Chapter 5: Implementation, Stabilization, and Maintenance
Chapter 5: Implementation, Stabilization, and Maintenance
In this chapter
- Preparation for Treatment
- Assessing Symptoms of Opioid Withdrawal for Buprenorphine Induction: SOAP Note Format
- Table 3: Induction, Stabilization, and Maintenance
“The easy part is learning about and administering buprenorphine. The hard part is changing the clinic culture to say, 'opioid dependence is a brain disease.' We need to curtail the notion that these patients are different.”- Dr. P. Todd Korthuis
Associate Professor of Medicine and Public Health/Preventive Medicine
Oregon Health and Science University HIV Program
Patients were often referred to opioid treatment from HIV medical care, psychiatry, mental health counseling, pain clinics, chemical dependency clinics, inpatient wards, community housing, and community drug treatment centers.
Eligible SPNS initiative patients had to meet the following criteria:
- Be at least 18 years old.
- Meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for opioid dependence. DSM-IV classifies opioid dependence as having three or more of the following within one year: tolerance; withdrawal; larger amounts/longer period than intended; inability to cut down or control use; increased time spent obtaining opioids; social or occupational activities given up or reduced; and despite adverse consequences, opioid use persists.45
- If a female patient, not be pregnant, nursing, or trying to become pregnant. (Buprenorphine is classified by the FDA as a Pregnancy Category C medication similar to methadone.)
- Be interested in receiving substance abuse services.
- Be HIV-positive and receive HIV primary care at the site.
Prior to administration of Suboxone, patients receive education and counseling. Any patient assessment questions should be targeted and open-ended to solicit detailed responses beyond a simple yes or no. Providers also discussed program expectations and answered patient questions. The initial assessment process was completed in one or two visits. Providers were also expected to have an emergency contingency plan for patients, such as an on-call number or backup system prior to program launch.16
To access consent form, patient treatment agreement, and eligibility criteria checklist templates, see these resources on the TARGET Center:
- BEEHIVE Buprenorphine Program Tools (UCSF);
- Miriam Hospital Buprenorphine Program Tools ;
- Buprenorphine/naloxone (Suboxone) Treatment Agreement (OSU); and
- CORE Buprenorphine Project Program Tools.
Grantees also had substance abuse counseling community linkages and collaborations, including onsite substance abuse counseling. Since "buprenorphine is a prescribed treatment, which is accepted by the 'Big Book' on which 12-step programs rely, an integrated care program can work with 12-step programs toward the goal of recovery" as well.69
Exclusion criteria included:
- uncontrolled or untreated psychiatric problems,
- serious uncontrolled or untreated medical problems (e.g., hypertension, asthma, diabetes, hepatic failure),
- patient currently on more than 30 mg of methadone,
- chronic pain disorder requiring high-dose opioid medication,
- allergy or hypersensitivity to buprenorphine or naloxone,
- benzodiazepine abuse or dependency (currently or within the past 6 months),
- aspartate aminotransferase/alanine aminotransferase ratio of >5x upper normal limit,
- binge drinking, and
- requires greater program structure such as that involved in methadone maintenance.69
Before physicians begin to prepare patients for treatment, they must answer four important questions:
- Who is to perform the induction and stabilization of patients receiving buprenorphine?
- How are patients to be maintained on buprenorphine treatment appropriately?
- What forms of counseling are necessary?
- How can care be coordinated between providers?42
All patients had to have a complete health history (including immunizations and tuberculin purified protein derivative status), recent physical exam documented in their medical charts, and pain evaluation.
Providers reviewed their entire substance use history and any co-occurring medical conditions, particularly liver disease, pain syndrome, and mood disorders.
Patient medications were also reviewed. Worth nothing, "many HIV antiretroviral and psychiatric medications are metabolized by the cytochrome P450 3A4 system and may necessitate buprenorphine and dose adjustments."69
Providers needed to ensure their onsite pharmacy or a community pharmacy was onboard with dispensing buprenorphine. In many cases, SPNS grantees worked with "benefits workers to enroll study patients in Medicaid, Medicare, or State ADAP programs and to have buprenorphine added to formularies and obtain prior authorization for buprenorphine prescriptions (where possible).
Providers assessed female patients' effective use of birth control.
Patients completed lab work to check liver enzymes, urinalysis, and for pregnancy. Their most recent HIV-related lab work was also reviewed to check HIV viral load, CD4 cell count, liver function tests, and hepatitis serologies.69 Hepatitis screens, syphilis test, lipid profile, serum electrolytes, blood urea nitrogen (BUN, a measurement used as part of routine bloodwork and to diagnose or monitor kidney disease) and creatinine, a complete blood count (CBC) with differential and platelet count, and TB test may also want to be considered.53
Patients prescribed narcotics or benzodiazepines and those with substance abuse histories (including illegal opioid use and other drugs) were all screened.
