Farmacovigilância em Portugal: Atividade da Unidade Regional do Centro

Abstract

Introduction:The aim of this study was to characterize the spontaneous reports of adverse events that were received by the Central Portugal Regional Pharmacovigilance Unit. Material and Methods: Spontaneous reports received between 01/2001 and 12/2013 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, origin and professional group of the reporter, type of adverse event and pharmacotherapeutic groups of the suspected drugs most frequently reported. Results:The Pharmacovigilance Unit received 2408 reports that contained 5749 adverse events. In 2013, the reporting rate was estimated at 171 reports per million inhabitants. Fifty-five percent of the reports were assessed as serious. Ninety percent of the cases were assessed as being at least possibly related with the suspected drug. The suspected drugs most frequently reported were antiinfectives for systemic use (n = 809, 33%). The most frequently reported adverse events were "Skin and subcutaneous tissue disorders" (n = 1139, 20%). There were 154 (6.4%) reports resulting in life-threatening situations and/or death, and 88 (3.6%) containing at least one adverse event assessed as serious, unknown and certain or probable. Discussion: The present results are in line with those found in other studies, namely the seriousness and type of the adverse events and the pharmacotherapeutic groups of the most frequently reported suspected drugs. Conclusion:In the last years, the Central Portugal Regional Pharmacovigilance Unit has registered a growth in the reporting rate in general, as well as an increase in the reporting of unknown and serious adverse drug reactions.

Analysis of Reports Sent to the Portuguese Pharmacovigilance System and Published Literature Regarding the Safety of Metformin in the Elderly

“…Of the 350 notifications, 237 were serious, and the most prevalent seriousness criterion in most cases was hospitalization, which demonstrates the seriousness of the ADRs that users developed; however, generally, individuals and health professionals have a greater sensitivity and tendency to report serious ADRs. This may also explain the results obtained [33,34].…”

Drug-Related Problems Identified in a Sample of Portuguese Institutionalised Elderly Patients and Pharmacists’ Interventions to Improve Safety and Effectiveness of Medicines

“…This bias, if present, will have particular influence on DRP 2 detected, which may not be real but rather a result of missing information. In regard to DRP 5, it should be noted that there was no record found for notifications made to the pharmacovigilance system, which indicates that these were either not made, which is in line with the low level of reporting practiced in Portugal [36], or simply not recorded in the patient file.…”

Retrospectiva de 20 anos de atividade da Unidade de Farmacovigilância do Porto, Portugal

“…Mais de metade dos casos (65%) reportados à UFPorto dizem respeito a reações adversas graves a medicamentos. Este resultado é consistente com as taxas de iatrogenia grave identificadas noutras unidades de farmacovigilância nacionais em anos anteriores 4,16,18 . Embora a evidência seja limitada, parece que os profissionais de saúde estão particularmente sensibilizados para a notificação de reações adversas graves a medicamentos, uma vez que estas estão fortemente associadas a aumento da morbilidade e dos custos em saúde 19 .…”