New Updated! The Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Improvement Protocol (TIP) 63: Medications for Opioid Use Disorder
First released by SAMHSA in 2018, the focus of Treatment Improvement Protocol (TIP) 63 is to inform treatment providers about the use of three Food and Drug Administration (FDA) approved medications used to treat opioid use disorder (OUD) — methadone, naltrexone, and buprenorphine — and the other strategies and services needed to support recovery. As is the case with all TIP manuals, TIP 63 is the result of efforts to develop topic-specific best-practice guidelines for behavioral health providers. TIP manuals represent the consensus of a panel of clinical, research, and administrative experts who draw upon their experience and knowledge to “convey ‘front-line’ information quickly but responsibly” and provide citations for research that supports approaches.
Tip manuals are updated or revised periodically to reflect new research in the field. Research is ongoing in any field and updates to publications may not necessarily keep pace with research. TIP 63 was reviewed, updated, and published in June 2019 and in 2020. The new July 2021 publication is a revision. This is very fortunate for behavioral health providers across the U.S. who are providing treatment and other services as it means that through TIP 63, they have access to the very latest empirically based treatment modalities and related information. The intended audiences for TIP 63 include:
- Healthcare professionals (physicians, nurse practitioners, physician assistants, and nurses).
- Professionals who offer addiction counseling or mental health services.
- Peer support specialists.
- People needing treatment and their families.
- People in remission or recovery and their families.
- Hospital administrators.
This updated blog post includes the original brief outline of TIP 63 with descriptions of the medications for treating OUD, engagement strategies for a variety of treatment settings, and strategies for communicating with prescribers and how to create supportive environments for clients being treated with medication for OUD. In addition, this post will include an overview of what is new in the revised 2021 edition of TIP 63.
Scope of the Problem
TIP 63 is based on the knowledge promoted by SAMHSA that:
- “Behavioral health is essential for health;
- Prevention works;
- Treatment is effective; and
- People recover” (CSAT, 2018).
The current opioid crisis caused 42,249 deaths nationwide, more that the number caused by motor vehicle crashes (CSAT, 2018). Some of the highlights of the vast amount of data showing the scope of the opioid problem in the U.S. are:
- “2.1 million people in the U.S., ages 12 and older, had opioid use disorder (OUD) involving prescription opioids, heroin, or both in 2016.
- Opioid-related emergency department (ED) visits nearly doubled from 2005 to 2014.
- Opioid-related inpatient hospital stays increased 64% nationally from 2005 to 2014.
- Opioid addiction is linked with high rates of illegal activity and incarceration” (CSAT, 2019).
First, medications are shown by research to work. There are three medications that have research supporting their effectiveness in reducing illicit opioid use, retaining people in treatment, and reducing the risk of opioid overdose death. Those medications are methadone, naltrexone, and buprenorphine. In fact, naltrexone and buprenorphine are shown to be better than placebo or no medication in reducing illicit drug use, and methadone and buprenorphine have been linked to fewer overdose deaths (CSAT, 2018). These OUD medications can be taken under medical supervision as part of either withdrawal from or maintenance of treatment. All three medications diminish or block illicit opioid drug effects. All three medications also blunt or eliminate cravings.
Second, medications are part of the principles of good care for patients with chronic diseases. Therefore, creating increased mechanisms for access to these pharmacotherapies is important both as a clinical strategy and as a public health strategy. Patient-centered care is at the heart of treatment, as is providing patients with the information they need to empower them to make informed decisions. SAMHSA uses an adapted list of the General Principles of Good Chronic Care (WHO, 2009):
- Develop a treatment partnership with patients.
- Focus on patients’ concerns and priorities.
- Support patient self-management of illness.
- Use the five A’s at every visit (assess, advise, agree, assist, and arrange).
- Organize proactive follow-up.
- Link patients to community resources/support.
- Work as a clinical team.
- Involve “expert patients,” peer educators, and support staff in the health facility.
- Ensure continuity of care (SAMHSA, 2009).
Third, cost-effectiveness analyses have found that treatment with methadone and buprenorphine are more cost effective that treatment without medication. When combined with counseling, use of buprenorphine shows greatly reduced healthcare costs when compared to little or no treatment; those treated with any of these three OUD medications have lower usage of healthcare and lower healthcare costs overall (CSAT, 2018). Although most cost benefit studies so not review the cost-benefit of treatment that includes medication for addiction separately from all addiction treatment, including medications in treatment potentially could reduce crime and related costs; use of the justice system and related costs; healthcare spending; and improve both earned income and quality of life (CSAT, 2018).
