HESA Committee Report
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Mr. Ben Lobb Dear Mr. Lobb: I am pleased to respond on behalf of the Government of Canada to the Second Report of the Standing Committee on Health entitled Government’s Role in Addressing Prescription Drug Abuse, tabled in the House of Commons on April 10, 2014. On behalf of the Government of Canada, I wish to thank Committee members for this extensive and valuable study. The Government of Canada welcomes the Committee’s recommendations. The abuse of pharmaceutical drugs has emerged as a leading consumer health and safety issue in Canada, marked by steep increases in rates of consumption, addiction, and death due to overdose. The Government of Canada is committed to doing our part to ensure that Canadians can safely benefit from prescription drugs while protecting families and communities from the devastating impacts of abuse. As announced in the 2013 Speech from the Throne and Economic Action Plan 2014, the Government has committed to expanding the scope of its National Anti-Drug Strategy to address prescription drug abuse. As highlighted throughout the Committee’s Report, prescription drug abuse is a complex societal issue that cannot be addressed by the actions of one level of government working in isolation from its partners. Combatting the abuse of prescription drugs requires collaboration from a number of stakeholders, including healthcare providers, federal, provincial and territorial governments, law enforcement, and community leaders. To articulate the Government’s recommendations to the challenges identified by the Committee, this response is organized along the themes of the Committee’s report. Regulation of the Pharmaceutical Supply Chain The Committee’s recommendations highlight the important role that the federal government plays in helping to combat prescription drug abuse through its oversight of the drug supply chain. As noted in the Committee’s Report, the regulation and oversight of prescription pharmaceuticals marketed in Canada draws upon two distinct legislative frameworks; namely, the Food and Drugs Act and the Controlled Drugs and Substances Act (CDSA). As part of its ongoing commitment to being a modern and effective regulator, the Government is regularly examining and updating its legislative frameworks with a view to identifying areas for improvement. The Government shares the Committee’s concerns regarding the rising rates of addiction and overdose deaths associated with the abuse of prescription drugs. Health Canada is open to studying how information concerning the harms associated with the abuse of prescription drugs outside of their intended medical use is considered within the regulatory frameworks governing the approval, sale and distribution of these products. As part of this work, the department will carefully consider whether amendments to the regulatory and policy framework are necessary. Health Canada regularly takes into consideration decisions made by other trusted regulatory authorities and actively engages in international cooperation initiatives. On the specific issue of prescription drug abuse, Health Canada has been closely following the work of the United States Food and Drug Administration and Office of National Drug Control Policy practices with respect to tamper-resistant formulations of prescription drugs. As detailed in the Committee’s Report, several pharmaceutical manufacturers are in the process of developing new formulations of opioids, designed to resist a number of common tampering methods and potentially provide barriers to abuse. While the science around tamper-resistance continues to evolve, the Government is encouraged by these efforts as they offer the potential to be an effective tool in reducing the overall incidence of prescription drug abuse, without compromising the therapeutic efficacy of the drug. The Government will consult with the public, provincial partners, industry, international counterparts and other key stakeholders as it considers the potential role of tamper resistant features in helping to curb prescription drug abuse. As a next step, Health Canada is developing a guidance document aimed at providing direction to companies interested in advancing tamper-resistant formulations of prescription pharmaceuticals. In April 2014, Health Canada reconvened a Scientific Advisory Panel to seek external advice on the data requirements and potential label claims for tamper-resistant formulations of opioid drugs. The Department is also seeking input from provinces and territories as well as industry representatives as it looks to finalize its guidance document. The Government also recognizes the importance of providing Canadians and their healthcare providers with the information they require to make informed decisions about the use of medications with high addiction potential. Pharmaceuticals approved for sale in Canada have a Product Monograph that outlines information regarding the safe and effective use of a drug and that includes information such as contraindications, warnings, precautions, adverse reactions, drug interactions, and symptoms and treatment of an overdose. The potential for dependence, tolerance and abuse are included in Product Monographs for all controlled release opioids drug products. The statements are located in the Warnings and Precautions section of the Product Monograph, as well as throughout other sections, including in the information that is targeted to the consumer. Health Canada has to negotiate