Published: June 2010

Publications

Medicine quality complaints

Information on this subject has been updated. Read the most recent information.

Prescriber Update 31(2): 18
June 2010

Complaints relating to the quality of medicines are reported to Medsafe by Consumers, Pharmacists, Wholesalers, Prescribers and the Pharmaceutical Industry.

Complaints are received for a wide range of issues. Examples of complaints reported to Medsafe include:

• Inactive tablets found in the active blister pockets of an oral contraceptive. This complaint led to a product recall.
• Inconsistent viscosity in an antibiotic suspension. This complaint led to the supplier changing the bottle to provide more headroom for shaking.
• Foreign particles found in antibiotic powder for suspension. This complaint led to a product recall.

Complaints may also relate to a labeling error, a crumbling tablet, a break in the cold chain, or identified failures of the product to meet specification.

When an issue relating to the quality of a medicine is identified, it should be reported promptly. This ensures the issue can be investigated and any corrective action, if it is necessary, can be taken quickly. Issues relating to the quality of specific products can sometimes be an indicator of a larger problem that requires addressing.

Medsafe assesses all complaints, with most complaints followed up with the supplier to ensure that the product continues to meet required standards. Medsafe may then request additional information from the supplier including copies of the batch manufacturing records or a health risk assessment of the issue.

All issues relating to the quality of a medicine do not necessarily result in a recall. Determining whether a product should be recalled depends on factors such as the potential of the issue to cause harm, the timing and extent of distribution, and the availability of alternative treatments.

Reporting a Problem

Issues that could indicate a problem with the quality of a medicine should be reported to either the Compliance Management Branch at Medsafe, to the company that distributes the product in New Zealand, or to both.

Questions about the quality complaints processes should be directed to the Compliance Management Branch (Ph 04-819-6800).

Complaints relating to the safety of medicines should be reported to CARM.