How to deal with a drug recall in pharmacy

Flaws in the manufacturing process can cause some drugs to be contaminated, ineffective, or labeled incorrectly. Overlooked quality control processes can then cause these drugs to slip through the cracks and be dispensed. Patients who take one of these drugs could end up being harmed or getting an incorrect product. For some patients, experiencing a serious adverse event from a drug can be a harrowing, or even life-threatening, event.

To prevent potential adverse events and protect public health, the FDA has implemented drug recall processes to obtain, replace, and dispose of defective, incorrectly labeled, or ineffective drugs. Drug recalls that can potentially affect patients are quite common in the United States: They occur around once per month. As a common touchpoint of care for patients, pharmacists are in a key position to alert patients of a pharmacy recall and facilitate the proper disposal of any drugs in question.

Continue reading to learn more about how to handle drug recalls and address the concerns of affected patients. 

Handling drug recalls in the pharmacy

Drug recalls are often voluntarily carried out by drug manufacturers. However, in many cases, the FDA requests or mandates that a drug is recalled. All pharmacies should seek to comply with medication recall procedures in accordance with the FDA. Having a written pharmacy drug recall policy and procedure document in place for all staff members can help ensure a smooth process, especially if an FDA inspector decides to verify any recalled drugs at your pharmacy.

There are three classes of recalls:

• Class I: The drug can cause serious complications or death.
• Class II: The drug has the potential to cause reversible or temporary health problems, although there is still a risk of significant harm. 
• Class III: The drug is not likely to cause harm to a patient’s health but may have defects in labeling or packaging.

Alerting patients of drug recalls

Drug manufacturers usually alert and notify patients directly, often before reaching out to pharmacies. In severe cases, the FDA may use social media to alert the public of any major drug recalls. Pharmacies can often learn about drug recalls through drug manufacturers, drug wholesalers, state boards of pharmacy, and other organizations. In addition, pharmacies can check for updates on medication recalls through the FDA Enforcement Reports, which are published on a weekly basis. 

Drug recall information and updates can also be found or searched for using the FDA recall search tool. The FDA also allows anyone to sign up for their email subscription service for recalls. 

Removing, storing, and disposing of the recalled drug

After receiving a drug recall notification, the pharmacy staff should go through the existing inventory to see if the recalled drug is in stock. The pharmacy should then contact all patients who may be affected and any healthcare providers that may be dispensing the medication. Pharmacists can identify the batch number of the recalled drug and compare it to the batch numbers dispensed to patients to determine who might be affected. Pharmacies can also notify any potentially affected patients when they pick up prescriptions. 

Recalled drugs can be stored in containers or bins designated as “Do Not Use – Recalled Drugs.” Recall notices may contain specific information for the disposal or return of the drug to the manufacturer or wholesaler. Pharmacies should stay alert for any new updates or notifications regarding the medicine recall and alert their patients as needed.

Documenting the drug recall

The drug recall notice from the drug manufacturer will indicate any documentation that needs to be completed. It is essential to document all activities related to the drug recall, including how much of the recalled drug was returned and how many patients responded to the drug recall notice. 

The FDA may send inspectors to pharmacies to verify that drug recall notices were received and taken care of. Refer to your state’s law requirements or your company’s drug recall policy to determine how and for how long to maintain records of activities related to drug recalls. 

Addressing patient concerns 

Patients may report adverse effects from a recalled drug to their pharmacist, doctor, or other healthcare providers. Patients and healthcare providers can also report any adverse effects directly to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

If the drug recall is unlikely to cause harm to the patient, the pharmacist can instruct the patient to continue taking the drug as normal. If the recall warrants the discontinuation of the drug by the patient, the pharmacist should take steps to replace the drug with one from an unaffected batch. The patient should not stop taking their medication without consulting with a healthcare provider to prevent any unnecessary disruptions in treatment.

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Bottom line

Pharmacists and pharmacy staff members are responsible for protecting the health and wellbeing of their patients. Policies and procedures should be set in place to outline the steps for executing a drug recall. After receiving a drug recall notice, pharmacists should reach out and alert patients as soon as possible. Notifying patients and properly disposing of recalled drugs can help prevent adverse events.

Patients may also have concerns about the effects of drug recalls. Counseling patients on the right actions depends on the severity of the recall. The FDA offers several tools for pharmacies to stay up-to-date on drug calls and notify their patients as necessary.