Patients were questioned about what they understood about buprenorphine treatment, and providers filled any "knowledge gaps. Providers also reinforced patient goals, motivations, and readiness. One SPNS grantee utilized patient education slides, which can be viewed on the TARGET Center.
Patients were asked to sign a contract that they would adhere to the program requirements and consent to treatment. Patients also signed an authorization to exchange health information. Lastly, patients were asked to sign a take-home dosage agreement. (Access examples of these documents on the TARGET Center.)
Providers who did not have onsite substance abuse counseling, psychotherapy, or self-help programs of any kind were asked to create formalized agreements with providers to whom patients would be referred for counseling.
SPNS grantees found it helpful to supply " kick packs to patients. Since patients had to arrive at the clinic on the first day in an opioid-free state, these "packs helped address any anticipated withdrawal symptoms, such as nausea, diarrhea, myalgias, and rhinorrhea."69 Read about what specific medications were included in the kick packs prepared by the UCSF grantee on the TARGET Center.
It's imperative that patients understand what buprenorphine can and can't do. There is no magic bullet for opiod dependence. Buprenorphine can dramatically assist opioid-dependent patients, but other interventions, such as harm reduction counseling, motivational interviewing, and behavioral counseling, should be used as well. It's important that patients understand that recovery, whether still maintained on MAT or not, is a lifelong process.
Physicians were also asked to manage expectations and continue education with staff to keep them abreast of the program and ensure their buy-in and cultural competency in assisting patients undergoing opioid treatment.
On Suboxone prescriptions, clinicians must include patient's full identification, including name, address, drug name, strength, dosage, quantity, and directions. As with other DEA-scheduled medications, prescriptions for Suboxone must be dated and signed on the date of issuance. The physician's DEA registration number and physician DATA 2000 registration number must be included on prescriptions as well.88
To keep track of prescriptions, one SPNS grantee utilized a Suboxone Treatment Record.
This phase is medically monitored, typically as observed therapy in a physician office for at least 2 hours. The induction phase begins with an initial “test dose” of buprenorphine.42
|Opioid Intoxication||Conscious; sedated or drowsy; slurred speech; "nodding" or intermittently dozing; memory impairment; mood normal to euphoric; constricted pupils|
|Opioid Overdose||Unconscious; pinpoint pupils; slow, shallow breathing (i.e., respirations below 10 per minute); pulse rate below 40 per minute|
Overdose triad: apnea, coma, pinpoint pupils (with terminal anoxia; fixed and dilated pupils)
The opioid-dependent person must have abstained from using opioids for 12 to 24 hours and must be in the early stages of withdrawal. Note, patients must be in early stages of withdrawal, otherwise buprenorphine will precipitate acute withdrawal. Many patients in the SPNS project were initially worried about having to be in “withdrawal” when they arrived their first day for Suboxone induction.
These worries were largely unfounded, and in fact, patients found the buprenorphine to work instantly. As one patient described, “With the bup . . . you’re not [feeling the heroin] . . . instantly you won’t feel it, but within a matter of a few days, maybe five days, you’re not having cravings, you’re just feeling normal. You just get up and you don’t miss it, nothing. This [stuff] works great.”
Inductions were scheduled on Mondays, Tuesdays, or Wednesdays to allow for two follow-up visits within the same week. The glue person was required to be at all patient appointments; however, the prescribing physician was required to be onsite only for the initial induction.69
To view induction protocol in table form, see Figures 4-1 and 4-2 of “Treatment Protocols” in the SAMHSA Guidelines.
Precipitated withdrawal is a more rapid and intense onset of symptoms. The purpose of induction is to safely suppress opioid withdrawal through dosing of buprenorphine. Longer-acting opioids, such as OxyContin and methadone, will require longer abstinence than shorter-acting opioids, such as heroin, Percocet, Vicodin, or oxycodone.89
Providers should use only time of last opioid use to anticipate withdrawal. Patients must also be at adequate withdrawal phase before buprenorphine initiation.89
To assess and assist with withdrawal, providers need:
- A penlight to assess pupil dilation,
- A stopwatch or clock to assess pulse rate, and
- A nearby bathroom, to ease the comfort of patients with active gastrointestinal and urinary symptoms associated with opioid withdrawal.
