Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 39 - Expanded Practice Standards › Rule 657-39.16 - Pharmacy Pilot or Demonstration Research Projects

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this rule is to specify the procedures to be
				followed in applying for approval of a pilot or demonstration research project
				for innovative applications in the practice of pharmacy. In reviewing projects,
				the board will consider only projects that expand pharmaceutical care services
				that contribute to positive patient outcomes. The board will not consider any
				project intended only to provide a competitive advantage to a single applicant
				or group of applicants.
(1)
Definitions.
For the purposes of this rule, the following
			 definitions shall apply:
"Act"
means Iowa Code chapter 155A, the Iowa
				pharmacy practice Act.
"Board"
means the Iowa board of
				pharmacy.
"Practice of pharmacy"
means the practice of
				pharmacy as defined in Iowa Code section
				155A.3(37).
"Project"
means a pilot or demonstration
				research project as described in this rule.
(2)
Scope of project.
A
			 project may not expand the definition of the practice of pharmacy. A project
			 may include therapeutic substitution or substitution of medical devices used in
			 patient care if such substitution is included under a collaborative pharmacy
			 practice agreement pursuant to rule
			 657-39.13 (155A).
(3)
Board approval of a
			 project.
Board approval of a project may include the grant of an
			 exception to or a waiver of rules adopted under the Act or under any law
			 relating to the authority of prescription verification and the ability of a
			 pharmacist to provide enhanced patient care in the practice of pharmacy.
			 Project approval, including exception to or waiver of board rules, shall
			 initially be for a specified period of time not exceeding 18 months from
			 commencement of the project. The board may approve the extension or renewal of
			 a project following consideration of a petition that clearly identifies the
			 project, that includes a report similar to the final project report described
			 in paragraph 39.16(6)
"a,"
that describes and explains any
			 proposed changes to the originally approved and implemented project, and that
			 justifies the need for extending or renewing the term of the project.
(4)
Applying for approval of a
			 project.
A person who wishes the board to consider approval of a
			 project shall submit to the board a petition for approval that contains at
			 least the following information:
a.
Responsible pharmacist.
Name, address, telephone number, and
			 pharmacist license number of each pharmacist responsible for overseeing the
			 project.
b.
Location of
			 project.
Name, address, and telephone number of each specific location
			 and, if a location is a pharmacy, the pharmacy license number where the
			 proposed project will be conducted.
c.
Project summary.
A
			 detailed summary of the proposed project that includes at least the following
			 information:
(1) The goals, hypothesis, and
			 objectives of the proposed project.
(2) A full explanation of the project and how
			 it will be conducted.
(3) The time
			 frame for the project including the proposed start date and length of study.
			 The time frame may not exceed 18 months from the proposed start date of the
			 project.
(4) Background information
			 or literature review to support the proposed project.
(5) The rule or rules to be waived in order
			 to complete the project and a request to waive the rule or rules.
(6) Procedures to be used during the project
			 to ensure that the public health and safety are not compromised as a result of
			 the waiver.