Current through Register Vol. 54, No. 44, November 2, 2024
(a) The
management of drug therapy under section 9.1 of the act (63 P. S. §
390-9.1) shall be performed under a written
protocol consistent with the institution's assignment of clinical duties.
Ordering of laboratory tests and ordering or performing other diagnostic tests
necessary in the management of drug therapy shall be consistent with the
testing standards of the institution.
(b) The written protocol for management of
drug therapy between physicians and pharmacists must contain:
(1) A statement identifying the physician
responsible for authorizing management of drug therapy.
(2) A statement identifying the pharmacist
authorized to perform management of drug therapy.
(3) A statement requiring that regimens for
the management of drug therapy be initiated by a physician for patients
referred to a pharmacist for management of drug therapy.
(4) A statement identifying the types of
decisions regarding the management of drug therapy that the pharmacist is
authorized to make, including a statement of the ailments or diseases involved
within the physician's scope of practice, and types of management of drug
therapy authorized.
(5) A statement
of the functions and tasks the pharmacist shall follow in the course of
exercising management of drug therapy, including the method for documenting
decisions made and a plan for communication or feedback to the authorizing
physician concerning specific decisions made. Documentation of each
intervention shall occur as soon as practicable, but no later than 72 hours
after the intervention in the patient's medical record and shall also be
recorded in the pharmacist's records.
(6) A statement that requires notification to
the authorizing physician of any changes in dose, duration or frequency of
medication prescribed as soon as practicable but no longer than 72 hours after
the change.
(7) A provision for
implementation of the written protocol when a physician or pharmacist who is a
party to the protocol is temporarily unavailable to participate in its
implementation.
(8) A provision for
notification of the role of the pharmacist by a physician to each referred
patient the management of whose drug therapy may be affected by the written
protocol and providing an opportunity for the patient to refuse management of
drug therapy by a pharmacist.
(9)
The signatures of the physicians and pharmacists who are entering into the
written protocol, and the dates signed.
(10) A statement allowing for the termination
of the written protocol at the request of any party to it at any
time.
(c) The written
protocol must be available as follows:
(1) At
the practice site of each physician who is a party to the written
protocol.
(2) At the practice site
of each pharmacist who is a party to the written protocol.
(3) At the institution where a written
protocol is in place.
(4) To any
patient the management of whose drug therapy is affected by the written
protocol, upon request of the patient.
(5) Upon request, to representatives of the
Bureau and the Department of Health.
(d) The written protocol shall be filed with
the Bureau.
(e) The written
protocol must be effective for a period not to exceed 2 years from the date of
execution. At the end of the 2-year period, or sooner, the parties shall review
the written protocol and make a determination as to its renewal, necessary
modifications or termination.
The provisions of this §27.301 amended under
sections 6(k)(9) and 9.3 of the Pharmacy Act (63 P. S. §§
390-6(k)(9) and
390-9.3).
