Department of Health says global shortage to blame for ARV scarcity

The national department of health (DoH) said a global shortage is to blame for the scarcity of second-line antiretroviral (ARV) treatment.

In a statement, the DoH said there is a global shortage of lamivudine which has affected the availability of abacavir/lamivudine and zidovudine/lamivudine.

“Mylan is contracted to supply abacavir/lamivudine and zidovudine/lamivudine however they are affected by the global shortage and cannot supply the entire ordered quantities. Mylan is supplying stock on a weekly basis as it is being produced,” the statement reads.

The supply constraints have led the department to advise 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 stockpiling in any particular facility so that all patients receive treatment.

“Secondly 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 the implementation of the above two measures are unsuccessful and there is no treatment (abacavir/lamivudine and zidovudine/lamivudine) at a facility, the recommended therapeutic alternative is tenofovir (TDF) 300mg/emtricitabine(FTC) 200mg dual formulation tablet, with dose adjustments for renal impairment,” the statement reads.

The DoH said it will be monitoring the situation closely in consultation with provincial departments and will continue to provide updated communication on this matter.

According to the DoH, the majority of patients (over 90%) that are on ARV treatments receive the first-line option, which is a single dose fixed-dose combination of Tenofovir/Emtricitabine/Efavirenz tablet. This first-line treatment is widely available and there is no shortage of this product, the DoH added.

Some patients (6%) are resistant and, or cannot tolerate the first-line regimen and are then put onto the second-line regimen of abacavir/lamivudine or zidovudine/lamivudine. The majority of patients moved to second-line largely due to resistance and not tolerability, the DoH said.

The Democratic Alliance (DA) has said that the Minister of Health, Dr Zweli Mkhize and the DoH did not have a concrete plan to deal with the shortage of the treatment.

DA MP Siviwe Gwarube said following reports of the shortage, the DA wrote to Mkhize, as well as the Health Ombudsman, Professor Malegapuru William Makgoba, to seek clarity on the matter.

Gwarube accused Mkhize of attempting to downplay why health facilities are running low or have simply run out of ARV treatment for patients.

“What is most concerning about the minister’s response, is the seeming avoidance of accepting culpability for the delay in supplying ARV treatments to these health facilities,” Gwarube said.

The DA MP said the party had been reliably informed that, in addition to the supplier, Mylan, being affected by the global shortage, the DoH had delayed awarding the tender to the company.

“This means the scale of the problem could have been avoided, had the department of health acted speedily,” Gwarube said.

The DA said prolonged periods without the treatment could present long-term complications and further resistance for patients.

Gwarube said Mkhize and the DoH’s response to the “crisis” was insufficient.

“The minister’s statement provides no contingency plan to address the shortages in facilities which have run out completely. In addition, there are no assurances to the people of South Africa who rely on this medication on how the department would cushion the blow of a global shortage in times like this, or how his department will put measures in place to ensure there are no delays in the tendering processes going forward.

“Mkhize’s first crisis in office is being handled poorly and those on the receiving end of the service being provided by the Department of Health can ill-afford the lethargic response of his department in moments of crisis.

“I urge the minister to take the country into his confidence and provide leadership on this issue before we find ourselves in a nation-wide ARV treatment stockout disaster.”

(Compiled by Makhosandile Zulu)

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