A report on the experience of monitoring medicines under the EU Black Triangle scheme

The European Commission (EC) had published a report for the European Council, on the European Medicines Agency’s (EMA) and Member States’ (MS) experiences of monitoring the safety of medicines that are subject to additional monitoring.In the European Union (EU), medicines that are being monitored closely by regulatory authorities are labelled with a black inverted triangle in the product information, because there is less information available about them. The primary aim of additional monitoring is to enhance side effect reporting.

A list of these medicines, classified as under “additional monitoring”, was first released in 2013, as part of the implementation of new pharmacovigilance provisions. A list is published every month by the EMA with additions and updates on the monitoring status of various medicines. The mandatory scope of the additional monitoring list was extended to certain products for which a post-authorisation safety study (PASS) was requested at the time of authorisation.

Since then, the EMA has been conducting various evaluations of these protocol. In 2017, they conducted a public survey to understand the awareness of reporting adverse drug reactions (ADR). They also analysed whether the inclusion of a medicine on the additional monitoring list had a significant effect on the reporting of ADRs, and the detection and management of safety signals related to that medicine.

Regarding public awareness, the report concludes that patients and healthcare professionals (HCP) have varying levels of knowledge and understanding of the concept of additional monitoring. It indicates there is a misunderstanding about the reasons for a medicine being subject to additional monitoring. There is inconclusive evidence to determine whether the list has any impact on ADR reporting. However, in a recent review by the EMA, the EU signal management system was shown to be successful in improving the safe use of medicines.

Furthermore, the Pharmacovigilance Risk Assessment Committee (PRAC) believe the mandatory trigger has led to too many established products being included and is of limited value to the primary aim. They noted that there have been cases where a PASS would be imposed for one product, whilst other similar products with the same active substance do not have a PASS, leading to the potential misunderstanding about the reasons for additional monitoring mentioned above.

The EC has recommended MSs and EMA to continue promoting ADR reporting and monitoring of the impact of the scheme, to “strengthen the evidence base for future review of the scheme”. However they do not recommend an immediate review of the additional monitoring list inclusion criteria. Competent authorities are encouraged to continue to collect data regarding medicines with an imposed PASS, to allow further assessment of the PRAC’s concerns at a later stage.

For the full results of the report, click here.