Indicates Matter Stricken

Indicates New Matter

 

Committee Report

February 28, 2024

 

H. 3988

 

Introduced by Reps. Davis, M. M. Smith, B. J. Cox, Pedalino and Forrest

 

S. Printed 02/28/24--H.                                                                       [SEC 3/15/2024 10:31 AM]

Read the first time February 16, 2023

 

________

 

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

To whom was referred a Bill (H. 3988) to amend the South Carolina Code of Laws by amending Section 40-43-30, relating to definitions in the Pharmacy Practice Act, so as to provide additional acts that, 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 40-43-30(73)(e) and (f) and inserting:

           (e) initiation, ordering, and administration of flu and COVID tests. Pharmacists may delegate the task of administering tests provided for in this subsection to a trained pharmacy technician or pharmacy intern, but the pharmacist must perform any interpretation of the results;

           (f) reporting of a person's flu or COVID test results and the referral of that patient for follow-up care to the health care provider identified by the patient or if none is identified, to an appropriate health care provider; or

Amend the bill further, by adding an appropriately numbered SECTION to read:

SECTION X. Section 40-43-40(A) and (B) of the S.C. Code is amended to read:

 

    Section 40-43-40.  (A) There is created the State Board of Pharmacy to be composed of nineten members, appointed by the Governor with advice and consent of the Senate, one of whom must be a lay member from the State at large, one of whom must be a state-certified pharmacy technician from the State at large, one of whom must be a pharmacist from the State at large, and seven of whom must be pharmacists representing each of the seven congressional districts. However, if no hospital pharmacist is selected to represent any of the seven congressional districts, the Governor shall appoint a hospital pharmacist as the pharmacist at large.

    (B) The pharmacist at large, the state-certified pharmacy technician, and the lay member shall serve coterminously with the appointing Governor and until their successors are appointed and qualify. The certified pharmacy technician must be actively engaged as a certified pharmacy technician. The board shall conduct an election to nominate three pharmacists from each congressional district to be submitted to the Governor for consideration for appointment. The Governor shall appoint one pharmacist to represent each congressional district from among the nominees submitted for that district. The election shall provide for participation by all pharmacists currently licensed and residing in the congressional district for which the nomination is being made. The pharmacists must be residents of the congressional district they represent, licensed, in good standing to practice pharmacy in this State, and actively engaged in the practice of pharmacy in this State. The members of the board representing the seven congressional districts shall serve terms of six years and until their successors are appointed and qualify. No member may serve more than two successive terms of office except that a member serving an unexpired term may be reelected and reappointed for two successive terms.

Amend the bill further, SECTION 4, by striking Section 40-43-190(B) and (C) and inserting:

    Section 40-43-190. (A)(1) Upon recommendation of the Joint Pharmacist Administered Vaccines Committee, the Board of Medical Examiners shall determine whether a specific vaccine is appropriate for administration by a pharmacist without a written order or prescription of a practitioner pursuant to this section. If a vaccine is approved, the Board of Medical Examiners shall issue a written protocol for the administration of vaccines by pharmacists without an order or prescription of a practitioner.

       (2) The administration of vaccines as authorized in this section must not be to a person under the age of eighteensixteen years;  provided, however, that:

           (a) the influenza vaccine may be administered to a person twelve years of age or older pursuant to protocol issued by the Board of Medical Examiners;

           (b) the influenza vaccine may be administered to a person under the age of twelve pursuant to protocol issued by the Board of Medical Examiners upon recommendation of the Joint Pharmacist Administered Vaccines Committee;  and

           (c) a pharmacist who has completed the training described in subsection (B)(1) may administer other vaccines approved by the Centers for Disease Control to a person of any age pursuant to a written order or prescription of a practitioner for a specific patient of that practitioner; and

           (d) if the person receiving a vaccine is under the age of eighteen years, a pharmacist must inform the patient and their caregiver of the importance of mental health and routine well care visits with a pediatrician or other licensed primary care provider and refer patients as appropriate.

