(007) Comparative Analysis of Medicines Under Additional Monitoring in the European Union and Bulgaria

Background: In 2012, European legislation on pharmacovigilance introduced a new measure for additional monitoring of specific medicines after their marketing authorization. A black inverted triangle, accompanied by a brief explanatory sentence, is displayed on their leaflet and in the summary of product characteristics. This symbol is uniformly used across all EU member states to indicate medicines subject to additional monitoring.

Objectives: This study aims to analyze the medicines under additional monitoring listed by the European Medicines Agency (EMA) and compare them with those available on the pharmaceutical market in Bulgaria.

Methods: A descriptive analysis was conducted on the EMA's list of medicines under additional monitoring as of November 2023 (EMA/245297/2013 Rev.116). Additionally, the financial accessibility of these medicines in Bulgaria was assessed through a detailed examination of the medicines under additional monitoring included in the Positive Drug List (PDL). Public electronic registers of the National Council on Prices and Reimbursement of Medicinal Products in Bulgaria were used.

Results: The EMA's list included a total of 357 medicines as of November 2023, with 105 of these medicines available on the Bulgarian pharmaceutical market. The analyzed medicines were categorized based on the following criteria: new active substances (n=28, 26.67%), new biologicals (n=12, 11.43%), medicines requiring post-authorization safety studies (PASS) (n=22, 20.95%), medicines with conditional approval (n=2, 1.91%), and those authorized under exceptional circumstances (n=4, 3.81%). The remaining medicinal products fall into more than one of the listed groups or there are restrictions regarding the safe and effective use of the medicinal product. By December 15, 2023, 80 medicines under additional monitoring were included in the PDL. Twelve medicines are not yet on the PDL, but Bulgarian patients can access them through a special EU-level mechanism, as they are used to prevent or treat COVID-19 infections.

Conclusions: The majority of medicines under additional monitoring available on the Bulgarian pharmaceutical market comprise new active substances, primarily in therapeutic areas such as oncology, haematology, and neurology. Patients and healthcare professionals are encouraged to report any suspected adverse drug reactions associated with medicines under additional monitoring to facilitate efficient analysis of newly received information.