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


CONCLUSIONS
It is important to clarify the ADR reporting procedure and increase the nurses reporting rate.
Northern Pharmacovigilance Center, Center for Health Tecnology and Services Research (CINTESIS), Faculty of Medicine, University of Porto, Portugal.
Joana Isabel O
JI
Mendes Marques
Faculty of Medicine and CINTESIS, University of Porto, Porto, Portugal.
Jorge Manuel J
JM
Polónia
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain.
Adolfo G
AG
Figueiras
Health Information and Decision Sciences Department and CINTESIS, Faculty of Medicine, University of Porto, Portugal.
Cristina Maria N
CM
Costa Santos
Institute for Research in Biomedicine - iBiMED Health Sciences, University of Aveiro, Aveiro, Portugal.
Maria Teresa F
MT
Herdeiro
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D001291:Attitude of Health Personnel; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009726:Nurses / Q000523:psychology*; D060735:Pharmacovigilance; D011174:Portugal; D011795:Surveys and Questionnaires
adverse drug reactions; nurse attitudes; pharmacovigilance system; spontaneous reporting