SUBCHAPTER 32u - Pharmacists vaccinations

 

SECTION .0100 - pharmacists vaccinations

 

21 NCAC 32U .0101          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 North Carolina Medical Board's office and on its website

(www.ncmedboard.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 a 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(r); 90-85.15B;

Emergency Adoption Eff. September 10, 2004;

Temporary Adoption Eff. December 29, 2004;

Eff. November 1, 2005;

Amended Eff. February 1, 2008;

Emergency Amendment Eff. October 9, 2009;

Temporary Amendment Eff. December 29, 2009;

Temporary Amendment Expired on October 12, 2010;

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