Regulation - LGIC
Proposed Amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act and Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act
Regulation Number(s):
O. Reg. 201/96; Regulation 935
Instrument Type:
Regulation - LGIC
Bill or Act:
Ontario Drug Benefit Act and Drug Interchangeability and Dispensing Fee Act
Summary of Decision:
The regulations to amend subsections 1(1.2), 12(9) and sub-paragraph 3(ii) of section 27 of Ontario Regulation 201/96 made under the Ontario Drug Benefit Act ("ODBA") and subsection 6(8) of Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act ("DIDFA") were filed as O. Reg. 20/13 and O. Reg. 21/13, respectively, on January 23, 2013 and were made effective retroactively to November 23, 2012.
The regulations set out specific conditions that a long-acting drug product that contains oxycodone as the only active ingredient would need to meet before it may be considered for public funding under the ODBA and/or be designated as an interchangeable product under the DIDFA. The conditions include providing evidence satisfactory to the Executive Officer of Ontario Public Drug Programs that the oxycodone product is manufactured in such a way to make it significantly more difficult to alter, break, crush, chew, dissolve or otherwise manipulate; or significantly less effective and less likely to be misused or abused, if the product is altered, broken, crushed, chewed, dissolved, or otherwise manipulated.
In addition to the above, a house-keeping reference to the Narcotics Safety and Awareness Act, 2010 ("NSAA") has been added to sub-paragraph 3(ii) of section 27 of O. Reg. 201/96 to provide additional clarity that the Executive Officer may suspend the rights of a pharmacy operator and a dispensing physician to receive payment under the ODBA, if they do not comply with the NSAA.
The regulations set out specific conditions that a long-acting drug product that contains oxycodone as the only active ingredient would need to meet before it may be considered for public funding under the ODBA and/or be designated as an interchangeable product under the DIDFA. The conditions include providing evidence satisfactory to the Executive Officer of Ontario Public Drug Programs that the oxycodone product is manufactured in such a way to make it significantly more difficult to alter, break, crush, chew, dissolve or otherwise manipulate; or significantly less effective and less likely to be misused or abused, if the product is altered, broken, crushed, chewed, dissolved, or otherwise manipulated.
In addition to the above, a house-keeping reference to the Narcotics Safety and Awareness Act, 2010 ("NSAA") has been added to sub-paragraph 3(ii) of section 27 of O. Reg. 201/96 to provide additional clarity that the Executive Officer may suspend the rights of a pharmacy operator and a dispensing physician to receive payment under the ODBA, if they do not comply with the NSAA.
Further Information:
Draft DIDFA Regulation Amendment
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Draft ODBA Regulation Amendment
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Ontario Drug Benefit Act Ontario Regulation 20/13
Drug Interchangeability and Dispensing Fee Act Regulation 21/13
Ontario Drug Benefit Act
Drug Interchangeability and Dispensing Fee Act
Proposal Number:
12-HLTC018
Posting Date:
November 23, 2012
Summary of Proposal:
The Ontario Government is proposing to amend subsections 1(1.2) and 12(9) of Ontario Regulation 201/96 made under the Ontario Drug Benefit Act ("ODBA") and subsection 6(8) of Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act ("DIDFA"). The proposed amendments would permit a drug product that contains oxycodone as the only active ingredient and that is a long-acting product that has been formulated in a solid dosage form for oral administration to be considered for funding under the ODBA and/or to be designated as an interchangeable product under the DIDFA, if and only if, specific conditions are met.
The proposed conditions would include:
. providing evidence that would be satisfactory to the Executive Officer that the drug product is tamper-resistant, in that it exhibits physiochemical properties that make it significantly more difficult or ineffective to alter the characteristics of the drug product for purposes of misuse or abuse when compared to drugs without such properties, as demonstrated by,
. in vitro testing,
. in vivo testing,
. another form of testing of equivalent reliability, or
. a combination of any of the forms of testing mentioned above
In addition to the above, the Ontario Government is also proposing to amend sub-paragraph 3(ii) of section 27 of O. Reg. 201/96 by adding a house-keeping reference to the Narcotics Safety and Awareness Act, 2010 ("NSAA"). The proposed amendment would provide the Executive Officer with clearer authority to suspend the right of a dispensing physician or operator of a pharmacy to receive payment under the ODBA if the dispensing physician or operator of a pharmacy did not comply with the NSAA.
The proposed regulations would provide that the regulations be made retroactive and would come into force on November 23, 2012.
The content of the final regulations are at the discretion of the Lieutenant Governor in Council ("LGIC") who may make the regulations with any changes that the LGIC considers appropriate.
Interested parties are invited to provide written comments on the proposed change to the draft regulations as part of the review. The ministry will consider comments received on or before December 24, 2012 at 5:00 p.m. EST ("comment period."). Please be advised that submissions received after the comment period may not be considered.
The proposed conditions would include:
. providing evidence that would be satisfactory to the Executive Officer that the drug product is tamper-resistant, in that it exhibits physiochemical properties that make it significantly more difficult or ineffective to alter the characteristics of the drug product for purposes of misuse or abuse when compared to drugs without such properties, as demonstrated by,
. in vitro testing,
. in vivo testing,
. another form of testing of equivalent reliability, or
. a combination of any of the forms of testing mentioned above
In addition to the above, the Ontario Government is also proposing to amend sub-paragraph 3(ii) of section 27 of O. Reg. 201/96 by adding a house-keeping reference to the Narcotics Safety and Awareness Act, 2010 ("NSAA"). The proposed amendment would provide the Executive Officer with clearer authority to suspend the right of a dispensing physician or operator of a pharmacy to receive payment under the ODBA if the dispensing physician or operator of a pharmacy did not comply with the NSAA.
The proposed regulations would provide that the regulations be made retroactive and would come into force on November 23, 2012.
The content of the final regulations are at the discretion of the Lieutenant Governor in Council ("LGIC") who may make the regulations with any changes that the LGIC considers appropriate.
Interested parties are invited to provide written comments on the proposed change to the draft regulations as part of the review. The ministry will consider comments received on or before December 24, 2012 at 5:00 p.m. EST ("comment period."). Please be advised that submissions received after the comment period may not be considered.
Contact Address:
Executive Officer of Ontario Public Drug Programs
Ministry of Health and Long-Term Care
80 Grosvenor Street, 9th Floor
Hepburn Block, Queen's Park
Toronto ON M7A 1R3
Fax: 416-325-6647
Email: PublicDrugPrgrms.moh@ontario.ca
Ministry of Health and Long-Term Care
80 Grosvenor Street, 9th Floor
Hepburn Block, Queen's Park
Toronto ON M7A 1R3
Fax: 416-325-6647
Email: PublicDrugPrgrms.moh@ontario.ca
Effective Date:
November 23, 2012
Decision:
Approved