Current through September 24, 2024
A. The medication used in the treatment of
opioid addiction must at a minimum:
1. Be
approved by the Food and Drug Administration;
2. Be administered only as authorized and
directed by orders signed by the Medical Director;
3. Be dispensed according to product
pharmaceutical label; and,
4. Be
appropriate to produce the desired response for the desired length of
time.
B. Urine drug
screening must be included as one (1) source of information in making
programmatic decisions, monitoring drug use, and making decisions regarding
people's capability to receive take-home medication. These screens must NOT be
used as the sole criterion to discharge a person from treatment.
C. The program must include methodology for
conducting a urine drug screening in its policies and procedures that at a
minimum, ensures the following:
1. Urine
specimens are obtained in a treatment atmosphere of trust and safety, rather
than of punishment and power;
2.
Results of all drug testing shall be filed in the person's record;
3. Urine testing shall be documented and
performed by a laboratory certified by an independent, federally approved
accreditation entity;
4. Specimen
testing includes the same panel and cutoff concentrations as the baseline
toxicology report;
5. Specimens are
obtained randomly on the basis of the individual clinic visit schedule; but no
less than twice a month for the first thirty (30) days and a minimum of eight
(8) times in any twelve (12) month period;
6. People have signed a statement that they
have been informed about how urine specimens are collected and of the
responsibility to provide a specimen when asked (a signed statement must be
maintained in the person's record);
7. The bathroom used for collection is clean
and always supplied with soap and toilet articles;
8. That specimens are collected in a manner
that minimizes falsification; if using direct observation, the procedures must
be carried out ethically and professionally;
9. That results of urine screens are
communicated promptly to the person to facilitate rapid intervention with any
drug that was disclosed or with possible diversion of methadone (or other
treatment) as evidenced by lack thereof or its metabolites in the urine;
and,
10. The program will develop a
specific, DMH approved policy, requiring that blood serum testing will be done
on a person if there is any reason for suspicion that the urine testing is
incorrect or in any manner thought to be false. This policy must be developed
and approved prior to opening the program.
D. The program must have written policies and
procedures that outline the documentation and implementation of standard
procedures for addressing a failed urine drug screen, which is defined as
positive toxicology results for illicit or non-prescribed drugs and/or negative
results for drugs provided by the Opioid Treatment Program in the course of
opioid maintenance therapy. These implemented policies and procedures must
include, but are not limited to the following:
1. Baseline toxicology testing results shall
be discussed with the person and documentation of this discussion recorded as a
progress note in the person's record.
2. For new people who are within the first
ninety (90) days of treatment, a failed urine drug screen will be discussed by
the counselor and the person during the next clinic visit to review the
treatment plan and modify services as needed.
3. For people with take-home privileges:
(a) The first failed urine drug test will
result in the following:
(1) Person will be
placed on probation for ninety (90) days;
(2) Person will receive a minimum of two (2)
random drug screens per month during the probationary period; and,
(3) Person must be required to meet with
his/her primary counselor to discuss toxicology results and individual service
plan.
(b) The second
failed urine drug test will result in the following:
(1) Person will be transferred to a lower
dosing phase;
(2) Person will
receive a minimum of two (2) random drug screens per month during the
probationary period; and,
(3)
Person must be required to participate in a clinical staffing with the
treatment team to develop and implement a remedial plan.
(c) The third and subsequent failed urine
drug test will result in the following:
(1)
Complete re-assessment;
(2)
Complete medical re-evaluation of medication dosage, plasma levels, metabolic
responses and adjustment of dosage;
(3) Assessment for co-occurring disorders and
modifications to treatment protocol as needed;
(4) Increase in counseling services, change
in primary counselor and/or family intervention as appropriate; and,
(5) Consideration of alternative opioid
addiction treatment.
(d)
The sixth consecutive failed urine drug test will result in the person being
informed that administrative withdrawal procedures will begin immediately and a
referral made to the appropriate level of care unless the Medical Director:
(1) Provides objective clinical
contraindications of the need for this action; and,
(2) Develops a written intervention plan in
consultation with the person and the treatment team to detoxify from any
substance not prescribed by the Opioid Treatment Program, and intensify
counseling.
