Explanation of agency authority:
The board shall adopt rules defining the active practice of pharmacy. the rules shall apply to all applicants for licensure under s. 450.05. [s. 450.02, Stats.]
The board may promulgate rules:
(a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
(d) Necessary for the administration and enforcement of this chapter and ch. 961.
(e) Establishing minimum standards for the practice of pharmacy.
Related statute or rule: ch. Phar 7
Plain language analysis:
This rule allows for the product verification to be completed by delegate-check-delegate.
Delegate-check-delegate allows a person delegated by the pharmacist to check the product verification of a product prepared by another person delegated by the pharmacist.
In order for a person to be delegated product verification, the individual must meet all of the following: be 18 years of age; completed an accredited technician training program or has a minimum of 500 hours of experience in product selection labeling and packaging; completed a didactic and practical training curriculum; and completed a validation process.
The didactic and practical training curriculum must include elements of a package label; medication and pharmacy abbreviations needed to match ordered medication with dispensed medication; common dispensing medication errors and concepts; eligible medications; policies and procedures on reporting of medication errors; overview of the pharmacy’s medication use process and a practical training designed to assess the competency of the individual. The validation process requires a check of 500 product verifications over at least 5 days with an accuracy rate of at least 99.8%.
A product is eligible in institution pharmacies if the medication is contained in a final package from a manufacturer or if the licensed pharmacist has ensured that the repackaging process of stock is labeled with the correct drug name, dose, strength, form, control or lot number and beyond use date. In an institutional pharmacy the medication is required to be administered by a health care provider or a person authorized to administration drugs at the institution.
Product verifications can be done by delegates in community pharmacies if the medication is contained in a final package from a manufacturer or if the licensed pharmacist has ensured that the repackaging process of stock is labeled with the correct drug name, dose, strength, form, control or lot number and beyond use date. In a community pharmacy the medication is required to include a description of the medication on the prescription label that allows for a patient to check the accuracy of the medication.
Each pharmacy is required to maintain policies, procedures, and training materials. The following records are required to be kept: all validation records, documentation of supervising and managing pharmacist responsibilities and dates of supervision responsibilities.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois does not have rules regarding technician-check-technician.
Iowa: Iowa has rules regarding technician-check-technician. The technician must have active Iowa registration, hold national technician certification, have experience as a technician and trained in technician-check-technician (including medication errors). There shall be a supervising pharmacist. The pharmacy is required to have policies and procedures in place and maintain records. The drug utilization review must be performed by a pharmacist. The medication checked by a technician must be checked by a licensed health care practitioner prior to administration.
Michigan: Michigan does not have rules regarding technician-check-technician.
Minnesota: Minnesota does not have rules regarding technician-check-technician.
Summary of factual data and analytical methodologies:
The Pharmacy Examining Board began a pilot program for delegate-check-delegate on October 1, 2016. The purpose was to study the accuracy and determine whether delegate-check-delegate improves the safety, quality or efficiency of the practice of pharmacy. The Pharmacy Examining Board determined that the procedures utilized in the pilot program were sufficient for the safety of the public and is amending the rules to allow for this practice.
The Pharmacy Examining Board also received information from the Pharmacy Society of Wisconsin’s community delegate-check-delegate study.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule was posted for economic comments and none were received. This rule does not require a pharmacy to utilize delegate-check-delegate process in the pharmacy.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435.
Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov.
Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received on or before October 23, 2019 to be included in the record of rule-making proceedings.
TEXT OF RULE
Section 1. Phar 7.21 is created to read:
Phar 7.21 Delegate-check-delegate. (1) Definitions. In this section:
(a) “Delegate” means a person to whom the pharmacist has delegated the task of product verification.
(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.
(c) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, and expiration or beyond use date, as part of the final check.
(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.
d. Expiration date.
e. Beyond use date.
2. Common dispensing medication errors and concepts including all of the following: