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APPENDIX 1

Collaborative Practice Agreement (CPA) for the Management of Anemia in Malignant Disease with Erythropoiesis Stimulating Agents at Froedtert and the Medical College of Wisconsin Cancer Centers

Operation:

The Wisconsin Medical Practice Act sec 448.03(2)(e) allows pharmacists to practice under a Collaborative Practice Agreement with individual physicians. It is the intent of this document to authorize the pharmacist to work in a collaborative fashion with and under the direct supervision of the physician(s) affiliated with Froedtert and the Medical College of Wisconsin Cancer Centers. The document summarizes guidelines for collaboration between the physician and pharmacist with regard to erythropoiesis stimulating agents (ESA) epoetin alfa (Procrit®) and darbepoetin alfa (Aranesp®). This agreement is voluntary and may be terminated at any time by either party. This document will be reviewed by both parties at least annually.

Objective:

To allow qualified pharmacists, directly involved with patient care at Froedtert and the Medical College of Wisconsin Cancer Centers, to write and sign orders, order laboratory tests, and manage ESA therapy. The authority of the pharmacist to write and sign orders would be subsequent to a first dose initiated by a physician or advanced practice provider (APP).

Goals:

1.  Increase the safe and efficacious use of medications at Froedtert and the Medical College of Wisconsin Cancer Centers.

2.  Standardize the workflow for ESA prescribing, titration, and documentation.

3.  Decrease the workload of physicians and APPs.

Workflow:

  1. The pharmacist’s authority to write and sign orders for epoetin alfa and darbepoetin alfa is subsequent to a physician or APP signed supportive care plan or treatment plan for the Pharmacist CPA for the Management of Anemia in Malignant Disease with Erythropoiesis Stimulating Agents. The provider will order the first ESA dose and the pharmacist will order all subsequent ESA doses.
  2. Epoetin alfa is the preferred ESA agent. Darbepoetin alfa should be reserved for patients who do not tolerate epoetin alfa or who were previously receiving darbepoetin alfa.

3.  The pharmacist reviews the patient’s indication for ESA therapy and laboratory values and uses this information to evaluate if the patient meets the prior to initiation criteria for ESA therapy. If necessary, the pharmacist may order appropriate labs, including hemoglobin (Hb), transferrin saturation (TSAT), ferritin, and erythropoietin level. If therapy is not indicated the pharmacist should contact the ordering provider.

4.  The pharmacist will determine whether the patient has received a transfusion in the last week. If the patient received a transfusion in the last seven days and is below the goal Hb, continue dosing per the guidelines. If the patient received a transfusion in the last seven days and is above the goal Hb, the dose should be held; the patient should follow up in approximately one week for repeat Hb labs and subsequent dosing should resume per the guidelines.

5.  The pharmacist will review the provider’s last chart note to determine whether ESA treatment has been discontinued for the patient. If the note indicates therapy should be discontinued, the provider should be contacted to discontinue the respective ESA treatment plan.

6.  If ESA is to be given or held based on the dosing guidelines, the pharmacist will document the dose, any dose changes, and expected follow-up in an ESA monitoring note.

7.  If ESA is to be discontinued based on the dosing guidelines, the pharmacist will communicate to the provider their recommendation for discontinuation and document the plan in an ESA monitoring note.

8.  The pharmacist may use clinical judgment when a patient does not fit into the protocol or when deemed appropriate.

Guidelines for Therapy:

1)  Therapeutic Use:

  1. Erythropoiesis stimulating agents bind to erythropoietin receptors on bone marrow cells and stimulate proliferation of red blood cell reducing transfusions and increasing hemoglobin levels in anemic patients.

2)  Dosing and Administration:

i.  Refer to the Erythropoiesis Stimulating Agents Medication Use Guideline for the treatment of Anemia in Malignant Disease.

3)  Monitoring:

i.  Baseline labs of Hb, TSAT, ferritin, and erythropoietin levels (in MDS patients) should be obtained at least 10 days prior to initiation of ESA therapy.

ii.  Hb should be obtained at baseline and within 72 hours prior to each subsequent ESA dose. The most recent Hb value should be used for dosing ESA therapy.

iii.  Blood Pressure (BP) should be monitored prior each ESA administration. If the BP is >170/110mmHg the provider will be contacted for further direction.

4)  Discontinuation of Therapy:

i.  Pharmacist will communicate to the provider their recommendation for discontinuation of therapy and document in an ESA monitoring note.

ii.  The physician will discontinue the order.