The purpose of the review is to ensure that the donated Diflucan® is used properly for the treatment of cryptococcal meningitis (CM) and esophageal candidiasis (EC) in government programs and institutions. Note: Having Diflucan® registered and obtaining the approval of national authorities are not review criteria but a condition for obtaining the donation.
The reviewer will rank the following areas for accuracy and relevance of information provided by the applicants. The higher the score, the more favorable the review will be.
Expertise and Track Record
It is crucial that the institution has trained health providers and the necessary diagnostic capacity to treat cryptococcal meningitis(CM) and esophageal candidiasis(EC).
The patient data will be reviewed with regard to number of HIV-positive patients and the number of cases of CM and EC in the past 12 months.
Management of HIV-related Conditions
Experience in diagnosing and treating opportunistic infections is very important. Diflucan® is currently used for treating two conditions: CM and EC.
Diagnosis and Treatment of Cryptococcal Meningitis and/or Esophageal Candidiasis
If Diflucan® is being requested for the treatment of CM, the review will focus on whether there are trained doctors, laboratories and equipment for spinal tap tests (or links with institutions that have this). If Diflucan® is only requested for the treatment of EC, the review will investigate whether doctors have been trained and are experienced in the diagnosis and treatment of EC. Specific treatment protocols must be reviewed for appropriateness and validity.
Health Information System and Follow-up
It is very important that an appropriate system exists for recording the cases of CM and EC. The applicant institutions must be able to explain how they will record the cases of CM and EC and how the data will be analyzed.
Distribution/Importation and Inventory Management
The review will assess whether the program or institution has appropriate procedures and experience with clearing shipments from customs and transport of drugs to program sites as well as appropriate warehouse facilities and management for storing the drug.