Health Canada has recently communicated separate type 1 drug recalls for propranolol and quinapril hydrochloride/hydrochlorothiazide. In both cases, the recall was issued due to a nitrosamine impurity. Recalls related to this type of impurity have been ongoing since 2018 and Health Canada continues to work with manufacturers to resolve these issues. Recalls in Canada are classified by degree of health hazard with type 1 posing the most risk to patients using these medications.
From a pharmacy perspective, staying informed and up to date on recalls is critical to ensure your drug inventory is safe. When recalls happen, every pharmacy needs a plan on how to quickly and efficiently deal with them to minimize risk to their patients.
What are my responsibilities?
Licensees
Every licensed pharmacy should have policy and procedure in place that directs the pharmacy team on how to identify and take action on recalled drugs. The pharmacy licensee needs to develop and maintain this policy. The policy should include
- awareness of how recall notices are delivered to the pharmacy and whose responsibility it is to act on them;
- an explanation of what the various levels of recalls mean, and what the potential risk to patients is;
- a description of which computer reports, or other means, can be used to identify patients that are affected by the recall;
- the actions required to be taken for return of recalled medications; and
- a recall log that documents recall activities including pharmacy/patient contact and required follow-up.
Pharmacists
Pharmacists need to assess patients affected by the recall and interpret their relative risk. Pharmacists should provide patients with advice and direction to ensure patient health is not affected. This may include referral back to the original prescriber or prescribing an alternative medication of the patient.
Pharmacy technicians
Pharmacy technicians can support the process by handling the technical aspects of the recall including contacting patients, creating a log, and collecting and returning or disposing of the drug as required.
It is the responsibility of every member of the pharmacy team to familiarize themselves with the drug recall policy and understand their role in managing drug recalls.
