CR 23-072 Rule Text

Agency contact person:

Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366; telephone [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366, or by email to [e-mail]. Comments must be received on or before the public hearing, held on January 18, 2024, to be included in the record of rule-making proceedings.

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TEXT OF RULE

SECTION 1. Phar 1.01, 1.02 (intro.), and 1.02 (Note) are amended to read:

Phar 1.01 Authority. Rules in chs. Phar 1 to 1719 are adopted under authority of ss.

15.08 (5) (b), 227.11 (2), Stats, and ch. 450, Stats.

Phar 1.02 (intro.) As used in ch. Par 1 to 1719.

Phar 1.02 (Note) The board office is located at 1400 East Washington Avenue 4822 Madison Yards Way Madison, WI 5370253705.

SECTION 2. Phar 1.01 (11m) is created to read:

Phar 1.01 (11m) “Pharmacy technician” means a person registered by the board under s. 450.068, Stats.

SECTION 3. Phar 5.07 is created to read:

Phar 5.07 Pharmacy Technicians. (1) All requirements for renewal and reinstatement of a pharmacy technician registration are specified in chapter Phar 19.

(2) No pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes is eligible to be registered as a pharmacy technician.

SECTION 4. Phar 7.07 (2); 7.14 (title); 7.14 (1) (a), (b) and (d); and 7.14 (2) are amended to read:

Phar 7.07 (2) For all prescription drug product products or device dispensing devices dispensed by a pharmacist, the prescription record shall identify the pharmacist responsible for each part of the final check. If sub. (1) (a) or (b) is completed by delegate-check-delegate a pharmacy product verification technician under s. Phar 7.14 or automated technology under s. Phar 7.55, the prescription record shall identify the delegate pharmacy product verification technician performing the check.

Phar 7.14 (title) Delegate-check-Delegate Pharmacy Product Verification Technician-check-Pharmacy Technician.

Phar 7.14 (1) (a) “Delegate Pharmacy product verification technician” means a person registered pharmacy technician to whom the pharmacist has delegated the task of product verification.

Phar 7.14 (1) (b) “Delegate-check-delegate Pharmacy product verification technician-check- pharmacy technician” means the process in which one delegate a pharmacy product verification technician conducts the task of product verification of technical dispensing functions completed by an unlicensed individual a pharmacy technician. A delegate pharmacy product verification technician may not conduct product verification as part of the final check of their own product preparation.

Phar 7.14 (1) (d) “Supervising pharmacist” means the pharmacist licensed in this state, who is responsible for the operations and outcomes of product verification done by a delegate pharmacy product verification technician and ensuring for direct supervision of the delegate pharmacy product verification technician.

Phar 7.14 (2) Delegate Pharmacy product verification technician qualifications. A pharmacist may delegate the product verification of a prescription or chart order to a delegate pharmacy technician who meets all of the following:

SECTION 5. Phar 7.14 (2) (a) is repealed.

SECTION 6. Phar 7.14 (2) (b), (2) (c) 3. and 6., (2) (d) 1. and 2., and (2) (e); 7.14 (3) (a) and (b); 7.14 (4) (a), (b), (b) 1., (c), and (d); 7.14 (5); and 7.14 (6) (a) 1. and 2. are amended to read:

Phar 7.14 (2) (b) Completed an accredited pharmacy technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging.

Phar 7.14 (2) (c) 3. Eligible medications products for delegate-check-delegate pharmacy product verification technician-check-pharmacy technician.

Phar 7.14 (2) (c) 6. A practical training designed to assess the competency of the delegate pharmacy technician prior to starting the validation process. The practical training shall include simulation of at least 2 occurrences of each of the following:

Phar 7.14 (2) (d) 1. The delegate pharmacy technician being validated shall make a product verification on the work of a pharmacist or unlicensed person another pharmacy technician for accuracy and correctness of a minimum of 500 product verifications over a minimum of 5 separate days and achieve an accuracy rate of at least 99.8%.

Phar 7.14 (2) (d) 2. A pharmacist shall audit 100% of the product verifications made by the delegate pharmacy technician during the validation process.

Phar 7.14 (2) (e) Notwithstanding pars. (a) (b) to (d), a delegate an individual who completed the board’s pilot program validation process between October 1, 2016 and September 30, 2019, meets the delegation pharmacy product verification technician qualifications unless the delegate individual fails to meet the quality assurance standards under sub. (4).

Phar 7.14 (3) (a) Institutional pharmacies. The delegate pharmacy product verification technician may do the product verification in an institutional pharmacy if all of the following requirements are met:

Phar 7.14 (3) (b) Community pharmacies. The delegate pharmacy product verification technician may do the product verification in a community pharmacy if all of the following requirements are met:

Phar 7.14 (4) (a) A minimum of 5% of each delegate’s pharmacy product verification technician’s verifications shall be audited by a licensed pharmacist. The accuracy of each delegate pharmacy product verification technician shall be tracked individually.

Phar 7.14 (4) (b) A record of each delegate-check-delegate pharmacy product verification technician-check-pharmacy technician audit shall include all of the following:

Phar 7.14 (4) (b) 1. Name of the pharmacy product verification delegate technician.

Phar 7.14 (4) (c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each delegate’s pharmacy product verification technician’s previous 12 months accuracy and correctness of delegate-check-delegate pharmacy product verifications including a review of the quality assurance log.

Phar7.14 (4) (d) A delegate pharmacy product verification technician shall be revalidated if the delegate individual fails to maintain a product verification accuracy rate of 99.8% based on the quarterly assessment of the previous 12 months or has not performed delegate- check-delegate product verifications within the last 6 months.

Phar 7.14 (5) POLICIES AND PROCEDURES. Each pharmacy shall maintain policies, procedures, and training materials for the delegate-check-delegate pharmacy product verification by technicians which shall be made available to the board upon request.

Phar 7.14 (6) (a) 1. All validation records of each delegate pharmacy product verification technician that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.

Phar 7.14 (6) (a) 2. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising delegate-check- delegate pharmacist, indicating the name of the supervising delegate-check-delegate pharmacist, and the dates the supervision responsibilities begin and end.

SECTION 7. chapter Phar 7 subchapter V (title) is amended to read:

Subchapter V – Unlicensed Persons Uncredentialed Pharmacy Staff

SECTION 8. Phar 7.60 (intro) is created to read:

Phar 7.60 Definitions. In this subchapter:

SECTION 9. Phar 7.60 (2) is repealed.

SECTION 10. Phar 7.60 (3) is created to read: