Communication of Drug Hazard Information: A Critical Analysis of the Relationship between the Pharmaceutical Industry,FDA,Clinicians,and Patients and the Impact on Patient Safety

Abstract

Adverse drug events (ADE) are common, costly, and responsible for significant morbidity and mortality among hospitalized patients. They are a leading cause of death, accounting for up to 106,000 American deaths annually. Our healthcare system relies on accurate reporting of ADE by clinicians to the pharmaceutical companies, and by the companies to the FDA. The system also relies on the pharmaceutical companies providing accurate and complete warnings and contraindications to physicians and patients. Frequently, however, these risks are not effectively communicated to those who prescribe and take the medications. A critical evaluation of the American drug hazard management system reveals several factors that contribute to these shortcomings and therefore impact patient safety. These system components interact to increase the probability of adverse drug events and accordingly, impact consumer safety.