Pharmaceutical company confirms widespread shortage in public hospitals of its antifungal drug amphotericin B, branded as Fungizone
CAPE TOWN — US pharmaceutical company Bristol Meyers Squibb confirmed doctors’ reports of a widespread shortage in South African public hospitals of its antifungal drug amphotericin B, branded as Fungizone.
It is the drug of choice for treating cryptococcal meningitis, as alternatives are less effective or unaffordable to the state. There are no generic versions available in SA.
Drug shortages like this are one of the reasons the government is keen to establish a local pharmaceutical manufacturing base .
The problem is not unique to SA : the US is experiencing shortages of dozens of drugs, according to a list published online by the American Society of Health System Pharmacists.
The US government recently put billions of dollars into re- establishing local vaccine production capacity after it realised it no longer had the capacity to make jabs for anthrax .
Cryptococcal meningitis primarily affects people with advanced HIV. About 7000 cases were reported last year to the National Institute of Communicable Diseases, but the true figure is likely to be higher, Prof Graham Meintjies, an executive committee member of the Southern African HIV Clinicians Society, said.
The standard treatment for cryptococcal meningitis in SA is two weeks of amphotericin B to clear the fungal infection, followed by a year of fluconazole to prevent relapse, he said.
Yesterday Bristol Meyers Squibb’s spokeswoman, Sonia Choi, said the company was "managing a worldwide supply shortage of Fungizone", because two batches of the product had failed to meet its quality standards. "We understand the urgent need for Fungizone in SA and are mobilising resources to ensure the medicine reaches the country. The next shipment of Fungizone is scheduled in SA on July 11; however, we hope to expedite the product availability and should have an update on timing shortly," she said
By yesterday, at least 10 public hospitals had either run out of Fungizone or were about to, according to the Treatment Action Campaign (TAC). The facilities included Helen Joseph, Charlotte Maxeke, GF Jooste, Potchefstroom, Mafikeng, Klerksdorp, Rustenberg, Mitchells Plain, McCord and Cecilia Makiwane.
The drug is used only in hospitals as it must be given intravenously over four to six hours, and may cause kidney failure. There are newer antifungal drugs, which coat amphotericin B in tiny droplets of fat to reduce the risk of kidney damage. But only one of these — AmBisome — is available in SA, and is so expensive the state cannot afford to procure it. A vial of amphotericin B costs R91 in the private sector, and about R30 in the state sector. AmBisome, which is distributed by Key Oncologics, costs R1946 and R1596 per vial in the private and state sectors respectively, according to the TAC.
All South African doctors had at their disposal was fluconazole, which took much longer to clear the infection from a patient’s central nervous system, said Prof Meintjies. The society issued guidelines last week advising hospitals how to manage limited supplies of Fungizone, and appealing to facilities with extra stock to pass it on to those that had run short.