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Authors
Advisor(s)
Abstract(s)
The Designated Medical Event (DME) is a serious medical event that isoften causally associated with medicines. This way, EMA has developed a list of DME,through Medical Dictionary for Regulatory Activities (MedDRA). The list is used bythe EMA and Member States to focus on suspected adverse drug reaction(ADR) re-ports that deserve special attention, irrespective of statistical criteria used to pri-oritise safety reviews. DME search in ADR reports is one of the methods used todetect safety signals. The objective of our study is to identify and characterize thereports of ADR that contain the DME, in Portugal.Methods:A retrospective studywas conducted to identify and characterize the spontaneous ADR reports with DME,occurred in Portugal, between 2014 to 2019. A descriptive analysis was performed forthe following data: type of notifier (consumer or healthcare professional), medicinesclassified by the Anatomical Therapeutic Chemical Code, ADR coded with MedDRAand description of ADR in the summary of product characteristics (SmPC).Results:During this 5-year period, the Portuguese Pharmacovigilance Systemreceived 15344 reports, of these 1335 correspond to reports with DME (1305 byhealthcare professionals; 30 by consumers). The annual percentage of reports withDME has been increasing, with the exception of the last year. The most frequent ATCgroup with or without DME is“Antiinfectives For Systemic Use”. The most frequentSystem Organ Classes of the reports with the DME is“Skin and subcutaneous tissuedisorders”. Of the 1335 reports with DME terms, 130 of these reports are notdescribed 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.
Description
Keywords
ADR Reports DME Perspective
Citation
Marques Rodrigues, N., & Silva, A. (2021). PNS22 Real-World DATA of ADR Reports in Signal Detection - DME Perspective. Value in Health, 24, S176. https://doi.org/https://doi.org/10.1016/j.jval.2021.04.877
Publisher
Elsevier