Volume
I, Issue 4
July 2, 2001
As a result of the transfer of Federal oversight
responsibilities from the FDA to CSAT, all methadone treatment programs that
desire to continue are required to complete an Application for Certification and
submit it to CSAT by August 17, 2001.
Failure to submit an Application for Certification by the August 17,
2001 deadline will result in the program being technically unlicensed.
For purposes of accreditation, all programs in
operation on May 18, 2001 will be considered by CSAT to be in transitional
status. After submitting the
application, programs will have two years to become accredited. Programs will
also be able to request a one year extension.
All exemptions currently in place carry over.
According to CSAT, only a few applications have been
received from New York State programs thus far. CSAT is urging that programs not wait until last minute. For a copy of the application or new Federal
regulations call CSAT directly at 301-443-7749.
Pre-conference Sessions
Announced for AMTA Conference in St. Louis
Continuing the unique partnerships that have
developed over the years, the American Methadone Treatment Association
announced a series of sessions
sponsored by CSAT, NIDA and the American Society of Addiction Medicine which
will be held in St. Louis immediately preceding the National Conference
scheduled for October 7 – 10. These
sessions include:
Physician Training for Buprenorphine Treatment of
Opiate Dependence
Saturday, October 6, 8:30 – 5:30, sponsored by
American Society of Addiction Medicine.
What do Opioid Treatment Programs Need to know about
new federal regulations
Saturday, October 6, 11:30-5:00, sponsored by CSAT
How are state methadone authorities roles changing
(closed session)
Saturday, October 6, 9-12 noon, sponsored by CSAT
Clinical Guidelines for Buprenorphine in
Office-based Treatment of Opioid Addiction
Sunday, October 7,
9-12, sponsored by CSAT
Staff training accreditation for opioid Treatment
Programs
Sunday, October Oct 7, 9-3:30, sponsored by CSAT
Empowering Treatment Communities Through Education
Sunday, October Oct 7, 9-5:00, sponsored by CSAT
Opioid Maintenance Pharmacotherapy Course for
Clinicians
Sunday, October Oct 7, 9-5:00, sponsored by NIDA
European Opiate Addiction Treatment Association
Sunday Oct 7 1-5
NIDA Clinical Trails Network “Blending clinical
practice and research to improve treatment
Sunday, October Oct 7, 1-5:00,
sponsored by NIDA
Women and Leadership
Sunday, October Oct 7, 1:30-5:00, sponsored by CSAT.
Those planning on attending the Conference are
encouraged to attend the pre-conference sessions as well, and by adding a
Saturday night stay, will benefit from reduced airfares too. And for fun, there
is an exhibit on Miles Davis at the St. Louis Historical Museum, a spectacular
Missouri Botanical Garden, riverboats, an art museum, a zoo full of lions and
tigers and bears, and the Arch and Museum of Westward Expansion. St. Louis is also the home of the Cardinals
and Rams, a welcome reception Sunday evening will feature a Motown review, and
this year’s Nyswander- Dole and Richard Lane Awards will be given at the Awards
Banquet on Tuesday evening.
Mark Parrino, President of AMTA, and representatives
from the AMTA Board recently met with officials of Ganes Chemicals. According
to Michael Pavlak, VP and GM of Siegfried CMS, Ganes parent company, the recent
problems arose after Ganes closed an outmoded plant in Carlstadt NJ and
relocated the manufacturer of Methadone Hydrochloride to a new plant in
Pennsville. Specifically, a flaw in
manufacturing process was causing the product not to dissolve properly. Ganes officials were pleased to report that
the problem was identified and fixed, the plant is up and running, and the DEA
approved Ganes once again for the production of bulk product, once again
providing the methadone treatment field a second bulk manufacturer. UDL is now expected to rejoin the market and
resume providing finished product to clinics.
Ganes officials also noted that at the end of August, Ganes Chemicals
will be changing their name to Siegfried.
AMTA President Mark Parrino noted that Mallincrodt deserves a note of
appreciation for their responsive and responsible behavior during the crisis
and urged programs to behave ethically in honoring existing contracts as
stability returns to the market.
In a year notable mostly for stalemate, the Legislature has quietly passed a flurry of bills to aid the poor and help them balance the requirements of the welfare system with child care and transportation challenges. Gov. George E. Pataki has raised no objections to them, but his office said on Friday that he had not yet decided whether to sign them.
