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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEThere is currently no known activity promoting direct pharmacy access to EC. Contraceptive equity legislation passed in 2000 increasing women’s financial access to EC.
CONTACTSJack Hutson Allie Hartry Kristina Diamond Cheryl Leclair
USEFUL LINKSRhode Island Board of Pharmacy Rhode Island Pharmacists Association State of Rhode Island General Assembly Planned Parenthood of Rhode Island Rhode Island Department of Health
PROTOCOL ENVIRONMENTPossible Environment: Revision to Existing Authority Required This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community. Pharmacist initiation of EC would require:
PHARMACY PRACTICE ACTPharmacy Practice Act Regulatory and Statutory Authority Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003. RHODE ISLAND Pharmacists practicing in any setting may implement collaborative practice agreements with individual physicians under rules jointly developed by the Boards of Pharmacy and Medicine. The pharmacist must have advanced training or experience relevant to the scope of collaborative practice and defined as 1) a BS, five years clinical experience, and completed two courses relevant to the agreement; 2) a PharmD with three years clinical experience and completion of one relevant course; or 3) residency training with two years clinical experience. A Collaborative Practice Committee shall advise the Board Director on all issues pertaining to regulations. The Committee is made up of three people appointed by the Board of Pharmacy and nominated by the pharmacists association, and three nominees appointed by the Board of Medical Licensure and nominated by the Medical Society. The scope of practice is outlined in the agreement and should include:
The Board of Medical Licensure and Discipline has adopted nearly identical companion regulations at R.I. Code R. 14.14.031.13 Hospital pharmacists working under collaborative practice agreements and protocols approved by the president of the hospital medical staff and the director of pharmacy are not subject to these guidelines. Statutory authority is granted in the Pharmacy Practice Act chapter on “Collaborative Pharmacy Practice” and sections on “collaborative pharmacy practice” and “collaborative practice in hospitals.” Regulatory authority from Board rules define pharmaceutical care, pharmacy and therapeutics committee, practice of pharmacy and monitoring drug therapy. Statutory authority: Provided in the Pharmacy Practice Act chapter on “Collaborative Pharmacy Practice,” and sections on “collaborative pharmacy practice” and collaborative practice in hospitals, R.I. Gen. Laws § 5-19.2, et seq. Regulatory authority: Provided in section of Pharmacy rules governing “Collaborative Pharmacy Practice” and related definitions, R.I. Code R. 14.130.001 and 14.130.022, and companion rules of the medical board, R.I. Code R. 14 140 031
RHODE ISLAND STATUTE TITLE 5 CHAPTER 5-19.2 Collaborative Pharmacy Practice § 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. SECTION 5-19.2-2 § 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 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 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:
(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 U.S.C. § 263a; 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.
RHODE ISLAND REGULATIONS 14. DEPARTMENT OF HEALTH 130. BOARD OF PHARMACY 001. RULES AND REGULATIONS PERTAINING TO PHARMACISTS, PHARMACIES AND MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS 14 130 001. Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors Section 1.0 Definitions . . . 1.10 “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. 1.33 “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: . . . 1.60 “Pharmaceutical care” is the provision of drugs and other pharmaceutical services intended to achieve outcomes related to cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. Pharmaceutical Care includes the judgment of a pharmacist in dispensing an equivalent drug or device in response to a prescription, after appropriate communication with the prescriber and the patient. 1.52 “Pharmacy and therapeutics committee” means the active standing committee in the hospital, nursing or hospice care facility which is the organizational line of communication and liaison between the medical and pharmacy staff which acts to review and promote rational drug therapy and utilization in the licensed facility. 1.67 “Practice of pharmacy” means the interpretation, evaluation and implementation of dispensing 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; participation in drug and device selection; drug regimen reviews and drug or drug related research;; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for the supervision for compounding and labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of non- prescription drugs and commercially packaged legend drugs and devices); proper and safe storage of drugs and devices, and maintenance of proper records for them.. Section 22.0 Collaborative Pharmacy Practice
