Volume IV, Issue VI I I (August 1999)
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New Federal Rules Proposed to Improve Quality
and Oversight of Methadone Treatment - DHHS Press Release
What the Proposed Federal Rules Mean for Methadone
Patients - Aaron Rolnick
Different Formulations of Methadone -
by Nancy Rose
Doctor's Column - Different
Formulations of Methadone
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New Federal Rules Proposed to Improve Quality
of Methadone Treatment
[U.S. Department of Health and Human Services (HHS) Press Release]
Methadone programs will have to be accredited under a new
proposal announced today by the U.S. Department of Health and Human Services.
The new accreditation program will be managed by the Substance Abuse and
Mental Health Services Administration (SAMHSA) and replaces a 30-year-old
inspection program conducted by the Food and Drug Administration (FDA).
The new program mirrors the recommendations that have been made
over the last decade by several independent groups, such as the Institute
of Medicine (IOM), the General Accounting Office (GAO), and a consensus
conference of the National Institutes of Health.
Under the proposed rule, published in the Federal Register, narcotic
treatment programs would be accredited by independent agencies in accordance
with standards established by SAMHSA's Center for Substance Abuse Treatment
(CSAT). These proposed standards emphasize improving the quality
of care, such as individualized treatment planning, increased medical supervision,
and assessment of patient outcomes. This new programs relies on "best
practice guidelines" developed by CSAT over the past 10 years.
The press release goes on to explain that, according to the White
House Office of National Drug Control Policy (ONDCP) estimates of
the number of heroin addicts in the United States, slightly less than one-fifth
(20%) of heroin addicts "currently receive methadone or LAAM [the only
opiates/opioids currently approved for the treatment of heroin addiction],
as part of an addiction treatment program." One purpose of the proposed
rules is to increase access to these treatment programs, according to ONDCP
Director/Drug Czar Barry McCaffrey. McCaffrey then explained how
methadone therapy is not just good for the patients, but for everyone.
[His assertions are backed up by various studies that indicate that the
monetary cost of methadone treatment is well outweighed by monetary benefits
to society—not to mention the non-monetary societal benefits, such as lower
crime rates and lower rates of HIV and Hepatitis C transmission.]
Thus, according to the press release, the new proposed rules will increase
access to methadone and LAAM treatment, and therefore, benefit all of society.
Another purpose of the proposed rules is to improve the quality
of treatment. The press release states that the accreditation standards
are based on "recommendations made by a recent National Institutes of Health
consensus panel… [and] a 1995 report by the Institute of Medicine…."
Furthermore, "accreditation has been proven over the years to
produce effective outcomes" and is commonly used to control the quality
of medical treatment. Thus, accreditation standards will not only
increase the ability of "…health care professionals to provide methadone
maintenance services to patients," but will improve the quality of care—by
maintaining minimum standards that treatment providers must follow.
This will be a considerable improvement over the current [over]regulation,
which actually limits the ability of health care professionals to provide
quality methadone treatment and does little to require or promote quality
standards or improvements.
In conclusion, the proposed rules "detail accreditation standards
and the requirements for accrediting organizations." There will be
a 120-day period for the public to comment and a public hearing before
the proposed rules may be finalized or adopted. At the present time,
"CSAT is conducting a study on a representative group of treatment facilities
that are implementing accreditation standards developed by the Commission
on Accreditation of Rehabilitation Facilities (CARF) and the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO)," two of the organizations
that may be responsible for developing standards and determining whether
treatment providers deserve accreditation. The standards may be altered
based on the results of this study. In the meantime, the current
regulations enforced by the FDA will still be in effect.
You can find the new proposed methadone regulations on the Internet
at http://www.access.gpo.gov/su_docs by clicking on Federal Register.
If you don't have access to the Internet and would like a copy of the proposed
regulations, send a self-addressed envelope and $5 to cover copy
costs and handling to the address on page 4.
Written comments on the rules may be submitted to: Documents
Management Branch (HFA-305) Food and Drug Administration, 5630 Fishers
Lane, Room 1061, Rockville, MD 20852-1706
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What the Proposed Federal Rules Mean
for Methadone Patients
by Aaron Rolnick
The proposed standards for methadone maintenance/opiate agonist treatment
represent an opportunity to finally change the current regulatory system—a
system that was mainly set up for the purpose of preventing diversion,
rather than for the benefit of patients. Please understand, however,
that these proposed rules are less than perfect. This proposal requires
that treatment providers be accredited, therefore, patients cannot simply
go to a doctor's office and receive methadone treatment (e.g.: medical
maintenance). Therefore, many of the same problems that exist currently
due to lack of competition, may still exist under the proposed rules (i.e.:
in many areas, there may only be one or two clinics and as a result,
patients are at the whim of these providers because there are no other
clinics to choose from). Unfortunately, this proposal does not contain
any protection/declaration of patients' rights. Another serious problem
with the proposal is that it relies on a small number of organizations
to handle accreditation—organizations that may have their own agenda, are
not really accountable to patients [at least, directly], and cannot be
voted out [they are chosen by a government agency made up of non-elected
employees]. Despite the proposal's shortcomings, if adopted, it represents
a considerable improvement over the current system.
