Mo. Code Regs. tit. 20 § 2220-6.055

Current through Register Vol. 49, No. 21, November 1, 2024.

Section 20 CSR 2220-6.055 - Non-Dispensing Activities

PURPOSE: This amendment establishes requirements for pharmacy technicians assisting pharmacists with non-dispensing activities authorized by the rule outside of a Missouri licensed pharmacy.

(1) Pursuant to section 338.220, RSMo, a pharmacist may perform the following non-dispensing activities outside of a licensed pharmacy:

(A) Patient counseling/education, as authorized by Missouri law, provided the pharmacist shall be obligated to comply with 20 CSR 2220-2.190, when applicable;

(B) Obtain patient history/information;

(C) Review patient records/medical histories;

(D) Patient assessment/evaluation, as authorized by Missouri law;

(E) Billing and insurance claim submissions/review;

(F) Drug utilization review;

(G) Assess health plan and medication eligibility/coverage;

(H) Pharmacy compliance audits/evaluations;

(I) Administer drugs, vaccines, or biologicals, as authorized by law and the rules of the board;

(J) Peer review/peer consultations;

(K) Review, select, and develop formularies or plan/practice guidelines;

(L) Review compliance with benefit guidelines;

(M) Manage inventory, including purchasing and ordering;

(N) Manage/review information systems;

(O) Patient medication review;

(P) Consultation with other health care professionals;

(Q) Patient referrals;

(R) Prescription orderentry/review, provided that a pharmacist shall only be authorized to accept a prescription on the premises of a Missouri licensed pharmacy, as required by section 338.095.5, RSMo; and

(S) Medication therapy management, pursuant to and as authorized by Chapter 338, RSMo, and the rules of the board.

(2) Confidentiality. A pharmacist, pharmacy technician, or intern pharmacist performing non-dispensing activities pursuant to this rule shall comply with all applicable state and federal confidentiality laws and regulations. Sufficient storage and security for confidential documents and electronic data processing hardware must be provided by the pharmacy permit holder or the pharmacist. In addition, data processing systems must utilize sufficient security software to ensure confidentiality and prevent unauthorized access. Any breach in the security or confidentiality of the data processing systems or confidential documents shall be documented and reported to the board in writing within seven (7) days of the breach.

(3) Notwithstanding any other provision of this rule, a pharmacist shall not meet with patients in the pharmacist's residence or living quarters.

(4) A pharmacist, pharmacy technician, or intern pharmacist performing non-dispensing activities pursuant to this rule shall ensure compliance with Chapter 338, RSMo, and the rules of the board at all times. Nothing in this rule shall be construed to eliminate or otherwise exempt any pharmacist, pharmacy technician, intern pharmacist, or pharmacy permit holder from the record-keeping, confidentiality, or security requirements otherwise imposed by Chapter 338, RSMo, or the rules of the board. Violations of this section shall constitute grounds for discipline.

(5) This rule shall not be construed to authorize a pharmacist to conduct the unauthorized practice of medicine or to conduct any activity for which a license is required pursuant to Chapters 330, 331, 332, 334, or 337, RSMo.

(6) A pharmacy technician and intern pharmacist may be used to assist a pharmacist with non-dispensing activities outside of a pharmacy subject to the following:

(A) The pharmacy technician/intern pharmacist must be under the direct supervision of a Missouri licensed pharmacist as required by 20 CSR 2220-2.710. The supervising pharmacist must ensure pharmacy technician/intern pharmacist activities comply with state and federal law and must provide the personal assistance, direction, and approval required to verify and ensure delegated non-dispensing activities are safely and properly performed;

(B) The pharmacy technician or intern pharmacist must have completed employer approved training in the activities performed and have an initial and, if applicable, annual documented assessment of proficiency. Documentation of the completed training and proficiency assessment must be maintained in the pharmacy's records for a minimum of two (2) years and provided to the board or the board's designee upon request;

(C) A sufficient mechanism must be in place to allow real-time communication between a pharmacist and the technician/intern pharmacist when needed. A pharmacist must be available to respond to pharmacy technician/intern pharmacist questions at all times non-dispensing activities are being performed; and

(D) Adequate security and supervision must be maintained at all times to prevent unauthorized access to, and unauthorized storage/transfer of, confidential patient information or patient records.

(E) The provisions of this section (6) do not apply to technicians or intern pharmacists engaged in delivering filled prescriptions/medication orders on behalf of the pharmacy as authorized by 20 CSR 2220-2.013.

20 CSR 2220-6.055

AUTHORITY: sections 338.010 and 338.220, RSMo Supp. 2009 and 338.140, RSMo 2000.* Emergency rule filed Oct. 23, 2009, effective Nov. 2, 2009, expired April 30, 2010. Original rule filed Oct. 22, 2009, effective June 30, 2010 .

Amended by Missouri Register July 15, 2020/Volume 45, Number 14, effective 8/31/2020

*Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009; 338.140, RSMo 1939, amended 1981, 1989, 1997; and 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009.