This chapter provides an overview of the Federal regulations governing the use
of levo-alpha-acetyl-methadol (LAAM), which are a subset of the regulations
for all opioid substitution therapy programs (see Exhibit 6-1). The chapter also presents suggestions for States that
desire to develop their own LAAM regulations. How the use of LAAM might affect
other systems, such as the public health system, is described. Ethical issues
involved in introducing LAAM treatment are discussed.
The Center for Substance Abuse Treatment (CSAT) has developed two publications
that provide information about the regulation of opioid substitution therapy.
The first, State Methadone Treatment Guidelines, is another Treatment Improvement
Protocol (TIP) in this series that provides guidelines for States and programs to
provide high-quality care in compliance with the regulations. The second publication
Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of
Federal and State Agencies is part of CSAT's Technical Assistance Publications
(TAP) series. To those seeking to establish an opioid substitution therapy program,
the latter offers a step-by-step overview of what to expect from Federal and
State agencies during the program approval and monitoring process. Sample application
forms are provided. Both publications are available free of charge from the
National Clearinghouse for Alcohol and Drug Information.
Opioid substitution therapy programs seeking to become approved to administer
LAAM must apply to the Food and Drug Administration (FDA) and to the State in
which they intend to operate. Federal programs, such as those operated by the
Department of Veterans Affairs, may use LAAM treatment even if the State in which
they are located has not yet approved LAAM for use by treatment programs.
Typically, an application must also be made to the Drug Enforcement Administration
(DEA) and notice given to the single State agencies (SSAs). At present, only
programs that are approved to use methadone are eligible for approval to administer
LAAM.
Some States require programs to obtain approval, some certification, and some
licensure. Some States are still in the process of obtaining the necessary approvals
or amending regulations to permit use of LAAM. (All States have their own
controlled substances laws and must reschedule LAAM from a Schedule I to a Schedule
II drug in order to allow clinics access to it [see below].) The SSAs can
advise treatment providers about whether LAAM is currently available in their
States and about the steps to follow to add LAAM therapy to their treatment regimens.
Providers should contact their State methadone authority. It and the
SSA are the best sources of information regarding local licensing and regulatory
requirements. The SSA is responsible for ensuring that use of LAAM is approved, that
all licensing and approval requirements are met, and that programs are in compliance
with the laws of the State.
The addition of LAAM therapy to a clinic's treatment options will necessitate
an expansion of the program's philosophy and mission statement. As a result,
program manuals, consent forms, and treatment approaches may need revision. Forms
related to release of information may also need revision. In addition, programs
may need to rewrite protocols for the dispensing and storage of drugs to meet
DEA requirements. Many of these revisions can simply follow the method used
by the Federal Government in revising the Federal Narcotic Treatment Regulations.
The word "methadone" was struck out wherever it occurred and the term
"narcotic drugs," a more inclusive term for the class of medications that includes
methadone and LAAM, was substituted. This method of revision obviates the need to
revise the basic regulations each time a new medication is introduced; language
pertinent to the new medication may simply be added (see Exhibit 6-1).
All opioid substitution therapy programs are subject to a thorough inspection
process related to the safety and security of inventory and storage control for
medications. Some States also require an onsite review focusing on program protocols,
qualifications of clinical staff, and patient records.
Regulatory monitoring, whether by the State or another oversight body, focuses on
patient outcomes as well as compliance with recordkeeping procedures. Members
of inspection teams may wish to conduct interviews with patients and staff
to better evaluate patient outcomes. Individuals with backgrounds in treatment
should have a role in the design and implementation of regulatory monitoring procedures.
All regulatory monitoring should be followed by technical assistance in
areas of identified need. Punitive approaches are counterproductive and may
contribute to poor patient retention in programs.
During the Labelling Assessment Study of LAAM, the DEA insisted that programs
keep methadone and LAAM medications separate; that is, each medication should
have a distinct dispensing vehicle and be stored separately (although not necessarily
in separate safes). Patient records should be coded so that records for patients
receiving LAAM can be easily identified. Programs must establish methods of distinguishing
clearly between methadone and LAAM patient records or files, particularly in dispensing
and inventory procedures. This requirement should be continued in the interest
of patient safety and adequate accountability of medications, especially in
States where local regulations do not differentiate between LAAM and methadone.
The inspecting agency (that is, DEA or the local drug control agency) should
clarify its requirements related to the separation of methadone and LAAM in terms
of inventory control, storage, dispensing, and administration to ensure safety,
efficacy, and ease of operation.
