Rule 5122-40-10 | Diversion.
(A) Each opioid treatment program 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 is to be reviewed and approved by the state authority.
(2) Diversion control plans are to minimize the diversion of medications used for medication assisted treatment to illicit use. Each plan 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 will have written pharmacy procedures that include:
(1) A requirement that accurate records for medications used for 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 are to be maintained for at least seven years from the last date of administering or dispensing the medication;
(2) A requirement that the opioid treatment program meet the security standards for the distribution and storage of controlled substances established the United States drug enforcement administration in 21 C.F.R. 1301.72 to 1301.76 and as specified in rule 4729:5-21 -03 of the Administrative Code;
(3) A requirement that the acceptance of delivery of medications used for medication assisted treatment 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 physician;
(a) The person accepting delivery of medications used in medication-assisted treatment is to be an employee of the opioid treatment program.
(b) The opioid treatment program is to maintain a current list of those employees who are authorized to receive delivery of medications used in medication-assisted treatment. The list 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) A requirement that the program is not to employ a physician or other employee who has access to controlled substances, including medications used in medication-assisted treatment, who has had an application for registration with the United States drug enforcement administration (DEA) denied or has had their registration revoked at any time;
(5) 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 in medication-assisted treatment upon the discovery of the loss or theft, the program is to do all of the following:
(a) Notify the field division of the United States drug enforcement administration for its geographical area by completing and submitting DEA form 106.
(b) Notify the state of Ohio board of pharmacy in accordance with rule 4729:5-3-02 of the Administrative Code.
(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) A statement that adequate precautions are to be taken to store medications under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security;
(7) A requirement that patients be mandated to wait in an area physically separated from the area used for storage of medications used in medication-assisted treatment and dispensing; and
(8) A requirement that the area used for storage and dispensing 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.
Last updated January 31, 2025 at 7:40 AM
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