Annual Report Issue - July 2017

This year’s QuarterWatch™ annual report issue focuses on drugs and specific adverse reactions that affect large patient populations and involve substantial numbers of serious injuries. In the absence of any official or unofficial systematic assessments of overall harms attributable to the therapeutic use of drugs, we examine notable signals of significant drug risks as reflected in 1.2 million adverse drug event reports received by the U.S. Food and Drug Administration (FDA) in 2016.  Key findings are described below.

Key Findings

• The types of injuries reported in 2016 affected every body system and include severe damage to the kidneys and liver, fatal cardiac events, cancer, potentially life-threating allergic reactions, as well neuropsychiatric effects such as depression, suicidal thoughts, and aggressive and violent acts. Although these largely voluntary reports capture only a fraction of the severe injuries that occur, the therapeutic use of drugs constitutes a major public health risk of the same order of magnitude as illicit use of drugs or violent crime.
• Exposure of the U.S. population to therapeutic drugs is extensive. In 2016, a total of 4.5 billion outpatient prescriptions were dispensed, a 1.9% increase over 2015, according to QuintilesIMS. Of that total, 89.5% were for generic drugs, the remainder for brand name drugs.
• Harms from oral anticoagulant drugs earn rank as the highest priority drug safety problem in 2016 by several measures.
• Patients who stop taking a wide variety of psychoactive drugs, including  antidepressants, sedatives/hypnotics, and opioids are at risk for withdrawal symptoms.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.