Regulation - LGIC

Proposed New Regulatory Provisions under the Narcotics Safety and Awareness Act, 2010

Regulation Number(s):
N/A
Instrument Type:
Regulation - LGIC
Bill or Act:
Narcotics Safety and Awareness Act, 2010
Summary of Decision:
The regulation was filed with the Registrar of Regulations as O. Reg. 381/11 under the Narcotics Safety and Awareness Act, 2010 on August 12, 2011. The regulation was published in the Ontario Gazette on August 27, 2011. The approved regulation:
- requires the prescriber to include an identifying number for the patient on a prescription for a narcotic or controlled substances
- specifies the information the dispenser must record when dispensing a narcotic or controlled substances
- specifies the type of identifying number that is acceptable i.e., government issued identification that bears the name of an individual and provides an acceptable level of certainty of the identity of the person - the list will be approved by the Minister and posted on the Ministry website
- requires dispensers to record the name, address and identifier for persons who pick up a narcotic or controlled substance from the pharmacy
- provides exemptions to allow a prescription to be prescribed and dispensed if patients do not have appropriate identification
- ensures that all opioids (including those not currently listed in the Controlled Drug and Substances Act (Canada),) are monitored drugs in Ontario
- exempts prescribers in certain settings such as a hospitals or prisons from the requirements of the NSAA
- describes the content of public notices and the method of disclosure that would include:
- information to be collected, used and disclosed under the NSAA
- the purposes for collection, use and disclosure
- contact information for prescribers, dispensers and public
Further Information:
Proposal Number:
11-HLTC022
Posting Date:
March 23, 2011
Summary of Proposal:
The Minister of Health and Long-Term Care invites public comments on proposed new regulations under section 17(1) of the Narcotics Safety and Awareness Act, 2010 (NSAA). The proposed new NSAA regulations would:

Section 1:
- define the term "identifying number" to mean the Ontario health card number or a number on an alternative form of identification that the Minister may permit; for example, this may include birth certificate, citizenship card or other immigration document, Certificate of Indian Status, valid driver's licence, valid Canadian passport, among others.

Section 2:
- add opioids not listed in the Controlled Drug and Substances Act (Canada), for example Tramadol, as monitored drugs.

Section 3:
- exempt prescribers who prescribe and dispensers who dispense a monitored drug to an in-patient, within the meaning of section 1 of the Public Hospitals Act from the application of the NSAA;
- exempt prescribers who prescribe and dispensers who dispense a monitored drug to Federal and Provincial inmates and young persons in a youth custodial facility;

Section 4:
- describe the content of the notice that includes:
- a summary of the information that may be collected, used and disclosed and the legal authority
- a summary of the purposes of the collection, use and disclosure of the information
- ministry contact information if a prescriber, dispenser or public has questions
- describe the method by which the notice on the collection, use and disclosure of information will be circulated to prescribers, dispensers, operators of pharmacies and the public. This includes postings on the ministry website, advertising in major newspaper for the public members, and sending a letter either in electronic or hard copy format to prescribers and dispensers, as applicable
Section 5:
- set out additional information that prescribers and dispensers must record in respect of prescriptions. This would include the health card number or other form of identification that is approved in Section 1.

Section 6:
- set out an exemption to permit a person to obtain the monitored drug in cases where the person is not able to present the appropriate identification noted in section 5 if the following conditions are met:
- the prescriber must note on the prescription the reason why the patient needs the monitored drug before he or she can obtain the appropriate documents,
- the dispenser keeps a record of the reason why the person needs to receive the monitored drug in cases where the patient is unable to present an identification
- the patient receives the monitored drug directly from the dispenser and cannot use a third party to pick up the drug or does not use a mail or courier service to receive the monitored drug.
- set out an exemption that the prescriber would not be required to record an identifying number on the prescription for a monitored drug if it is intended to be used during the course of the prescriber?s practice (i.e., for office use).

Section 7:
- require that dispensers record the name, address and the form of identification used by the person who picks up or receives a monitored drug on behalf of the patient
Section 8:
- provide that the exemption for hospital in-patient in clause 3(1)(a) will be revoked on July 1, 2016

Section 9:
- provide the commencement date of the proposed regulation
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
Effective Date:
November 1, 2011
Decision:
Approved