FDA is moving into an era of opioid substitution therapy as a general, expanded
concept of therapy, as opposed to a more narrow modality named after a specific
medication--methadone. The introduction of LAAM therapy for narcotic addiction treatment is likely
to pave the way for the introduction of other medications that are opioid
substitutes and for adjunct treatment medications.
States that prefer to write their own regulations for LAAM, as well as those that
have regulations related to methadone and wish to add LAAM to them, should be
encouraged to do so in such a way that the regulations need not be rewritten each
time a new opioid addiction medication using Schedule I or II compounds is introduced.
This process can be accomplished by using generic terms such as opioid substitution therapy, narcotic addiction treatment (the Federal term),
narcotic treatment services, or narcotic addiction therapies, rather
than LAAM therapy. This language will facilitate future revision of the regulations.
States should consider an expedited regulatory mechanism for scheduling new medications,
thereby encouraging treatment programs to utilize the latest developments in pharmacological
therapy, as long as the technology and indications are not radically different (such
as an antagonist medication rather than an agonist medication). States may
want to consider how regulations must vary if a new medication were classified
as a Schedule VI drug rather than a Schedule II drug, allowing greater flexibility
and use by physicians in office practice.
All States have their own controlled substances laws and must reschedule LAAM
from a Schedule I to a Schedule II drug in order to allow clinics access to
it. The mechanism for rescheduling varies by State. States may want to explore
the use of an automatic scheduling process that would mirror (or replicate)
Federal scheduling of new medications for use in treatment. The alternative can
be a long process requiring the approval of several State agencies before
rescheduling takes place. (As of this writing, LAAM has still not been rescheduled
in some States.) Such processes create barriers to programs that want to
offer the latest advances in pharmacological therapy.
States are strongly encouraged to write regulations to incorporate "sunsetting"--that
is, a mechanism requiring that regulations be reviewed and updated within a
specified period of time (for example, 3 years, as in Texas). This review would
allow the regulations to reflect advances in the field (new medications and new
treatment modalities) in a timely manner.
Regulations should emphasize that medications and services must be delivered
together, in a complementary fashion, for any treatment medication. Programs using
LAAM therapy must have the capability to administer methadone as needed in order
to adequately address patients' needs, ensure their safety, and resolve problems
of individual patients. Considerations must include necessary patient travel,
vacations, program holidays, disasters, inclement weather, and other logistical issues.
Serious consideration should be given to modifying the regulations to
allow take-home doses of LAAM in cases in which there is a clinical need. (See Chapter 3 for suggested ways of handling interruptions in treatment.)
Training requirements should be included in State regulations, which should specify
a minimum amount of staff training required per year in order to be licensed
to operate. Minimum annual training should include some basic coverage of
pharmacology. For example, 24 hours of annual training might include 3 hours of psychopharmacology
and an additional 12 hours related to opiate addiction treatment. Because
data about LAAM therapy is still accumulating, training should be constantly
upgraded.
Any State agencies that regulate dispensing and pharmacy would normally be
involved in the program approval process. States that regulate dosage and other
clinical matters should ensure that their regulations are consistent with the new
clinical guidelines for methadone maintenance; they should not use the same criteria
for LAAM as for methadone. Regulations should avoid drug-specific requirements
(such as specifying dose levels) and should be based on treatment efficacy rather
than solely on community, philosophical, or ideological concerns.
States that develop a certification or licensure process and regulations should
involve providers (and consumers) within the State in the development of certification
protocols and new regulations. When appropriate, States should contact programs
in other States that have had experience with LAAM (through clinical trials)
and their SSAs, as well as the National Institute on Drug Abuse (NIDA) and
the Center for Substance Abuse Treatment, when developing or revising regulations.
Treatment programs should serve as the primary sources of data on therapeutic protocols,
advances, and the need for regulations. Programs should be proactive and work cooperatively
with States by investing the time and energy in the regulatory process to develop
useful and practical regulations and encourage regulatory changes. With the current
restrictions on LAAM, such as lack of take-home doses and restrictions on use in pregnant
women, it is not possible to use the new medication to its greatest potential
for patients' needs. Clinical personnel should be proactive in focusing on
optimal patient needs and working toward regulations that will better meet those
needs.
