(A) Medication administration shall
consist of face-to-face interactions with patients, and methadone medication
shall only be administered or dispensed in oral, liquid doses.
(B) Medication administration shall be
provided in a manner to ensure privacy.
(C) Methadone medication shall only be
administered orally.
(D) Opioid treatment programs are permitted to establish
medication units following the guidelines of 42 CFR part 8 subsection
8.11(i)(1).
(E) Medication shall be administered by individuals who have one
or more of the following credentials from the applicable state of Ohio board:
(1) Licensed
physician;
(2) Pharmacist who is
authorized to manage drug therapy pursuant section 4729.39 of the Revised Code
but only if specifically authorized by a consult agreement and to the extent
specified in the agreement;
(3) Registered nurse;
(4) Licensed practical nurse who has
proof of completion of a course in medication administration approved by the
Ohio board of nursing; or,
(5) Physician assistant who has proof of
completion of a course in medication administration approved by the state
medical board of Ohio.
(F) Dispensing or personally furnishing medication shall be
performed in accordance with rules adopted by the state board of pharmacy and
may only be done by individuals who have one or more of the following
credentials from the applicable state of Ohio board:
(1) Licensed physician;
(2) Pharmacist pursuant
to section 4729.39 of the Revised Code; or,
(3) Certified nurse
practitioner with an exemption request approved by SAMHSA and the state
authority.
(G) Providers of medication administration services shall be
supervised by individuals who have one of the following credentials from the
applicable state of Ohio board:
(1) Licensed physician;
or,
(2) Registered nurse.
(H) A written, signed, and dated prescriber's order shall be
required and a copy maintained in the patient's record, for all medication
administered, personally furnished, or dispensed. The prescriber must be a
staff member or contract employee of the opioid treatment program.
(I) Labels for dispensing or personally furnishing medication
shall be prepared in accordance with 21 C.F.R. 1306.14 and section 3719.08 of
the Revised Code and in accordance with agency 4729 of the Administrative
Code.
(J) Medication orders shall be written by a prescriber who is
appropriately licensed and registered with the U.S. drug enforcement
administration to order medications for opioid use disorder. The following
procedures shall be followed in writing prescriber orders for these
medications.
(1) A prescriber's
order for medication shall be valid for a maximum time period of ninety
days.
(2) A prescriber's
order for medication shall be reviewed at least every ninety days and adjusted,
reordered, or a notation made that the medication is to be
discontinued.
(K) Opioid treatment programs shall be open and administer
medication at least six days per week every week, except that programs may
close on federal holidays indicated in paragraph (O) of this rule. Upon
approval of an exception request from the state authority and SAMHSA, opioid
treatment programs may close for one business day twice per year for
administrative planning purposes. Closure dates may not be within the same
sixth month period.
(L) The take-home supply of medication for patients enrolled in
an opioid treatment program receiving methadone during the first ninety days of
treatment is limited to a single dose each week. The patient shall ingest all
other doses under appropriate supervision in accordance with 42 CFR 8.12
(i)(3). At the discretion of the medical director or other authorized
prescriber, a patient may receive one additional take-home dose for those
holidays listed in paragraph (O) of this rule if the opioid treatment program
is closed in observance of the holiday.
(M) The take-home supply of medication
for patients enrolled in an opioid treatment program receiving partial opioid
agonist during the first ninety days of treatment is limited to a fourteen
days' supply. After the first ninety days of treatment, the amount of
take-home supply of medication may never exceed one month.
(N) Take-home doses of medication shall not be permitted for
clients who are on short-term opiate detoxification except on federal holidays
and Sundays if the program is closed.
(O) If the opioid treatment program is closed for any of the
federal holidays set forth in 5 U.S. Code 6103 including but not limited to the
following holidays, all patients receiving methadone may be given a one-day
take-home dose at the discretion of the medical director.
(1) Thanksgiving day.
(2) Christmas day.
(3) New year's day.
(4) Martin Luther King
day.
(5) President's day
(6) Memorial day
(7) Juneteenth national
independence day
(8) Fourth of July
(9) Labor day
(10) Columbus day
(11) Veteran's day
(P) The opioid treatment program shall have written procedures
for take-home medication doses that include:
(1) Statement that the
opioid treatment program decisions on dispensing take-home doses of medication
shall be determined by the medical director or other authorized program
prescriber;
(2) Statement that the
dispensing of medication for home administration is permitted only when such
dispensing is found to be safe, outweighs potential risks, and is beneficial
for the patient. Such dispensing is not a right and is not automatic. Rather it
is subject to medical-legal considerations on an individual case by case basis.
