Canada Gazette, Part 2, Volume 152, Number 9: Regulations Amendin... http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html Home (http://www.canada.ca/en/index.html) How government works (http://www.canada.ca/en/government/system/index.html) Treaties, laws and regulations (https://www.canada.ca/en/government/system/laws.html) Canada Gazette (/accueil-home-eng.html) Publications (/rp-pr/publications-eng.html) Part II: Vol. 152 (2018) (/rp-pr/p2/2018/index-eng.html) May 2, 2018 (/rp-pr/p2/2018/2018-05-02/html/index-eng.html) Regulations Amending the Food and Drug Regulations (Opioids): SOR/2018-77 Canada Gazette, Part II, Volume 152, Number 9 Registration April 23, 2018 FOOD AND DRUGS ACT P.C. 2018-429 April 20, 2018 Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30a of the Food and Drugs Act b, makes the annexed Regulations Amending the Food and Drug Regulations (Opioids). Regulations Amending the Food and Drug Regulations (Opioids) Amendments 1 Subsections C.01.005(2) and (3) of the Food and Drug Regulations 1 are replaced by the following: (2) Subsection (1) does not apply to (a) a drug in dosage form that is compounded by a pharmacist under a prescription or by a practitioner; or (b) a drug in dosage form that is sold under a prescription if the following information appears on the drug’s label: (i) the drug’s proper name, common name or brand name, (ii) the drug’s potency, and (iii) the name of the drug’s manufacturer. (3) In this section and in sections C.01.005.1 and C.01.014, drug in dosage form means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing. 2 The Regulations are amended by adding the following after section C.01.005: C.01.005.1 (1) No pharmacist or practitioner shall sell a Class A opioid — including one that is 1 de 31 5/21/2018, 11:19 AM Canada Gazette, Part 2, Volume 152, Number 9: Regulations Amendin... http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html compounded by a pharmacist under a prescription or by a practitioner — unless (a) the drug’s package has applied to it a warning sticker that meets the specifications set out in the source document; and (b) the drug is accompanied by a patient information handout that meets the specifications set out in the source document. (2) Subsection (1) does not apply in respect of the sale of a Class A opioid by a pharmacist or practitioner if (a) the opioid will be, or is, administered under the supervision of a practitioner; or (b) the sale is to a pharmacist or practitioner. (3) The following definitions apply in this section. Class A opioid means a drug in dosage form set out in Part A of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opioïde de catégorie A) source document means the document entitled Information for Patients Concerning Opioids, published by the Government of Canada on its website, as amended from time to time. (document source) 3 Subsection C.01.014(1) of the Regulations is replaced by the following: C.01.014 (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled under section C.01.014.6. 4 The Regulations are amended by adding the following after section C.01.014.2: C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a Class B opioid or amend those terms and conditions. (2) The Minister shall notify, in writing, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions. (3) In subsection (1), Class B opioid means a drug set out in Part B of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. Coming into Force 5 (1) These Regulations, except section 4, come into force on the day that, in the sixth month after the month in which they are registered, has the same calendar number as the day on which they are registered or, if that sixth month has no day with that number, the last day of that sixth month. (2) Section 4 comes into force on the day on which these Regulations are registered. REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) 2 de 31 5/21/2018, 11:19 AM Canada Gazette, Part 2, Volume 152, Number 9: Regulations Amendin... http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html Executive summary Issues: The potential for harm associated with opioid drugs and the growing related public health crisis is the subject of increasing concern for Canadians and other levels of government in Canada. Health Canada has identified the need for strengthened post- market oversight of opioids to help monitor and mitigate their risks, and the need for patients to receive additional, clear information about the safe use of opioids and the risks associated with their use. Description: The amendments to the Food and Drugs Regulations expressly permit the Minister of Health (the Minister) to add or amend terms and conditions to an authorization for the sale of an opioid. This authority can be used by the Minister to compel an opioid authorization holder to develop and implement a risk management plan to appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use of these products. The amendments also require that a patient information handout and warning sticker accompany prescription opioids at the time of sale, with the exception of instances when the opioid is directly administered by a health care professional. Cost-benefit statement: The costs of this proposal are associated with the requirement to print and provide the patient information handout and to apply a warning sticker to opioid containers. These costs have been estimated at $76,522,000 over a 10-year period when discounted at 7% and are expected to be borne primarily by pharmacies. These costs will be offset by a number of qualitative benefits, including patients receiving key information that is expected to increase their awareness of the risks associated with opioids and encourage safer use of these drugs. The benefits associated with the ability to impose terms and conditions on opioid authorizations arise from stronger post-market oversight of opioids in Canada, including the ability to require, for example, the development and implementation of risk management plans for opioids. Such plans are expected to result in measures to mitigate risks identified with these products and better protect the health and safety of Canadians. “One-for-One” Rule and small business lens: The “One-for-One” Rule does not apply to this proposal, as it is not expected to increase the administrative burden on businesses. The small business lens applies, as over three quarters of pharmacies are considered small businesses. The requirement to provide a patient information handout and apply a warning sticker whenever opioids are dispensed is expected to increase costs for small businesses by $1,075 annually. To minimize the burden on small businesses, a flexible regulatory option was identified: the patient information handout has been designed to be printed in black and white. This aspect of the proposal will also have a six-month coming-into-force provision to facilitate compliance with the new requirements. This flexible regulatory option will reduce compliance costs for small businesses by $36,862,000 over 10 years. Domestic and international coordination and co-operation: The amendments will enhance Health Canada’s regulatory alignment with the United States and the European Union. 3 de 31 5/21/2018, 11:19 AM Canada Gazette, Part 2, Volume 152, Number 9: Regulations Amendin... http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html Background Opioid crisis and federal response Opioids offer effective pain relief for many patients. Examples of opioids include oxycodone, morphine, hydromorphone, fentanyl and codeine. The strength of opioid medications varies greatly, and nearly all are available by prescription only, the exception being products that contain low doses of codeine. Opioids pose potential harms due to the safety risks associated with this class of drugs, including their association with physical dependence, substance use disorder, overdose and death. Physical dependence occurs with continued use of opioids over time, and can make it difficult to stop taking these medicines. Furthermore, people who are physically dependent on opioids may experience withdrawal symptoms if they stop using the drug abruptly. Long-term use of opioids can lead to development of tolerance, making higher doses necessary to maintain the intensity of their effects. Opioid overdose is more likely at higher doses and can lead to death. Taking an opioid with alcohol or other sedating drugs increases the risk of overdose and death. Before the 1990s, prescription opioids were primarily used for palliative care, cancer pain, or post- surgical pain. In the late 1990s, rates of opioid prescribing grew rapidly. Canadians are the second highest per capita consumers of prescription opioids in the world, and their use of prescription opioids increased by 203% between 2000 and 2010.