Title of Session: Restricting the Marketing and Advertising of Opioids in Canada Date of Session: September 5, 2018

Transcription

1 Title of Session: Restricting the Marketing and Advertising of Opioids in Canada Date of Session: September 5, 2018

2 Purpose To update stakeholders on Health Canada s actions to date, and to consult on further restricting the marketing and advertising of opioids 2

3 Background Approximately 4,000 opioid-related deaths in 2017 Prescription opioids have contributed to the current crisis Canadians are the second highest users per capita of prescription opioids in the world, and rates of opioid prescribing and opioid-related hospital visits and deaths have been increasing Industry s marketing of opioids to health professionals can unduly influence prescribing practices Stakeholders have voiced concerns about industry s marketing practices The Government of Canada is taking immediate measures to address the marketing and advertising of prescription opioids 3

4 Examples of marketing and advertising activities Activities Print material and information shared at conferences (e.g. ads in journals, promotional messages) Design of continuing education courses or materials Proactive sales rep visits to distribute information and materials, including drug samples Industry funding of speakers, conferences, and events, gifts, meals Target Audience All health professionals, including: Family physicians Surgeons Specialists (including pain) Registered nurses and nurse practitioners Dentists Pharmacists Medical students 4

5 Evidence on industry marketing influence on prescribing practice The information provided by industry to health care practitioners is less likely to include the harms compared to the benefits of a drug Industry s marketing and advertising can unduly influence physician prescribing, contributing to increased sales and availability of prescription opioids Physicians are often unaware of the impacts these marketing techniques have on their drug product knowledge which can lead to more frequent, expensive and poorer quality prescribing 5

6 Health Canada is taking action On June 19, 2018, the Minister of Health announced actions to address the marketing and advertising of opioids: A public consultation on the Government of Canada s intention to restrict prescription opioid marketing and advertising A proactive approach to monitor marketing and enforce existing rules around improper advertising, funded by $5M over 5 years A call on opioid manufacturers and distributors to voluntarily cease opioid marketing activities to health care professionals in Canada 6

7 Regulating the Advertising of Opioids Advertising: includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device - Food and Drugs Act The advertising of opioids directly to the public is prohibited Opioid drugs authorized by Health Canada can be advertised to health care practitioners provided that the advertisement aligns with the terms of market authorization Health Canada strongly encourages advertising be pre-cleared by external bodies Health Canada reviews complaints if: The advertising contravenes the Act and regulations The advertising presents significant health risks The drug is unauthorized for sale in Canada The complaint is not resolved through the pre-clearance agencies mechanisms 7

8 Recent regulatory changes on opioid advertising New regulations published in May 2018 provide the Minister of Health the authority to add or amend terms and conditions on opioid products These will include risk management plans which will require all opioidrelated materials that would be provided to health care professionals be pre-cleared by an external body This pre-clearance would verify that advertising of opioids: Presents balanced information on benefits and risks Aligns with the product monograph Is not false or misleading 8

9 Health Canada has moved from reactive to proactive monitoring Previous Health Canada acted on complaints received regarding opioid advertising New comprehensive approach announced June 2018 Health Canada is now: Proactively monitoring by identifying and responding rapidly to non-compliance, and continuing to address complaints received Moving to mandatory preclearance of opioid related advertising materials Monitoring advertising trends Making it easier to report suspect industry advertising activities 9

10 What we heard through consultation Health Canada received 41 responses to the Notice of Intent to restrict the marketing and advertising of opioids from June 19 to July 18, 2018 Stakeholders were supportive of Health Canada taking federal action to restrict opioid marketing and advertising: Some recognized the need for marketing and advertising restrictions for all prescription drugs, including opioids Others stated transparency and disclosure requirements could be considered as a means of achieving better regulatory oversight of marketing and advertising of opioids 10

11 What we heard through consultation Health Canada heard from stakeholders that it is important that any marketing and advertising restrictions consider the following: Continue allowing access to educational or scientific information about opioids, including treatments for opioid use disorder Ensure individuals with acute or chronic pain, and those with opioid use disorder, continue to have access to the treatments they need The factors contributing to the opioid crisis are complex and therefore a range of actions are required, beyond addressing the marketing and advertising of prescription opioids 11

12 We want to hear from you Table discussion: 30 minutes What impact would further restrictions to the marketing and advertising of opioids have on: Healthcare professionals? Patients with acute or chronic pain? People living with substance use disorder? Others, such as individuals or a group/organization you represent? 12

13 Reporting back Please limit comments to one key theme per table Written comments will be collected at the end of the session Additional comments can be sent to: by September 21 13

14 How you can stay involved Additional comments can be sent to by September 21 Visit to keep up to date You can also share your experience and/or knowledge of opioidrelated industry activities that may influence health care professionals A written summary of this session will be made available in the coming months 14

15 THANK YOU Additional comments can be sent to: by September 21 15

16 References National report: Apparent opioid-related deaths in Canada. Published Available at International Narcotic Control Board. Narcotic Drugs Technical report: Estimated World Requirements for 2017 Statistics for Canadian Institute for Health Information - Pan-Canadian Trends in the Prescribing of Opioids, 2012 to Published in 2017; available at: Opioid crisis having significant impact on Canada s health care system (2018); available at: Dhalla, I. et al Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ. 181(12). Lexchin, J et al. The danger of imperfect regulation: Oxycontin use in the United States and Canada. International Journal of Risk & Safety in Medicine, 23, Van Zee, A The promotion and marketing of oxycontin: commercial triumph, public health tragedy. Am J. Public Health. 99 United States General Accounting Office. December Report to Congressional Requesters. Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem. GAO Mintzes, B. et al. Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States. Journal of General Internal Medicine, 28 (10) October Robertson, C. et al Effect of Financial Relationships on the Behaviours of Health Care Professionals: A Review of the Evidence. Journal of Law, Medicine & Ethics Sah, S. and Fugh-Berman, A. Physicians under the Influence: Social Psychology and Industry Marketing Strategies. Journal of Law, Medicine & Ethics. Fall 2013 Wazana, A. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? JAMA 283, no 3 (2000). Hadland, S. et al Association of Pharmaceutical Industry Marketing of Opioid Products to Physicians with Subsequent Opioid Prescribing. JAMA. Hadland, S. et al Industry Payments to Physicians for Opioid Products, AJPH. Vol 107 (9). Spurling, G. et al Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians Prescribing: A Systematic Review. PLOS Medicine 7. 16