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CMAJ: Ontario takes aim at painkiller abuse

CMAJ: Ontario takes aim at painkiller abuse.

More stringent Oxycontin marketing regulations unnecessary, says Health Canada

Health Canada took no specific action in response to a major United States report that concluded that manufacturer Purdue Pharma’s aggressive initial marketing of OxyContin minimized the risk of addiction.

Nor does the federal regulator believe additional measures are warranted, spokesperson Gary Holub stated in an email.

The US General Accounting Office reviewed Purdue Pharma’s marketing push after OxyContin, introduced in 1996, became the most-prescribed brand name narcotic medication for treating moderate-to-severe pain in the United States.
The Drug Enforcement Administration characterized the pharmacological effects of OxyContin as “similar to those of heroin,” and noted that general practitioners accounted for nearly half of all prescribers by 2003, states the watchdog’s report, OxyContin Abuse and Diversion and Efforts to Address the Problem.

But Health Canada has not received complaints regarding the advertising and promotion of OxyContin, Holub stated in the email.

The regulator has distributed a document and pamphlet entitled “Abuse and Diversion of Controlled Substances: A Guide for Health Professionals” and the current OxyContin product monograph “is considered sufficiently restrictive and the use/misuse potential of the drug is appropriately addressed, in line with the international regulatory jurisdictions,” he added.

Further, “the conduct of sales representatives working for companies that are members of Canada’s Research Based Pharmaceutical Companies (Rx&D) is regulated by Rx&D,” Holub stated. (Purdue Pharma is a member of Rx&D.)

The US report recommended that manufacturers of newly-approved controlled drugs submit to the US Food and Drug Administration plans “that contain a strategy for identifying potential problems with abuse and diversion.” In 2007, Purdue Pharma pled guilty in a Virginia court to charges of misbranding the addictive drug and was fined $654 million.

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