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Report of the Center for Substance Abuse Work Group
Federation of State Medical Boards of the United States,
Inc., The recommendations contained
herein were adopted as policy by the House of Delegates of the Federation of
State Medical Boards of the United States, Inc. April 2002
Introduction On October 17, 2000,
The Childrens Health Act of 2000 (HR 4365) was signed into
federal law. Section 3502 of that Act
sets forth the Drug Addiction Treatment Act of 2000 (DATA).This
legislation is of particular interest to state medical boards because it
provides for significant changes in the oversight of the medical treatment of
opioid addiction.For the first time in almost a century, physicians may treat
opioid addiction with opioid medications in office-based settings.These opioid
medications, Schedules III, IV, and V opioid drugs with Food and Drug
Administration (FDA) approved indication for the treatment of opioid
dependence, may be provided to patients under certain restrictions.This new
treatment modality makes it possible for physicians to treat patients for
opioid addiction with these Schedules III-V narcotic controlled substances
specifically approved by the FDA for addiction treatment in their offices
without the requirement that they be referred to specialized opioid treatment
programs (OTPs) as previously required under federal law.
The
DATA requires changes in the oversight systems within the Department of Health
and Human Services (HHS) and the Drug Enforcement Administration (DEA).The
Secretary of HHS has delegated authority in this area to the Center for
Substance Abuse Treatment (CSAT), within the Substance Abuse and Mental Health
Services Administration (SAMHSA).Bringing the treatment of opioid addicted
patients into the scope of individual physician practice significantly
increases the role of the state medical board in overseeing opioid addiction
treatment.For this reason, the Federation of State Medical Boards entered into
an agreement with CSAT to develop model guidelines for use by state medical
boards in regulating the office-based treatment of opioid addiction.
The following model guidelines are designed to encourage state medical boards
to adopt consistent standards, promote public health by availing opioid
addicted patients of appropriate treatment, and educating the regulatory and
physician communities on new treatment modalities offering an alternative in
the treatment of opioid addiction.
The Federation recognizes CSAT for
initiating this project and cooperating in the development of the
guidelines.The Federation also acknowledges the efforts of the following
individuals who participated in the workgroup that provided direction to this
project:
George C. Barrett, MD Immediate Past President, Federation
of State Medical Boards
Regina M. Benjamin, MD, MBA Alabama State
Board of Medical Examiners
Jack Blaine, MD National Institute on
Drug Abuse
W. Joseph Burnett, MD, Director Executive Director,
Mississippi State Board of Medical Licensure
Carlos Campos, MD, MPH
Former Member, Texas State Board of Medical Examiners
Charles
Cichon President, National Association of Drug Diversion
Investigators
Dorynne Czechowicz, MD Division of Treatment Research
and Development National Institute on Drug Abuse
Stephen L. Dilts,
MD, PhD President, American Academy of Addiction Psychiatry/American
Medical Association
William H. Fleming, III, MD Texas State Board
of Medical Examiners
Patricia M. Good Chief, Liaison and Policy
Section/Office of Diversion Control Drug Enforcement Administration
William L. Harp, MD Executive Director, Virginia Board of Medicine
D. Christopher Keyes, MD, MPH Chief, Section of Toxicology,
Division of Emergency Medicine University of Texas Southwestern Medical
School at Dallas
Walter Ling, MD Director, UCLA Integrated
Substance Abuse Programs
Ira Lubell, MD Santa Clara Valley Medical
Center
James J. Manlandro, DO President, American Osteopathic
Academy of Addiction Medicine
Tom McGinnis, Director Pharmacy
Affairs, Office of Policy, U.S. Food and Drug Administration
Laura F.
McNicholas, MD, PhD Chair, CSAT Clinical Guidelines Consensus Panel on
Buprenorphine
Rev. Daniel W. Morrissey, OP Director-at-large,
Federation of State Medical Boards
Richard T. Suchinsky, MD
Associate Director for Addictive Disorders Veterans Health
Administration
R. Russell Thomas, Jr., DO, MPH Texas State Board of
Medical Examiners
Alan Trachtenberg, MD, MPH Medical Director,
SAMHSA/CSAT/OPAT
George J. Van Komen, MD President, Federation of
State Medical Boards
Donald R. Wesson, MD American Society of
Addiction Medicine
Donald H. Williams National Association of
Boards of Pharmacy
Federation Staff Bruce A. Levy, MD, JD Deputy Executive
Vice President Federation of State Medical Boards
Lisa Robin
Director, Leadership Support Service Federation of State Medical
Boards
Jeanne Hoferer Legislative Services Federation of State
Medical Boards
Model Policy Guidelines for Opioid Addiction Treatment in
the Medical Office
Section I: Preamble The (name of board) recognizes
that the prevalence of addiction to heroin and other opioids has risen sharply
in the United States and that the residents of the State of (name of state)
should have access to modern, appropriate and effective addiction treatment.
