Reporting of adverse drug reactions: a study among clinicians

ABSTRACT

Adverse drug reactions [ADRs] are an important public health problem. Serious ADRs lead to morbidity and mortality and considerable economic burden on the society and healthcare systems. Only 6-10% of all ADRs are reported. Spontaneous reporting of ADRs enhances detection of serious, unexpected and unusual ADRs. Health care professionals play an integral role in the success of the safety surveillance of drugs. This study aimed to investigate knowledge, practice and factors affecting ADR reporting among clinicians. A cross sectional study was carried out among all the clinicians of Gulf Medical College Hospital and Research Centre [GMCHRC] irrespective of their gender, specialization and experience. A validated self-administered questionnaire was used to assess the knowledge, practice and factors influencing ADR reporting. The questionnaire was distributed among clinicians during their duty hours, who were given adequate time to fill in the forms. The filled in self-administered questionnaire was returned by only 42 clinicians. The 42 clinicians included in the study comprised more than 50% males, had a mean age 36 +/- 8 years and represented a multi-ethnic population of varying clinical experience. The most frequent ADR the clinicians had come across was rashes. The commonly implicated drugs were antibiotics and analgesics. With regard to ADR reporting, the majority of the clinicians correctly identified which of the ADRs had to be reported and the individuals who can report ADRs. Very few clinicians had reported ADRs to the Pharmacovigilance Centre. The common factor discouraging reporting of ADR was that most clinicians did not know how to report ADRs [71%]. A majority of the clinicians were willing to undergo training on this aspect. The study revealed the existence of under-reporting of ADRs, but also the willingness of clinicians to be trained in ADR reporting and thus contributing to the Pharmacovigilance program