Senator Martin proposes the following amendment (SR-3988.JG0019S):
Amend the bill, as and if amended, SECTION 1, by deleting Section 40-43-30(73)(f).
Amend the bill further, SECTION 5, by striking Section 40-43-190(A) and inserting:
(A) As used in this section:(1)"gene therapy" means any product that mediates its effects by transcription or translation of transferred genetic material or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms;
(2) "vaccine" means a suspension of attenuated or killed microorganisms, or of antigenic proteins derived from them, that is administered for prevention, amelioration, or treatment of infectious diseases; and
(3) "novel vaccine" means a vaccine which has obtained Emergency Use Authorization by the U.S. Food and Drug Administration (FDA), or which has otherwise not been approved by the FDA, or which has been approved for use by the FDA for less than 5 years. The term "novel vaccine" does not include vaccines for which the contents have only been modified by antigenic subtype to address the most prevalent strain of virus including, but not limited to, the yearly influenza vaccine.
(A)(B)(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.
(e) a pharmacist shall only administer a vaccine to a person less than sixteen years of age if that person's caretaker (with written parental consent), parent, or legal guardian is present at the time the vaccine is administered.
(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)(C) 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 writteninformed 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. For purposes of this section, "informed consent" means a written document that is signed and dated by an individual; or if the individual is a minor, by a parent or legal guardian; or if the individual is incapacitated or without sufficient mental capacity, by a designated health care agent pursuant to a health care power of attorney, that at a minimum includes:
(a) an explanation of the vaccine or treatment that is written in language that is understandable to the average lay person;
(b) a description of the potential risks and benefits resulting from vaccine or treatment, along with a realistic description of the most likely outcome;
(c) a statement acknowledging risks associated with the vaccine or treatment if the vaccine or treatment is an indemnified product as defined in Section 44-1-55(A)(7);
(d) language that clearly indicates that the individual agrees to the administration of the vaccine or treatment, that the individual has had time to thoughtfully and voluntarily accept or decline the vaccine or treatment free from coercion: and
(e) if the vaccine or treatment is an investigational medical product or is made available through an Emergency Use Authorization by the Federal Food and Drug Administration, a statement acknowledging its investigational nature and the civil liability protections afforded it by law.
(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 a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE) which includes, at a minimum, hands-on injection technique and the recognition and treatment of emergency reactions to vaccines; 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) (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.