The appropriate application of up-to-date knowledge and treatment modalities
can successfully treat patients who suffer from opioid addiction and reduce the
morbidity, mortality and costs associated with opioid addiction, as well as
public health problems such as HIV, HBV, HCV and other infectious diseases.The
Board encourages all physicians to assess their patients for a history of
substance abuse and potential opioid addiction.The Board has developed these
guidelines in an effort to balance the need to expand treatment capacity for
opioid addicted patients with the need to prevent the inappropriate, unwise or
illegal prescribing of opioids.
Until recently, physicians have been
prohibited from prescribing and dispensing opioid medications in the treatment
of opioid addiction, except within the confines of federally regulated opioid
treatment programs.Because of the increasing number of opioid-addicted
individuals and the associated public health problems, as well as the limited
availability of addiction treatment programs, federal laws now enable qualified
physicians to prescribe Schedule III-V medications approved by the Food and
Drug Administration for office-based treatment of opioid addiction
[1].
Physicians who consider office-based
treatment of opioid addiction must be able to recognize the condition of drug
or opioid addiction and be knowledgeable about the appropriate use of opioid
agonist, antagonist, and partial agonist medications.Physicians must also
demonstrate required qualifications as defined under and in accordance with the
Drug Addiction Treatment Act of 2000 (DATA) (Public Law 106-310,
Title XXXV, Sections 3501 and 3502) and obtain a waiver from the Substance
Abuse and Mental Health Services Administration (SAMHSA), as authorized by the
Secretary of HHS. In order to qualify for a waiver, physicians must hold a
current license in the State of (name of state) and, at a minimum, meet one or
more of the following conditions to be considered as qualified to treat opioid
addicted patients in an office-based setting in this state:
- Subspecialty board certification in addiction psychiatry from
the American Board of Medical Specialties
- Subspecialty board certification in addiction medicine from the
American Osteopathic Association
- Addiction certification from the American Society of Addiction
Medicine
- Completion of not less than 8 hours of training related to the
treatment and management of opioid-dependent patients provided by the American
Society of Addiction Medicine, the American Academy of Addiction Psychiatry,
the American Medical Association, the American Osteopathic Association, the
American Psychiatric Association, or other organization approved by the board.
- Participation as an investigator in one or more clinical trials
leading to the approval of a narcotic drug in Schedule III, IV, or V or a
combination of such drugs for treatment of opioid addicted patients (must be
evidenced by a statement submitted to the Secretary of Health and Human
Services by the sponsor of such approved drug).
- Additional qualification criteria may be added through
legislative enactment.
In addition to the waiver, physicians must have a valid DEA
registration number and a DEA identification number that specifically
authorizes such office-based treatment.
The waiver to provide addiction
treatment under DATA is granted by the Secretary of HHS, presumably through
SAMHSA, no later than 45 days after receipt of the physicians written
notification. Upon request from SAMHSA, the Attorney General, presumably
through DEA, will automatically assign the physician an identification number
that will be used with the physicians DEA registration number. However,
if SAMHSA has not acted on the physicians request for a waiver by the end
of this 45-day period, DEA will automatically assign the physician an
identification number.
Furthermore, if a physician wishes to prescribe
or dispense narcotic drugs for maintenance or detoxification treatment on an
emergency basis in order to facilitate the treatment of an individual patient
before the 45-day waiting period has elapsed, the physician musty notify SAMHSA
and the DEA of the physicians intent to provide such treatment.
The Board recognizes that new treatment modalities offer an alternative in the
treatment of opioid addiction.Based on appropriate patient assessment and
evaluation, it may be both feasible and desirable to provide office-based
treatment of opioid addicted patients with Schedules III-V opioid medications
approved for such use by the FDA and regulated in such use by Center for
Substance Abuse Treatment (CSAT)/SAMHSA. Physicians are referred to the
Buprenorphine Clinical Practice Guidelines, available at the CSAT/SAMHSA,
Office of Pharmacologic and Alternative Therapies, Rockwall II, Room 7-222,
5515 Security Lane, Rockville, MD 20857; (301) 443-7614 or
http://dpt.samhsa.gov.