Lawmakers and advocates say the measures are part of a growing trend in the country toward pragmatism by both the right and the left about what is needed to get people off welfare and into jobs. Advocates for the poor say that, taken together, the bills represent the greatest step the Legislature has taken in years to help the poor.
The proposed legislation would make it easier for poor people to get state-financed child care and to keep that care when they gain or lose jobs; allow welfare recipients to receive small windfalls or save money to buy a car without having their benefits threatened; and expand the number of immigrants eligible for food stamps. Lawmakers and advocates for the poor say the most important bill deals with child care.
Parents who work in low-wage jobs or workfare programs qualify for state-financed day care for those hours. But people who move from welfare to work, or who lose their jobs, temporarily lose that benefit and must reapply for child care. While no definitive statistics are available, state officials and lobbyists for the poor say that tens of thousands of New Yorkers temporarily lose their day care that way each year. The new legislation provides for "seamless" child care in such situations, without reapplication. It also allows low-income parents who are in college to qualify for subsidized day care for the hours they are in school, just as they do for the hours when they work.
Current law guarantees subsidized child care only to people on welfare; other poor people qualify for that benefit, but may not receive it. But some people who are poor enough to collect welfare do not want the cash, only the day care, for any number of reasons, like not wanting to use up their five-year lifetime allocation of benefits. Another recent bill would guarantee them child care, too.
A bill to help welfare recipients buy cars may be the most significant part of the package upstate, where public transportation is sparse and owning a vehicle is often crucial to getting work. Now, a welfare family cannot save more than $2,000 without it counting against benefits. The bill would raise that ceiling to $4,650 if the money were to be used for a car.
Another bill would allow a family to receive a one-time payment, like an inheritance, of up to $25,000 without losing welfare benefits. Under current law, any windfall leaves a family ineligible for welfare for a period of time based on the cash assistance it was receiving. For instance, a family that receives $500 a month and inherits $5,000 is knocked off the rolls for 10 months.
Hepatitis C is a potentially life threatening
disease which affects the liver, and for some the only hope remaining is liver
transplant. Unfortunately, it is being
reported from around the country that patients on methadone programs are being
denied access to transplants all together or are being told that they will have
to taper off of methadone prior to being considered. The Legal Action Center is interested in pursuing litigation in
discrimination cases related to liver transplants, and is asking that they be
contacted should programs become aware of any such cases. Criteria for acceptance of cases include
patients enrolled in methadone treatment programs who are HCV+, doing well in
treatment, and have no positive toxicology results. The Legal Action Center can be reached at 212-243-1313.
Mention harm reduction to a colleague working in the
HIV field and often you will hear praise for methadone treatment. Mention harm reduction to staff and
administrators of a methadone treatment program and you may hear a collective groan. In fact, at
recent meetings of the OASAS Methadone Task Force and the AMTA Board, the term drew strong
reactions and generated considerable discussion.
Many working in the field acknowledge that
incremental change and motivational counseling are sound therapeutic approaches, and that harm reduction techniques
can be a valuable tool in reducing the harm caused by opiate addiction and
preventing the spread of HIV. However,
this knowledge is balanced by the need of programs to produce outcomes, control
negative behaviors, prevent diversion, and ensure that they are good
neighbors.
There is general consensus that appropriate behavior
at program facilities and within the community should be non-negotiable, and
clearly no program should hide behind harm reduction to justify poor
treatment. But beyond this, opinions
diverge, and this issue will only sharpen as accreditation moves forward,
measurable outcomes are required, program siting issues become more pronounced,
concepts such as differential / phased treatment are developed, and the field
works to reduce to negative stigma attached to methadone treatment.
To further the dialogue about this and other
difficult topics, COMPA will be holding a series of working forums around the
state during the coming year. Look for more information in upcoming Bulletins.
