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Proposed Regulatory Amendments Limiting Access to Generic OxyContin

Archived Backgrounder

Proposed Regulatory Amendments Limiting Access to Generic OxyContin

Ministry of Health

Ontario is proposing regulations to amend the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act to limit access to generic OxyContin unless it is tamper-resistant.

The draft regulations set out specific conditions whereby long-acting oxycodone products would not be considered for funding under the Ontario Drug Benefit Act unless they meet tamper-resistant criteria.  Also, long-acting oxycodone products would not be designated as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act unless they meet tamper-resistant criteria.

When a drug is designated as interchangeable, a pharmacist can legally substitute the generic drug for the brand name without authorization from the prescriber.

By declaring that long-acting generic oxycodone is not interchangeable unless it meets tamper-resistant criteria, Ontario is limiting the situations where the more easily abused generic OxyContin could be dispensed.

Ontario is also proposing to strengthen the Executive Officer of Ontario's Public Drug Programs   authority to not pay a dispensing physician or operator of a pharmacy who does not comply with the Narcotics Safety and Awareness Act.

The proposed regulations would provide that the new measures be made retroactive to Nov. 23, 2012.

The draft regulations have been posted for consultation on the ministry's website to provide the public with an opportunity to review and comment on this important issue. The regulation will be posted until Dec. 24, 2012.

Read the regulation here.

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