A. In addition to the definitions
in R9-10-101 and R9-10-1001, the following definitions apply in this Section
unless otherwise specified:
1. Opioid treatment services"
means medical services, nursing services, health-related services, and
ancillary services provided to a patient receiving an opioid agonist treatment
medication for opiate addiction.
2. Opioid agonist treatment
medication" means a prescription medication that is approved by the U.S. Food
and Drug Administration under 21 U.S.C. § 355 for use in the treatment of
opiate addiction.
B.
A. A governing
authority of an outpatient treatment center that is authorized to provide
opioid treatment services shall:
1. Ensure
that the outpatient treatment center obtains certification by the Substance
Abuse and Mental Health Services Administration before providing opioid
treatment,
2. Maintain a current
Substance Abuse and Mental Health Services Administration certificate for the
outpatient treatment center on the premises, and
3. Ensure that the administrator appointed as
required in
R9-10-1003(B)(3)
is named on the Substance Abuse and Mental Health Services Administration
certificate as the individual responsible for the opioid treatment services
provided by or at the outpatient treatment center.
C.
B. An
administrator of an outpatient treatment center that is authorized to provide
opioid treatment services shall ensure that:
1. In addition to the policies and procedures
required in
R9-10-1003(D),
policies and procedures are established, documented, and implemented to protect
the health and safety of a patient that:
a.
Include the criteria for receiving opioid treatment services and address:
i. Comprehensive maintenance treatment
consisting of dispensing or administering an opioid agonist treatment
medication at stable dosage levels to a patient for a period in excess of 21
calendar days and providing medical and health-related services to the patient,
and
ii. Detoxification treatment
that occurs over a continuous period of more than 30 calendar days;
b. Include the criteria and
procedures for discontinuing opioid treatment services;
c. Address the needs of specific groups of
patients, such as patients who:
i. Are
pregnant;
ii. Are
children;
iii. Have chronic or
acute medical conditions such as HIV infection, hepatitis, diabetes,
tuberculosis, or cardiovascular disease;
iv. Have a mental disorder;
v. Abuse alcohol or other drugs; or
vi. Are incarcerated or detained;
d. Contain a method of patient
identification to ensure the patient receives the opioid treatment services
ordered;
e. Contain methods to
assess whether a patient is receiving concurrent opioid treatment services from
more than one health care institution;
f. Contain methods to ensure that the opioid
treatment services provided to a patient by or at the outpatient treatment
center meet the patient's needs;
g.
Include relapse prevention procedures;
h. Include for laboratory testing:
i. Criteria for the assessment of a patient's
opioid agonist blood levels,
ii.
Procedures for specimen collection and processing to reduce the risk of
fraudulent results, and
iii.
Procedures for conducting random drug testing of patients receiving an opioid
agonist treatment medication;
i. Include procedures for the response of
personnel members to a patient's adverse reaction during opioid treatment;
and
j. Include criteria for
dispensing one or more doses of an opioid agonist treatment medication to a
patient for use off the premises and address:
i. Who may authorize dispensing,
ii. Restrictions on dispensing, and
iii. Information to be provided to a patient
or the patient's representative before dispensing;
2. A physician provides direction
for the opioid treatment services provided at the outpatient treatment
center;
3. If a patient requires
administration of an opioid agonist treatment medication as a result of chronic
pain, the patient:
a. Receives consultation
with or a referral for consultation with a physician or registered nurse
practitioner who specializes in chronic pain management, and
b. Is not admitted for opioid treatment
services:
i. Unless the patient is physically
addicted to an opioid drug, as manifested by the symptoms of withdrawal in the
absence of the opioid drug; and
ii.
A medical practitioner at the outpatient treatment center coordinates with the
physician or registered nurse practitioner who is providing chronic pain
management to the patient; and
4. In addition to the requirements in
R9-10-1009(C), a
medical record for each patient contains:
a.
If applicable, documentation of the dispensing of doses of an opioid agonist
treatment medication to the patient for use off the premises; and
b. If applicable, documentation of the
patient's discharge from receiving opioid treatment services.
D.
