Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes requirements for
pharmacy technicians/intern pharmacists performing technology assisted
prescription/medication order verification under the supervision of a
pharmacist.
(1) Definitions.
(A) "Authorized intern pharmacist"-An
individual who holds a current and active Missouri intern pharmacist license
and has completed employer-approved training in technology assisted
verification using the pharmacy's approved technology assisted verification
system.
(B) "Authorized pharmacy
technician"-A currently registered Missouri pharmacy technician who-
1. Holds an active pharmacy technician
certification issued by a certification entity accredited by the National
Commission for Certifying Agencies;
2. Has completed employer-approved training
in technology assisted verification using the pharmacy's approved technology
assisted verification system; and
3. Has assisted in the practice of pharmacy
as a registered/licensed pharmacy technician in the state of Missouri or
another U.S. state or territory for a minimum of one (1) year.
(C) "Technology Assisted
Verification" (TAV)-The process of verification of the final prescription or
medication order and affixed label by an authorized pharmacy technician or
authorized intern pharmacist using a technology assisted verification system
that complies with this rule.
(D)
"Technology Assisted Verification System" (TAVS)-An electronic system that
utilizes barcode technology or another electronic process/method to
electronically verify the final medication prescription or medication order has
been properly dispensed and to electronically verify the
prescription/medication order has been properly labeled for the correct
patient.
(2) Pharmacy
Technicians/Intern Pharmacists. A Missouri-licensed pharmacist may allow an
authorized pharmacy technician or authorized intern pharmacist to verify the
final prescription/medication order using a TAVS if-
(A) The medication is a non-controlled
substance and will be dispensed in the original manufacturer's unopened unit of
use package, or the non-controlled medication has been repackaged in compliance
with 20 CSR
2220-2.130 and previously verified by a
pharmacist;
(B) The authorized
pharmacy technician or intern pharmacist is under the supervision of a
Missouri-licensed pharmacist who is physically present within the dispensing
area and able to provide immediate assistance. A current list of pharmacy
technicians/intern pharmacists authorized to perform TAV must be maintained at
the pharmacy along with proof of the required training and competency
assessment;
(C) The authorized
pharmacy technician/intern pharmacist is competent to perform the duties
assigned and has completed a documented initial and annual assessment of
competency using the pharmacy's approved TAVS. A pharmacist may not
simultaneously supervise a total of more than two (2) pharmacy technicians or
intern pharmacists performing TAV as authorized by this rule. The
pharmacist-in-charge may petition the board to increase the number of
supervised technicians/intern pharmacists for good cause;
(D) A pharmacist verifies the accuracy of
prescription/medication order data entry prior to dispensing and completes a
prospective drug utilization review. The identity of the verifying pharmacist
must be recorded in the pharmacy's records as required by 20 CSR
22202.080;
(E) The TAVS is used to
verify the proper prescription label has been affixed to the correct
manufacturer unit of use package or repacked container for the correct patient.
The identity of the authorized pharmacy technician or intern pharmacist
performing the TAV and the supervising pharmacist must be documented in the
pharmacy's records; and
(F) No
manual manipulation of the prescription/medication order occurs after the TAV
occurs. For purposes of this rule, manual intervention does not include
preparing a finished prescription/medication order for mailing, delivery, or
storage.
(3) Technology
Requirements. Technology assisted verification systems must be maintained in
good working order, and must verify prescriptions/medication orders and the
affixed labels with one hundred percent (100%) accuracy. Use of the TAVS must
be terminated and the root cause identified and corrected if a verification
error is detected. Only a pharmacist shall be authorized to initiate the
operation of a TAVS or override any technology generated errors, warnings,
alerts, or exceptions related to TAVS functioning or medication
verification/accuracy.
(A) The TAVS must be
implemented and validated by a pharmacist prior to initial use to confirm the
technology's accuracy and correctness. At a minimum, the TAVS must complete one
thousand (1,000) consecutive product verifications during the initial
validation process with a one hundred percent (100%) accuracy rate. A
pharmacist must audit one hundred percent (100%) of product verifications
completed during the initial validation process before dispensing and confirm
accuracy. The required pharmacist audit may not be delegated to an intern
pharmacist or a pharmacy technician.
(B) A pharmacist must conduct daily random
quality testing on a sample size of prescriptions verified by the TAVS. The
required sample size shall not be less than two percent (2%) of
prescriptions/med-ication orders verified via the TAVS on the last day of
system operation. Use of the TAVS must be terminated and the root cause
identified and corrected if quality testing results show less than one hundred
percent (100%) accuracy.
(C) A TAVS
must be revalidated by a pharmacist in accordance with the pharmacy's policies
and procedures.
(D) The required
revalidation process must include a sampling of prescriptions/medication order
verifications by the TAVS using a sample size that is sufficient to confirm the
technology is properly and accurately functioning. A pharmacist must audit and
verify one hundred percent (100%) accuracy of the sampled verifications prior
to further use of the TAVS. The required pharmacist audit may not be delegated
to an intern pharmacist or a pharmacy technician.
(E) Proof of compliance with validation,
revalidation, and testing requirements must be documented and maintained in the
pharmacy's records, including but not limited to the name, initials, or
identification code(s) of the pharmacist performing the required
validation/testing and validation/testing date(s) and results.
(5) Quality Assurance. Pharmacies
using TAV as authorized by this rule must maintain an ongoing and documented
quality assurance system that monitors the performance of the TAVS and the TAV
process to ensure proper and accurate functioning. The quality assurance system
must include procedures for reporting dispensing errors, system malfunctions,
or other compliance concerns. Notification of any dispensing error involving a
TAV that reaches the patient must be submitted to the board electronically or
in writing within ten (10) days of discovery. The required notification must
include the date of the incident, patient name, the technician or intern
pharmacist who performed the TAV, a description of the error, the applicable
prescription/medication order number or unique identifier, and the supervising
pharmacist of record.
(6) Policies
and Procedures. Pharmacies using TAV must maintain current, written policies
and procedures governing all aspects of technology assisted verification
activities, including but not limited to:
(A)
Staff training and competency assessments;
(B) Operation of the required quality
assurance system, including reporting, investigating, and addressing errors,
system malfunctions, and other quality assurance issues;
(C) Testing, validation, and revalidation of
the TAVS to ensure proper functioning; and
(D) System maintenance, including any routine
or preventative maintenance.
(7) Recordkeeping. Records required by this
rule must be maintained by the pharmacy electronically or in writing 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.
(8) Applicability.
Compliance with this rule is not required if a pharmacist physically verifies
the final prescription/medication order and the affixed label before
dispensing. Final prescription/medication order verification for a Class R
Remote Dispensing Site pharmacy must comply with
20 CSR
2220-2.680.
