2023-2024 Bill 3870 Text of Previous Version (Mar. 29, 2023)

(Text matches printed bills. Document has been reformatted to meet World Wide Web specifications.)

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Committee Report

March 29, 2023

H. 3870

Introduced by Reps. Wooten, Erickson, Caskey, Ballentine, West, Hewitt, Wetmore, Dillard, M. M. Smith and Davis

S. Printed 03/29/23--H.

Read the first time February 02, 2023

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The committee on House Medical, Military, Public and Municipal Affairs

To who was referred a Bill (H. 3870) to amend the South Carolina Code of Laws by adding Section 40-43-72 so as to authorize the permitting and operation of narcotic treatment programs, to establish, etc., respectfully

Report:

That they have duly and carefully considered the same, and recommend that the same do pass with amendment:

Amend the bill, as and if amended, SECTION 1, by striking Section 40-43-72(D)(3) and inserting:

(3) The provisions of Section 40-43-86(A)(12) shall be waived in the NTP to allow practitioners and practitioner agents access to an NTP pharmacy at a time when a pharmacist is not on duty for the purpose of obtaining drugs from the NTP pharmacy's medication safe for administration and retrieving pharmacist-verified take-home doses of narcotics for delivery. The bulk inventory must be secured against access and alteration when the pharmacist is not present.

Renumber sections to conform.

Amend title to conform.

SYLLESTE DAVIS for Committee.

statement of estimated fiscal impact

Explanation of Fiscal Impact

State Expenditure

This bill requires the Board of Pharmacy, which is under the administration of the Department of Labor, Licensing and Regulation (LLR), to issue a narcotic treatment program (NTP) permit to an NTP before methadone or other narcotic treatment medications may be administered, dispensed, or delivered to the NTP. The permit must be inspected annually by the Board of Pharmacy. Further, the bill expands the use of methadone and its salts to include use by NTPs for treatment, maintenance, or detoxification programs as approved by DHEC.

Department of Health and Environmental Control. The bill charges DHEC with additional responsibilities that the agency is able to accomplish by assigning duties among existing staff and by using existing equipment and supplies. Therefore, there is no expenditure impact to DHEC.

Department of Labor, Licensing and Regulation. LLR reports that there are currently about thirty treatment centers in the state and that inspections are performed biennially. This bill specifies that inspections must be performed annually. If the number of centers does not increase considerably, there will be no expenditure impact to the agency. However, if the number of centers increases by more than about thirty, LLR indicates the need for an additional inspector, a vehicle and equipment for the inspector, travel, and IT support due to the increased workload and the increase in the number of inspections. These costs amount to approximately $3,200 in one-time expenses and approximately $145,700 in recurring expenses. Therefore, Other Funds expenditures of LLR could increase by these amounts if the number of treatment centers increases due to the provisions of the bill. If so, the agency will need to request an increase in Other Funds authorization.

State Revenue

This bill requires an NTP to obtain a permit from LLR. The bill does not specify whether a fee may be charged for the permit, but LLR does not expect the agency's Other Funds revenue to increase unless the number of centers increases significantly.

The Board of Pharmacy falls under the Division of Professional and Occupational Licensing. Proviso 81.3 of the FY 2022-23 Appropriations Act requires LLR to remit 10 percent of the board's expenditures to the General Fund annually unless the board has an overall negative ending cash balance. Therefore, if the number of treatment centers increases, General Fund revenue will increase by $14,890 in FY 2023-24 and by $14,570 in each fiscal year thereafter.

Frank A. Rainwater, Executive Director

Revenue and Fiscal Affairs Office

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A bill

TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY ADDING SECTION 40-43-72 SO AS TO AUTHORIZE THE PERMITTING AND OPERATION OF NARCOTIC TREATMENT PROGRAMS, TO ESTABLISH CERTAIN REQUIREMENTS FOR NARCOTIC TREATMENT PROGRAMS AND THEIR ASSOCIATED PHARMACISTS, PRACTITIONERS, AND PRACTITIONER AGENTS, TO REQUIRE THE BOARD OF PHARMACY TO FULFILL CERTAIN OBLIGATIONS, AND FOR OTHER PURPOSES; AND BY AMENDING SECTION 44-53-720, RELATING TO RESTRICTIONS ON USE OF METHADONE, SO AS TO MAKE CONFORMING CHANGES.

