The Treatment Action Campaign (TAC) says it has found stockouts of Aids medicines, antiretrovirals, at Limpopo health facilities. Groundup reports that the organisation lists 17 health facilities in which essential medicines are lacking. The most commonly missing one has the brand name Dumiva. It contains the antiretrovirals abacavir and lamivudine. It is used to treat many adults who have developed resistance to, or cannot tolerate, other antiretrovirals.
The report says the national Health Department has confirmed that a global shortage of lamivudine has been reported by pharmaceutical company Mylan, which is contracted to supply the health department. The lamivudine shortage has caused stockouts of pills that combine lamivudine with other drugs, including abacavir and zidovudine. But the TAC also found other vital drugs missing at some facilities.
One facility did not have an antiretroviral pill frequently prescribed to new adult patients. This contains the drugs tenofovir, lamivudine emtricitabine and efavirenz. Another did not have stock of the four-drugs-in-one-pill treatment for TB. Some were out of stock of antiretroviral syrups used to treat children with HIV.
Moses Makhomisani, the TAC’s provincial manager, said in the report that his organisation was “seriously concerned” about the shortages, which meant HIV targets might not be met. He was also worried that people may develop resistance or even get sick because of interruptions in their treatment.
Limpopo Health Department spokesperson Neil Shikwambana said there was a shortage of Dumiva in some facilities but the department had rectified the problem last week. When provided with the TAC’s list he said he would contact the facilities to confirm.
The report says Lamivudine is the unsung hero of antiretroviral treatment. It was approved for treating HIV in the US in 1995. It’s cheap, its patent has long ago expired and it very seldom causes serious side effects. It has consistently been part of the ideal initial regimen prescribed to patients.
The causes of global drug shortages are mysterious. The report says accurate, transparent information is hard to come by. Mylan appears to be struggling to source the active ingredient for its lamivudine-containing pills (the active ingredient is lamivudine
itself, but drug companies then have to process it into a useable form).
There are alternatives to it. In recent years emtricitabine, a very similar drug, has become widely used. But the Health Department is expected to soon name a new initial regimen for first-time adult patients containing the three drugs tenofovir, dolutegravir and lamivudine.
The report says for most patients this is the best antiretroviral regimen yet developed; it has few side-effects, it is excellent at suppressing HIV and patients seldom develop resistant HIV strains when using it. It would be a setback to plans to make it widely available if lamivudine is difficult to obtain.
The Health Department had said earlier that it was managing the global shortage of Lamivudine that has affected the availability of this ARV in health facilities across the country. According to an IoL report, the Health Department said 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/Emtricitabine/Efavirenz tablet.
“This first-line treatment is widely available and there is no shortage of this product. Some patients (6%) are resistant/cannot tolerate the first-line regimen and are then put on to the second-line regimen of Abacavir/Lamivudine or Zidovudine/Lamivudine,” department spokesperson Popo Maja is quoted in the report as saying.
According to Maja, the majority of patients are moved to the second-line regimen largely due to resistance and not tolerability. “The global shortage of Lamivudine has affected the availability of Abacavir/Lamivudine and Zidovudine/Lamivudine.”
Maja stated that the pharmaceutical company Mylan was contracted to supply Abacavir/Lamivudine and Zidovudine/Lamivudine. “However, they are affected by the global shortage and cannot supply the entire ordered quantities.” Mylan supplies stock on a weekly basis as it is being produced.
“Due to the current supply constraints, we have 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,” Maja added.
Secondly, the report says 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,” Maja added.
The department said it will continue to monitor the situation closely in consultation with provinces, and will continue to provide updated communication on this matter.