SB 895 — AN ACT CONCERNING CHANGES TO VARIOUS PHARMACY STATUTES.

895 or a licensed health care practitioner for use by their own patients.

The machine shall only be placed in an area where contents sSB895can /be Filestored No.in accordance with the manufacturer's recommendation, unless the secured machine can provide adequate environmental controls independent of the external environment.

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361 can be stored in accordance with the manufacturer's recommendation, unless the secured machine can provide adequate environmental controls independent of the external environment.

[(d)] (e) Any person who violates any provision of this section shall be fined not more than five hundred dollars or imprisoned not more thanPublic oneAct yearNo. or both.

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895 than one year or both.

Each patient's collaborative drug therapy management shall be governed by a written sSB895protocol /[specific Fileto No.that patient] which may include guideline-directed management established by the treating physician or advanced practice registered nurse in consultation with the pharmacist.

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361 protocol [specific to that patient] which may include guideline-directed management established by the treating physician or advanced practice registered nurse in consultation with the pharmacist.

Such agreement may specifically address issues that may arise during a medication reconciliation and concerns related to polypharmacy that enable an authorizedPublic pharmacistAct toNo. implement, modify, continue, discontinue or deprescribe drug therapy.

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895 authorized pharmacist to implement, modify, continue, discontinue or deprescribe drug therapy.

The pharmacist shall report [at least every] any encounters within the scope of the collaborative drug therapy management agreement within thirty days to the physician or sSB895advanced /practice Fileregistered No.nurse regarding the patient's drug therapy management or document such information within a shared medical record.

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361 advanced practice registered nurse regarding the patient's drug therapy management or document such information within a shared medical record.

(d) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, shall adopt regulations, in accordancePublic withAct chapterNo. 54, concerning competency requirements for participation in a written protocol-based collaborative drug therapy management agreement described in subsection (a) of this section, the minimum content of the collaborative drug therapy management agreement and the written protocol and such other matters said commissioners deem necessary to carry out the purpose of this section.

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895 accordance with chapter 54, concerning competency requirements for participation in a written protocol-based collaborative drug therapy management agreement described in subsection (a) of this section, the minimum content of the collaborative drug therapy management agreement and the written protocol and such other matters said commissioners deem necessary to carry out the purpose of this section.

Subsection (j) of section 21a-254 of the general statutes is repealed and the following is substituted in lieu thereof (Effective fromJuly passage):1, 2022):

The program shall be designed to provide information regarding the prescription of controlled substances in order to prevent the improper or illegal use of the controlled substances and shall not infringe on the sSB895legitimate /prescribing Fileof No.a controlled substance by a prescribing practitioner acting in good faith and in the course of professional practice.

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361 legitimate prescribing of a controlled substance by a prescribing practitioner acting in good faith and in the course of professional practice.

(3) Prior to July 1, 2016, each pharmacy, nonresident pharmacy, as defined in section 20-627, outpatient pharmacy in a hospital or institution and dispenser shall report to the commissioner, at least weekly,Public byAct electronicNo. means or, if a pharmacy or outpatient pharmacy does not maintain records electronically, in a format approved by the commissioner, the following information for all controlled substance prescriptions dispensed by such pharmacy or outpatient pharmacy:

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895 weekly, by electronic means or, if a pharmacy or outpatient pharmacy does not maintain records electronically, in a format approved by the commissioner, the following information for all controlled substance prescriptions dispensed by such pharmacy or outpatient pharmacy:

(ii) the date the prescription for the controlled sSB895substance /was Filefilled; No.

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361 substance was filled;

(x) the date the prescription for the controlled substance was issued by the prescribing practitioner and the prescribingPublic practitioner'sAct DrugNo. Enforcement Agency's identification number;

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895 prescribing practitioner's Drug Enforcement Agency's identification number;

sSB895(7) /The Filecommissioner No.shall provide, upon request, controlled substance prescription information obtained in accordance with subdivisions (3) and (4) of this subsection to the following:

361(A) 13The sSB895prescribing Filepractitioner or such practitioner's authorized agent, who is treating or has treated a specific patient, provided the information is Public Act No.

36121-192 (7)14 The commissioner shall provide, upon request, controlled substance prescription information obtained in accordance with subdivisions (3) and (4) of this23 subsectionSubstitute toSenate theBill following:No.

(A)895 The prescribing practitioner or such practitioner's authorized agent, who is treating or has treated a specific patient, provided the information is obtained for purposes related to the treatment of the patient, including the monitoring of controlled substances obtained by the patient;

Whenever a prescribing practitioner prescribes a controlled substance, other than a schedule V nonnarcotic controlled sSB895substance, /for Filethe continuous or prolonged treatment of any patient, such prescriber, or such prescriber's authorized agent, shall review, not Public Act No.

