New Tools in the Fight
Published on 29 March 2017
In recent years, there has been a growing national conversation surrounding the use and abuse of opioids. The rate of deaths due to drug overdoses has been on a steady rise, surpassing car accidents as the number one cause of injury death, according to the U.S. Drug Enforcement Administration. In 2014, the National Center for Health Statistics at the Centers for Disease Control and Prevention reported deaths resulting from overdoses of prescription opioids had more than tripled since 2001. In response to the epidemic, and with bipartisan support, Sen. Sheldon Whitehouse (D-RI) introduced sweeping legislation to tackle the problem. After successful passage by Congress, the Comprehensive Addiction and Recovery Act of 2016 (CARA), S.524, was signed into law by President Barack Obama on Friday, July 22, 2016.
The first federal addiction legislation passed in 40 years, the 85-page act takes a sweeping approach to opioid addiction and addresses prevention, education, law enforcement, treatment and recovery. The legislation creates mechanisms to enhance and improve research, data collection and law enforcement. It also provides grant funding for the creation and implementation of tools and education. According to a press release issued by Whitehouse’s office, “The Comprehensive Addiction and Recovery Act establishes a range of policies to prevent and treat addiction to opioid drugs, including programs to increase education on drug use, to expand medication-assisted treatment, to improve prescription drug monitoring programs, and to promote comprehensive state responses to the opioid crisis.” The legislation also recognizes the important role pharmacists play in addressing the crisis.
Expanding the Conversation
CARA outlines provisions to establish an inter-agency Task Force on Pain Management. The task force, including representatives of the Department of Health and Human Services, Department of Veterans Affairs, Department of Defense, Office of National Drug Control Policy, as well as pharmacists, researchers, and experts in pain management and addiction, will review contemporary research and establish best practices to advance drug abuse awareness and education. The legislation also creates a special Food and Drug Administration (FDA) advisory committee to review applications for new opioids and provide recommendations prior to approval. Additionally, it requires the FDA Pediatric Advisory Committee to provide recommendations on the labeling of opioids for pediatric patients.
Improving Access to Treatments
To improve access to overdose reversal medications, CARA provides grant funds to support the establishment of prescribing programs, offset the costs of treatments, establish protocols to connect patients to treatment services, and provide training for providers, pharmacists and first responders. States may also receive funding to implement strategies that allow pharmacists to dispense opioid overdose reversal medications pursuant to standing orders.
Fostering New Research
With an eye toward the future, CARA authorizes the National Institutes of Health (NIH) to coordinate “fundamental, translational and clinical research” to expand the current understanding of pain, develop new therapies for the treatment of chronic pain and develop alternatives to opioids. Evan Kharasch, M.D., Ph.D., director of the Center for Clinical Pharmacology explains that the center, a collaboration between St. Louis College of Pharmacy and Washington University School of Medicine in St. Louis, was established for just this type of research. “Opioids are among the oldest and most effective drugs available to treat acute and severe pain,” Kharasch said. “Much of the science we have today was not available when these drugs were developed. There are unmet needs for better and safer ways to use existing opioids, develop new and safer opioids, and non-opioid pain medicines.”
Improving Drug Monitoring
CARA also seeks to improve drug monitoring programs by reauthorizing the National All Schedules Prescription Electronic Reporting (NASPER) Act of 2005. CARA also provides grants to states (or local governments where state programs have not been legislated) for the establishment, implementation or improvement of prescription drug monitoring programs (PDMPs). The grants incentivize states to create integration and information sharing mechanisms between PDMPs and national abuse agencies to better identify patients in need of treatment services.
Expanding Prevention Efforts
CARA supports the prevention of prescription medication abuse by supporting the expansion of drug take-back programs. By creating additional disposal sites at locations such as community, hospital and health-system pharmacies, law enforcement agencies, and long-term care facilities, the act seeks to reduce the rate of opioid abuse through the safe disposal of unwanted prescriptions. “By expanding take-back programs in our cities and communities, patients will have greater access to resources to dispose of unused opioids, which will help prevent accidental poisonings and decrease diversion of these powerful medications,” said Amy Tiemeier, Pharm.D., BCPS, director of community partnerships and associate professor of pharmacy practice.
The act also includes a provision that allows for the partial fill of opioid prescriptions. By reducing the amount of medication a patient is issued at one time, lawmakers hope to reduce drug abuse and diversion. Although the act has been widely praised, there are concerns as well. Stakeholders note the lack of funding for provisions and programs. The $920 million in funding for CARA was voted down in the House of Representatives before the bill reached the Senate. Although the legislation would authorize $181 million in spending each year, funding is not attached to the final bill and must be authorized through the appropriations process each year. Despite concerns, stakeholders, advocates and health care practitioners agree that CARA is a step forward in the ongoing fight against opioid addiction.