Drug manufacturers required to report shortages under new rules
Marlene Leung and Angela Mulholland, CTVNews.ca
Published Tuesday, February 10, 2015 12:24PM EST
Last Updated Tuesday, February 10, 2015 9:18PM EST
Drug makers and pharmacists say that while they welcome new mandatory drug shortage reporting rules announced today, reporting on shortages will not be enough to end them.
Health Minister Rona Ambrose announced the new mandatory reporting regulations Tuesday in Vancouver, saying the new rules will give Canadian health care providers and patients advance notice of upcoming shortages to allow them to arrange alternative treatments.
"We know that drug shortages are a very complex global problem, but they have impacts that are felt right here in Canada," she said. "Nobody feels these impacts more than patients and their families."
Ambrose said it has become clear that the current voluntary shortage reporting system was inadequate.
She said information on current and anticipated shortages will now be reported to the public on a new third-party website. It will replace the current, industry-run shortage website, drugshortages.ca, which was launched in 2012.
Ambrose said a Public Notification Register will be formed on the new site that will list all the manufacturers that fail to post shortages. It will also contain letters sent to drug companies that have failed to report shortages.
"Let me be clear: this public register will name and shame those pharma companies who fail to publicly post information on drug shortages, making industry commitments, but more importantly industry actions clear for all to see," she said.
Not enough to address root causes of shortages
The Canadian Pharmacists Association, the Canadian Generic Pharmaceutical Association, and Canada’s Research-Based Pharmaceutical Companies (Rx&D) said in separate statements that they welcomed the new mandatory shortage reporting system.
But all agreed that the root causes of drug shortages are complex and this initiative alone will not be enough to end them.
The president of the Canadian Medical Association, Dr. Chris Simpson, said his group has been calling on the government to address the issue of drug shortages since 2010.
“Persistent shortages in the supply of drugs pose a serious disruption to clinical treatment, increase medical error and put unhelpful pressure on the entire health care system,” he said in a statement.
Jeff Morrison, director of public affairs for the Canadian Pharmacists’ Association, told CTV News Channel Tuesday that his group has been sounding the alarm about drug shortages for the past five years.
“The fact is that the pharmaceutical supply chain is incredibly complex,” he said.
Drugs often go through long approvals and shipment processes before they reach your local pharmacy, Morrison said. Reasons for their shortages can be both global and domestic, he said.
Information about any kind of interruption in the drug supply is “absolutely crucial” to pharmacists, Morrison said.
Russell Williams, president of Canada’s Research-Based Pharmaceutical Companies (Rx&D) said mandatory reporting is an important step to helping doctors and patients access the most up-to-date information on shortages.
But he added that in general, four out of five drug shortages are associated with generic pharmaceutical companies.
"Although all our members are committed to voluntarily report shortages on this publicly-available and bilingual database, the same cannot be said for some companies outside of our association," he said.
The Canadian Generic Pharmaceutical Association said in its own statement that reporting drug shortages does not prevent or stop drug shortages, or deal with their root causes, which they said are "complex and are influenced by both domestic and global factor."
The CGPA said it would continue to work with others in the field to address the root causes of drug shortages, which it said included working with hospital purchasing groups to improve purchasing practices, working with Health Canada to ensure reasonable regulatory requirements, and working with the provincial and territorial governments to negotiate "a sustainable pricing and reimbursement model for generic drugs."