Code of Massachusetts Regulations › 243 CMR - BOARD OF REGISTRATION IN MEDICINE › Title 243 CMR 2.00 - Licensing and the practice of medicine › Part 2 - THE PRACTICE OF MEDICINE › Section 2.12 - Collaborative Drug Therapy Management (CDTM) with Authorized Pharmacists

Current through Register 1525, July 5, 2024
M.G.L. c. 94C, §§ 7 and 9 and M.G.L. c. 112, §§ 24B½ and 24B¾ authorize pharmacists and physicians to engage in collaborative drug therapy management (CDTM) in the Commonwealth pursuant to collaborative practice agreements meeting the requirements of 247 CMR:
Board of Registration in Pharmacy
and in Medicine. The Board of Registration in Pharmacy has promulgated 247 CMR 16.00:
Collaborative Drug Therapy Management
in accordance with M.G.L. c. 112, §§ 24B½ and 24B¾. 243 CMR 2.12 includes additional definitions and requirements applicable to pharmacists and physicians entering into collaborative practice agreements to practice CDTM in the Commonwealth.
(1)
Definitions
. Additional definitions applicable to the practice of CDTM in the Commonwealth appear in 243 CMR 2.12 and in 247 CMR 2.00:
Definitions
and 247 CMR 16.00:
Collaborative Drug Therapy Management
. As used in 243 CMR 2.12, all references to "written" regarding collaborative practice agreement referrals, consents and any other documents related to a collaborative practice agreement shall be:
(a) if paper based, written in ink, indelible pencil or any other means; or
(b) transmitted electronically in a format that maintains patient confidentiality and can be read and stored in a retrievable and readable form. Collaborative practice agreements and related referrals, consents and other documentation may be transmitted electronically with the electronic signature(s) without alteration of the information, provided the electronic transmission is in accordance with the requirements of M.G.L. c. 94C, § 23(g); 105 CMR 721.00:
Standards for Prescription Format and Security in Massachusetts
; 247 CMR 9.01(19)  and 9.07(1)(a).
As used in 243 CMR 2.12 and defined in M.G.L. c. 112, § 24B½(a), the following words shall have the following meanings:
Authorized Pharmacist
means a pharmacist who:
(a) is currently registered by the Board of Registration in Pharmacy and is in good standing;
(b) meets the requirements of 247 CMR 16.02:
Pharmacist Qualifications
; and
(c) is participating in drug therapy management with a supervising physician pursuant to a written CDTM agreement with written protocols.
Board
means the Board of Registration in Medicine.
Collaborative Drug Therapy Management
or
CDTM
means the initiating, monitoring, modifying and discontinuing of a patient's drug therapy by an authorized pharmacist under the supervision of a physician in accordance with a collaborative practice agreement. 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 does not include a diagnostic component.
Collaborative Practice Agreement
or
CDTM Agreement
means 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 practice. 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 written referral of an identified patient from the supervising physician to an authorized pharmacist, and shall include a written consent to the CDTM agreement by the named patient.
Community Pharmacy
means a retail drug business setting, licensed pursuant to M.G.L. c. 112, §§ 38 and 39. When there is a collaborative drug therapy management agreement between an authorized pharmacist in a community pharmacy and a supervising physician, the physician must obtain the informed consent of the patient in writing prior to participating in CDTM.
License
means a certificate of registration which the board issues to a person pursuant to the requirements of M.G.L. c. 112, §§ 2, 9 and 9B, and which authorizes the person to engage in the practice of medicine.
Patient
means, for the purposed of 243 CMR 2.12, a person who is referred to an authorized pharmacist by a supervising physician for the purpose of receiving collaborative drug therapy management services from the pharmacist. In the community pharmacy setting, the patient must be notified of, and provide written consent to, the collaborative drug therapy management services, and the supervising physician must provide the patient with a copy of the referral to the authorized pharmacist and the written consent to the referral provided by the patient.
Referral
means the individual patient referral by a supervising physician to an authorized pharmacist for the purpose of receiving CDTM services in a community pharmacy setting. In all other practice settings,
Referral
means the consultation of a supervising physician and an authorized pharmacist about a patient for the purpose of the patient's receiving CDTM services. In the community pharmacy setting, the supervising physician shall execute a written CDTM referral which shall include, but is not limited to, the patient's name and address, the primary diagnosis for which CDTM services are authorized, the diagnosis of any comorbid conditions for which CDTM services are authorized, any known patient drug allergies, a statement that the patient has executed a written consent to CDTM services, and any other specific instructions to the authorized pharmacist.
Supervising Physician
means a physician who holds an active license to practice medicine in the Commonwealth of Massachusetts. A supervising physician in a CDTM agreement may only delegate to an authorized pharmacist pursuant to the written agreement and protocols with the pharmacist.