RPS Launches Guidance on the Additional Monitoring of Medicines

03 Oct 2016

Working with the APBI Pharmacovigilance Expert Network, RPS has produced a Quick Reference Guide and a more detailed Advice for Pharmacists document on the EU wide scheme for the additional monitoring of medicines, commonly known in the UK as the black triangle. This guidance highlights the importance of the additional monitoring scheme (the black triangle), and discusses the ways in which pharmacists and other healthcare professionals can contribute to medicines’ safety by reporting any adverse reactions to medicines with the black triangle symbol.

When a new medicine is approved, it will have been used in a relatively small number of participants in clinical trials meaning that not all safety issues may be established. It is only when the medicine is used in a large number of patients that adverse reactions that are rare or take a longer time to develop are identified.  A black triangle is assigned to any new medicine when approved for the first time if it contains a new active substance, or is a biological medicinal product. The black triangle indicates that information on all adverse reactions to a medicine is being gathered, but does not mean that the product is unsafe for use in patients.

In the EU, a black triangle is usually assigned to a medicine for a period of five years following first authorisation, although in some cases the period may be longer. The black triangle may also be re-instated at a later stage in a medicine's life cycle if a new safety concern has been identified that requires monitoring. The list of medicines subject to additional monitoring is reviewed each month and updated by the European Medicines Agency (EMA) and can be found on the EMA website. Pharmacists, other healthcare professionals and patients are encouraged to report any suspected adverse reaction for medicines with a black triangle which differs to established medicines which only require all serious suspected adverse reactions to be reported. Reports can be submitted via the Yellow Card Scheme and/or directly to the marketing authorisation holder.

The black triangle symbol appears next to the name of relevant medicines in their Summary of Product Characteristics, Patient Information Leaflet, in publications such as the BNF and MIMS, on advertising and educational materials for healthcare professionals and on patient support materials. It does not appear on the outer packaging of medicines.

Pharmacists with their expert knowledge of medicines should be vigilant and report all suspected adverse reactions for black triangle medicines and can support and educate patients with any questions they may have regarding the scheme.