with pharmaceutical companies any changes to labels of their products while the medication remains on the market. Although the Minister of Health has the power to revoke a company’s marketing authorization, more harm could be caused by pulling the drug from the market than by leaving it on the market without revising the label. The proposed legislative amendments to the Food and Drugs Act within Bill C-17 (Vanessa’s Law) would allow Health Canada to address this issue by providing the Minister of Health with the power to compel drug companies to revise labels to clearly reflect health risk information, including the risk of abuse and addiction of a prescription pharmaceutical. The pharmaceutical industry also has an obligation to market the sale of their products in a responsible manner and should be held accountable if they engage in illegal marketing practices that distort the safety profile of their products. The Department works with the industry and health care professional associations to ensure that all parties are aware of their respective obligations regarding the lawful promotion of pharmaceutical products in Canada. Advertising material for prescription drugs directed to health professionals is reviewed and precleared by an independent agencies recognized by Health Canada (i.e. the Pharmaceutical Advertising Advisory Board, Advertising Standards Canada). Health Canada has also contacted every provincial and territorial College of Physicians in Canada to inform them about issues related to illegal advertising by their members and has issued a specific policy clarification document intended for physicians. The amendments to the Food and Drug Act proposed within Vanessa’s Law will strengthen the Government’s ability to take swift and decisive action in situations where the rules are not being followed. Vanessa’s Law proposes to provide the Government with an injunction power which will allow the Minister of Health to apply to a court to direct a person to refrain from an action that constitutes a violation of the Food and Drugs Act. This will provide a faster means to stop prohibited advertising than through a prosecution. As outlined in Economic Action Plan 2014, the Government will continue to take action to prevent the diversion of prescription drugs into the illicit market. In February 2014, Health Canada sought input from a broad range of health, public safety, industry and justice stakeholders on their views regarding any gaps and suggested improvements to the CDSA and its regulations. As part of the feedback received, stakeholders recommended that the regulations under the CDSA be clarified to provide clear and consistent guidance on the destruction and return of controlled substances and other pharmaceuticals at high risk of diversion. Health Canada recognises the importance of standardized procedures and guidelines governing the destruction and return of unused controlled substances. Health Canada has issued guidance to licensed dealers, pharmacists, practitioners and persons in charge of hospitals outlining the procedure to follow to dispose of narcotics and other controlled drugs. Through the Healthy Canadians website, Health Canada also provides guidance to Canadians on the procedures to follow to dispose of their unwanted medicine. Going forward, Health Canada will also consider whether additional regulatory changes are required to support the safe and timely destruction of controlled substances. Support for a Pan-Canadian Strategy to Address Prescription Drug Abuse The Committee recognized the importance of a coordinated response from all levels of government and stakeholders to respond to the issue of prescription drug abuse and identified the Pan-Canadian Strategy entitled, First Do No Harm: Responding to Canada’s Prescription Drug Crisis, developed by the Canadian Centre on Substance Abuse (CCSA), as an important tool to guide collective action. The Government agrees with Committee’s recommendation and considers the “First Do No Harm” report as an important roadmap that will help to inform the Government’s actions as we expand Canada’s National Anti-Drug Strategy to include prescription drug abuse. Consistent with the recommendations put forward in the “First Do No Harm” report, Economic Action Plan 2014 is proposing to invest an additional $44.9M over the next five years to support the following priorities: educating Canadian consumers on the safe use, storage and disposal of prescription drugs; enhancing prevention and treatment services in First Nation Communities; increasing inspections to minimize the diversion of prescription drugs; and, building surveillance data to track and monitor prescription drug abuse in Canada. The Government of Canada will continue to work with groups like the CCSA, different levels of government, doctors, pharmacists, First Nations representatives, law enforcement and addictions specialists to help combat prescription drug abuse. This past January, I was pleased to co-host with the CCSA a National Symposium on reducing Prescription Drug Abuse that focused on identifying actions to address prescription drug abuse under the three action plans of the National Anti-Drug Strategy: Prevention, Treatment, and Enforcement. This event brought together government and First Nations leaders with experts in the health and law enforcement fields to take collective action on prescription drug abuse. Best Practices for Prevention and Raising Awareness The Committee identified improved public awareness of the dangers of prescription