One area that the proposed rule may make a big difference in is
in the rules regarding take-home doses. Not withstanding "exceptions"
that are sometimes granted on an individual basis, the current system requires
methadone patients to attend a clinic [at least] 1-6 days per week—even
after being "clean" for years. The proposed rules have the potential
to increase the amount of take-home doses allowed at one time considerably—especially
after a patient has been on the program for over a year.
The proposed rules list four possible options regarding "take-home
privileges." The secretary states that [at this point] he favors
Option #2. Option #2 would replace the current take-home schedule
with the following [minimum] requirements:
For the first month of treatment, the maximum take-home supply
is limited to a single dose each week and the patient shall ingest all
other doses under appropriate supervision.
In the second month of treatment, the maximum take-home supply
is two doses after each supervised ingestion.
In the third month of treatment, the patient should have ingestion
observed at least twice a week, with take-home permitted for other doses.
In the remaining months of the first year, the maximum take-home
supply of methadone is three doses after each supervised ingestion.
After one year, a selected patient would become eligible for less intensive
supervision of medical ingestion and may be given up to a 31-day supply
of take-home medication and monthly visits. [In another variation
of Option #2, the maximum supply of take-homes would be 14 days after one
year, and 31 days after two years.]
Note that, as with the current regulations, these are only minimum
requirements. In other words, clinics/treatment providers can give
patients up to the take-home supply specified in the regulations—treatment
providers could elect to give patients less take-homes than specified there
but not more.
Another obstacle patients may have to obtaining greater take-home
privileges is state regulations: if passed, these proposed rules
will not nullify current state regulations regarding methadone treatment
and does not preclude states from passing new regulations. [As is
the case with treatment providers, states can place greater restrictions
on treatment than are in the federal regulations.] Currently, some
states have an absolute prohibition on methadone maintenance treatment,
including Vermont, Idaho, and Mississippi; several other states have regulations
on maintenance treatment [that are more restrictive than the current federal
regulations]. If the proposed rules are adopted, some states that
currently do not have such regulations, may decide to pass legislation
that maintains the minimum standards contained in the current federal regulations
(i.e.: they may limit take-home supplies to 1-6 days per week, which
is the maximum amount allowed by the federal regulations currently without
What does all this mean for methadone maintenance treatment patients?
Now more than ever, methadone patient advocacy is vital to securing greater
freedom from overly restrictive regulations and clinic policies.
Even if the proposed rules are adopted, states may enact regulations, or
may already have regulations, that limit the effects of these rules.
And clinics can have their own rules in addition to state and federal regulations—so
patient advocacy will be needed as much as ever at the clinic level.
But these proposed rules represent an opportunity to make changes for the
better; let's take advantage of it.
We need you more than ever to become involved in patient
advocacy and/or to help us make the relaxed regulations a reality.
Contact Beth at Methadone Today if you would like to help.
See the address on page 4 or call (810) 658-9064.
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Different Formulations of Methadone
by Nancy Rose
There has been ongoing discussion between methadone patients around
the United States about different types of methadone. Different clinics
offer varying formulations of methadone or methadose. (If you're lucky,
your clinic offers more than one type to choose from!) Some patients say
they "feel" one type better than another, or that one kind "holds" longer
than another. Some patients report they experience various side effects
from different formulations. One patient wrote in to Methadone Today's
"Dear Doctor" column asking about these different formulations and their
side effects (see this issue's column).
Various formulations include (but are not limited to):
Methadone powder (to be mixed with water), white tablets (5 mg and 10
mg, also 40 mg), orange Diskettes (40 mg), cherry or other-flavored methadose,
and clear liquid methadone. Another patient wrote in to our "Dear Doctor"
column asking about a "methadone patch"; we're waiting for the responses
from our Medical Advisory Board and will print the information in a future
The following are some of the side effects patients have
experienced with various forms of methadone they've been prescribed over
the past years and their preferences. (remember, these are the opinions
of individual patients; your body chemistry may be different, so you may
have a different experience!):
"I get constipation from ALL of them!" (J, a male patient)
"I notice a big difference between the orange wafers and all the
others. I prefer the orange wafers." (N, male)
"I notice the ladies seem to put on more pounds with clear liquid,
even as opposed to cherry stuff (my wife certainly did after our clinic
changed from cherry to clear!). (M, male)
"With the cherry methadose, I gained weight, experienced swelling
in my hands and feet (water swelling), and developed stomach problems.