       (3) The written protocol must further authorize pharmacists to administer without an order or prescription of a practitioner those medications necessary in the treatment of adverse events. These medications must be used only in the treatment of adverse events and must be limited to those delineated within the written protocol.

       (4) The Board of Medical Examiners must issue the written protocol upon its approval of the vaccine for administration pursuant to this section.

       (5) A pharmacist who has completed the training described in subsection (B)(1) may administer a vaccine approved by the Centers for Disease Control pursuant to written order or prescription of a practitioner for a specific patient of that practitioner.

 

    (B) The written protocol must provide that:

       (1) A pharmacist seeking authorization to administer a vaccine approved pursuant to this section shall successfully complete a course of training accredited by the Accreditation Council for Pharmacy Education or a similar health authority or professional body approved by the Board of Pharmacy and the Board of Medical Examiners. Training must comply with current Centers for Disease Control guidelines and must include study materials, hands-on training, and techniques for administering vaccines and must provide instruction and experiential training in the following content areas:

           (a) mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after vaccine administration;

           (b) standards for adult vaccination practices;

           (c) basic immunology and vaccine protection;

           (d) vaccine-preventable diseases;

           (e) recommended vaccination schedules;

           (f) vaccine storage management;

           (g) biohazard waste disposal and sterile techniques;

           (h) informed consent;

           (i) physiology and techniques for vaccine administration;

           (j) prevaccine and postvaccine assessment and counseling;

           (k) vaccination record management;

           (l) management of adverse events, including identification, appropriate response, emergency procedures, documentation, and reporting;

           (m) understanding of vaccine coverage by federal, state, and local entities;

           (n) needle stick management.

       (2) A pharmacist administering vaccinations without an order or prescription of a practitioner pursuant to this section shall:

           (a) obtain the signed written consent of the person being vaccinated or that person's guardian;

           (b) maintain a copy of the vaccine administration in that person's record and provide a copy to the person or the person's guardian;

           (c) notify that person's designated physician or primary care provider of a vaccine administered;

           (d) report administration of all vaccinations to the South Carolina Immunization Registry in compliance with regulations established by the Department of Health and Environmental Control as the department may require;  provided, however, that the phase-in schedule provided in Regulation 61-120 for reporting vaccinations does not apply to vaccinations administered pursuant to this section;

           (e) maintain a current copy of the written protocol at each location at which a vaccination is administered pursuant to this section.

       (3) A pharmacist may not delegate the administration of vaccines to a pharmacy technician or certified pharmacy technician.

       (4) A pharmacy intern or pharmacy technician may administer vaccinations under the direct supervision, as defined in Section 40-43-84(C), of a pharmacist who has completed vaccination training as required by item (1) if the pharmacy intern or pharmacy technician:

           (a) is certified through a basic life support or CPR provider-level course that is jointly approved by the Board of Medical Examiners and the Board of Pharmacy and completes this course of training described in item (1); and

           (b) completes this course of training described in item (1).if a pharmacy technician, the pharmacy technician must be:

               (i) state-certified; or

               (ii) nonstate-certified but administered vaccinations and received training pursuant to the federal Public Readiness and Emergency Preparedness (PREP) Act prior to the effective date of this section and registers with the Board of Pharmacy as an authorized vaccination provider.

       (5) A pharmacist or pharmacy technician administering vaccinations shall, as part of the current continuing education requirements pursuant to Section 40-43-130, complete no less than one hour of continuing education each license year regarding administration of vaccinations.

 

Amend the bill further, SECTION 5, by striking Section 40-43-200 and inserting:

    Section 40-43-200. (A) There is created a Joint Pharmacist Administered Vaccines  Committee as a committee to the Board of Medical Examiners which consists of seven members with experience regarding vaccines. The committee is comprised of two physicians selected by the Board of Medical Examiners, two pharmacists selected by the Board of Pharmacy, and two advanced practice nurse practitioners selected by the Board of Nursing. One member of the Department of Health and Environmental Control designated by the director of the department also shall serve on the committee. Members of the committee may not be compensated for their service on the board and may not receive mileage, per diem, and subsistence as otherwise authorized by law for members of state boards, committees, and commissions.