drug abuse as well as additional tools to promote sound prescribing practices as important elements of a comprehensive strategy to address prescription drug abuse. Preventing drug use among young people is one of the fundamental pillars of Canada’s National Anti-Drug Strategy. As part of the National Anti-Drug Strategy (NADS), the Government helps to provide information to those most affected by drug use, including parents, young people, educators, law enforcement authorities, and communities. This is accomplished in part through Health Canada’s Drug Strategy Community Initiatives Fund (DSCIF), which provides approximately $9.6M per year in contribution funding to support a variety of recipients in delivering health promotion and prevention projects that facilitate the development of national, provincial, territorial, and local community-based solutions to drug use and promotes public awareness of substance abuse issues. With the expansion of NADS to include prescription drug abuse, 34 projects have already been expanded to include a focus on the dangers associated with the abuse of prescription drugs. Building upon the success of Canada’s youth drug prevention mass media campaign (DrugsNot4Me), Economic Action Plan 2014 proposes additional federal funding to increase awareness about the risks associated with prescription drug abuse, and increase knowledge about how to properly and securely store, monitor and dispose of prescription drugs. As highlighted in the Committee’s Report, inappropriate prescribing practices are a contributing factor to the rising rates of prescription drug abuse. Health Canada agrees that tools such as the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain can play an important role in supporting sound prescribing practices. Health Canada is working with provincial and territorial partners to facilitate the development and sharing of best practices with respect to the prescribing practices of pharmaceuticals. In support of this work, the Canadian Institutes for Health Research’s (CIHR) Drug Safety and Effectiveness Network is supporting a project to develop an online warehouse of strategies that promote the appropriate use of prescription opioids. Through this project, it is expected that communities affected by opioid abuse will have access to information on effective strategies for tackling this public health problem. Building on these efforts, the Government is also proceeding with a targeted call for proposals to facilitate the development of new evidence-based guidelines for drugs at high risk of abuse, where guidelines do not exist. It will also support developing prescriber education tools and mechanisms to improve the uptake, monitoring and evaluation of existing guidelines. In light of the rising number of overdose deaths linked to prescription drugs, the Committee’s report also recommends that Health Canada examine the risks and benefits of the opioid antagonist naloxone in addressing prescription drug abuse. In Canada, naloxone has been approved as a prescription pharmaceutical for the reversal of opioid respiratory depression (i.e., overdose) for over 40 years. Health Canada’s approach to naloxone is in line with that of the United States Food and Drug Administration, where the pharmaceutical is also available by prescription. Naloxone is generally used in clinical settings as an emergency treatment for opioid overdose. Health Canada makes naloxone available in First Nations communities where primary care services are delivered for management of opioid overdose. Health Canada has requested that the Canadian Agency for Drugs and Technology in Health undertake a review of the potential risks and benefits of making naloxone available in home or community settings, where it would be administered by non-health professionals. Finally, the Committee recommends that Health Canada consider the merits of introducing federal legislation that would exempt individuals seeking help for themselves or others during overdose situations from criminal prosecution for trafficking and possession of controlled substances. The Government recognizes that it may not always be in the public interest to prosecute an individual seeking assistance during an overdose situation. However, law enforcement and the Crown are best placed to exercise their discretion when assessing the circumstances of a particular case to determine when it is or is not appropriate to lay charges or pursue a prosecution. Monitoring and Surveillance The Committee highlighted the importance of building Canada’s surveillance capacity in order to help identify the scope of the prescription drug abuse, promote appropriate prescribing, and prevent diversion of prescription drugs from the pharmaceutical supply chain. As outlined in Economic Action Plan 2014, the Government recognizes that it has an important leadership role to play in terms of supporting pan-Canadian data collection and reporting efforts with respect to prescription drug abuse. Health Canada collects and monitors a broad range of data related to prescription drug abuse. The Department currently funds the Canadian Alcohol and Drug Use Monitoring Survey that helps to track the use and abuse of opioid pain relievers, sedatives and stimulants, and the Canadian Student Tobacco, Alcohol and Drugs Survey, which collects similar data for students in grades 6 to 12. The Department also collects and monitors data related to the reporting on losses and thefts of prescription drugs. In the fall of 2012 new measures were