Eligibility
GOAL OF ELIGIBILITY SCREENING
The goal of eligibility screening is to determine if a patient suffers from an Opioid Use Disorder and if they have any specific contraindications to buprenoprhine treatment.
Research suggests that most patients with OUD can stabilize in a primary care setting. However, a significant proportion (30-40%) will require a higher level of care, if only temporarily. No one indicator of illness severity (e.g. duration of illness, IV drug use, polysubstance use) is sufficient to determine the need for a higher level of care. The number and scope of destabilizing factors is also likely to impact a patient's ability to stabilize in an outpatient or primary care setting.
Vermont has pioneered a cooperative model of OUD treatment in which primary care providers treat patients when with lower levels of instability and work with speciality care providers to provide more intensive services when needed. To determine eligibility for primary care stabilization, they use a Treatment Needs Questionnaire. Scores on this questionnaire help determine whether to induce a patient on buprenorphine in primary care or refer them to a higher level of care. It should be noted that this document was developed intuitively and has not been rigorously tested. Some primary care settings may find that they can manage higher levels of instability and others that they must be more selective in the patients they treat.
CONTRAINDICATIONS (ASAM, P. 25)
Buprenorphine is ‘‘contraindicated’’ for the following conditions:
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Patients with hypersensitivity to buprenorphine or any component of the formulation.
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Patients with severe liver impairment are not good candidates for office-based treatment with buprenorphine. (Patients with hepatitis C infection who do not have severe liver impairment may, however, be considered for buprenorphine.)
Buprenorphine should be used with ‘‘caution’’ for the following conditions:
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Patients in whom hepatitis has been reported, particularly in patients with previous hepatic dysfunction. A direct comparison of the effects of buprenorphine and methadone, however, showed no evidence of liver damage during the initial 6 months in either treatment groups.55 Monitoring liver function in patients at increased risk for hepatotoxicity may be considered.
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Patients who, at present, have an alcohol use or sedative, hypnotic, or anxiolytic use disorder.
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Patients with hypovolemia, severe cardiovascular disease, or taking drugs that may exaggerate hypotensive effects. Buprenorphine may cause hypotension, including orthostatic hypotension and syncope.
Significant ‘‘medication interactions’’ to consider before starting buprenorphine include the following:
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Alcohol and sedatives, hypnotics, or anxiolytics may enhance the central nervous system depressive effect of buprenorphine.
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Buprenorphine is metabolized to nor-buprenorphine primarily by cytochrome CYP3A4; therefore, potential interactions may occur when buprenorphine is given concurrently with agents that affect CYP3A4 activity. The concomitant use of buprenorphine with CYP3A4 inhibitors (eg, azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, and HIV protease inhibitors) should be monitored and may require dose reduction of one or both agents.
ADOLESCENTS
Buprenorphine products are FDA-approved for ages 16 and older, and the American Society of Addiction Medicine recommends: "Clinicians should consider treating adolescents who have opioid use disorder using the full range of treatment options, including pharmacotherapy." Few adolescent treatment programs include pharmacotherapy and it is often suggested (contrary to the evidence) that adolescents should try non-medical treatments prior to receiving agonist therapies.
There are relatively few studies of buprenorphine in adolescents, but existing studies show buprenorphine maintenance to be much more effective than placebo or brief detox in retaining patients and reducing illicit opioid use. Take for example, this study that compares the use of buprenorphine for detoxification versus maintenance in 15-21 year olds (N=152). All received weekly individual and group counseling at minimum. At Week 4, 84% of patients in the maintenance group had been retained and 74% of those had been opioid abstinent in the past week; in the detox group, 21% had been retained and 37% of those had been opioid abstinent in the past week. Maintenance was much more effective at both retaining patients and helping them eliminate opioid use.
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PREGNANT WOMEN
Decisions to use opioid agonist medications in pregnant women with opioid use disorder revolve around balancing the risks and benefits to maternal and infant health. Opioid agonist treatment is thought to have minimal long-term developmental impacts on children relative to harms resulting from maternal use of heroin and prescription opioids. Therefore, women with opioid use disorder who are not in treatment should be encouraged to start opioid agonist treatment with methadone or buprenorphine monotherapy (without naloxone) as early in the pregnancy as possible. Furthermore, pregnant women who are on agonist treatment should be encouraged not to discontinue treatment while they are pregnant.
Pregnancy in women with opioid use disorder should be co-managed by an obstetrician and an addiction specialist physician. Release of information forms need to be completed to ensure communication among healthcare providers.
Pregnant women who are physically dependent on opioids should receive treatment using agonist medications rather than withdrawal management or abstinence as these approaches may pose a risk to the fetus. Furthermore, withdrawal management has been found to be inferior in effectiveness over pharmacotherapy with opioid agonists and increases the risk of relapse without fetal or maternal benefit.
For women who are pregnant or breastfeeding, opioid agonist treatment with methadone or buprenorphine is seen as the most appropriate treatment, taking into consideration effects on the fetus, neonatal abstinence syndrome, and impacts on perinatal care and parenting of young children. Methadone is the accepted standard of care for use during pregnancy; however, buprenorphine monoproduct is a reasonable alternative and also has some advantages over methadone. Infants born to mothers treated with buprenorphine had shorter hospital stays (10 vs. 17.5 days), had shorter treatment durations for neonatal abstinence syndrome (NAS) (4.1 vs. 9.9 days), and required a lower cumulative dose of morphine (1.1 vs. 10.4 mg) compared to infants born to mothers on treatment with methadone.102 However, in this trial, mothers treated with buprenorphine were more likely to drop out of treatment compared to mothers treated with methadone.
There is some evidence suggesting that buprenorphine/ naloxone is equivalent in safety and efficacy to the monoproduct for pregnant women. At present, however, this evidence is insufficient to recommend the combination buprenorphine/naloxone formulation in this population. The buprenorphine monoproduct should be used instead.