May 7, 2001
CSAT Technical Assistance Workshop Scheduled for NYC
On May 18, 2001 the Final Rule, which replaces the
current FDA inspection-focused methadone regulations with a accreditation
system operating under the oversight of the Center for Substance Abuse
Treatment (CSAT), becomes effective. In
order to assist providers in understanding the new regulations, complete the
required application, and prepare for accreditation, CSAT will be sponsored a
Technical Assistance Workshop on Monday May 21 from 9:00 am to 4:00 pm at the
New York Marriott East Side Hotel. Call
Kare Ellis at 301-294-5551 or via email kellies@hq.row.com
for more information and registration.
An article in the Winter 2001 Addiction Treatment
Forum states that many programs continue to prescribe inadequate
daily doses of methadone based on philosophical, moral or psychological reasons
rather than sound science and the mistaken belief that low doses prevent
methadone overmedication and will eventually lead to opioid abstinence. Such attitudes and practices, however, are
contrary to recent scientific evidence that suggests that even doses in the 80
– 120 mg range are inadequate for a great number of patients. In a recent study [Maxwell S. and
Schinderman M; Optimizing Response to Methadone Maintenance Treatment
(Psychoactive Drugs 1999;31(2):95-102)] 164 patients who had a excessive rates
of continued illicit opiate use were selected for higher-dose (HD) methadone
and were raised to an average dosage of 211mg.. Compared with a randomly selected control group, which had an
average dose of 69 mg., those in the HD group were taking more prescribed
psychotropic medications and had a more severe addiction history. During the study, opioid positive urine
samples decreased in the HD group from 87% to 3%, compared with a decrease from
55% to 36% for the control group. Further, the one year retention rate for the
HD group was 86%, compared with 35% for the control group. Maxwell and
Shinderman state that medical evaluation of objective signs and subjective
symptoms of abstinence syndrome is a sensitive, reliable, cost effective method
of dose titration, and they stressed that as long as the patient does not
exhibit signs / symptoms of methadone overmedication, adequate methadone doses
may be quite high in a truly individualized treatment milieu. Other research
has indicated that increasingly higher levels of heroin purity and increased
use contributes to addiction severity and, consequently, the need for increased
methadone doses.
The Food and Drug Administration recently issued a
strong warning regarding the use of ORLAAM as a result of 10 cases of serious
heartbeat rhythm changes among patients taking the drug. ORLAAM, or Levomethadyl acetate HC, is
manufactured by Roxane Laboratories Inc. of Columbus, Ohio. About 33,000 patients have been treated with
ORLAAM since it was approved by the FDA in 1993. The FDA will now require a stronger warning on the label of
ORLAAM warning of the risk of irregular heart rhythm. According to the FDA, patients who know or suspect they have had
irregular heartbeats should not use ORLAAM, and any other drug that affects
cardiac rhythm should not be taken with ORLAAM. The FDA also said ORLAAM is not
to be used as a first line of treatment, but rather reserved for patients who
fail to respond to other addiction treatments.
The agency said that adverse health effects from taking ORLAAM can be
reported to 1 (800) 332-0178 or on the Internet at http://www.fda.gov/medwatch.
Roxane Laboratories subsequently mailed the
following letter to physicians who prescribe the drug to alert them to the new
warning:
April 11. 2001 IMPORTANT
PRESCRIBING INFORMATION FOR ADDICTION TREATMENT SPECIALISTS
Dear Healthcare
Professional:
Cases of QT prolongation and
severe arrhythmia have been reported
during post-marketing treatment with ORLAAM~ (Levometfladyl Acetate
Hydrochloride Oral Solution, 10 mg/mL).
Roxane Laboratories, Inc. has made important changes to ORLMM labeling.
To date there have been seven reports of known or suspected torsade de pointes
and three additional cases of symptomatic arrhythmia associated with a
prolonged QT Interval that have been submitted via ongoing safety surveillance
activities. Therefore. Roxane
Laboratories Inc. has made important changes to the ORLMM label. These changes will be implemented within the
next several weeks in conjunction with additional revisions made to reflect
final regulation (21 CFR Part 291 and 42 CFR Part 6) approved January 17. 2001
and effective on May 18, 2001.
Highlights of the safety
changes include the following:
Due to its potential (or serious
and possibly Life threatening proarrhythmic effects, ORLAAM should be reserved
for use in the treatment of opiate. addicted patients who fall to show an
acceptable response to other adequate treatments for opiate addiction, either
because of Insufficient effectiveness or the inability to achieve effective
dose due to intolerable adverse effects from those drugs.
ORLAAM is contraindicated in
patients with known or suspected QT prolongation. Prior to induction/initiation of ORLAAM therapy all patients
should undergo a 12 lead ECG to determine if a prolonged QT interval is
present. If there is a prolonged QT
interval, ORLAAM should not be administered.