The following information was
adapted and
updated by Marc N. Gourevitch, M.D., M.P.H. from an article titled Interactions between
Methadone and Medications Used to Treat
HIV Infection: A Review, originally published as: Gourevitch MN, Friedland GF. Updated March
2001 and
published in THE
MOUNT SINAI JOURNAL OF MEDICINE Vol. 68 No. 3 May 2001 227
TABLE
Medication Formally Effect on Methadone Effect on HIV-Related
Studied? Medication / Reference
NRTI
Zidovudine (AZT) Yes None
> AZT AUC by 40% (1, 2)
Didanosine (ddI) Yes None
< ddI AUC by 60% (3)
Zalcitabine (ddC) No Not studied or reported Not
studied or reported
Stavudine (d4T) Yes None
< d4T AUC by 18% (3)
Lamivudine (3TC) Yes None
Not studied (4)
Abacavir (ABC) Yes >Methadone
clearance >Time to peak concentration
< Peak
concentration (5)
NNRTI
Nevirapine Yes Withdrawal
symptoms Not studied or reported (6 – 8)
< Methadone
levels by 46%
Need for >
methadone dose observed
Delavirdine No >Methadone
levels predicted Not
studied or reported
Efavirenz Yes <
Methadone levels by 48% Not studied
or reported (8, 9)
Heroin use
relapse
Need for >
methadone dose observed
PI
Indinavir No Not
reported Not
reported
Ritonavir Yes <
Methadone levels reported† No
effect reported † (10)
<
Meperidine levels (11)
Nelfinavir Yes <
Methadone levels, but no No (12)
withdrawal
symptoms observed
Saquinavir Planned Not studied or
reported Not studied or reported
Amprenavir* Yes <
Methadone levels, but no Not
studied or reported (13)
withdrawal
symptoms observed
Lopinavir* PDR data only <Methadone levels reported† Not studied or reported (14)
Other
medications used in the treatment of HIV-infected persons
Rifampin Yes <Methadone
levels, often sharply None reported (15)
Rifabutin Yes No
change in methadone levels None
reported (16)
Mild narcotic
withdrawal symptoms
Fluconazole Yes >
Methadone levels by approximately None reported (17)
30%, clinical
significance unknown
Phenytoin Yes <
Methadone levels, often sharply None
reported (18)
Phenobarbital Yes <
Methadone levels, often sharply None
reported (19)
Carbamezipine Yes <
Methadone levels None reported (20)
Fluvoxamine* No (case > Methadone levels by 20 – 100% None reported
(21, 22)
series only)
Fluoxetine* No (case Minimal > methadone levels None reported
series only)
Sertraline* Yes Transient
mild > methadone levels None reported (23)
NRTI = nucleoside reverse transcriptase
inhibitors
NNRTI = non-nucleoside reverse transcriptase
inhibitors
PI = protease inhibitor
AUC = area under curve
† Study design limits clinical utility of
results.
* New
References
1. Schwartz EL, Brechbühl AB,
Kahl P, et al.
Pharmacokinetic interactions of zidovudine and
methadone in intravenous drug-using patients with HIV infections. J Acquir
Immune Defic Syndr 1992; 5:619 – 626.
2. McCance-Katz EF, Rainey PM, Jatlow P,
Friedland GH.
Methadone effects on zidovudine disposition
(AIDS Clinical Trials Group 262). J Acquired Immune Defic Syndr 1998; 18:435 –
443.
3. Rainey PM, Friedland GH, McCance EF, et al.
Interaction of methadone with didanosine (ddI)
and stavudine (d4T). J AIDS Hum Retrovirol 2000; 24:241 – 248.
4. Rainey PM, Friedland G, Snidow J, et al.
Effects of zidovudine plus lamivudine on
methadone disposition. 101st Annual Meeting of the American Society for
Clinical Pharmacology and Therapeutics; 2000 Mar 15 – 17; Los Angeles, CA.
Abstract PIII-94.
5.
Sellers E, Lam R, McDowell J, et al.
The
pharmacokinetics (PK) of abacavir (ABC) and methadone (M) following
co-administration:
CNAA1012. 39th Interscience Conference on
Antimicrobial Agents and Chemotherapy; 1999 Sep 26 – 29; San Francisco, CA.
Abstract No. 305.
6. Staszewski S, Haberl A, Gute P, et al.
Nevirapine/didanosine/ lamivudine once daily
in HIV-1-infected intravenous drug users. Antiviral therapy 1998; 3(Suppl 4):55
– 56.
7. Altice FL, Friedland GH, Cooney EL.
Nevirapine induced opiate withdrawal among
injection drug users with HIV infection receiving methadone. AIDS 1999; 13:957
– 962.
8. Clarke S, Mulcahy F, Back D, et al.
Managing methadone and non-nucleoside reverse
transcriptase inhibitors: guidelines for clinical practice. Seventh Conference
on Retroviruses and Opportunistic Infections; 2000 Jan 30 – Feb 2; San
Francisco, CA. Abstract No. 88.
9. Tashima K, Bose T, Gormley J, et al.
The potential impact of efavirenz on methadone
maintenance. Ninth European Congress of
Clinical Microbiology and Infectious Diseases; 1999 Mar 21 – 24; Berlin,
Germany. Abstract No. P0552.
