Nurses' attitudes and spontaneous adverse drug reaction reporting: a case-control study in Portugal

Abstract

Aim: To identify the attitudes and knowledge associated with adverse drug reactions (ADR) under-reporting by nurses.

Background: The voluntary reporting system is fundamental for expediting the detection of ADR during post-marketing surveillance.

Methods: We performed a case-control study. A self-administered questionnaire was sent by mail to 1325 nurses. The knowledge and attitudes related to ADR under-reporting were primarily based on Inman's seven deadly sins.

Results: The overall response rate was 34.2%. Nurses working in primary care were 12-fold more likely to report an ADR. A change of attitude increased the probability of ADR reporting for:'The belief that the one case an individual nurse might see could not contribute to medical knowledge'; 'I do not know how the information reported is used by the system'; 'I would be more likely to report if the method was easier'; 'I think the most correct way to report is to inform the doctor' and 'I do not have time to think about the involvement of the drug in ADRs'.

Conclusions: Our study shows that the beliefs of nurses, such as 'one single report would not make any difference' and 'the pharmacovigilance system is very complex', act as a barrier to ADR reporting.

Implications for nursing management: It is important to clarify the ADR reporting procedure and increase the nurses reporting rate.

Keywords: adverse drug reactions; nurse attitudes; pharmacovigilance system; spontaneous reporting.