At the time, I wasn't sure whether to "blame" these things on the methadose,
but after my clinic switched to the clear methadone (about 6 months ago),
my swelling went down quite a bit, and my stomach problems have eased up
considerably! (And I've had no other changes in my life or diet to account
for this.) The clear methadone seems to hold much longer, also. (I still
need to lose weight though!)" (G, female)
"For me, cherry methadose wears off sooner and isn't quite as
strong as the flavorless clear liquid. The 40 mg wafers are somewhere in
between and seem to hold longer." (J, male)
"I like wafers ‘cause they hold longer for me than liquid. In
the beginning, I gained weight and craved sweets, but my weight has leveled
out. Now I don't have a good appetite, but I'm under lots of stress." (S,
"I like wafers best; also tried clear liquid and dolophine tabs.
I sweat with all of them, but I still choose the wafers." (E, female)
"I've had quite a few over the years at different clinics: cherry
methadose, wafers, dolophine, clear methadone, lemon-flavored methadose,
and orange-flavored methadose. Here's my experience: All the flavored
methadose had the MOST side effects for me. With wafers, I got a decrease
in side effects. Pills had the LEAST side effects. With pills, I get slight
constipation. With clear liquid methadone, heavy constipation. With flavored
methadose, heavy sweating!" (S, male)
"My best experience was with 5 mg tablets that fizzed when added
to water (like Alka-seltzer). It was back in the early 1980's at Beth Israel
clinic, I got "Westadone", yellow-green color, scored tablets that broke
in half easily. With Westadone, I lost 50 pounds! (After switching from
wafers)." (D, male, New York)
"I get powdered methadone at my clinic mixed with distilled water
@ 5 mg per ml then mixed with juice of your choice. I get sweating and
constipation, but the methadone is VERY effective!" (W, male, Canada)
"I've had both the cherry methadose and the clear liquid methadone.
At the same dose, the clear lasts WAY LONGER! I was surprised there was
such an obvious difference! In fact, when my clinic made a temporary change
(for two weeks) from clear to cherry methadose, quite a few patients went
in asking for increases. The clinic decided to get the clear back. (N,
"I've taken all forms of methadone, including dolophine and the
red cherry methadose. Now I take orange wafers which are by far the best
for me! I switched to clear liquid for a week and didn't feel well at all.
I wasn't dying; it just didn't hold me well at all. (I also got put on
a ‘split dose' recently -- 160 mg divided into 100 mg in the morning and
60 mg in the evening. I feel a whole lot better in the mornings now!)"
Patients had different experiences with telling staff about their preferences.
There were a few staff people who said something along the lines of "It's
all in your head!" It shouldn't be surprising to staff to hear that patients
have preferences. After all, don't some "regular" (non-addict people) have
preferences when it comes to getting prescriptions filled? I've heard many
people say they don't want a "generic" brand of some medication because
it "doesn't work as well"!
I'm glad to hear that there are more methadone treatment clinics
offering a choice to their patients as to what type formulation they prefer.
It's a good feeling when staff takes your opinion seriously; after all,
WE are the patients, WE are the ones ingesting this medication (sometimes
for years), WE are the best judge of what we feel!
One clinic physician, when asked his opinion about different formulations
and patients having various side effects and preferences, said he was genuinely
puzzled because research and MRI testing showed that ALL the formulations
worked in the same way on the same parts of the brain. But he believed
the patients, and said he would consider offering more than one type of
methadone in his clinic.
Another staff person (a counselor) suggested that possibly it's
the additives that cause different side effects. (Well, I noticed that
at least one company added alcohol to their methadone!)
We at Methadone Today would like to hear YOUR experience
with different kinds of methadone, and what types of methadone YOUR CLINIC
offers. Methadone Today, PO Box 164, Davison, MI
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Dear Methadone Today,
I just received my April issue of Methadone Today.
I was somewhat surprised, then elated to see my letter and cartoon printed
in the issue! I surmise you used the name "Allan" as the writer of
the article to protect my anonymity. Anyhow, I appreciate your printing
it, for it will not only be helpful to others in my situation, it also
gave me a boost in my self-esteem -- to see something positive of mine,
serving as a valuable tool in the community.
I have a question to ask: is there anybody on a methadone
maintenance program who is also on probation or parole in Wayne County
(Michigan)? If so, I assume they must have their parole or probation
officer's approval and cooperation. If somebody has this "luxury",
perhaps they would be so kind as to write to me. It sure would dispel
any trepidation I have because I will be paroled very soon.
Beth, if you print this letter, could you ask that they write
to me in care of your newsletter? Thank you so much.
