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Prescription Medicine

SAFE Takes analyzes and assesses the federal recommendations and proposals made by the White House and National Governors Association.

SAFE Takes reflects our analysis and assessment of the progress made in each of the recommendations made by the President’s Commission (Commission) on Combatting Drug Addiction and the Opioid Crisis (November 2017) and the National Governors Association’s (NGA) Recommendations for Federal Action to End the Nation’s Opioid Crisis (January 2018). The following SAFE Takes focuses on government action pertaining to prescription medicine.

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RECOMMENDATIONS S.A.F.E. TAKE
Commission #6: Various federal agencies should develop model statutes, regulations and policies with stakeholders, that ensure informed patient consent prior to an opioid prescription for chronic pain.

 

STATUS

Completed

 

While H.R. 6, SUPPORT for Patients and Communities Act, is a step in the right direction its scope is limited because it only addresses one population receiving opioids.

The Pain Management Best Practices Inter-Agency Task Force completed their Final Report as suggested by the 2018 original SAFE Take. While SAFE had concerns about this Task Forces ability to share their findings, their release shows this Commission Recommendation was fulfilled.

Many states taking initiative to pass their own laws in line with this recommendation can create more pressure for federal agencies to publish model regulations and for other states to continue passing laws to support this.

RECOMMENDATIONS S.A.F.E. TAKE
Commission #7: Health & Human Services (HHS) should coordinate the development of a national curriculum and standard of care for opioid prescribers – to supplement the Centers for Disease Control (CDC) guideline targeted to primary care physicians.

 

STATUS 

Completed

 

Healthcare providers and their patients must have enough information to help them determine if the benefit of an addictive medication outweighs the risk. The CDC guidelines were complex and long (52 pages) and created controversy over whether or not they hurt patients with unique healthcare needs who depend on opioids for chronic and acute pain. The online training aims to mitigate these issues and offers an incentive for health professionals by allowing them to earn free continuing education credits for completing courses.

H.R. 6 SUPPORT for Patients and Communities Act instructed FDA to develop evidence-based opioid analgesic prescribing guidelines (where they don’t exist), consult stakeholders and other agencies in creating them, and report on how they will be used to protect the public health. This includes a requirement to make a clear statement that the guidelines are intended to inform prescribers and patients in clinical decisions and not restrict, limit, delay, or deny coverage. The FDA has attempted to fulfill this instruction by commissioning the consensus report and gathering up to date and appropriate information.

State and institutional support highlights the importance of this recommendation and builds on the work doing by the federal agencies.

RECOMMENDATIONS S.A.F.E. TAKE
Commission #8: Federal agencies should collect participation data on prescribing patterns, matched with participation in continuing medical education (CME) data to determine effectiveness and to share with clinicians, stakeholders, and state licensing boards.

 

STATUS 

Unknown

 

Some of these organizations are better equipped to handle this than others. While state Prescription Data Management Programs can identify patterns of prescribing, these programs don’t always talk to programs in other states or federal systems.States and private entities can already do this, and some healthcare systems have already taken it upon themselves to start tracking patterns and directing educational efforts based on the results. If you would like to learn more about how to implement this kind of change locally, S.A.F.E. can help.
RECOMMENDATIONS S.A.F.E. TAKE
Commission #9:  The Administration should develop a model training program to be disseminated at all levels of medical education on screening for substance use and mental health status to identify at-risk patients.

 

STATUS

Education Organizations Leading

 

This effort seems to be moving forward primarily because of groups like the Association of American Medical Colleges (AAMC), the Accreditation Council for Graduate Medical Education (ACGME), the Accreditation Council for Continuing Medical Education (ACCME), and the other medical education organizations. This is because they have an inherent interest in it being a successful model.
RECOMMENDATIONS S.A.F.E. TAKE
Commission #10: Congress should amend the Controlled Substances Act to allow the Drug Enforcement Agency (DEA) to require that all prescribers desiring to be relicensed to prescribe opioids show participation in an approved Continuing Medical Education (CME) on opioid prescribing.

 

STATUS 

State Progress

 

State licensing boards have the ability to provide and require CMEs with this focus. Getting the Controlled Substances Act amended will take time and may not have the desired result. Supporting the states in their effort may be the better approach.
RECOMMENDATIONS S.A.F.E. TAKE
Commission #11: Health and Human Services, Department of Justice, Drug Enforcement Agency, Office of National Drug Control Policy, and pharmacy associations should train pharmacists on best practices to evaluate legitimacy of opioid prescriptions and not penalize them for denying inappropriate prescriptions.

 

STATUS 

Unknown

 

Some of these organizations are better equipped to handle this than others. The last DEA guide on prescription fraud was published in 2000 and their focus has been more on distribution than individual pharmacists. The variability of licensing and education requirements for pharmacy staff in each state would also be a factor. This is probably best achieved through an inter-agency working group.
RECOMMENDATIONS S.A.F.E. TAKE

Commission #52:  Federal agencies, including Health & Human Services (NIH, CDC, CMS, FDA, and the SAMHSA), Department of Justice, the Department of Defense, the Veterans Administration, and Office of National Drug Control Policy, should engage in a comprehensive review of existing research programs and establish goals for pain management and addiction research (both prevention and treatment).

Commission #53: Congress and the Federal Government should provide additional resources to the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to fund the research areas cited above.

