Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2220 - State Board of Pharmacy
Chapter 2 - General Rules
Section 20 CSR 2220-2.995 - Board Approved Pilot and Research Projects

Universal Citation: 20 MO Code of State Regs 2220-2.995

Current through Register Vol. 49, No. 6, March 15, 2024

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

(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) 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) Proposal Requirements. Proposed pilot projects must be submit-ted to the board in writing and include-

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

(B) A narrative description of the following:
1. Activities that will be undertaken as part of the pilot project, including, the intended audience;

2. The goals and objectives of the project. Services and antici-pated outcomes must be clearly described and align with section 338.143, RSMo;

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 qualifi-cations;

4. Procedures for training staff on project operations;

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;

6. A projected timeline for implementation and completion of the proposed pilot project. The proposed pilot project must be eligi-ble for completion within eighteen (18) months of approval, unless otherwise authorized by the board;

7. Evaluation measures for assessing impact and effectiveness; and

8. A plan for pilot project termination

(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:

(A) Any grounds authorized for discipline under section 338.055.2, RSMo;

(B) Failure to report on project operations, as requested by the board;

(C) To prevent or avoid patient harm or undue patient risk;

(D) To protect the public health, safety, or welfare; or

(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.

Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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