Health-e (Cape Town)

7 June 2012

South Africa: Tenofovir Shortage Almost Over

The national health department has contracted additional pharmaceutical manufacturers to make up the critical shortage of the antiretroviral tenofovir across the country.

HIV clinicians and doctors warned last week that the continued stock out of tenofovir and the failure to advise health workers on how to deal with it was a looming disaster.

Reports of stock outs go as far back as October last year with the explanation given that the drug suppliers Aspen Pharmacare and Sonke Pharmaceuticals were not able to meet the demand once they were awarded the tender.

It emerged this week that the national health department had directed provinces to order tenofovir from two additional suppliers.

Dr Anban Pillay, Cluster Manager for Financial Planning and Health Economics in the national health department, confirmed that Adcock Ingram Pharmaceuticals as well as Cipla Medpro Pharmaceuticals were now also supplying tenofovir to provinces.

"The procurement rules allow that. Obviously, there's a good reason for it. The current suppliers are not able to keep up with the total need. So, for the balance they are allowed to go out and get it from other suppliers," Pillay explained.

Aspen Pharmacare and Sonke Pharmaceuticals were initially contracted to supply tenofovir to the public sector antiretroviral programme, but they have struggled to meet the demand.

"The split between Aspen Pharmacare and Sonke is a 70 30 split, meaning that 70% of the volume goes to Aspen and 30% to Sonke. Unfortunately, Sonke hasn't been able to ramp up its production to the level that is required to meet the demand," said Pillay.

The national health department estimates that tenofovir is dispensed to about 1.2 million patients every month.

Aspen Pharmacare was only able to increase its production to the 70 per cent tender requirement in recent weeks. With Sonke Pharmaceuticals not being able to supply its quota of the tender, the supplies from Aspen Pharmacare were not sufficient to serve all patients on tenofovir, resulting in the shortage.

Pillay said the production of the drug has now started to improve with Aspen Pharmacare able to ramp up its production since April now providing over one million units of Tenofovir a month.

Sonke, however is still unable to make a significant contribution.

"That facility is able to produce around 200 000 units per month. The operation is very small and that unit is not able to go beyond that. I cannot confirm exactly what they've been supplying. It's more difficult to get a sense from Sonke of what their actual supplies have been on a month on month (basis). But Aspen's been far more efficient at providing us with information. What I know is that Sonke can provide us with about 200 000 maximum in a month," said Pillay.

Stavros Nicolauou of Aspen Pharmacare said the company was committed to meeting the increased demand.

"We were servicing 250 000 patients in a month. That increased in December quite dramatically to around 800 000 patients. Tenofovir has ramped up in its present form to around 1.1 (million) to 1.2 million patient treatments per month. And I can tell you that Aspen is only required to supply 70% of that. So, we should be responsible for around 750 000 to 800 000 packs per month. I can tell you that, for example, this month we will supply almost 1.2 million packs. We are, in fact, over-supplying, according to the requirements right now. We've stepped in where others cannot supply. Now we're supplying the full 1.2 million units a month. The second supplier, who has got the 30% obligation, they don't seem to be fulfilling their 30% commitment," said Nicolaou.

Sotse Segoneco, CEO of Sonke Pharmaceuticals, failed to respond to several requests for comment.

Mark Heywood, Director of SECTION27 and executive member of the Treatment Action Campaign, said the drug manufacturers were not entirely to blame for the shortage of tenofovir with some of the blame aimed at the health department.

"I think the suppliers are part of the problem, but I think there are a number of other factors. One is that the scale of the antiretroviral programme has grown immensely. The figures show us, for example, that in the last calendar year 600 000 people were newly enrolled onto antiretroviral treatment.

"That is phenomenal and it is phenomenally large. So, it means that we have to have a degree of sophistication in monitoring the programme, which we don't have at the moment. And the second is that the Department of Health is custodian of this programme and that means it's custodian of people's lives. They have to have oversight. The problem should be identified before it becomes a problem within the Department of Health and they should find means to address it."

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