1. (a) A pharmacist or pharmacy intern authorized by the Board to administer injectable medications, biologicals and immunizations may only do so under either an order or written protocol.

2. (b) The order from a licensed prescriber must be written, received electronically or if received orally be reduced to writing, and contain at a minimum the following:

   1. (1) The identity of the licensed prescriber issuing the order.
   2. (2) The identity of the patient to receive the injection.
   3. (3) The identity of the medication, immunization or vaccine, and dose, to be administered.
   4. (4) The date of the original order and the date or schedule, if any, of each subsequent administration.

3. (c) An authorized pharmacist may enter into a written protocol, either approved by a physician or authorized by the medical staff of an institution, governing the administration of injectable medications, biologicals and immunizations for a specific period of time or purpose. The written protocol may be valid for a time period not to exceed 2 years. The protocol must include the following:

   1. (1) The identity of the participating pharmacist and physician or institution.
   2. (2) The identification of the medication, biological or immunization, which may be administered.
   3. (3) The identity of the patient or groups of patients to receive the authorized injectable medication, biological or immunization.
   4. (4) The identity of the authorized routes and sites of administration allowed.
   5. (5) A provision establishing a course of action the pharmacist shall follow to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions and accidental needle sticks.
   6. (6) A provision establishing a length of time the pharmacist shall observe an individual for adverse events following an injection.
   7. (7) The identity of the location at which the pharmacist may administer the authorized medication, biological or immunization.
   8. (8) Recordkeeping requirements and procedures for notification of administration.
   9. (9) A provision that allows for termination of the protocol at the request of any party to it at any time.

Authority

The provisions of this § 27.404 amended under sections 4(j), 6(k)(1) and (9) and 9.2(a) of the Pharmacy Act (63 P.S. § § 390-4(j), 390-6(k)(1) and (9) and 390-9.2(a)).

Source

The provisions of this § 27.404 adopted June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237; amended July 8, 2022, effective July 9, 2022, 52 Pa.B. 3822. Immediately preceding text appears at serial pages (347437) to (347438).

Cross References

This section cited in 49 Pa. Code § 27.12 (relating to practice of pharmacy and delegation of duties); and 49 Pa. Code § 27.406 (relating to notification requirements).