10. Hsu A, Granneman GR, Carothers L, et al.
Ritonavir does not increase methadone exposure
in healthy volunteers. Fifth Conference on Retroviruses and Opportunistic
Infections; 1998 Feb 1 – 5; Chicago IL. Abstract No. 324.
11. Piscitelli S, Rock-Kress D, Bertz R, et
al.
Ritonavir decreases meperidine exposure in
HIV-negative subjects. Sixth Conference on Retroviruses and Opportunistic
Infections; 1999 Jan 31 – Feb 4; Chicago, IL. Abstract No. 373.
12. Hsyu PH, Lillibridge JH, Maroldo L, et al.
Pharmacokinetic
(PK) and pharmacodynamic (PD) interactions between nelfinavir and methadone.
Seventh Conference on Retroviruses and Opportunistic Infections; 2000 Jan 30 –
Feb 2; San Francisco, CA. Abstract No.
87.
13. Hendrix C, Wakeford J, Wire MB, et al.
Pharmacokinetic and pharmacodynamic evaluation
of methadone enantiomers following
co-administration with amprenavir in
opioid-dependent subjects. 40th Interscience Conference on Antimicrobial Agents
and Chemotherapy; 2000 Sep 17 – 20; Toronto, Ontario, Canada. Abstract 1649.
14. Kaletra Product Information. Abbott
Laboratories, Inc., North Chicago, IL, 2000.
15. Kreek MJ, Garfield JW, Gutjahr CL, Giusti
LM.
Rifampin-induced methadone withdrawal. N Engl
J Med 1976; 294:1104 – 1106.
16. Brown LS, Sawyer RC, Li R, et al.
Lack of pharmacologic interaction. between
rifabutin and methadone in HIV-infected former injecting drug users. Drug
Alcohol Depend 1996; 43:71 – 77.
17. Cobb M, Desai J, Brown LS, et al.
The effect of fluconazole on the clinical
pharmacokinetics of methadone. Clinical Pharmacol
Ther 1998; 63:655 – 662.
18.
Tong TG, Pond SM, Kreek MJ, et al.
Phenytoin-induced
methadone withdrawal. Ann Intern Med 1981; 94:349 – 351.
19. Liu SJ, Wang RI.
Case report of barbiturate-induced enhancement
of methadone metabolism and withdrawal syndrome. Am J Psychiatry 1984; 141:1287
– 1288.
20. Saxon AJ, Whittaker S, Hawker SC.
Valproic acid, unlike other anticonvulsants,
has no effect on methadone maintenance: Two cases. J Clin Psychiatry 1989;
50:228 – 229.
21. Bertschy G, Baumann P, Eap CB, Baettig D.
Probable metabolic interaction between
methadone and fluvoxamine in addict patients. Ther Drug Monit 1994; 16:42 – 45.
22. DeMaria PA, Serota RD.
A therapeutic use of the methadone fluvoxamine
drug interaction. J Addict Dis 1999; 18:5 – 12.
23. Hamilton SP, Nunes EV, Janal M, Weber L.
The effect of sertraline on methadone plasma
levels in methadone-maintained patients Am J Addict 2000; 9:63 – 69.
SUBJECT AREAS
Not
Very
ADMINISTRATIVE:
Important Important Important
Standard Policies and Procedures Manual 5 12 15
Preparation
for Accreditation 2 8 22
Development of Quality Assurance (QA) 7 14 10
and Continuous Quality Improvement (CQI) Plan 5 14 11
Workscope and Treatment Outcome Measures 6 6 20
On-going Skills Development for Managers 3 9 21
Not
Very
COUNSELING/CLINICAL:
Important Important Important
Methadone Treatment: Orientation for new Staff 4 12 15
Behaviorally-Oriented
Treatment Planning 4 11 16
Not
Very
MEDICAL/NURSING: Important Important Important
Methadone/LAAM Dosing
5 15 11
Treatment for Co-morbid Substance Abuse and 1 9 22
Mental Illness
Medical Needs of Geriatric Patients
11 1 5 5
Gynecological Problems of Female Patients
9 14 8
Criminal Justice System
2 15 14
Legislators
3 13 16
General Public
1
13
17
The American Methadone Treatment Association has
received a commitment of funds from CSAT which will enable it to provide
another session of its popular Physicians Training Symposium. It is expected that the session with be held
in New York City in mid to late August.
