The visibility of Adverse Drug Events (ADEs) data for physicians is insufficient, making it difficult for them to adjust their prescribing practices, perpetuating the occurrence of preventable error-related injuries and their associated liability risks.

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Adverse Drug Events (ADEs) are the largest single category of adverse events in hospitalized patients responsible for 19% of all injuries. An estimated 380,000 to 450,000 preventable ADEs occur annually in U.S. hospitals. The incremental cost of an ADE was estimated to be $5857 22 years ago (Bates, 1997) and is undoubtedly higher today. This places the estimated cost of ADEs at $3.5 billion a year and $25 billion a year if unreported ADEs are considered. In inpatient settings, ADEs account for 1 in 3 of all hospital AEs, affect about 2 million hospital stays a year and prolong hospital stays by 1.7 to 4.6 days.

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 In outpatient settings, ADEs account for over 3.5 million physician office visits and 1 million emergency department visits a year and approximately 125,000 hospital admissions a year. High-priority targets of the National ADE Action Plan include bleeding linked to anticoagulants, hypoglycemia associated with diabetes agents and opioid overdose. The financial burden of pharmacovigilance activities has been steadily increasing over the last decade. The main drivers include more stringent regulatory requirements, increasing incidence and prevalence of adverse drug reactions due to demographic changes and liability resulting from high-profile product failures. Yet, other stakeholders in the healthcare ecosystem such as physicians, pharmacists, hospital administrators, and patients remain underappreciated and underserved by current pharmacovigilance practice.

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