E. When dispensing Methadone the program
must:
1. Ensure that each medication
administration and dosage change is ordered and signed by the program Medical
Director;
2. Ensure that
administration of each dose is documented in the person's record;
3. Ensure that administration of each dose is
documented in the medication sheets;
4. Document administration of the dose with
signature or initials of the qualified person administering the medication;
and,
5. Document the exact number
of milligrams of the medication dispensed with daily totals.
F. The initial dose of methadone
should be prescribed by the Medical Director based on standard medical practice
and sound clinical judgment. For each new patient enrolled in a program, the
initial dose of methadone shall not exceed 30 mg and the total daily dose for
the first day may not exceed 40 mg unless the Medical Director documents in the
person's record that 40 mg did not suppress opioid abstinence
symptoms.
G. Subsequent doses of
medication shall be:
1. Individually
determined based upon the Medical Director's evaluation of the history and
present condition of the person.
2.
Reviewed and updated according to the person's treatment plan and in
consideration of the following criteria:
(a)
Cessation of withdrawal symptoms
(b) Cessation of illicit opioid use as
measured by:
(1) Negative drug tests;
and,
(2) Reduction of drug-seeking
behavior
(c)
Establishment of a blockade dose of an agonist
(d) Absence of problematic craving as
measured by:
(1) Subjective reports;
and,
(2) Clinical
observations
(e) Absence
of signs and symptoms of too large an agonist dose after an interval adequate
for the person to develop complete tolerance to the blocking dose
3. Subject to a process which
shall be established and implemented by the program to address people who are
objectively intoxicated or who are experiencing other problems that would
render the administration of methadone unsafe.
H. The program shall have a written policy
implemented for split dosing that m ust:
1.
Include input from the Medical Director in consultation with the treatment team
and the State Opioid Treatment Authority;
2. Accurately reflect that split dosing is
guided by outcome criteria that shall include:
(a) The person complains that the dosage
level is not holding.
(b) The
person exhibits signs and symptoms of withdrawal.
(c) The Medical Director employs peak and
trough criteria for split dosing, if appropriate.
(d) The Medical Director is unable to obtain
a peak and trough ratio for 2.0 or lower, increasing intervals of dosing may be
appropriate.
(e) Addressing the
failure of all avenues of stabilization
(f) Addressing stabilization failures with
the person involving the Medical Director and the treatment team
3. Include provisions for
education of the person on the rationale for split dosing and take-home
medication.
I. The
program shall develop, implement, maintain, and document implementation of
dosing policies and procedures for the provision of medication to a guest
person "Guest Dosing." The Guest Dosing policies shall at a minimum specify:
1. The person must be enrolled in his/her
home Opioid Treatment Program for a minimum of thirty (30) days before being
eligible for a guest dose at another Opioid Treatment Program, unless approval
is obtained by the State Opioid Treatment Authority prior to enrollment as a
guest.
2. The receiving program
must have evidence of two (2) consecutive successful urine drug screens within
a thirty (30) day period prior to a person being enrolled for guest dosing,
unless approval is obtained by the State Opioid Treatment Authority prior to
enrollment as a guest.
3. The
sending program's responsibilities include, at a minimum:
(a) Develop a document to utilize in
transmitting all relevant person and dosing information to the receiving
program to request guest dosing privileges;
(b) Forward this document to the receiving
program;
(c) Provide the person
with a copy of the document that was sent to the receiving program;
(d) Verify receipt of the information sent to
the receiving program;
(e) Verify
that the person understands all stipulations of the guest dosing process
including, but not limited to, fees, receiving program contacts, dosing times
and procedures;
(f) Accept the
person upon return from guest dosing unless other arrangements have been made;
and,
(g) Document all procedures
implemented in the guest dosing process in each person's record.
4. The receiving program's
responsibilities include, at a minimum:
(a)
Verify receipt of the sending service's request for guest dosing privileges and
acceptance or rejection of the person for guest medication within forty-eight
(48) hours of the request;
(b)
Communicate any requirements of the receiving program that have not been
specified on the document submitted by the sending program;
(c) Establish a process for medical personnel
to verify dose prior to dosing; and,
(d) Document all procedures implemented in
the guest dosing process in each person's record.
5. If guest dosing exceeds fourteen (14)
days, a drug screen shall be obtained.
6. Guest dosing shall not exceed twenty-eight
(28) days.
J. No dose of
methadone in excess of 120 mg per day may be ordered or administered without
the prior approval of the State Opioid Treatment Authority.
