Published: June 2010
Publications
Medicine Recalls
Prescriber Update 31(2): 17
June 2010
This article outlines the medicine recall process in New Zealand and how to obtain information about specific recalls.
The Recall Process
Most recalls are initiated by a medicine supplier in response to information suggesting there is an issue relating to the quality of one or more batches of their product.
Where a recall may be required a risk assessment is performed by Medsafe and appropriate action is agreed upon with the supplier. When it is known where the affected product has been distributed, a recall will be conducted targeting only those organisations who have received affected supplies of the product. A recall may be to wholesaler, retail/hospital, healthcare professional or consumer level.
Every New Zealand manufacturer, supplier and wholesaler must have a pre-determined system for recalling a medicine. All recalls must be carried out with the knowledge and consent of Medsafe and in accordance with the Code of Good Manufacturing Practice (GMP) part V which deals with the conduct of recalls. The Code is available for download at no cost from the Medsafe website at: www.medsafe.govt.nz/safety/RecallCode.pdf.
Once a recall has been agreed, the supplier submits a draft recall letter to Medsafe for approval. A template for recall letters is included in the Code of GMP. The recall letter must include the following information:
- The reason for the recall.
- The health risk associated with the issue (if known).
- A clear indication of the action required.
- The need to immediately quarantine and prevent further use of the medicine.
- The procedure to be followed in returning the medicine.
- An acknowledgement form to be returned confirming the letter has been received and acted on.
The supplier will then arrange to send the letter by fax or, depending on the circumstances, Medsafe may agree to another form of distribution. Any recalls conducted by telephone must be promptly followed up by written confirmation.
When a medicine needs to be recalled down to consumer level a supplier is expected to notify wholesalers, retailers and health professionals prior to a notice appearing in newspapers.
Healthcare Professional Responsibilities
The prompt return of recall acknowledgement forms by healthcare professionals is very important, even if no affected stock is held. These forms demonstrate that those who may have affected stock have been informed of the recall. This also allows the company to monitor how effective the recall was and take further action if required.
Once the supplier has completed the recall process (usually between six weeks and three months) a final report is provided to Medsafe. This report includes a summary of the actions taken, the response from healthcare professionals, and details of any action taken to prevent the issue happening again. Actions may include changes to how the product is manufactured.
Further information on the recall process can be obtained from the Compliance Management Branch at Medsafe (Ph 04-819-6800). Information about specific recalls is available on the Medsafe website at: www.medsafe.govt.nz/hot/RecallActionNoticesNew/RecallsActions.asp