Amend the bill further, SECTION 5, by striking Section 40-43-200(C) and inserting:

    (C) The committee shall assist and advise the Board of Medical Examiners in determining whether a specific vaccine is appropriate for administration by a pharmacist without a written order or prescription of a practitioner pursuant to Section 40-43-190. For a specific vaccine recommended by the committee to the Board of Medical Examiners, the committee also must submit a proposed written protocol for the purpose of authorizing pharmacists to administer the vaccine as authorized by Section 40-43-190. The committee must submit its initial recommendations to the board no later than four months after the passage of this act, and periodically thereafter as determined by the committee.

Amend the bill further, by striking SECTION 6 and inserting:

SECTION 6.  The Joint Pharmacist Administered Vaccines Committee must submit its initial recommendations to the board no later than four months after the passage of this act, and periodically thereafter as determined by the committee.

 

Renumber sections to conform.

Amend title to conform.

 

S.H. DAVIS for Committee.

 

 

statement of estimated fiscal impact

Explanation of Fiscal Impact

State Expenditure

This bill makes changes to the Pharmacy Practice Act to allow pharmacists to delegate the initiation, ordering, and administration of tests to trained pharmacy technicians and pharmacy interns.  The bill also allows pharmacists to dispense certain drugs without a written order or prescription and provides written protocol requirements related to the dispensing of drugs and devices without a written order.  The bill further lowers the vaccine recipient age from eighteen to twelve for when a pharmacist may administer a vaccine without a written order. Also, the bill authorizes pharmacy technicians who have the required certifications and training to administer vaccinations under the direct supervision of a pharmacist and amends the certification and training requirements for pharmacy interns to administer vaccines.  Further, the bill renames the Joint Pharmacist Administered Vaccines Committee as the Joint Pharmacist Access Committee.  In addition to the existing duties, the committee will also be responsible for the determination of whether a specific drug may be dispensed by a pharmacist without a written order or prescription from a practitioner.

 

LLR indicates that this bill may require an additional two to three joint committee meetings to add the responsibility of determining whether a specific drug may be dispensed without a written order from a practitioner. LLR further indicates that these additional meetings may be held virtually.  However, if a court reporter is needed for the additional meetings, Other Funds expenses would increase by an amount up to $6,300 in FY 2023-24. It is unclear if this expense is a one-time expense or if it will occur annually. Therefore, the expenditure impact on Other Funds of LLR beginning in FY 2024-25 is undetermined.

 

State Revenue

The Board of Pharmacy and the Board of Medical Examiners fall under the Division of Professional and Occupation Licensing.  Proviso 81.3 of the FY 2022-23 Appropriations Act requires LLR to remit annually to the General Fund an amount equal to 10 percent of expenditures unless the board has an overall negative ending cash balance. Therefore, this bill could increase General Fund revenue by an amount up to $630 in FY 2023-24 if a court reporter is needed for the additional meetings. Since it is unclear if the aforementioned expense is a one-time expense or if it will occur annually, the impact on General Fund revenue is undetermined beginning in FY 2024-25.

 

 

Frank A. Rainwater, Executive Director

Revenue and Fiscal Affairs Office

 

________

 

 

 

 

 

 

 

 

 

A bill

 

TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY AMENDING SECTION 40-43-30, RELATING TO DEFINITIONS IN THE PHARMACY PRACTICE ACT, SO AS TO PROVIDE ADDITIONAL ACTS THAT CONSTITUTE THE PRACTICE OF PHARMACY, TO PERMIT THE DELEGATION OF CERTAIN ACTS TO TRAINED PHARMACY TECHNICIANS AND PHARMACY INTERNS, AND TO DEFINE AN ADDITIONAL TERM; BY AMENDING SECTION 40-43-84, RELATING TO PHARMACY INTERNS AND EXTERNS, SO AS TO REMOVE CERTAIN DIRECT SUPERVISION REQUIREMENTS; BY AMENDING SECTION 40-43-190, RELATING TO PROTOCOL FOR PHARMACISTS TO ADMINISTER VACCINES WITHOUT practitioner orders, SO AS TO INCLUDE THE DISPENSATION OF CERTAIN DRUGS AND DEVICES, TO LOWER THE VACCINATION RECIPIENT AGE TO TWELVE YEARS OF AGE, TO AUTHORIZE DIRECTLY SUPERVISED PHARMACY INTERNS TO ADMINISTER CERTAIN VACCINATIONS, AND TO PROVIDE WRITTEN PROTOCOL REQUIREMENTS, AMONG OTHER THINGS; BY AMENDING SECTION 40-43-200, RELATING TO the JOINT PHARMACIST-ADMINISTERED VACCINES COMMITTEE, so as to rename the committee as THE "JOINT PHARMACIST ACCESS COMMITTEE" AND MAKE OTHER CONFORMING CHANGES; AND TO PROVIDE THE PHARMACIST ACCESS COMMITTEE MUST SUBMIT ITS INITIAL RECOMMENDATIONS TO THE BOARD of pharmacy NO LATER THAN FOUR MONTHS AFTER THE PASSAGE OF THIS ACT, AND PERIODICALLY THEREAFTER AS DETERMINED BY THE COMMITTEE.

 

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

 

SECTION 1.  Section 40-43-30(73) of the S.C. Code is amended to read:

 

    (73) "Practice of pharmacy" means the:

           (a) interpretation, evaluation, and dispensing of prescription drug orders in the patient's best interest; 

           (b) participation in drug and device selection, drug administration, prospective drug reviews, and drug or drug-related research; 

           (c) provision of patient counseling and the provision of those acts or services necessary to provide pharmacy care and drug therapy management;  and

           (d) responsibility for compounding and labeling of drugs and devices, (except labeling by a manufacturer, repackager, or distributor or nonprescription drugs and commercially packaged legend drugs and devices) proper and safe storage of drugs and devices and maintenance of proper records for them;  or

           (e) initiation, ordering, and administration of a test, including COVID tests, that is waived under the federal clinical laboratory improvement amendments (CLIA) of 1988 and authorized by the Food and Drug Administration. Pharmacists may delegate the authority to administer tests provided for in this subsection to a trained pharmacy technician or pharmacy intern;

           (f) collection of specimens, notifications, reporting of patient results, and referring patients to other health care providers for follow-up care pursuant to a written joint protocol of the Joint Pharmacy Access Committee; or

           (g) the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, education, management, and control of pharmacy.

 

SECTION 2.  Section 40-43-30 of the S.C. Code is amended by adding:

 

    (93) "Direct supervision" means a pharmacist is readily and immediately available to the person who they are supervising during all professional activities.

 

SECTION 3.  Section 40-43-84(C) of the S.C. Code is amended to read:

 

    (C) An intern/extern may engage in the practice of pharmacy if such activities are under the direct supervision of a licensed pharmacist. A pharmacist must be in continuous personal eye and voice contact with, and actually giving instructions to, the intern/extern during all professional activities throughout the entire period of the internship/externship. The pharmacist shall physically review the prescription drug order and the dispensed product before the product is delivered to the patient or the patient's agent. The pharmacist is responsible for the work of the intern/extern. A pharmacist may not supervise more than one intern at any one time.

    Pharmacy interns/externs shall not be left in sole charge of a prescription department or other approved site at any time. Violation of this may result in cancellation of any and all internship/externship hours toward licensure that may have been accrued by the intern/extern, and may, in the discretion of the board, cause the board after sufficient notice to the pharmacy intern/extern, to revoke or suspend the internship certificate as provided above. The supervising pharmacist or designated pharmacist may also be subject to disciplinary action by the board.

    An applicant for licensure, who is guilty of compounding or dispensing a prescription of a practitioner or selling legend drugs or medicines while not under the supervision of a licensed pharmacist may be refused licensure.

