Get Prescription Drugs Off The Street (GPDOTS) wishes to express our concern at the possibility of a new high-dose, extended-release opioid, Zohydro (hydrocodone bitartrate) coming to Canada’s market.  The Canadian license-holder, Paladin Labs, recently announced it is planning to submit the drug to Health Canada for approval. (CMAJ, News, March 20, 2014 – Canadian Approval Sought for Controversial Pain Drug) 

Taking into consideration the Canadian epidemic of addiction and death related to the use of opioids, GPDOTS strongly urges Health Canada not to approve Zohydro and to place an immediate cessation on the approval of any new opioids which fail to implement abuse deterrent technology. The abuse and diversion of opioids is impacting communities across Canada, failure to use abuse deterrent technology is reckless and puts public safety at risk. This behavior should not be tolerated by Health Canada.

 What is also concerning is the fact that Paladin Labs is manufacturing methadone for the treatment of opioid addiction. This conflict of interest is very unethical as the sales of their addiction treatment product could be directly impacted by the high potential for abuse and addiction with their product Zohydro.

 The data available in regards to opioid use, addiction, and overdose is alarming. Federal Government needs to take immediate action to protect the health and public safety of Canadians.

 

·         In 2011, the semi-synthetic opioid hydrocodone remained the narcotic drug with the highest consumption in terms of doses consumed. Global consumption of hydrocodone amounted to 43 tons in 2011.

 

·         The 2012 Nova Scotia Drug Use Survey indicates grade 7 students admit to abusing non prescribed opioid pain medications at higher rates than tobacco, alcohol, or marijuana. 16.4% of grade 12 students admitted to using non prescribed opioid pain medication. 

 

·         According to the Nova Scotia Prescription Monitoring Program narcotic prescriptions in Nova Scotia have increased from 578,325 to 747,227 between 2008/09 and 2011/12. An increase of 29% in four years. Request for patient profiles from law enforcement has increased 943% in that same time period. 

 

·         In Ontario from 2005/06 to 2010/11, there was an almost 250 per cent increase in the number of emergency room visits related to narcotics withdrawal, overdose, intoxication, psychosis, harmful use and other related diagnoses. 

 

·         Overdose and addiction do not discriminate. There are no socioeconomic boundaries.

 

·         There are over 200,000 Canadians addicted to prescription pain killers ,  though given the lack of surveillance data combined with stigma and shame surrounding addiction, it is challenging to accurately track the disease and therefore the true prevalence is unknown. 

The introduction of such a powerful opioid narcotic, especially one with no abuse deterrent technology, will only exacerbate the already crippling effects the opioid use epidemic is having on Canadians.

As stated by Dr. David Juurlink, Head of the Division of Clinical Pharmacology and Toxicology in Toronto, Ontario and co-author of a forthcoming article critical of the US Food and Drug Administration's (FDA) approach to approving opioids, including Zohydro (‘Painful Decision Making at the FDA’, Expert Opinion on Drug Safety 2014 13[4]): “This is a drug that nobody needs.There's really no bigger drug safety crisis facing North Americans today.“

Health Canada has the opportunity to put the safety of the Canadian public before the special interests of the pharmaceutical industry. As Canadians let’s be a leader, not a follower in patient and public safety. There needs to be higher standards in terms of accountability and ethics in the approval of opioid narcotics in Canada. This will not only reduce the harms associated with illicit opioid use but prevent legitimate pain patients from being exposed to a drug that could have serious side effects such as addiction and overdose.

We strongly suggest you consider denying the approval of Zohydro based on the undeniable risk of addiction, overdose, and abuse potential.