LCO \\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00186-R01- SB.docx 1 of 6 General Assembly Substitute Bill No. 186 February Session, 2022 AN ACT CONCERNING COLLABORATIVE DRUG THERAPY MANAGEMENT AGREEMENTS AND POLICIES. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. Section 20-631 of the 2022 supplement to the general 1 statutes is repealed and the following is substituted in lieu thereof 2 (Effective from passage): 3 (a) For the purposes of this section: 4 (1) "Care-giving institution" has the same meaning as provided in 5 section 20-571; 6 (2) "Commissioner" means the Commissioner of Consumer 7 Protection; 8 (3) "Collaborative drug therapy care plan" means a written document 9 memorializing the outcome of the process through which a patient and 10 one or more health care providers discuss, review and agree on an 11 approach to achieve the patient's desired health outcome; 12 (4) "Collaborative drug therapy management agreement" means an 13 agreement between one or more qualified pharmacists and one or more 14 prescribing practitioners to manage the drug therapy of individual 15 patients, or a patient population, based on a written protocol or a 16 collaborative drug therapy care plan; 17 Substitute Bill No. 186 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00186- R01-SB.docx } 2 of 6 (5) "Collaborative drug therapy management policy" means a written 18 policy adopted by a care-giving institution under which one or more 19 qualified pharmacists manage the drug therapy of individual patients, 20 or a patient population, based on a written protocol or a collaborative 21 drug therapy care plan; 22 (6) "Pharmacist" has the same meaning as provided in section 20-571; 23 (7) "Prescribing practitioner" has the same meaning as provided in 24 section 20-571; 25 (8) "Provider-patient relationship" means a relationship between a 26 prescribing practitioner and a patient in which (A) the patient has made 27 a medical complaint, (B) the patient has provided such patient's medical 28 history, (C) the patient has received a physical examination, and (D) 29 there exists a logical connection between such medical complaint, 30 medical history and physical examination and any drug prescribed for 31 such patient; and 32 (9) "Qualified pharmacist" means a pharmacist who (A) is deemed 33 competent under regulations adopted by the commissioner pursuant to 34 subsection (e) of this section, and (B) has reviewed the latest edition of 35 the "Pharmacists' Patient Care Process" published by the Joint 36 Commission of Pharmacy Practitioners. 37 [(a)] (b) Except as provided in section 20-631b, one or more qualified 38 pharmacists [licensed under this chapter who are determined 39 competent in accordance with regulations adopted pursuant to 40 subsection (d) of this section] may enter into a [written protocol-based] 41 collaborative drug therapy management agreement [with one or more 42 physicians licensed under chapter 370 or advanced practice registered 43 nurses licensed under chapter 378 to] or manage the drug therapy of 44 individual patients, or a patient population, under a collaborative drug 45 therapy management policy. In order to enter into a [written protocol-46 based] collaborative drug therapy management agreement [, such 47 physician or advanced practice registered nurse shall have established] 48 Substitute Bill No. 186 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00186- R01-SB.docx } 3 of 6 or collaborative drug therapy care plan, or operate under a collaborative 49 drug therapy management policy, a prescribing practitioner must first 50 establish a provider-patient relationship with the patient or patients 51 who will receive collaborative drug therapy. Each patient's collaborative 52 drug therapy management shall be [governed by a written protocol 53 which may include guideline-directed management established by the 54 treating physician or advanced practice registered nurse in consultation 55 with the pharmacist. For purposes of this subsection, a "provider-patient 56 relationship" is a relationship based on (1) the patient making a medical 57 complaint, (2) the patient providing a medical history, (3) the patient 58 receiving a physical examination, and (4) a logical connection existing 59 between the medical complaint, the medical history, the physical 60 examination and any drug prescribed for the patient] based on a 61 diagnosis made by such patient's prescribing practitioner or a specific 62 test set forth in a collaborative drug therapy management agreement or 63 collaborative drug therapy management policy. 64 [(b)] (c) A collaborative drug therapy management agreement or 65 collaborative drug therapy management policy may authorize a 66 [pharmacist to implement] qualified pharmacist or qualified 67 pharmacists to initiate, modify, continue, discontinue or deprescribe a 68 drug therapy that has been prescribed for a patient, order associated 69 laboratory tests and administer drugs, all in accordance with a patient-70 specific or patient population-specific written protocol [. Such 71 agreement] or collaborative drug therapy care plan, but may not 72 authorize a qualified pharmacist or qualified pharmacists to establish a 73 port to administer parenteral drugs. A collaborative drug therapy 74 management agreement or collaborative drug therapy management 75 policy may specifically address issues that may arise during a 76 medication reconciliation and concerns related to polypharmacy that 77 enable an authorized qualified pharmacist or qualified pharmacists to 78 [implement] initiate, modify, continue, discontinue or deprescribe drug 79 therapy. In instances where drug therapy is discontinued or 80 deprescribed, the qualified pharmacist or qualified pharmacists shall 81 notify the [treating physician or advanced practice registered nurse] 82 Substitute Bill No. 186 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00186- R01-SB.docx } 4 of 6 prescribing practitioner of such discontinuance or deprescribing [no] 83 not later than twenty-four hours [from the time of such discontinuance 84 or deprescribing] after such drug therapy is discontinued or 85 deprescribed. Each written protocol or collaborative drug therapy care 86 plan developed, pursuant to [the] a collaborative drug therapy 87 management agreement or collaborative drug therapy management 88 policy, shall contain detailed direction concerning