Starting your own program sounds like an impossible goal — while it will be
hard work it is doable! You will not be first patient to open a program and
hopefully, you will not be the last. The primary reason for a patient opening a
program is that it will give you and the patients on the program control over
your treatment. This can ensure that policies set by the program are patient
oriented and make sense instead of placing treatment and policy in the hands of
so-called professionals who do not understand addiction or the medication they
administer. The system has become abusive, uncaring with poor quality treatment
and support services.
Providers like to blame the regulating agencies for the contra-therapeutic
policies they must adhere to. Patients and even professionals working in the
field have believed this for years while the reality has been that it is the
programs themselves that set the most abusive policies. For example, the federal
regulations do not set dosing limits. The Food and Drug Administration which is
responsible for this asks to be notified about any patient prescribed 100 mg/day
or more. A few states like Pennsylvania do set a limit of 80 mgs/day, but that
is still a therapeutic dose. So why do over half of the programs in the US set a
policy of prescribing no dose over 50 mg/day or even less at 40 mgs/day? The
answer is simple, they have based their decision on ignorance — ignorance over
the biology of addiction and the medication that controls it namely, methadone.
Other examples are blind dosing (about 37% of all programs do it) and urine
testing for which the federal regulations state that programs must ensure that
urine samples are not falsified. The way to do this is left up to the programs
resulting in the demeaning policy to supervise urines, video cameras, see
through mirrors and all the contraptions and humiliations that programs put
patients through.
Why do programs do these things? The only answer that seems to make sense is
ignorance. Programs are primarily administered by social workers —
behaviorists. They have had no education on drug use — nothing. The education
that most social workers, clinical psychologists and rehabilitation counselors
receive is anti-medication and if methadone is mentioned at all it is negative.
The neurobiology of addiction is not included in the curriculum, instead
behaviorists are taught that addiction is a character disorder. Like the public,
behaviorists erroneously view addiction as a choice — except that they are
suppose to be the experts!
Yes, but what about the physician in the program, after all doctors should
have a basic understanding of the biology of addiction. Unfortunately, the
education in medical and nursing schools, like schools for social workers teach
students that addiction is primarily a behavior disorder. Young doctors are
warned about heroin addicts and told to keep away from them because they just
want drugs. Thus, medical professionals do not see heroin addiction as being
under their domain and acquiesce to the behaviorists.
This is slowly beginning to change, but changing 70 years of the DEA’s
propaganda will take time. The American Society of Addiction Medicine (ASAM)
which was very anti- narcotic maintenance now has a committee for maintenance
medications. Another positive change is the American Medical Association’s (AMA)
recognition of Addiction Medicine as a speciality. Physicians can now obtain
training and certification through ASAM.
The only answer for the moment is to open your own program. It will require
work, but think of the advantages and most important you will have control over
your treatment and so will the patients on the program.
A General Outline
Every state will have their own set of regulations to follow for licensing
and some areas may have local regulations. Below is a general outline of the
things that you will have to do. However, depending on your area there may be
differences in the order that things should be accomplished.
1. The first thing you must do is align yourself with the professional
“half” of your team.
- You first have to find a doctor willing to act as Medical Director for
your facility.
- It’s imperative, if you wish to have any credibility (or public funding)
that you have qualified, certified, substance abuse counselors and be able
to point to this when you begin dealing with the regulatory agencies.
2. Choosing a site may be the most difficult obstacle depending upon your
community. This past year several new clinics were unable to open because of
community opposition. If your area requires community approval then the location
you choose will be very important and the opening of the clinic can be dependent
on it. You will probably need the support of community leaders and local
politicians. This will have to be handled very tactfully and to get their
support you will have to educate them about methadone treatment and heroin
addiction – that most addicts are unable to maintain abstinence; that there are
strong biological components of addiction, including genetic; how methadone
works and that it is not a substitute. A good strategy would be to ask local
policy makers, community leaders and politicians to sit on the Board of
Directors.
