Reporting of adverse drug reactions: predictors of under-reporting in Malaysia.
BACKGROUND
Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood.


OBJECTIVE
To identify factors, which would predict physicians' failure to send ADR reports.


METHODS
Face-to-face interview using a structured questionnaire involving physicians working at the University of Malaya Medical Centre, Malaysia.


RESULTS
About a third of the physicians in the Centre participated. Sixty-five of the 415 approached refused to participate. A high proportion of the respondents (81.4%) indicated that they had suspected an ADR but did not report it, while about 40% of the respondents were not aware of the existence of the national reporting system in Malaysia. Logistic regression modelling identified the variable 'ADR considered to be too trivial or too well known to report' as the strongest predictor of not reporting, followed by physicians' category and uncertainty that the reaction had been definitely caused by a drug.


CONCLUSIONS
Important predictor variables, which limit physicians from reporting ADR in Malaysia, were related to uncertainty of types of reaction to report, lack of awareness about the existence, function and purpose of national ADR reporting. The findings could be useful for planning strategies to improve the reporting rate.
Aziz
Zoriah
Z
Department of Pharmacy, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. zoriah@um.edu.my
Siang
Tan Ching
TC
Badarudin
Nurul Suhaida
NS
D000046:Academic Medical Centers / Q000706:statistics & numerical data*; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D001291:Attitude of Health Personnel; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D016015:Logistic Models; D008296:Malaysia; D008297:Male; D010819:Physician's Role; D011237:Predictive Value of Tests; D011795:Surveys and Questionnaires