441-01431 (Health)

On behalf of Health Canada, we wish to extend our sincere condolences to the family and friends of Grace-Lindsay McSweeney.

Acetaminophen is one of the most commonly used medications for pain (analgesic) and fever (antipyretic). There is significant public reliance on acetaminophen-containing products, as evidenced by the concerns raised and heightened media attention generated by recent shortages of these products. Although generally considered to be a safe medicine when used appropriately, taking more than the recommended amount of acetaminophen can lead to unintended adverse effects, such as serious and possible fatal liver injuries.

Over the past decade, Health Canada has taken a number of steps to help mitigate the risks of serious liver injury associated with the improper use of acetaminophen products. In 2009, Health Canada issued several public risk communications and updated the Acetaminophen Labelling Standard for non-prescription acetaminophen products to include warnings related to serious (including fatal) liver injury that can be associated with acetaminophen overdose or extended use.

In January 2014, Health Canada completed a safety review, which was followed by a technical discussion in July 2014 on the proposed risk minimization options with key stakeholders, including health professionals, patients, and industry. Through this meeting, the Acetaminophen Education Approach Steering Committee was formed, comprised of representatives from Health Canada and stakeholder associations (which included industry and patient advocacy groups), and was tasked with developing an educational approach to raise awareness of liver injury risks. In addition, they collaborated with Food, Health & Consumer Products of Canada to conduct a survey to examine consumer knowledge of acetaminophen with the goal to inform potential changes to the educational messages and identify possible knowledge gaps in awareness of the risks associated with acetaminophen.

In Fall 2014, Health Canada developed a web page about acetaminophen safety for the Canadian public on the Healthy Canadians website. This information can be found here.

In July 2015, a summary of the review outcome (i.e., Summary Safety Review) was posted on Health Canada’s website, as well as an Information Update on the Healthy Canadians website.

A technical discussion was held in November 2015 with health professionals, patient groups, and industry to discuss the risk minimization options in further detail. The outcome was that a revised labelling standard for non-prescription acetaminophen products was published, which includes stronger warnings, clearer instructions, plainer language, and the addition of a drug facts table on product packages to help consumers better identify products that contain acetaminophen, understand its risks, and use these products as directed. A second outcome was that children's liquid products be supplied with an accurate dosing device to reduce the risk of dosing errors, which was only a requirement for pediatric products.

In January 2016, social media messages about acetaminophen safety commenced on the Healthy Canadians’ Twitter and Facebook pages.

Further to Health Canada’s past and ongoing efforts to support the safe and appropriate use of acetaminophen in Canada, we wish to comment on the following calls to action, as listed in the petition:

       1. Require warning labels about letal overdose risk on all medical products that contain acetaminophen;

All acetaminophen products in Canada are required to include a warning statement warning about taking:

• more than the recommended dose in 24 hours;
• with other drugs containing acetaminophen; and,
• while drinking three (3) or more alcoholic drinks every day (for adult use products only).

Health Canada continually reviews the labelling requirements for acetaminophen-containing and other non-prescription drugs available in a self-selection environment (e.g., over the counter at local drugstores and other general retailers), specifically in the context of informing consumers of severe or possible consequences that may occur when a consumer takes too much of the medication. Health Canada promotes, where possible, increased visibility of the existing warnings, particularly on peel-back labels.

       2. Remove acetaminphen from nonalgesic over-the-counter products and ensure the sale of acetaminophen products be from behind the counter, with a minimum purchasing age; 

The National Association of Pharmacy Regulatory Authorities (NAPRA) is responsible for determining how an over-the-counter drug can be sold in different settings in Canada. NAPRA regulates the practice of pharmacy across Canada, which includes deciding where drug products can be sold, whether it is at a pharmacy or another retail outlet, and the placement of drug products within a pharmacy; this process is referred to as drug scheduling.

Health Canada is an observer of the NAPRA’s National Drug Scheduling Advisory Committee (NDSAC) and will bring the above petition request to the attention of NAPRA for consideration at the next meeting. While ultimately any decision regarding the placement of sale and/or age restrictions would be taken by NAPRA, Health Canada will be available to support NAPRA in any future decision-making with respect to the scheduling of acetaminophen. However, internationally, acetaminophen is largely available via most retail outlets, and assigning a more stringent drug schedule in Canada would be a notable contrast to our foreign regulators. Health Canada seeks to avoid limiting access of these important pain and fever relief therapies to Canadians, and complexities are particularly noteworthy for certain consumer and vulnerable patient populations (e.g., pregnant women with limited safe pain relief alternatives, people who suffer from arthritis in the hands, people who are sensitive or allergic to other analgesics, etc.). Regarding purchasing age restrictions, it remains unclear to Health Canada whether a difference in scheduling, based on indicated subpopulations, could result in real-world impact at point-of-sale. Such a restriction may not be an appropriate mechanism to address intentional overdose, particularly when considering the prominence of acetaminophen-containing products in Canadian households. Limiting access of acetaminophen-containing products to older children and adolescents may introduce unintended consequences (e.g., limit the ability of young Canadians to support aging parents or grandparents, or those suffering from other health complications, such as arthritis, etc.), which could lower the quality of life for many vulnerable Canadians and Canada’s aging population.

