Drug Therapy Committee Highlights: April 2003
Volume XIII, Issue 5


Proposed Guidelines for the Management of Chemotherapy-Induced Anemia: Approved for use within DFCI Protocol Only

The Committee was presented with the proposed guidelines for the management of chemotherapy-induced anemia. The guidelines address improving the appropriate utilization of erythropoietin for hematology and oncology patients. The guidelines were developed to outline the appropriate initiation, monitoring, dose escalation and reduction and non-responders in an effort to contain costs of one of the most expensive drugs Partners-wide. The guidelines address the use of erythropoetin and darbepoetin and the appropriate monitoring. It is recommended that hemoglobin responses be assessed at four to six weeks. Responses are generally seen in four weeks with erythropoietin and in six weeks with darbepoetin, taking into account the longer half-life and delayed response of the latter. The recommendations also discuss discontinuing the drug after 12 weeks if there is no hematopoietic response. Additionally, the guidelines address the appropriate utilization of iron products. The Committee approved the guidelines with the following provisions:

  • Remove the darbepoetin 100mcg weekly fixed dosing
  • Implement a POE order template
 
Critical Care Guidelines for the Use of IV Valproate Sodium (Depacon): Approved

The Committee was presented with the updated Critical Care Guidelines for the use of IV valproate sodium (Depacon). The Committee approved the guidelines with no suggested revisions and the new guidelines will be added to the on-line reference.
  Lindane (Kwell): Removed from Formulary

The Committee was presented with a product alert for Lindane (Kwell) from the FDA. The product alert was issued due to the recent number of pediatric deaths associated with repeated applications of Lindane. Lindane is approved for the treatment of scabies and lice as a one-time application only. Permethrin (Nix) is also on Formulary and is indicated for the use in treating scabies and lice. The Committee approved the removal of Lindane from Formulary.
     

Amifostine (Ethyol) Subcutaneous: Approved with restrictions

The Committee was presented with the request to add a subcutaneous route of administration for amifostine for a research protocol and for the use of this agent post-operatively in surgical resection patients with head and neck cancer. Amifostine is an organic thiophosphate cytoprotective agent currently being studied in a DFCI protocol to prevent xerostomia in patients with head and neck cancer receiving radiation therapy. The intravenous formulation is associated with a high incidence of nausea, vomiting, and dose-limiting hypotension. Data suggest that using the subcutaneous formulation may decrease the incidence of adverse events and facilitate the use within the DFCI protocol. The literature correlates efficacy between the SC and IV formulations. The financial impact was discussed due to the high cost ($12,000-$16,000/6 week therapy) and lack of funding for study drug from the company. Most insurance carriers can be billed for the drug expense and the company has agreed to help pay for the drug if the claim is denied. The Committee deferred the addition of amifostine for the use in radiation/oncology due to the lack of positive supportive data. The Committee approved the addition of the subcutaneous route of administration of amifostine to the Formulary with the following provisions:

  • Restricted to use within protocol only
  • Remove the SC option under POE, but leave the IV for use in GYN under COE