1. A. A protocol shall:

   1. (1) Be:

      1. (a) Written; and
      2. (b) Condition or disease-state specific; and

   2. (2) Contain the following:

      1. (a) The condition that the protocol is designed to manage;
      2. (b) A list of medications that may be used under the auspices of the protocol;

      3. (c) Monitoring parameters including laboratory tests for the:

         1. (i) Condition; and
         2. (ii) Medication employed;
      4. (d) A list of circumstances requiring contact with the authorized prescriber or authorized prescribers who are a party to the prescriber-pharmacist agreement;
      5. (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;
      6. (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;
      7. (g) Information to be documented;
      8. (h) A listing of provisions within the protocol that may be customized within a therapy management contract; and
      9. (i) An action plan for situations when the pharmacist encounters a situation that is not addressed in the protocol.

2. B. A protocol may authorize:

   1. (1) The modification, continuation, and discontinuation of drug therapy;
   2. (2) The ordering of laboratory tests;
   3. (3) Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and
   4. (4) For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols.
3. C. A protocol may not authorize acts that exceed the scope of practice of the parties to the prescriber-pharmacist agreement.
4. D. Technical modifications to the protocol shall be registered with the Board of Pharmacy within 30 days of the technical modification.

Authority: Health Occupations Article, §§12-6A-01 — 12-6A-10, Annotated Code of Maryland

Effective date: December 11, 2003 (30:24 Md. R. 1742)

Chapter revised effective April 15, 2013 (40:7 Md. R. 611)

Regulation .01B amended effective March 28, 2016 (43:6 Md. R. 409)

Regulation .02 amended effective March 28, 2016 (43:6 Md. R. 409)

Regulation .03 amended effective March 28, 2016 (43:6 Md. R. 409)

Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 409)

Regulation .05 amended effective March 28, 2016 (43:6 Md. R. 409)

Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 409)

Regulation .07 amended effective March 28, 2016 (43:6 Md. R. 409)