3. The site will probably have to be renovated and outfitted with furniture.
Approving and inspecting the site is the responsibility of the Drug Enforcement
Administration (DEA) and I would suggest that you check with them before
proceeding with this step. They have particular construction criteria for the
safe, the doors, Walls, every aspect of the pharmacy in particular and
everything else in general.
4. Begin to consider any other patients who will be able to contribute to the
organizing of the program. You will need patients that are
“functional” and willing to work hard and for the benefit of others.
Make sure that the patients you place in any key positions have been in recovery
at least five years or longer and have been clean for a good number of years.
- You must make certain to set things up to insure that employed patients
never have access to methadone. This means not signing for shipments, not
having access to the pharmacy or anything else that could leave you open to
question or criticism.
- You will want to utilize patients in every other manner possible i.e.,
janitorial, snow removal, building and construction, secretarial,
accounting, computer programming, etc. (This is also useful because patients
can, in this manner, work off their clinic fees, thus saving the clinic in
the area of much-needed cash flow.)
5. Educate yourself about methadone and know who the top professionals in the
field are. Don’t be afraid to call any and everybody you think has something to
share that can help you. (After all the only thing they can say is no.)
6. Study policies and regulations to know what has to be done and in what
order.
7. Set up an organization with a president and a Board of Directors. This is
a very important step. Never forget that the Board of Directors basically owns
your not-for-profit clinic and can do with it as it sees fit once the Board is
in place. To insure the continuation of a patient coalition, you should consider
an all-patient Board of Directors with an Advisory Board made up of reputable
members of the community and professionals.
You will want to be very familiar with your state laws governing open meeting
and public participation laws.
8. You will want to incorporate. The easiest way to do this is to purchase
one of the ready made incorporation packages at a large book store. All of the
forms that you will need should be in the package as well as instructions to
incorporate. The cost and procedures to incorporate can be very difficult
depending on the state. Maryland is suppose to be the easiest and New York is
one of the most difficult. For example, in New York there is a list of special
words that either can’t be used or require approval. Methadone is one of the
words and NAMA had to get written approval from the FDA to incorporate in New
York. Therefore, if you live in New York do not use the word
“methadone” in your name unless you want to spend 6-10 months.
9. The next step is to acquire not-for-profit status which will take about
6-10 months. This is not absolutely imperative though and it is even possible to
operate up to approximately 15 months without it if necessary. This may vary by
state however and you should check with your Secretary of State.
10. The next step is to prepare the proposals that you will need to obtain
licensing. In general, begin at the federal level, then the state and finally
local. This will be a long process and will have several sub-steps.
11. Acquiring correct licensing and the order in which to obtain them is
different for each region.
12. If you want to be able to accept public medical funding (Medicaid) you
may need approval from the state. Above all, if you do get Federal and State
funding in additional to Medicaid it is advisable to develop alternative sources
of income to insure the longevity of the program. This should be a joint effort
between patients, staff and Board of Directors.
13. Finally you will have to find a means to let addicts who want treatment
and methadone patients know that you are there and the clinic is open.
Federal Agencies
National Clearinghouse for Alcohol and Drug Information (NCADI):
The information is usually free. Ask them to send you the “State Methadone
Treatment Guidelines” which contains valuable information to
“begin” implementing a program. You will need a current copy of the
federal regulations which I believe does cost money (about $30). For information
call NCADI at 1-800-SAY-NO-TO(DRUGS)
Food and Drug Administration (FDA):
This is the federal regulating agency. They license and oversee programs on the
federal level. Primarily this involves ensuring that records are up to date, the
correct number of urines are taken, that patients with take out medication are
documented as employed, going to school or homemakers with children under 5
years. The FDA is also the agency that programs must place a formal request to
when:
- a patient requests over 13 days of medication for a vacation or business
trip,
- to ask that a patient who is taking 100 mgs/day or more can have take
homes,
- to request an exception to the regulations i.e., a patient in treatment
and good standing for 18 months that is working asks for once a week pick up
schedule.
Resources
The first point of inquiry for information about FDA approval should be the
FDA district office.
