Regulation .02 Content of Protocol.
Regulation .02 Content of Protocol.LinkCopy Citation
A.
A protocol shall:
(1)
Be:
(a)
Written; and
(b)
Condition or disease-state specific; and
(2)
Contain the following:
(a)
The condition that the protocol is designed to manage;
(b)
A list of medications that may be used under the auspices of the protocol;
(c)
Monitoring parameters including laboratory tests for the:
(i)
Condition; and
(ii)
Medication employed;
(d)
A list of circumstances requiring contact with the authorized prescriber or authorized prescribers who are a party to the prescriber-pharmacist agreement;
(e)
A statement prohibiting substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber unless permitted in the therapy management contract;
(f)
A list of circumstances under which the pharmacist may alter doses, modify the treatment regimen, or switch the agent under the terms of the therapy management contract;
(g)
Information to be documented;
(h)
A listing of provisions within the protocol that may be customized within a therapy management contract; and
(i)
An action plan for situations when the pharmacist encounters a situation that is not addressed in the protocol.
B.
A protocol may authorize:
(1)
The modification, continuation, and discontinuation of drug therapy;
(2)
The ordering of laboratory tests;
(3)
Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and
(4)
For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols.
C.
A protocol may not authorize acts that exceed the scope of practice of the parties to the prescriber-pharmacist agreement.
D.
Technical modifications to the protocol shall be registered with the Board of Pharmacy within 30 days of the technical modification.