Health Canada orders mandatory reporting of drug shortages

Health Canada has announced a new mandatory system for reporting drug shortages, but experts say it will not solve the root causes of drug shortages.

'I am hoping Health Canada will step up,' says mom whose son will run out of critical medication

So much depends on a little white pill in the Smith household. 

Nicholas, 16, needs Clobazam three times a day to keep his epileptic seizures in check and his life on track. 

Problem is, his supply is set to run out on Aug. 1 because of a countrywide shortage.

"It is heartbreaking," said his mother, Tina Smith, who lives in Guelph, Ont.

She is dreading the day her son takes his last tablet, because with it goes his dream of getting his driver's licence this summer, something unimaginable before Clobazam, which — along with a drug cocktail — has all but stopped his grand mal seizures. 

"I am angry. I am disturbed. I can't believe two years later we are going through this again." 

The last time his drugs ran out, Nicholas's epilepsy returned with a vengeance; twice monthly seizures turned into almost daily occurrences, which his school was not equipped to handle. He stayed home for two months. 

On Thursday, Health Canada acknowledged that drug shortages cause tremendous anxiety for patients and announced a new measure to help — mandatory reporting for drug companies that will be made public through a website and app. This replaces the current system, which is a voluntary industry-run site. 

"It is a great first step," said Suzanne Nurse, chair of the Canadian Epilepsy Alliance drug shortage committee. "This in and of itself will not address the main issue of drug shortages and the fact that they are continuing and getting worse over the last few years."

We have a shortage right now, and there is no evidence that anyone is doing anything to address the shortage or mitigate it.- Suzanne Nurse, Canadian Epilepsy Alliance 

She added that Health Canada needs to take the lead to mitigate shortages by talking to drug companies or even shipping supplies in from other countries. 

"Our concern is that in any case we have a shortage right now and there is no evidence that anyone is doing anything to address the shortage or mitigate it," said Nurse, who has a more positive view of the U.S. approach, which aims to stop shortages before they occur. 

Other drugs from chemotherapy to painkillers to antibiotics have run out in Canada recently. The causes range from production issues, sole source contracting, unexpected surges in demand for a drug and difficulties accessing raw supplies, according to Health Canada. 

Twenty thousand Canadians like Nicholas Smith depend on Clobazam, according to Nurse, but it is not the only epilepsy drug that has run out in Canada. 

"Since 2015 … the percentage of epilepsy medications that have been affected by a drug shortage has gone from 64 per cent of anti-seizure drugs to 74 per cent of the medications used to treat epilepsy in Canada," said Nurse.

For Tina Smith, these statistics are unacceptable. 

"I am hoping Health Canada will step up," said Smith, who would like the department to figure out how much of the drug is required by Canadians per year and make sure the supply is on track.

"We need to hold drug companies accountable," she said.

Innovative Medicines Canada, the industry group that represents name-brand drugs and runs the current shortage database, said it will participate in the new Health Canada reporting system. The group added it works to address and prevent drug shortages before they start. 

The Canadian Generic Pharmaceutical Association stated it too is working to address the problem, but acknowledges "reporting drug shortages does not … prevent or stop drug shortages, or deal with the root causes of shortages." 

"Moving forward, Health Canada will continue to evaluate our collaborative approach and work with stakeholders to identify opportunities to make it work even better," wrote Health Canada in an email.