Kj. Belton et al., ATTITUDE SURVEY OF ADVERSE DRUG-REACTION REPORTING BY HEALTH-CARE PROFESSIONALS ACROSS THE EUROPEAN-UNION, European Journal of Clinical Pharmacology, 52(6), 1997, pp. 423-427
Objectives: This survey was conducted to assess the attitudes of medic
al practitioners in the European Union regarding their national sponta
neous 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 professio
nals reporting individual cases of suspected ADRs to a central or regi
onal agency. National schemes, however, vary considerably and reportin
g rates and patterns differ between member states. Accumulating eviden
ce suggests that doctors' attitudes to national ADR reporting schemes
are significant determinants of reporting rates. Methods: A self-admin
istered questionnaire and letter of invitation was sent to a random sa
mple of approximately 1% of medical practitioners in each of nine EU m
ember states (Denmark, France, Ireland, Italy, the Netherlands, Portug
al, Spain, Sweden and the UK). One month later, a reminder letter and
a second copy of the questionnaire was sent to the non-responders (exc
ept Denmark and Italy). Results: Response rates, and the percentage of
responders who stated that they had reported previously an ADR, varie
d substantially between countries. Issues that appeared to discourage
reporting included lack of availability of report forms; the address o
r 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 confid
entiality; 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 t
his survey demonstrate some of the advantages and disadvantages of tra
nsnational, 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.