SSAs should evaluate opioid substitution therapy programs that incorporate LAAM
treatment by using a combination of outcomes variables and process variables. Outcomes
evaluations in alcohol and other drug (AOD) abuse treatment programs have thus far
focused on discharged patients, an approach that is highly inadequate for measuring
the success of maintenance therapies. It is hoped that the introduction of
LAAM therapy will move the evaluation process toward an effective and clinically
relevant one in which outcomes variables are based on patient achievements (and
quality-of-life improvements as a result of the treatment process), not on the numbers
of patients "successfully" discharged (McLellan and Durell, submitted for publication).
The expansion of narcotic addiction treatment to include LAAM therapy puts
programs in a position to improve outcomes evaluation. Outcomes variables should
be defined in a way that measures progress rather than failure. A program
should evaluate treatment outcomes with an instrument that is predictable, reliable,
valid, and targeted to the goals of the program--and communicate the results of
that process to the State, in order to add to the information base from which
regulatory change derives. (See Chapter 5 for a discussion of outcomes measures.)
Patients who need opioid substitution therapy should be assessed by a clinician
who is familiar with the treatment alternatives but who does not have a stake
in which modality is chosen. Thus, some form of centralized intake may be
required. Such a system must use a standardized assessment procedure for patients,
who may have a variety of problems. The availability of treatment slots must
be known. Assessment staff must understand the types of treatment offered
and the populations served, as well as the characteristics of both patients
and programs that will facilitate optimal matching of patients to appropriate
treatment modalities. States that have target cities programs should be further
along in the development of centralized intake and standardized assessment systems.
States should ensure that several systems and agencies work together to integrate
services. These include the substance abuse treatment, mental health, public health,
criminal justice, and primary medical care delivery systems. This approach will
assist programs in the transition to managed care. Thus, it behooves States and
programs to integrate the services of all systems. If they do not, they run the
risk of being subject to the decisions of an outside agent that may not integrate
services in a quality-focused manner.
The introduction of LAAM treatment has implications for other areas of the
substance abuse treatment system, not just opiate addiction treatment programs.
The introduction of LAAM treatment will have effects on other systems and organizations,
as discussed below.
It has been suggested that, like methadone maintenance, LAAM could stretch
the public health treatment dollar by reducing the spread of sexually transmitted
diseases and human immunodeficiency virus (HIV) (through needle sharing) and integrating
public health and substance abuse treatments. The anticipated reduction in waiting
lists due to the introduction of LAAM treatment may also eventually result in
decreases in HIV and acquired immunodeficiency syndrome (AIDS) and the associated
risk and incidence of tuberculosis. Success with either methadone or LAAM maintenance
results in a stabilized patient in treatment, and continuing treatment has been
shown to reduce high-risk behavior, improve overall health, and reduce health care
costs related to other medical complications. These are important public health
concerns.
HIV imposes huge costs in health and human terms. Mainstream medicine--including
managed care companies, health maintenance organizations, and other health care
providers--may be willing to accept LAAM because it is new and may be implemented in a
more innovative way than the current methadone maintenance treatment programs.
It is also being introduced at a time when harm reduction is an important
public health consideration.
Regulatory restrictions and the past hostility of prison administrators to opioid
substitution therapy make it unlikely that many prisons will provide this treatment,
but prisons that have licenses to dispense methadone should expand their capabilities
to include LAAM treatment. In fact, LAAM should be easier for prison health
authorities to provide because of the reduced dosing schedule.
Until LAAM is widely used, prison staff may not know how to handle patients receiving
LAAM. Criminal justice system staff (including judges) should receive the same
type of education that is provided to health care providers to familiarize them
with the pharmacology and use of LAAM.
States should write regulations that encourage methadone or LAAM maintenance of
patients whose expected period of incarceration is short (less than 3 months).
Fewer clinic visits will give LAAM-maintained patients a more flexible schedule,
allowing them to better avail themselves of the services of social service organizations.
Such organizations include agencies that provide legal, vocational, educational,
and family social services, such as job training programs.
Insurers frequently set caps on the number of visits to treatment programs of any
kind. They often do not distinguish ongoing maintenance treatment as a separate
modality that requires frequent visits. Treatment programs and others in the substance
abuse treatment system should work to ensure that funding agencies, payers, and
insurance companies receive education about the cost-effectiveness of opioid substitution
therapy, including LAAM treatment. This will help insurers understand that it is
not appropriate to arbitrarily cap the number of visits.
