What We Heard: Summary of Responses to the Notice of Intent to Restrict the Marketing and Advertising of Opioids

Introduction

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 rapidly. Prescriptions written by health care professionals are a common source of opioids in Canada. Health care professionals receive information from a variety of sources to inform their prescribing decisions and advice to patients, including from the pharmaceutical industry.

Recognizing the influence industry marketing and advertising activities have on prescribing practices, Health Canada released a Notice of Intent (Notice) to restrict the marketing and advertising of opioids to health care professionals. The Notice was open for a 30 day consultation period from June 19, 2018 to July 18, 2018.

This What We Heard Report contains a summary of the feedback about Health Canada's Notice, reflecting the views of individuals and groups who chose to respond. As such, this summary cannot be accurately generalized to the wider Canadian population and does not necessarily reflect the Government of Canada's position.

Who provided feedback to Health Canada?

The Notice was open for comments from all interested stakeholders. In total, 42 responses were received, including from health care professionals, patients, academics, and the pharmaceutical industry. The breakdown of responses by stakeholder group is shown in Figure 1.

Figure 1: Number of responses to the Notice of Intent to restrict the marketing and advertising of opioids, by stakeholder group

Respondent Type	Total
Health Care Professionals and Health Care Professional Associations	21
Patients and Patient Organizations	11
Industry and Industry Associations	6
Provincial Government Officials	3
Academia	1Footnote *
Total count	42

What did stakeholders say?

Summary of Key Themes

Respondents shared their views on experiences related to the marketing and advertising of drugs, the current system in place to review marketing and advertising material as well as impacts of drug marketing material on prescribing practices.

Respondents were supportive of federal action to address Canada's opioid crisis, and provided various suggestions for actions that could help reduce the harms related to opioids. Specifically related to the marketing and advertising of opioids, respondents were generally supportive of restrictions and noted the importance of unbiased educational information to encourage appropriate prescribing. Many respondents noted that the measures taken to restrict the advertising and marketing of opioids should not inadvertently limit the availability of evidence-based information.

Many respondents also underscored the importance of ensuring that individuals with acute or chronic pain, and those with opioid use disorder, continue to access the treatments they need.

Respondents provided suggestions for a range of actions to achieve better regulatory oversight of marketing and advertising of opioids, such as mandatory transparency and disclosure requirements. Additionally, some respondents noted that the factors contributing to the opioid crisis are complex, and therefore, actions are required beyond addressing the marketing and advertising of prescription opioids.

Summary of Feedback

Health Care Professionals and Health Care Professional Associations

Respondents highlighted that accurate, factual information and educational activities are essential for supporting health care professionals in their roles as they provide good quality patient care. Health professional associations support taking further action, though some respondents expressed concern that restrictions on marketing and advertising of opioids could lead to reduced access to opioids for pain treatment and opioid use disorder treatment. In summary:

Marketing and Advertising

• Reflecting on personal experience, some respondents described industry's information and sponsored events for health care professionals as biased and containing promotional content. Other respondents indicated that the information and learning opportunities provided by industry contained valuable information about effective pain management.
• Advertising that omits or de-emphasizes information on a drug's risks or adverse effects is potentially harmful.

Unbiased Educational Information

• Health care professionals have a role in minimizing industry's bias in continuing medical education by following existing standards, guidelines and codes of ethics related to their relationships with the pharmaceutical industry.
• Educational programs and training are important, and a distinction should be made between activities that are promotional and those that support safe and appropriate prescribing.
• Treatments for opioid use disorder are a pressing need, so restrictions to advertising and marketing should not reduce health care professionals' access to educational information and training in this area, reduce the development of new treatments, or prevent the pharmaceutical industry from notifying the public of their products.
• Some respondents indicated educational materials or programs developed or delivered by industry should be reviewed by a third party to ensure they are factual and accurate, while others responded that educational materials should not be developed by pharmaceutical manufacturers. The materials should communicate both benefits and risks, and include details that help in decision-making, such as non-opioid treatments available, guidelines for use, efficacy of treatment and cost effectiveness.
• There is a need to address challenges in funding for continuing medical education for pain management using both pharmaceutical and non-pharmaceutical options.

Access to Treatments

• Restricting marketing of opioids could have negative impacts for patients living with pain if they do not have access to the most appropriate treatments for pain management, due to less information being shared with health care professionals about the risk of drug interactions, new technologies and new drugs.

Range of Actions

• Illegal opioids are a large contributing factor to the opioid crisis. Therefore, efforts to restrict marketing and advertising of prescription opioids may have limited effectiveness in addressing the current crisis.
• There is a need to restrict promotional activities related to opioids, as well as for all prescription and non-prescription drugs. There should be strict penalties for non-compliance, including criminal charges if appropriate.
• Restrictions should apply to all forms of industry communication including verbal, written, electronic, social media communications and personal visits from sales representatives to health care professionals.
• Restrictions could extend to advocacy groups that receive industry funding.
• The current, voluntary pre-clearance system for drug advertising by agencies such as the Pharmaceutical Advertising Advisory Board needs to be more robust and systematic and should define opioid-specific advertising criteria.
• There is support for greater transparency, disclosure and mandatory reporting of marketing activities, funding and incentives provided by pharmaceutical companies to health care professionals, associations and patient groups.
• Physicians should be prohibited from receiving industry payments, including for providing educational lectures to other health care professionals. Health care professionals should be compensated for their time as speakers, but the amount of monetary compensation could be limited.
• Industry could be permitted to fund educational programs if the activity was certified by a regulatory body. Similarly, any industry funding to organizations should be used for unbiased learning events.
• New opioid products could be approved with conditions that would, for example, require additional studies to verify clinical benefits and identify gaps in knowledge.

