Regulatory bodies expect pharmaceutical companies to maintain an up-to-date awareness of the safety implications of not only their own drugs but those from the same drug class and with the same target that are marketed by their competitors. This places significant demands on pharmacovigilance teams, who are challenged to maintain safety and compliance with limited resources amid increasingly stringent, globally diverse regulations.
In addition, the World Health Organization’s (WHO) Programme for International Drug Monitoring (PIDM) is concerned with the detection, assessment, understanding and prevention of adverse effects and other drug-related problems, such as lack of efficacy.
Despite increasingly stringent regulations, pre-marketing clinical trials designed to ensure safety do not involve a sufficiently large or diverse population and are not long enough to detect all potential safety issues. Adverse events that have a low incidence rate, or those resulting from drug-drug interactions, are thought to be responsible for up to 30% of adverse events.
In most countries, adverse event reporting is now a regulatory requirement for pharmaceutical companies and has resulted in more than 100 drugs being removed from the market in the past 40 years. However, many of these, such as Vioxx (Rofecoxib) and Meridia (sibutramine), had already been prescribed to millions of patients worldwide and adverse events remain one of the leading causes of death in the United States.
Clearly more comprehensive, systematic monitoring is required in order to detect, validate and act upon new adverse events as early as possible.
WHO defines a safety signal as: “reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously”. Pharmaceutical companies are now obliged to scan a range of credible data sources for such relationships (so-called “signal detection”), rapidly assess their validity and then – based on severity – notify the responsible regulatory bodies within a reasonable timeframe.
This places significant demands on pharmacovigilance teams, who are challenged to maintain safety and compliance with the same, or fewer, resources amid increasingly stringent, globally diverse regulations. The growing amount of data and increasingly diverse range of sources make it almost impossible to maintain a comprehensive and up-to-date understanding, with the result that the manual approach to signal detection is no longer practical.
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