The medical
recognition and management of opioid addiction should be based upon current
knowledge and research and includes the use of both pharmaceutical and
non-pharmaceutical modalities.Prior to initiating treatment, physicians should
be knowledgeable about addiction treatment and all available pharmacologic
treatment agents as well as available ancillary services to support both the
physician and patient. In order to undertake treatment of opioid addicted
patients, in accordance with these guidelines, physicians must demonstrate a
capacity to refer patients for appropriate counseling and other ancillary
services.
The (state medical board) is obligated under the laws
of the State of(name of state) to protect the public health and safety. The
Board recognizes that inappropriate prescribing of controlled substances,
including opioids, may lead to drug diversion and abuse by individuals who seek
them for other than legitimate medical use. Physicians must be diligent in
preventing the diversion of drugs for illegitimate and nonmedical uses.
Qualified physicians need not fear disciplinary action from the Board or other
state regulatory or enforcement agency for appropriate prescribing, dispensing
or administering approved opioid drugs in Schedules III, IV, or V, or
combinations thereof, for a legitimate medical purpose in the usual course of
opioid addiction treatment. The Board will consider appropriate prescribing,
ordering, administering, or dispensing of these medications for opioid
addiction to be for a legitimate medical purpose if based on accepted
scientific knowledge of the treatment of opioid addiction and in compliance
with applicable state and federal law.
The Board will determine the
appropriateness of prescribing based on the physicians overall treatment
of the patient and on available documentation of treatment plans and outcomes.
The goal is to document and treat the patients addiction while
effectively addressing other aspects of the patients functioning,
including physical, psychological, medical, social and work-related factors.
The following guidelines are not intended to define complete or best practice,
but rather to communicate what the Board considers to be within the boundaries
of accepted professional practice.
Section II: Guidelines The Board has adopted the following
guidelines when evaluating the documentation and treatment of opioid addiction
under DATA:
Compliance with Controlled Substances Laws and
Regulations Generally, to prescribe and dispense Schedules III-V opioid
medications for the treatment of opioid addiction under DATA, the physician
must be licensed in the state, have a valid DEA controlled substances
registration and identification number, comply with federal and state
regulations applicable to controlled substances, and have a current waiver
issued by SAMHSA. To obtain this waiver, the physician must submit written
notification to the Secretary of HHS of their intent to provide this treatment
modality, certifying the physicians qualifications and listing his/her
DEA registration number. SAMHSA will then notify DEA whether a waiver has been
granted. If SAMHSA grants the physician a waiver, DEA will issue the qualifying
physician an identification number. In addition to these requirements, the DATA
limits the number of patients that a physician or a group practice is permitted
to treat to 30. This numerical limitation may be changed by regulation in the
future.
Physicians are specifically prohibited from delegating
prescribing opioids for detoxification and/or maintenance treatment purposes to
non-physicians.Physicians are referred to DEA regulations (21CFR, Part 1300 to
end) and the DEA Physicians Manual
www.deadiversion.usdoj.gov and
(any relevant documents issued by the state medical board) for specific rules
governing issuance of controlled substances prescriptions as well as applicable
state regulations.
Evaluation of the Patient A recent,
complete medical history and physical examination must be documented in the
medical record. The medical record should document the nature of the
patients addiction(s), evaluate underlying or coexisting diseases or
conditions, the effect on physical and psychological function, and history of
substance abuse and any treatments therefore.The medical record should also
document the suitability of the patient for office-based treatment based upon
recognized diagnostic criteria.[2]
DSM-IV-TR
Substance Dependence Criteria [3]
A maladaptive
pattern of substance use, leading to clinically significant impairment or
distress, as manifested by three (or more) of the following, occurring at any
time in the same 12-month period:
- tolerance, as defined by either of the following:
- a need for markedly increased amounts of the substance to
achieve intoxication or desired effect, or
- markedly diminished effect with continued use of the same
amount of the substance
- withdrawal, as manifested by either of the following:
- the characteristic withdrawal syndrome for the substance, or
- the same (or closely related) substance is taken to relieve
or avoid withdrawal symptoms
- the substance is often taken in larger amounts or over longer
period than was intended
- there is a persistent desire or unsuccessful efforts to cut
down or control substance use
- a great deal of time is spent in activities necessary to obtain
the substance (e.g., visiting multiple doctors or driving long distances), use
the substance (e.g., chain-smoking), or recover from its effects
- important social, occupational or recreational activities are
given up or reduced because of substance use
- the substance use is continued despite knowledge of having a
persistent or recurrent physical or psychological problem that is likely to
have been caused or exacerbated by the substance (e.g., current cocaine use
despite recognition of cocaine-induced depression, or continued drinking
despite recognition that an ulcer was made worse by alcohol consumption)
Treatment Plan The written treatment plan should
state objectives that will be used to determine treatment success, such as
freedom from intoxication, improved physical function, psychosocial function
and compliance and should indicate if any further diagnostic evaluations are
planned, as well as counseling, psychiatric management or other ancillary
services.This plan should be reviewed periodically.After treatment begins, the
physician should adjust drug therapy to the individual medical needs of each
patient.Treatment goals, other treatment modalities or a rehabilitation program
should be evaluated and discussed with the patient.If possible, every attempt
should be made to involve significant others or immediate family members in the
treatment process, with the patients consent.The treatment plan should
also contain contingencies for treatment failure (i.e., due to failure to
comply with the treatment plan, abuse of other opioids, or evidence that the
Schedules III-V medications are not being taken).
