Royal Pharmaceutical Society releases new pharmacovigilance guidance

Woman reading a patient information leaflet, where the 'black triangle' can be found

The Royal Pharmaceutical Society (RPS) has launched new guidance on the EU-wide scheme for the additional monitoring of medicines, commonly known in the UK as the ‘black triangle’ scheme.

In collaboration with the Association of the British Pharmaceutical Industry’s (ABPI) Pharmacovigilance Expert Network (PEN), the RPS has produced a quick reference guide and an ‘Advice for pharmacists’ document highlighting the importance of the black triangle and explaining the ways in which healthcare professionals can contribute to medicines’ safety by being vigilant and reporting any adverse reactions to black triangle medicines.

In the EU, a black triangle is usually assigned to a medicine for five years following initial authorisation. It can then be reinstated at any later stage in a medicine’s life cycle if there are safety concerns that require monitoring. The black triangle can be found next to the name of relevant medicines on the summary of product characteristics, patient information leaflet, in the BNF or on advertising and educational materials for healthcare professionals and patients.

Pharmacists, other healthcare professionals and patients are encouraged to report any suspected adverse reaction for medicines with a black triangle. Reports can be submitted via the Yellow Card scheme and/or directly to the marketing authorisation holder.

Last updated
The Pharmaceutical Journal, Royal Pharmaceutical Society releases new pharmacovigilance guidance;Online:DOI:10.1211/PJ.2016.20201792

You may also be interested in