Oncologists in Montreal and across Canada are alarmed by a chronic shortage of three essential cancer drugs, and in the case of one of the medications, do not know when it will become available again.
The scarce drugs, all delivered intravenously to patients, are Vinorelbine, approved by Health Canada for non-small lung cancer and metastatic breast cancer; Leucovorin, used to decrease the toxic side effects of two other chemo drugs; and Etoposide for lung cancer, malignant lymphomas and testicular cancer.
Dr. Gerald Batist, director of the Segal Cancer Centre at the Jewish General Hospital, said the lack of Leucovorin is the “tip of the iceberg.”
“It is a drug we commonly use, so its absence is serious,” Batist wrote in an email to the Montreal Gazette. “We are missing an even more important drug in Etoposide for the same reasons and for many months. Last week we learned that another important drug called Vinorelbine is on back order, and a new Canadian producer is being sought.”
The most serious shortage involves Vinorelbine, with no projected date for when supplies will resume.
Two pharmaceutical companies, Pfizer Canada and Teva Canada Ltd., have stopped producing the drug. Pfizer has cited “raw material availability” as the cause for its discontinuation, while Teva will no longer make the drug as of Sept. 15 for “business reasons,” according to drugshortagescanada.ca, a website under contract with Health Canada.
The discontinuations have put additional pressure on two generic drug makers that do produce Vinorelbine, Fresenius Kabi Canada Ltd., and Generic Medical Partners Inc. But those companies are struggling with their shortages as well. Fresenius has cited “disruption of the manufacture of the drug,” while Generic Medical Partners have given the same reason, along with “demand increase for the drug.”
What Vinorelbine, Leucovorin and Etoposide share in common is they’ve all gone off-patent, and therefore, are not as profitable to manufacture as so-called brand name medications. For the time being, the cancer-drug shortages have had no impact on patients, as oncologists have been using equally effective substitutes. But they’re worried that this approach can last for only so long.
“It seems to be getting worse,” Batist said in an interview on Monday. “There were some (shortages) a few years ago that were resolved after a few months. I can tell you at the Jewish no patient has been impacted yet, because we’re shifting them around where there are other options. Patients are being given other options. But where this is the best drug, we’re absolutely giving them the drug.”
However, if the shortages drag on, Batist warned, “it will affect people. I don’t know what’s happening in the rest of the province, but everyone is scrambling to try and do their best. It’s like a bunch of divers all breathing off of one (oxygen) tank. They have to share. It’s crazy.”
On Friday, the Canadian Pharmacists Association released the results of a survey revealing that drug shortages overall (not just involving cancer medications) have increased in the past five years.
“Drug shortages have become a time-consuming and unwelcome part of pharmacists’ daily practice, as they spend more and more of their time helping to mitigate the impact on their patients,” the association concluded in a statement.
Anna Maddison, a spokesperson for Health Canada, insisted the federal department is monitoring the situation closely.
“Health Canada recognizes that drug shortages can have a significant impact on patients and health professionals and is committed to working with all stakeholders — including provinces and territories and companies — to help prevent or minimize their impact on patients and their families,” Maddison said in a statement.
The shortage of Leucovorin is expected to end on Sept. 15. For Etoposide, Teva’s shortage could end as early as Tuesday. However, Sandoz Canada Ltd. anticipates resuming its supply of Etoposide by May 4, 2020.
“In order to maintain the highest quality standards, an important manufacturing set-up change was required, thus causing a disruption in the supply of this molecule,” explained Isabelle Troïtzky, a spokesperson for Sandoz Canada.
“We are working in collaboration with the manufacturing site and Health Canada to ensure the earliest possible market reintroduction.”
Matthew R. Kuhn, senior director of external communications for Fresenius Kabi USA, blamed the shortage of Vinorelbine on “challenges sourcing the active pharmaceutical ingredient.”
Batist, however, is skeptical of all the excuses. “It’s a story of corporate irresponsibility…and then regulatory lack of oversight because no one was able to anticipate these things.”
“And so we’re constantly catching up,” Batist added.