Md. Code Regs. 10.34.29.02
Current through Register Vol. 51, No. 22, November 1, 2024
Section 10.34.29.02 - Content of ProtocolA. A protocol shall: (1) Be: (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:(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.Md. Code Regs. 10.34.29.02
Regulation .02 amended effective 43:6 Md. R. 409, eff.3/28/2016