Thank you, Madam Chair, for the opportunity to appear before the Standing Committee on Health to speak to this important issue.
My name is Robert Ianiro, and I am the director general of the Controlled Substances and Tobacco Directorate in the Healthy Environments and Consumer Safety Branch of Health Canada.
I am with several of my colleagues, all of whom are responsible for programs that collectively support the government's ongoing efforts to protect Canadians against the risks associated with prescription drugs.
Dr. John Patrick Stewart is the senior medical director in the Health Products and Food Branch and is able to speak to Health Canada's role in establishing and maintaining prescription drug accessibility while decreasing the risk of abuse associated with certain drugs.
I am also joined by Ms. Debra Gillis and Ms. Sandra Bruce, both directors general from the First Nations and Inuit Health Branch, who are able to speak to the range of activities under way to protect and promote the health of first nations and Inuit.
As committee members will be aware from various media reports and other sources, prescription drug abuse is a public health and safety issue in many areas across the country. It has been marked by increases in rates of consumption and, in many cases, addiction and death due to overdose. While there is little national-level data on prescription drug abuse presently available in Canada, there is growing evidence of the nature and scope of the problem.
You have probably heard media reports about OxyContin and fentanyl. These drugs are potent opioids frequently used for the relief of moderate to severe pain. According to the International Narcotics Control Board, Canada is currently the world's second largest consumer of opioids per capita, second only to the United States.
Opioid pain relievers have been used for the treatment of cancer pain and in palliative care settings for many years. However, in the 1990s, these drugs started to be marketed for treatment of chronic non-cancer pain, like back pain and arthritis. OxyContin quickly emerged as one of the top prescribed opioids for pain management. Unfortunately, OxyContin became very popular for non-medical use due to the euphoric high that users obtain by crushing and injecting this drug. Shortly thereafter, communities began reporting public health concerns related to the abuse of OxyContin, as well as public safety concerns related to its diversion from legal sources to the illicit market.
There is growing evidence that prescription drugs have become popular among youth, and that they increasingly represent a path to addiction for both youth and adults.
There is growing evidence that prescription drugs have become popular among youth, and that they increasingly represent a path to addiction for both youth and adults. According to the most recent Youth Smoking Survey, prescription drugs are now the third most commonly used group of substances among Canadian youth, after alcohol and marijuana.
Several overarching factors contribute to the growth of this problem.
While Canadians understand the dangers involved with illicit drug use, there is not the same understanding of the harms related to prescription drugs. Prescription drugs are commonly perceived as safe. This misconception directly affects consumer practices on use, storage, and disposal of prescription medications.
The second factor relates to inappropriate prescribing practices. Prescribers, including those from the College of Physicians and Surgeons of Ontario, have acknowledged that their lack of knowledge and training for pain management has contributed to the growth of the problem. According to a Canadian study conducted in 2009 on curricula in health professional education, veterinary students receive five times the training on this subject than medical students.
As a result, some Canadians leave their physicians' offices with prescriptions for inappropriate or excessive quantities of powerful medications without proper information about these drugs, and without the appropriate follow-up from their healthcare team.
As a consequence, the demand for treatment for opioid dependence has increased in many jurisdictions. In Ontario, admissions to publicly funded substance abuse centres rose by 129% between 2004 and 2011.
Finally, lack of awareness of safe storage and disposal practices is an important driver. There is evidence that the home represents a common point of access to medications for abuse for many Canadians. Many unused and expired medications remain in unlocked medicine cabinets, making them vulnerable to diversion and abuse.
For example, the results from the 2011 Ontario student drug use and health survey indicated that 67% of youth in Ontario who reported misusing prescription drugs obtained them from within the home as a result of a prescription from a family member.
Effectively combatting prescription drug abuse requires a coordinated and comprehensive response across a broad range of sectors.
Federal, provincial and territorial governments share responsibility for addressing prescription drug abuse. The provinces and the territories are responsible for the delivery of health care services, which includes providing treatment services, and through regulatory colleges and licensing bodies for establishing training requirements and practice standards for health professionals.
