BACKGROUND Pharmacovigilance 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 patt...

Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality and contribute to the incidence of adverse events, resulting in increased healthcare costs. Healthcare providers need to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, all essential activities for optimizing patient safety. The purpose of this article is...

On June 13, 2009, proposed regulations amending the Food and Drug Regulations1 with respect to adverse drug reaction reporting (“Proposed Regulations”) were published in the Canada Gazette. The Proposed Regulations permit more rigorous monitoring of drug safety by the Minister of Health and bolster the Minister’s ability to enforce Canada’s reporting requirements for adverse drug reactions.2 Un...

An article in the National Post on suicidal effects associated with varenicline (Champix) highlights deficiencies in the Canadian spontaneous reporting system (SRS) for adverse drug reactions (ADRs). The issues of under-reporting, poor quality information, duplication of reports and lack of a population denominator of drug use are discussed. Canada's SRS is deficient. There are immediate and me...

OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction...

Globally, adverse drug reactions (ADRs), one of the leading causes of morbidity and mortality, will continue to pose a threat to public health as long as drugs are being used to treat various ailments. Prompt ADR reporting is crucial in ensuring drug safety. The aim of this narrative review was to highlight the role of pharmacists in pharmacovigilance and to identify barriers and facilitators t...

BACKGROUND Severe adverse drug reactions (ADRs) are an important cause of childhood morbidity and mortality. 95% of ADRs are likely not reported, less than 25% of marketed drugs can be advertised as safe and effective in children; yet over 50% of Canadian children receive prescription drugs annually. OBJECTIVES To increase understanding of reported ADRs in Canadian children. METHODS A retro...

background pharmacovigilance (pv) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. this paper describes the pv systems of india, uganda and south africa based on literature and key informant (ki) interviews and compares them with the world health organization’s (who’s) minimum pv requirements for a functional national pv syste...

user-generated medical messages on internet contain extensive information related to adverse drug reactions (adrs) and are known as valuable resources for post-marketing drug surveillance. the aim of this study was to find an effective method to identify messages related to adrs automatically from online user reviews.we conducted experiments on online user reviews using different feature set an...