Current through Register Vol. 54, No. 44, November 2, 2024
(a)
Before practicing the management of drug therapy in a non-institutional
setting, a pharmacist shall enter into a written collaborative agreement with a
physician authorizing the management of drug therapy for diseases or for
conditions or symptoms of diseases.
(b) The collaborative agreement must be
between a physician and a pharmacist.
(c) A pharmacist may not provide economic or
other incentives, inducements or benefits to a physician for the purpose of
entering into a collaborative agreement for the management of drug
therapy.
(d) A pharmacist who is
employed by a physician under a collaborative agreement for the purpose of
management of drug therapy may not engage in retail dispensing while in the
health care practice or within the context of employment.
(e) Participation in a collaborative
agreement authorizing the management of drug therapy is voluntary. A physician
or pharmacist is not required to participate.
(f) The collaborative agreement must contain:
(1) A statement identifying the physician
responsible for authorizing the management of drug therapy.
(2) A statement identifying the pharmacist
authorized to perform the 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 within the physician's scope of practice and types of
management of drug therapy authorized.
(5) A statement identifying the terms under
which a pharmacist providing the management of drug therapy is permitted to:
adjust the drug regimen, the drug strength and the frequency of administration
or the route of administration; administer drugs; order laboratory tests; and
order and perform other diagnostic tests necessary in the management of drug
therapy without prior written or oral consent by the collaborating physician.
This paragraph does not provide prescriptive authority to a
pharmacist.
(6) 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, and be recorded in the pharmacist's records.
(7) A statement that requires notification to
the authorizing physician of changes in dose, duration or frequency of
medication prescribed as soon as practicable but no longer than 72 hours after
the change.
(8) A provision for
implementation of the collaborative agreement when a physician or pharmacist
who is a party to the agreement is temporarily unavailable to participate in
its implementation.
(9) 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
collaborative agreement and providing an opportunity for the patient to refuse
management of drug therapy by a pharmacist.
(10) The signatures of the physicians and
pharmacists who are entering into the collaborative agreement and the dates
signed.
(11) A statement allowing
for the termination of the collaborative agreement at the request of a party to
it at any time.
(g) The
collaborative agreement must be available:
(1)
At the practice site of each physician who is a party to the collaborative
agreement.
(2) At the practice site
of each pharmacist who is a party to the collaborative agreement.
(3) To any patient the management of whose
drug therapy is affected by the agreement, upon request of the
patient.
(4) Upon request, to
representatives of the Bureau and the Department of Health.
(h) The collaborative agreement
shall be filed with the Bureau.
(i)
The collaborative agreement must be maintained on the premises of the pharmacy
for review during inspection by or upon request of representatives of the
Bureau and the Department of Health.
(j) The collaborative agreement must be
effective for no more than 2 years from the date of execution. At the end of
the 2-year period, or sooner, the parties shall review the collaborative
agreement and make a determination as to its renewal, necessary modifications
or termination.
(k) A pharmacist
who is party to a collaborative agreement authorizing the management of drug
therapy shall:
(1) Utilize an area for
in-person, telephonic or other approved electronic consultations regarding the
management of drug therapy that ensures the confidentiality of the patient
information being discussed.
(2)
Initiate the management of drug therapy only upon a written referral to the
pharmacist from the physician. The written referral must include the minimum
frequency in which the pharmacist shall conduct the management of the drug
therapy in person.
(3) Confirm that
the physician who is a party to the collaborative agreement holds an active and
unrestricted license and that the terms of the collaborative agreement are
within the scope of the physician's current practice at the time of the
execution of the collaborative agreement.
(l) Patient records regarding the management
of drug therapy may be maintained in a computerized recordkeeping system which
meets the requirements for Federal and State-certified electronic health care
records, subject to the following:
(1) The
pharmacist who is a party to the collaborative agreement shall have access to
the records of the patient who is the recipient of the management of drug
therapy.
(2) The physician who is a
party to the collaborative agreement shall have access to the pharmacy records
of the patient who is the recipient of the management of drug
therapy.
(3) The handling of
patient records by the pharmacist providing the management of drug therapy
shall comply with the Health Insurance Portability and Accountability Act of
1996 (Pub. L. No.
104-191, 110 Stat. 1936), the Health Information
Technology for Economic and Clinical Health Act (Pub. L. No. 111-5,
Div. A, Title XIII, Div. B, Title IV, 123 Stat. 226, 467), and associated rules
and regulations.