Be it enacted by the General Assembly of the State of South Carolina:

SECTION 1. Chapter 43, Title 40 of the S.C. Code is amended by adding:

Section 40-43-72. (A) For purposes of this section:

(1) "Narcotic treatment program" or "NTP" means a program licensed by the Department of Health and Environmental Control that dispenses and administers methadone or other narcotic treatment medications.

(2) "NTP permit" means a permit issued by the South Carolina Board of Pharmacy that governs dispensing and administration of medications in an NTP.

(3) "NTP satellite permit" means a permit issued by the South Carolina Board of Pharmacy that governs dispensing and administration of medication in a mobile component or satellite medication unit operated by a licensed NTP.

(4) "Pharmacist" means an individual licensed as a pharmacist pursuant to Chapter 43.

(5) "Practitioner" means a physician, physician assistant, or advanced practice registered nurse licensed in South Carolina and registered under South Carolina and federal law to prescribe, dispense, and administer opioid drugs.

(6) "Practitioner agent" means a registered nurse or licensed practical nurse supervised by and under the order of a practitioner.

(7) "Stat box" means an additional drug box that contains stock doses of medications prepared by a pharmacist prior to receipt of a patient-specific order from a practitioner.

(B) An NTP shall apply for and must be issued an NTP permit before methadone or other narcotic treatment medications may be administered, dispensed, or delivered at that NTP.

(1) retain a pharmacist-in-charge who, along with the NTP permit holder, shall sign a new or renewal application for an NTP permit. The pharmacist-in-charge must agree in writing to assume the responsibilities of pharmacist-in-charge of the NTP. The NTP permit holder and pharmacist-in-charge shall notify the Board of Pharmacy in writing within ten days of a change of the NTP's pharmacist-in-charge. A designation of an individual as a pharmacist-in-charge or delegation of duties to a pharmacist-in-charge by a holder of an NTP permit does not relieve the permit holder of the NTP permit holder's duties under federal laws or regulations;

(2) be inspected annually by the Board of Pharmacy; and

(3) comply with the security control requirements of 21 C.F.R. Chapter II.

(D)(1)(a) A pharmacist must be physically present at the NTP to dispense drugs for administration and to dispense and label drugs for delivery to patients for at-home use.

(b) A pharmacist is not required to be physically present at the NTP when drugs are administered or delivered to patients for at-home use, provided that the pharmacist-in-charge must be onsite a sufficient amount of time necessary to perform all duties, including those set forth in Section 40-43-86(B)(3). Regulations or guidance of the Board of Pharmacy establishing specific percentages of time or hours during which a pharmacist-in-charge must be physically present at a pharmacy do not apply to the pharmacist-in-charge of an NTP.

(c) The pharmacist-in-charge of an NTP may not be the pharmacist-in-charge for more than two NTP permit holders, which does not include NTP satellite permits.

(2)(a) A practitioner agent may administer and deliver doses of narcotic drugs which have been previously prepared, checked, and labeled with a patient-specific label by a pharmacist.

(b) If a practitioner-ordered dose change is needed immediately, and a pharmacist is not physically present at the NTP, a stat box with properly labeled stock doses may be used to provide immediate service to a patient.

(c) A practitioner agent performing administration and delivery of medications in an NTP is not required to register as a pharmacy technician.

(4) A pharmacist is in compliance with the requirement of patient counseling in Section 40-43-86(L)(1) by ensuring that written directions for use and other information relating to proper utilization of the medication prescribed are included with each new order of medication delivered by the opioid treatment program. The written information must include a telephone number at which the pharmacist may be contacted by patients.

(5) An NTP satellite permit holder is exempt from the requirements of subsections (D)(1) and (D)(2) and may:

(a) facilitate the administration and delivery of take-home doses of narcotic drugs without the presence of a pharmacist so long as the doses are prepared in advance by a pharmacist; and

(b) utilize a stat box.

SECTION 2. Section 44-53-720 of the S.C. Code is amended to read:

Section 44-53-720. Methadone and its salts are restricted to:

(1) use in treatment, maintenance, or detoxification programs as approved by the Department of Health and Environmental Control, including narcotic treatment programs operating pursuant to Section 40-43-72.

(2) dispensing by a hospital for analgesia, pertussis, and detoxification treatment as approved by the Department of Health and Environmental Control.

(3) dispensing by a retail pharmacy for analgesia as provided for by R. 61-4, Section 507.5.

SECTION 3. This act takes effect upon approval by the Governor.

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