Patients and Patient Organizations

The majority of patient organization respondents expressed concerns with the intent to restrict the marketing and advertising of opioids, due to potential unintended consequences and impacts on patients. Individual members of the public, including people who live with pain, shared a range of comments that largely focused on the importance of individuals having access to opioids to manage pain. In summary:

Marketing and Advertising

• The advertising and marketing of opioids is part of a larger, more complex problem.
• Restrictions to activities such as journal advertisements would be unlikely to have an impact on prescribing practices.

Unbiased Educational Information

• Educational programs and materials for prescribers to support appropriate prescribing through education on pain management, use of alternative therapies, and new and evolving evidence, are important.
• The pharmaceutical industry plays an important role in supporting continuing medical education and sufficient oversight is in place.
• Educational events sponsored by industry provide valuable information to practicing clinicians.

Access to Treatments

• Restrictions on marketing could lead to reductions in prescribing or dosages, create access problems for those in pain, and further stigmatize those who live with pain and prescribers who prescribe opioids for pain control.
• It can be challenging to access prescription opioids to manage pain. Reducing access to prescription opioids would leave patients with fewer options for pain management, would negatively affect their quality of life, and may lead people to use illegal drugs.

Range of Actions

• This initiative should restrict the marketing and advertising of all drugs, and not just opioids. While the opioid crisis is a complex and multifaceted issue, illegal opioids are the principal driver, rather than the marketing of prescription opioids.
• The federal government taking immediate action on drug marketing is supported. The importance of hearing from people who are immediately affected by opioid use when developing potential restrictions should inform this action.

Industry and Industry Associations

Respondents from the pharmaceutical industry expressed concerns with restrictions that might impact their ability to provide materials to health care professionals to support the safe use of products, and reiterated the importance of industry in continuing to provide such information. Other industry respondents highlighted the potential benefits of regular mandatory reporting on the marketing and advertising of opioids. In summary:

Marketing and Advertising

• The pharmaceutical industry raised concerns with the premise of the proposal, suggesting it is simplistic to frame interactions between industry and health care professionals as marketing, indicating mandatory reporting of advertising activities would be redundant, and noting that many identified activities should not be considered advertising.

Unbiased Educational Information

• Being able to disseminate non-promotional information to health care professionals related to appropriate prescribing and the safe use of prescription medications is important.
• Health care professionals' access to educational programs and materials is fundamental. Evidence-based, independently accredited, continuing health education programs are essential to improving clinical care and patient outcomes.

Access to Treatments

• Any restrictions should take into account potential impacts and/or unintended consequences on patients with chronic pain and those living with opioid use disorder. In particular, products or information that aim to reduce or prevent risks or harms associated with problematic opioid use warrant particular consideration when setting restrictions. Some respondents believe that recent measures requiring risk management plans for opioids are beneficial, while questions were raised as to whether regulations are needed.

Range of Actions

• Other respondents noted that addressing the opioid crisis has economic and social gains, and transparency measures such as mandatory reporting on the marketing and advertising of opioids would enable investors to hold companies accountable.

Provincial Government Officials

Respondents in this group provided various comments about potential restrictions. In summary:

Unbiased Educational Information

• Opioid prescribing decisions are not solely influenced by industry marketing.
• It is important for marketing materials to contain an equal balance of information on the potential harms and benefits of opioids.
• Any restrictions should still allow for information, education and training for health care professionals related to appropriate opioid use, as well as the distribution of clinical research and educational materials. This can help encourage evidence-based treatment decisions by health care professionals which can include opioid and non-opioid treatments.

Access to Treatments

• Restrictions must not affect access for individuals seeking pain management.

Range of Actions

• Measures to improve appropriate prescribing will assist in addressing the opioid crisis.
• Increased transparency of the marketing and advertising of opioids is important. Regulatory bodies should be engaged to enact appropriate policies to encourage compliance.

Academia

The single submission represented 11 academics from various academic institutions in Canada, the United States and Australia. This submission strongly supported restricting the marketing and advertising of opioid products, while also emphasizing that the effects of drug promotion in general are not limited to opioids. In summary:

Marketing and Advertising

• The current opioid crisis can, in part, be attributed to the pharmaceutical industry's marketing practices due to their considerable resources for promotion, and promotional materials often offering poor quality information.
• Physicians are exposed to drug promotion in multiple ways, noting that evidence suggests that reliance on information from pharmaceutical companies is associated with less appropriate prescribing.

Range of Actions

• Improved regulation of drug promotion is needed. Further, the Pharmaceutical Advertising Advisory Board, which reviews and pre-clears drug advertising, is not sufficiently independent from the influence of the pharmaceutical industry and a new, independent regulatory agency should be established.
• Specific to opioids, there should be increased oversight of promotion by Health Canada, restrictions to advertisements, and requirements for companies to develop plans to support appropriate prescribing. Materials to health care professionals should include advice on the de-prescribing of products.

Closing Remarks

We thank all respondents for providing comments on this proposal.

The feedback received will inform next steps for federal action including policy development and potential restrictions. We are continuing to engage stakeholders and subject matter experts throughout the fall of 2018.

For more information

Visit our Marketing and Advertising of Opioids page for updates on our work.