Informed Consent
and Agreement for Treatment The physician should discuss the risks and
benefits of the use of these approved opioid medications with the patient and,
with appropriate consent of the patient, significant other(s), family members,
or guardian. The patient should receive opioids from only one physician and/or
one pharmacy when possible. The
physician should employ the use of a written agreement between physician and
patient addressing such issues as (1) alternative treatment options; (2)
regular toxicologic testing for drugs of abuse and therapeutic drug levels (if
available and indicated); (3) number and frequency of all prescription refills
and (4) reasons for which drug therapy may be discontinued (i.e.; violation of
agreement).
Periodic Patient Evaluation Patients should be
seen at reasonable intervals (at least weekly during initial treatment) based
upon the individual circumstance of the patient. Periodic assessment is necessary to
determine compliance with the dosing regimen, effectiveness of treatment plan,
and to assess how the patient is handling the prescribed medication.
Once a stable dosage is achieved and urine (or other toxicologic) tests
are free of illicit drugs, less frequent office visits may be initiated
(monthly may be reasonable for patients on a stable dose of the prescribed
medication(s) who are making progress toward treatment objectives). Continuation or modification of opioid
therapy should depend on the physicians evaluation of progress toward
stated treatment objectives such as (1) absence of toxicity (2) absence of
medical or behavioral adverse effects (3) responsible handling of medications
(4) compliance with all elements of the treatment plan (including
recovery-oriented activities, psychotherapy and/or other psychosocial
modalities) and (5) abstinence from illicit drug use. If reasonable treatment
goals are not being achieved, the physician should re-evaluate the
appropriateness of continued treatment.
Consultation The
physician should refer the patient as necessary for additional evaluation and
treatment in order to achieve treatment objectives.The physician should pursue
a team approach to the treatment of opioid addiction, including referral for
counseling and other ancillary services.Ongoing communication between the
physician and consultants is necessary to ensure appropriate compliance with
the treatment plan.This may be included in the formal treatment agreement
between the physician and patient.Special attention should be given to those
patients who are at risk for misusing their medications and those whose living
or work arrangements pose a risk for medication misuse or diversion.The
management of addiction in patients with comorbid psychiatric disorders
requires extra care, monitoring, documentation and consultation with or
referral to a mental health professional.
Medical Records
The prescribing physician should keep accurate and complete records to
include (1) the medical history and physical examination; (2) diagnostic,
therapeutic and laboratory results; (3) evaluations and consultations; (4)
treatment objectives; (5) discussion of risks and benefits; (6) treatments; (7)
medications (including date, type, dosage, and quantity prescribed and/or
dispensed to each patient); (8) 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; (9)
instructions and agreements; and (10) periodic reviews. Records should remain
current and be maintained in an accessible manner and readily available for
review. The physician must adhere to the special confidentiality requirements
of 42CFR, Part 2, which apply to the treatment of drug and alcohol addiction,
including the prohibition against release of records or other information,
except pursuant to a proper patient consent or court order in full compliance
with 42CFR2, or the Federal or State officials listed in 42CFR2, or in cases of
true medical emergency or for the mandatory reporting of child abuse.
Section III: Definitions For the purposes of these
guidelines, the following terms are defined as follows:
Addiction: A primary, chronic, neurobiologic disease, with
genetic, psychosocial, and environmental factors influencing its development
and manifestations. It is characterized by behaviors that include one or more
of the following: impaired control over drug use, compulsive use, continued use
despite harm and craving.
