The United States has seen a surge in deaths from overdoses of opioids, including both prescription drugs and illegal opioids such as heroin. Nonmedical users and abusers often obtain prescription opioids diverted from the legal to the illegal market. In the hope of reducing opioid use, abuse, and overdoses, policymakers have focused on developing and promoting tamper-resistant or abuse-deterrent formulations (ADFs) that render diverted opioids unusable if individuals attempt to use them for nonmedical (i.e., recreational) purposes.
Although the benefits of ADFs seem to be nonexistent, these formulations have led to real harms. ADFs have encouraged users to switch to more dangerous opioids, including illegal heroin. In at least one instance, the reformulation of a prescription opioid led to a human immunodeficiency virus (HIV) outbreak. Along the way, ADFs unnecessarily increase drug prices, imposing unnecessary costs on health insurance purchasers, taxpayers, and particularly patients suffering from chronic pain. Like the federal government’s promotion of abuse-deterrent alcohol a century ago, these efforts are producing unintended consequences, such as making legal pain relief unaffordable for many patients and possibly increasing morbidity and mortality.
Congress allows pharmaceutical manufacturers in effect to extend the patent life of opioids by introducing ADFs. The U.S. Food and Drug Administration (FDA) encourages manufacturers to develop tamper-resistant opioids. Some state legislatures have required insurance plans to cover the cost of those reformulated drugs.