www.samhsa.gov/sites/default/files/quick-start-guide. ENIHPRONERPUB

QUICK START GUIDE ENIHPRONERPUB

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Specifically discuss safety concerns: Understand that

discontinuing

buprenorphine

increases risk of

overdose death upon

opioid use. return to illicit alcohol or

Know that use of benzodiazepines

with buprenorphine

increases the risk of

overdose and death. importance of Understand the

informing providers

if they become

pregnant.

Tell providers if they

are having a

procedure that may

require pain

medication.

Facts About Buprenorphine

FDA approved for Opioid Use Disorder treatment in an office-

based setting.

buprenorphine is often a safe choice.

For those with tolerance to opioids as a result of OUD,

Buprenorphine acts as a partial mixed opioid agonist at the μ- affinity for the μ-receptor than other opioids, and it can receptor and as an antagonist at the κ-receptor. It has a higher

precipitate withdrawal symptoms in those actively using other It is dosed daily, has a long half-life, and prevents withdrawal in opioids.

opioid dependent patients.

Many formulations contain naloxone to prevent injection Can be in tablet, sublingual film, or injectable formulations.

diversion. This formulation is the preferred treatment medication. women to decrease potential fetal exposure to naloxone.

The buprenorphine only version is often used with pregnant

There is a “ceiling effect” in which further increases above 24mg in cardiovascular function.

dosage does not increase the effects on respiratory or

program that includes psychosocial support. Treatment should Buprenorphine should be part of a comprehensive management Overdose with buprenorphine in adults is less common, and most not be withheld in the absence of psychosocial support.

occurring substances like alcohol or benzodiazepines.

likely occurs in individuals without tolerance, or who are using co-

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Assess the need for treatment 1

For persons diagnosed with an opioid use

disorder,* first determine the severity of

patient’s substance use disorder. Then identify

any underlying or co-occurring diseases or

conditions, the effect of opioid use on the

patient’s physical and psychological

functioning, and the outcomes of past

treatment episodes.

Your assessment should include:

A patient history

Ensure that the assessment includes a medical

and psychiatric history, a substance use psychosocial supports.

history, and an evaluation of family and

Access the patient’s prescription drug use

history through the state’s Prescription Drug

Monitoring Program (PDMP), where available,

to detect unreported use of other medications, such as sedative-hypnotics or alcohol, that may interact adversely with the treatment medications.

A physical examination that focuses on physical findings related to addiction and its complications.

Laboratory testing to assess recent opioid use and to screen for use of other drugs. Useful tests include a urine drug screen or other toxicology screen, urine test for alcohol (ethyl glucuronide), liver enzymes, serum bilirubin, serum creatinine, as well as tests for hepatitis B and C and HIV. Providers should not delay treatment initiation while awaiting lab results.

2

Educate the patient about how the medication works and the associated risks and benefits; obtain informed consent; and educate on

overdose prevention.

There is potential for relapse & overdose on discontinuation of the medication. Patients should be educated about the effects of using opioids and other drugs while taking the prescribed medication and the potential for overdose if opioid use is resumed after tolerance is lost.

3

Evaluate the need for medically managed withdrawal from opioids

Those starting buprenorphine must be in a state of withdrawal.

4

Address co-occurring disorders

Have an integrated treatment approach to meet the substance use, medical and mental health, and social needs of a patient.

5

Integrate pharmacologic and nonpharmacologic therapies

All medications for the treatment of the opioid use disorder may be prescribed as part of a comprehensive individualized treatment plan that includes counseling and other psychosocial therapies, as well as social support through participation in mutual-help programs.

6

Refer patients for higher levels of care, if necessary

Refer the patient for more intensive or specialized services if office-based treatment with buprenorphine or naltrexone is not effective, or the clinician does not have the resources to meet a particular patient’s needs. Providers can find programs in their areas or throughout the United States by using SAMHSA’s Behavioral Health Treatment Services Locator at http://www.findtreatment.samhsa.gov.

*See The Criteria from American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,. Washington, DC, American Psychiatric Association, page 541.

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The dose of buprenorphine depends on the severity of withdrawal symptoms, and the history of last opioid use (see flowchart in appendix for dosing advice).

Long acting opioids, such as methadone, require at least 48-72 hours since last use before initiating buprenorphine.

Short acting opioids (for example, heroin) require approximately 12 hours since last use for sufficient withdrawal to occur in order to safely initiate treatment. Some opioid such as fentanyl may require greater than 12 hours.

Clinical presentation should guide this decision as individual presentations will vary.

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Objective withdrawal signs help establish physical dependence

Determine Withdrawal

The risk with initiating buprenorphine too soon is that buprenorphine has a very high affinity for the mu receptor and will displace any other opioid on the receptor, thereby causing precipitated opioid withdrawal.

