Tenofovir shortages endanger lives Living with AIDS # 518
Widespread shortages of the antiretroviral drug, Tenofovir, have been reported since October last year. In all of this time, the problem has still not been fully resolved.
‘We’re hearing reports of shortages of the drug, Tenofovir, both in big urban centres like Johannesburg, but we’re also hearing reports of shortages in out-lying and rural areas such as Zithulele Hospital in the Eastern Cape, parts of Mpumalanga, parts of Limpopo. So, clearly, there is a problem. And, clearly, it’s a problem that needs to be addressed quickly’, says Mark Heywood, an executive member of the Treatment Action Campaign (TAC).
Heywood says the shortage has forced doctors to ration Tenofovir supply to patients and to also switch their treatment and give them a regimen that is not easy to tolerate.
‘Doctors are being put in a very difficult situation where they are either having to give people smaller quantities of the medicine and tell them to come back sooner than would be normal or in some cases they are even having to swop it with another antiretroviral medicine, which it can be swopped with ‘ the drug d4T, but it’s certainly not ideal to do that because d4T is associated with more side-effects’, he says.
This short-term measure has been devised by the Southern African HIV Clinicians’ Society.
‘We, as the Clinicians’ Society, decided to put together clinical guidelines for health care workers to be able to swop out medications. You can safely swop antiretroviral therapy in some patients who’ve got an undetectable viral load and some you can’t. There are some people who have to be on Tenofovir because they have Hepatitis B. That group of patients cannot be swopped out. That’s only about 8% – 10% of the population. The rest of the population can be swopped. If the patient’s got an undetectable viral load, for a month or two, you can change to either AZT or d4T ‘ and that’s quite a safe thing to do in the short term. It’s not ideal, but it’s certainly better than a patient taking only two or no drugs at all’, explains Dr Francesca Conradie, president of the Southern African HIV Clinicians’ Society.
But Conradie says it may well be that clinicians are not following these contingency plan guidelines as the Health Department has not yet ratified them for use.
‘We submitted our document on the clinical changing in about February and it’s still not been ratified by the Department of Health, which means that clinicians on the ground are not able to do it. And that’s a great pity. It’s not good that we’ve run out of Tenofovir, but that we don’t have a plan is a disaster’, she says.
This means that are actually getting drugs that are not complete, which actually means that their treatment is sub-optimal.
‘Sub-optimal treatment in antiretroviral therapy is a disaster. The other two drugs, 3TC and Efavirenz in the regimen have a low barrier to resistance, and it will fail. For the health care system not to be providing drugs or plans when drugs are in stock-outs, is not good’, COnradie adds.
One Johannesburg patient who refused to be named confirmed that her clinic in Mofolo, Soweto, has told patients that it has run short of Tenofovir. She finished her rationed supply of the drug yesterday (Wednesday). She was told to come back this Thursday, that is, today to see if her supply of Tenofovir can be replenished.
Meanwhile, the national Health Department has laid the blame for the problem at the door of drug manufacturers, Aspen Pharmacare and Sonke Pharmaceuticals for failing to produce enough Tenofovir.
‘Tenofovir is procured by the State through a tender system. That tender was awarded in 2010, December and during the period 2011, January ‘ December 2011, we had supply of Tenofovir in addition to the suppliers on tender from the US government. We had donation stock, as we would call it. The USAID donation was going to terminate in December 2011. So, we met with suppliers in November 2011 to highlight the fact that, firstly, the supplies from the USAID donations was going to come to an end and that the additional stock will then have to come from themselves’¦ to alert the suppliers to this so that they could make the necessary preparations to be able to supply this increased volume. Clearly, what happened, though, is that that was not adequate time for them. They could not keep up with the demand’, according to the national Health Department’s Dr Anban Pillay.
But the TAC says the national Health Department is also largely to blame. As the custodian of the AIDS treatment programme it should have been able to have a timeous forecast of the shortage and should have intervened earlier.
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Tenofovir shortages endanger lives Living with AIDS # 518
by khopotsobodibe, Health-e News
May 31, 2012