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 Next month Health Canada plans to publish a detailed proposal for
the stickers, which Philpott said would warn that opioid painkillers
can cause addiction and overdose. In March, an advisory panel is set
to consider a second measure, revising the official label definition
of how opioids should – and should not - be used, officials said.
Any revision would affect marketing efforts by manufacturers,
including privately held Purdue Pharma and Pharmascience, as well as
publicly traded Teva Pharmaceuticals Industries, Mallinckrodt Plc,
Novartis's Sandoz and Johnson & Johnson’s Janssen Pharma.
Warning stickers would be a first and could serve as an example. The
measures would follow other strategies that failed to stem addiction
and death involving prescription opioids, such as OxyContin and
Hydromorph Contin, as well as illicit ones, including heroin and
powerful fentanyl smuggled from China.
Fatal overdoses have increased across Canada, mirroring the much
larger epidemic in the United States. In Ontario, the most populous
province, prescription opioid deaths rose 40 percent in six years;
in the western province of Saskatchewan, they more than doubled
since 2010. An influx of illicit variations of fentanyl fueled an 80
percent increase in deaths last year in British Columbia to a record
914.
Philpott has called the opioid epidemic the nation’s greatest public
health crisis and pledged to use every tool at her disposal to fix
it.
“We’re concerned when opioid prescriptions are on the increase,” she
told Reuters. “We need to understand what’s behind that and make
wise recommendations.”
Drug companies have said they support measures to increase patient
safety. Several companies and industry groups declined to comment
until the government lays the new proposals.
Some doctors and public health experts who have long clamored for
safeguards said the new measures may be too little, too late.
“Stickers may have been helpful in 2006, 2007,” said Edmonton,
Alberta, addiction doctor Hakique Virani. “But when we’ve created
this huge demand for opioids that is now being met by powder from
China, and you can traffic a million doses of that stuff in a
10-gram greeting card envelope, I’m sorry, but stickers on pill
bottles is not going to solve this problem.”
Philpott said she recognizes the challenge.
“You don’t want to drive people to use even more harmful street
drugs and illicit substances,” Philpott said. “So it needs to be
done with a tremendous amount of wisdom and thoughtfulness, and we
are certainly consulting widely to make sure we don’t have any
unintended consequences from our actions.”
“RE-CENTERING THE PENDULUM”
Officials declined to provide a timetable. Health Canada plans
to put the warning sticker proposal to focus groups and gather
public comment before Philpott makes a decision.
Philpott envisions stickers similar to those pharmacists put on pill
bottles reminding patients to take a medication with food. In
addition to warning of the risks, she said, they would advise
patients where to get more information and help if needed.
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Rewriting label definitions of evidence-supported opioid use would
change how drug companies sell opioids in Canada, an
$881-million-a-year market.
Doctors are allowed to prescribe “off-label,” tailoring
prescriptions to patients’ individual needs. But pharmaceutical
companies must follow the labels' language in all marketing,
including advertisements and sales calls on physicians.
In an email, spokesman Grant Perry said OxyContin and Hydromorph
Contin maker Purdue "supports providing the most relevant and up to
date information" to doctors and patients, as well as evidence-based
updates.
Representatives for Mallinckrodt, Teva and Sandoz did not respond to
Reuters' queries. Pharmascience representatives did not return calls
or emails.
Spokeswoman Jennifer McCormack said in an email Janssen would
"continue to work with Health Canada to help ensure the safe and
appropriate use" of prescription opioids and it was "important to
carefully balance anti-abuse efforts" with patient needs.
In an effort to address Canada's drug problem, health officials made
it more difficult to obtain OxyContin after Purdue introduced a
tamper-resistant formulation of the drug in 2012. But physicians and
addicts switched to different drugs.
Illegal fentanyl flooded Canada’s streets, and doctors began
prescribing more Hydromorph Contin, which has eclipsed oxycodone and
fentanyl as the most commonly prescribed opioid in Ontario, B.C.,
Alberta, Saskatchewan and Quebec.
Canadian and U.S. public health advocates have campaigned
unsuccessfully to restrict the long-term use of any opioid for
non-cancer pain.
“The best available evidence does not support their use for
treatment of chronic pain,” said David Juurlink, an addiction
specialist at Toronto’s Sunnybrook Health Sciences Center.
The U.S. Centers for Disease Control and Prevention released
non-binding guidelines last year cautioning against the use of
long-acting opioids as first-line treatment for chronic pain and
urging low initial doses and discontinuation as soon as possible.
Supriya Sharma, Chief Medical Advisor at Health Canada, said it's
too soon to say whether the agency's changes would be that sweeping.
“They can be that specific, and they can be much broader,”
she said in an interview.
With prescriptions and deaths rising, Sharma said, “We’re trying to
re-center that pendulum.”
(Editing by Amran Abocar and Lisa Girion)
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