As the health department sources alternative drug suppliers, doctors may be forced to make tough decisions with at least five key cancer drugs in short supply.
Charlotte Maxeke Johannesburg Academic Hospital and Pretoria’s Steve Biko Academic Hospital are just two facilities facing drug stock-outs. Both hospitals have confirmed shortages of, for instance, the drug leucovorin used to treat childhood leukaemias and lymphomas (cancer of immune cells called lymphocytes). The drug is one of several cancer treatments that the health department has confirmed are in short supply nationally – largely because of supplier problems, according to department deputy director general for regulation and compliance Anban Pillay.
Pillay says Teva Pharmaceuticals, which supplies the government with leucovorin, has been unable to meet demand for the drug following manufacturing problems at its factory. Similar shortages have also been reported in the United States, according to the US Food and Drug Administration’s website.
Head of paediatric haematology and oncology at Charlotte Maxeke Hospital, Janet Poole, says her department was only informed of the shortage once it had already begun to affect patients.
“The company only sent out a letter when there was nothing,” she says.
“They have done nothing to alleviate the problem and, as far as I am concerned, have had no communications with doctors.”
Teva Pharmaceuticals did not respond to requests for comment.
Drug regulator allows special access to generics amid shortages
South Africa’s national drug regulator, the Medicines Control Council, has now granted permission for an unregistered alternative to leucovorin to be imported to meet public sector demand until supply stabilises.
The Medicines Control Council is taking similar measures on a per-patient basis to provide adult and paediatric cancer patients with the generic version of dexamethasone. Used to treat leukaemia as well as terminal brain tumours, brand name dexamethasone is no longer available after patent holder Merck & Company discontinued production.
No generics of the drug are registered for use in South Africa. It can take up to four years to register a new drug in South Africa due to Medicines Control Council delays, according to a 2016 South African Medical Journal article.
Poole says the council has been slow to respond to special requests for access to dexamethasone.
As failed batches of the leukaemia drug cytarabine and unexpected demand for other cancer drugs mesna and cisplatin continue to fuel stock-outs, the health department is looking to contract more suppliers.
Doctors face tough calls as hospitals go without
In the meantime, oncologists and patient groups are scrambling. Oncologist William Stevens* has just diagnosed a young boy with Hodgkin’s Lymphoma, a type of blood cancer. Stevens can treat the boy, but drug shortages mean his young patient isn’t getting the best care.
“I can’t use my usual treatment protocol because I don’t have [the drug] procarbazine,” says Stevens who works in the public and private sectors.
“We now have to put him on chemotherapy, which is more toxic to the heart. On a personal level, that is difficult because we’re putting him more at risk [of complications].”
The Childhood Cancer Foundation South Africa (CHOC), the Cancer Alliance and the clinician-based South Africa Childhood Cancer Study Group say they wrote to health minister Aaron Motsoaledi about the stock outs about a month ago and have yet to receive a response, according to CHOC spokesperson Zelda Jacobs.
“Most childhood cancers are curable and these are routine drugs,” Jacobs says.
“The potential of not curing the child [given treatment interruptions] means they might die of their cancer when they could have been cured.”
Pillay says all provincial health departments are tasked with ensuring sufficient supplies of cancer drugs are available during on-going shortages. Patients or doctors experiencing a stock out can report it to the department via email [email protected].
*Not his real name