Receiving buprenorphine should not be contingent upon receiving
counseling as well, according to a “Dear Colleague” letter issued May 9 by
the Food and Drug Administration (FDA) and the Substance Abuse and
Mental Health Services Administration (SAMHSA). In the letter, states that
“an often-cited barrier to prescribing buprenorphine for the treatment of OUD
[opioid use disorder] is the perception that patients must engage in counseling
and other services in order to start or continue receiving the medication,” and
goes on: “This letter serves to clarify the importance of counseling and other
services as part of a comprehensive treatment plan, but to also reiterate that
the provision of medication should not be made contingent upon participation
in such services.”
The FDA-authorized label states that buprenorphine must be administered as
part of a comprehensive treatment program. The May 9 letter, however, states
that counseling “should be offered as individuals stabilize on buprenorphine
and progress in their treatment and recovery.” But if counseling should be
offered, that means someone needs to be able to provide it.
Like other medical decisions, the decision about counseling should be
made in collaboration with the patient, the letter noted.
And there is one other issue: There is no evidence base for exactly
what type of counseling or services are best for different patients. “This
reflects the person-centered nature of treatment interventions, as well as the
need for practitioners to work with patients and to meet them where they are
to support sustained recovery.”
“Given the elevated risk of fatal overdose without medication therapy, any
difficulty in connecting patients with counseling and/or other behavioral
health resources should not prevent practitioners from prescribing
buprenorphine for the treatment of OUD,” the letter states. “Evidence reveals
that when counseling or other resources are not immediately available,
patients can still benefit from buprenorphine treatment.”
However, twice, the letter uses the word “should” in terms of
counseling. “While counseling should always be offered to patients, this
reflects the understanding that engaging people with OUD in treatment is
complex and can begin with stabilization on medication.”
H. Westley Clark, M.D., J.D., former director of SAMHSA’s Center for
Substance Abuse Treatment, made the following comment:
I want to applaud SAMHSA and the FDA for acknowledging
that substance use disorders, in general, and opioid use disorders, in
particular, are often accompanied by complex psychosocial issues that
“may impact treatment and for which medication alone may be
insufficient for optimal outcomes.” It is important to recognize that by
the time that symptoms of an OUD develop, patients may also have co-
occurring psychological disorders, such as PTSD [post-traumatic
stress disorder], major depression, anxiety, disorders of thought
and/or disorders of trust. Additionally, issues of income, food, and
housing insecurity may be pronounced.
“While medications may be critical to initially address
withdrawal symptoms or to stabilize a person experiencing an OUD,
clinicians who do not have the ability or interest in assessing the
unique needs of a patient cannot truly provide patient-centered
care. Clinicians should be careful not to let a hectic schedule or a busy
practice reduce the clinician-patient relationship into a simple
prescription with the hope that some remote time in the future a
comprehensive assessment of the patient may be possible. Given the
dropout rate from medication treatment, that comprehensive
assessment may never occur.
“While the FDA and SAMHSA state that they are committed to
reducing the overdose epidemic in their recent Dear Colleague letter,
and while medication alone may be an important harm reduction
strategy, a whole patient care approach is essential to assist a person
experiencing an OUD to achieve recovery.”
Interestingly, Indivior, which makes the Suboxone brand of
buprenorphine, has insisted on counseling, regardless of how many
patients are being treated by one physician.
But much has changed. No longer is an X-waiver required to
prescribe buprenorphine for OUD.
The label for buprenorphine hasn’t changed as a result of this Dear Colleague letter,
the FDA told us.
Under indications and use, the current label for the Suboxone brand of
buprenorphine states: SUBOXONE sublingual film should be used as part of a
complete treatment plan that includes counseling and psychosocial support.
Also from the label:
Treatment should be initiated with supervised administration, progressing to
unsupervised administration as the patient’s clinical stability permits. SUBOXONE
sublingual film is subject to diversion and abuse. When determining the prescription
quantity for unsupervised administration, consider the patient’s level of stability, the
security of his or her home situation, and other factors likely to affect the ability to
manage supplies of take‐home medication.
Ideally patients should be seen at reasonable intervals (e.g., at least weekly during
the first month of treatment) based upon the individual circumstances of the patient.
Medication should be prescribed in consideration of the frequency of visits.
Provision of multiple refills is not advised early in treatment or without appropriate
patient follow‐up visits. Periodic assessment is necessary to determine compliance
with the dosing regimen, effectiveness of the treatment plan, and overall patient
Once a stable dosage has been achieved and patient assessment (e.g., urine drug
screening) does not indicate illicit drug use, less frequent follow‐up visits may be
appropriate. A once‐monthly visit schedule may be reasonable for patients on a
stable dosage of medication who are making progress toward their treatment
objectives. Continuation or modification of pharmacotherapy should be based on the
healthcare provider’s evaluation of treatment outcomes and objectives such as:
- Absence of medication toxicity.
- Absence of medical or behavioral adverse effects.
- Responsible handling of medications by the patient.
- Patient’s compliance with all elements of the treatment plan (including
recovery‐oriented activities, psychotherapy, and/or other psychosocial
- Abstinence from illicit drug use (including problematic alcohol and/or
If treatment goals are not being achieved, the healthcare provider should
re‐evaluate the appropriateness of continuing the current treatment.