Betty Jones
Chief, Regulatory Management Branch
Division of Scientific Investigations
Food and Drug Administration
7520 Standish Place
Rockville, MD 20855
Phone: (301) 295-8029
FAX: (301) 295-8204
Drug Enforcement Administration (DEA):
This federal agency is involved in the security of methadone and diversion. They
ensure that methadone cannot be stolen i.e., methadone is the only narcotic that
must be stored in two (2) safes. Also, the DEA is responsible for the lay out or
architecture of the clinic. Yes, they measure doorways, rooms etc. not for the
safety of patients or staff, but to protect the methadone.
The first point of inquiry for information should be the appropriate DEA
field office.
G. Thomas Gitchel
Chief, Liaison and Policy Section
Office of Diversion Control
U.S. Dept. of Justice
Drug Enforcement Administration
Washington, DC 20537
Phone: (202) 307-7297
FAX: (202) 307-8570
National Institute on Drug Abuse (NIDA):
NIDA is primarily a research agency. At one time NIDA was the only federal
agency involved in administration and funding of all funding drug programs,
including methadone and research. However, the Reagan administration split the
agency in half and created the Center for Substance Abuse Treatment (C-SAT) to
oversee the administration and funding of drug programs. Still NIDA is a very
large agency and has many divisions i.e., Development of New Medications, AIDS,
International and Policy. They fund Demonstration Grants which provides funding
to establish and evaluate new programs i.e., Bleach Programs. Once their
effectiveness is established the new program must look to C-SAT for funding.
This is what happened to many of the Bleach Programs which were part of a large
block funding. When the demonstration period ended it became up to local
authorities to continue funding and of course many could not – so that was the
demise of the Bleach Programs.
James Cooper, M.D.
Associate Director for Medical Affairs
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-A-12
Rockwall II Building
Rockville, MD 20857
Phone: (301) 443-4877
FAX: (301) 443-8674
Center for Substance Abuse Treatment (CSAT):
This agency oversees and administers the state block Grant funding for drug
treatment and prevention programs. They also fund some research to evaluate the
effectiveness of the programs they fund. C-SAT publishes a superb series of
reports called the Treatment Improvement Protocols or TIPS. Number one in the
series is the invaluable “State Methadone Treatment Guidelines” which
is available through NCADI.
Robert Lubran, M.S., M.P.A.
Senior Advisor for Quality Assurance
Division for State Programs
Center for Substance Abuse Treatment
5600 Fishers Lane
Rockwall II, 8th Floor
Rockville, MD 20857
Phone: (301) 443-8391
FAX: (301) 433-8345
Selected Bibliography
There is a vast amount of literature about methadone which can be obtained
through NCADI, but you must be more specific than just “methadone”
because of the vast number of publications (I would estimate that one could fill
several large tractor trailers).
Methadone Maintenance and Patient Self Advocacy by Arlene Ford. NAMA
Education Series Number 1 (March, 1991).
Drug Policy in the Age of AIDS: The Philosophy of Harm Reduction by Rod Sorge.
NAMA Education Series Number 2 (April, 1991).
Myths About Methadone by Emmett Velten. NAMA Education Series Number 3
(March, 1992).
Methadone, HIV Infection and Immune Function by Herman Joseph. NAMA Education
Series Number 4 (August, 1994).
Basic Pharmacology: How Methadone Works? by Joycelyn Woods. NAMA Education
Series Number 5 (May, 1995).
The Addict as Patient by M.J. Kreek. (In: Comprehensive Textbook on Chemical
Dependency, 1990).
Narcotic Blockade by V.P. Dole, M.E. Nyswander and M.J. Kreek. (Archives of
Internal Medicine 1966 (October) 118: 304-309.)
Addictive Behavior by V.P. Dole. Scientific American 1980 (December) 243(6):
138-154.
Implications of Methadone Maintenance for Theories of Narcotic Addiction by
V.P. Dole. Journal of the American Medical Association 1988 (November 25)
260(20): 3025-3029.
