Section 16.04 - Collaborative Practice Agreements - Required Agreement Terms for All Practice Settings; Duties; Biennial Renewal; Termination; Agreement to Be Filed in Primary Practice Setting; and Employment Relationships(1) A collaborative practice agreement must be a written and signed agreement between an authorized 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 authorized pharmacist and supervising physician propose to engage. The collaborative practice must be within the scope of the supervising physician's practice. In the community pharmacy setting, the CDTM agreement shall include:(a) a written referral of a specific patient from the supervising physician to an authorized pharmacist; and(b) the written consent of the patient to the CDTM agreement.(2)Required Agreement Terms for All Practice Settings. In addition to specific practice setting collaborative practice agreement requirements, pursuant to 247 CMR 16.03, and in accordance with M.G.L. c. 112, § 24B3/4 and 243 CMR 2.12, all collaborative practice agreements must also include: (a) specific disease state(s) being co-managed, with each disease state identified as either primary or co-morbid;(b) specific pharmacist prescribing authority pursuant to the CDTM agreement;(c) detailed practice protocols;(d) description of risk management activities;(e) documentation of any initiation, modification or discontinuation of a patient's medication in the patient's permanent medical record;(f) description of outcome measurements;(g) detailed informed consent procedures appropriate to the practice setting;(h) detailed procedures and periods by which time any test results, copies of initial prescriptions, modifications or discontinuances, copies of the patient consent and the CDTM agreement, and other patient information will be forwarded by the authorized pharmacist to the supervising physician, and a specific procedure for the authorized pharmacist to identify and transmit any urgent communications; description of the nature and form of the supervision of the authorized pharmacist by the supervising physician, and a description of the procedure to follow when either the authorized pharmacist or supervising physician is unavailable or absent;(i) the authorized pharmacist's attestation of satisfaction of the qualifications listed in 247 CMR16.02(1) for participating in collaborative drug therapy management; and (j) the supervising physician's attestation of satisfaction of the qualifications listed in 243 CMR 2.12 for participating in collaborative drug therapy management.(3)Duties. A collaborative practice agreement shall specify those duties of the authorized pharmacist that may be delegated to other appropriately trained and authorized staff and those duties under the agreement that shall not be delegated. A collaborative practice agreement shall specify when and how an authorized pharmacist may delegate duties under the agreement, and the duration and scope of the delegation. Pharmacy interns and pharmacy technician duties providing support to an authorized pharmacist acting pursuant to a collaborative practice agreement must perform services in accordance with 247 CMR 8.01 (pharmacy interns) and 8.02 through 8.06 (pharmacy technicians).(4)Biennial Renewal. A collaborative practice agreement must be reviewed and renewed by the authorized pharmacist and supervising physician(s) at least every two years.(5)Termination. Prior to termination or non-renewal of a CDTM agreement, an authorized pharmacist and supervising physician shall arrange for an uninterrupted continuation of the patient's drug therapy, in accordance with the terms of the CDTM agreement. When a CDTM agreement is not renewed or CDTM is otherwise terminated, an authorized pharmacist and supervising physician shall inform the patient in writing of the termination and of the procedures in place for the continuation of the patient's drug therapy, in accordance with the terms of the CDTM agreement.(6)Agreement to Be Filed in Primary Practice Setting. An authorized pharmacist must maintain a copy of the current CDTM agreement, including copies of current patient referral and patient consent, in the primary practice setting, readily retrievable at the request of the Board of Registration in Pharmacy and Board of Registration in Medicine. In accordance with 243 CMR 2.12: Collaborative Drug Therapy Management (CDTM) with Authorized Pharmacists, the supervising physician must maintain the original of the current CDTM agreement, including the original current patient referral and patient consent, in the patient's medical record in the custody of the supervising physician.(7)Employment Relationships. In accordance with M.G.L. c. 112, § 24B1/2, subsection (e):(a) A qualified pharmacist may be hired by a physician or group of physicians for the purpose of practicing collaborative drug therapy management under an agreement for the benefit of a patient of that physician or physician group;(b) A community pharmacy may hire a physician or licensed medical practitioner to conduct quality assurance reviews of pharmacists engaged in collaborative drug therapy management; and(c) No community pharmacy may employ a physician for the purpose of maintaining, establishing or entering into a collaborative practice agreement.Amended by Mass Register Issue 1354, eff. 12/15/2017.