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The 192nd General Court of the Commonwealth of Massachusetts

Section 24B1/2: Pharmacist collaborative practice agreements; collaborative drug therapy management

Section 24B1/2. (a) As used in this section and section 24B3/4 the following words shall, unless the context clearly requires otherwise, have the following meanings:—

''Collaborative drug therapy management'', the initiating, monitoring, modifying and discontinuing of a patient's drug therapy by a pharmacist in accordance with a collaborative practice agreement; provided, however, that collaborative drug therapy management may include: collecting and reviewing patient histories; obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration; and, 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 when the evaluation shall not include a diagnostic component.

''Collaborative practice agreement'', a written and signed agreement between a pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising physician that defines the collaborative practice in which the pharmacist and supervising physician propose to engage. The collaborative practice shall be within the scope of the supervising physician's practice. Each collaborative practice agreement shall be subject to review and renewal on a biennial basis. A collaborative practice agreement shall include individually developed guidelines for any prescriptive practice of the pharmacist.

''Commissioner'', the commissioner of the department of public health.

''Department'', the department of public health.

''Patient'', a person who is referred to a pharmacist by his supervising physician for the purpose of receiving collaborative drug therapy management services from the pharmacist. The supervising physician shall assess the patient and include a diagnosis when referring the patient to the collaborating pharmacist. The patient shall be notified of, and shall consent to, the collaborative drug therapy management services in the retail drug business setting. Individual referral and consent shall be recorded by the pharmacist and the supervising physician in the patient's record.

(b) In order for a pharmacist to enter into a collaborative practice agreement, the pharmacist shall: (1) hold a current license to practice pharmacy in the commonwealth and currently be engaged in pharmacy practice in the commonwealth; (2) have at least $1,000,000 of professional liability insurance; (3) have earned a doctor of pharmacy degree or have completed 5 years of experience as a licensed pharmacist or the equivalent; (4) agree to devote a portion of his practice to the defined drug therapy area that the pharmacist shall co-manage; (5) agree to complete, in each year of the agreement, at least 5 additional contact hours or 0.5 continuing education units of board-approved continuing education that addresses areas of practice generally related to collaborative practice agreements; and (6) apply to participate in the medical assistance program administered by the secretary of health and human services in accordance with chapter 118E and Title XIX of the Social Security Act and any federal demonstration or waiver relating to such medical assistance program for the limited purpose of ordering and referring services covered under the program if regulations governing such limited participation are promulgated under chapter 118E.

(c) Collaborative drug therapy management shall only be allowed in the following settings: (1) hospitals licensed pursuant to section 51 of chapter 111, subject to approval by the medical staff executive committee at a licensed hospital or designee; (2) long-term care facilities licensed pursuant to section 71 of chapter 111, subject to approval by the long-term care facilities' medical director or designee; (3) inpatient or outpatient hospice settings licensed pursuant to section 57D of chapter 111, subject to approval by the hospice's medical director or designee; (4) ambulatory care clinics licensed pursuant to section 51 of chapter 111, with on-site supervision by the attending physician and a collaborating pharmacist, subject to approval by the ambulatory care clinic's medical staff executive committee or designee, or medical director or designee; (5) a collaborating pharmacist in a retail drug business, as registered in section 38 of chapter 112 and limited by this section, with supervision by a physician according to the terms of his collaborative practice agreement and limited to the following: patients 18 years of age or older; an extension by 30 days of current drug therapy prescribed by the supervising physician; and administration of vaccines or the modification of dosages of medications prescribed by the supervising physician for asthma, chronic obstructive pulmonary disease, diabetes, hypertension, hyperlipidemia, congestive heart failure, HIV or AIDS, osteoporosis and co-morbidities identified by the supervising physician for the individual patient along with the primary diagnosis. The collaborative practice agreement shall specifically reference each disease state being co-managed. A patient shall be referred by a supervising physician to that physician's collaborating pharmacist and shall be given notice of the collaboration and shall consent to the collaboration. No collaborative practice agreement in the retail drug business setting may permit the prescribing of schedule II through V controlled substances, as defined in section 3 of chapter 94C. A pharmacist in the retail setting, who has a collaborative practice agreement with a supervising physician which specifically allows initial prescriptions for referred patients of the supervising physician, may issue prescriptions for schedule VI controlled substances, as defined in clause 6 of section 3 of chapter 94C. Such prescriptions shall be for a patient diagnosis specified in the supervising physician's individual referral of that patient. A copy of the prescription shall be sent to the supervising physician within 24 hours.

(d) A retail drug business practicing in collaborative drug therapy management under this section shall not be required to register as a Health Facility under 105 CMR 700.004(A)(2)(d).

(e) A physician or a physician group may hire pharmacists for the purpose of practicing collaborative drug therapy management under a collaborative practice agreement, as defined in subsection (a), for the benefit of a patient of that physician or physician group. No retail pharmacy may employ a physician for the purpose of maintaining, establishing or entering into a collaborative practice agreement with a patient. Nothing shall prohibit a retail pharmacy from hiring a physician or licensed medical practitioner for the purpose of conducting quality assurance reviews of its pharmacists that are engaged in the practice of collaborative drug therapy.