C. An administrator of an outpatient treatment center
that is authorized to provide opioid treatment services shall ensure that for a
patient receiving opioid treatment services:
1. The opioid treatment services provided to
the patient meet the needs of the patient;
2. A physician or a medical practitioner
under the direction of a physician:
a.
Performs a medical history and physical examination on the patient within 30
calendar days before admission or within 48 hours after admission,
and
b. Documents the medical
history and physical examination in the patient's medical record within 48
hours after admission;
3. Before receiving opioid treatment, the
patient is informed of the following:
a. The
progression of opioid addiction and the patient's apparent stage of opioid
addiction;
b. The goal and benefits
of opioid treatment;
c. The signs
and symptoms of overdose and when to seek emergency assistance;
d. The characteristics of opioid agonist
treatment medication, including common side-effects and potential interaction
effects with other drugs;
e. The
requirement for a staff member to report suspected or alleged abuse or neglect
of a child or an incapacitated or vulnerable adult according to state
law;
f. Confidentiality
requirements;
g. Drug screening and
urinalysis procedures;
h.
Requirements for dispensing to a patient one or more doses of an opioid agonist
treatment medication for use by the patient off the premises;
i. Testing and treatment available for HIV
and other communicable diseases; and
j. The patient complaint process;
4. Documentation of the provision
of the information specified in subsection (C)(3) is included in the patient's
medical record;
5. The patient
receives a dose of an opioid agonist treatment medication only on the order of
a medical practitioner;
6. The
patient begins detoxification treatment only at the request of the patient or
according to the outpatient treatment center's policy and procedure for
discontinuing opioid treatment services required in subsection
(B)(1)(b);
7. If the patient has an
adverse reaction during opioid treatment, a personnel member and, if
appropriate, a medical practitioner responds by implementing the policy and
procedure required in subsection (B)(1)(i);
8. Before the patient's discharge from opioid
treatment services, the patient is provided with patient follow-up instructions
that:
a. Include information that may reduce
the risk of relapse; and
b. May
include a referral for counseling, support groups, or medication for depression
or sleep disorders; and
9. After the patient's discharge from opioid
treatment services provided by or at the outpatient treatment center, the
medical practitioner responsible for the opioid treatment services provided to
the patient documents the patient's discharge in the patient's medical record
within 30 calendar days after the patient's discharge and includes:
a. A description of the patient's medical
condition and the opioid treatment services provided to the patient,
and
b. The signature of the medical
practitioner.
F.
D. An administrator of
an outpatient treatment center that is authorized to provide opioid treatment
services shall ensure that an assessment for each patient receiving opioid
treatment services:
1. Includes, in addition
to the information in
R9-10-1010(B):
a. An assessment of the patient's need for
opioid treatment services,
b. An
assessment of the patient's medical conditions that may be affected by opioid
treatment,
c. An assessment of
other medications being taken by the patient and conditions that may be
affected by opioid treatment, and
d. A plan to prevent relapse;
2. Identifies the treatment to be
provided to the patient and treatment goals; and
3. Specifies whether the patient may receive
an opioid agonist treatment medication for use off the premises and, if so, the
number of doses that may be dispensed.
Notes
Ariz. Admin.
Code §
R9-10-1020
Adopted as an emergency
effective November 17, 1983, pursuant to A.R.S. §
41-1003, valid for only 90 days
(Supp. 83-6). Former Section R9-10-1020 adopted as an emergency now adopted and
amended as a permanent rule effective February 15, 1984 (Supp. 84-1). Repealed
by summary action, interim effective date July 21, 1995 (Supp. 95-3). The
proposed summary action repealing R9-10-1020 was remanded by the Governor's
Regulatory Review Council which revoked the interim effectiveness of the
summary rule. The Section in effect before the proposed summary action has been
restored (Supp. 97-1). Section repealed by final rulemaking at 5 A.A.R. 1222,
effective April 5, 1999 (Supp. 99-2). New Section made by exempt rulemaking at
19 A.A.R. 2015, effective October 1, 2013 (Supp. 13-2). Amended by exempt
rulemaking at 20 A.A.R. 1409, effective
7/1/2014.