22.2 Amendments to the agreement must be documented, signed, and dated. 22.3 The pharmacist shall initiate drug therapy management for a particular patient pursuant to a medical order from the physician. 22.4 The pharmacist shall have adequate access to the patient's history, disease states, drug therapy and laboratory and procedure results. 22.5 An agreement shall be valid for a period not to exceed two (2) years. The signatories shall implement a procedure for reviewing and, if necessary, revising the procedures and protocols of a collaborative agreement at least every two (2) years. 22.6 A pharmacist with advanced training and experience relevant to the scope of collaborative practice shall be a licensed pharmacist in this state with post-graduate educational training relevant to the scope of the collaborative practice agreement. Such training shall include residency training, board certification or certification from an accredited professional organization, educational institution, or continuing education provider. The pharmacist shall meet one of the following qualifications:
22.7 Any pharmacist participating in a collaborative pharmacy practice agreement shall earn twenty (20) hours of practice-relevant continuing education each year and shall maintain documentation of these hours at the practice site to be made available for inspection by the Boards of Medical Licensure and Discipline and Pharmacy. These hours shall be in addition to the continuing education requirements as set forth in section 7.4 herein. 22.8 Any pharmacist who has not participated in a collaborative pharmacy practice arrangement for a period of two (2) years and seeks to enter into such an arrangement, must have obtained and/or maintained the certification set forth in subsections 22.6 (2) or (3), as applicable, or have earned thirty-five (35) hours of relevant continuing education within the prior year. 22.10 An order for a specific patient from the prescribing physician authorizing the implementation of drug therapy management pursuant to the agreement shall be noted in the patient's medical record and kept on file by the pharmacist. 22.11 A copy of the informed written consent from the patient shall be maintained in the patient's medical record and kept on file along with the practitioner's order by the pharmacist in a readily retrievable manner. [December 2002] MEDICAL BOARD RULES 140. OFFICE OF HEALTH PROFESSIONALS REGULATION 031. LICENSURE AND DISCIPLINE OF PHYSICIANS 14 140 031. Licensure and Discipline of Physicians Section 1.0 Definitions 1.5 “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 Section 13.0 Collaborative Pharmacy Practice 13.2 Any physician engaging in a collaborative pharmacy practice shall execute a written agreement with a pharmacist which shall include, but is not limited to, the following: 13.3 All services provided pursuant to a collaborative practice agreement shall be consistent with said agreement and shall be performed in a setting that ensures patient privacy and confidentiality. 13.4 A patient shall be fully informed of the collaborative nature of drug therapy management for his/her medical conditions. 13.5 A patient may decline to participate in a collaborative pharmacy practice and may withdraw at any time without terminating the physician- patient relationship. 13.6 A separate practice protocol shall be written for each disease or condition to be managed in the collaborative pharmacy practice. The protocol(s) shall be appended to the collaborative practice agreement, and may be revised from time to time by mutual agreement of the parties without affecting the term of the agreement. Practice protocols shall provide, at a minimum: 13.7 Collaborative pharmacy practice protocols shall only be used for conditions or diseases with generally accepted standards of care. The scope of the collaborative practice shall not include research, clinical or investigational trials. 13.8 Each signatory of a collaborative pharmacy practice agreement shall keep a copy of the agreement with appendices on file at his/her primary place of practice. 13.9 Each patient receiving care pursuant to a collaborative pharmacy practice agreement shall have an authorized prescriber's order in the primary medical record and on file with the pharmacist authorizing the implementation of drug therapy management. 13.10 A file of completed, signed patient consent forms authorizing release of medical information among the health professionals in the collaborative pharmacy practice shall be maintained at the physician practice site and on file with the pharmacist. 13.11 The physician establishing a collaborative practice shall notify the board in writing within 30 days of the effective date of the collaborative practice. The notice shall be submitted on a prescribed form and shall include, at a minimum the principals in the collaborative and the drug therapies to be managed. The Department may request additional information as required to determine compliance with these rules.
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