OBJECTIVES:The Designated Medical Event (DME) is a serious medical event that is often causally associated with medicines. This way, EMA has developed a list of DME, through Medical Dictionary for Regulatory Activities (MedDRA). The list is used by the EMA and Member States to focus on suspected adverse drug reaction(ADR) reports that deserve special attention, irrespective of statistical criteria used to prioritise safety reviews. DME search in ADR reports is one of the methods used to detect safety signals. The objective of our study is to identify and characterize the reports of ADR that contain the DME, in Portugal.

METHODS:A retrospective study was conducted to identify and characterize the spontaneous ADR reports with DME, occurred in Portugal, from 2014 to 2019. A descriptive analysis was performed for the following data: type of notifier (consumer or healthcare professional), medicines classified by the Anatomical Therapeutic Chemical Code, ADR coded with MedDRA and description of ADR in the summary of product characteristics (SmPC).

RESULTS:During this 5-year period, the Portuguese Pharmacovigilance System received 15344 reports, of these 1335 correspond to reports with DME (1305 by healthcare professionals; 30 by consumers). The annual percentage of reports with DME has been increasing, with the exception of the last year. The most frequent ATC group with or without DME is “Antiinfectives For Systemic Use”. The most frequent System Organ Classes of the reports with the DME is “Skin and subcutaneous tissue disorders”. Of the 1335 reports with DME terms, 130 of these reports are not described in the SmPC.

CONCLUSIONS:It is important to obtain real-word data, especially in the area of drug safety, because it is a way to prevent ADR. In this way, notifiers should be made aware of the importance of sharing data related to ADR, thus increasing knowledge about the safety profile of medicines.