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

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Ugandaby Richard Hasunira, Prima Kazoora, Aaron Muhinda,Rosette Mutambi, and Beatrice WereThe limited provision of support and care services to PLWHA remains the weakestlink in the national response to the HIV/AIDS epidemic in Uganda. For the mostpart, the provision of such services has been left to the non-governmental sector.The major NGOs providing such services, including TASO, Uganda Cares, and AIM,have helped people access ART, but their capacity is limited.The latest figures from the MoH indicate that the number of people accessing ARTreached 100,000 in the 2006–2007 fiscal year. 1 That is far less than half of theestimated 234,500 who need treatment now. As of October 2007, there were atotal of 212 ART centers across the country.At the accredited centers, ARVs are provided free of charge, but private facilitiescharge for consultation and treatment of OIs. PLWHA also must arrange and payfor their own transport, which can be complicated if not impossible when they livefar from treatment centers. (Transport costs are particularly significant during drugstock-outs, when patients are simply told to “keep checking” or are referred toother, usually more distant centers. Referral for a routine CD4 count test can createa burden: Most up-country districts do not have CD4 count machines; as a result,many patients must travel hundreds of kilometers to obtain such tests.)The ongoing difficulties associated with accessing ART are the primary reasonsbehind the high drop-out rate from treatment.Drug registration processAll pharmaceutical products intended for human use are supposed to be registeredby the National Drug Authority (NDA) before they are sold or used in Uganda.The registration procedures are set out in the guidelines on the Registration ofPharmaceuticals for Human Use in Uganda (revised July 2006).The drug registration process is working relatively well in Uganda. The country hasan elaborate drug registration procedure set out in the guidelines on Registration ofPharmaceuticals for Human Use in Uganda. The only problem is that the process isfairly cumbersome and registration can take as long as six months at a minimum—and that length of time is potentially applicable only when the applicant does not97
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
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Missing the Target #5:Improving AID
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ArgentinaDr. María Lorena Di Giano
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Executive SummaryAt the G8 meeting
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• UN agencies should provide incr
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Price should not be a barrier when
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The Global Fund and UNITAID: The Fu
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The real cost of free treatmentBy a
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Remaining work for asuccessful prog
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DOMINICAN REPUBLICto access rapid t
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DOMINICAN REPUBLICIn Santo Domingo
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ZIMBABWEtreatment, representing 35
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ZIMBABWEAccording to the Medicines
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ZIMBABWEZimbabwe’s application fo
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ZIMBABWENational government• Addr
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RUSSIAMigrantsRussia, with the seco
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a person with HIV will die very qui
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FamiliesIn Kenya, families are the
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INDIA2. Provide pediatric formulati
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Linking nutrition and treatmentBy W
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Most people living with advanced HI
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only available in the capital, Yaou
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ZAMBIAFindings in particular provin
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The DACA for Chadiza District was a
Page 54 and 55: Many health care workers are inadeq
Page 56 and 57: DRUG REGISTRATION BARRIERS & LOGJAM
Page 58 and 59: Country ATV RLPV/rLPV/r(HS)TDFArgen
Page 60 and 61: development and registration. Likew
Page 62 and 63: Capacity issues and delays in the W
Page 64 and 65: Lack of post-approval quality assur
Page 66 and 67: ARV PROCUREMENT, REGISTRATION,AND S
Page 68 and 69: ARGENTINAParallel importingRelating
Page 70 and 71: ARGENTINAAccess to ARVsNo difficult
Page 72 and 73: Viral load tests are available, but
Page 74 and 75: Cambodiaby Mony PenOnly pharmacists
Page 76 and 77: ChinaBy anonymous Missing the Targe
Page 78 and 79: CHINAThe current process for regist
Page 80 and 81: Dominican RepublicBy Eugene Schiff
Page 82 and 83: IndiaBy Abraham KK, Celina D’Cost
Page 84 and 85: MalawiBy Lot Nyirenda and Grace Bon
Page 86 and 87: MALAWIStock-outsAccording to an ext
Page 88 and 89: MoroccoBy Othman MelloukMorocco has
Page 90 and 91: Determine the patent status of all
Page 92 and 93: MOROCCOThe shortage occurred becaus
Page 94 and 95: As of November 2007, the unit cost
Page 96 and 97: NIGERIADiagnostic testsDiagnostic t
Page 98 and 99: The government’s initial inabilit
Page 100 and 101: Increase training and capacity buil
Page 102 and 103: treatment practice. The Minster ann
Page 106 and 107: UGANDAExtracts from the MoH’s rep
Page 108 and 109: ZAMBIAIn gathering this information
Page 110 and 111: However, since manufacturing prices
Page 112 and 113: 105SHORT SUMMARY
Page 114: PAKISTANAccess for marginalized gro
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Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

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