For patients in whom the
potential benefit of LAAM treatment is felt to outweigh the risks of
potentially serious arrhythmia, and ECG should be performed prior to treatment,
12-14 days after initial treatment, and periodically thereafter to rule out any
alterations in the QT interval.
Any drug known to have the
potential to prolong the QT interval should not be used together with ORLAAM.
Possible pharmacodynamic interactions can occur between ORLAAM and potentially
arrhythmogenic agents such as class I or III antiarrhythmics, antihistamines
that prolong the QT Interval, antimalarials, calcium channel blockers,
neuroleptics that prolong the QT interval, and antidepressants. Caution should be exercised when prescribing
concomitant drugs known to induce hypokalemia or hypomagnesemia as they may
precipitate QT prolongation and interact with ORLAAM. These may include
diuretics, laxatives and supraphysiological use of steroid hormones with
mineral ocorticoid potential.
ORLAAM is metabolized
to active metabolites by the cytochrome P450 isoform, CYP3A4. Therefore, the
addition of drugs that induce or inhibit this enzyme could increase the levels
of parent drug or its active metabolites in a patient that was previously at
steady state, and this could potentially precipitate severe arrhythmias,
including torsade de pointes.
If a patient taking ORLAAM
experiences symptoms suggestive of an arrhythmia (such as palpitations,
dizziness, light-headedness, syncope, or seizures), that patient should
seek medical attention immediately.
For patients currently
receiving ORLAAM:
An individualized benefit to
risk assessment should be confirmed taking into account patient presentation
and medical history.
The occurrence of symptoms
suggestive of an arrhythmia (such as palpitations, dizziness, light-headedness,
syncope, or seizures) should prompt immediate medical evaluation and
comprehensive assessment.
For further questions about
ORLAAM and these labeling changes, please call Roxane Laboratories Technical
Product Information: 1-800.962.8364. You can further our understanding of adverse
events by reporting all cases to Roxane Laboratories. Inc., at 1-800-962-8364
or to the FDA at 1-8OO-FDA-1088.
Manfred Haehl, MD; Senior
Vice President Medical & Drug Regulatory Affairs; Roxane Laboratories
A rally, march and festival in support of repeal of the Rockefeller Drug Laws has been
announced for Friday, June 15th.
Beginning with a rally from
2:00-4:00 pm in front of the Harlem State Office Building (125th and
Adam Clayton Powell Blvd), participants will then march to Marcus Garvey Park
(124th and Madison) where there will be a cultural educational festival from 5:00-7:30 pm which features speeches,
performances, workshops, music, and food.
Enacted in 1973, New York's Rockefeller Drug Laws
are among the harshest mandatory minimum sentencing laws in the nation. As a
result of these laws, the criminal justice system loses the discretionary power
to divert offenders to treatment and thousands have been needlessly jailed. These draconian laws have sparked a movement
for reform that includes original sponsors of the Rockefeller Drug Laws,
lawmakers, judges, members of the New York Bar Association, community leaders,
civil rights activists, and clergy. For
more information call Tamar Kraft-Stolar at the Correctional Association of NY,
(212) 254-5700 x306.
The White House announced on April 25th
that President Bush plans to appoint John P. Walters to be the next drug
czar. Walters, who was the deputy
director of the Office of National Drug Control Policy under William Bennett,
is a staunch conservative who supports a hard-line approach to drugs, including
stiff criminal penalties for users. Walters also favors stigmatizing drug abuse
(despite scientific evidence showing that stigma makes it more difficult for
people with substance abuse problems to step forward and get treatment), and
prohibiting patients from
using medical marijuana to ease their pain and
suffering. For more information see the
April 26th edition of the New York Times or visit
http://www.lindesmith.org/news/news_bush.html
President Bush Releases Detailed FY 2002 Budget
On Monday, April 9th, President Bush released his FY 2002
budget. This budget expanded on an earlier outline that Bush had released in late
February. Two-thirds of the increase in funding proposed by the President would
go to six programs: Social Security, Medicare, Medicaid, education, the
National Institutes of Health, and the Pentagon. In light of the fact that about $24 billion of the total budget
was eliminated or shifted to other areas, drug treatment and prevention
programs fared relatively well. Major funding increases include $60,000,000 for
the Substance Abuse Block Grant, $40,000,000 in discretionary funds for the
Center for Substance Abuse Treatment, $126,395,000 for the National Institute
on Drug Abuse, and $41,364,000 for the National Institute on Alcoholism and
Alcohol Abuse. Funding for the Center
for Substance Abuse Prevention (CSAP) and the Safe and Drug Free Schools Program
remained at 2001 levels.