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Buprenorphine’s side effects may be less intense than those of full agonists. Otherwise, they resemble those of other mu-opioid agonists. Possible side effects include: Oral numbness, constipation, tongue pain, oral mucosal erythema, vomiting, intoxication, disturbance in attention, palpitations, insomnia, opioid withdrawal syndrome, sweating, and blurred vision

Buprenorphine FDA labels list all potential side effects

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Precipitated withdrawal can occur due to replacement of full opioid receptor agonist (heroin, fentanyl, or morphine) with a partial agonist that binds with a higher affinity (Buprenorphine). Symptoms are similar to opiate withdrawal.

Avoid by ensuring adequate withdrawal before induction (COWS > 12; Fentanyl may require higher COWS score and lower initial dosing), starting Buprenorphine at a lower dose (2.0mg/0.5 mg), and reassessing more frequently.

Should precipitated withdrawal occur, treatment includes:

Providing support and information to the patient

Management of acute symptoms Avoid the use of benzodiazepines Encourage the patient to try induction again soon

Co-prescribing of overdose reversal agents such as Naloxone is also recommended

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How can providers minimize diversion risk?

1.Early in treatment patients should be seen often, and less frequently only when the provider determines they are doing well.

2.Providers should inquire about safe and locked storage of medications to avoid theft or inadvertent use, especially by children. Patients must agree to safe storage of their medication. Counsel patients about acquiring locked devices and avoiding storage in parts of the home frequented by visitors.

3. Limit medication supply. Prescribe an appropriate amount of medications until the next visit. Do not routinely provide an additional supply “just in case.”

4.Use buprenorphine/naloxone combination products when medically indicated. Reserve daily buprenorphine monoproducts for pregnant patients and/or patients who could not afford treatment if the combination product were required.

5.Counsel patients on taking their medication as instructed and not sharing medication.

6.Ensure that the patient understands the practice’s treatment agreement and prescription policies. Providers can utilize the sample treatment agreement in SAMHSA’s TIP 63, Page 3-78. A treatment agreement and other documentation are clear about policies regarding number of doses in each prescription, refills, and rules on “lost” prescriptions.

7.Directly observe ingestion randomly when diversion is suspected.

8.Providers should order random urine drug testing to check for other drugs and for metabolites of buprenorphine. Providers should also consider periodic point of care testing.

9.Doctors should schedule unannounced pill/film counts. Periodically ask patients to bring in their medication containers for a pill/film count.

10.Providers should make inquiries with the Prescription Drug Monitoring program in their state to ensure that prescriptions are filled appropriately and to detect prescriptions from other providers.

11.Early in treatment, providers can ask the patient to sign a release of information for a trusted community support individual, such as a family member or spouse, for the purpose of communicating treatment concerns including diversion.

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Goal = once-daily dosing, no withdrawal between doses. Ideally, average dosing does

not exceed 16 mg/4 mg (See flowchart in appendix)

Check PDMP regularly to ensure prescriptions are filled, and to check other prescriptions.

Order urine drug testing (UDT) and consider confirmatory testing for unexpected results. UDT can facilitate open communication to change behavior.

Assess for readiness for extended take-home dosing

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Although people often focus on the role of medications in MAT, counseling and behavioral therapies that address psychological and social needs may also be included in treatment. To find treatment, please consult http://www.findtreatment.gov.

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Diversion is defined as the unauthorized rerouting or misappropriation of prescription medication to someone other than for whom it was intended (including sharing or selling a prescribed medication); misuse includes taking medication in a manner, by route or by dose, other than prescribed.

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Misuse or diversion doesn’t mean automatic discharge from the practice.

Document and describe the misuse and diversion incident. Also document the clinical thinking that supports the clinical response, which should be aimed at minimizing future risk of diversion

while still supporting the use of MAT.

Strongly consider smaller supplies of medication and supervised dosing.

Treatment structure may need to be altered, including more frequent appointments, supervised administration, and increased psychosocial support.

When directly observed doses in the office are not practical, short prescription time spans can

be considered.

In situations where diversion is detected, open communication with the patient is critical. Providers may consider injectable and implantable buprenorphine to reduce diversion, once verified.

Disclaimer: Nothing in this document constitutes an indirect or direct endorsement by the Substance Abuse and Mental Health Services Administration (SAMHSA) or the U.S. Department of Health and Human Services (HHS) of any non-federal entity’s products, services, or policies and any reference to a non-federal entity’s products, services, or policies should not be construed as such. No official support of or endorsement by SAMHSA or HHS for the opinions, resources, and medications described is intended to be or should be inferred. The information presented in this document should not be considered medical advice and is not a substitute for individualized patient or client care and treatment decisions.

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Tablets/film may be split if necessary

May take up to 10 min to dissolve completely (no talking, smoking, or swallowing at this time) Absorption better with moistened mouth

Algorithm for In-Office Induction (for home induction prescriptions may be given)

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