Pharmacy Examining Board
The statement of scope for this rule, SS # 032-16, was approved by the Governor on April 25, 2016, published in Register 725A2 on May 9, 2016, and approved by Pharmacy Examining Board on May 19, 2016. This emergency rule as approved by the Governor on Nov. 8, 2016
An order of the Pharmacy Examining Board to repeal and recreate Phar 7.10 relating to administration of drug products and devices other than vaccines.
Analysis prepared by the Department of Safety and Professional Services.
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:
2015 Act 290 creates the ability for a person engaged in the practice of pharmacy to administer by injection a prescribed drug product or device pursuant to requirements and procedures established in the rules promulgated. This rule to implement 2015 Act 290 will create increased patient access and adherence to medications by allowing pharmacists to assist patients in the community with self-injectable medications or in the institutional setting as part of the multidisciplinary care team. Preservation of the public health, safety, and welfare necessitates putting the rule into effect prior to 2017.
Statutes interpreted: ss. 450.035 (1r) and (1t), Stats.
Statutory authority: ss. 15.08 (5) (b) and 450.02 (2g) (b), Stats.
Explanation of agency authority:
Each examining board: shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession. [s. 15.08 (5) (b), Stats.]
The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in s. 450.035(1g), by a pharmacist under s. 450.035(1r). [s. 450.02(2g)(b), Stats.]
Related statute or rule:
Plain language analysis:
This proposed rule establishes requirements and procedures for a pharmacist or pharmacist intern to administer a prescribed drug product or device in order to implement 2015 Act 290. (A drug product or device does not include vaccinations.)
A pharmacist may not administer by injection a prescribed drug product or device unless the pharmacist has completed a course of study and training in administration techniques.
A person who has successfully completed their third year and is enrolled in a school of pharmacy or a pharmacist licensed in another state who has applied for a Wisconsin pharmacist license may not administer a drug product or device unless they successfully complete a course of study and training in administration technique and administers the drug product or device only under the direct supervision of a pharmacist who has successfully completed the course of study.
The course of study must be approved by the Accreditation Council for Pharmacy Education or the Board. The Board will evaluate programs using criteria substantially equivalent to the criteria used by the Accreditation Council or Pharmacy Education.
After the pharmacist administers a prescribed drug product or device, the pharmacist or the pharmacist’s agent shall notify the prescribing practitioner or enter the information in a patient record system the pharmacist shares with the prescribing practitioner.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois does not have rules relating to administration of drugs or devices other than vaccinations/immunizations.
Links to Admin. Code and Statutes in this Register are to current versions, which may not be the version that was referred to in the original published document.