The Role of the US Food and Drug Administration’s Patient Information Initiative in Cost-Effective Drug Therapy

Summary

The use of drug and biological products often entails complex risk-benefit deliberations by prescribers. Yet. there is often little or no information shared by prescribers or dispensers with patients about the potential risks and benefits of taking a prescription drug as part of the patient’s therapeutic regimen. In 1994, drug-related morbidity and mortality has been estimated to cost $US76.6 billion. The largest component of this cost was associated with patient misadventures with their prescription medications. Industry experts, practitioners, and consumers agree that patients must have some basic information about prescription drugs to adhere successfully to their prescribed drug therapy. Patients today are discharged from hospitals more quickly than in the past and are expected to assume greater responsibility for their own care on discharge. Recently, there has been new and encouraging evidence that a greater percentage of patients are now receiving written information with their prescriptions. Developments in computer technology have made it relatively easy for pharmacies and physicians’ offices to store and generate written information for patients.

The US Food and Drug Administration (FDA) believes written information should be used to support, enhance and reinforce oral counselling. The FDA also believes that improved patient education will improve adherence to prescribed regimens and will give patients the information they need to make truly informed decisions about the drugs they take, thereby decreasing costly and unnecessary physician visits and hospitalisations.