Alerts, recalls and disposals
Drug alerts and recalls
Manufacturers are obliged to report any quality defect in a medicinal product to the Medicines and Healthcare products Regulatory Agency (MHRA).
In the majority of cases, the MHRA issues a Drug Alert which is classified from one to four depending on the risk presented to public health by the defective product (see table below). Class 1 is the most critical and requires an immediate recall; Class 4 is the least critical and advises ‘caution in use’.
Pharmacies are required to act on NHS patient safety alerts and other alerts, such as drug recalls, within the required timescale as part of the contractual clinical governance requirements. They are also required to keep records of the actions taken in response to these alerts.
| Drug alerts | |
| Class 1 | Immediate action (includes out of hours) |
| Class 2 | Action within 48 hours |
| Class 3 | Action within five days |
| Class 4 | Caution in use |
Safe disposal of medicines
All community pharmacies are obliged to accept returns of unwanted medicines from households or individuals requiring safe disposal as part of the Community Pharmacy Contractual Framework (CPCF) essential services.
Read the NHS Community Pharmacy Contractual Framework service specification that outlines the responsibility of community pharmacy in the return of medicines.
Any returned medicines must be dealt with in accordance with the Hazardous Waste Regulations 2005.
References
- Royal Pharmaceutical Society. Professional guidance on the safe and secure handling of medicines. December 2018.