(3) Requirement that
take-home doses of medication shall be given only to a patient, who, in the
opinion of the medical director or other authorized prescriber, is responsible
in handling medication;
(4) Except during program
closure on Sundays and federal holidays listed in paragraph (O) of this rule, a
statement that before a medical director or other authorized prescriber
authorizes take-home doses of medications, the medical director or other
authorized prescriber shall record the individualized rationale for this
decision in the patient's clinical record and consider, at a minimum, the
following criteria:
(a) Absence of recent abuse of opioid or other drugs and
alcohol;
(b) Regularity of clinic attendance for medication
administration;
(c) Regularity of clinic attendance for counseling
sessions;
(d) Absence of serious behavioral problems at the
clinic;
(e) Absence of known recent criminal activity, for example, drug
dealing;
(f) Stability of the patient's home
environment;
(g) Stability of the patient's social
relationships;
(h) Length of time in comprehensive maintenance
treatment;
(i) Assurance that take-home doses of medication can be safely
stored within the patient's home;
(j) Determination if the rehabilitation benefit to the patient by
receiving a take-home dose of medication outweighs the potential risks of
diversion; and,
(k) Employment status of patient.
(5) Statement that
prescriber orders for take-home doses of medication shall expire every ninety
days;
(6) Requirement that
education on the proper safe storage and disposal of take-home dose of
medication be provided to patients prior to the first take-home
dose.
(7) Requirement that child-resistant
packaging or caps be used for take-home doses of medications; and,
(a) If a take-home bottle or other form of packaging is returned
by a patient for refills, the opioid treatment program shall accept the bottle
or other form of packaging and dispose of it.
(b) If a take-home bottle or other form of packaging is utilized
for take home doses, the medication bottles -shall only be used once.
(c) Under no circumstance is medication to be placed in a
container provided by a patient (including previous take-home bottle).
(8) Requirement that each take-home
bottle or other form of medication packaging used have a label that contains
the following information:
(a) The opioid treatment program's name, address and
telephone number;
(b) Name of patient;
(c) Name of practitioner prescribing the medication;
(d) The name of the medication;
(e) The dosing instructions and schedule;
(f) Date that the take-home dose was prepared;
(g) The label shall contain the following warning "Caution:
Federal law prohibits the transfer of this drug to any person other than the
patient for whom it was prescribed."; and,
(h) Any other requirements pursuant to rules adopted by the state
board of pharmacy.
(9) Condition that any
take-home policies and procedures be individualized to each patient's
treatment needs.
(Q) An individual must be a patient of a opioid treatment program
licensed by the department in order to receive medication under the provisions
of this rule except as otherwise provided in this rule.
(R) A patient may attend a different opioid treatment program if
prior approval is obtained from the patient's medical director or
prescriber to receive services on a temporary basis from another opioid
treatment program licensed under this chapter or by SAMHSA. The approval shall
be noted in the patient's record and shall include the following
documentation:
(1) The patient's
signed and dated consent for disclosing identifying information to the program
which will provide services on a temporary basis;
(2) A medication change
order by the referring medical director or prescriber permitting the patient to
receive services on a temporary basis from the other program for a length of
time not to exceed thirty days; and,
(3) Evidence that the
medical director or prescriber for the program contacted to provide services on
a temporary basis has accepted responsibility to treat the visiting patient,
concurs with his or her dosage schedule, and supervises the administration of
the medication.
(S) A patient may receive medication at a
community mental health services or addiction services provider certified for
the residential and withdrawal management substance use disorder services as
defined in rule 5122-29-09 of the Administrative Code, long-term care provider,
or skilled nursing provider from an opioid treatment program. A temporary
medication request will be submitted through the SAMHSA extranet and approved
by the state authority. Medication orders are to be renewed every seven days.
Medication approval will be noted in the patient's record and will include
the following documentation:
(1) The patient's
signed and dated consent for disclosing identifying information to the program
which will provide services on a temporary basis; and
(2) A chain of custody
document showing that any medication used for medication assisted treatment is
transferred from medical staff of the opioid treatment program to medical staff
of the partnering provider.
(T) The provision of interim maintenance with medication is
prohibited under this rule unless the opioid treatment program has a waiver
from the department in addition to authorization from SAMHSA in accordance with
42 C.F.R. 8.11(g).
(1) All of the
requirements for comprehensive maintenance treatment apply to interim
maintenance treatment with the following exceptions for patients receiving
methadone: no take-home doses are permitted except on Sundays and federal
holidays if the program is closed on those days; a primary counselor is not
required; and the rehabilitative and other services described in 42 C.F.R.
8.12(f)(4), (f)(5)(i), and (f)(5)(iii) are not required.
