Opioid Controls: Regulate to Educate

Abstract

Successful marketing of “designer” opioids (new formulations to either extend activity or speed onset) contributed appreciably to the vast increases in opioid prescribing for pain that occurred in the United States in the 1980s and 1990s [1]. Some in the medical community were persuaded that because the new formulations could produce a steady state, thus avoiding peak concentrations, they were less likely to cause addiction and could be used safely and effectively for long-term treatment of chronic pain [2]. Extending opioids to patients with chronic pain had clear advantages in terms of the market: chronic pain is commonplace, and it lasts forever. Regulations that require clinicians to be registered and monitored when prescribing controlled substances had countered misuse of prescription opioids fairly effectively throughout most of the 20th century. But with the recent precipitous rise in opioid prescribing, prescription opioid misuse increased in parallel [3]. Prescription opioid abuse, misuse, overdose, and death rates have all proliferated, often spreading from the individuals receiving treatment, to those around them [4]. Prescription opioids freely available in the community led to more misuse. Prescription opioid misuse is now seen by the regulatory authorities as a societal problem of enormous proportions and one that needs urgent intervention. Since immediate action is warranted, it has been decided that the Food and Drug Administration (FDA) should act under authority already in place given to it by the 2007 FDA Amendments Act. Under this authority, the FDA will require drug companies to develop, use, and continuously evaluate new Risk Evaluation and Mitigation Strategies (REMS). Previous REMS had focused on informing prescribers …