Withdrawal consists of predictable signs and symptoms resulting from the removal of or decrease in opioid use.53 Clinicians in the SPNS Buprenorphine Initiative found the Clinical Opiate Withdrawal Scale (COWS) to be effective in measuring symptoms during induction. 90, 91 Using the COWS scale allows clinicians to better identify whether patients are still experiencing opioid effects or are adequately in withdrawal to begin induction.
The University of California, San Francisco found the COW Scale in combination with the SOAP (Subjective data, Objective data, Assessment, Plan) Note Format below to be helpful.
While patients are undergoing induction, they should be engaged by health personnel. SPNS grantees found these patients needed interaction and direction from the moment they arrived to ensure a successful induction. Patient observation typically ranged from 2 to 4 hours following induction.
If patients experience precipitated withdrawal, clinicians should administer an additional 2- to 4-mg dose of buprenorphine hourly until symptoms resolve.92 Note, patients with cardiovascular disease or other severe conditions will need comanagement with the appropriate specialist.53
Patients typically feel relief within the first 5 to 15 minutes after Suboxone has been dissolved under the tongue. In the SPNS project, patients were given Suboxone tablets. Today, Suboxone film exists and dissolves faster, which may bring even faster relief.
For the SPNS project, treatment began with a sublingual dose of 2 mg (2 mg buprenorphine/.5 mg naloxone) for patients with mild withdrawal and 4 mg for patients with severe withdrawal69 (Suboxone is also available in an 8 mg buprenorphine/2 mg naloxone formulation). 93 If patients experienced no change or only mild improvement of withdrawal symptoms, they were given an additional 2- or 4-mg dosage.69
If administration of Suboxone resulted in precipitated withdrawal, patients were reviewed for their last opioid use, offered nonopioid symptom management, and told to return the following day for reevaluation.
Patients for whom administration of Suboxone was successful were provided an additional 2- to 4-mg dose to take later that evening, and take-home doses for the next 1 to 2 days, along with instructions and education about their use. Patients then returned in the next 1 to 2 days for evaluation and upward dose titration.
- Typical daily first week dose: 8 to 12 mg (not to exceed 16 mg).69
- Typical daily second week dose: Some patients achieved stable dose between 12 and 16 mg daily from the second week thereafter; for others, dosage increased to as much as 20 to 24 mg during this time period.69
Criteria for dose increases included significant opioid cravings, significant withdrawal symptoms, and positive urine opioid drug test.
Overall, most patients found optimal relief at 12 to 16 mg. Finding the appropriate therapeutic dose (usually by titrating the dose over time) is a hallmark of the stabilization phase, as is greatly reducing or ceasing opioid use without adverse effects or cravings. To achieve this, physicians may need to adjust dosages for patients still struggling. Behavioral intervention such as counseling may begin during this phase to help patients adapt to opioid-free living and adherence to buprenorphine.42
For those on boosted atazanavir and other ritonavir-containing ARVs, lower doses were sufficient. For patients on efavirenz-containing regimens, higher buprenorphine doses were required.69
Daily dosage of buprenorphine at 32 mg is considered the maximum, and the ceiling for which no further effects of craving or withdrawal are typically seen.9 Dosage at or below 24 mg, however, has been shown to help diminish concerns about hepatotoxicity.64 (See also What Do I Need to Know About Buprenorphine and Liver Enzymes? in Chapter 2.)
Recommended timing of induction and transition into stabilization and maintenance phases are outlined in Table 3 below.
- Elicit symptoms of opioid withdrawal: cravings, anxiety, discomfort, pain, nausea, hot or cold flushes. Include patient’s subjective rating of these symptoms (mild, moderate, or severe).
- Document signs of opioid withdrawal, including autonomic excitation (elevated blood pressure, increased heart rate), mydriasis, tremors, agitation or restlessness, yawning, rhinorrhea, piloerection, hot and cold flushes, diaphoresis, lacrimation, vomiting, and muscle fasciculations. Utilize COWS.
- Observe for signs of substance intoxication, including but not limited to alcohol odor, nystagmus, positive Romberg test, disinhibition, or other altered mental status.
- Collect urine and send to clinical lab for routine toxicology and, for female patients, pregnancy testing.
- Is the patient in opioid withdrawal? YES or NO. Include severity (mild, moderate, severe) based on COWS score. The patient should exhibit objective signs of at least mild withdrawal and have a COWS score >5 prior to receiving the first dose of buprenorphine.
- NO: If the patient appears intoxicated or exhibits no signs of withdrawal, then he or she should not be started on buprenorphine. Reschedule the patient for a later date or time. Counsel the patient on the importance of presenting in some withdrawal for a more comfortable overall induction.
- YES: Begin treatment with Suboxone and titrate to the target dose.