 

SECTION 4.  Section 40-43-190 of the S.C. Code is amended to read:

 

    Section 40-43-190. (A)(1) Upon recommendation of the Joint Pharmacist Administered Vaccines Access Committee, the Board of Medical Examiners shall determine whether a specific vaccine or drug is appropriate for administration or dispensing by a pharmacist without a written order or prescription of a practitioner pursuant to this section. If a vaccine or drug is approved, the Board of Medical Examiners shall issue a written protocol for the administration of vaccines or dispensing of drugs by pharmacists without an order or prescription of a practitioner.

       (2) The administration of vaccines as authorized in this section must not be to a person under the age of eighteentwelve years;  provided, however, that:

           (a) the influenza vaccine may be administered to a person twelve years of age or older pursuant to protocol issued by the Board of Medical Examiners;

           (b) the influenza vaccine may be administered to a person under the age of twelve pursuant to protocol issued by the Board of Medical Examiners upon recommendation of the Joint Pharmacist Administered Vaccines Access Committee;  and

           (c) (b) a pharmacist who has completed the training described in subsection (B)(1) may administer other vaccines approved by the Centers for Disease Control to a person of any age pursuant to a written order or prescription of a practitioner for a specific patient of that practitioner.

       (3) The written protocol must further authorize pharmacists to administer without an order or prescription of a practitioner those medications necessary in the treatment of adverse events. These medications must be used only in the treatment of adverse events and must be limited to those delineated within the written protocol.

       (4) The Board of Medical Examiners must issue the written protocol upon its approval of the vaccine or drug for administration or dispensing pursuant to this section.

       (5) A pharmacist who has completed the training described in subsection (B)(1) may administer a vaccine approved by the Centers for Disease Control pursuant to written order or prescription of a practitioner for a specific patient of that practitioner.

       (6) Dispensing without a written order or prescription under this section is limited to drugs, drug categories, or devices that are:

           (a) dispensed in accordance with the product's federal Food and Drug Administration-approved labeling;

           (b) have a test that is used to guide diagnosis or clinical decision making and are waived under the federal clinical laboratory improvement amendments (CLIA); and

           (c) identified by drug or drug class in the protocol.

    (B) The written protocol for vaccines must provide that:

       (1) A pharmacist seeking authorization to administer a vaccine approved pursuant to this section shall successfully complete a course of training accredited by the Accreditation Council for Pharmacy Education or a similar health authority or professional body approved by the Board of Pharmacy and the Board of Medical ExaminersJoint Pharmacist Access Committee. Training must comply with current Centers for Disease Control guidelines and must include study materials, hands-on training, and techniques for administering vaccines and must provide instruction and experiential training in the following content areas:

           (a) mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after vaccine administration;

           (b) standards for adult vaccination practices;

           (c) basic immunology and vaccine protection;

           (d) vaccine-preventable diseases;

           (e) recommended vaccination schedules;

           (f) vaccine storage management;

           (g) biohazard waste disposal and sterile techniques;

           (h) informed consent;

           (i) physiology and techniques for vaccine administration;

           (j) prevaccine and postvaccine assessment and counseling;

           (k) vaccination record management;

           (l) management of adverse events, including identification, appropriate response, emergency procedures, documentation, and reporting;

           (m) understanding of vaccine coverage by federal, state, and local entities;

           (n) needle stick management.

       (2) A pharmacist administering vaccinations without an order or prescription of a practitioner pursuant to this section shall:

           (a) obtain the signed written consent of the person being vaccinated or that person's guardian;

           (b) maintain a copy of the vaccine administration in that person's record and provide a copy to the person or the person's guardian;

           (c) notify that person's designated physician or primary care provider of a vaccine administered;

           (d) report administration of all vaccinations to the South Carolina Immunization Registry in compliance with regulations established by the Department of Health and Environmental Control as the department may require;  provided, however, that the phase-in schedule provided in Regulation 61-120 for reporting vaccinations does not apply to vaccinations administered pursuant to this section;

           (e) maintain a current copy of the written protocol at each location at which a vaccination is administered pursuant to this section.

       (3) A pharmacist may not delegate the administration of vaccines to a pharmacy technician or certified pharmacy technician.

