STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULE-MAKING : PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE )
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PROPOSED ORDER
An order of the Pharmacy Examining Board to create Phar 7.20 relating to automated technology product verification check.
Analysis prepared by the Department of Safety and Professional Services.
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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 (2), 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 automated technology.
Automated technology (machines) can be utilized for the product verification of a prescription if the machine is located within the pharmacy, utilizes barcodes or other machine readable technology and the automated technology is validated for accuracy.
Product verifications can be done by automated technology if it is contained in a final package from a manufacturer or if the licensed pharmacist has ensured that the packaging process results in a final package that is labeled with the correct drug name, dose, strength, form, control or lot number and beyond use date.
The medication is required to be administered by a health care provider or a person authorized to administrater drugs at the institution.
Each pharmacy is required to maintain policies, procedures, and training materials. The following records are required to be kept: all validation records, names of supervising pharmacist, managing and supervising pharmacist responsibilities, manufacturer’s recommended maintenance and quality assurance measures, dates of all software upgrades, and documentation of all service performed outside of the manufacturer’s standard maintenance recommendations.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois does not allow for automated technology to complete the product verification.
Iowa: Iowa allows automated technology to conduct the product verification if the system utilizes barcode scanning technology and the product is prestocked and no manipulation of drug or package other than affixing a patient label is taking place. If the product is going to require further manipulation than a pharmacist is required to do the product verification prior to dispensing to a patient.
Michigan: Michigan does not allow for automated technology to complete the product verification.
Minnesota: Minnesota does not allow for automated technology to complete the product verification.
Summary of factual data and analytical methodologies:
The Pharmacy Examining Board began a pilot program for automated technology to complete the product verification on October 1, 2016. The purpose was to study the accuracy and determine whether allowing automated technology 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.
