Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group

Abstract

Objectives: This survey was conducted to assess the attitudes of medical practitioners in the European Union regarding their national spontaneous reporting scheme, to identify reasons for under-reporting and to determine what steps might be effective in increasing reporting rates. National spontaneous reporting schemes rely on health care professionals reporting individual cases of suspected ADRs to a central or regional agency. National schemes, however, vary considerably and reporting rates and patterns differ between member states. Accumulating evidence suggests that doctors' attitudes to national ADR reporting schemes are significant determinants of reporting rates.

Methods: A self-administered questionnaire and letter of invitation was sent to a random sample of approximately 1% of medical practitioners in each of nine EU member states (Denmark, France, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden and the UK). One month later, a reminder letter and a second copy of the questionnaire was sent to the non-responders (except Denmark and Italy).

Results: Response rates, and the percentage of responders who stated that they had reported previously an ADR, varied substantially between countries. Issues that appeared to discourage reporting included lack of availability of report forms; the address or telephone number of the reporting agency; lack of information on how to report; and not having enough time to report. Issues which did not apparently discourage reporting included concern about patient confidentiality; fear of legal liability or appearing foolish; reluctance to admit that harm had been caused to a patient; and ambition to collect and publish a personal series of cases.

Conclusions: The results of this survey demonstrate some of the advantages and disadvantages of transnational, multilingual studies of this type, but indicate that there is scope for the further development of such techniques and their use on a wider basis in the EU and elsewhere.