Defective Medicines Report Centre

Defective Medicines Report Centre

The MHRA’s Defective Medicines Report Centre (DMRC) plays a major part in the protection of public health by minimising the hazard to patients arising from the distribution of defective medicinal products. It does this by providing an emergency assessment and communications system between suppliers of medicinal products, the regulatory authorities and the users. It achieves this by receiving and assessing reports of suspected defective medicines, monitoring and as necessary advising and directing appropriate actions by the responsible authorisation holder and communicating the details of this action as necessary and with appropriate urgency to recipients of the products and other interested parties in the UK and elsewhere by means of drug alerts.

Recalls and drug alerts

Where a defective medicine is considered to present a risk to public health, the marketing authorisation holder, or the manufacturer as appropriate, is responsible for recalling the affected batch(es) or, in extreme cases, removing all batches of the product from the market. The DMRC will normally support this action by the issue of a drug alert notification to healthcare professionals. Drug alerts are classed from 1 to 4 according to their criticality and the speed with which action must be taken to remove the defective medicine from the distribution chain and, where necessary, from the point of dispensing and use. This varies from immediate action for a Class 1 alert, to action within five days for a Class 3 alert. In some low-risk circumstances the product may be allowed to remain in the supply chain when the DMRC will issue a Class 4 “caution in use” alert. In the case of Class 1 and Class 2 drug alerts, the DMRC will notify regulators in other countries using the European Rapid Alert System.

Reporting suspected quality defects

Manufacturers, importers and distributors are obliged to inform the MHRA of any suspected quality defect in a medicinal product that could or would result in a recall, or restriction on supply. Healthcare professionals also have a responsibility to inform the MHRA of any matter coming to their attention that might reasonably cause the Agency to conclude that it relates to a quality defect.

If a patient or member of the public has reason to believe that their medicine is not of an acceptable quality they should, in the first instance, consult with their doctor or a pharmacist who may then decide to refer the matter to the MHRA. This is the Agency’s preferred option, because the doctor or pharmacist may be in a better position to provide prompt advice and/or reassurance to the patient. However, if it is not possible to speak to a doctor or pharmacist and the patient feels that the matter is urgent, they may contact the DMRC direct.

Ways to report suspected defects

Suspected quality defects can be reported in a number of ways:

Telephone:

020 3080 6574 (08:45 - 16:45 Monday to Friday)
020 7210 3000 (urgent calls outside working hours, at weekends or on public holidays)

Email:

dmrc@mhra.gsi.gov.uk

Online:

Suspected defect reporting form

Further guidance is available in the MHRA’s Guide to Defective Medicinal Products (200Kb)