Adverse drug reaction reporting in a pharmacovigilance centre of Nepal

Abstract

BackgroundPharmacovigilance is the "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems". Nepal joined the international pharmacovigilance programme as a full member in 2007. KIST Medical College, Lalitpur, Nepal joined the national programme as a regional centre from mid-July 2008. Currently, the pattern and scope of adverse drug reactions (ADRs) in Nepal remains unexplored. Aims To observe and analyse the pattern of ADRs at KIST Medical College, Lalitpur, Nepal. Method A retrospective analysis of all ADRs reported to the centre from mid July 2008 to July 2011 was performed. Data was analysed for ADR severity, causality, and preventability. Results A total of 113 ADR reports were obtained from various clinical departments. The maximum number of reactions was due to antimicrobials, followed by anti-hypertensives and NSAIDs. Conclusion Antimicrobials were the commonest group of drugs causing ADRs and the most commonly seen ADR was maculopapular rash followed by diarrhea and vomiting.

Pharmacovigilance Knowledge among Patients at a Teaching Hospital in Lalitpur District, Nepal

“…This finding highlights the need for this type of study in Nepal where self medication is common mostly due to lack of qualified health care professionals in most areas of the country [12,13].…”

Do community pharmacists in Nepal have a role in adverse drug reaction reporting systems?

“…8 Nepal became a full member of the International Pharmacovigilance Program in 2007. 9 Surveillance infrastructures are in place to report adverse events. For example, hospitals and various tertiary care centres report adverse drug reactions to regional centres, the regional centres report to the national centre and then final reporting is provided to the Uppsala Monitoring Centre in Sweden.…”

“…For example, hospitals and various tertiary care centres report adverse drug reactions to regional centres, the regional centres report to the national centre and then final reporting is provided to the Uppsala Monitoring Centre in Sweden. 9 An online database system called Vigibase Online is used for online reporting of adverse drug events. 10 The Nepal Drug Act 5 does not make it mandatory for the pharmaceutical industry to provide safety data from studies conducted in the Nepalese population before the approval of medicines, 9 thus a systematic and organised pharmacovigilance system is required to ensure appropriate reporting of adverse drug reactions (ADRs) and to facilitate expeditious corrective action.…”

Increasing ADR reporting in Nepal

“…I also agree that knowledge about pharmacovigilance and its importance is poor even among pharmacologists and pharmacists. Under reporting remains a problem and a previous study conducted at KIST Medical College had examined adverse drug reactions (ADRs) submitted to the centre and possible steps to improve reporting rates 2 . Communication between the centres and the reporters remains a problem.…”