       3. Ensure all acetaminophen products be required to have a child lock cap, and reduction on the quantity being sold to 36 units;

Acetaminophen products intended for infants and children are required, in all circumstances, to be packaged in a child-resistant container. Products intended for adults and children aged 12 and over may be sold without a child-resistant container, but require additional labelling, and the manufacturer must make a child-resistant version available for consumer purchase. This approach to labelling and packaging aims to balance the safety considerations to control access of drug products to children while allowing other vulnerable people who require pain relief medication but may have difficulty opening child resistant containers (such as the elderly or people with debilitating arthritis in their hands) to have access to these products. Additionally, in 2021/22, Health Canada created a social media campaign aimed at promoting awareness of safe use and storage of medications, including acetaminophen. Health Canada leveraged messaging through high exposure social medial channels (i.e., Facebook, Twitter, etc.) to educate and inform the public of how to properly and safely store medications, such as acetaminophen, to prevent their access by children. Health Canada will consider options for regular future public awareness communications.

       4. Restrict products to a maximum of 325 mg of acetaminophen per unit dose, thus reducing risk of both intentional and unintentional overdoses; and,

While 325 mg acetaminophen per unit dose provides pain and fever relief for many Canadians, evidence to support greater effectiveness exists for higher-dose acetaminophen products (including 500 mg and 650 mg). Ensuring that Canadians have access to medications to manage their symptoms is an important consideration when evaluating the appropriateness of higher-dose products. For example, these products become critical for people who have trouble swallowing, or for those who take many medications. Any amendments to these limits would require considerable evidence and justification to support that the benefit-risk profile of the drug is not favorable when used as intended.

       5. Offer immediate assistance to the provinces in the provision of mental health counselling for Canadian youth in need.

Our government recognizes the significant mental health challenges being faced by Canadian youth and is committed to supporting their mental health needs. Budget 2023 confirmed that the Government of Canada will increase health funding to provinces and territories by close to $200 billion over 10 years, including for mental health and substance use services and supports. Of this funding, $25 billion will be flowed through tailored bilateral agreements across four priority areas, which includes mental health and substance use health.

This investment will build on the 2017 investment of $5 billion over 10 years to provinces and territories to improve access to mental health and addictions services, which includes a focus on expanding community-based mental health and substance use services for children and youth. One way in which provinces and territories are supporting this priority area is by expanding Integrated Youth Services (IYS). IYS models of care provide locally relevant, effective, youth-focused, and integrated services for mental health, substance use within the community. This includes “one stop shop” integrated youth hubs. There are currently approximately 70 operational integrated youth hubs across Canada and more under development.

All 13 provinces and territories have developed or are developing an IYS network in their regions to implement and advance the IYS model through the sharing of best practices. Provinces and territories could use the new investment to further advance access to IYS for mental health/substance use health.

Another key initiative that Canadians, including youth, can access is the Wellness Together Canada (WTC) portal. The portal, launched in April 2020 in response to the COVID-19 pandemic, provides free, credible information and supports available 24/7 to individuals across Canada in both official languages to help address their mild to moderate mental health and substance use issues.

Through the portal, Kids Help Phone delivers one-to-one counselling via phone and text lines dedicated to youth, so that youth can access services tailored to their needs. PHAC provided more than $14.8 million over 36 months, from April 2020 to March 2023, to Kids Help Phone to provide crisis support to children and youth during the COVID-19 pandemic. WTC also features extensive youth-specific content available through a specific landing page designed for youth to make it easier to access tools and resources dedicated for them.

The introduction of 9-8-8, a national three-digit number for suicide prevention and emotional distress in Canada, is also a priority for our government. Budget 2023 announced $158.4 million over three years to support the implementation and operation of 9-8-8. The number will replace Talk Suicide, and, through this service, Canadians will be able to call or text when in need of immediate suicide prevention and emotional distress support. This number will be activated across Canada on November 30, 2023.

Previous Distress Line Investments

The Government of Canada is committed to supporting initiatives that will help to prevent suicide and provide support to those affected by suicide. This is why we are providing $21 million over five years to the Centre for Addiction and Mental Health (CAMH) to implement Talk Suicide Canada, a pan-Canadian suicide prevention service. Talk Suicide Canada is currently providing suicide crisis support from trained responders, in English and French, and is available by calling toll-free at 1-833-456-4566 (available 24/7), or by texting 45645 between 4pm to 12am ET. This service includes immediate access to information and resources, such as emergency services, referrals, safety plans, and bereavement support.

We are also working with community-based organizations to ensure children and youth, including post-secondary students, have access to mental health supports as they recover from the pandemic and in the long-term. This includes:

• $2M from 2021-26 to CHEO to spread the Aaniish Naa Gegii: the Children’s Health and Well-being Measure co-developed with Indigenous partners;
• $6.8M from 2019-24 to Foundry to help organizations implement integrated models of youth mental health care; 
• $9M in funding to Frayme from 2019-2024 to promote broader implementation of integrated youth services in Canada;
• $7M to the YMCA to spread enhance and spread Y Mind and Mind Medicine programs aimed at 13-30-year-olds with anxiety and depression;
• $2M to the Canadian Mental Health Association to pilot a Campus Peer Support program in five universities; and,
• support to MHCC for the development of the National Standard of Canada for Mental-Health and Well-Being for Post-Secondary Students.

I would like to reiterate my most profound condolences to the family and friends of Grace-Lindsay McSweeney. We are deeply saddened by this tragic loss.