PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULEMAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING EMERGENCY RULES
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The statement of scope for this rule, SS #060-19, was approved by the Governor on July 29, 2019, published in Register 764A1 on August 5, 2019, and approved by the Pharmacy Examining Board on August 15, 2019. This emergency rule as approved by the Governor on September 19, 2019. ORDER
An order of the Pharmacy Examining Board to create Phar 7.21 relating to delegate check delegate.
Analysis prepared by the Department of Safety and Professional Services.
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FINDING OF EMERGENCY
The Pharmacy Examining Board finds that an emergency exists and that this rule is necessary for the immediate preservation of the public peace, health, safety, or welfare. A statement of facts constituting the emergency is:
The Pharmacy Examining Board may authorize a pilot program and grant a waiver or variance in connection with the pilot program from any rule promulgated by the Board and the pilot program may not last longer than 3 years pursuant to s. 450.02 (3r), Stats. The pilot program waives Phar 7.01(1)(c) and (d), and 7.015(3) (a) and (4), Wis. Admin. Code. Pharmacies, including those operating in hospitals, have been operating in the pilot program since October 1, 2016. Testimony received at the public hearing held on April 12, 2019 on the permanent rule CR 19-024 included comments indicating that hospital patient care services would be negatively impacted without the rule. CR 19-024 was submitted to the legislature on July 16, 2019. The pilot program will expire prior to the completion of legislative review and adoption. -----------------------------------------------------------------------------------------------------------
ANALYSIS
Statutes interpreted: s. 450.11, Stats. 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.
