Guidance on How to Handle Drug Recall in a Pharmacy

The Food and Drug Administration, despite its lengthy approval and screening processes, is sometimes forced to recall medications it has previously approved. There are three classes of recall to delineate the severity of the nature of the recall. By far the most serious is Class I, where the medication is believed to cause serious harm to patients, including possible death.

Recall Procedures for Retail Pharmacies

• In the event of a medication recall, the FDA or the manufacturer has the responsibility to notify all pharmacies and locations that have the product in question.

  Upon receipt of the recall notification, pharmacy staff should immediately inspect and remove all stock from shelves, refrigerators and freezers.

  The pharmacy should place the recalled medication in a designated area or container, and depending upon the instructions set forth in the recall notice, either return the drug or dispose of it in accordance with disposal laws.

  Staff is encouraged to document all actions taken.

  Of special note, it is the responsibility of the prescribing physicians to notify patients currently taking the recalled medication, if treatment is to be discontinued or altered.

  Once all appropriate steps are taken, the pharmacy should (in a manner predetermined by the recall notice) notify the FDA that it has completed the removal of the recalled drug.

Recall Procedures for Hospital Pharmacy

• All hospital staff is to be notified of the recalled drug.

  This information should be immediately entered into the hospital's medication management system as an alert and immediately removed from the hospital's formulary.

  Physician practices, if associated with the hospital pharmacy, shall be notified as well. It is up to the prescribing physician to determine whether or not patients should be notified to discontinue or modify treatment.

  Pharmacy staff should inspect all possible storage areas, i.e. stock, patient care areas, medication stations, emergency supplies, patient cassettes, patient storage units within hospital rooms and floor stock.

  Depending on the instruction outlined on the recall notice, the recalled medication should be disposed of or quarantined in a designated area until further instructions from the FDA or manufacturer are received.

  The pharmacy should document and file all actions taken to remove the recalled medication.

  The Joint Commission, a healthcare accreditation firm, has made recall procedures a requirement for all accredited hospitals. Failure to comply with this requirement can jeopardize a hospital's accreditation and as a result, its reimbursement rates.

Regulations

• The Food and Drug Administration regulates all recall actions. From time to time, a manufacturer will initiate a voluntary recall. In that case, the same steps should be taken.