(Editor's Note: Marshall was to be paroled in late May
1999. If any Wayne County reader is on parole or probation and also on
methadone maintenance and would like to write Marshall, please send your
letter to Methadone Today, PO Box 164, Davison, Michigan 48423-0164, and
I will be happy to forward it to him.)
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Dear Ms. Francisco,
I just received my first copy of Methadone Today—given/sent to
me through the good graces and thoughtfulness of my younger brother.
I must begin with major kudos and accolades for you and the staff
and all contributors to Methadone Today. Every single article and
letter struck a nerve and hit home with me—or someone I know at my clinic.
A real Godsend!
My story is not unlike all of our stories--a 40-plus-year struggle
with opiates with all of the accompanying baggage and wreckage--rehabs,
meetings, stigma galore, depression, confusion, even a 10-year stint in
AA/NA . . . most of it spent in therapy trying desperately, earnestly,
and honestly to figure out what the hell was wrong with me. You name
it, and I did it. During this period of "sobriety" (I use the term
loosely, as it implies "soundness of mind"), I married the woman of my
dreams—an old friend I bumped into at an AA meeting when I was just over
a year clean. We had [have] two beautiful children, bought two beautiful
homes, and had all the appearances of a well-to-do middle-class family
on their way up.
Our second home involved a move back to the rural community where
we were both raised—a return "home." It seemed as though we had arrived
in our heaven. We both ran our own successful businesses, the kids
were healthy and happy, I had built my "dream shop" in our large new mountain
retreat, we both were into our meetings of AA/NA, we had a large circle
of wonderful friends and good spiritual lives—on and on, ad nauseum.
Nearing my tenth year of total abstinence, I was on my way to
do an estimate one sunny fall day, taking a back road I hadn't traveled
in years. Suddenly I saw an old connection/friend I hadn't seen in
over 12 years alongside the road. Not thinking for a moment, I pulled
over to offer him a lift. Long story short—the "back country road"
I had "chosen" was now known as "smack alley", and my old connection was
doing just that—connecting.
Within 15 minutes I had my tie from around my neck around my arm
and bought an ounce of tar heroin from "Jack." Needless to say, I
never made my 10-year AA/NA anniversary. I spent the next four months
hiding my addiction from my wife, shooting dope in my basement shop under
the guise of "meditating" in the early mornings when I needed a fix.
Things quickly unraveled, and I finally called my wife that fateful day
and told her all.
Naturally, she was shattered. "We" spent the next
year or so trying to "get me back on track": three rehabs, two of
them residentials, a million meetings, thousands of "steps", more therapy—you
get the picture.
It was during this torturous period that I was introduced to methadone
maintenance treatment by a local shrink with an empathy—and some real knowledge—about
opiate "addiction." It was he who told me that perhaps I actually
needed an opiate to feel real, that not unlike the diabetic who is "insulin
challenged" that perhaps I was "neuro-chemically challenged" and merely
needed a neurochemical "supplement" to feel O.K.
Skeptical at first, I approached my first methadone clinic with
all of the misinformation one has when uneducated about methadone maintenance
treatment. I even tried to get off of my treatment by volunteering
for an FDA clinical study in the West Indies—under the direction of a neuropharmacologist
from the University of Miami. I spent two weeks on this island after
being dosed with a drug called ibogaine, a psychedelic plant from West
Africa, and being very thoroughly poked and probed (as only the FDA can
However, two weeks after my return from this incredibly extravagant
attempt at once again trying to rid myself of my "addiction", I was strung
out on heroin. After a three-month "terror run," I crawled back to
my old clinic and am happy to say have been "on the good foot" for nearly
three years now.
Believe me when I say I will NEVER again attempt to get off of
my methadone maintenance treatment. I am a methadone patient—I take
what I consider a lifesaving medication called methadone because I am afflicted
with a neurochemical imbalance disorder that has very inappropriately been
My wife never did grasp this truth. She hung onto the 12-
step/therapeutic belief that my "addiction" was all about a legalized high,
copping out on "sobriety", and being weak. So for ignorance, I lost
my beautiful family, my business, and much of what I'd worked so very hard
for, for many years.
I'm working hard on the resentments I packed up and took with
me. The "IF ONLY's" and the "SHOULD HAVE's" are finally starting
to thin out--not because of methadone—because I am able to keep a straight
head while I deal with my past. But without methadone maintenance
treatment, none of my progress these past few years would exist—period.
I would surely be locked into that horrific cycle of jails, institutions,
Thanks for taking the time to read this. May God guide the
powers that be into realizing the miraculous truth about methadone maintenance
treatment so that we—as patients—can begin to enjoy life; unencumbered
by ignorance, stigma and backwards attitudes. Perhaps someday—in
the not-so-distant future--we will able to enjoy medical maintenance, the
lifting of draconian practices by many clinics, and the true freedom that
any medical patient has a right to.
Via con dios, SF
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