Ohio Admin. Code 5122-40-10 - Diversion
(A) Each
opioid treatment program shall
will, as part of its quality improvement plan, have a
diversion control plan that contains specific measures to reduce the
possibility of diversion of controlled substances from legitimate treatment use
and that assigns specific responsibility for implementing the plan to the
medical and administrative staff of the program.
(1) The diversion control plan
shall
is to be
reviewed and approved by the state authority.
(2) Diversion control plans
shall
are to
minimize the diversion of medications used for medication assisted treatment to
illicit use. The
Each plan shall
will include:
(a) Clinical and administrative continuous
monitoring of the potential for and actual diversion of
controlled substances, including an investigation, tracking, and monitoring system of incidents of diversion;
and,
(b) Proactive planning and procedures for
problem identification, correction, and
prevention.
(B) Each opioid treatment program
shall
will
have written pharmacy procedures that include:
(1)
Requirement
A
requirement that accurate records for medications used for
medication assisted
medication-assisted treatment administered and
dispensed be traceable to specific patients and show the date, quantity, and batch or lot number of the medication bottle
used for preparing individual doses of medication. These records
shall
are to
be maintained for at least seven years from the last date of administering or
dispensing the medication;
(2)
Requirement
A
requirement that the opioid treatment program meet the security standards
for the distribution and storage of controlled substances
as required by
established the United States drug enforcement
administration as outlined in 21
CFR
C.F.R.
1301.72 to 21 CFR 1301.76 and
pursuant to
as
specified in rule 4729-9-11
4729:5-21 -03 of the Administrative Code;
(3)
Requirement
A
requirement that the acceptance of delivery of medications used for
medication assisted treatment shall
is only to be made
by a physician, pharmacist, registered nurse, or
licensed practical nurse who has proof of completion of a course in medication
administration approved by the Ohio board of nursing and does so under the
direction of a licensed physician;
(a) The person accepting delivery of
medications used for medication assisted
in medication-assisted treatment
must
is to be
an employee of the opioid treatment program.
(b) The opioid treatment program
shall
is to
maintain a current list of those employees who are authorized to receive
delivery of medications used for medication
assisted
in medication-assisted
treatment. The list shall
is to indicate the name and license number of each
person and be signed and dated by the medical director of the opioid treatment
program. For purposes of this paragraph, a signature
may be handwritten or in any of the following forms:
(i)
A code consisting
of a combination of letters, numbers, characters, or symbols that is adopted or
executed by an individual as that individual's electronic
signature;
(ii)
A computer-generated signature code created for an
individual; or
(iii)
An electronic image of an individual's handwritten
signature created by using a pen computer.
(4)
Requirement
A
requirement that the program shall
is not
to employ a physician or other employee who has
access to controlled substance
substances, including medications used
for medication assisted
in medication-assisted treatment, who has had an
application for registration with the U.S.
United States
drug enforcement administration (DEA) denied or has had their registration
revoked at any time;
(5)
Requirement
A
requirement that the program notifies the field division of the United
States drug enforcement administration for its geographical area of, upon discovery of any theft or significant loss of
any controlled substance, including medications used for medication assisted
in
medication-assisted treatment upon the discovery of the loss or theft, the program is to do all of the following:
(a)
The program
shall complete
Notify the field division of
the United States drug enforcement administration for its geographical area by
completing and submitting DEA form 106 regarding any loss or theft.
(b)
The Ohio state
board of pharmacy,
Notify the state of Ohio
board of pharmacy in accordance with rule 4729-9-15
4729:5-3-02
of the Administrative Code, the Ohio department of
mental health and addiction services, and the local law enforcement authorities
shall be immediately notified of any loss or theft.
(c)
Notify the
department of mental health and addiction services.
(d)
Notify local law
enforcement authorities in accordance with section
2921.22 of the Revised
Code.
(6)
Statement
A
statement that adequate precautions shall
are to be taken
to store medications under proper conditions of sanitation, temperature, light,
moisture, ventilation, segregation, and
security;
(7)
Requirement
A
requirement that patients be required
mandated to
wait in an area physically separated from the medication assisted treatment storage and
dispensing area used for storage of
medications used in medication-assisted treatment and dispensing;
and,
(8)
Requirement
A
requirement that medications used for
medication assisted treatment
the area used
for storage and dispensing areas
shall
of medications used in
medication-assisted treatment will:
(a)
Be located where personnel will not be unduly interrupted when handling
drugs;
(b) Be maintained in a clean
and orderly manner; and,
(c) Not be cleaned by a current patient of
the program.
Notes
Promulgated Under: 119.03
Statutory Authority: R.C. 5119.37
Rule Amplifies: R.C. 5119.37
Prior Effective Dates: 07/01/2001, 10/01/2003, 06/01/2017, 01/01/2019
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