The most common side effects associated with buprenorphine include sweating, headaches, nausea, constipation, reduced sexual drive, and drowsiness and disrupted sleep (although less sedation than is associated with methadone). Patients with viral hepatitis may also experience mild increases in liver enzymes, particularly in alanine aminotransferase (ALT) levels; changes in ALT are most severe if buprenorphine is abused and injected intravenously.9
The stabilization phase begins after a person has discontinued— or greatly reduced—their drug use, no longer has cravings, and has few or no side effects. Buprenorphine dosage may need to be adjusted during this phase.69 To view stabilization protocol in table form, see Figure 4-3 of the SAMHSA Treatment Protocols.
Buprenorphine has a long half-life because it tightly binds to plasma proteins, and it assists in maintaining opioid levels in the brain. This allows for improved administration and less frequent dosing. For example, buprenorphine’s effects may last anywhere from 1 to 3 days, depending on the individual and dosage.93
If clinicians transfer patients to alternate-day dosing, this phase may need to be supervised in the physician’s office or may take place at home with frequent monitoring during office visits.69 Overall, induction and stabilization of buprenorphine were conducted over a 1- to 3-week period and maintenance continued as needed on a patient-by-patient basis. The SOAP Note Format described in the table above was used not only for assessing when to start patients on treatment but also in monitoring maintenance.
|Induction||Day 1||Observe patient take one 8-mg Suboxone tablet* sublingually in clinic.||Week 1: Daily counseling.||Give patient 1 tablet to take home: No Rx.|
|Day 2||Check criteria for dose increase.|
Observe patient take one 8-mg Suboxone tablet sublingually.
|Give patient 1 tablet to take home: No Rx.|
|Day 3||Observe patient take one 8-mg Suboxone tablet sublingually.||Give Rx for weekly supply.|
|Stabilization||Weeks 2–4||Once weekly: Check patient’s symptoms for underdosing.||- Week 2: Once or twice weekly.|
- Weeks 3 and 4: Once weekly.
|Give Rx for weekly supply.|
|Maintenance||Months 2–12||Monthly check depending on clinical stability and dose.||Months 2–12: Once< every 2–4 weeks.||Give Rx for monthly supply; if dosage is >16 mg, give RX for biweekly supply.|
Through opioid treatment, physicians should maintain patient records that outline:
- “Medical history and physical examination;
- Diagnostic, therapeutic, and laboratory results;
- Evaluations and consultations;
- Treatment objectives;
- Discussion of risks and benefits;
- Medications (including date, type, dosage, and quantity prescribed and/or dispensed to each patient);
- A physical inventory of all Schedules III, IV, and V controlled substances on hand that are dispensed
by the physician in the course of maintenance or detoxification treatment of an individual;
- Instructions and agreements; and
- Periodic reviews.”88
Physicians must keep all records for a minimum of two years, should DEA decide to conduct an inspection. In addition, physicians are prohibited from releasing records without proper patient consent, court order, mandatory reporting of child abuse, or medical emergencies.88
The maintenance phase occurs when the person has been sustained on a steady dose of buprenorphine. In most instances, patients entered the maintenance phase of treatment within the first 2 weeks.
Medication visits were scheduled weekly, then tapered to biweekly and then to monthly. This was possible because up to a month of Suboxone may be prescribed at a time.16 Physician visits were scheduled once every 3 months. Urine drug testing was conducted throughout phases of treatment to aid in adherence and identify any continual drug use.
The total length of this phase was individualized. The SPNS Buprenorphine Initiative was 5 years long.
In evaluating patients, SPNS providers collected and examined information on multiple measures via chart abstraction. These included:
- Suboxone dosage prescribed.
- Number of Suboxone-related office visits (considered any visit relevant to Suboxone treatment, clinical care, or counseling, as well as urine collection and prescription pick up).
- Number of urine toxicology analyses performed. (Note, guidelines recommend monthly urine toxicology monitoring and more frequent monitoring among those with ongoing illicit drug use.)64
Providers knew to include progress notes in each patient's medical record, and these notes were reviewed quarterly. The Buprenorphine-administering clinician or glue person notified primary care providers and others engaged in patient care about the patient's progress. Any treatment consent forms, authorizations, etc. were added to the medical record, as was any Suboxone dispensing.
Any patient on Suboxone who was clinically stable and wanted to discontinue treatment was tapered off buprenorphine slowly, as slow tapers have been shown to be more effective than rapid ones.69
To ensure clinic success, several grantees instituted patient satisfaction surveys. These assisted in identifying any additional areas for improvement and helped sustain patient buy-in.