. An adverse event is considered serious if it fatal, life-threatening, requires hospitalization, causes a congenital anomaly, or if medical or surgical intervention was needed to avoid permanent consequences.[15] This failure of reporting further emphasizes the importance of pharmacists consulting the FDA Enforcement Report Index.