36121-192 1415 sSB895of File23 Substitute Senate Bill No.

361895 substance, for the continuous or prolonged treatment of any patient, such prescriber, or such prescriber's authorized agent, shall review, not less than once every ninety days, the patient's records in such prescription drug monitoring program.

(B) Notwithstanding the provisions of subparagraph (A) of this subdivision, a prescribing practitioner who is employed by or provides professional services to a hospital shall, prior to designating an authorized agent to review the electronic prescription drug monitoring programPublic andAct patient controlled substance prescription information on sSB895 / File No.

36121-192 1516 sSB895of File23 Substitute Senate Bill No.

361895 program and patient controlled substance prescription information on behalf of the prescribing practitioner, (i) submit a request to designate one or more authorized agents for such purposes and a written protocol for oversight of the authorized agent or agents to the commissioner, in the form and manner prescribed by the commissioner, and (ii) receive the commissioner's approval to designate such authorized agent or agents and of such written protocol.

The pharmacist and anyPublic authorizedAct pharmacyNo. technician shall be subject to the provisions of 45 CFR 164.308, as amended from time to time, concerning administrative safeguards for the protection of electronic protected health information.

A21-192 pharmacist17 mayof be23 subjectSubstitute toSenate disciplinaryBill action sSB895 / File No.

361895 16any sSB895authorized Filepharmacy No.technician shall be subject to the provisions of 45 CFR 164.308, as amended from time to time, concerning administrative safeguards for the protection of electronic protected health information.

361A pharmacist may be subject to disciplinary action for acts of the authorized pharmacy technician.

A pharmacist designated as the person responsible for overseeing the pharmacy technician'saccessto suchprogrammaybesubjectsuchprogrammay besubject to disciplinary action for acts of the authorized pharmacy technician.

(13) The provisions of this section shall not apply to any institutional pharmacy or pharmacist's drug room operated by a facility, licensed underPublic sectionAct 19a-495No. and regulations adopted pursuant to said section 19a-495, that dispenses or administers directly to a patient an opioid agonist for treatment of a substance use disorder, unless the patient has signed a consent to disclose the patient's records to a prescription drug monitoring program that is compliant with 42 CFR 2 Subpart B.

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895 under section 19a-495 and regulations adopted pursuant to said section 19a-495, that dispenses or administers directly to a patient an opioid agonist for treatment of a substance use disorder, unless the patient has signed a consent to disclose the patient's records to a prescription drug monitoring program that is compliant with 42 CFR 2 Subpart B.

If consent is withdrawn by the patient, the sSB895institutional /pharmacy Fileor No.pharmacist's drug room operated by a facility shall immediately discontinue disclosing information about the specific patient who withdrew consent.

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361 institutional pharmacy or pharmacist's drug room operated by a facility shall immediately discontinue disclosing information about the specific patient who withdrew consent.

(16) Each pharmacy, nonresident pharmacy, as defined in section 20- 627,outpatientpharmacyinahospitalorinstitution,anddispensershall report to the commissioner, at least daily, by electronic means or, if a pharmacy or outpatient pharmacy does not maintain records electronically, in a format approved by the commissioner information for all insulin drugs, glucagon drugs, diabetes devices and diabetic ketoacidosisPublic devicesAct prescribedNo. and dispensed by such pharmacy or outpatient pharmacy, except suchreporting requirement shallnot apply to any veterinarian, licensed under chapter 384, who dispenses insulin drugs, glucagon drugs, diabetes devices and diabetic ketoacidosis devices for animal patients.

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895 ketoacidosis devices prescribed and dispensed by such pharmacy or outpatient pharmacy, except suchreporting requirement shallnot apply to any veterinarian, licensed under chapter 384, who dispenses insulin drugs, glucagon drugs, diabetes devices and diabetic ketoacidosis devices for animal patients.

For the purposes of this sSB895subdivision, /"insulin Filedrug", No."glucagon drug", "diabetes devices" and "diabetic ketoacidosis device" have the same meanings as provided in section 20-616.

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361 subdivision, "insulin drug", "glucagon drug", "diabetes devices" and "diabetic ketoacidosis device" have the same meanings as provided in section 20-616.

(A) A retail pharmacy or a pharmacy within a licensed hospital that supplies to another such pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or V controlled substance normally stocked by such pharmacies to provide forPublic theAct immediate needs of a patient pursuant to a prescription or medication order of an authorized practitioner, (B) a pharmacy within a licensed hospital that supplies drugs to another hospital or an authorizedpractitionerfor researchpurposes, (C)aretailpharmacy that supplies a limited quantity of a noncontrolled drug or of a schedule II, III, IV or V controlled substance for emergency stock to a practitioner who is a medical director of a chronic and convalescent nursing home, of a rest home with nursing supervision or of a state correctional institution, and (D) a pharmacy within a licensed hospital that contains another hospital wholly within its physical structure that supplies to suchcontainedhospitalaquantityofanoncontrolleddrugor aschedule II, III, IV, or V controlled substance normally stocked by such hospitals sSB895 / File No.

