Annual Report Issue - September 2015

This issue of QuarterWatch™ provides an overview of prominent drug safety issues as reflected in 833,076 adverse drug events reported to the U.S. Food and Drug Administration during 2014. For this annual review, we identify the drugs that account for the most reports overall and in key subgroups such as children, cases from legal claims, and reports indicating product problems. For each perspective it is important to consider both the insights revealed and the substantial limitations of the underlying data.

Although drug adverse effects are estimated to account for 100,000 to 200,000 patient deaths and 1 to 2 million hospitalizations each year, neither the FDA nor the Centers for Disease Control and Prevention publishes annual assessments of serious injury and death resulting from drugs in therapeutic use. Despite a world of proliferating digital data, the primary source for identifying injuries from therapeutic drugs remains the voluntary reports to the FDA’s Adverse Event Reporting System (FAERS). The QuarterWatch™ assessment is based on publicly released excerpts of case reports submitted for the first time in 2014.

The U.S. system for postmarket surveillance depends primarily on reports prepared by drug manufacturers. The types of reports that the FDA received in 2014 are described in Table 1. In 2014, manufacturers submitted 798,962 (95.9%) of the reports that the FDA received. The remaining 34,114 (4.1%) cases were submitted directly to the agency’s MedWatch drug information program portal by consumers and health professionals.

Any individual who desires to report an adverse drug event has the option of either submitting one directly to the FDA or contacting a drug manufacturer. Manufacturers, in turn, are required to report every adverse event they learn of through any channel that could range from a consumer help-line telephone contact to a refill reminder that was returned indicating the patient had died. The strength of the system is that it collects information from a wide array of sources that range from episodes observed by hospital pharmacists to legal claims for drug-induced injury filed in state and federal courts. Reporting events to the FDA is closed to no one.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the US 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.