21 NCAC 46 .2507. ADMINISTRATION OF VACCINES BY PHARMACISTS

(a)  An Immunizing Pharmacist shall administer only those vaccines or immunizations permitted by G.S. 90-85.15B and shall do so subject to all requirements of that statute and this Rule.

(b)  The following words and terms, when used in this Rule, have the following meanings:

(1)           "Administer" means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or other means by:

(A)          an Immunizing Pharmacist or a Pharmacy Intern who is under the direct, in-person supervision of an Immunizing Pharmacist; or

(B)          the patient at the direction of either an Immunizing Pharmacist or a health care provider authorized by North Carolina law to prescribe the vaccine.

(2)           "Immunizing Pharmacist" shall have the meaning provided in G.S. 90-85.3(i1).

(3)           "Pharmacy Intern" shall have the meaning provided in 21 NCAC 46 .1317(28).

(4)           "Physician" means an M.D. or D.O. currently licensed with the North Carolina Medical Board who is responsible for the supervision of the Immunizing Pharmacist pursuant to the Written Protocol between the Immunizing Pharmacist and the Physician.

(5)           RESERVED

(6)           RESERVED

(7)           RESERVED

(8)           RESERVED

(9)           RESERVED

(10)         RESERVED

(11)         RESERVED

(12)         "Written Protocol" is a document prepared, signed, and dated by the Physician and Immunizing Pharmacist that shall contain the following:

(A)          the name of the Physician responsible for authorizing the Written Protocol;

(B)          the name of the Immunizing Pharmacist authorized to administer vaccines;

(C)          the immunizations or vaccinations that may be administered by the Immunizing Pharmacist;

(D)          the screening questionnaires and safety procedures that shall at least include the then-current minimum standard screening questionnaire and safety procedures adopted by the Medical Board, the Board of Nursing, and the Board of Pharmacy pursuant to S.L. 2013-246, s. 6, and available at the Board of Pharmacy's office and on its website (www.ncbop.org).

(E)           the procedures to follow, including any drugs required by the Immunizing Pharmacist for treatment of the patient, in the event of an emergency or adverse event following vaccine administration;

(F)           the reporting requirements by the Immunizing Pharmacist to the Physician, including content and time frame; and

(G)          the locations at which the Immunizing Pharmacist may administer immunizations or vaccinations.

The Physician and the Immunizing Pharmacist shall review the Written Protocol at least annually and revise it if necessary.

(c)  An Immunizing Pharmacist who, because of physical disability, is unable to obtain a current provider level CPR certification pursuant to G.S. 90-85.3(i1)(1), may administer vaccines in the presence of a pharmacy technician or pharmacist who holds a current provider level CPR certification.

(d)  With each dose of vaccine, either the Immunizing Pharmacist or a Pharmacy Intern shall give the most current vaccine information regarding the purpose, risks, benefits, and contraindications of the vaccine to the patient or legal representative.  The Immunizing Pharmacist or Pharmacy Intern must ensure that the patient or legal representative has the opportunity to read, or to have read to him or her, the information provided and to have any questions answered prior to administration of the vaccine.

(e)  In agreeing to serve as a supervising Physician, the Physician shall agree to meet the following requirements:

(1)           be responsible for the formulation or approval of the Written Protocol and review the Written Protocol and the services provided to patients under the Written Protocol, as set out in Subparagraph (b)(12) of this Rule;

(2)           be accessible to the Immunizing Pharmacist or be available through direct telecommunication for consultation, assistance, direction, and provide back-up coverage; and

(3)           receive periodic status reports from the Immunizing Pharmacist, including any problems or complications encountered.

(f)  The following requirements pertain to drugs administered by an Immunizing Pharmacist:

(1)           Drugs administered by an Immunizing Pharmacist under the provisions of this Rule shall be in the legal possession of:

(A)          a pharmacy, which shall be the pharmacy responsible for drug accountability, including the maintenance of records of administration of the immunization or vaccination; or

(B)          the Physician, who shall be responsible for drug accountability, including the maintenance of records of administration of the immunization or vaccination;

(2)           Drugs shall be transported and stored at the proper temperatures indicated for each drug;

(3)           Immunizing Pharmacists, while engaged in the administration of vaccines under the Written Protocol, shall have in their custody and control the vaccines identified in the Written Protocol and any other drugs listed in the Written Protocol to treat adverse events; and

(4)           After administering vaccines at a location other than a pharmacy, the Immunizing Pharmacist shall return all unused prescription medications to the pharmacy or Physician responsible for the drugs.

(g)  Record Keeping and Reporting.

(1)           An Immunizing Pharmacist shall maintain the following information, readily retrievable, in the pharmacy records in accordance with the applicable rules and statute regarding each administration:

(A)          the name, address, and date of birth of the patient;

(B)          the date of the administration;

(C)          the administration site of injection (e.g., right arm, left leg, right upper arm);

(D)          route of administration of the vaccine;

(E)           the name, manufacturer, lot number, and expiration date of the vaccine;

(F)           dose administered;

(G)          the name and address of the patient's primary health care provider, as identified by the patient; and

(H)          the name or identifiable initials of the Immunizing Pharmacist.

(2)           An Immunizing Pharmacist shall document the annual review with the Physician of the Written Protocol as required in this Rule.

(3)           An Immunizing Pharmacist shall report adverse events associated with administration of a vaccine to either the prescriber, when administering a vaccine pursuant to G.S. 90-85.15B(a), or the patient's primary care provider, if the patient identifies one, when administering a vaccine pursuant to G.S. 90-85.15B(b).

(h)  The Immunizing Pharmacist shall maintain written policies and procedures for handling and disposal of used or contaminated equipment and supplies.

 

History Note:        Authority G.S. 90-85.3; 90-85.6; 90-85.15B;

Eff. April 1, 2003;

Emergency Amendment Eff. May 11, 2004;

Temporary Amendment approved by RRC October 21, 2004;

Amended Eff. February 1, 2008; November 1, 2005; November 1, 2004;

Emergency Amendment Eff. October 9, 2009;

Temporary Amendment Eff. December 29, 2009;

Amended Eff. September 1, 2014; March 1, 2012.