Ariz. Admin. Code § 4-23-411

Current through Register Vol. 30, No. 24, June 14, 2024

Section R4-23-411 - Pharmacist-administered or Intern-administered Immunizations

A. Authorization to administer immunizations, vaccines, and emergency medications, as defined at A.R.S. § 32-1974(N), to an eligible adult patient or eligible minor patient. As used in this Section, "eligible adult patient" means an eligible patient 13 years of age or older and "eligible minor patient" means an eligible patient at least three years of age but less than 13 years of age. A pharmacist or an intern in the presence of and under the immediate personal supervision of a pharmacist may administer, without a prescription, immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient, if:

1. Both the pharmacist and intern meet the qualifications and standards specified by A.R.S. § 32-1974 and this Section;

2. The Board authorizes both the pharmacist and intern as specified in subsection (D);

3. For an eligible adult patient, the immunization or vaccine is:

a. Recommended for adults by the United States Centers for Disease Control and Prevention; or

b. Recommended by the United States Centers for Disease Control and Prevention's Health Information for International Travel;

4. For an eligible adult patient, the immunization or vaccine is not on the Arizona Department of Health Services list specified in A.A.C. R9-6-1301 as required under A.R.S. § 32-1974(I);

5. For an eligible minor patient, the immunization or vaccine is for influenza or a booster dose as described under A.R.S. § 32-1974(B)(2); and

6. For an eligible minor patient, any immunizations or vaccines other than influenza or a booster dose as described under A.R.S. § 32-1974(B)(2) are administered in response to a public health emergency declared by the Governor under A.R.S. § 36-787.

B. A pharmacist or an intern in the presence of and under the immediate personal supervision of a pharmacist, may administer, with a prescription, any immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient, if:

1. Both the pharmacist and intern meet the qualifications and standards specified by A.R.S. § 32-1974 and this Section; and

2. The Board authorizes both the pharmacist and intern as specified in subsection (D).

C. A pharmacist or intern who is authorized to administer immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient shall:

1. Not delegate the authority to any other pharmacist, intern, or employee not specifically authorized by rule; and

2. Maintain their current certificate for inspection by the Board or its designee or review by the public.

D. Qualifications to administer immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient. After receipt of a completed application form, the Board shall authorize the administration of immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient by a pharmacist or intern who meets the following qualifications:

1. Has a current license to practice pharmacy in this state,

2. Successfully completes a training program specified in subsection (E), and

3. Has a current certificate in basic cardiopulmonary resuscitation.

E. Immunizations training program requirements. A training program for pharmacists or interns to administer immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient shall include the following courses of study:

1. Basic immunology and the human immune response;

2. Mechanics of immunity, adverse effects, dose, and administration schedule of available vaccines;

3. Response to an emergency situation as a result of the administration of an immunization, vaccine, or medication including administering an emergency medication to counteract the adverse effects of the immunization, vaccine, or medication given;

4. Administration of intramuscular injections;

5. Other immunization administration methods; and

6. Recordkeeping and reporting requirements specified in subsection (F).

F. Recordkeeping and reporting requirements.

1. A pharmacist or intern authorized under this Section to administer immunizations, vaccines, and emergency medications to an eligible patient shall provide to the pharmacy the following information and documentation regarding each immunization, vaccine, or emergency medication administered:

a. The name, address, and date of birth of the patient;

b. The date of administration and site of injection;

c. The name, dose, manufacturer's lot number, and expiration date of the vaccine, immunization, or emergency medication;

d. The name and address of the patient's identified primary-care provider or physician;

e. The name of the pharmacist or intern administering the immunization, vaccine, or emergency medication;

f. A record of the pharmacist's or intern's consultation with the patient determining that the patient is an eligible patient as defined in R4-23-110;

g. Consultation or other professional information provided to the patient by the pharmacist or intern;

h. The name and date of the immunization or vaccine information sheet provided to the patient; and

i. For an immunization or vaccine given to an eligible minor patient, a consent form signed by the minor's parent or guardian.

2. As required under A.R.S. § 32-1974(F)(1), the pharmacist or intern shall provide a written or electronic report to the patient's primary-care provider or physician containing the documentation required in subsection (F)(1)(a) through (d). The pharmacy shall document the time and date the report is sent and make the record of compliance with this subsection available in the pharmacy or on request, within 72 hours, for inspection by the Board or its designee.

3. A pharmacy's pharmacist-in-charge or permittee shall maintain the records required in subsection (F)(1) in the pharmacy or database for a minimum of seven years from the administration date.

G. Confidentiality of records. A pharmacist, intern, pharmacy permittee, or pharmacist-in-charge shall comply with applicable state and federal privacy statutes and rules when releasing patient health information.

H. Pharmacist-administered or intern-administered adult immunizations that require a prescription order. A pharmacist or intern authorized by the Board to administer adult immunizations or vaccines shall not administer any immunization or vaccine listed in A.A.C. R9-6-1301 without a prescription order. In addition to filing a prescription order as required in A.R.S. § 32-1964, a pharmacist or pharmacy intern who administers an immunization or vaccine listed in A.A.C. R9-6-1301 shall comply with the recordkeeping requirements of subsection (F)(1).

Ariz. Admin. Code § R4-23-411

New Section made by final rulemaking at 10 A.A.R. 3967, effective November 13, 2004 (Supp. 04-3). Amended by final rulemaking at 12 A.A.R. 279, effective March 11, 2006 (Supp. 06-1). Amended by final rulemaking at 14 A.A.R. 3674, effective November 8, 2008 (Supp. 08-3). Amended by final rulemaking at 15 A.A.R. 1930, effective November 3, 2009 (Supp. 09-4). Amended by final rulemaking at 17 A.A.R. 2596, effective February 4, 2012 (Supp. 11-4). Amended by final rulemaking at 23 A.A.R. 211, effective 3/5/2017. Amended by final rulemaking at 25 A.A.R. 1015, effective 6/1/2019. Amended by final rulemaking at 26 A.A.R. 223, effective 3/14/2020. Amended by final rulemaking at 28 A.A.R. 994, effective 7/2/2022.