Health Canada officials are working “around the clock” to approve 23 new drug applications in one month to combat national meds shortages caused by troubles at Sandoz.
Quebec-based injectables manufacturer Sandoz, owned by Novartis, accounts for around 90 per cent of Canada's generic injectable drugs.
But following a string of manufacturing problems – including a fire at its Boucherville plant February, and this week’s discovery of ampoules of isoproterenol in boxes labelled as morphine – Canada’s injectables supply has taken a nose dive.
Now in an unconventional move, the Canadian regulators will work “24/7” to cut the approval process – which would normally take six months – in the hopes it will plug up the gaps in the market.
The measure was unanimously backed by the Government last week when it was proposed in the House of Commons.
Federal Health Minister Leona Aglukkaq said: "In circumstances where the shortage of important drugs does occur, Health Canada will work with the provinces, territories, manufacturers and health professionals to minimize the impact."
The British Colombian Health Minister Mike de Jong has now issued a quarantine on all two-milligram ampoules of morphine produced at Sandoz.
Contrary to the Government’s general stance, he insisted there would be no morphine shortage.
“There are, and continue to be, alternative morphine products available,” he said. “We do not believe there will be a shortage, particularly if the issue is resolved by Health Canada and Sandoz as quickly as possible”.
Sandoz has vowed to fix the issue quickly, and says it will replace the quarantined drugs with no extra charge. "Sandoz and Novartis do not view the current supply situation in Canada as an opportunity to increase our profits,'' spokeswoman Marija Mandic said in a statement.
Foresight is better than hindsight
Despite regulators working around the clock for a solution within the month, industry still remains fearful for the near future.
Clinical director of pharmacy services for meds buyer HealthPro Canada Michael Blachard told the Ottawa Citizen: "Even if the government expedites its review, that's only a component of the whole process.
"For some items, it's still another three to four months before we see some relief. For others, it might be another six months, and that's in a best-case scenario."
During the meeting, the Canadian Anaesthesiologists’ Society urged the Government to form an early warning system to prevent this problem in the future.
The system would force manufacturers to report any planned disruptions to Health Canada well in advance – something they are not currently obliged to do.
Rick Chisholm, president of the society, said: "We need a system of vigilance on the drug supply that tells us as soon as possible that there's a problem”.
Chilsolm also suggested a “strategic stockpile” should be created for unforeseeable issues.
“What would happen if we had something like the earthquake and tsunami and nuclear meltdown in Japan?” he said. "I think a strategic stockpile of medications is something that we should be looking at."