Current through December 10, 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 30 days and a minimum of eight (8) times
in any 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 OTP 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 90 days of treatment, a failed urine drug screen will be
discussed by the therapist 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 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
their primary therapist 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 OTP 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 50 mg, and the total daily dose for the first day
may not exceed 60 mg, unless the Medical Director documents in the person's
record that 60 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 must:
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 their home
OTP for a minimum of 30 days before being eligible for a guest dose at another
OTP 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 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 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 14 days, a drug
screen shall be obtained.
6. Guest
dosing shall not exceed 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 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 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
Miss. Code §
3-3-7.
4. Take-home medication will not be allowed
in short-term detoxification (i.e., withdrawal management up to 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.
Miss. Code
Ann. §
41-4-7
