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.
Notes
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