Part 3, Chapter 7: Manual Appendix C
Purpose
The Indian Health Service (IHS) recognizes the unique circumstances surrounding the use of prophylactic and therapeutic agents for Human Immunodeficiency Virus (HIV). Many different medications and combinations of medications are being evaluated in clinical trials. This document shall establish criteria for the use of these drugs in the Agency.Policy:
The IHS shall, in general, follow the recommendations of the Food and Drug Administration (FDA) in the use of drugs for the treatment of HIV infection and HIV-related illness. This will insure the safety and efficacy of said drugs. The IHS shall monitor both the Federal and private medical communities for developments and innovations in the treatment of HIV-related illness. In view of the rapidly changing nature of AIDS drug treatment, this document will require regular revision. These drugs are intended for patients eligible for IHS services. The patients shall be followed by an IHS provider while receiving AIDS drug therapy.Procedure:
Zidovidine (AZT, Retrovir): This drug shall be available to IHS eligible patients who meet the criteria included in the package insert provided with the medication, i.e., constitutionally ill HIV-seropositive (as verified by Elisa/Western Blot tests from a credible source) individuals with CD4 helper lymphocyte counts of 200 or less. Patients diagnosed as having AIDS related dementia do not need to meet the CD4 count restriction. The use of AZT in any other HIV infected patient not fulfilling the CD4 provision shall be approved by local Pharmacy and Therapeutics and/or HIV committees on a case by case basis. Similarly, the use of any other non-approved or experimental drug or therapy for HIV infected patients, particularly as a prophylactic measure, is not recommended unless by the approval of the committees designated above, again on a case by case basis.As noted above, this is an evolutionary document and will change with progressive knowledge and the results of current and future clinical trials. To obtain information regarding the procedure for obtaining medications for AIDS patients and for clarification of issues in this document, contact the Clinical Support Center at (602) 263-1581.
