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

TLDR

The study seeks to elicit hospital physicians’ views on barriers to spontaneous adverse drug reaction reporting and to identify potential solutions to enhance reporting. A qualitative design involved 15 focus groups with 208 physicians from a tertiary teaching hospital, whose discussions were recorded and thematically analyzed. Physicians identified four main obstacles—diagnostic uncertainty, workload and time constraints, pharmacovigilance system organization, and conflict concerns—and proposed solutions such as defining reportable ADRs, simplifying contact, providing support and feedback, and fostering closer ties with the pharmacovigilance centre to improve reporting.

Abstract

To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them.A 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.Four types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADR(S) 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 reporting were to define the kind of ADR(S) 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.The perception of the different obstacles by the hospital physicians is an important factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous reporting. 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 ADR(S) in specialized healthcare.