Hospitals and pharmacies across the country are bracing for possible shortages of a swath of drugs used to treat everything from various cancers to serious infections.
Health Canada announced Thursday that more than a dozen drugs imported by several different companies may be indefinitely in short supply in this country as a result of “deficiencies” identified at Ben Venue Laboratories Inc., a contract manufacturer based in Ohio. There are also growing concerns that the rising number of drug shortages in the past few months may be linked to the increased concentration of drug manufacturers.
The announcement comes as health professionals grapple with ongoing, widespread shortages of countless drugs, forcing patients to take substitutes that could lead to more side effects or be less effective, according to experts.
Some experts are particularly concerned by the new shortages because they involve a number of cancer drugs that can’t easily be replaced with other treatments.
“In general, in cancer, we don’t have substitutions that can easily be made,” said Malcolm Moore, head of medical oncology and hematology at Princess Margaret Hospital, one of Canada’s premier cancer centres. “It’s a very difficult situation.”
One drug already in short supply or unavailable across parts of Canada is Caelyx, used to treat ovarian and other types of cancer. Many patients have been put on alternative therapies for now.
Organizations such as Cancer Care Ontario, Cancer Care Manitoba and the Canadian Society of Hospital Pharmacists played down the severity of drug shortages, saying they will be able to work together to find alternative therapies and ensure patients receive the best treatment.
But Kathy Vu, a clinical pharmacy practitioner at St. Michael’s Hospital in Toronto, said even if good alternatives are found, it won’t alleviate problems.
“[Patients]don’t know if they will be able to receive their treatment on time. If they are switched to another regimen, they will always wonder if they got the best treatment and therefore the best chances at survival,” she wrote in an e-mail.
Continuing drug supply problems, which some say have become steadily worse over the past two years, are raising questions about the implications of allowing drug production to become increasingly concentrated among manufacturers. Problems at Ben Venue Laboratories, a large company that produces liquid and freeze-dried products under contract to customers, means at least 17 critically important medications may soon be in shortage here.
“We’ve actually been calling for greater visibility, greater recognition of the dangers of monopolization within the drug market,” said Jeff Morrison, director of government relations and public affairs at the Canadian Pharmacists Association.
Mr. Morrison said the causes behind supply issues appear systemic, prompting fears shortages are becoming the norm.
Although many drug companies remain tight-lipped about supply problems, a number of factors, such as contamination or scarcity of raw ingredients, manufacturing glitches and regulatory challenges, are at play.
Ben Venue Laboratories declined an interview, but spokesman Jason Kurtz said in an e-mail the company continues to face “manufacturing capacity constraints” resulting in product back orders.
But Health Canada said it had identified shortcomings with the company’s manufacturing practices, problems significant enough that the department has increased oversight and clamped down on importations from Ben Venue’s plant in Bedford, Ohio.
Health Canada did not respond to questions about the specific nature of the deficiencies.
Shortages of common antibiotics, heart drugs and medications used to anesthetize patients have become commonplace in Canada in recent months. In many cases, the drugs in question tend to be older and not used as widely as newer agents, leading to criticisms that generic drug makers are slowing production of medications that aren’t very profitable.
That’s one of the reasons the new announcement of shortages has Dr. Moore so worried. Many drugs on Health Canada’s shortage list, such as Caelyx, Tomudex, Torisel and BiCNU are used in chemotherapy or other aspects of cancer care. Some, such as Torisel, are relatively new, Dr. Moore said, meaning no generic versions are available elsewhere and there are few good substitutions.
“You can’t run a cancer program on the brink,” he said. “It’s a big problem for us.”
Dr. Moore and a growing number of health professionals say Health Canada should be doing much more to take action on drug shortages. They also say drug companies have a responsibility to be more forthcoming with information.
“There has to be some sort of solution so that this doesn’t continue to happen,” he said.
Canada’s Research-Based Pharmaceutical Companies, which represents drug companies, declined to be interviewed but president Russell Williams said in a statement they are working with Health Minister Leona Aglukkaq to keep everyone informed about drug shortages.
A complete list of drugs involved in the new shortage can be found here.