GENERAL

Interpretation 1. In this Regulation, “identifying number” means the unique number relating to an individual on a form of identification that, (a) has been issued by a government or governmental agency, (b) bears the name of the individual, (c) has been approved by the Minister as providing an acceptable level of certainty of identification of the individual, and (d) has been listed on the website of the Ministry of Health and Long-Term Care. “out of province health professional” means any person who is exempted by a regulation made under a health profession Act, within the meaning of the Regulated Health Professions Act, 1991, from, (a) a provision in that Act that restricts the use of a title, and (b) a provision in that Act that prohibits the person from holding themselves out as qualified to practise in the applicable health profession. (“professionnel de la santé hors province”) O. Reg. 381/11, s. 1; O. Reg. 132/26, s. 1. Dispensers and prescribers 1.1 (1) For the purposes of the Act and this Regulation, a “dispenser” includes an out of province health professional who, under a provision of Ontario Regulation 107/96 (Controlled Acts) made under the Regulated Health Professions Act, 1991, is exempt from subsection 27 (1) of that Act for the purpose of dispensing a drug that is a monitored drug. O. Reg. 132/26, s. 2. (2) For the purposes of the Act and this Regulation, a “prescriber” includes an out of province health professional who, under a provision of Ontario Regulation 107/96 (Controlled Acts) made under the Regulated Health Professions Act, 1991, is exempt from subsection 27 (1) of that Act for the purpose of prescribing a drug that is a monitored drug. O. Reg. 132/26, s. 2. Additional monitored drugs 2. Any drug product that is an opioid that is not listed under the Controlled Drugs and Substances Act (Canada) is designated as a monitored drug for the purposes of the Act. O. Reg. 381/11, s. 2. Exemption 3. (1) The Act does not apply with respect to the prescription by a prescriber, or the dispensing by a dispenser, of a monitored drug, (a) to an in-patient as part of his or her treatment in a hospital; or (b) to a prisoner or inmate. O. Reg. 381/11, s. 3 (1). (2) In this section, “in-patient” means an in-patient within the meaning of the Public Hospitals Act; (“malade hospitalisé”) “prisoner or inmate” means a person confined in a correctional institution, penitentiary, prison or youth custody facility. (“prisonnier ou détenu”) O. Reg. 381/11, s. 3 (2). Notice 4. (1) The notice referred to in section 6 of the Act shall contain, (a) a summary of the information that may be collected, used and disclosed and the legal authority for doing so; (b) a summary of the purposes of the collection, use and disclosure of the information; (c) a reference to the Ministry of Health and Long-Term Care’s written statement under subsection 16 (1) of the Personal Health Information Protection Act, 2004; and (d) the contact information of a person to contact if a prescriber, dispenser or a member of the public has any questions about the notice. O. Reg. 381/11, s. 4 (1). (2) The Minister shall give the notice by, (a) posting it on the website of the Ministry of Health and Long-Term Care; (b) advertising it in newspapers of general circulation in Ontario within three months after the coming into force of section 6 of the Act; and (c) sending a letter in electronic or hard copy format to prescribers and dispensers, as applicable, within three months after the coming into force of section 6 of the Act. O. Reg. 381/11, s. 4 (2). Additional information 5. (1) For the purposes of paragraph 7 of subsection 10 (1) of the Act, a prescriber shall record on the prescription an identifying number that is provided by the person for whom a monitored drug is prescribed and the type of identifying number it is. O. Reg. 381/11, s. 5 (1). (2) For the purposes of paragraph 8 of subsection 11 (1) of the Act and subsection 11 (2) of the Act, a dispenser shall keep a record of an identifying number that is provided by the person for whom a monitored drug is dispensed and the type of identifying number it is. O. Reg. 381/11, s. 5 (2). Exceptions: medical condition; prescriber’s office use 6. (1) Section 5 does not apply where all of the following conditions are met: 1. A person is unable to present an identifying number to the prescriber of the prescription. 2. The prescriber records on the prescription the reason why the person needs to receive the monitored drug before he or she can present an identifying number. 3. The dispenser keeps a record of the reason why the person needs to receive the monitored drug before he or she can present an identifying number. 4. The dispenser provides the monitored drug directly to the person, either at the dispenser’s place of business or through the dispenser’s delivery service, without an agent being used to receive the drug on the person’s behalf and without a third-party mail or courier service being used to deliver the monitored drug. O. Reg. 381/11, s. 6 (1). (2) Section 5 does not apply in respect of a prescription for a monitored drug that has been prepared for a prescriber in order for the prescriber to use the monitored drug for the prescriber’s practice. O. Reg. 381/11, s. 6 (2). Monitored drug received by agent 7. The following rules apply where a person who has been prescribed a monitored drug and has provided an identifying number uses an agent to receive the monitored drug from a dispenser: 1. The dispenser shall, in addition to meeting the requirements of section 11 of the Act and subsection 5 (2) of this Regulation, verify the name and address of the agent before dispensing the monitored drug. 2. The dispenser shall keep a record of, i. the name and address of the agent, ii. the form of identification provided by the agent that verifies the name and address of the agent, and iii. the distinguishing number on the form of identification. O. Reg. 381/11, s. 7. 8. Omitted (provides for coming into force of provisions of this Regulation). O. Reg. 381/11, s. 8.