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DoH blames ARV supply issues on global shortage

A global shortage of lamivudine, a second line regimen of antiretroviral (ARV) treatment has affected the availability of this ARV in health facilities in the country, the National Department of Health says.
Only 6% of patients are on the second-line regimen as they have developed a resistance or cannot tolerate the first-line regimen and are then put onto the second line regimen of abacavir/lamivudine or zidovudine/ lamivudine,” said department spokesperson Popo Maja. The majority of patients (over 90%) that are on ARV treatment receive the first-line option which is a single dose fixed dose combination of Tenofovir/Emtricitabane/Efavirenz tablet.

The drug cocktail abacavir/lamivudine and zidovudine/ lamivudine is supplied by pharmaceutical company Mylan, but the global shortage means that it can only supply stock on a weekly basis as it is being produced, the department says.

However, the Stop Stockouts Project (SSP), said in a statement earlier this month that the stockouts have been unresolved since the second half of
last year and the situation has now escalated into a crisis. The failure of relevant stakeholders to act swiftly will put scores of lives at risk, it says.

“A supplier responsible for delivery informed us on 29 May 2019 that they have delivered over 1-million additional packs of second-line ARVs, when only 128,000 packs were ordered by National Department of Health late last year. The National Department of Health contends that there should only be approximately 100,000 people on the second line regimen,” says Kopano Klaas, project coordinator at SSP.
"In addition, SSP has been informed that the current second line regimen is in the process of being phased out and will shortly no longer be available as supply has been reduced to 58,000 packs in the new tender. This is very concerning, because while some people may be able to be switched back to first line there are still a significant number of people who will need to continue on the second line.

“We do not know what plan has been put in place for a second line regimen to fill the gap but strongly feel that there needs to be time for manufacturers to build supply or there will be stockouts for the remainder of this, and next year,” said Klaas.


Meanwhile the department says it has advised provincial departments to closely monitor the distribution and rational use of these medicines until the supply is fully restored.“These measures include firstly, the redistribution of stock between facilities so there is no stock piling in any particular facility so that all patients receive treatment,” says Maja.

Secondly, the department has alerted health officials that patients should be dispensed a lower quantity of stock than usual which may include issuing a month’s supply instead of the standard two or three-month supply.

“Our clinicians have been informed that if implementation of the above two measures are unsuccessful and there is no treatment at a facility, the recommended therapeutic alternative is tenofovir (TDF) 300mg/emtricitabane (FTC) 200mg dual formulation tablet, with dose adjustments for renal impairment,” says Maja.
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