K. Take-home privileges. The service must
develop, implement, maintain, and document implementation of policies and
procedures that govern the process utilized by the Medical Director and
treatment team for determination of unsupervised consumption of medication,
referred to as take-home privileges. All information utilized to determine
take-home privileges must be documented in the person's record, with
documentation to include at a minimum, the following:
1. Absence of recent use of drugs and/or
failed urine drug screens;
2.
Regularity of clinic attendance;
3.
No observed, reported, or otherwise known serious behavioral
problems;
4. Absence of known
recent criminal activity;
5.
Stability of the person's home environment and social relationships;
6. Length of time in treatment;
7. Assurance that take-home medication can be
safely stored within the person's home;
8. Personal possession of a secure locking
storage device in order to receive the medication from the clinic (NO
exceptions); and,
9. Decisions and
rationale for the approval of take-home privileges.
L. The program will adhere to the following
schedule of Treatment Phases based on the clinical judgment of the Medical
Director and the treatment team's behavioral assessment of the person served.
The quantity of take-home medication and frequency of urine drug screens must
not be less restrictive than the following:
1.
Phase 1 - During the first ninety (90) days of treatment, people will
successfully complete a minimum of two (2) urine drug screens per month but
will NOT be eligible for any take-home medication.
2. Phase 2 - During days 91-180 of treatment,
people will successfully complete one (1) urine drug screen per month to be
eligible for two (2) doses per week of take-home medication.
3. Phase 3 - During days 181-270 of
treatment, people will successfully complete one (1) urine drug screen per
month to be eligible for three (3) doses per week of take-home
medication.
4. Phase 4 - During
days 271-365 of treatment, people will successfully complete one (1) urine drug
screen per month to be eligible for six (6) doses per week of take-home
medication.
5. Phase 5 - During the
second continuous year of treatment, people will successfully complete one (1)
urine drug screen per month to be eligible for thirteen (13) doses of take-home
medication.
6. Phase 6 - During the
third and subsequent continuous years of treatment, people will successfully
complete one (1) urine drug screen per month to be eligible for a one (1) month
supply of take-home medication.
M. Temporary take-home medication for
non-emergency: The program shall develop, implement, maintain, and document
implementation of written policies and procedures for the process to allow for
temporary take-home medication for exceptional circumstances which shall
include at a minimum:
1. The need for
temporary take-home medication shall be clearly documented with verifiable
information in the person's record;
2. The person must meet the minimum
requirements for take-home privileges outlined in Rule 53.5.K;
3. Take-home medication may be assessed and
authorized, as appropriate, for a Sunday, or legal holiday as identified by
Section
3-3-7,
Mississippi Code of 1972,
Annotated (Amended in regular Session 1987,
effective from and after passage March 20, 1987.);
4. Take-home medication will not be allowed
in short-term detoxification (i.e., withdrawal management up to thirty [30]
days); and,
5. Requests for
temporary special take-home medication shall be approved in writing by the
State Opioid Treatment Authority prior to dispensing and administering
medication to the person.
N. Temporary take-home medication for
emergency: The program shall develop, implement, maintain, and document
implementation of written policies and procedures for the process to allow for
temporary take-home medication for exceptional circumstances which shall
include at a minimum:
1. The need for
emergency take-home medication shall be clearly documented with verifiable
information in the person's record.
2. Requests for emergency take-home
medication shall be approved in writing by the program's Medical Director and
shall not exceed a three (3) day medication supply at any one (1)
time.
3. Requests for emergency
special take-home medication shall be approved in writing by the State Opioid
Treatment Authority prior to dispensing to the person.
4. Situations that might warrant emergency
take-home medication include:
(a) Death in the
family;
(b) Illness;
(c) Inclement weather; and,
(d) Other similar uniquely identified
situations.
5. Take-home
medication will not be allowed in short-term detoxification.
O. Since the use of take-home
privileges provides opportunity not only for diversion, but also accidental
poisoning, the Medical Director and the treatment team must make every attempt
to ensure that the take-home medication is given only to people who will
benefit from it and who have demonstrated responsibility in handling their
medication(s). The program must have in writing and utilize a "call-back"
procedure that requires a randomly scheduled drug test or, with reasonable
cause, the patient returns to the program with the amount of medication that
should be remaining based upon prescribed dosing.
Section
41-4-7
of the Mississippi Code, 1972, as Amended
