Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

make any mistakes or leave gaps in the drug’s dossier at the time of submissionor is not presenting a drug from an unfamiliar manufacturer. Unfortunately, manyapplicants have been asked for clarifications and additional information, whichconsume valuable time and lead to further delays in processing their applications.There have been such delays in the registration processes of several new ARVs,developments that have led to interruptions in treatment for PLWHA in need.The delays are often caused by incomplete information provided by applicants aswell as the lengthy laboratory analyses required. NDA has been known to deny adrug registration altogether if the samples provided for analysis do not meet therequired quality standards. But even for successfully registered drugs, registrationhas to be renewed upon payment of registration renewal fees payable annually aswell as “retainance” fees payable every three years. Drugs that default on such feesare deregistered.Uganda’s first-line ART regimen, as defined by the National ART Policy, consistsof zidovudine (AZT) or stavudine (d4T) + lamivudine (3TC) + nevirapine (NVP) orefavirenz (EFV). The standard second-line regimen is zidovudine (AZT) + didanosine(ddI) + lopinavir/ritonavir (LPV/r). There is no standard third-line treatment.It should be noted that as of October 2007, the first- and second-line options wereunder review because of the changing nature of HIV and the emergence of newARVs.ARV stock-outsUGANDADrug stock-outs are a growing problem in the delivery of ART in Uganda. The entirecountry has in the recent past experienced shortages of certain drugs. Up-countryART centers in particular have become accustomed to intermittent drug supplies.People on ART have gone without drugs in the districts of Katakwi, Pallisa, Luwero,Soroti, Hoima, and Mityana. In Moroto, people who were on efavirenz were givencotrimoxazole instead for up to four months, even though the latter has neverbeen prescribed to treat HIV. In Nebbi, meanwhile, drug shortages meant thatsome infants went without drugs for several days. At some centers, patients wereswitched back from second-line to first-line treatment even though first-line therapypreviously had failed.Field visits were conducted October 15–19, 2007 as part of the annual NationalHealth Assembly and Joint Review Mission. Researchers found that stock-outs hadoccurred in most districts at one time or another. Between April and September2007, for example, only two out of a sample of seven centers in eastern Ugandadid not experience drug stock-outs. The rest did not have the drugs they needed forbetween 15 to 60 days, according to the MoH’s report on the supervision of ARVsupply chain management for the third quarter of 2007.98