APPENDIX 1: MEDICINE ERROR, INCIDENT AND DEFECT REPORTING SYSTEMS What systems are and when to use them When to Use Examples (not Report Sent Contact Information exhaustive To list) MHRA Suspected or actual product defect Serious MHRA Telephone: Defective where patient safety clearly at risk. unexpected Defective 020 3080 6574 Medicines Guidance from the MHRA here reaction. Medicines Reporting Severe, visible Reporting (08:45 - 16:45 Centre microbial or Centre weekdays) particulate 641532 for urgent contamination. Suspected calls outside of normal counterfeit working hours, at product weekends or on public holidays. dmrc@mhra.gsi.gov.uk Quality Product defects which are quality Empty blister in Inform Assurance assurance in nature, with no strip. Missing manufacturer. Defect immediate severe risk to patient batch number If necessary Reporting safety. Defects reported to the or expiry date, send sample Scheme MHRA should also be copied to particulate to an NHS CMU for contract lines contamination. Regional QA Defective service unlicensed medicines should also be reported. ProMS Incidents where products have Selection of Send to an As for minor defects (Potential been selected or supplied lookalike and NHS above. Risk of incorrectly, where issues relating to sound-alike Regional QA Medication packaging design and presentation drugs. Service In addition must be Selection) are felt to be contributory factors. Manufacturer's reported via the Trust packaging has Incident Reporting poor process via Datix differentiation between different products or strengths. CMU Issues relating to supply of Change in Relevant See contact details for medications purchased through manufacturer of CMU buyer individual buyers. CMU contracts. product for Trust supplied. concerned. Financial and
APPENDIX 1: MEDICINE ERROR, INCIDENT AND DEFECT REPORTING SYSTEMS What systems are and when to use them When to Use Examples (not exhaustive list) Report Sent To Contact Information MHRA Defective Medicines Reporting Centre Suspected or actual product defect where patient safety clearly at risk. Guidance from the MHRA here Serious unexpected reaction. Severe, visible microbial or particulate contamination. Suspected counterfeit product MHRA Defective Medicines Reporting Centre Telephone: 020 3080 6574 (08:45 - 16:45 weekdays) 641532 for urgent calls outside of normal working hours, at weekends or on public holidays. dmrc@mhra.gsi.gov.uk Quality Assurance Defect Reporting Scheme Product defects which are quality assurance in nature, with no immediate severe risk to patient safety. Defects reported to the MHRA should also be copied to CMU for contract lines Empty blister in strip. Missing batch number or expiry date, particulate contamination. Defective unlicensed medicines should also be reported. Inform manufacturer. If necessary send sample to an NHS Regional QA service ProMS (Potential Risk of Medication Selection) Incidents where products have been selected or supplied incorrectly, where issues relating to packaging design and presentation are felt to be contributory factors. Selection of lookalike and sound-alike drugs. Manufacturer's packaging has poor differentiation between different products or strengths. Send to an NHS Regional QA Service As for minor defects above. In addition must be reported via the Trust Incident Reporting process via Datix CMU Issues relating to supply of medications purchased through CMU contracts. Change in manufacturer of product supplied. Financial and Relevant CMU buyer for Trust concerned. See contact details for individual buyers.