2.7 Unstable Patients
Healthcare providers will need to decide when they cannot appropriately provide
further management for particular patients. For example, some patients may be
abusing or dependent on various drugs, or unresponsive to psychosocial intervention
such that the healthcare provider does not feel that he/she has the expertise to
manage the patient. In such cases, the healthcare provider may want to assess
whether to refer the patient to a specialist or more intensive behavioral treatment
environment. Decisions should be based on a treatment plan established and agreed
upon with the patient at the beginning of treatment.
Patients who continue to misuse, abuse, or divert buprenorphine products or other
opioids should be provided with, or referred to, more intensive and structured
5.1 Addiction, Abuse, and Misuse
SUBOXONE sublingual film contains buprenorphine, a schedule III controlled
substance that can be abused in a manner similar to other opioids, legal or illicit.
Prescribe and dispense buprenorphine with appropriate precautions to minimize risk
of misuse, abuse, or diversion, and ensure appropriate protection from theft,
including in the home. Clinical monitoring appropriate to the patient’s level of
stability is essential. Multiple refills should not be prescribed early in treatment or
without appropriate patient follow‐up visits [see Drug Abuse and Dependence
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Discuss the availability of naloxone for the emergency treatment of opioid overdose
with the patient and caregiver.
Because patients being treated for opioid use disorder have the potential for relapse,
putting them at risk for opioid overdose, strongly consider prescribing naloxone for
the emergency treatment of opioid overdose, both when initiating and renewing
treatment with SUBOXONE sublingual film. Also consider prescribing naloxone if
the patient has household members (including children) or other close contacts at
risk for accidental ingestion or opioid overdose [see Dosage and Administration
Advise patients and caregivers that naloxone may also be administered for a known
or suspected overdose with SUBOXONE sublingual film itself. Higher than normal
doses and repeated administration of naloxone may be necessary due to the long
duration of action of SUBOXONE sublingual film and its affinity for the
mu‐opioid receptor [see Overdosage (10)].
Inform patients and caregivers of their options for obtaining naloxone as permitted
by individual state naloxone dispensing and prescribing requirements or guidelines
(e.g., by prescription, directly from a pharmacist, or as part of a community‐based
Educate patients and caregivers on how to recognize respiratory depression and, if
naloxone is prescribed, how to treat with naloxone. Emphasize the importance of
calling 911 or getting emergency medical help, even if naloxone is administered [see
Patient Counseling Information (17)].
5.4 Unintentional Pediatric Exposure
Buprenorphine can cause severe, possibly fatal, respiratory depression in children
who are accidentally exposed to it. Store buprenorphine‐containing medications
safely out of the sight and reach of children and destroy any unused medication
appropriately [see Patient Counseling Information (17)].
5.5 Neonatal Opioid Withdrawal Syndrome
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable
outcome of prolonged use of opioids during pregnancy, whether that use is
medically‐authorized or illicit. Unlike opioid withdrawal syndrome in adults,
NOWS may be life‐threatening if not recognized and treated in the neonate.
Healthcare professionals should observe newborns for signs of NOWS and manage
accordingly [see Use in Specific Populations (8.1)].
Advise pregnant women receiving opioid addiction treatment with SUBOXONE
sublingual film of the risk of neonatal opioid withdrawal syndrome and ensure that
appropriate treatment will be available [see Use in Specific Populations (8.1)]. This
risk must be balanced against the risk of untreated opioid addiction which often
results in continued or relapsing illicit opioid use and is associated with poor
pregnancy outcomes. Therefore, prescribers should discuss the importance and
benefits of management of opioid addiction throughout pregnancy.
The following serious adverse reactions are described elsewhere in the labeling:
-Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
-Respiratory and CNS Depression [see Warnings and Precautions (5.2),
-Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions
-Adrenal Insufficiency [see Warnings and Precautions (5.6)]
-Opioid Withdrawal [see Warnings and Precautions (5.7, 5.10)]
-Hepatitis, Hepatic Events [see Warnings and Precautions (5.8)]
-Hypersensitivity Reactions [see Warnings and Precautions (5.9)]
-Orthostatic Hypotension [see Warnings and Precautions (5.16)]
-Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions
-Elevation of Intracholedochal Pressure [see Warnings and Precautions
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared to
rates in the clinical trials of another drug and may not reflect the rates observed in
The safety of SUBOXONE sublingual film is supported by clinical trials using
SUBUTEX® (buprenorphine) sublingual tablets and SUBOXONE (buprenorphine
and naloxone) sublingual tablets, and other trials using buprenorphine sublingual
solutions, as well as an open‐label study in 194 patients treated with SUBOXONE
sublingual film administered sublingually and 188 patients treated with the film
administered buccally. In total, safety data from clinical studies are available from
over 3000 opioid‐dependent subjects exposed to buprenorphine at doses in the
range used in the treatment of opioid dependence.
Few differences in the adverse event profile were noted with regard to sublingually
and bucally administered SUBOXONE sublingual film, SUBOXONE sublingual
tablets, SUBUTEX sublingual tablets and a buprenorphine ethanolic sublingual