introduced specifically to monitor the potential diversion of controlled release oxycodone products, including generic versions of OxyContin. Licensed dealers are now required to report to Health Canada sales of these products separately from those of other products, including spikes in sales and changes in distribution patterns, as well as any unusual orders. Health Canada is also working in partnership with its provincial and territorial counterparts to build a more comprehensive picture of prescription drug abuse in Canada. An important component of this work involves building the foundation for a pan-Canadian surveillance plan for prescription drug abuse to identify key indicators and data required to identify emerging patterns of prescription abuse. As highlighted in the Committee’s report, with its proven track record in establishing national data standards, the Canadian Institute for Health Information is well positioned to contribute to these efforts. Prescription Monitoring Programs help to detect unusual prescribing patterns and provide an opportunity for education. The programs, currently operating in some, but not all, provinces and territories, monitor trends in prescribing practice and help to identify patients receiving prescriptions from more than one physician or ‘double doctoring’. Health Canada’s Non-Insured Health Benefits (NIHB) Program has a Prescription Monitoring Program that closely monitors First Nations and Inuit clients whose utilization profiles indicate that they are at high risk of misusing certain drugs such as opioids, stimulants and sedatives. Clients in the prescription monitoring program face restrictions in terms of the approval process; all claims for these drugs must be pre-authorized by a pharmacist in the NIHB Program, or the client restricts themselves to seeing one physician for prescriptions for these drugs. Health Canada is working with jurisdictions to establish a national prescription monitoring network. With proper privacy safeguards in place, the network will facilitate sharing information and best practices across jurisdictions as well as help to inform their development in other provinces and territories that currently do not have established monitoring programs. In support of this important work, CIHR through its Canadian Research Initiative in Substance Misuse is funding a team of researchers and service providers to evaluate existing prescription monitoring programs with a view to defining the core components that should be shared across all prescription monitoring programs. As highlighted by the Committee, comprehensive and timely adverse drug reaction reporting has the potential to provide important data that can contribute to a better understanding of the harms associated with prescription drug abuse. Under the Food and Drugs Act and its regulations, market authorization holders must report all serious adverse drug reactions associated with their products to Health Canada including reactions of drug abuse and dependence. With the passing of Bill C-17 (Vanessa’s Law), the reporting requirement for serious adverse drug reactions would be extended to prescribed healthcare institutions. Reportable reactions could include those that result in hospitalization, disability, and even death, and can be a consequence of prescription drug abuse and dependence. Health Canada has also partnered with Canadian poison control centres, in a pilot project, to obtain adverse reaction information on health products. Poison control centres receive a large number of calls related to accidental and intentional misuse and overdose associated with prescription drugs. The Government will continue to work closely with provinces and territories, health care institutions and providers as it works to strengthen adverse event reporting practices across Canada. Prevention and Treatment of Prescription Drug Abuse in First Nations and Inuit Communities The Committee’s Report highlights the importance of working in partnership with First Nations and Inuit communities as the Government looks to expand its prevention and treatment programs under NADS. Health Canada provides funding to support First Nations and Inuit communities to deliver culturally relevant addiction prevention and treatment programming. The primary network of addiction treatment and prevention programming in place is supported through two national federally funded programs: the National Native Alcohol and Drug Abuse Program (NNADAP) and the National Youth Solvent Abuse Program (NYSAP). Implementation of these programs is informed by Honouring Our Strengths: A Renewed Framework to Address Substance Use Issues Among First Nations People in Canada. This framework was funded by NADS and has been successful in strengthening the system of addiction services for First Nations people. NADS funding supports ongoing implementation of the Framework at the community, regional and national levels and has contributed to: re-orienting treatment centres to more effectively meet community needs, more treatment centres achieving accreditation, and, an increase in addiction workers receiving training and certification. Economic Action Plan 2014 proposes to build on this work with additional funding to enhance culturally-based prevention and treatment services in First Nations communities. The Government will continue to engage First Nations partners on prescription drug abuse issues as it looks to expand and build upon existing treatment and prevention services in First Nations communities. Health Canada