A worldwide shortage of an active pharmaceutical ingredient is the reason behind the anti-retroviral (ARV) medication shortfall across the country, Health-e News reports the Health Department has confirmed. The anti-retroviral drug called Lamivudine is currently in short supply globally and this has affected ARVs that contain this ingredient, deputy director general for health regulation and compliance Dr Anban Pillay said.
Lamivudine is separately combined with Abacavir and Zidovudine to make the two combination drugs that are in shortage, which are mainly supplied by international drug manufacturer Mylan under the brand names Dumiva and Zovilam. According to tender documents, Mylan was awarded 53% and 28% of these combination HIV drugs respectively.
This medication is referred to as second-line ARVs which is taken when patients’ bodies have become resistant to the HIV drugs they take after starting treatment for the first time.
The report says this is not the first time Mylan has been blamed for nationwide shortages of essential medicines. In July last year, the pharmaceutical company failed to supply the national health department with oral contraceptives such as Oralcon, Trigestrel and Famynor. Mylan was also a majority, and in some cases, the sole provider of these birth control pills that were stocked out.
According to Pillay, Mylan has continuously miscalculated the amount of second-lined ARVs needed in South African health facilities. “The challenge relates to the capacity of the contracted supplier, Mylan, and their consistent underestimation of the demand. In numerous meetings the supplier was requested to adjust their production plan based on the average monthly demand,” he explained. “However, the supplier has consistently reverted to the demand based on the published tender estimates which are no longer relevant.”
The report says it’s not just life-saving HIV drugs that are currently in the shortfall. Pillay also confirmed there is a short supply of the injectable contraceptive Nur-Isterate because of production problems by pharmaceutical manufacturer Bayer which is the sole manufacturer. “Bayer has been supplying stock but it may not satisfy the demand,” he explained. Nur-Isterate has been in short supply since the new tender for contraceptives was awarded in October 2017.
Pillay said it’s the Health Department’s policy is to ensure that women have uninterrupted access to quality safe contraceptives that allows them to choose which one best suit their personal circumstances. “Currently, the preferred contraceptive method are intrauterine devices which are long-acting contraceptives and are freely available… Nur-Isterate has not been supplied in the ordered quantities – there have been shortages from time to time (but) not a stockout,” said Pillay.
The Health Department only awarded the new tender for the birth control five months later — in late February 2018, Bayer’s head of communications Tasniem Patel is quoted in the report as saying earlier. At the time, the stockouts were blamed on the late tender award which affected Bayer’s production capacity.
Stop Stockouts Project (SSP) said in the report that these stockouts have been unresolved since the second half of last year and the situation has now escalated into a crisis. SSP coordinator Kopano Klaas said the organisation has received numerous calls over the past two months from patients who were not getting their medication at clinics. “The government has been getting the little medication that some (public) health facilities have at the moment from the private pharmacies. They know that this problem is huge but they’re not doing anything in terms of coming up with alternatives,” Klaas said.
The report quotes Pillay as saying that the department helped Mylan to obtain special authorisation from the medicine regulator South African Health Products Regulatory Authority to bring stock into the country in terms of Section 21 of the Medicines Act. “The volumes are just sufficient to meet the demand and alternative suppliers are being engaged.”
Currently, the Treatment Action Campaign (TAC) is conducting inspections in Gauteng and Free State clinics and say the stockouts go beyond just ARVs and contraceptives. “There isn’t even flu vaccines for children. Some clinics don’t have a fix dose combination of ARVs, but it’s not as bad with Dumiva,” Bongani Radebe, the TAC Gauteng deputy chair is quoted in the report as saying. According to Radebe, some clinics are giving patients alternative ARV medication because of the Dumiva. “As TAC we are not encouraging that because the doses of the different ARVs are not the same,” he said.
According to the report, Pillay also said there is enough stock available in the country, but it may not be evenly distributed. The department is working on redistributing excess stock across facilities so that patients don’t go without treatment. He explained: “Mylan has been bringing in stock on a weekly basis. It is anticipated by the end of this month that all orders would be fulfilled.”
But the Democratic Alliance (DA) says that the Minister of Health, Dr Zweli Mkhize and the Health Department do not have a concrete plan to deal with the shortage of the treatment. The Citizen quotes DA MP Siviwe Gwarube as saying that 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.
According to the report, the DA MP said the party had been reliably informed that, in addition to the supplier, Mylan, being affected by the global shortage, the Health Department 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 in the report that 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.”
[link url="https://www.health-e.org.za/2019/06/05/global-ingredient-shortage-caused-arv-stockouts/"]Health-e News report[/link]
[link url="https://citizen.co.za/news/south-africa/health/2141535/department-of-health-excuse-about-arv-scarcity-not-good-enough-says-da/"]The Citizen report[/link]