(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.(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:
(a) Is at least 18 years old.
(b) Completed an accredited technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging.
(c) Completed a didactic and practical training curriculum approved by the supervising and managing pharmacist that includes training in all of the following:
1. Elements of correct product including all of the following:
a. Drug name.
b. Strength.
c. Formulation.
d. Expiration date.
e. Beyond use date.
2. Common dispensing medication errors and concepts including all of the following:
a. Wrong medication.
b. Wrong strength.
c. Wrong formulation.
d. Extra or insufficient quantity.
e. Omitted medications if utilizing unit dose or compliance packaging.
f. Expired medication.
g. Look-alike or sound-alike errors.
h. High-alert medications.
3. Eligible medications for delegate-check-delegate.
4. Organizational policies and procedures on reporting of medication errors.
5. Overview of the medication use process including all of the following:
a. Procurement.
b. Ordering.
c. Dispensing.
d. Administration.
e. Monitoring.
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 two occurrences of each of the following:
a. Wrong drug.
b. Wrong strength.
c. Wrong formulation.
d. Omitted medication, if utilizing unit dose or compliance packaging.
(d) Completed the following validation process:
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%.
2. A pharmacist shall audit 100% of the product verifications made by the delegate during the validation process.
(e) Notwithstanding, par (a) to (d), a delegate who completed the 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).
(3) Eligible product. (a) Institutional pharmacies. The delegate may do the product verification in an institutional pharmacy if the dispensing meets all of the following:
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.
2. Has a drug utilization review performed by a pharmacist prior to dispensing.
3. Will be administered by an individual authorized to administer medications at the institution where the medication is administered.
(b) Community pharmacies. The delegate may do the product verification in a community pharmacy if the dispensing meets all of the following:
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.
2. Has a drug utilization review performed by a pharmacist prior to dispensing.
3. Unless the drug product or device is in the original packaging from a manufacturer, the drug product or device includes a description of the drug product or device on the prescription label that allows for a non-pharmacist to check the accuracy of the medication after it is delivered.
(4) Quality assurance. (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.
(b) A record of each delegate-check-delegate audit shall include all of the following:
1. Name of the product verification delegate.
2. Total number of product verifications performed.
3. Number of product verifications audited by the pharmacist.
4. Percentage of product verifications audited by pharmacist.
5. Percentage of accuracy.
6. Number of product verification errors identified.
7. Type of error under sub. (2) (c) 3.
(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.
(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.
(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.
(6) Records. (a) Each pharmacy shall maintain for 5 years the following records:
1. All validation records of each delegate that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
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.
3. Quality assurance audits and quarterly assessments.
(b) Records shall be made available to the board upon request.
Subchapter III — Central Shared Services
7.30 Definitions. In this subchapter:
(1) “Central shared services pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy.
(2) “Labeling pharmacy” means the central shared services pharmacy or originating pharmacy which is responsible for product verification under s. Phar 7.07 (1) (a) and (b). (3) “Originating pharmacy" means a pharmacy licensed in this state that uses a central shared services pharmacy.
7.31 Requirements. An originating pharmacy may use a central shared services pharmacy only pursuant to the following requirements:
(1) The central shared services pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract.
(2) The central shared services pharmacy shall maintain a record of all originating pharmacies, including name, address and DEA number that it provides services to.
(3) The central shared services pharmacy and originating pharmacy maintain a written protocol delineating each pharmacy’s assumption of responsibility for compliance with state and federal law.
(4) Unless the central shared services pharmacy shares a computer system with the originating pharmacy meeting the requirements of s. Phar 7.04 (4) and contains the medication profile record under s. Phar 7.11 (3), it may not perform drug utilization review under s. Phar 7.03 to satisfy the final check requirement under s. Phar 7.07 (1) (c). (5) The prescription label attached to the container shall contain the name and address of the labeling pharmacy. The date on which the prescription was dispensed for purposes of s. 450.11 (4) (a) 2., Stats., shall be the date on which the labeling pharmacy filled the prescription order. (6) The originating pharmacy or central shared services pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law.
(7) In addition to meeting the other recordkeeping requirements required by state and federal law, the central shared services pharmacy and originating pharmacy shall each maintain records to identify each of its pharmacists responsible for the final check under s. Phar 7.07 (1). Subchapter IV — Delivery Systems and Remote Dispensing
Phar 7.40 Definition. In this subchapter:
(1) “Delivery system” means a structure, controlled by a pharmacy licensed in this state, that a prescription is placed in for patient pick-up.
(2) “Supervising pharmacy” means a licensed pharmacy that oversees the operations and administration of remote dispensing.
Phar 7.41 Delivery system (1) Prescription shall be stored in a secure delivery system immediately upon delivery to the location of the delivery system. Only the patient or patient’s agent shall be able to open the door or locker containing only the patient’s prescription.
(2) The delivery system shall be designed in a manner which does not disclose protected health information.
(3) The delivery system shall maintain appropriate environmental controls, including temperature and humidity, to prevent drug adulteration.
