Black Triangle: Additional Monitoring of Medicines

Quick Reference Guide

This guide provides an overview of the EU wide scheme for the additional monitoring of medicines, also commonly known in the UK as the black triangle (▼). It highlights the roles that healthcare professionals (HCPs), including pharmacists, play in supporting the safe and effective use of medicines. 

This guide highlights the importance of the additional monitoring scheme (the black triangle), and discusses the ways in which HCPs can contribute to medicines’ safety by being vigilant and reporting any adverse reactions to black triangle medicines.

What is the black triangle symbol?

Although the black triangle - has been running in the UK for many years to highlight medicines that are subject to intensive safety monitoring, since 2013, it has become part of an EU wide scheme and is now known as additional monitoring. Medicines under additional monitoring carry a black triangle symbol (an inverted equilateral black triangle; ▼) to let patients and HCPs know that these medicines are being closely monitored by European regulatory authorities.

Why do new medicines require additional monitoring?

When new medicines are initially approved, the relatively small number of participants in clinical trials means that not all safety issues may be established. It is only when the medicine is used in a large number of patients that rare or long latency adverse reactions (i.e. those taking a longer time to develop) are identified. It is essential that new medicines are intensely monitored to further establish their safety profile by picking up any emerging safety concerns and so minimise risk for patients. While a black triangle highlights that information on all adverse reactions to a medicine is being gathered, it does not indicate that the product is unsafe for use in patients.

What does a black triangle on a medicine mean

The black triangle denotes that a medicine is on a list of medicines subject to additional monitoring. The black triangle is a mechanism to strengthen monitoring and to actively encourage patients and HCPs to report any possible adverse reactions observed with these medicines.

On what medicines can I expect to find a black triangle?

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 such as plasma derived medicines, vaccines or biosimilars. Other criteria include specific conditions of authorisation e.g. the conduct of a Post-Authorisation Safety Study (PASS) by the marketing authorisation holder after approval or restrictions with regards to the safe and effective use of the medicinal product, e.g. a controlled access scheme. The black triangle can also be assigned or re-instated in some cases at later stages of a medicine’s life cycle if a new safety concern has been identified that requires monitoring.

What types of suspected adverse reactions should be reported for black triangle medicines?

Pharmacists, other HCPs and patients are encouraged to report any suspected adverse reaction for black triangle medicines. For other established medicines, all serious suspected adverse reactions should be reported even if the effect is well recognised. Reports can be submitted via the Yellow Card Scheme at: Yellow Card Scheme - MHRA and/or directly to the marketing authorisation holder. For biologicals (including biosimilar medicines), adverse reaction reports should clearly state the brand name and the batch number of the suspected medicine

Where will I find the black triangle symbol?

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

How long does a medicine have a black triangle symbol and under what circumstances will it be removed?

Typically new medicines are assigned a black triangle for a period of five years following first authorisation in the EU. In some cases the period may be longer than five years e.g. if there are ongoing safety concerns, or to complete PASS studies. The decision to remove the medicines from the additional monitoring list must be agreed by the EU regulators following which there may be a delay before updated product information is available.

What roles can pharmacists play in handling black triangle medicines?

Pharmacists should be vigilant and report all suspected adverse drug reactions for black triangle medicines and help support and educate patients with any questions they may have regarding the scheme. Pharmacists should be familiar with any risk minimisation materials a medicine may have and ensure that they are distributed to patients and that patients are counselled on their use.

Where will I find information on which medicines are subject to additional monitoring?

The list of medicines for monitoring is reviewed each month by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) and updated as required. The list of medicines under additional monitoring is published on their website.

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Produced in conjunction with the ABPI Pharmacovigilance Expert Network.

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