Chapter Phar 7

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)(a) (a) Safe injection practices to prevent infections.

Phar 7.13(6)(b) (b) Anatomy.

Phar 7.13(6)(c) (c) Proper injection techniques.

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 Phar 7.14 Pharmacy product verification technician-check-pharmacy technician.

Phar 7.14(1) (1) Definitions. In this section:

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

Phar 7.14(1)(b) (b) “Pharmacy product verification technician-check- pharmacy technician” means the process in which a pharmacy product verification technician conducts the task of product verification of technical dispensing functions completed by a pharmacy technician. A pharmacy product verification technician 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 pharmacy product verification technician and ensuring for direct supervision of the pharmacy product verification technician.

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

Phar 7.14(2)(b) (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) (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)1. 1. Elements of correct product including all of the following:

Phar 7.14(2)(c)1.a. a. Drug name.

Phar 7.14(2)(c)1.b. b. Strength.

Phar 7.14(2)(c)1.c. c. Formulation.

Phar 7.14(2)(c)1.d. d. Expiration date.

Phar 7.14(2)(c)1.e. e. Beyond use date.

Phar 7.14(2)(c)2. 2. Common dispensing medication errors and concepts including all of the following:

Phar 7.14(2)(c)2.a. a. Wrong medication.

Phar 7.14(2)(c)2.b. b. Wrong strength.

Phar 7.14(2)(c)2.c. c. Wrong formulation.

Phar 7.14(2)(c)2.d. d. Extra or insufficient quantity.

Phar 7.14(2)(c)2.e. e. Omitted medications if utilizing unit dose or compliance packaging.

Phar 7.14(2)(c)2.f. f. Expired medication.

Phar 7.14(2)(c)2.g. g. Look-alike or sound-alike errors.

Phar 7.14(2)(c)2.h. h. High-alert medications.

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

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)5.a. a. Procurement.

Phar 7.14(2)(c)5.b. b. Ordering.

Phar 7.14(2)(c)5.c. c. Dispensing.

Phar 7.14(2)(c)5.d. d. Administration.

Phar 7.14(2)(c)5.e. e. Monitoring.

Phar 7.14(2)(c)6. 6. A practical training designed to assess the competency of the 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)(c)6.a. a. Wrong drug.

Phar 7.14(2)(c)6.b. b. Wrong strength.

Phar 7.14(2)(c)6.c. c. Wrong formulation.

Phar 7.14(2)(c)6.d. d. Omitted medication, if utilizing unit dose or compliance packaging.

Phar 7.14(2)(d) (d) Completed the following validation process:

Phar 7.14(2)(d)1. 1. The pharmacy technician being validated shall make a product verification on the work of a pharmacist or 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. 2. A pharmacist shall audit 100% of the product verifications made by the pharmacy technician during the validation process.

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

Phar 7.14(3) (3) Eligible product.

Phar 7.14(3)(a) (a) Institutional pharmacies. The 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)(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 pharmacy product verification technician 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) (4) Quality assurance.

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

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

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

Phar 7.14(4)(b)2. 2. Total number of product verifications performed.

Phar 7.14(4)(b)3. 3. Number of product verifications audited by the pharmacist.

Phar 7.14(4)(b)4. 4. Percentage of product verifications audited by pharmacist.

Phar 7.14(4)(b)5. 5. Percentage of accuracy.

Phar 7.14(4)(b)6. 6. Number of product verification errors identified.

Phar 7.14(4)(b)7. 7. Type of error under sub. (2) (c) 2. a. to c. and e.

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

Phar 7.14(4)(d) (d) A pharmacy product verification technician shall be revalidated if the 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 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 pharmacy product verification by technicians which shall be made available to the board upon request.

Phar 7.14(6) (6) Records.

Phar 7.14(6)(a) (a) Each pharmacy shall maintain for 5 years the following records:

Phar 7.14(6)(a)1. 1. All validation records of each 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. 2. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist, and the dates the supervision responsibilities begin and end.