Phar 7.11 History
History: CR 19-145: cr.
Register December 2020 No. 780, eff. 1-1-21; correction in (1), (3) (b) 3. made under s.
35.17, Stats.,
Register December 2020 No. 780.
Phar 7.12
Phar 7.12
Delegation by a physician. The pharmacist shall document the delegation by a physician under s.
450.033, Stats. The delegated act may not be started prior to the documentation. The documentation shall be maintained for a minimum of 5 years after the last delegated act under that delegation.
Phar 7.12 History
History: CR 19-145: cr.
Register December 2020 No. 780, eff. 1-1-21; correction made under s.
35.17, Stats.,
Register December 2020 No. 780.
Phar 7.13
Phar 7.13
Administration of drug products and devices other than vaccines. Phar 7.13(1)(1)
In this section, “course of study” means one or more classes, workshops, seminars, or continuing education programs.
Phar 7.13(2)
(2) A pharmacist may administer a drug product, as defined in s.
450.01 (11), Stats., or device, as defined in s.
450.01 (6), Stats. After the pharmacist administers a prescribed drug product or device, the pharmacist, a person engaged in the practice of pharmacy under s.
450.03 (1) (f) or
(g), Stats., or the pharmacist's agent shall notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner.
Phar 7.13(3)
(3) A pharmacist may not administer by injection a prescribed drug product or device unless the pharmacist has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board.
Phar 7.13(4)
(4) A person engaged in the practice of pharmacy under s.
450.03 (1) (f) or
(g), Stats., may not administer a prescribed drug product or device unless the person satisfies all of the following:
Phar 7.13(4)(a)
(a) Successfully completes a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board.
Phar 7.13(4)(b)
(b) Administers the prescribed drug product or device only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council of Pharmacy Education or the board.
Phar 7.13(4)(c)
(c) After administering the prescribed drug product or device, notifies the prescribing practitioner or enters the information in a patient record system shared by the prescribing practitioner.
Phar 7.13(5)
(5) The board may approve courses of study which meet criteria substantially equivalent to criteria used by the Accreditation Council for Pharmacy Education.
Phar 7.13(6)
(6) A course of study and training in administration technique shall include all of the following topics:
Phar 7.13(6)(d)
(d) The 5 rights of administration including right patient, right drug, right dose, right route, and right time.
Phar 7.13(6)(e)
(e) Patient reassessment after administration including signs and symptoms of adverse drug reactions.
Phar 7.13(6)(f)
(f) Best practices in documentation of the medication administration.
Phar 7.13(7)
(7) This section does not apply to the administration of vaccines.
Phar 7.13 Note
Note: To administer a vaccine a pharmacist must meet the requirements in s.
450.035, Stats.
Phar 7.13 History
History: CR 19-145: cr.
Register December 2020 No. 780, eff. 1-1-21; correction in (6) (d) made under s.
35.17, Stats.,
Register December 2020 No. 780.
Phar 7.14(1)(a)
(a) “Delegate” means a person to whom the pharmacist has delegated the task of product verification.
Phar 7.14(1)(b)
(b) “Delegate-check-delegate” means the process in which one delegate conducts the task of product verification of technical dispensing functions completed by an unlicensed individual. A delegate may not conduct product verification as part of the final check of their own product preparation.
Phar 7.14(1)(c)
(c) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, as part of the final check and ensure the product has not reached its expiration or beyond use date.
Phar 7.14(1)(d)
(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 and ensuring for direct supervision of the delegate.
Phar 7.14(2)
(2)
Delegate qualifications. A pharmacist may delegate the product verification of a prescription or chart order to a delegate who meets all of the following:
Phar 7.14(2)(b)
(b) Completed an accredited technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging.
Phar 7.14(2)(c)
(c) Completed a didactic and practical training curriculum approved by the supervising and managing pharmacist that includes training in all of the following:
Phar 7.14(2)(c)2.
2. Common dispensing medication errors and concepts including all of the following:
Phar 7.14(2)(c)4.
4. Organizational policies and procedures on reporting of medication errors.
Phar 7.14(2)(c)5.
5. Overview of the medication use process including all of the following:
Phar 7.14(2)(c)6.
6. A practical training designed to assess the competency of the delegate 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.
1. The delegate being validated shall make a product verification on the work of a pharmacist or unlicensed person 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.
2. A pharmacist shall audit 100% of the product verifications made by the delegate during the validation process.
Phar 7.14(2)(e)
(e) Notwithstanding pars.
(a) to
(d), a delegate who completed the board's pilot program validation process between October 1, 2016 and September 30, 2019, meets the delegation qualifications unless the delegate fails to meet the quality assurance standards under sub.
(4).
Phar 7.14(3)(a)(a)
Institutional pharmacies. The delegate may do the product verification in an institutional pharmacy if all of the following requirements are met:
Phar 7.14(3)(a)1.
1. The source drug product or device is in an original package from a manufacturer or a licensed pharmacist has ensured that the source package is labeled with the correct name, strength, form, control or lot number, and beyond use or expiration date.
Phar 7.14(3)(a)2.
2. A drug utilization review performed by a pharmacist prior to dispensing.
Phar 7.14(3)(a)3.
3. The drug product will be administered by an individual authorized to administer medications at the institution where the medication is administered.
Phar 7.14(3)(b)
(b)
Community pharmacies. The delegate may do the product verification in a community pharmacy if all of the following requirements are met:
Phar 7.14(3)(b)1.
1. The source drug product or device is in an original package from a manufacturer or a licensed pharmacist has ensured that the source package is labeled with the correct name, strength, form, control or lot number, and beyond use or expiration date.
Phar 7.14(3)(b)2.
2. A drug utilization review performed by a pharmacist prior to dispensing.
Phar 7.14(3)(b)3.
3. A non-pharmacist shall be able to check the accuracy of the medication by one of the following:
Phar 7.14(3)(b)3.a.
a. The drug product or device is in the original packaging from a manufacturer.
Phar 7.14(3)(b)3.b.
b. The drug product or device includes a description of the drug product or device on the prescription label.
Phar 7.14(3)(b)3.c.
c. The pharmacist shows the patient or patient's agent the drug product or device and provides a monograph that includes a description of the drug product or device.
Phar 7.14(4)(a)(a) A minimum of 5% of each delegate's product verifications shall be audited by a licensed pharmacist. The accuracy of each delegate shall be tracked individually.
Phar 7.14(4)(b)
(b) A record of each delegate-check-delegate audit shall include all of the following:
Phar 7.14(4)(c)
(c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each delegate's previous 12 months accuracy and correctness of delegate-check-delegate product verifications including a review of the quality assurance log.
Phar 7.14(4)(d)
(d) A delegate shall be revalidated if the delegate 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)
(5)
Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the delegate-check-delegate which shall be made available to the board upon request.
