(a) Before a
pharmacist or pharmacy technician who holds a national certification or a
pharmacist intern acting under the supervision of a pharmacist may administer a
human vaccine or related emergency medication to a patient who does not have
immunization contraindications as listed by the CDC, FDA, or manufacturer's
package insert, or to a patient under a prescription drug order from a
prescriber, the pharmacist or pharmacy technician who holds a national
certification or pharmacist intern acting under the supervision of a pharmacist
(1) must successfully complete a course
accredited by the ACPE or a comparable course for pediatric, adolescent, and
adult immunization practices;
(2)
must maintain certification and keep documentation in adult and pediatric
cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED)
training;
(3) who has not
administered a vaccine during the past 10 years, must successfully complete a
course set out under (1) of this subsection; and
(b) A pharmacy that administers a human
vaccine or related emergency medication under this section
(1) must stock the following emergency
medications in an emergency medication kit that is separate from the regular
dispensing inventory and that is carried by the pharmacist if providing
off-site immunizations:
(A) oral and
injectable diphenhydramine; and
(B)
adult and pediatric auto-inject epinephrine devices or injectable
epinephrine;
(2) must
maintain a policies and procedures manual detailing the immunization practices
that must be followed; the policies and procedures manual must
(A) designate either the pharmacist-in-charge
or an assigned vaccine coordinator who will be responsible for maintaining the
policies and procedures manual;
(B)
document that the policies and procedures manual has been reviewed and updated
annually;
(C) address how
vaccine-related adverse reactions are to be reported to the CDC's and FDA's
Vaccine Adverse Event Reporting System (VAERS);
(D) address proper vaccine storage, handling,
and maintenance, including maintaining manufacturer-recommended temperatures
during transportation of vaccines;
(E) address proper disposal of used or
contaminated supplies;
(F) contain
a written emergency protocol for handling accidental needlesticks and adverse
reactions, including the administration of related emergency medications;
and
(G) detail how records must be
kept;
(3) must have
access to the CDC's Epidemiology and Prevention of Vaccine-Preventable
Diseases, 14th edition, 2021, adopted by reference, for reference to
routinely used vaccines and the diseases they prevent; and
(4) must display the licensee's certification
of completing an immunization course described in (a)(1) of this
section.
(c) A
pharmacist or pharmacy technician who holds a national certification or a
pharmacist intern acting under the supervision of a pharmacist administering a
human vaccine must
(1) offer the patient or
the patient's agent the current vaccine information statement (VIS) issued by
the CDC for each vaccine administered; and
(d) A pharmacist may independently administer
epinephrine auto-injectors.
(e) A
pharmacist may independently prescribe epinephrine auto-injectors to a person
who has completed an epinephrine auto-injector training program approved by the
board under
AS
17.22.020(b).
(f) Failure to comply with this section
constitutes unprofessional conduct and is a basis for the imposition of
disciplinary sanctions under
AS
08.01.075.
(g) In this section,
(1) "CDC" means the United States Department
of Health and Human Services, Centers for Disease Control and
Prevention;
(2) "FDA" means the
United States Food and Drug Administration.
Notes
12
AAC 52.992
Eff. 7/9/2017,Register
223, October 2017; am 4/3/2020, Register 234; am
5/19/2023,
Register
246, July 2023; am 1/19/2024,
Register
249, April 2024
The Epidemiology and Prevention of Vaccine-Preventable
Diseases, 14th edition, 2021, adopted by reference in 12 AAC 52.992, may be
obtained from the Centers for Disease Control and Prevention Internet website
at https://www.cdc.gov/vaccines/pubs/pinkbook/chapters.html
or at the Department of Commerce, Community, and Economic Development, Division
of Corporations, Business and Professional Licensing, Board of Pharmacy, State
Office Building, 9th Floor, 333 Willoughby Avenue, Juneau, Alaska 99801; phone
(907) 465-2550.
Authority:AS
08.01.075
AS 08.80.030
AS 08.80.116
AS 08.80.168
AS 08.80.261
AS
08.80.480