36121-192 1920 sSB895of File23 Substitute Senate Bill No.

361895 for the immediate needs of a patient pursuant to a prescription or medication order of an authorized practitioner, (B) a pharmacy within a licensed hospital that supplies drugs to another hospital or an authorizedpractitionerfor researchpurposes, (C)aretailpharmacy that supplies a limited quantity of a noncontrolled drug or of a schedule II, III, IV or V controlled substance for emergency stock to a practitioner who is a medical director of a chronic and convalescent nursing home, of a rest home with nursing supervision or of a state correctional institution, and (D) a pharmacy within a licensed hospital that contains another hospital wholly within its physical structure that supplies to suchcontainedhospitala quantityofanoncontrolleddrugor aschedule II, III, IV, or V controlled substance normally stocked by such hospitals to provide for the needs of a patient, pursuant to a prescription or medication order of an authorized practitioner, receiving inpatient care on a unit that is operated by the contained hospital shall not be deemed a wholesaler under this section;

(k)IfPublic itAct isaNo. legenddrug, asdefined in subdivision [(14)] (16)of section 20-571, as amended by this act, that is not administered, dispensed, prescribed or otherwise possessed or distributed in accordance with federal and state laws and regulations;

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895 (k)If it isa legenddrug, asdefined in subdivision [(14)] (16)of section 20-571, as amended by this act, that is not administered, dispensed, prescribed or otherwise possessed or distributed in accordance with federal and state laws and regulations;

Existing regulations shall continue in effect unless superseded by action sSB895of /said Filecommissioner No.pursuant to this subsection.

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361 of said commissioner pursuant to this subsection.

Each individual health insurance policy providing coverage of the typespecifiedinsubdivisions(1),(2),(4),(6),(10),(11)and(12)ofsection 38a-469, delivered, issued for delivery, renewed, amended or continued in this state shall provide coverage for hypodermic needles or syringes prescribed by a prescribing practitioner, as defined in subdivision [(24)] (28) of section 20-571, as amended by this act, for the purpose of administering medications for medical conditions, provided such medicationsPublic areAct coveredNo. under the policy.

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895 medications are covered under the policy.

sSB895Sec. / File No.

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361 Sec.

ThisApproved actJuly shall13, take2021 effectPublic asAct followsNo. and shall amend the following sections:

Section21-192 123 fromof passage23 20-571 Sec.

2 from passage New section Sec.

3 from passage 21a-65 Sec.

4 from passage 20-631 Sec.

5 from passage 21a-254(j) Sec.

6 from passage 21a-70(a) Sec.

7 from passage 21a-106(k) Sec.

8 from passage 21a-115(e) Sec.

9 from passage 21a-249(j) Sec.

10 from passage 38a-492a Sec.

11 from passage 38a-518a Sec.

12 from passage 53a-13(b)(1) GL Joint Favorable Subst.

sSB895 / File No.

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361 The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose.

In general, fiscal impacts are based upon a variety of informational sources, including the analyst’s professional knowledge.

Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

OFA Fiscal Note State Impact:

Agency Affected Fund-Effect FY 22 $ FY 23 $ Consumer Protection, Dept.

GF - Cost Up to None 200,000 Note:

GF=General Fund Municipal Impact:

None Explanation The bill requires opioid agonists for the treatment of a substance use disorder to be uploaded to the Prescription Drug Monitoring Program (PDMP) resulting in a cost of up to $200,000 in FY 22.

The cost is for the vendorto makeprogrammaticchangesto thePDMPso thedatabase can collect the data required by the bill.

The Out Years None.

sSB895 / File No.

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361 OLR Bill Analysis sSB 895 AN ACT CONCERNING CHANGES TO VARIOUS PHARMACY STATUTES.

SUMMARY This bill makes several unrelated changes concerning pharmacy practice, including:

1.

allowing long-term care pharmacies to use automated prescription dispensing machines in nursing homes (§§ 1 & 2);

2.

making minor changes to the law on collaborative drug therapy agreements between pharmacists and practitioners (§§ 1 & 4);

3.

authorizing registered syringe service programs, with Department of Consumer Protection (DCP) approval, to use secure machines to provide patients with clean needles and syringes (§ 3);

4.

requiring dispensed opioid agonists for treatment of a substance use disorder to be uploaded into the electronic Prescription Drug Monitoring Program’s (PMP) database (§ 5);

and 5.

exempting veterinarians from reporting to the PMP database dispensed diabetes drugs and devices (§ 5).