With accreditation and issues such as adequate dosing still problematic
for the field, and with accrediting entities focusing on physician and medical
staff training specific to methadone, this is an excellent low cost opportunity
to begin preparing for accreditation.
Medical CME credit will be
available. For further information contact AMTA at 212-566-5555.
Preparing for JACHO
Accreditation
COMPA will be sponsoring a day long workshop this Fall
focused on the JACHO accreditation process and what methadone treatment
programs should be doing to prepare for accreditation surveys. Watch for further information in upcoming
COMPA Bulletins.
Methadone Treatment: The
Hope for a New Life
COMPA’s new video, Methadone Treatment: The Hope
for New Life is an informative documentary focused on the role of methadone
in saving lives and benefiting society. Presenting the real story of opiate
addiction and its devastating effect on both the user and the community, the
video examines the disease of addiction, addresses the question of who becomes
an addict, and highlights the role of treatment in rebuilding the lives of
users.
This 30 minute presentation, which is ideal for new
staff as well as those unfamiliar with methadone treatment, is built around
interviews with several patients as well as some of the key researchers and
practitioners in the field, including Dr. Vincent Dole, Dr. Mary Jean Kreek,
Dr. Beny Primm, Dr. Edward Salsitz and many others.
The video may be purchased from COMPA for $90
each. Discounts are available for
quantity purchases: $75 for 4 – 10 copies; $60 for 11 or more. Please add $5 shipping and handling for the
first copy and $2 for each additional video.
To order, mail your request to COMPA at 250 Fifth Avenue, Suite 210, New
York, NY 10001. Please include either a check payable to COMPA or a purchase
order with your order.
This year’s American Methadone Treatment Association
Conference, Opioid Treatment in the 21st Century: Implementing the
Vision, will be held at the Regal Riverfront Hotel in St. Louis from October 7
– 10. In addition to the usual
conference activities, both NIDA and CSAT are sponsoring numerous
Pre-Conference Sessions which will begin on Saturday, October 6. For Conference information contact Anthony
Celenza at Tally Management, acelenza@talley.com, or by phone at 856.423.7222, X224.
“Advancing the Conversation” has been selected as
the theme of this year’s Alcoholism and Substance Abuse Providers of NYS (ASAP)
conference, which will be held in Saratoga Springs from October 21 – 24,
2001. Conference information can be
obtained by calling 518-426-3122 or through their web site at www.asapnys.org
The Committee of Methadone Program Administrators of New York State is a not-for-profit coalition representing New York State’s methadone treatment system which serves over 46,000 individuals suffering from opioid addiction and other substance abuse disorders.
Opioid addiction is a chronic, relapsing medical
disorder, with serious consequences related to public health and safety. Methadone treatment has proven to be the
most effective means of treating this disorder.
COMPA’s mission is to further the treatment of
opioid addiction and other substance abuse disorders in order to address the
medical, social and psychological consequences of use, prevent the spread of
HIV and other infectious diseases, reduce criminal behavior, promote employment
and self-sufficiency, and support the return to a healthy and productive
lifestyle.
In order to support this mission, COMPA and its
member organizations are committed to the promotion and expansion of methadone
treatment through education of elected officials, providers, consumers, and the
public at large. COMPA advocates for
expanded models of service delivery, co-located services and consumer
empowerment to provide increased access to treatment. COMPA supports enhanced services, a comprehensive continuum of
care, the provision of high quality treatment and ongoing professional staff
development. COMPA encourages the involvement of membership in the development
of public policy, standards of care, and regulatory oversight.
Peter Coleman, NYC Health and Hospitals Corporation,
President
Ira Marion, AECOM-Montefiore, Vice President
Johanne Morne, Whitney Young MMTP, Secretary
Richard Woytek, Long Island Jewish MMTP, Treasurer
Herbert Barish, Lower
Eastside Service Center
Willard Campbell, Suffolk
County Division of Alcohol and Substance Abuse Services
Robert Krauss, Long Beach
Hospital MMTP
Robert Sage, A.R.T.C.
Sheila Tierney, Crouse
Hospital
Ira Wolfe, St. Luke’s
Hospital
Membership in COMPA
automatically confers membership in AMTA.
The COMPA Bulletin is
compiled, written and distributed by:
The Committee of Methadone
Program Administrators of NYS Inc.
250 Fifth Avenue, Suite 210
New York, N.Y. 10001
212-447-6682