Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.29 - Drug Therapy Management
Section 10.34.29.02 - Content of Protocol
Universal Citation: MD Code Reg 10.34.29.02
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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