Non medical prescribing in Scotland: implementation guide

Adverse Drug Reaction Reporting: how to report a suspected adverse reaction to a medicine prescribed by a nurse

MHRA/ CHM Yellow Card Scheme

101. The Yellow Card Scheme is a voluntary scheme through which healthcare professionals notify the Medicines and Healthcare products Regulatory Agency ( MHRA)/Commission on Human Medicines ( CHM) of suspected adverse drug reactions. The MHRA/ CHM encourage the reporting of all suspected adverse drug reactions to newly licensed medicines that are under intensive monitoring/ surveillance (identified by a symbol both on the product information for the drug (and in the BNF and MIMS) and all serious suspected adverse drug reactions to all other established drugs, including herbal medicines. Serious reactions include those that are fatal, life-threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant.

102. The electronic Yellow Card provides a simple and fast way to report suspected adverse reactions. The electronic Yellow Card, together with instructions on how to use it, is available at: www.yellowcard.gov.uk. Health professionals are encouraged to report all suspected adverse drug reactions using this method, although hard copy Yellow Cards are also acceptable (and can be found bound to the back of the BNF).

103. Patients, parents, carers, etc. can also report suspected adverse drug reactions using the above methods. There is also a freephone number, 0808 100 3352, that can be used.

104. The bulletin 'Current Problems in Pharmacovigilance', issued by the MHRA/ CHM, contains advice and information on drug safety issues. All prescribers are encouraged to routinely consult the bulletin and keep up to date with new information about safe use of medicines. Copies are on the MHRA's website, which can be found on: www.mhra.gov.uk

The role of NHS Quality Improvement Scotland

105. Drug alerts are issued directly to the NHS by the Chief Pharmaceutical Officer. Alerts issued by the National Patient Safety Agency (which covers England and Wales) are issued in Scotland by NHS Quality Improvement Scotland ( NHSQIS). Any follow up of NHS Boards' response to recommendations in alerts would be carried out by NHSQIS as part of their patient safety work programme. Each local health system should have processes for circulation of drug alerts and hazard warnings to nurse independent prescribers, and a system for reporting medication errors and learning lessons from mistakes to ensure patient safety and good nursing practice. As detailed in paragraphs 70-75, clinical governance systems should be in place for nurse prescribing and related activities, and risk management plans put in place.