Learning from incidents The Medication Safety Officer or delegated senior pharmacist will review all reported medication incidents for accuracy of the medication-related details, to provide professional input, and to escalate incidents for further investigation if necessary. If any trends are identified, this will be escalated via the Medicines Management Committee. Adverse Drug Reaction Reporting Any drug may produce unwanted or unexpected adverse drug reactions. Detecting and reporting of these is of vital importance. Prompt reporting should be carried out for any suspected adverse drug reactions to new drugs that are subject to additional monitoring by regulatory bodies. These medicines are identified in the BNF and in product literature by the inverted black triangle symbol (▼). Reporting must also be undertaken for unlicensed medicines and for any serious or unusual reactions to established products. Reporting should be carried out for prescribed drugs, and for medicines obtained by patients over the counter/ herbal products. Suspected adverse reactions related to a drug or combination of drugs should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the national yellow card reporting scheme. Copies of the card can be found at the back of the British National Formulary (BNF), or from the MHRA website (www.mhra.go.uk) Medicine Defect Reporting A defect is present if the product, as supplied by the manufacturer, is not of the expected standard. Defects may relate to inadequate or incorrect labelling, ineffective packaging, contamination, discolouration, breakage, or incorrect contents. If a defect is found or suspected in a medicine, it should be reported to Pharmacy. Any remaining product and associated equipment should be retained and quarantined. If the product has been administered to a patient, the patient’s doctor should be informed, and details of the defect should be recorded in the patient’s medical record. The incident should be reported via DATIX. Medication Safety Alerts and Drug Recalls If a defect is identified in a medicinal product that may pose a hazard to health, the MHRA may issue a alert’ letter. These drug alerts will be ‘drug actioned by Pharmacy; out of hours, this will be led by the on-call pharmacist.
Learning from incidents The Medication Safety Officer or delegated senior pharmacist will review all reported medication incidents for accuracy of the medication-related details, to provide professional input, and to escalate incidents for further investigation if necessary. If any trends are identified, this will be escalated via the Medicines Management Committee. Adverse Drug Reaction Reporting Any drug may produce unwanted or unexpected adverse drug reactions. Detecting and reporting of these is of vital importance. Prompt reporting should be carried out for any suspected adverse drug reactions to new drugs that are subject to additional monitoring by regulatory bodies. These medicines are identified in the BNF and in product literature by the inverted black triangle symbol (▼). Reporting must also be undertaken for unlicensed medicines and for any serious or unusual reactions to established products. Reporting should be carried out for prescribed drugs, and for medicines obtained by patients over the counter/ herbal products. Suspected adverse reactions related to a drug or combination of drugs should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the national yellow card reporting scheme. Copies of the card can be found at the back of the British National Formulary (BNF), or from the MHRA website (www.mhra.go.uk) Medicine Defect Reporting A defect is present if the product, as supplied by the manufacturer, is not of the expected standard. Defects may relate to inadequate or incorrect labelling, ineffective packaging, contamination, discolouration, breakage, or incorrect contents. If a defect is found or suspected in a medicine, it should be reported to Pharmacy. Any remaining product and associated equipment should be retained and quarantined. If the product has been administered to a patient, the patient’s doctor should be informed, and details of the defect should be recorded in the patient’s medical record. The incident should be reported via DATIX. Medication Safety Alerts and Drug Recalls If a defect is identified in a medicinal product that may pose a hazard to health, the MHRA may issue a ‘drug alert’ letter. These drug alerts will be actioned by Pharmacy; out of hours, this will be led by the on-call pharmacist.
CORPORATE%20POLICY%20-%20Medicines%20Management%20Policy%20-%20POLCPCM033-6.docx