There has recently been an increase in the number of on-site visits to health care facilities by Food and Drug Administration (FDA) inspectors to validate several recent drug recalls. The inspectors are looking for specific lot numbers based on a facility's purchase history. In this post, we'll share some brief background on recalls and tips to help hospital pharmacies comply with medication recall procedures.
A recall is an action taken when a product is found to be in violation of laws and regulations administered by the FDA. Medications may be recalled for a variety of reasons including safety, mislabeling, contamination and deviations in strength or potency. Recalls may be conducted by a voluntary action by the manufacturer/supplier, by request from the FDA, or by a legally mandated order from the FDA. There are three recall classifications:
- Class I: products that could cause serious health problems or death;
- Class II: products that may cause a temporary or reversible adverse health problem or where the probability of a serious health problem is remote; and
- Class III: products that are unlikely to cause any adverse health problems but violate FDA manufacturing or labeling laws.
Pharmacies are notified of recalled medications from a variety of sources including drug manufacturers, compounding pharmacies, outsourcing facilities, drug wholesalers and other vendors, and government agencies such as the FDA, state departments of health, and boards of pharmacy. The FDA has a Web site that lists all recalls: www.fda.gov/Safety/Recalls/default.htm. The FDA also has a free subscription service that notifies subscribers of recalls: http://go.fda.gov/subscriptionmanagement.
When a notification is received, pharmacy staff needs to communicate the recall information to prescribers and staff who dispense or administer medications. Common methods include e-mail notices, memos, staff meetings and posters/flyers in medication rooms. Review dispensing records and medication sample logs to identify patients taking the recalled product. When required by law and regulation or organizational policy, patients must be notified of medication recalls.
Identification and Removal of Recalled Medications
When a recall notice is received, the pharmacy must determine if any of the affected product or preparation is present in the organization by inspecting medication storage areas, reviewing automated dispensing cabinet stock lists and facility-approved manual floorstock lists, purchasing records and medication sample logs.
All areas where medications are stored and used, including outpatient areas, must be inspected, even areas that obtain medications from sources other than the pharmacy department. Particular attention should be given to ancillary areas (e.g., imaging and procedural areas), clinics (including off-site locations), and hospital-owned physician practices.
All recalled medications must be promptly removed and returned to the pharmacy or other departments, as directed by the manufacturer, for proper disposition. Recall notices should contain specific instructions. Continue to monitor incoming shipments of medications from vendors to ensure that no recalled product is received.
Storage and Disposition of Recalled Medications
Upon removal from storage areas, quarantine recalled medications in a designated area in the pharmacy while awaiting disposition. Post a sign or label in the area such as "Recalls - Do Not Use."
Recalled products must be disposed of according to instructions outlined in the recall notice. In most cases, recalled medications are returned to the wholesaler or manufacturer. In addition, any documentation required by the recall notice must be completed and submitted (e.g., manufacturer's inventory notification form).
Documentation of Recall Activities
Documentation of recall activities is important for demonstrating compliance with recall notices. Federal regulations require manufacturers to report not only the quantity of recalled product returned, but also the number of receivers of the product that respond and those that do not. The FDA can request the identity of non-responding organizations, which may lead to an inspection.
Various government agencies conduct inspections to monitor compliance, including the FDA, boards of pharmacy, and state departments of health. Fines may be levied if noncompliance is found. In addition, surveyors from the Centers for Medicare and Medicaid Services (CMS) and accrediting organizations (i.e., The Joint Commission, DNV GL - Healthcare, American Osteopathic Association - Healthcare Facilities Accreditation Program and the Center for Improvement in Healthcare Quality) may ask for this documentation during surveys.
To demonstrate compliance, maintain appropriate records including copies of the recall notice and documents submitted to the supplier as well as documentation of recall activities. The records must be retained according to law and regulation and the organization's document retention policy. The following information should be documented for each recall:
- Date notified
- Date(s) action taken
- Action(s) taken including areas inspected; quantities removed; notification of shipment to wholesaler/manufacturer; notifications to prescribers and staff and other actions required by the recall notice, law or regulation, and organizational policy.
Tips for Recall Compliance
- Develop a checklist with all steps needed to conduct a recall so that any staff member can perform the recall procedures and steps are not forgotten.
- Ensure the pharmacy buyer staples the packing list to the wholesaler/supplier invoice. This will assist in tracking and retrieval of recalled medications.
- Identify all areas where medications are stored and used. Be sure to include outpatient areas, as well as any off-site locations such as clinics and hospital-owned physician practices.
- Maintain current lists of medication stocks in each area including medications in automated dispensing cabinets (ADCs).
- Implement a standard process for requisitioning floor stock that ensures pharmacy has knowledge of all medication locations and quantities in the event of a recall.
- Maintain dispensing logs for medication samples that include recording the lot numbers.
- Include checks for recalled medications in the medication area inspections.
- Check with state laws, the applicable accreditation agency standards, and organizational policies that may include the notification of patients currently using a recalled medication.