The UK’s Black Triangle scheme, used to intensively monitor the safety of new medicines, has been adopted for use in Europe following new legislation.
The Black Triangle identifies medicines that are being monitored particularly closely because less information about the medicine is available – for example it has recently been introduced. It does not mean that the medicine is unsafe.
The changes mean that the Black Triangle symbol will feature in Patient Information Leaflets alongside Summaries of Product Characteristics. The accompanying advice will explain that the symbol means that the medicine is being monitored particularly closely and encourages reporting of suspected adverse drug reactions. A list of Black Triangle medicines is available at www.mhra.gov.uk/blacktriangle.
The Yellow Card Scheme collects suspected ADR reports from the whole United Kingdom in relation to all medicines, including those which are prescription only, over-the-counter or available from general retail sales outlets, and medicines which are unlicensed. The Yellow Card Scheme primarily acts as an early warning system for the identification of previously unrecognised suspected adverse reactions and also provides valuable information on recognised ADRs, allowing the MHRA to identify and refine the understanding of risk factors that may affect the clinical management of patients. The value of the Scheme has been demonstrated many times and it has helped to identify numerous important safety issues.
The European Medicine Agency have provided an information video about the Black Triangle: www.youtube.com