Abstract
Purpose: The aim of the study was to evaluate the opinions and concerns of hospital doctors about adverse drug reactions (ADRs) and pharmacovigilance. Methods: A qualitative study was undertaken using focus groups in sessions on pharmacovigilance activities conducted in thirteen clinical services of a tertiary university hospital. A total of 296 physicians participated in these sessions by giving their opinions or expressing their doubts about ADR and pharmacovigilance activities which were recorded by different observers and subsequently analysed. Results: Doctors remarked on: a) the importance, concern, frequency and specific types of ADRs that were observed in clinical practice; b) problems of clinical decision making related to the suspected ADRs; c) methods for improving detection and reporting ADRs; d) monitoring of specific ADRs or ADRs caused by specific drugs; e) and measures to prevent and minimize the risk of ADRs. Physicians expressed doubts related to: a) the basic concepts of ADRs; b) the methods of ADR identification and evaluation; c) the objectives and procedures of pharmacovigilance programmes; d) and the impact of pharmacovigilance activities. Conclusions: Hospital doctors believe that ADRs are a matter for concern in their daily clinical practice, and monitoring ADRs as well as measures for preventing the risk of ADRs are needed. Nevertheless, doctors have doubts about what an ADR is, the accuracy of diagnostic methods, the development of pharmacovigilance activities and their impact on clinical practice. Pharmacovigilance should be better explained through a continuous feedback and close relationship with hospital doctors.
Highlights
Adverse drug reactions (ADRs) are a relevant problem in health care, and in the hospital setting [1,2,3]
Impact of ADRs on clinical practice: Doctors often stated that ADRs were important in their experience from a clinical perspective in terms of concerns, frequency, and clinical consequences
Doctors usually talked about characteristics of ADRs seen in their practice with particular emphasis on the drugs most used in their area of clinical expertise
Summary
Adverse drug reactions (ADRs) are a relevant problem in health care, and in the hospital setting [1,2,3]. It is important to know the opinions, perceptions and attitudes of hospital doctors with respect to ADRs because their knowledge can help to improve the spontaneous reporting of ADRs. Several studies have assessed the knowledge, behaviour and attitudes of physicians regarding ADRs and their reporting to the pharmacovigilance systems [7,8,9,10,11,12,13,14]. Several studies have assessed the knowledge, behaviour and attitudes of physicians regarding ADRs and their reporting to the pharmacovigilance systems [7,8,9,10,11,12,13,14] Those studies have not evaluated the doubts, uncertainties, misunderstandings and misconceptions that medical doctors may have about ADRs and pharmacovigilance systems, which are barriers to the development of pharmacovigilance activities. The objective of our study was to analyze the opinions and doubts that hospital doctors have about ADRs and pharmacovigilance activities
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