# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 29 — Drug Therapy Management

#### Regulation .02 Content of Protocol.

*COMAR 10.34.29.02*

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.