Pharmacovigilance: Importance, concepts, and processes

Adverse drug reactions (ADRs) were suggested to be the cause of over 100,000 deaths in 1994 in the United States.1 A study conducted in England found that between 1999 and 2008, ADRs were associated with 0.9% of all emergency hospital admissions and 26,399 deaths.2 A comprehensive meta-analysis indicated that ADRs may occur in 16.9% of hospitalized patients.3 Therefore, knowledge, minimization, and prevention of undesirable and harmful effects of medicinal products are important objectives of successful pharmacotherapy. Pharmacists in both community and institutional settings commonly encounter reports of adverse events. (The distinctions among adverse event, adverse effect, and adverse reaction are described later in this article.) However, the extent of pharmacists’ participation in reporting adverse events is largely unknown. A survey of 377 Texas pharmacists found that 67.9% of them had never reported an adverse event and 65.7% had inadequate knowledge about the reporting process.4 Other studies have suggested a lack of awareness about and experience with adverse-event reporting in both professional pharmacists5 and pharmacy students.6–8