the actions that the 89 qualified pharmacist or qualified pharmacists may perform for [that] the 90 patient [. The] or patient population. Such written protocol or 91 collaborative drug therapy care plan shall include, but need not be 92 limited to, (1) the specific drug or drugs, therapeutic class of drug or 93 classes of drugs, or medical devices to be managed by the qualified 94 pharmacist or qualified pharmacists, (2) the terms and conditions under 95 which drug therapy may be [implemented] initiated, modified, 96 continued, discontinued or deprescribed, (3) the conditions and events 97 upon which the qualified pharmacist is, or qualified pharmacists are, 98 required to notify the [physician or advanced practice registered nurse, 99 and] prescribing practitioner, (4) the laboratory tests that may be 100 ordered, and (5) a definition of the patient population included in such 101 written protocol or collaborative drug therapy care plan. All activities 102 performed by the qualified pharmacist or qualified pharmacists in 103 conjunction with the protocol shall be documented in the patient's 104 medical record [. The pharmacist shall report any encounters within the 105 scope of the collaborative drug therapy management agreement within 106 thirty days to the physician or advanced practice registered nurse 107 regarding the patient's drug therapy management or document such 108 information within a shared medical record. The] in accordance with all 109 applicable care-giving institution policies. Each collaborative drug 110 therapy management agreement, [and protocols] collaborative drug 111 therapy management policy, written protocol and collaborative drug 112 therapy care plan shall be available for inspection by the [Departments] 113 Department of Consumer Protection and the Department of Public 114 Health. [and Consumer Protection.] A copy of the protocol shall be filed 115 in the patient's medical record. 116 Substitute Bill No. 186 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00186- R01-SB.docx } 5 of 6 [(c)] (d) A pharmacist shall be responsible for demonstrating, in 117 accordance with regulations adopted pursuant to subsection [(d)] (e) of 118 this section, the competence necessary for [participation] the pharmacist 119 to participate in each collaborative drug therapy management 120 agreement, [into which such pharmacist enters] collaborative drug 121 therapy management policy and collaborative drug therapy care plan in 122 which such pharmacist seeks to participate by, among other things, 123 demonstrating that such pharmacist has reviewed the latest edition of 124 the "Pharmacists' Patient Care Process" published by the Joint 125 Commission of Pharmacy Practitioners. 126 [(d)] (e) The Commissioner of Consumer Protection, in consultation 127 with the Commissioner of Public Health, shall (1) adopt regulations, in 128 accordance with chapter 54, concerning competency requirements for 129 participation in a [written protocol-based] collaborative drug therapy 130 management agreement, [described in subsection (a) of this section,] the 131 minimum content of the collaborative drug therapy management 132 agreement [and the written protocol] and such other matters said 133 commissioners deem necessary to carry out the purpose of this section, 134 and (2) on or after the effective date of this section, amend such 135 regulations to include competency requirements for participation in a 136 collaborative drug therapy management policy or collaborative drug 137 therapy care plan and the minimum content of collaborative drug 138 therapy management policies, collaborative drug therapy care plans 139 and written protocols governing collaborative drug therapy 140 management. 141 Sec. 2. Section 19a-521d of the general statutes is repealed and the 142 following is substituted in lieu thereof (Effective from passage): 143 A medical director of a nursing home facility, as defined in section 144 19a-521, may establish protocols for a prescription drug formulary 145 system in accordance with guidelines established by the American 146 Society of Health-System Pharmacists and any applicable collaborative 147 drug therapy management agreement or collaborative drug therapy 148 management policy, as [described] defined in section 20-631, as 149 Substitute Bill No. 186 LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00186- R01-SB.docx } 6 of 6 amended by this act. The medical director of a nursing home facility that 150 implements a prescription drug formulary system may make a 151 substitution for a drug prescribed to a patient of the facility in 152 accordance with the provisions of this section. Prior to making any 153 substitution for a drug prescribed to a patient of the facility in 154 accordance with the facility's protocols, the medical director, or the 155 medical director's designee, shall notify the prescribing practitioner of 156 the medical director's intention to make such substitution. If the 157 prescribing practitioner does not authorize the medical director or the 158 medical director's designee to make such substitution or objects to such 159 substitution, the medical director, or the medical director's designee, 160 shall not make the substitution. Notwithstanding the provisions of this 161 section, a facility, when administering prescription drugs to a patient 162 who receives benefits under a medical assistance program administered 163 by the Department of Social Services, shall consider and administer 164 prescription drugs to such patient in accordance with (1) the 165 department's preferred drug list, developed in accordance with section 166 17b-274d, (2) prescription drug formularies under Medicare Part D, or 167 (3) the patient's health insurance policy, as the medical director of the 168 nursing home facility deems appropriate. 169 This act shall take effect as follows and shall amend the following sections: Section 1 from passage 20-631 Sec. 2 from passage 19a-521d Statement of Legislative Commissioners: In Section 1(b), "patients or a patient population" was changed to "patients, or a patient population," for clarity; in Section 1(c), "that" was bracketed and "the" was inserted after the closing bracket, and "caregiving institution" was changed to "care-giving institution", for consistency; and in Section 1(e)(2), "and" was inserted before "the minimum" for clarity. GL Joint Favorable Subst. -LCO