With syphilis spreading in Canada at rates unseen in decades, doctors are struggling to cope with a shortage of the main drug used to treat the potentially deadly infection.
The Public Health Agency of Canada took the rare step recently of posting guidelines on how to ration Bicillin, and what alternative medications might be appropriate in some cases.
It’s the latest in a string of pharmaceutical supply crises to bedevil the health-care system in recent years, as government and industry hunt for solutions.
A national database lists more than 800 drugs in shortage, the date they might return to normal supply often unknown.
“It is very, very concerning to us to have supply of this drug run out, because we are in a period of resurgence of syphilis in many parts of Canada”
More worrisome is that every year sees a few “tier-three” shortages, where the lack of a drug actually affects people’s health, said Dr. Supriya Sharma, a Health Canada senior medical advisor.
The Bicillin case – caused by manufacturing problems at Canada’s sole supplier, a Pfizer plant in the United States – is one of those.
“It is very, very concerning to us to have supply of this drug run out, because we are in a period of resurgence of syphilis in many parts of Canada,” said Dr. Ameeta Singh, an Edmonton infectious-disease specialist and national syphilis expert.
“It’s actually a really big deal,” agreed Dr. Lynora Saxinger, another infectious-disease specialist at the University of Alberta. “Right now, we’re really concentrating on conserving our supplies.”
Syphilis, a major killer in the 1800s, declined steadily after the Second World War period and had almost disappeared in Canada by the 1990s. But incidence began to climb again around 2001, with the per-capita rate doubling in 10 years and the number of cases now reaching more than a 3,000 a year.
Most of the transmission has been among men having sex with men, the blame going to unsafe sex and, recently, the popularity of social-media sites that bring together partners who know little about each other’s sexual history.
But women are also getting sick, and there have been several cases recently of congenital syphilis, where mothers transmit the bacteria to newborns.
Bicillin is a form of penicillin injected into the muscle and, with its long-lasting effect, usually requires only one shot to cure the patient.
The alternative is doxycycline, an oral antibiotic taken twice daily for about two weeks.
“Now our hands are tied a bit more”
The pills are not given to pregnant women because of the risk of birth defects, and patients stay contagious longer, meaning they have to avoid sex for three weeks after the course is finished. Doctors worry patients will fail to comply with the doxycycline treatment, making it more likely they will spread the bug further.
Pregnant women unable to receive Bicillin must get intravenous penicillin, administered in a hospital every four to 10 hours.
“The problematic element for me is that at a time when syphilis rates are increasing, having a more complicated treatment regime could make it harder to control,” said Dr. Vanessa Allen of Public Health Ontario. “Now our hands are tied a bit more.”
Vincent Lamoureux, a Pfizer spokesman, refused to say what caused the production problem but said the company hopes to have it resolved by July. In the meantime, Health Canada is working with Pfizer to import surplus doses from Australia, which, ironically, were made at the same U.S. factory.
The situation arose barely two months after the last tier-three shortage, involving the epilepsy drug Epival.
The shortage problem, which first came to the fore in 2010, mostly involves older, low-cost medicines, often made by just a few generic producers. Echoing the view of many experts, Sharma said reasons for the continuing hassles are complex.
They include: provinces and health authorities contracting with only one or two suppliers; a shrinking number of companies worldwide making the active ingredients; a growing reliance on countries like India and China for pharmaceutical supply; and the impact of falling generic prices.
A “multi-stakeholder” steering group organized by federal, provincial and territorial governments is trying to hammer together solutions, said Sharma.
Lamoureux said fixing the problem is certainly not just a task for industry. Governments need to do more contingency planning, and design their drug-pricing, reimbursement and purchasing systems to lessen the risk of supply glitches, said the Pfizer official.