W. Va. Code R. § 11-8-4

Current through Register Vol. XLI, No. 49, December 6, 2024

Section 11-8-4 - Collaborative Pharmacy Practice Agreements

4.1. Collaborative pharmacy practice agreements are voluntarily implemented by practitioners who seek to serve patients with active pharmacist participation in drug therapy management and other related protocols.

4.2. Collaborative pharmacy practice is a collaborative, physician-directed approach which may be utilized after informed consent is received from the patient and recorded in the patient medical record.

4.3. A collaborative pharmacy practice agreement shall establish the pharmacist's scope of practice for purposes of the agreement.

4.4. A pharmacist may not diagnose patients.

4.5. Collaborative pharmacy practice agreements shall be in writing. All pharmacists and physicians who are parties to the agreement shall sign the agreement, and copies of the agreement shall be made available to all individuals collaborating thereunder.

4.6. Collaborating pharmacists shall maintain a copy of the collaborative practice agreement at their place of practice.

4.7. Collaborative practice agreements shall incorporate protocols containing detailed direction concerning the services that collaborating pharmacists may perform for patients and the role of collaborating physicians. The protocols shall, at a minimum, include:

4.7.1. The specific drug or drugs to be managed by the collaborating pharmacist, and the terms and conditions under which drug therapy may be implemented, modified, or discontinued, including:

4.7.1.a. The protocols may authorize implementation or modification of drug dosages based on symptoms or laboratory or patient evaluations defined in the protocol;

4.7.1.b. The protocol shall include information specific to the drugs authorized by the collaborating physician;

4.7.1.c. In instances where drug therapy is discontinued, the pharmacist shall notify the treating physician of the discontinuance within seventy-two hours unless the protocol incorporates a shorter time period for notice;

4.7.1.d. Specific protocols for patients identified by the collaborating physician as having complex medical conditions or comorbidities, one or more of which are under treatment by another medical provider or specialist;

4.7.1.e. The protocol may not authorize the pharmacist to change a controlled substance or to initiate a drug not included in the established protocol.

4.7.2. The conditions and events upon which the pharmacist is required to notify the physician, including but not limited to the need for new prescription orders and reports of the patient's therapeutic response or adverse reaction. All evaluation notes shall be in the patient's medical record within one week of the evaluation and/or drug management change. If there are no drug therapy changes the information shall be provided to the physician within 30 days unless the protocol incorporates a shorter time period for such notice;

4.7.3. The laboratory tests that may be ordered in accordance with drug therapy management, including:

4.7.3.a. Authorization of the collaborating pharmacist to obtain or to conduct specific laboratory tests related to the drug therapy management;

4.7.3.b. The collaborating pharmacist may only obtain the laboratory tests specified in the collaborative pharmacy practice agreement;

4.7.3.c. Laboratories utilized by the pharmacist may be in a pharmacy or pharmacy center; and

4.7.3.d. All laboratory results obtained are to be sent to the physician within forty-eight hours, except that any severely abnormal or critical values shall be sent by the pharmacist to the physician immediately;

4.7.4. The mutually agreed upon patient evaluations the pharmacist may conduct;

4.7.5. The protocol may authorize the pharmacist to monitor specific patient activities;

4.7.6. Procedures for documenting patient informed consent in the patient's medical record;

4.7.7. A provision for the collaborative drug therapy management protocol to be reviewed, updated, and re-executed or discontinued at least every two years;

4.7.8. A description of the method the pharmacist shall use to document the pharmacist's decisions or recommendations for the physician;

4.7.9. Procedures for record keeping, record sharing, and long-term record storage.

4.7.10. Procedures to follow in emergency situations.

4.7.11. A description of the mechanism for the pharmacist and the physician to communicate with each other and for documentation by the pharmacist of the implementation of collaborative drug therapy. Pharmacist visits may not be substituted for physician visits.

4.8. A copy of the protocols set forth in the collaborative pharmacy practice agreement shall be filed in the patient's medical record.

4.9. A collaborating pharmacist may not delegate drug therapy management to anyone other than another collaborating pharmacist that has signed the applicable protocol.

4.10 A collaborating physician may not delegate collaborative drug therapy management to any unlicensed person or licensed person other than another physician, a collaborating physician assistant or a collaborating pharmacist.

W. Va. Code R. § 11-8-4