Agonists: Agonist drugs are substances
that bind to the receptor and produce a response that is similar in effect to
the natural ligand that would activate it. Full mu opioid agonists activate mu
receptors, and increasing doses of full agonists produce increasing
effects.Most opioids that are abused, such as morphine and heroin are full mu
opioid agonists.
Approved Schedule III-V
Opioids:Opioids referred to by the DATA, specifically approved by the
FDA for treatment of opioid dependence or addiction.
Antagonists:Antagonists bind to but do not activate
receptors.They prevent the receptor from being activated by an agonist
compound. Examples of opioid antagonists are naltrexone and naloxone.
Maintenance Treatment: Maintenance treatment means the
dispensing for a period in excess of 21 days of an opioid medication(s) at
stable dosage levels in the treatment of an individual for dependence upon
heroin or other morphine-like drugs.
Opioid Dependence: A
maladaptive pattern of substance use, leading to clinically significant
impairment or distress, manifested by 3 or more of the following, occurring at
any time in the same 12-month period:
- A need for markedly increased amounts of the substance to
achieve intoxication or desired effect or markedly diminished effect with
continued use of the same amount of substance;
- The characteristic withdrawal syndrome for the substance or the
same (or closely related) substance is taken to relieve or avoid withdrawal
symptoms;
- The substance was taken in larger amounts or over a longer
period of time than was intended;
- There is a persistent desire or unsuccessful efforts to cut
down or control substance use;
- Significant time is spent on activities to obtain the
substance, use the substance, or recover from its effects;
- Important social, occupational, or recreational activities are
discontinued or reduced because of substance use;
- Substance use is continued despite knowledge of having a
persistent physical or psychological problem that is caused or exacerbated by
the substance.
Opioid Drug: Opioid drug means any drug having an
addiction-forming or addiction-sustaining liability similar to morphine or
being capable of conversion into a drug having such addiction-forming or
addiction sustaining liability. (this is referred to as an opiate in the
Controlled Substances Act)
Opioid Treatment Program (OTP)
(sometimes referred to as a methadone clinic or narcotic treatment program):
Opioid treatment program means a licensed program or practitioner engaged in
the treatment of opioid addicted patients with approved Scheduled II opioids
(methadone and/or LAAM).
Partial Agonists: Partial agonists
occupy and activate receptors. At low doses, like full agonists, increasing
doses of the partial agonist produce increasing effects. However, unlike full
agonists, the receptor-activation produced by a partial agonist reaches a
plateau over which increasing doses do not produce an increasing effect. The
plateau may have the effect of limiting the partial agonists therapeutic
activity as well as its toxicity. Buprenorphine is an example of a partial
agonist.
Physical Dependence: A state of adaptation that is
manifested by a drug class specific withdrawal syndrome that can be produced by
abrupt cessation, rapid dose reduction, decreasing blood level of the drug,
and/or administration of an antagonist.
Qualified Physician: A
physician, licensed in the State of (name of state) who holds a current waiver
issued by SAMHSA (as authorized by the Secretary of HHS) and meets one or more
of the conditions set forth in Section 1. In addition, a physician must have a
valid DEA registration and identification number authorizing the physician to
conduct office-based treatment.
Substance Abuse: A maladaptive
pattern of substance use leading to clinically significant impairment or
distress, as manifested by one or more of the following, occurring within a
12-month period:
- Recurrent substance use resulting in a failure to fulfill major
role obligations at work, school, or home;
- Recurrent substance use in situations in which it is physically
hazardous;
- Recurrent substance-related legal problems;
- Continued substance use despite having persistent or recurrent
social or interpersonal problems caused or exacerbated by the effects of the
substance.
Tolerance: A state of adaptation in which exposure to a
drug induces changes that result in diminution of one or more of the
drugs effects over time.
Waiver: A documented
authorization from the Secretary of HHS issued by SAMHSA under the DATA that
exempts qualified physicians from the rules applied to OTPs. Implementation of
the waiver includes possession of a valid DEA certificate with applicable
suffix.
[1] Drug Addiction Treatment Act of 2000,
Public Law 106-310, Title XXXV, Section 3501 and 3502.
[2] Buprenorphine Clinical Practice Guidelines, Table
3-1.
[3] American Psychiatric Association,
Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text
Revision, Washington, D.C.
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