Takeaways for Using Medication During Opioid Treatment
TIP 63 provides greater detail of the issues that should be considered during OUD treatment using medications. These are just a few of the ones covered in the manual that will hopefully lead to behavioral health and general medical providers using and applying the full document to the services they provide:
- General principles for treating chronic diseases should guide OUD treatment.
- While only physicians, nurse practitioners, and physician assistants can prescribe buprenorphine for OUD, and must get a federal waiver to do so, and only federally certified, accredited opioid treatment programs (OTPs) can dispense methadone to treat OUD, any prescriber can offer naltrexone.
- OUD medication is very versatile and can be taken on a short or long-term basis, including as part of medically supervised withdrawal and as maintenance treatment.
- Patients taking medication for OUD are considered to be in recovery.
- All healthcare practices should screen for alcohol, tobacco, and other substance misuse (including opioid misuse), and a thorough assessment should address patients’ medical, social, SUD, and family histories.
- Validated screening tools and symptom surveys should be used and many of these and other resources are listed in TIP 63.
- Patients who screen positive for risk of harm from substance use should be assessed using tools that determine whether substance use meets diagnostic criteria for a substance use disorder (SUD). Laboratory tests should be used to inform treatment planning.
- When onsite SUD treatment is not available, treatment plans or referral strategies should be developed.
- Pharmacotherapy should be considered for all patients with OUD, with Opioid pharmacotherapies being reserved for patients with moderate to severe OUD with physical dependence.
- Patients with OUD should be informed of the risks and benefits of pharmacotherapy, treatment without medication, and no treatment.
- Patients should be advised on where and how to get treatment with OUD medication as counseling benefits many patients taking OUD medication. Counseling should be part of treatment so that clients learn to address the many challenges and consequences of addiction, and to help them develop recovery capital.
- Education about family-oriented systems of care and resources for both patients and their families to help them navigate a variety of systems and resources increases the effectiveness of all treatment services.
TIP 63 also provides information and resources about how to address challenges to implementing OUD Medication, including links to regulations and guidelines to which OTPs and healthcare provider are subject, such as the need for maintaining confidentiality, adequate medical, counseling, vocational, educational, and other services either onsite or in collaboration with outside agencies or providers. Familiarity with these regulations is essential for overcoming this barrier to using OUD medications with patients as this knowledge will help providers to address issues such as when and how take-home doses are permissible and criteria that must be met to implement that type of administration. Dosage regulations for all three medications are also covered in detail with concerning methods of administration and appropriate links to additional information.
What Is New in the 2021 Revision of TIP 63?
SAMHSA is committed to ensuring that people with SUDs receive appropriate care that is appropriate, relevant, and timely/ To this end, SAMHSA has revised all five sections of TIP 63. The content is now current and ultimately useful in the practice of using medications to assist in the treatment of OUD. Some of the important revisions include:
- Updated statistical data from sources such as SAMHSA, Centers for Disease Control and Prevention, and reliable sources on deaths, overdoses, accidents, and hospitalizations related to the use of opioids;
- Current information on qualifications that make practitioners eligible to apply for waivers for prescribing buprenorphine (i.e., clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives) and the inclusion of exceptions to buprenorphine practice guidelines for obtaining waivers;
- References to naltrexone have been clarified to include either the oral formulation of the extended-release injectable formulation;
- Recent citations have been added supporting induction to extended-release naltrexone for people who test positive in urine tests for opioids when the pass the naloxone challenge;
- Information that clarifies the fact that naltrexone can result in decreased opioid cravings has been added;
- Online resources with broken hyperlinks have been corrected or removed to allow access to the most current resources.
The TIP 63 Executive Summary states: “The goal of treatment for opioid addiction or opioid use disorder (OUD) is remission of the disorder leading to lasting recovery. Recovery is a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their full potential.” This blog post has highlighted just a few of the many approaches, tools, resources, and solid, empirically-based information provided in the Revised 2021 edition of TIP 63. This information is seriously needed by providers that will enable them to use the three Food and Drug Administration (FDA)-approved medications used to treat OUD—methadone, naltrexone, and buprenorphine—and the other strategies and services needed to support recovery for people with OUD.
Additional information and the revised 2021 edition of TIP 63 can be found in the CASAT OnDemand Resources & Downloads section.
Relevant Catalyst blog posts include:
A full list of opioid-related posts can be found in the Opioid category of the Catalyst blog page.