Mo. Code Regs. tit. 20 § 2220-2.011

Current through Register Vol. 49, No. 20, October 15, 2024

Section 20 CSR 2220-2.011 - Electronic Final Product Verification (Pharmacists)

PURPOSE: This rule establishes requirements for electronic final product verification by a pharmacist using qualifying technology.

(1) Pharmacist Verification. A Missouri licensed pharmacist may use an electronic verification system to verify the accuracy of a final prescription/medication order, provided-

(A) The electronic verification system allows the pharmacist to see an exact, clear, and unobstructed visual image or images of the filled prescription/medication order contents and the label affixed to the container. If multiple units are being dispensed, the pharmacist must be able to see and verify an image or images of each unit and each individual affixed label. A mechanism must be in place to record or communicate the pharmacist's verification approval;

(B) The identity of the pharmacist responsible for verifying the final product is documented in the pharmacy's records as required by 20 CSR 2220-2.080;

(C) Pharmacy technicians and intern pharmacists assisting the pharmacist with electronic verification must be trained and competent to perform the duties assigned and have a documented initial and annual assessment of competency using the pharmacy's approved electronic verification system;

(D) No further manipulation of the prescription/medication order occurs after the pharmacist's electronic verification is complete other than applying the required container lid or seal. For purposes of this section, manipulation does not include preparing a finished prescrip-tion/medication order for mailing, delivery, or storage; and

(E) Except as otherwise provided by law, compounded preparations cannot be verified via an electronic verification system. Compounded preparations must be personally verified by a pharmacist.

(2) Technology Requirements. Electronic verification systems must be maintained in good working order and must provide a clear, unobstructed visual image or images of the filled prescription/medication order contents and the affixed label for each individual prescription or medication order. Use of the electronic verification system must be terminated if the system is not properly functioning and the root cause identified and corrected before further use. Prior to dispensing, a pharmacist shall review and authorize overrides performed by a pharmacy technician or intern pharmacist of any technology generated errors, warnings, alerts, or exceptions related to system functioning or medication verification/accuracy. Documentation of the pharmacist's review and authorization must be maintained in the pharmacy's records.

(A) The electronic verification system must be implemented and validated by a pharmacist prior to initial use to confirm proper functioning. The system must be revalidated by a pharmacist in accordance with the pharmacy's policies and procedures.

(B) Proof of compliance with validation/revalidation requirements must be documented and maintained in the pharmacy's records, including but not limited to the identity of the pharmacist performing the required validation/testing and validation/testing date(s) and results.

(3) Quality Assurance. Pharmacies using an electronic verification system as authorized by this rule must maintain an ongoing and documented quality assurance system that monitors the performance of the electronic verification system and the electronic assisted verification process to ensure proper and accurate functioning. The quality assurance system must include procedures for reporting dispensing errors and system malfunctions.

(4) Policies and Procedures. Pharmacies utilizing an electronic verification system pursuant to this rule must maintain current, written policies and procedures governing all aspects of electronic-assisted verification activities, including, but not limited to:

(A) Staff training and competency assessments;

(B) Operation of the quality assurance system, including reporting, investigating and addressing errors, system malfunctions, and other quality assurance issues;

(C) Testing, validation, and revalidation of electronic verification technology to ensure proper functioning; and

(D) System maintenance, including, any routine or preventative maintenance.

(5) Recordkeeping. Except as otherwise provided herein, records required by this rule must be maintained electronically or in writing by the pharmacy for a minimum of two (2) years. Records must be made available for inspection or copying, and produced to the board or the board's authorized designee upon request.

(6) The provisions of this rule do not modify, amend, or supersede any provisions of law governing pharmacy technician or intern pharmacist supervision requirements.

20 CSR 2220-2.011

Adopted by Missouri Register July 15, 2022/Volume 47, Number 14, effective 8/31/2022