Harrington, 26, has seven days until he runs out of his much-needed antiseizure medicine, Celontin, despite not being warned of a shortage of the drug.
It’s s precisely the type of problem predicted in documents obtained by The Canadian Press, which reveal Health Canada staff had fears a voluntary reporting system implemented in April would be “susceptible to bad company behaviour.”
Celontin is the only drug Harrington has found to reduce his roughly 200 seizures a day to just three. The Woodstock, Ont. man with epilepsy has been on the drug for more than 20 years, but in October, his pharmacist let Harrington’s mother, Bridgette, know they only had a seven-day supply left.
“Seven days, that’s life or death,” Bridgette Harrington said Thursday.
The drug is not listed on Health Canada’s voluntary-notice website, drugshortages.ca. Harrington never received warning so that his family could apply for special access to the drug, which is still produced in the U.S.
Federal Health Minister Leona Aglukkaq opted to launch the voluntary system in April, despite concerns from her own staff.
Internal Health Canada documents obtained by The Canadian Press through the Access to Information Act include an outline comparing voluntary versus mandatory approaches that cautioned with a voluntary system there would be no way to punish manufacturers who fail to report production gaps.
The documents also included a July 2011 report commissioned by Health Canada that advised giving manufacturers no choice but to provide an immediate alert on outages of drugs produced by one or a small number of manufacturers.
Aglukkaq spokesperson Steve Outhouse told The Canadian Press the voluntary system was chosen because it would take too long to implement a mandatory system.
The issue of drug shortages made headlines last winter when a facility upgrade and plant fire crippled Sandoz Canada’s production, leading to cancelled surgeries.
Harrington’s family has found enough Celontin to last until Jan. 3. It’s unclear why the drug wasn’t listed on the drugshortages.ca website. No one from the manufacturer, ERFA Canada, could be reached for comment Thursday evening.
Harrington’s application to receive the drug from the U.S. has been approved by Health Canada but is under review by Pfizer, the U.S. manufacturer.
In the meantime, his family has purchased $1,100 worth of expired Celontin as a backup plan. That would be a five-month supply for Harrington, who lives in a group home, has trouble walking and functions at a reduced intellectual capacity.
Bridgette Harrington had to sign a waiver to relieve the pharmacy of responsibility in case of side effects.
“It’s sad that we make this acceptable,” she said.
Suzanne Nurse, a patient advocate with Canadian Epilepsy Alliance and Best Medicines Coalition, said Harrington’s case isn’t isolated, and pointed to the mandatory reporting system in the U.S. that President Barack Obama pushed through in the fall of 2011.
Original Article
Source: the star
Author: Jeff Green
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