2016 -- S 2498 SUBSTITUTE A

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LC004821/SUB A

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - COLLABORATIVE PHARMACY

PRACTICE

     Introduced By: Senators Doyle, Nesselbush, P Fogarty, and DiPalma

     Date Introduced: February 25, 2016

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Sections 5-19.2-2 and 5-19.2-3 of the General Laws in Chapter 5-19.2

entitled "Collaborative Pharmacy Practice" are hereby amended to read as follows:

     5-19.2-2. Definitions. -- (a) "Collaborative practice agreement" is a written and signed

agreement, entered into voluntarily, between a pharmacist, with advanced training and experience

relevant to the scope of collaborative practice, one or more licensed pharmacist(s), with advanced

training and experience relevant to the scope of collaborative practice and one or more physicians

that defines the collaborative pharmacy practice in which the pharmacist pharmacist(s) and

physician(s) propose to engage. Collaborative practice agreements shall be made in the best

interest of public health.

      (b) "Collaborative practice committee" shall consist of six (6) individuals: three (3)

individuals to be appointed by the board of pharmacy from nominees provided by the Rhode

Island Pharmacists Association and three (3) individuals to be appointed by the board of medical

licensure and discipline from nominees provided by the Rhode Island Medical Society. The

collaborative practice committee shall advise the director on all issues pertinent to the regulation

of collaborative practice agreements.

      (c) "Collaborative pharmacy practice" is that practice of pharmacy whereby a

pharmacist, with advanced training and experience relevant to the scope of collaborative practice

one or more licensed pharmacist(s), with advanced training and experience relevant to the scope

of collaborative practice agrees to work in collaboration with one or more physicians for the

purpose of drug therapy management of patients, such management to be pursuant to a protocol

or protocols authorized by the physician(s) and subject to conditions and/or limitations as set

forth by the department. A health care professional who has prescribing privileges and is

employed by a collaborating physician may be in such an agreement.

      (d) "Drug therapy management" means the review, in accordance with a collaborative

practice agreement, of drug therapy regimen or regimens of patients by a pharmacist one or more

licensed pharmacist(s) for the purpose of rendering advice to one or more physicians who are

party to the agreement, or their physician designees, regarding adjustment of initiating, adjusting,

monitoring, or discontinuing the regimen. Decisions involving drug therapy management shall be

made in the best interests of the patient. In accordance with a collaborative practice agreement,

drug therapy management may include:

      (1) Modifying and managing Initiating, adjusting, monitoring, or discontinuing drug

therapy;

      (2) Collecting and reviewing patient histories;

      (3) Obtaining and checking vital signs, including pulse, height, weight, temperature,

blood pressure, and respiration; and

      (4) Under the supervision of, or in direct consultation with a physician one or more

physician(s), ordering and evaluating the results of laboratory tests directly related to drug

therapy when performed in accordance with approved protocols applicable to the practice setting

and providing such evaluation does not include any diagnostic component.

      (e) "Limited-function test" means those tests listed in the federal register under the

Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests. For the purposes

of this chapter, limited-function test shall include only the following: blood glucose, hemoglobin

Alc, cholesterol tests, and/or other tests that are classified as waived under CLIA and are

approved by the United States Food and Drug Administration for sale to the public without a

prescription in the form of an over-the-counter test kit.

      (f) "Pharmacist with advanced training and experience relevant to the scope of

collaborative practice" means a licensed pharmacist in this state with post-graduate educational

training. Such training shall include, but not be limited to, residency training; board certification;

certification from an accredited professional organization educational institution; or any other

continuing education provider approved by the director of health relevant to the proposed scope

of the collaborative practice agreement. "Pharmacist with advanced training and experience

relevant to the scope of collaborative practice" means a licensed pharmacist in this state with a

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Bachelor of Science in Pharmacy and post-graduate educational training or a Doctor of Pharmacy

degree. Such training shall include, but not be limited to, residency training; board certification;

certification from an accredited professional organization educational institution; or any other

continuing education provider approved by the director of health relevant to the proposed scope

of the collaborative practice agreement.

      (g) "Practice of pharmacy" means the interpretation, evaluation, and implementation of

medical orders, including the performance of clinical laboratory tests, provided such testing is

limited to limited function tests as defined herein; the dispensing of prescription drug orders;

participation in drug and device selection; drug regiment reviews and drug or drug-related

research; provision of patient counseling and the provision of those acts or services necessary to

provide pharmaceutical care; drug therapy management pursuant to a collaborative practice

agreement; and the responsibility for the supervision for compounding and labeling of drugs and

devices (except labeling by a manufacturer, repackager, or distributor of nonprescription drugs

and commercially packaged legend drugs and devices); proper and safe storage of drugs and

devices; and maintenance of proper records for them.

     5-19.2-3. Collaborative pharmacy practice. -- (a) A pharmacist may engage in

collaborative pharmacy practice pursuant to a collaborative practice agreement in accordance

with provisions of this chapter or other applicable sections of the regulations. Any pharmacist or

physician desiring to engage in collaborate pharmacy practice shall execute a collaborative

practice agreement in accordance with regulations promulgated by the department. Each

collaborative practice agreement shall set forth at least the following: (1) site and setting where

the collaborative practice is to take place; (2) informed consent procedures; (3) qualifications of

participating pharmacist pharmacists and physicians; (4) the role of any employed health care

professional with prescriptive privileges participating in the collaborative practice; (5) scope of

conditions or diseases to be managed; (6) practice protocols; (7) risk management activities; and

(8) outcomes measurements. Each collaborative practice agreement shall be subject to review and

renewal on an annual a biennial basis.

      (b) Any pharmacist or physician who deviates from or practices in a manner inconsistent

with the terms of a collaborative practice agreement shall be in violation of this chapter; such

shall constitute grounds for disciplinary action pursuant to this chapter. There shall be no civil

liability on the part of, or cause of action of any nature against, a physician or physician's agents

or employees for participation in collaborative pharmacy practice as the result of negligence or

fault on the part of the pharmacist participating in such collaborative practice agreement.

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     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - COLLABORATIVE PHARMACY

PRACTICE

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     This act would redefine the type of advanced training and experience that is needed for

pharmacists to engage in collaborative practice and provides for biennial review of collaborative

practice agreements.

     This act would take effect upon passage.

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