Andrea Farcaş1, Andreea Măhălean1, Noémi Beátrix Bulik1, Daniel Leucuta2, Cristina Mogoșan1. 1. a Drug Information Research Center , "Iuliu Haţieganu" University of Medicine and Pharmacy , Cluj-Napoca , Romania. 2. b Medical Informatics and Biostatistics Department , "Iuliu Haţieganu" University of Medicine and Pharmacy , Cluj-Napoca , Romania.
Abstract
BACKGROUND: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC). METHODS: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014-November 2017 were analyzed and classified. RESULTS: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC. A total of 154 signals were triggered by spontaneous reporting, 31 by literature case reports, and 26 by observational studies. In 188 signals, the drugs involved were authorized for more than 5 years. The drug classes for which most signals were detected were antineoplastic/immunomodulators (n = 75), anti-infectives (n = 34), and drugs acting on the nervous system (n = 27). Signals were triggered for drug interactions (n = 15), in utero exposure (n = 7), medication errors (n = 6), and for different disorders, among which the skin/subcutaneous tissue disorders were more common. PRAC recommendations consisted in label updates (n = 86), in Direct Healthcare Professional Communications (n = 17), and in eight recommendations for a more complex evaluation through referral procedures. CONCLUSIONS: Most new signals assessed were triggered by spontaneous reporting and led to routine risk minimization measures, such as updating the product information.
BACKGROUND: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC). METHODS: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014-November 2017 were analyzed and classified. RESULTS: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC. A total of 154 signals were triggered by spontaneous reporting, 31 by literature case reports, and 26 by observational studies. In 188 signals, the drugs involved were authorized for more than 5 years. The drug classes for which most signals were detected were antineoplastic/immunomodulators (n = 75), anti-infectives (n = 34), and drugs acting on the nervous system (n = 27). Signals were triggered for drug interactions (n = 15), in utero exposure (n = 7), medication errors (n = 6), and for different disorders, among which the skin/subcutaneous tissue disorders were more common. PRAC recommendations consisted in label updates (n = 86), in Direct Healthcare Professional Communications (n = 17), and in eight recommendations for a more complex evaluation through referral procedures. CONCLUSIONS: Most new signals assessed were triggered by spontaneous reporting and led to routine risk minimization measures, such as updating the product information.
Keywords:
European Union; Pharmacovigilance Risk Assessment Committee; risk; safety signals; spontaneous reporting systems