Proposed Regulations under the Safeguarding our Communities Act (Patch for Patch Return Policy), 2015
Regulation - LGIC
Bill or Act:
Safeguarding our Communities Act (Patch for Patch Return Policy), 2015
Summary of Decision:
Final regulation includes the following:
1) Criteria that must be met for a drug to be considered a "fentanyl patch" under the Act and regulation.
2) Provision specifying that non-pharmacy dispensers as dispensers subject to the Act's requirements.
3) Additional requirements on prescribers of fentanyl patches
4) Limited exemptions for pharmacy dispensers
5) Contingency plans that must be followed by pharmacy dispensers when the P4P rule is not met (i.e. patient does not return used patches or returns counterfeit/misused patches)
6) Provisions that establish different classes of prescribers and dispensers and rules for each class
June 1, 2016
Summary of Proposal:
The Safeguarding our Communities Act (Patch for Patch Return Policy), 2015 is the main legislative authority for safeguarding patients relating to the use of fentanyl patches by providing a mechanism to address abuse, misuse, and diversion of fentanyl patches.
The Act sets out requirements for prescribers and dispensers of fentanyl patches.
The Ministry of Health and Long-Term Care is proposing a regulation that would assist with the implementation of the Act. The proposed regulation would:
• Prescribe criteria that must be met in order for a drug product to be considered a "fentanyl patch" under the Act;
• Prescribe persons who dispense fentanyl patches outside of a pharmacy as "dispensers" under the Act (e.g. dispensing physicians);
• Prescribe additional requirements for prescribers of fentanyl patches;
• Prescribe additional requirements for pharmacy dispensers of fentanyl patches; and
• Prescribe different classes of prescribers and dispensers and establish rules for each class.
A copy of the proposed regulation and summary of the proposed regulation is available in English and French in PDF format below.
Should you wish to forward supporting materials as attachment to your comments to the Regulatory Registry, you may send to the following email address: PublicDrugPrgrms.email@example.com.
Executive Officer, Ontario Public Drug Programs
Ministry of Health and Long-Term Care
80 Grosvenor St., 9th Floor
Hepburn Block, Queen's Park
Toronto, ON M7A 1R3
October 1, 2016