STATUS

Lots of Action

 

Good News! National Institute of Health (NIH) has started the HEAL Initiative (Helping to End Addiction Long-Term) with $500 million in federal appropriations for a variety of efforts, including increased research to:

Improve Treatments for Opioid Misuse and Addiction; Expand therapeutic options for opioid addiction, overdose prevention and reversal; Enhance treatments for infants born with Neonatal Abstinence Syndrome (NAS)/Neonatal opioid withdrawal syndrome (NOWs); Optimize effective treatment strategies for opioid addiction; Enhance Pain Management; Understand the biological underpinnings of chronic pain; Accelerate the discovery and pre-clinical development of non-addictive pain treatments; Advance new non-addictive pain treatments through the clinical pipeline.

There is still a lot of shuffling of money and priorities as well as partnerships that may still be awaiting funding. Look forward to more efforts on this front.

RECOMMENDATIONS S.A.F.E. TAKE
Commission #54: Center for Medicare & Medicaid Services (CMS), Food and Drug Administration (FDA), and  United States Preventive Services Task Force (USPSTF) should implement a fast-track review process for any new evidence-based technology supporting substance use disorder (SUD) prevention and treatments (further research of Technology-Assisted Monitoring and Treatment for high-risk patients and SUD patients).

 

STATUS 

Focusing Elsewhere

 

The process for creating fast-tracking in a way that preserves that accountability could be a distraction from ongoing efforts to address the opioid crisis. Current “fast-tracking” efforts of these federal agencies are focused on growing access to existing evidence-based treatment where there are currently shortages (i.e. Medicaid Innovation Accelerator Program).
RECOMMENDATIONS S.A.F.E. TAKE
Commission #55: The Commission recommends that commercial insurers and the Center for Medicare & Medicaid Services (CMS) fast-track creation of Healthcare Common Procedure Coding System (HCPCS) codes for FDA – approved technology-based treatments, digital interventions, and biomarker-based interventions. NIH should develop a means to evaluate behavior modification apps for effectiveness.

 

STATUS 

Unknown

 

Technological interventions will only be as good as the support system ready to act when technology detects a crisis or an opportunity to intervene. If there is no support available, the person still faces a crisis alone.This is a growing area of research for many healthcare challenges, but progress specific to SUD treatment is unknown. Some of this could come up in the investment and research from recent government funding.

RECOMMENDATIONS S.A.F.E. TAKE
Commission #56:  The Commission recommends that the FDA establish guidelines for post-market surveillance related to diversion, addiction, and other adverse consequences of controlled substances.

 

STATUS

In Process

 

Understanding whether or not anti-abuse and deterrent properties of medication are functioning as designed or being overridden, as OxyContin time release coating has been, is a critical part of medicinal safety.

The FDA continues to evaluate its process to ensure safety around diversion and abuse.

In 2008, the FDA was funded to create Sentinel, another post-market surveillance program which complemented the Adverse Events Reporting System (FAERS) already in place. While the FAERS public dashboard is currently updated, some of the FAERS webpages on the FDA website contain links that are outdated or have been removed. The President’s Commission report does not mention this program in relation to this recommendation so it is unclear if it was considered in this recommendation. While originally assumed that the relaunch of the Drug Abuse Warning Network (DAWN) under the Substance Abuse and Mental Health Services Administration in 2019 would assist with this data in post-market stage, currently there is no evidence of DAWN data beyond 2014.

RECOMMENDATIONS S.A.F.E. TAKE
Commission #42: The Commission recommends further use of the National Health Service Corps to supply needed health care workers to states and localities with higher than average opioid use and abuse.

 

STATUS 
Steady Funding
 
HRSA’s National Health Service Corps (NHSC) received $105 million in Fiscal Year 2018 to expand and improve access to quality opioid and substance use disorder (SUD) treatment in rural and underserved areas nationwide. This funding was appropriated again for 2019.
RECOMMENDATIONS S.A.F.E. TAKE
Commission #31: Health & Human Services (HHS), Center for Medicare & Medicaid Services (CMS), Substance Abuse and Mental Health Services Administration (SAMHSA), the Veterans Administration (VA), and other federal agencies should incorporate quality measures that address addiction screenings and treatment referrals. HHS should review the scientific evidence on the latest opioid use disorder (OUD) and SUD treatment options and collaborate with the U.S. Preventive Services Task Force (USPSTF) on provider recommendations.

 

STATUS 
Some Progress
 
SAMHSA’s Treatment Improvement Protocol (TIP) 63: Medications for Opioid Use Disorder, updated in 2020, offers screening, assessment, treatment and referral guidelines for primary care settings.

HR 6 Support for Patients and Communities Act includes a demonstration project to increase access to comprehensive, evidence-based outpatient treatment for Medicare beneficiaries with opioid use disorders and includes the development of measures of quality and outcomes for treatment, but does not specifically address measures for screening and referrals.

RECOMMENDATIONS S.A.F.E. TAKE
NGA: The Drug Enforcement Agency should remove the requirement for medical residents to apply for federal waiver to prescribe buprenorphine – already practicing under physician supervision.

 

STATUS
Slow Moving, But Gaining Popularity
 
Currently, doctors and other healthcare providers made recently eligible under H.R. 6 Support for Patients and Communities Act, must go through training to receive a waiver to prescribe buprenorphine, an opioid agonist, used to treat opioid use disorder. The hurdles to treat an opioid use disorder are much greater than the hurdles to prescribe the opioids that lead to such a disorder. In order to increase access to this important tool in treating OUD, laws have been changed to increase the number of patients that a waivered provider can treat and the types of providers that can use waivers, but the requirement to receive the training and apply for a waiver remains in place.

Despite no official legislation passed to remove the waiver, there is clear momentum. The letter sent by officials from New York, New Mexico, Idaho, Louisiana, Maryland, Indiana and Oregon highlights state’s interests while the proposed bill not only expressed the desires of states and Congress members, but underscores the bipartisan support behind this effort. Several other entities support this effort as well.