Or. Admin. Code § 855-115-0305

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-115-0305 - Services: Administration of Vaccines, Drugs, or Devices

(1) In accordance with ORS 689.645 and ORS 689.655, a Pharmacist may administer a vaccine, drug or device as specified in this rule. The Pharmacist must be acting:

(a) Under the direction of or pursuant to a lawful prescription or order issued by a licensed practitioner acting within the scope of the practitioner's practice; or

(b) In accordance with a statewide drug therapy management protocol per OAR 855-115-0345; or

(c) In accordance with a clinical pharmacy agreement or collaborative drug therapy management agreement per OAR 855-115-0315.

(2) A Pharmacist who administers a vaccine, drug or device must:

(a) Prior to administration of an injectable drug or device, receive practical training on the injection site and administration technique that is utilized. For orally administered drugs, training is not required.

(b) Hold active CPR certification issued by the American Heart Association or the American Red Cross or any other equivalent program intended for a healthcare provider that is specific to the age and population receiving the vaccine, drug or device, contains a hands-on training component, and is valid for not more than three years. The most current CPR certification record must be retained according to OAR 855-104-0055;

(c) Ensure that any drug administered to a patient was stored in accordance with the drug storage rules for pharmacies in OAR 855-041-1036;

(d) Observe, monitor, report, and otherwise take appropriate action regarding desired effect, side effect, interaction, and contraindication associated with administering the vaccine, drug or device;

(e) Ensure that vaccine, drug or device administration is documented in the patient's permanent record; and

(f) Ensure records and documents are retained according to OAR 855-104-0055. Records of administration must include but are not limited to:

(A) Patient identifier;

(B) Vaccine, drug or device and strength;

(C) Route and site of administration;

(D) Date and time of administration; and

(E) Pharmacist identifier.

(3) For vaccines only, the requirements in (2) and the following apply, and the Pharmacist who administers or supervises each administration of a vaccine to a patient must:

(a) Complete training that includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The training may include programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college or school of pharmacy, state or local health department programs, training by an appropriately qualified practitioner, or programs approved by the board; and

(b) Make vaccine recommendations;

(c) Select each vaccine to be administered;

(d) Ensure compliance with (1);

(e) Ensure the appropriate Vaccine Information Statement (VIS) is provided to the patient or patient's agent prior to each dose of vaccine.

(f) Perform verification prior to administration that includes but is not limited to:

(A) Prescription order accuracy verification; and

(B) Vaccine product accuracy review;

(g) Advise or counsel on therapeutic values, content, hazards and use of each vaccine;

(h) Manage adverse events;

(i) Report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient;

(j) Verify accuracy and completeness of documentation for vaccine administration;

(k) Ensure all persons administering vaccines under their supervision are appropriately trained and qualified;

(l) Follow the guidance in the Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Toolkit (v. 4/12/2022); and

(m) Have access to a current edition of the CDC reference, "Epidemiology and Prevention of Vaccine-Preventable Diseases" (v. 8/2021);

(4) The Pharmacist may administer a drug or device in conjunction with training the patient or the patient's agent on how to administer or self-administer the drug or device.

(5) Records and documents must be retained according to OAR 855-104-0055.

(6) An appropriately trained and qualified Pharmacist may permit an appropriately trained and qualified:

(a) Intern to perform the same duties as a Pharmacist except as prohibited in OAR 855-120-0150.

(b) Certified Oregon Pharmacy Technician or Pharmacy Technician to conduct the physical act of administering a vaccine in accordance with OAR 855-125-0305.

(7) The appropriately trained and qualified Pharmacist who is supervising an Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician in administering a vaccine must be immediately available to the vaccinator to respond in the case of an adverse reaction and any other issue that may arise.

Or. Admin. Code § 855-115-0305

BP 30-2023, adopt filed 12/19/2023, effective 3/1/2024; BP 18-2024, minor correction filed 03/01/2024, effective 3/1/2024

Statutory/Other Authority: ORS 689.205, 2023 HB 2486 & 2023 HB 2278

Statutes/Other Implemented: ORS 689.655, 2023 HB 2486 & 2023 HB 2278