Published: 5 September 2014
Publications
What are medicine quality complaints?
Prescriber Update 35(3): 40
September 2014
What are medicine quality complaints?
Medicine quality complaints can encompass a wide range of issues identified after medicines have been released for distribution. These issues can affect the identity, quality, durability, reliability, safety or effectiveness of a medicine, which may make it unsafe or unfit for purpose.
Quality complaints can include:
- Suspected mislabelled medicines
- Abnormal odour or taste
- Inaccurate or unreadable product labels/labelling (including the package insert)
- Capsule leakage
- Packaging that is torn or punctured
- Chipped, cracked, or splitting tablets
- Sterile containers or vials that are punctured or leaking
- Tablet or capsule discolorations
- Packaging or product mix-ups
- Broken, cracked, or chipped syringes
- Suspected product contamination
- Sterile products with floating objects or growth
- Inconsistent tablet sizes
- Leaking vials
Some examples of complaints reported to Medsafe include:
- Illegible writing on container labels for tablets. This complaint was resolved by the manufacturer changing the font size and colour for the labelling text.
- Foreign particles found in solution for injection. This complaint led to a product recall.
- Inconsistent sizing of tablets which could potentially lead to an overdose or under dose. This complaint led to a product recall.
Who can make a medicines quality complaint to Medsafe?
Complaints relating to the quality of medicines are reported to Medsafe by consumers, pharmacists, wholesalers, prescribers and the pharmaceutical industry.
Medsafe complaint investigation process
Medsafe assesses all complaints received and assigns a priority for review and action based on the perceived degree of risk the to New Zealand public. For example, a serious issue with a widely used prescription medicine will be investigated as a high priority, while a minor issue with website advertising may be treated as a low priority.
Medsafe may request additional information from the relevant parties such as manufacturers, sponsors and reporters if required to proceed with the investigation. They may also seek assistance and/or information from other specialists at Medsafe in relation to good manufacturing practice, pre-market medicines assessment and/or clinical risk assessment to help formulate a decision.
A health risk analysis is performed to assess the potential health impact in New Zealand and to determine the most appropriate action.
Reporting a Problem
When an issue related 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 necessary, can be taken quickly.
Issues related to the quality of specific products can sometimes be an indicator of a larger problem which needs to be addressed immediately. Where applicable, complaint samples should be quarantined and stored in a safe place as these may be required for further testing.
Complaints should be reported to either the Compliance Management Branch at Medsafe, or to the company that distributes the product in New Zealand, or to both.
Questions about the quality complaints process should be directed to the Compliance Management Branch Phone: 04-819-6800 or email recalls@health.govt.nz.
Reports of adverse drug reactions should be reported to the Centre for Adverse Reactions Monitoring (CARM): https://nzphvc.otago.ac.nz/report/.
