Published: 6 September 2018

Publications

The Medsafe Files – Episode Seven: Medicine Recalls

Prescriber Update 39(3): 44–45
September 2018

Key Messages

  • A medicine recall is the removal of affected medicinal products from supply or use, when there are issues or deficiencies concerning their safety, quality or efficacy.
  • Companies supplying medicines (known as ‘Sponsors’) are responsible for carrying out recalls. Contact the sponsor for any questions relating to a recall.
  • Medicines may be recalled to the wholesale level, hospital/laboratory level, healthcare professional level, pharmacy/retail level or consumer level.
  • Those involved in a recall should follow the instructions provided by the sponsor conducting the recall.
  • Medsafe publishes a list of medicine recalls on the Medsafe Online Recall Database (MORD).
  • All consumer-level recalls are also published on the Ministry of Business, Innovation and Employment’s Product Recalls website.

Purpose

A medicine recall is the removal of affected medicinal products from supply or use, when there are issues or deficiencies concerning their safety, quality or efficacy1.

Sponsors are responsible for carrying out recalls in New Zealand

‘Sponsor’ is the term used for the person or organisation that is legally responsible for a medicine in New Zealand. This may be a New Zealand manufacturer, supplier or importer1.

Sponsors are responsible for identifying potential issues with their medicines, assessing the risks of any identified hazards and mitigating those risks. The overall responsibility for medicine recalls lies with the sponsor and any questions relating to a recall should be addressed to the sponsor1.

Medsafe’s role in the recall process is to ensure that the right decisions are made and that appropriate actions are taken. For example, Medsafe approves the sponsor’s recall procedure and recall letters, to ensure the potential for patient harm has been minimised.

Levels of recall

Medicines may be recalled to the wholesale level, hospital/laboratory level, healthcare professional level, pharmacy/retail level or consumer level.

The principal factors when determining the level (or depth) of a recall action are the significance of the risk to the consumer, and the medicine’s distribution channels. In certain circumstances, where a medicine has only been supplied to a limited number of known customers, a recall may be limited to those customers only1.

Responsibilities of healthcare professionals

Healthcare professionals have an ethical and professional obligation to safeguard their patients in any recall action. The healthcare professional may delegate these tasks to a competent person but should remain vigilant for clinical repercussions1.

Carefully read any recall letters and take the appropriate actions in response to the notification. If there is an acknowledgement form included with the recall letter, promptly return it to the sponsor to assist with the stock reconciliation process.

Where an affected medicine has been supplied to another organisation (eg, a nursing home), advise that organisation of the recall action and inform the sponsor conducting the recall1.

Phases of activity during a recall1

Phase 1: Initiation

The sponsor investigates and scopes the issue, conducts a hazard/risk assessment, formulates a recall action plan and consults with Medsafe.

Phase 2: Implementation

The sponsor is responsible for notifying and carrying out the recall action to the agreed level.

Medsafe monitors the recall action process to ensure that it is carried out in an effective and timely manner by reviewing progress reports provided by the sponsor.

Phase 3: Review

The sponsor reviews the effectiveness of the recall action and decides whether a follow-up recall action is necessary.

This phase includes identifying the root cause of the issue and assessing whether the corrective actions proposed/implemented by the manufacturer/sponsor are likely to manage the risk of the same issue recurring.

Medsafe also reviews corrective actions and determines whether it is appropriate for the medicine to be supplied to the market in the future.

For more information

New Zealand Medicines and Medical Devices Recall Code

This document provides principles and general guidance to sponsors, wholesalers, retailers and healthcare professionals on the effective conduct of recall actions, including an outline of their roles and responsibilities (available at www.medsafe.govt.nz/safety/RecallCode.pdf).

Medsafe Online Recall Database (MORD)

MORD provides summary information on all medicine recall actions initiated in New Zealand since 2012 (available at www.medsafe.govt.nz/hot/recalls/RecallSearch.asp).

Product Recalls website

The Product Recalls website (www.recalls.govt.nz) publishes recalls from the Ministry of Business, Innovation and Employment, the New Zealand Transport Authority and Medsafe (consumer-level recalls for medicines). It also links to the Ministry for Primary Industries for recalled food products.

References
  1. Medsafe. 2015. New Zealand Medicines and Medical Devices Recall Code. URL: www.medsafe.govt.nz/safety/RecallCode.pdf (accessed 17 July 2018).
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