§ 20-631 — Collaborative drug therapy care plans, management agreements and policies. Scope. Care-giving institutions, devices and qualified pharmacists. Regulations.

Connecticut § 20-631

• Jurisdiction: Connecticut
• Title 20: Professional and Occupational Licensing, Certification, Title Protection and Registration. Examining Boards
• Ch. 400j: Pharmacy

Text

(a) For the purposes of this section: (1) “Care-giving institution” has the same meaning as provided in section 20-571 ; (2) “Commissioner” means the Commissioner of Consumer Protection; (3) “Collaborative drug therapy care plan” means a written document memorializing the outcome of the process through which one or more qualified pharmacists and one or more prescribing practitioners discuss, review and agree on an approach to achieve a patient's desired health outcome; (4) “Collaborative drug therapy management agreement” means an agreement between one or more qualified pharmacists and one or more prescribing practitioners to manage the drug therapy of, and devices prescribed to, individual patients, or a patient population, based on a written protocol or a collaborative drug therapy care plan; (5) “Collaborative drug therapy management policy” means a written policy adopted by a care-giving institution under which one or more qualified pharmacists manage the drug therapy of, and devices prescribed to, individual patients, or a patient population, based on a written protocol or a collaborative drug therapy care plan; (6) “Device” has the same meaning as provided in section 20-571 ; (7) “Pharmacist” has the same meaning as provided in section 20-571 ; (8) “Prescribing practitioner” has the same meaning as provided in section 20-571 ; (9) “Provider-patient relationship” means a relationship between a prescribing practitioner and a patient in which (A) the patient has made a medical complaint, (B) the patient has provided such patient's medical history, (C) the patient has received a physical examination, and (D) there exists a logical connection between such medical complaint, medical history and physical examination and any drug or device prescribed for such patient; and (10) “Qualified pharmacist” means a pharmacist who (A) is deemed competent under regulations adopted by the commissioner pursuant to subsection (e) of this section, and (B) has reviewed the latest edition of the “Pharmacists' Patient Care Process” published by the Joint Commission of Pharmacy Practitioners. (b) Except as provided in section 20-631b , one or more qualified pharmacists may enter into a collaborative drug therapy management agreement or manage the drug therapy of, and devices prescribed to, individual patients, or a patient population, under a collaborative drug therapy management policy. In order to enter into a collaborative drug therapy management agreement or collaborative drug therapy care plan, or operate under a collaborative drug therapy management policy, a prescribing practitioner shall first establish a provider-patient relationship with the patient or patients who will receive collaborative drug therapy or devices. Each patient's collaborative drug therapy or device management shall be based on a diagnosis made by such patient's prescribing practitioner or a specific test set forth in a collaborative drug therapy management agreement or collaborative drug therapy management policy. (c) A collaborative drug therapy management agreement or collaborative drug therapy management policy may authorize a qualified pharmacist or qualified pharmacists to initiate, modify, continue, discontinue or deprescribe a drug therapy, or initiate, continue or discontinue use of, or deprescribe, a device, that has been prescribed for a patient, order associated laboratory tests and administer drugs, all in accordance with a patient-specific or patient population-specific written protocol or collaborative drug therapy care plan, but shall not authorize a qualified pharmacist or qualified pharmacists to establish a port to administer parenteral drugs. A collaborative drug therapy management agreement or collaborative drug therapy management policy may specifically address issues that may arise during a medication reconciliation and concerns related to polypharmacy that enable an authorized qualified pharmacist or qualified pharmacists to initiate, modify, continue, discontinue or deprescribe drug therapy. In instances where drug therapy is discontinued or deprescribed, the qualified pharmacist or qualified pharmacists shall notify the prescribing practitioner of such discontinuance or deprescribing not later than twenty-four hours after such drug therapy is discontinued or deprescribed. Each written protocol or collaborative drug therapy care plan developed, pursuant to a collaborative drug therapy management agreement or collaborative drug therapy management policy, shall contain detailed direction concerning the actions that the qualified pharmacist or qualified pharmacists may perform for the patient or patient population. Such written protocol or collaborative drug therapy care plan shall include, but need not be limited to, (1) the specific drug or drugs, therapeutic class of drug or classes of drugs, or devices to be managed by the qualified pharmacist or qualified pharmacists, (2) the terms and conditions under which drug therapy may be initiated, modified, continued, discontinued or deprescribed, or use of a device may be initiated, continued or discontinued, or a device may be deprescribed, (3) the conditions and events upon which the qualified pharmacist is, or qualified pharmacists are, required to notify the prescribing practitioner, (4) the laboratory tests that may be ordered, and (5) a definition of the patient population included in such written protocol or collaborative drug therapy care plan. All activities performed by the qualified pharmacist or qualified pharmacists in conjunction with the protocol or collaborative drug therapy care plan shall be documented in the patient's medical record in accordance with the prescribing practitioner's policies or, in the case of a care-giving institution, all applicable care-giving institution policies. Each collaborative drug therapy management agreement, collaborative drug therapy management policy, written protocol and collaborative drug therapy care plan shall be available for inspection by the Department of Consumer Protection and the Department of Public Health. A copy of the protocol shall be filed in the patient's medical record. (d) A pharmacist shall be responsible for demonstrating, in accordance with regulations adopted pursuant to subsection (e) of this section, the competence necessary for the pharmacist to participate in each collaborative drug therapy management agreement, collaborative drug therapy management policy and collaborative drug therapy care plan in which such pharmacist seeks to participate by, among other things, demonstrating that such pharmacist has reviewed the latest edition of the “Pharmacists' Patient Care Process” published by the Joint Commission of Pharmacy Practitioners. (e) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, shall (1) adopt regulations, in accordance with chapter 54, concerning competency requirements for participation in a collaborative drug therapy management agreement, the minimum content of the collaborative drug therapy management agreement and such other matters said commissioners deem necessary to carry out the purpose of this section, and (2) on or after July 1, 2022, amend such regulations to include competency requirements for participation in a collaborative drug therapy management policy or collaborative drug therapy care plan and the minimum content of collaborative drug therapy management policies, collaborative drug therapy care plans and written protocols governing collaborative drug therapy and device management.

