March 22, 2018

Warren, Capito Introduce Reducing Opioid Risk Act

Legislation Requires Drug Companies to Educate Health Care Providers on Partial Fill Option

Bill Text | One-Pager

Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Shelley Moore Capito (R-W.Va.) today introduced the Reducing Opioids Risk Act to improve implementation of the bipartisan law they worked to pass in 2016 and to ensure that more doctors and patients know about the option to partially fill opioid prescriptions. The legislation builds on the senators' Reducing Unused Medications Act of 2016, which allows prescriptions for opioid medications to be partially filled by pharmacists at the request of patients and doctors, cutting down on the number of unused painkillers in circulation. The legislation became law as part of the Comprehensive Addiction and Recovery Act (CARA) of 2016.

When patients have the option to partially fill a prescription for opioids, they can choose to take home only a few days' worth of pills - and then return to the pharmacy for more of their prescription if their pain persists. Reducing unused prescription painkillers is a key part of tackling the opioid crisis, which has been fueled by an increase in the number of opioid prescriptions.

After the legislation became law, Senators Warren and Capito sent a series of letters to every governor in the country and major medical organizations to gather feedback on the implementation of the new partial fill option. Responses indicated that while states and medical groups are eager to increase the partial filling of prescriptions, implementation of the new law remains uneven.

"To really confront the opioid crisis, patients and their health care providers first need to know about the option to partially fill a prescription. Our bill will do just that," said Senator Warren. "I'm glad to continue working with Senator Capito to empower patients and health care providers to determine appropriate pain treatment, while reducing unused opioids in family medicine cabinets."

"Pursuing solutions on all fronts is critical to effectively ending the opioid epidemic," said Senator Capito. "Allowing the partial filling of opioid prescriptions is one way we can reduce the drug supply and prevent unused prescriptions from ending up in the wrong hands. We made progress in this area when the Reducing Unused Medications Act of 2016 was signed into law as part of CARA, and this legislation takes that effort one-step further. Health care providers are an important partner in our fight to end the drug epidemic, and our bipartisan bill will help provide them with the knowledge necessary to treat patients in a responsible and reasonable way."

The Reducing Opioid Risk Act would build on the senators' bipartisan legislation by clarifying the FDA's authority to require drug companies to educate health care providers about state and federal regulations of controlled substances, including the option to partially fill a prescription. FDA's requirements for drug companies to provide this type of education is a key component of the Risk Evaluation and Mitigation Strategies (REMS), one of the major tools used by the FDA to ensure drug safety. REMS are risk-management plans that drug companies must develop and deploy to ensure that a product can be used safely, and that the benefits of its use outweigh the risks.

See bill text here. See bill summary here.