Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital

Abstract

AimTo describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them. MethodsA qualitative study was carried out. Fifteen focus groups were conducted among physicians working in a tertiary teaching hospital. A total of 208 physicians from different medical specialities participated. The focus group discussions were recorded by three different observers and the transcripts of each session were analysed for issues and themes emerging from the text. ResultsFour types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADRs diagnosis; (ii) problems with the usual workload and lack of time; (iii) problems related to the organization and activities of the pharmacovigilance system; (iv) and problems related to potential conflicts. The potential solutions suggested for improving spontaneous repor ting were to define the kind of ADRs which should be reported, to facilitate an easy contact and quick access to the hospital pharmacovigilance system, to facilitate information and support for reporting and feedback of pharmacovigilance activities. ConclusionsThe perception of the different obstacles by the hospital physicians is an impor tant factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous repor ting. A closer relationship between the doctors and the pharmacovigilance centre is suggested as a means of solving these problems. More information is needed to improve the spontaneous reporting of ADRs in specialized healthcare.

Farmacovigilância em Portugal: Atividade da Unidade Regional do Centro

“…45 Algumas das razões apontadas como possíveis causas da subnotificação nos hospitais são a falta de organização do sistema de Farmacovigilância hospitalar, falta de tempo dos profissionais de saúde ou problemas com a confidencialidade da informação. 46 Os medicamentos suspeitos mais frequentemente notificados, nos casos recebidos pela UFC, foram os anti--infeciosos de uso sistémico, onde se inserem as vacinas e os antibióticos, seguidos dos medicamentos que atuam no sistema musculosquelético, na sua maioria anti-inflamatórios não-esteroides, e dos medicamentos que atuam no sistema nervoso, principalmente antidepressivos, antipsicóticos e ansiolíticos. Estes resultados estão em linha com os dados nacionais.…”

Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Healthcare Workers in a Tertiary Centre in Northern Nigeria

“…Out of the several methods of detecting ADRs, spontaneous reporting is one that has contributed significantly to improved levels of pharmacovigilance in many countries [5,6]. The importance of healthcare workers in the area of spontaneous reporting of ADRs and development of ADR databases worldwide has been established in previous studies [7,8].…”

A study of assessing knowledge, attitude and practice of pharmacovigilance among medical students of a South Indian teaching hospital

“…8 The underreporting of ADR may be due to lack of adequate knowledge, attitude and practice among healthcare professionals towards ADR reporting. 9 Health professionals are more likely to identify and report important ADRs if they have confidence in their ability to diagnose, manage and prevent such reactions. Pharmacovigilance Programme of India (PvPi) plays a vital role by encouraging the activities of pharmacovigilance in the field of medicine, pharmacy and nursing.…”