PURPOSE: This rule establishes application requirements and criteria for pilot projects authorized by section 338.143, RSMo.

1. (1) This rule establishes requirements for the approval and operation of pharmacy pilot or demonstration research projects related to technology assisted verification or remote medication dispensing that are designed to enhance patient care or safety, improve patient outcomes, or expand access to pharmacy services, as authorized by section 338.143, RSMo.
2. (2) Applicants to operate a pilot program pursuant to this rule shall file an application on a form provided by the board. To be eligible, the applicant must hold a current and active license, registration, or permit from the board that is not under discipline.

3. (3) Proposal Requirements. Proposed pilot projects must be submitted to the board in writing and include—

   1. (A) A one (1) page abstract of the project that includes the project’s goals, purpose, scope, and proposed timelines;

   2. (B) A narrative description of the following:

      1. 1. Activities that will be undertaken as part of the pilot

project, including, the intended audience;

1. 2. The goals and objectives of the project. Services and

anticipated outcomes must be clearly described and align with section 338.143, RSMo;

1. 3. A description of the capacity and structure the applicant

has in place to operate the proposed pilot program, including, staff and personnel who will be monitoring, supervising, or participating in the pilot project and their relevant education, experience, or qualifications;

1. 4. Procedures for training staff on project operations;
2. 5. An explanation of how the proposal will enhance

patient care or safety, improve patient outcomes, or expand access to pharmacy services for Missouri citizens;

1. 6. A projected timeline for implementation and completion

of the proposed pilot project. The proposed pilot project must be eligible for completion within eighteen (18) months of approval, unless otherwise authorized by the board;

1. 7. Evaluation measures for assessing impact and

effectiveness; and

1. 8. A plan for pilot project termination.

1. (4) Pilot Projects shall be awarded at the discretion of the board with due consideration to public protection, patient safety, feasibility, the needs of the state, and the impact on pharmacy practice. Approved pilot projects shall report on program activities, as requested by the board. Approval of a pilot project may be withdrawn or rescinded by the board for the following:

   1. (A) Any grounds authorized for discipline under section 338.055.2, RSMo;
   2. (B) Failure to report on project operations, as requested by the board;
   3. (C) To prevent or avoid patient harm or undue patient risk;
   4. (D) To protect the public health, safety, or welfare; or
   5. (E) Exceeding/Failure to comply with approved project guidelines. Deviations from approved pilot project operations must be reported to the board within five (5) business days.

AUTHORITY: sections 338.140 and 338.143, RSMo Supp. 2019.* Emergency rule filed Sept. 13, 2019, effective Sept. 27, 2019, expired March 24, 2020. Original rule filed Sept. 13, 2019, effective March 30, 2020. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019 and 338.143, RSMo 2019.