also welcomes the opportunity to work with the territorial governments and the Inuit leadership on the development of Inuit specific approaches to prescription drug abuse. The Non-Insured Health Benefits (NIHB) Program has carried out a utilization review of specific drugs of concern among the Program’s Inuit client base and has shared the results with Inuit Tapiriit Kanatami (ITK). Health Canada has an existing network that could support ITK in its efforts to develop an Inuit specific approach to issues surrounding prescription drug abuse. As highlighted in the Committee’s Report prescription medications are quickly becoming the first course of action that is used to treat chronic pain, with little consideration of alternative pain management services or traditional healing options. While provincial and territorial governments have primary responsibility for the design and delivery of health care services, Health Canada supports the assessment and dissemination of innovative multi-disciplinary health care delivery models. For example, Health Canada is currently funding 10 Mental Wellness Teams, a community-based and multi-disciplinary team approach to providing mental health and addictions services in First Nations and Inuit communities that blend or enhance traditional, cultural and mainstream approaches. As part of Health Canada’s ongoing collaboration with provincial and territorial partners on prescribing practices and the treatment of pain, the Government will work with provinces and territories to consider the role of multidisciplinary and alternative pain management programs. Combatting the Stigma of Addiction As noted in the Committee’s Report, many people in recovery remain silent about their experiences in part because of the stigma associated with addiction. The Government recognizes that by celebrating individual successes we can help inspire, educate and empower more people to begin their own journey towards recovery. In December I was proud to co-host with the Canadian Centre on Substance Abuse (CCSA) a roundtable on treatment and recovery at Cedars at Cobble Hill Addiction Treatment Centre on Vancouver Island. The roundtable provided an excellent opportunity to initiate a dialogue with physicians and leading addiction recovery specialists to discuss practical solutions to support Canadians in prevention and recovery. Building off the success of the roundtable discussions, I intend to work with stakeholders to organize a National Symposium on Recovery and Addiction. The Symposium would help to draw experts and stakeholders together to deepen the dialogue and to identify potential measures to accelerate expansion of the recovery model in Canada. The importance of combating stigmatization, marginalization and discrimination of those in recovery is expected to be a key topic of discussion at the symposium. Health Canada also continues to work with addiction experts, communities, and individuals in an effort to address the stigma associated with addiction. As highlighted above, Health Canada, in partnership with First Nations Leaders, has developed a renewed framework for First Nations addiction services. The Framework’s community-based approach to prevention and treatment services includes guidance on how to address the stigma of addiction. The Department is also working with First Nations partners on the development of a First Nations Mental Wellness Continuum Framework. The Framework is expected to be finalized in fall 2014 and will include the identification of promising practices at the community level to improve access to mental health and addictions services; a key component of improved access is the reduction of stigma. The Committee’s report also highlights the importance of including guidance to Canadians on how to properly store and dispose of prescription drugs as part of the Government’s efforts to inform Canadians about the risks associated with prescription drug abuse. The Government agrees with this recommendation as the home represents one of the most common sources of supply for misuse and abuse of prescription drugs. An immediate promotional activity undertaken by the Government along with our partners, the National Association of Chiefs of Police and Partnership for a Drug Free Canada, is to encourage Canadians to return their unused or unwanted prescription drugs to take back programs or to local pharmacies. National Prescription Drug Drop Off Day took place in communities across the country on May 10. Last year, Prescription Drug Drop Off Day saw between two and to three tonnes of unused medications returned. Conclusion In closing, I would again like to thank the Committee for this important work. This report is both timely and highly relevant and it has helped to shed light on actions the Government should carefully consider as we continue to expand and strengthen our efforts to address prescription drug abuse. I trust that this response articulates the Government’s commitment to work with all partners to respond to the growing crisis of prescription drug abuse in Canada. Sincerely,
Rona Ambrose Attachments – Appendix – List of Recommendations Appendix to the Letter
Regulation of the Pharmaceutical Supply Chain
Support for a Pan-Canadian Strategy to Address Prescription Drug Abuse
Best Practices for Prevention and Raising Awareness
Monitoring and Surveillance
Prevention and Treatment of Prescription Drug Abuse in First Nations and Inuit Communities
Combatting the Stigma of Addiction
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