Chapter 4729:5-12 Medication Therapy Management

4729:5-12-01 Medication therapy management - definitions.

As used in in Chapter 4729:5-12 of the Administrative Code:

(A) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, and provide personal review and approval of all professional activities.

(B) "Medication therapy management" or "MTM" means:

(1) A distinct service or group of services that is intended to optimize the therapeutic outcomes of a patient. Medication therapy management can be an independent service provided by a pharmacist or pharmacy intern under the direct supervision of a pharmacist or can be in conjunction with the dispensing of a dangerous drug with the objectives of:

(a) Enhancing appropriate medication use;

(b) Improving medication adherence;

(c) Increasing detection of adverse drug events;

(d) Improving collaboration between a prescriber and pharmacist; and

(e) Improving outcomes.

(2) Medication therapy management may only be performed by the following:

(a) An Ohio licensed pharmacist;

(b) An Ohio licensed pharmacy intern practicing in this state under the direct supervision of a pharmacist; and

(c) A pharmacist or pharmacy intern practicing in another state in accordance with that state's laws and rules.

(C) "Limited category II terminal distributor of dangerous drugs license with a medication therapy management classification" means a limited category II terminal distributor of dangerous drugs license issued by the state board of pharmacy in accordance with section 4729.54 of the Revised Code to a person solely engaged in the practice of medication therapy management.

A limited category II terminal distributor of dangerous drugs license with a medication therapy management classification does not entitle the holder to possess or sell dangerous drugs.

(D) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that they can be separated out from all other records and produced for review by an agent of the board within three business days.

(E) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

Effective: 4/1/2018
Five Year Review (FYR) Dates: 04/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54, 4729.55

4729:5-12-02 Medication therapy management.

(A) A pharmacist or pharmacy intern under the direct supervision of a pharmacist that provides medication therapy management services shall practice at a location that complies with one of the following:

(1) If the person or entity solely performs medication therapy management in this state or to residents of this state, the location shall be licensed as a limited category II terminal distributor of dangerous drugs license with a medication therapy management classification; or

(2) If the person or entity engages in the sale of dangerous drugs, the location is appropriately licensed as a terminal distributor of dangerous drugs.

(B) A non-resident provider of medication therapy management shall obtain the appropriate licensure in accordance with paragraph (A) of this rule.

(C) The number of interns engaged in the practice of medication therapy management at any time is limited to not more than two for each pharmacist on duty unless otherwise approved by the board.

(D) A pharmacist or pharmacy intern under the direct supervision of a pharmacist that provides medication therapy management services shall ensure that they are provided according to the individual needs of a patient and may include the following:

(1) Performing or otherwise obtaining a patient's health status assessment;

(2) Developing a medication treatment plan for monitoring and evaluating a patient's response to therapy;

(3) Monitoring the safety and effectiveness of the medication therapy;

(4) Performing a medication review to identify, prevent or resolve medication related problems;

(5) Providing education and training to a patient or a patient's agent on the use or administration of the medication;

(6) Documenting the delivery of care, communications with other involved healthcare providers and other appropriate documentation and records pursuant to paragraph (E) of this rule;

(7) Providing necessary services to enhance a patient's adherence with the therapeutic regimen;

(8) Integrating medication therapy management services within the overall health management plan for a patient;

(9) Providing for the safe custody and security of all records and compliance with all applicable federal and state laws, rules and regulations concerning the security and privacy of patient information; and

(10) Any other activity as determined by the board.

(E) All records relating to medication therapy management service shall:

(1) Provide accountability and an audit trail; and

(2) Be uniformly maintained for a period of three years and shall be made readily retrievable.

Effective: 4/1/2018
Five Year Review (FYR) Dates: 04/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54, 4729.55