Abstract
The aims of pharmacovigilance are early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescribing and regulation. The pharmacovigilance programme in Nepal is a recent development. The Department of Drug Administration (DDA) took the initiative to set up a pharmacovigilance program in 2002; however, it was initiated systematically only after two years. DDA acts as the National Pharmacovigilance Centre (NPC). It collects ADR case reports from the Regional Pharmacovigilance Centre (RPC). Currently there are six RPCs operating in the country. The current reporting trends suggest high under-reporting of suspected ADRs. This paper is a review of those studies which are focused on pharmacovigilance and healthcare professionals’ perspectives on ADR reporting in Nepal. It also recommends the possible ways to improve the ADR reporting based on the context of Nepal.DOI: http://dx.doi.org/10.3126/nje.v3i1.8286 Nepal Journal of Epidemiology 2013;3 (1): 230-235
Highlights
The thalidomide tragedy of 1960s was a disastrous incident that shed light on the lapses of drug safety assurance
Pharmacovigilance aims for early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescription and regulation
We conducted a search on the Pubmed database and Google Scholar using search terms such as pharmacovigilance, adverse drug reaction, adverse drug reaction monitoring combined with programmes in Nepal
Summary
The thalidomide tragedy of 1960s was a disastrous incident that shed light on the lapses of drug safety assurance. It is near unattainable to be able to rule out all possible adverse effects of the drug which may occur in the real world In most cases, it is beyond the scope of clinical trials. Exposure of limited human subjects, in most of the cases less than 5000 subjects which is only favorable to detect the more common types of ADRs. In reality, clinical trials cannot provide information on rate or very rare types of ADRs. A large sample size is required to detect such types of ADRs, which is normally calculated by “rule of 3” 8. Even well-designed clinical trials cannot provide overall drug safety information. Strict requirement of informed consent in case of pharmacovigilance research may lead to selection bias and reduced response rates, which leads to invalid results
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call