NYC HRA Update
OASAS, HRA and OTDA have reportedly reached a
consensus on HRA’s Letter of Agreement and related documents and May 25th
has been set as the new deadline for signing and returning the revised
agreement to HRA if agencies wish to remain on HRA’s approved provider
list. Commissioner Jean Somers Miller
has also set a meeting at 10:30 am on Thursday, May 17th to discuss
the agreement with NYC providers. This
meeting will be held at the NYC OASAS Office at 501 Seventh Avenue in the 8th
floor Conference Room. Providers should
call their program manager to confirm attendance.
According to the latest information available,
modifications have been made to the Clinical Practice Guidelines and they have
been relabeled as “Program Standards for Moving Clients with Substance Abuse
Disorders from Welfare to Work. ” A
Notice to Patients about disclosing to HRA has also been written.
While some of the objectionable language has been
removed and progress has been made in addressing provider concerns, problems
remain. In particular, COMPA remains
dismayed by the apparent insistence of HRA that the Program Standards for
Methadone Treatment continue to state that “whenever clinically indicated,
include a methadone to abstinence approach in the individual client’s treatment
plan.” This provision, while softened somewhat in the revised document by an
introductory sentence, is contrary to 30 years of extensive clinical
experience, research and evaluation; injects a political agenda into what is
already a controversial document; and could well have the effect of promoting
unsound medical and clinical practices. COMPA continues to advocate for the
complete removal of this provision.
COMPA is also concerned that the Notice to patients
about disclosure to HRA does not
indicate any of the potential risks involved in doing so, and therefore does
not constitute “informed consent”. And
while reporting through STARS may have some advantages to paper reporting, the
fact remains that the reporting requirements put in place by HRA over the last
few years have become particularly onerous and negatively impact upon staff
time available for direct services.
COMPA continues to be concerned as well about the
potential violation of confidentiality due to the level of detail required by
the reporting, an issue addressed cautiously in the past by OASAS in regard to
releasing information to the criminal justice system (Administrative Bulletin
92-2).
The COMPA Nurses’ Committee will hold a full day
conference on June 6, 2001. For more
information contact Rita Williams (212-387-3949), Joanne Filoia (845-486-2860),
or Sandy O’Brien (212-206-0635).
NASW 33rd Annual Addictions Institute
The NYC Chapter of the National Association of
Social Workers is sponsoring a one day Institute titled New Forces, New
Directions: Looking Forward in the Addictions Field on Wednesday, May 16th
at Fordam University’s Lincoln Center Campus.
Both morning and afternoon workshops will be offered and Dr. H. Westley
Clark, Director of the Center for Substance Abuse Treatment (CSAT) will give a
keynote address at the mid-day plenary session. For information call NASW at
212-668-0050.
OASAS
and the NYS Division of Criminal Justice Services (DCJS) will once again join
forces to sponsor a conference to be held on June 18-20, 2001 at the Holiday
Inn Turf on Wolf Road in Albany. This year’s
Conference is titled: What Works – Successful and Promising Treatment
Interventions with the Criminal Justice Population. There is a $100 registration fee and CASAC hours will be
available. Contact Andy Evans at
518-485-2116 for more information.
Summer Institute for Advanced Social Work Practice & Addiction Studies
Sponsored
by the Program of professional Social Work Continuing Education and the
Institute for Addiction Studies and Training at SUNY Buffalo, the 16th
Annual Summer Institute will be held from July 7 through 28, 2001 in Buffalo.
For more information call the School of Social Work at the University of
Buffalo; 716-645-6140.
This year’s American Methadone Treatment Association
Conference 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 Christine
Rossiter or Michelle Thompson at Tally Management (856-423-7222 ex. 350)
“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 ASAP at 518-426-3122 or through their web site at
www.asapnys.org
COMPA Executive Director - Those interested in being
considered for this position should submit an expression of interest, along
with salary requirements, and a resume
to: Herb Barish at the Lower Eastside Service Center; 157 Chambers Street – 8th
Floor; New York, NY 10007. Resumes may
also be faxed to 212-732-5224.
Interested candidates must be willing and able to spend time in both New
York City and Albany. Applications must
be received no later than May 15th and preliminary interviews will
be held in New York and Albany during the end of May.
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
Eugenia Curet, NY
Presbyterian Cornell Medical Center MTP
Robert Krauss, Long Beach
Hospital MMTP
Robert Sage, A.R.T.C.
Sheila Tierney, Crouse
Hospital
Ira Wolfe, St. Luke’s
Hospital
The COMPA Bulletin is
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
News, articles, research, events and other items of
interest to the field, as well as announcements regarding conferences,
trainings, personnel changes and job openings may be submitted for possible
inclusion in the COMPA Bulletin.
Submissions should be titled “COMPA Bulletin Submission” and directed to
info@compa-ny.org