/ 12 December 2003

Alarm over Aids drug shortage

There is an urgent need for local suppliers of anti-retrovirals (ARVs), according to people living with HIV/Aids, pharmacies and manufacturer GlaxoSmithKline. This was highlighted by shortages this week in the supply of ARVs to South Africa.

Despite the government’s decision to roll out the provision of ARVs, a lack of planning has meant temporary shortages — and could presage future crises if problems are not dealt with. An interruption in ARV treatment could have serious health consequences for people on a programme of treatment. For instance, a dose missed early can result in strong resistance to the drugs later, making them ineffective. There are no substitutes for ARVs. At present, ARVs are imported.

This week, GlaxoSmithKline lost two batches of 300mg Retrovir (AZT) in transit. The pharmaceutical company’s spokesperson, Vicki Ehrich, described the loss as a ”rare short-term hitch”, but concurred that an alternative local supplier would be helpful.

GlaxoSmithKline, she said, had done its bit by granting a voluntary licence to generic drug manufacturer Aspen Pharmacare for the manufacture and sale of three anti-retrovirals — Epivir (3TC), Retrovir and Combivir — in 2001.

Aspen Pharmacare is, however, still awaiting approval from the Medicines Control Council (MCC) to manufacture the drugs. Linda Philip, chief operating officer of Aspen Group Operations, said Aspen had been ”lobbying hard” to ensure that their dossier containing the pharmaceutical’s work on the drugs is processed by the MCC as soon as possible.

”We are hopeful that there may be some news emerging from the MCC’s meetings scheduled for later this month and in January,” she added.

Aspen submitted its dossier to the MCC in 2002. Philip explained: ”To be fair to the MCC, they have to be very thorough. It is their responsibility to ensure that South Africans have access to medicines which are superior and effective. There are certain unscrupulous people who dump inferior drugs in the African continent. On the other hand, it is urgent to start manufacturing the medicines as soon as possible.”

Inconsistent supply of ARVs could kill people living with HIV/Aids sooner than the disease itself, complained a patient to the Mail & Guardian this week.

The patient, who asked not to be named, said he would have to miss out on his 300mg dose of Retrovir after his pharmacy ran out of its supply. Ehrich pointed out that other strengths of Retrovir were still available and patients could take combinations. The Retrovir dosage is usually a single 300mg tablet twice a day.

The pharmacy in question, which has been providing ARVs at cost price around the country, confirmed the shortage of 300mg Retrovir.

Pharmacies seem to be battling with the ever-increasing demand for ARVs.

According to a recent World Health Organisation and UNAids report, South Africa has the highest number of HIV-infected people in the world — 5,3-million at the end of 2002.

The United Nations agency said: ”Because of South Africa’s relatively recent epidemic, and given current trends, Aids deaths will continue to increase rapidly over the next five years at least; in short, the worst still lies ahead.” About 600 South Africans are believed to die daily of diseases related to the syndrome.

A pharmacist who did not want to be named said her pharmacy was having trouble estimating the demand for the ARVs every month. ”We keep getting new customers and the demand varies — sometimes it goes up by 10%, at times by 20% or even 30%, so it is difficult to estimate what the demand is going to be,” she explained.

Aspen’s Philip, also citing the ever-increasing infection rate in South Africa, underlined the need to nurture a domestic pharmaceutical industry. ”It does help to have the medicines available locally.” Such a factory would also be ”at the MCC’s doorstep to inspect and monitor quality control”.

But Treatment Action Campaign spokesperson Mark Heywood attributed the current shortage to the incompetence of pharmacies and suppliers: ”You can always plan for emergencies.” He said local drug manufacturers could be part of a back-up plan should imported supplies fall short.