Prescription Drugs: Monitoring, Safety, Use and Management Programs

The Prescription Drug User Fee Act authorized the Food and Drug Administration to collect user fees from industry to support the approval of new drugs and biologics. The Prescription Drug User Fee Agreement has been a success bringing safe and effective new products to patients in a timely manner as reported in chapter 1. Chapter 2 provides an overview of prescription drug monitoring programs (PDMPs), including their operation, enforcement mechanisms, costs, and financing. It also examines the effectiveness of PDMPs and outlines federal grants supporting PDMPs. Finally, it discusses relevant considerations for policymakers including interstate data sharing, interoperability, protection of health information, and the possible link between the crackdown on prescription drug abuse and rise in heroin abuse. Chapter 3 examines federally recommended and other available methods patients may use to dispose of unused prescription opioids, and what is known about patients use of these methods. Monitoring prescription drug use patterns at the population level can inform research and clinical practice. These patterns may shift over time in response to changing health needs, updated clinical guidelines, policy changes, and other factors. Chapters 4 and 5 examine statistics pertaining to drug use monitoring. Chapter 6 examines bill (H.R. 5675) to amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries.