Regulatory Update - Health Canada confirms proposed regulations requiring tamper resistance for Oxycodone will not move forward at this time
Health Canada takes the issue of problematic opioid use very seriously and has a comprehensive strategy in place to address its many causes and effects.
As part of that strategy, the department consulted on a proposed set of regulations in the summer of 2015, the Tamper-Resistant Properties of Drugs Regulations under the Controlled Drugs and Substances Act. The proposed regulations would have required therapeutic products containing controlled‑release oxycodone to have tamper-resistant properties before they could be sold in Canada.
Following the consultation, and a review of the latest scientific evidence, the department has concluded that this specific regulatory approach, requiring tamper-resistance, would not have had the intended health and safety impact.
Specifically, requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use.
While the proposed regulations will not move ahead at this time, Health Canada supports efforts to develop strategies that can address problematic opioid use including industry efforts to develop tamper-resistant formulations of drugs.
To that end, Health Canada has recently published guidance to drug manufacturers on what evidence is required under the Food and Drugs Act to demonstrate tamper-resistant properties for prescription drugs that are at a high risk of abuse.
The department’s comprehensive approach to addressing problematic opioid use also includes
- educating consumers on the safe use, storage and disposal of prescription medication;
- increasing inspections to minimize diversion of prescription drugs from pharmacies;
- appropriate labelling of medications;
- educating prescribers on the abuse risks of certain drugs;
- improving surveillance data on problematic opioid use in Canada;
- making the overdose antidote naloxone more available; and
- working with our First Nations partners to enhance prevention and treatment services.
Health Canada will continue to work with health care providers and stakeholders to identify further tools and interventions that can help address this growing problem.
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