SS 032-16

Statement of Scope

PHARMACY EXAMINING BOARD

Rule No.:

Phar 7.10

Relating to:

Administration of Drug Products and Devices Other Than Vaccines

Rule Type:

Both Permanent and Emergency

1. Finding/nature of emergency (Emergency Rule only):

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. Act 290 went into effect on March 31, 2016. A final rule submitted to the legislature in the remaining months of 2016 will not be considered received until the first day of the next regular session of the legislature. Due to the timing of the Act’s effective date, this creates a delay in the implementation of Act 290.

Rules promulgated to implement 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.

2. Detailed description of the objective of the proposed rule:

The objective of the proposed rule is to establish requirements and procedures for a pharmacist or pharmacist intern to administer a prescribed drug product or device in order to implement 2015 Act 290.

3. Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives:

Prior to Act 290, a pharmacist or pharmacist intern could only administer an injectable prescribed drug product or device in the course of teaching self-administration techniques to a patient. Act 290 removes the restriction for the purposes of patient teaching only. The proposed rule would update the requirements and procedures to reflect the statutory change.

4. Detailed explanation of statutory authority for the rule (including the statutory citation and language):

s. 15.08 (5) (b), Stats. 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. 450.02 (2g) (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).

5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:

75 hours

6. List with description of all entities that may be affected by the proposed rule:

Pharmacists, pharmacist interns, and patients.

7. Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule:

None

8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):

None to minimal. It is not likely to have a significant economic impact on small businesses.

Contact Person: Sharon Henes, Administrative Rules Coordinator, [phone]