       (4) A pharmacy intern or pharmacy technician may administer vaccinations under the direct supervision, as defined in Section 40-43-84(C), of a pharmacist who has completed vaccination training as required by item (1) if the pharmacy intern or pharmacy technician:

           (a) is certified through a basic life support or CPR provider-level course that is jointly approved by the Board of Medical Examiners and the Board of Pharmacy;Joint Pharmacy Access Committee  and completes this course of training described in item (1); and

           (b) completes this course of training described in item (1).if a pharmacy technician, the pharmacy technician must be:

               (i) state-certified; or

               (ii) nonstate-certified but administered vaccinations and received training pursuant to the federal Public Readiness and Emergency Preparedness (PREP) Act prior to the effective date of this section and registers with the Board of Pharmacy as an authorized vaccination provider.

       (5) A pharmacist or pharmacy technician administering vaccinations shall, as part of the current continuing education requirements pursuant to Section 40-43-130, complete no less than one hour of continuing education each license year regarding administration of vaccinations.

    (C)   The written protocol for dispensing must provide that:

       (1) a pharmacist seeking authorization to dispense pursuant to this section shall successfully complete a course of training accredited by the Accreditation Council for Pharmacy Education or a similar health authority or professional body approved by the Joint Pharmacist Access Committee; and

       (2) a pharmacist dispensing pursuant to this section without an order or prescription of a practitioner pursuant to this section shall:

           (a) obtain the signed written consent of the patient or the patient's guardian;

           (b) notate the dispensing in the patient's record and provide a copy to the patient or the patient's guardian;

           (c) notify that patient's designated physician or primary care provider of a drug dispensed pursuant to the protocol;

           (d) maintain a current copy of the written protocol at each location at which a drug is dispensed pursuant to this section.

           (e) complete no less than one hour of continuing education regarding the protocol as part of their continuing education requirements each license year.

    (C) (D) Informed consent must be documented in accordance with the written protocol for vaccine administration issued pursuant to this section.

    (D) (E) All records required by this section must be maintained in the pharmacy for a period of at least ten years from the date of the last vaccination or dispensing for adults and at least thirteen years from the date of the last vaccination or dispensing for minors.

    (E) (F) All documentation, records, and copies required by this section may be stored electronically.

 

SECTION 5.  Section 40-43-200 of the S.C. Code is amended to read:

 

    Section 40-43-200. (A) There is created a Joint Pharmacist Administered Vaccines Access Committee as a committee to the Board of Medical Examiners which consists of seven members with experience regarding vaccines. The committee is comprised of two physicians selected by the Board of Medical Examiners, two pharmacists selected by the Board of Pharmacy, and two advanced practice nurse practitioners selected by the Board of Nursing. One member of the Department of Health and Environmental Control designated by the director of the department also shall serve on the committee. Members of the committee may not be compensated for their service on the board and may not receive mileage, per diem, and subsistence as otherwise authorized by law for members of state boards, committees, and commissions.

    (B) The committee shall meet at least once annually and at other times as may be necessary. Five members constitute a quorum for all meetings. At its initial meeting, and at the beginning of each year thereafter, the committee shall elect from its membership a chairperson to serve for a one year term.

    (C) The committee shall assist and advise the Board of Medical Examiners in determining whether a specific vaccine, drug, drug category, or device is appropriate for administration or dispensing by a pharmacist without a written order or prescription of a practitioner pursuant to Section 40-43-190. For a specific vaccine, drug, drug category, or device recommended by the committee to the Board of Medical Examiners, the committee also must submit a corresponding proposed written protocol for the purpose of authorizing pharmacists to administer the vaccine or dispense in accordance with Section 40-43-190. as authorized by Section 40-43-190. The committee must submit its initial recommendations to the board no later than four months after the passage of this act, and periodically thereafter as determined by the committee.

 

SECTION 6.  The Joint Pharmacist Access Committee must submit its initial recommendations to the board no later than four months after the passage of this act, and periodically thereafter as determined by the committee.

 

SECTION 7.  This act takes effect upon approval by the Governor.

----XX----