Protocol for pharmacists to administer vaccines without order of practitioner; informed consent; records.

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(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 eighteen 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.

(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 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:

(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

(b) completes this course of training described in item (1).

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

(D) 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 for adults and at least thirteen years from the date of the last vaccination for minors.

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

HISTORY: 2010 Act No. 224, Section 1, eff July 1, 2010; 2015 Act No. 29 (S.413), Section 1, eff June 1, 2015; 2020 Act No. 158 (H.4663), Section 1, eff September 28, 2020.

Editor's Note

2020 Act No. 158, Section 2, provides as follows:

"SECTION 2. This act takes effect upon approval by the Governor. The initial recommendation required in Section 40-43-190(A)(2)(b) must be submitted to the Board of Medical Examiners no later than three months after the effective date of this act."

Effect of Amendment

2015 Act No. 29, Section 1, rewrote the section.

2020 Act No. 158, Section 1, in (A)(2), inserted (b) and redesignated former (b) as (c); in (c), substituted "other vaccines" for "a vaccine"; and made a nonsubstantive change.


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