On March 11, the Senate voted 94-1 to approve the Comprehensive Addiction and Recovery Act (CARA), aimed at fighting heroin and prescription opioid abuse. The bill would allow hospitals and other healthcare facilities to apply for federal and state grants to establish safe prescription drug disposal programs. The act will also fund expanded prescription drug monitoring programs (PDMP) and use of naloxone to treat opioid overdoses.
CARA represents three years of bipartisan work and authorizes up to $725 million in funding to tackle the opioid crisis. While the bill doesn’t provide the funding itself, it would utilize $400 million was appropriated by the Senate to combat opioid addiction last December.
CARA’s provisions include:
- Issuing grants to hospitals, pharmacies, and clinics to establish prescription medication disposal sites.
- Improving state PDMPs to help physicians monitor and track drug diversion and stay more informed about a patient’s prescription history.
- Expanding the availability of naloxone, a drug used to reverse opioid overdoses, to law enforcement agencies and other first responders. CARA would also provide more liability protection for responders using naloxone.
- More funding towards treating incarcerated individuals suffering from drug addiction.
- More funding towards treating veterans suffering from drug addiction.
- Giving federal, state and local grants to non-profits organizations working on opioid prevention and treatment.
- Launching an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country.
- Launching a medication-assisted treatment and intervention demonstration program.
There had been a push to attach an extra $600 million in emergency funding to the bill, but the proposal was voted down. CARA still needs approval by the House, though most think it will pass.
“I don’t know of a single specific objection on the House side, and they’d be very hard-pressed to find one,” Sen. Sheldon Whitehouse (D-R.I.), who co-authored the bill, told reporters. The overwhelming Senate vote in favor of the bill, he added, should quell any fears in the House about being criticized for supporting the measure.
The Joint Commission has added new requirements for opioid treatment programs accredited under its Behavioral Health Care Program.
The requirements go into effect on July 1, 2016 and are aligned with the Substance Abuse and Mental Health Services Administration’s Federal Guidelines for Opioid Treatment Programs.
The changes are in the Care, Treatment, and Services, Emergency Management, Human Resources Management, Leadership, Medication Management, and Rights and Responsibilities of the Individual chapters in the Comprehensive Accreditation Manual for Behavioral Health Care Organizations.
With opioid addictions and deaths on the rise, members of the National Governors Association (NGA) recommended that physicians be given a limit to the number of opioids they can prescribe. On February 22, the association presented its proposal to President Obama, who politely rejected it, saying that sometimes painkillers are the only effective treatment for patients.
“If we go to doctors right now and say ‘Don’t overprescribe’ without providing some mechanisms for people in these communities to deal with the pain that they have or the issues that they have, then we’re not going to solve the problem, because the pain is real, the mental illness is real,” Obama said. “In some cases, addiction is already there.”
The NGA also hadn’t developed a solid number to cap prescriptions at, and Obama said that any attempt to limit prescriptions needs to be a part of a comprehensive approach.
The president’s opinion was supported by Steven Stack, the president of the American Medical Association.
“The complexity of the problem makes it difficult to create a successful one-size-fits-all approach,” Stack said in a statement.
Obama applauded the NGA’s bipartisan commitment to ending the opioid crisis, which the Centers for Disease Control and Prevention now reports kills 78 Americans per day.
Amidst the growing opioid epidemic, the Food and Drug Administration (FDA) has now released details about its Opioid Action Plan. The fact sheet details the agency’s policy changes and the outcomes it hopes will result.
Expanding use of advisory committees
- The FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.
- The Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved.
- The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when it raises novel issues.
Outcome:Before the approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling, it will be reviewed by external experts who will give advice on the drug. In addition, there will be opportunity for public input for every new opioid.
Develop warnings and safety information for immediate-release (IR) opioid labeling
- The agency is developing changes to IR opioid labeling, including additional warnings and safety information, similar to the labeling for extended-release/long-acting (ER/LA) opioid analgesics.
Outcome:Better information for doctors about the risks and how to prescribe safely.
Strengthen postmarket requirements
- There is a substantial lack of an evidence base to guide the use of opioid medications, particularly for their long-term use.
- The agency is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids.
Outcome:Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.
Update Risk Evaluation and Mitigation Strategy (REMS) Program
- ER/LA opioids are currently subject to a REMS program that requires sponsors to fund low-cost or free continuing medical education courses on the appropriate use of ER/LAs.
- The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements.
Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs to decrease inappropriate opioid prescribing.
Expand access to ADFs to discourage abuse
- The FDA will issue draft guidance with its recommendations for the approval standards for generic ADFs.
- Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs.
Outcome:Spur innovation and generic ADF product development.
Support better treatment
- The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone.
- The FDA also supports the Centers for Disease Control and Prevention guidelines for prescribing opioids and will facilitate the development of evidence and improved treatments.
Outcome:Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.
Reassess the risk-benefit approval framework for opioid use
- The FDA will seek advice from its Science Board in March 2016 on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them.
- The FDA is already working with the National Academies of Sciences, Engineering, and Medicine on the same topic.
- Once completed the reports will be made publicly available.
Outcome:Formal incorporation of the broader public health impact of opioid abuse in approval decisions.
The Centers for Disease Control and Prevention (CDC) formally announced a draft of its new opioid prescribing guidelines on December 14. The guidelines aim to stem the rise of opioid addiction in the U.S. while still providing pain relief to patients who need it. Some of the key provisions of the CDC guidelines are:
• Consider the use of non-pharmacologic therapy and non-opioid therapy for chronic pain. Opioids should only be prescribed if the expected benefits for pain and function are greater than the risks.
• Establish treatment goals before starting long-term opioid therapy. Physicians should only continue prescribing opioids if there is “clinically meaningful improvement” that outweighs safety risks.
• When starting opioid therapy, doctors should prescribe short-acting opioids instead of extended-release, long-acting opioids.
• When opioids are started, doctors should prescribe the lowest possible effective dosage.
• When prescribing for acute pain, the lowest effective dose of short-acting opioids should be prescribed and only in quantities for the expected duration of the pain.
• Patients should be evaluated within one to four weeks of beginning long-term opioid therapy, and be reevaluated at once every three months afterwards to assess benefits and harms of continued treatment.
The opioid guidelines have been postponed to later in the year. Within days of being release, the guidelines were criticized as unfairly restrictive to patients needing pain care. The CDC will have the National Center for Injury Prevention and Control’s Board of Scientific Counselors review the guidelines and public comments on January 7. The comment section is still open at this time.