The bill also makes minor, technical, and conforming changes.

EFFECTIVE DATE:

Upon passage §§ 1 & 2 — PRESCRIPTION DISPENSING MACHINES This bill allows licensed long-term care pharmacies to use “automated prescription dispensing machines” in nursing homes.

sSB895 / File No.

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361 These are machines and associated software operated by a licensed state pharmacy or registered nonresident pharmacy through which the operators, based on a verified prescription, package and label patient- specific medications that are dispensed by the machine.

A registered nurse or a licensed practical nurse must administer the dispensed medication packets.

The bill requires the DCP commissioner to adopt regulations concerning these machines but specifies that they may be operated before then if DCP approves the operational protocol in writing.

Machines must be operated in compliance with the regulations, once they are adopted.

The fee to operate a machine is $100 per machine per year.

§§ 1 & 4 — COLLABORATIVE DRUG THERAPY MANAGEMENT AGREEMENTS By law, certain pharmacists may enter into written protocol-based collaborative drug therapy agreements with physicians or advanced practice registered nurses (providers) to manage a patient’s drug therapy.

These agreements can authorize a pharmacist to implement, modify, or discontinue a drug therapy the provider prescribes;

order associatedlabtests;andadministerdrugs.Eachagreementmust contain detailed direction concerning the pharmacist’s permitted actions.

The bill specifies that (1) a pharmacist is also authorized to continue or deprescribe a drug therapy and (2) agreements may include guideline-directed management, rather than be patient-specific.

The bill also allows an agreement to specifically address issues that may arise during medication reconciliation and concerns related to polypharmacy.

The bill replaces current law’s requirement that a pharmacist update thepatient’sprovideratleastevery30dayswitharequirementthatthey report any encounters within the agreement’s scope within 30 days, or document it in a shared medical record.

Definitions sSB895 / File No.

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361 The bill defines “deprescribing” as the systematic process of identifying and discontinuing drugs when existing or potential harms outweigh existing or potential benefits in the context of an individual patient’s care goals, current functioning level, life expectancy, values, and preferences.

“Medication reconciliation” is the process of comparing a patient’s prescribed medications with newly ordered medications, to address duplication, omissions, and interactions.

“Polypharmacy” is a patient’s use of multiple drugs, including medication that is inappropriate or not medically necessary, such as medications that are ineffective, duplicative, or not indicated.

§ 3 — SECURE SYRINGE DISPENSING MACHINES The bill authorizes registered syringe service programs, after receiving DCP approval, to use secure, immobile machines to provide patients with up to 10 hypodermic needles and syringes (“needles”) at a time.

(Syringe service programs,overseenbytheDepartmentofPublic Health, provide needle and syringe exchange services to intravenous drug users in communities impacted by HIV or hepatitis C.) The machines must prevent unauthorized access and dispense only to patients using a patient-specific access number, personalized magnetic strip card, or another technology that identifies individual patients.

Machines must store needles as recommended by the manufacturer, unless the machines can provide adequate environmental controls.

Machines must be equipped with a locked used needle disposal container, or one must be available near the machine.

Only authorized program staff may collect and dispose of used needles.

When dispensing needles, the machine must also give information on accessing treatment services.

§ 5 — PMP DATABASE Opioid Agonists sSB895 / File No.

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361 Under certain conditions, the bill requires opioid agonists for treatment of a substance use disorder (e.g., methadone) to be uploaded into the PMP database (see BACKGROUND).

The requirement applies to the currently exempt substance abuse treatment-related opioid agonist dispensers and administrators (including federal Substance Abuse and Mental Health Services Administration-certified substance use disorder clinics) when the patient has consented to disclosure and it complies with federal substance abuse confidentiality regulations.

Under the bill, signed consent forms must be available, upon request, to DCP for review.

If a patient withdraws consent, opioid agonist information related to that patient must no longer be uploaded to the PMP.

Veterinary Diabetes Drugs and Devices The bill eliminates a requirement that veterinarians upload to the PMP database or report to DCP information on dispensed animal patient (1) insulin and glucagon drugs and (2) diabetes and diabetic ketoacidosis devices.

BACKGROUND PMP The PMP collects prescription data on most controlled substances (i.e., Schedule II-V) into a centralized online database to prevent improper or illegal drug use or improper prescribing.

As prescribing practitioners, veterinarians who dispense controlled substance prescriptions must submit information on the dispensed substance to the PMP.

COMMITTEE ACTION General Law Committee Joint Favorable Substitute Yea 18 Nay 0 (03/23/2021) sSB895 / File No.

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