(2) Interim maintenance
cannot be provided to an individual for more than one hundred and twenty days
in any twelve month period.
(3) To receive interim
maintenance, a patient must be fully eligible for admission to comprehensive
maintenance.
(4) Interim maintenance
treatment is for those patients who cannot be enrolled in comprehensive
maintenance treatment in a reasonable geographic area within fourteen days of
application for admission.
(5) During interim
maintenance, the initial toxicology and at least two additional toxicology
screening tests should be obtained.
(6) Programs offering
interim maintenance must develop clear policies and procedures governing the
admission to interim maintenance and transfer of patients to comprehensive
maintenance.
(U) Each opioid treatment program shall have written
procedures for pregnant patients that include at least the following:
(1) Requirement that each
pregnant person admitted to the opioid treatment program be informed of the
possible risks to themselves or to their unborn child from the use of
medication assisted treatment, and be informed that abrupt withdrawal from
these medications may adversely affect the unborn child;
(2) Statement that a
pregnant person, regardless of age, who has a documented opioid use disorder
and who may be in direct jeopardy of resuming illicit opioid use with all of
its attendant dangers during pregnancy, may be placed on a medication assisted
treatment regimen.
Statement that for such pregnant person,
evidence of current physiological dependence on opioid drugs is not needed if
the medical director or other authorized prescriber certifies the pregnancy,
determines and documents that the person may resort to the use of opioid drugs
and determines that medication assisted treatment is justified in their
clinical opinion;
(3) Requirement that the admission of
each pregnant person to an opioid treatment program be approved by the medical
director or other authorized prescriber prior to admitting the person to the
program;
(4) Requirement that opioid treatment
programs develop a form for release of information between themselves and the
healthcare provider providing obstetrical care. This voluntary form should be
offered for coordination of medical care;
(5) Requirement that each pregnant person
be given education on recognizing the symptoms of neonatal abstinence syndrome
near the time of delivery;
(6) Procedures for prenatal care that
include:
(a) Provisions for providing prenatal care by the program or by
referral to an appropriate health care provider. If appropriate prenatal care
is neither available on-site or by referral, or if the pregnant person cannot
afford care or refuses prenatal care services on-site or by referral, an opioid
treatment program, at a minimum, should offer basic prenatal instruction on
maternal, physical, and dietary care as part of its counseling services. If a
pregnant person refuses the offered on-site or referred prenatal services, the
medical director or treating prescriber must use informed consent procedures to
have the person formally acknowledge, in writing, refusal of these services;
(b) Requirement that if a person is referred to prenatal care
outside the agency, the name, address and telephone number of the health care
provider shall be recorded in the woman's clinical record;
(c) If prenatal care is provided by the opioid treatment program,
the clinical record shall include documentation to reflect services
provided;
(d) Requirement that if a person is referred outside of the
agency for prenatal services, the provider to whom they have been referred
shall be notified that the person is taking medication for an opioid use
disorder; however, such notice shall only be given after the patient has signed
a release of information;
(e) Requirement that any changes in medication be communicated to
the appropriate healthcare provider if the person has prenatal care outside the
agency and if the person allows communication among providers;
(f) Requirement that the program monitor the medication dose
carefully throughout the pregnancy, moving rapidly to supply increased or split
dose if it becomes necessary;
(g) Recommendation that blood serum levels of methadone be
monitored once a trimester prior to delivery. Post-partum, the patient's
withdrawal symptoms and clinical status should be re-evaluated every three days
for two weeks to determine the appropriate dose of MAT by the appropriate
healthcare professional. The medical director or other authorized prescriber
shall request and review serum levels to determine whether any changes to
treatment are indicated; and,
(h) Requirement that the program shall offer on-site parenting
education and training to all patients who are parents or shall refer
interested patients to appropriate alternative services for the
training.
(7) Statement that if a person refuses
prenatal service by the opioid treatment program and by an outside
provider:
(a) The medical director or other authorized prescriber shall
note this in the clinical record; and,
(b) The patient will be asked to sign a statement that says
"I have been offered the opportunity for prenatal care by the opioid
treatment program or by a referral to a prenatal clinic or by a referral to the
physician of my choice. I refuse prenatal counseling by the opioid treatment
program. I refuse to permit the opioid treatment program to refer me to a
physician or prenatal clinic for prenatal services." If the patient
refuses to sign the statement, the medical director or other authorized
prescriber shall indicate in the signature block that "patient refused to
sign" and affix their signature and the date on the
statement.
(V) If a patient desires to be permanently transferred,
medication administration shall continue until the patient completes the
admission process at the admitting program.
