2001-H 5798B am
Enacted 7/5/2001

A  N     A   C   T


Introduced By:  Representatives Costantino, Slater, McCauley, Schadone and Montanaro Date Introduced:   February 6, 2001

It is enacted by the General Assembly as follows:

SECTION 1. Title 5 of the General Laws entitled "Businesses and Professions" is hereby amended by adding thereto the following chapter:


5-19.2-1. Introduction. -- The legislature finds that the practice of pharmacy is a learned profession. The sole legislative purpose for enacting this chapter is to ensure that every pharmacist practicing in the state and every pharmacy meet minimum requirements for safe practice. It is the legislative intent that pharmacists who fall below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in this state. The practice of pharmacy has evolved from a product-oriented profession to one that is based on patient outcomes through the provisions of pharmaceutical care. Contemporary pharmacy practice and the roles pharmacists are currently playing exceed the boundaries of traditional statutory definitions. The intent of this chapter is to promote relationships between the pharmacist, patient and patient's physician for the advancement of patient care. It is not to be construed or perceived as permitting or promoting the practice of pharmacy independent of the physician/patient relationship.

5-19.2-2. Definition of terms. - - (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 and one or more physicians that defines the collaborative pharmacy practice in which the pharmacist 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; 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 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(s) of patients by a pharmacist for the purpose of rendering advice to one (1) or more physicians that are party to the agreement, or their physician designees, regarding adjustment of 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 drug therapy;

(2) Collecting and reviewing patient histories;

(3) Obtaining and checking vital signs, including pulse, temperature, blood pressure, and respiration; and

(4) Under the supervision of, or in direct consultation with a physician, 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) "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 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.

(f) "Practice of pharmacy" means the interpretation, evaluation, and implementation of medical orders; including the performance of clinical laboratory tests provided such testing is conducted in conformity with the federal Clinical Laboratories Improvement Act, as amended, 42 USCS section 26; 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 pharmacist and physicians participating; (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 basis.

(b) Any pharmacist 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.

5-19.2-4. Collaborative practice in Rhode Island licensed hospitals. -- Nothing in this section shall be construed to prohibit hospital pharmacists from participating in drug therapy management by protocol approved by the president of the hospital medical staff and the director of pharmacy for the care and treatment of patients.

5-19.2-5. Immunity. - The director of health, board members, the collaborative practice committee, and their agents and employees shall be immune from suit in any action, civil or criminal, based on any disciplinary proceeding or other official act performed in good faith in the course of their duties under this chapter. There shall be no civil liability on the part of, or cause of action of any nature against the board, director, their agents or their employees or against any organization or its member, peer review board or its members, or other witnesses and parties to board proceedings for any statements made in good faith by them in any reports, communications or testimony concerning an investigation by the board of the conduct or competence of any licensee under this chapter.

SECTION 2. This act shall take effect upon passage.

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