As drug recalls become more common, pharmacies should ensure they are prepared to effectively manage them and minimize risk for patients and their business.

More importantly, policies and procedures should spell out, in detail, your pharmacy’s recall process and steps each staff member should take in accordance with your plan.

Compounded Medications

For compounding pharmacies, a drug recall usually results from one or a combination of the following situations:

• Chemical source recall: Your chemical sourcing company recalls a lot of an active pharmaceutical ingredient (API) or excipient for one or more reasons.
• Company finding: Through the pharmacy’s own routine testing program, a preparation lot does not meet one or more of the specifications established for the product.
• Patient complaints: Often a problem is discovered after the pharmacy receives complaints from customers. Most complaints are tied to an odd odor, poor visual quality of a preparation, or an unusual feel of a preparation, if topical.
• FDA observation: Recalls can also be the result of an observation made during an inspection by the U.S. Food and Drug Administration (FDA). Significant compliance deficiencies noted by the FDA may require your pharmacy to recall some or all of its preparation lots.

Notifying Patients, Clinicians

If a compounded product prepared by your pharmacy was compounded incorrectly, injured a patient, or needed to be recalled for other reasons, all patients and clinicians who received or prescribed the preparation must be notified, usually within 24 hours.

Recall Process Tips for Compounded Medications

• A list of all affected preparation lot numbers and prescriptions should be compiled using data from your compounding records, prescription records, testing results, and/or hard copy files.
• For separate dispensing/labeling systems: If your pharmacy uses a comprehensive software system to house compounding records that captures lot numbers/expiration dates via barcode scanning, ensure there is also a mechanism for locating the prescription number attached to the same compounding record. The two must be linked in some fashion.
• If your pharmacy creates compounding records manually, you will need to comb through each one by hand to locate affected recalled component lot numbers. You’ll need to do the same to tie these records to the dispensing system’s prescription number.
• Remember to include stock solutions or “subformulas.” Subformulas, with their own series of ingredient lot numbers, should be linked back to the prescription and ultimately the patient.
• Once all patients who received the affected preparation are notified and steps are taken to retrieve and/or replace the medication (if applicable), a formal recall letter should be written, detailing the nature of the recall, affected lot numbers, and dates of dispensing.
• The pharmacist will ensure that all dispensed affected preparations are accounted for and no patient is harmed.
• Recalls will be reported to governing bodies in accordance with applicable laws and regulations.
• To ensure pharmacy staff is prepared to handle drug recalls, training based on mock recalls should be conducted periodically. All new staff should also be trained on your recall process.

Here for You

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