Medical costs associated with untreated opiate addiction can be high. Patients
who enter opioid substitution therapy usually suffer from years of neglected
health and welfare. Thus, in the first year of treatment, costs may be greater
than in later years. However, once the patient enters treatment, the program
can provide some assurance that the patient will receive appropriate and cost-effective
services. In particular, programs can help patients access primary care rather than
hospital and emergency room care, access which will reduce costs. Because the use
of LAAM offsets other medical costs, insurers should cover LAAM therapy and
be willing to reimburse costs of required pregnancy tests. Insurers should
view health problems in substance-abusing patients in the same way as those
in other populations.
The decision to medicate with LAAM or methadone should be made with a focus
on the patient rather than on financial considerations or programmatic convenience.
Programs with a patient mix that includes both publicly funded and private-pay
patients should ensure that the source of reimbursement does not dictate the medication
or other treatment services delivered. Programs must evaluate their treatment
decisions in light of good ethical practice and not succumb to the temptation to
overload their program staff with more patients than can be treated in a comprehensive,
patient-focused manner.
Informed consent is an ongoing process of interaction between staff and patients
about treatment decisions. Its goal is to lead to informed choice. Patients
must understand the nature and purpose of the treatment; its potential risks,
side effects, and benefits; any interactions with other drugs or treatments;
and alternative therapies.
Programs are encouraged to develop an educational process that includes the following
elements, documented in the patient record with a signature:
Patient hears the information (adequate disclosure).
Patient understands the information (assessment that disclosure was comprehended).
Staff assesses patient voluntariness (voluntariness is absent when a patient
makes a choice solely out of desperation or other emotional reactions) and reasons
for making the choice (capacity for decisionmaking). Program staff are then
obligated to make the best choice based on this assessment.
The confidentiality issues attending the administration of LAAM are identical
to those surrounding all other forms of AOD abuse treatment. Several TIPs
in this series have separate chapters that present detailed guidelines for
providing substance abuse treatment in compliance with the Federal confidentiality
regulations. For example, the reader is referred to Chapter 5 of the TIP Simple Screening Instruments for Outreach for Alcohol and Other Drug Abuse and
Infectious Diseases. Issues addressed include the proper use of consent forms
and communicating with other agencies. CSAT has also prepared a separate document
Confidentiality of Patient Records for Alcohol and Other Drug Treatment,
as part of its Technical Assistance Publication (TAP) series. The TAP
contains sample patient consent forms and other forms for programs to use in releasing
information to other agencies.
In the process of providing patient education and obtaining informed consent,
women should be told specifically that if they become pregnant while receiving
LAAM, the physician will switch them to methadone. Staff should ensure that
a patient understands this information. After the pregnancy, patients may
be transferred back to LAAM.
Providing information about the consequences of noncompliance should be part of the
informed consent process. The criteria for noncompliance should be clear to patients
and should not differ for LAAM and methadone patients. Programs should avoid
terminating patients from treatment for continued substance abuse problems. Rather,
programs should seek improved or alternative treatment plans or methods that may
better meet patients' needs.
Treatment is not punishment, and patients should not be changed involuntarily from
one medication to another nor should the treatment be changed in any way that
they might perceive as a punishment. Clinic staff should ensure that a patient
understands the reason for any medication change.
It has been reported that some programs have engaged in unethical advertising
practices. For example, some programs have told patients that they would receive
extra take-home medication if they brought a new patient into treatment. Some
programs have advertised that they give higher doses and more take-home doses than
"competing" programs in the area.
Advertising by opioid substitution therapy programs should be approached with great
care and sensitivity--especially advertising in print or electronic media. A
program may seek to "market" its services in places where referrals are likely
to be found, such as emergency rooms, detoxification centers, police stations
and other criminal justice agencies, and health and human service agencies.
Churches and other groups that help community members in distress can
also be approached. In certain geographic regions, it may be valuable to recommend
that clinics form associations for self-regulation of issues such as advertising.
Some patients are not ready to engage fully in treatment. The question of whether
it is appropriate to use LAAM while delivering minimal clinical services until
the patient engages in treatment should be examined carefully. "Minimal" services
usually involve an initial assessment of severity of substance abuse, which allows
clinicians to determine the level of care a patient will receive when he or she enters
treatment. In some situations, case management is provided for patients whose conditions
require immediate and ongoing attention. In addition, some further contact is
necessary for urinalyses to ensure that the patient is not using other substances.
This level of services may be appropriate for patients who are unable
to engage in treatment for psychosocial or medical reasons. Minimum treatment
should include TB testing and HIV prevention education, which is required under
Federal block grant regulations.
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