Reporting of adverse drug reactions: predictors of under-reporting in Malaysia.
Pharmacoepidemiol Drug Saf
; 16(2): 223-8, 2007 Feb.
Article
en En
| MEDLINE
| ID: mdl-16947117
ABSTRACT
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. DESIGN ANDSETTING:
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.CONCLUSION:
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.
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Banco de datos:
MEDLINE
Asunto principal:
Rol del Médico
/
Sistemas de Registro de Reacción Adversa a Medicamentos
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
/
Centros Médicos Académicos
Tipo de estudio:
Prognostic_studies
/
Qualitative_research
/
Risk_factors_studies
Límite:
Female
/
Humans
/
Male
País/Región como asunto:
Asia
Idioma:
En
Año:
2007
Tipo del documento:
Article