Legislative History

(P.A. 02-41, S. 1; P.A. 03-164, S. 1; June 30 Sp. Sess. P.A. 03-6, S. 146; P.A. 04-169, S. 17; 04-189, S. 1; P.A. 05-217, S. 1; P.A. 10-117, S. 91; P.A. 19-98, S. 22; P.A. 21-192, S. 4; P.A. 22-118, S. 69.) History: (Revisor's note: In codifying this section the Revisors editorially changed two references in Subsec. (b) from “pharmacists” to “pharmacist” for consistency); P.A. 03-164 amended Subsec. (a) by designating existing provisions as Subdiv. (1), making a technical change therein, and adding Subdiv. (2) allowing pharmacists employed by nursing home facilities to enter into collaborative drug therapy management agreement, and made conforming changes in Subsec. (c); June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Commissioner and Department of Consumer Protection with Commissioner and Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; P.A. 05-217 amended Subsec. (a) by adding Subdiv. (3) allowing hospital pharmacists to enter into collaborative drug therapy management agreements to manage drug therapy of patients receiving outpatient hospital care or services for diabetes, asthma, hypertension, hyperlipidemia, osteoporosis, congestive heart failure or smoking cessation; P.A. 10-117 amended Subsec. (a) by adding exception re Sec. 20-631b, replacing provision re pharmacist eligibility in accordance with Subsec. (c) with provision re pharmacist competency in accordance with regulations adopted pursuant to Subsec. (d), adding provisions requiring and defining physician-patient relationship for purposes of agreement, deleting former Subdiv. (1) designator and deleting provisions therein and former Subdivs. (1) and (2) re pharmacist employed by or under contract with a hospital or nursing home facility, amended Subsec. (c) by requiring demonstration of pharmacist competency in accordance with regulations adopted pursuant to Subsec. (d) and deleting former provisions re competency determination, and amended Subsec. (d) to require Commissioner of Consumer Protection, in consultation with Commissioner of Public Health, to adopt regulations re pharmacist competency requirements for participation in agreements (Revisor's note: In codifying P.A. 10-117, S. 91, a reference to “section 2 of this act” was deemed by the Revisors to be a reference to “section 92 of this act” and therefore cited as “section 20-631b” in Subsec. (a)); P.A. 19-98 amended Subsecs. (a) and (b) by adding references to advance practice registered nurse and further amended Subsec. (a) by replacing “physician-patient relationship” with “provider-patient relationship”; P.A. 21-192 amended Subsec. (a) by replacing “specific to the patient” with “which may include guideline-directed management”, amended Subsec. (b) by adding references to continuing and deprescribing drug therapy, adding provision re agreement addressing medication reconciliation and polypharmacy, changing provision re reporting every 30 days to encounters within scope of agreement and authorizing documenting information within shared medical record rather than reporting, effective July 13, 2021; P.A. 22-118 added new Subsec. (a) defining “care-giving institution”, “commissioner”, “collaborative drug therapy care plan”, “collaborative drug therapy management agreement”, “collaborative drug therapy management policy”, “device”, “pharmacist”, “prescribing practitioner”, “provider-patient relationship” and “qualified pharmacist”, redesignated existing Subsecs. (a) to (d) as Subsecs. (b) to (e), substantially amended redesignated Subsec. (b) re qualified pharmacists and redesignated Subsec. (c) re collaborative drug therapy management agreements including addition of provisions re collaborative drug therapy management policies, devices, patient populations, ports to administer parenteral drugs and Subdiv. (5) re definition of patient population included in written protocol or collaborative drug therapy care plan, amended redesignated Subsec. (d) by adding provisions re collaborative drug therapy management policies, collaborative drug therapy care plans and pharmacist review of latest edition of “Pharmacists' Patient Care Process” published by Joint Commission of Pharmacy Practitioners, amended redesignated Subsec. (e) by designating existing provisions re regulations as Subdiv. (1) and adding Subdiv. (2) re regulations re competency requirements and minimum content of collaborative drug therapy management policies, collaborative drug therapy care plans and written protocols governing collaborative drug therapy and device management, and made technical and conforming changes, effective July 1, 2022.