Later this month, the patent on the opioid drug OxyContin is set to expire.  Federal Health Minister Leona Aglukkaq could have slammed the door on a generic version of the drug.  Instead, she has informed provincial and territorial health ministers that the government won't act to stop the regulatory approval process.   I think the government has made a huge mistake.

OxyContin was launched with great fanfare in Canada more than a decade ago.  Used as directed, the drug was formulated to provide immediate and extended pain relief for up to twelve hours.  Used appropriately, the drug was intended to provide pain relief to patients with cancer pain and chronic non-cancer pain.  

OxyContin is made from oxycodone, a powerful opioid with effects comparable to morphine.  It has long been known that all opioid drugs have a dual effect.  While the drug can be used effectively to relieve severe pain, it can also be abused to produce a heroin-like high and can used as a drug of choice by addicts.

As I have written before, I gave many lectures and educational workshops to allied health professionals that were sponsored by Purdue Pharma, maker of OxyContin.  It was certainly my hope to be part of a process of educating my colleagues on how to prescribe OxyContin safely and responsibly without adding to the problem of addiction.  As we know all too well, this did not happen.  

Not long after the drug was released in the United States, it soon became apparent that OxyContin's time-release formula could be tampered with to cause all of the contents of one pill to be released immediately.   This greatly enhanced OxyContin's desirability as a drug of choice among recreational drug abusers as well as addicts.  

The problem soon migrated north to Canada.  After the United States, Canada has become the world's largest consumer of oxycodone-based products.  OxyContin abuse became an acute problem first in Atlantic Canada followed by other parts of the country.  First Nations communities have been hard hit by OxyContin abuse and addiction.  Crimes related to acquiring a supply of the drug have increased dramatically.  We chronicled many of these problems in Generation Rx,a Town Hall on the problem of prescription drug abuse held last year in Brockville, Ontario.

Among the most serious problems associated with OxyContin has been the associated death rate due to intentional and accidental overdose.  Currently, more than one thousand people a year die of oxycodone misuse in this country.   In Canada, between 1991 and 2004, deaths from opioid pain relievers more than doubled.  Although many of these deaths involve multiple substances of abuse in combination with alcohol, it's clear in my opinion that OxyContin created a rising tide of abuse and opioid-related deaths.

I have seen personally many instances of inappropriate prescribing by colleagues who - despite efforts to educate them at seminars - seemed unaware of the serious abuse potential of the drug.  These examples convinced me that no amount of education would permit controlled release oxycodone to be prescribed safely by the vast majority of prescribers.  For that reason, I no longer speak for pharmaceutical companies, and no longer endorse the concept of continuing education paid for by pharma.

In March of this year, Purdue Pharma stopped selling OxyContin and replaced it with OxyNeo, a new formulation of time-release oxycodone that is supposedly much harder to tamper than OxyContin.  Some provinces such as Ontario have put OxyNeo on their formularies albeit with greater controls on access than were placed originally on OxyContin.

Make no mistake.  Ending the sale of OxyContin created all kinds of chaos.  Without adequate places in addiction treatment programs, many drug abusers have frequented emergency departments and clinics - not to mention the street - in search of a substitute fix.   Legitimate pain sufferers had to be transitioned to OxyNeo or some other opioid analgesic.

But the removal of OxyContin was like drawing a line in the sand in the desert of opioid drug abuse.  Now, the stage has been set for an egg painfully unscrambled to be scrambled again.

This week, federal Health Minister Leona Aglukkaq said the government will not act to stop the approval of generic controlled-release oxycodone.  In letter dated November 19, 2012 to provincial and territorial counterparts, Aglukkaq said "There is no basis in the Food and Drugs Act for the Minister of Health to withhold approval of a drug where the drug is otherwise considered safe and effective for its recommended use.  The law does not permit approval to be withheld on the basis of misuse."

I'm sorry, but "otherwise considered safe and effective for its recommended use" completely glosses over the fact that we have a huge social problem because controlled-release oxycodone has not been used as recommended.  

More than that, the federal government has a paramount role to play in the regulation of controlled substances, of which oxycodone is an example.  Through its controlled substance legislation, it designates drugs as controlled because such drugs can be used therapeutically and can also be abused.  The federal government - not the provinces - places controlled substances in schedules based on their abuse potential. 

There is nothing to stop the federal government from rescheduling oxycodone or even to create a new schedule for the drug based on its actual abuse.

Aglukkaq said the federal government will tighten existing drug licensing rules so that distributors of oxycodone will have to report unexpected increases in sales and patterns of distribution of the drug.  She said if necessary, the government is prepared to place additional controls on who can prescribe and who can dispense oxycodone - as is the case with the drug methadone.

In my opinion, the time to put such restrictions in place is now.  Failing that, I think the government should say no to generic OxyContin.  As Ontario Health Minister Deb Mathews told Canadian Press, "National problems require a national solution."