Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 16.00 - Collaborative Drug Therapy Management › Section 16.03 - Practice Setting Requirements

Current through Register 1525, July 5, 2024
In accordance with M.G.L. c. 112, § 24B½(c), collaborative drug therapy management may be performed in the following settings by pharmacists meeting the requirements of 247 CMR 16.02(1)  and authorized by a supervising physician pursuant to a current collaborative practice agreement:
(1) Hospitals licensed pursuant to M.G.L. c. 111, § 51, subject to approval by the hospital medical staff executive committee or designee;
(2) Long-term Care Facilities licensed pursuant to M.G.L. c. 111, § 71, subject to approval by the long-term care facility medical director or designee;
(3) Inpatient or Outpatient Hospice Settings licensed pursuant to M.G.L. c. 111, § 57D, subject to approval by the hospice medical director or designee;
(4) Ambulatory Care Clinics licensed pursuant to M.G.L. c. 111, § 51, with on-site supervision by an attending physician affiliated with the ambulatory clinic and an authorized pharmacist, subject to approval by the ambulatory care clinic medical staff executive committee or designee, or medical director or designee;
(5) Community Pharmacies (retail drug business settings) licensed by the Board pursuant to M.G.L. c. 112, § 39, subject to the restrictions listed below and pursuant to a current collaborative practice agreement that includes the following requirements:
(a)
Patient Age
. Patients must be 18 years of age or older.
(b)
Vaccine Administration
. Pharmacists, as authorized pursuant to a collaborative practice agreement, may administer vaccines.
(c)
Patient Referral and Consent
. In accordance with 243 CMR 2.12, the collaborative practice agreement must provide that the supervising physician will:
1. provide a written referral of the patient to the authorized pharmacist;
2. specify the primary diagnosis for the patient and any secondary diagnoses in the written referral or a subsequent referral;
3. provide a copy of the written referral of the patient to the authorized pharmacist for CDTM services to the patient; and
4. obtain the patient's written informed consent to the collaboration in the collaborative practice agreement and provide a copy of the consent to the patient.
(d)
Record of Referral and Consent
. The authorized pharmacist and supervising physician must maintain a written record of both the individual patient referral and the patient's written informed consent to the collaboration in the patient's records which are maintained by the authorized pharmacist and the supervising physician. In accordance with 243 CMR 2.12, the supervising physician shall:
1. maintain the original patient consent to the referral in the record in the custody of the supervising physician;
2. transmit a copy of the patient's consent to the authorized pharmacist within 24 hours; and
3. provide copies of the referral and consent to the patient in a timely manner.
(e)
Limited Prescribing Authority
.
1. An authorized pharmacist currently registered by the Department, pursuant to M.G.L. c. 94C, §§ 7 and 9 and 105 CMR 700.000:
Implementation of M.G.L. c. 94C
, to prescribe and possess controlled substances, who practices in a community pharmacy pursuant to a collaborative practice agreement that includes individually developed prescriptive practice guidelines pursuant to which the supervising physician has authorized the pharmacist to prescribe, may:
a. extend current drug therapy by 30 days for not more than two 30 day periods or as may otherwise be specifically authorized by the supervising physician in the referral of the patient and as provided in the CDTM agreement;
b. initiate, modify or discontinue dosages of medications prescribed by the supervising physician for:
i. asthma;
ii. chronic obstructive pulmonary disease;
iii. diabetes;
iv. hypertension;
v. hyperlipidemia;
vi. congestive heart failure;
vii. HIV or AIDS;
viii. osteoporosis; and
ix. co-morbidities listed in 247 CMR 16.03(5)(e)1.b.i. through viii. and identified by the supervising physician along with the primary diagnosis in the supervising physician's referral of the patient.
2. The authorized pharmacist must provide a copy of an initial prescription or a modification or discontinuation of a prescription to the supervising physician within 24 hours of issuance, unless more urgent notification is required under the circumstances and must note the action taken in the patient's medical record. A copy of all prescriptions must be included in the patient's medical record in the custody of the supervising physician.
3. No authorized pharmacist in a community pharmacy may prescribe or be authorized to prescribe Schedule II through V controlled substances, as defined in M.G.L. c. 94C, § 3, subsections (2) through (5).
4. An authorized pharmacist in a community pharmacy may be authorized by a supervising physician to issue prescriptions for Schedule VI controlled substances, as defined in M.G.L. c. 94C, § 3, subsection (6), for the diagnoses specified in the supervising physician's patient referral.