(1) Prior to initially engaging in collaborative practice, a pharmacist must provide the board with an executed written and electronic copy of the collaborative practice agreement.

(2) The collaborative practice agreement must include:

(a) the identification and signature of individual practitioner(s) authorized to prescribe drugs and responsible for the delegation of drug therapy management;

(i) the practitioner as defined in 37-2-101, MCA, must be licensed in good standing in Montana; and

(ii) the practitioner must be in active practice in the community in which the collaborating pharmacist practices. A request for an exception to this provision must be in writing and will be decided by the board.

(b) the identification and signature of individual pharmacist(s) authorized to dispense drugs and engage in drug therapy management;

(c) the types of drug therapy management decisions that the pharmacist is allowed to make which may include:

(i) a specific description of the types of diseases and drugs involved, and the type of drug therapy management allowed in each case; and

(ii) a specific description of the procedures and methods, decision criteria and plan the pharmacist is to follow.

(d) a detailed description of the procedures and patient activities the pharmacist is to follow in the course of the protocol, including the method for documenting decisions made and a plan or mechanism for communication, feedback and reporting to the practitioner concerning specific decisions made. Documentation shall be recorded within 24 hours following each intervention and may be recorded on the patient medication record, patient medical chart, or a separate log book. Documentation of drug therapy management must be kept as part of the patient's permanent record and shall be considered confidential information;

(e) a method by which adverse events shall be reported to the practitioner;

(f) a method for the practitioner to monitor clinical outcomes and intercede when necessary;

(g) a provision that allows the practitioner to override protocol agreements when necessary;

(h) a provision that allows either party to cancel the agreement by written notification;

(i) the effective date of the protocol. The duration of each protocol shall not exceed one year;

(j) the annual date by which review, renewal, and revision, if necessary, will be accomplished;

(k) the addresses where records of collaborative practice are maintained; and

(l) the process for obtaining the patient's written consent to the collaborative practice agreement.

(3) Patient records shall be maintained by the pharmacist for a minimum of seven years and may be maintained in an automated system pursuant to ARM 24.174.817.

(4) Collaborative practice agreements approved by an institutional committee such as the pharmacy and therapeutics committee and that will be used solely for inpatients are exempt.