This point is reinforced in the recent national prescription drug abuse strategy developed by the Canadian Centre on Substance Abuse, called First Do No Harm.
Provinces and territories have expressed willingness to collaborate with Health Canada to address the issue. Early opportunities for collaboration to support better collection and sharing of information, and improve prescribing practices, were recently endorsed by federal, provincial and territorial ministers of health this past October.
Health Canada's role in preventing prescription drug abuse supports that of the provinces and the territories. This is realized through our role as a regulator under the Food and Drugs Act and the Controlled Drugs and Substances Act, and as a service provider for first nations and Inuit.
I will take a few moments now to speak about Health Canada's role in ensuring the overall safety of drugs on the market, including safeguards that are in place to promote proper use. Under the Food and Drugs Act and its regulations, a new drug will be issued market authorization if, after a risk-based decision-making process, Health Canada determines that the drug demonstrates an acceptable level of safety, substantial efficacy, and high quality.
The regulations require that a manufacturer file a new drug submission with substantial data to support the safety, efficacy, and quality of the drug for its intended use.
Based on the information submitted, Health Canada scientists determine whether the data meet the current standards to support approval and whether a drug should only be available through a doctor's prescription.
Information on addiction and abuse potential is taken into consideration during the review process. If a drug has a significant risk of addiction and/or abuse, substantial data supporting the efficacy of the drug must be shown in a serious condition, such as severe pain, to justify the risks.
Additionally, through the approval of the final product monograph, information on the potential for addiction and abuse is communicated to health care providers and consumers. Physicians are advised to prescribe and handle such drugs with caution, assess patients for their clinical risks for abuse or addiction prior to prescribing the drug, and routinely monitor patients for signs of addiction and abuse.
The product monograph further contains information for the consumer about the dangers of a drug with addiction and abuse potential. Patients are advised to take the medication only as indicated by the treating physician, to tell their doctor if they have questions or concerns about addiction or abuse, and to keep the medication safe, and to never give it to anyone else as it may be abused and cause serious harm, including death.
Manufacturers may also be required to implement a specific risk management plan as a condition for approval. Such plans may include monitoring of events related to abuse and addiction once the drug is on the market, as well as education materials for health care professionals and patients.
Once a drug is on the market, Health Canada monitors its safety through surveillance of serious side effects reported within and outside Canada. As new information becomes available about side effects, the product monograph is updated to inform physicians and patients about the new safety information. The risk management plan can also be altered to address changes in risks, or a drug can be removed from the market if experience with the drug shows that its benefits no longer outweigh its risks.
Several drug classes, such as opioids, central nervous system stimulants and depressants, cannabinoids, and nicotine-like compounds are already well known to be potentially addicting and have abuse liability.
To this end, Health Canada put in place a guideline to assist manufacturers in conducting studies assessing whether a new drug produces acute effects such as euphoria, or drug-liking effects that could lead to addiction or abuse. Results of such studies are required to be included in drug submissions, and help guide benefit-risk assessments and decisions relating to drug approval, scheduling under the Controlled Drugs and Substances Act, prescribing information within the product monographs, information for the consumer, and risk management plans.
Through this work, Health Canada works to establish and maintain prescription drug accessibility, while decreasing the risk of abuse associated with certain drugs. Protecting the health of Canadians remains the primary concern. Public awareness among prescribers, dispensers and patients about the problems with drugs that are addictive or that could be abused promotes good medical practices, fosters dialogue, and more importantly, helps ensure patient access to effective medications while protecting them and others from the potential harms of these types of drugs.
I will now speak briefly to some of Health Canada's work to ensure that First Nations and Inuit have access to health services, including mental health and addictions programs, and to prevent prescription drug abuse in First Nations communities.
While there is limited data available, some first nations have reported significant challenges with the abuse of prescription drugs.
To respond to the serious problem of substance abuse, Health Canada invests approximately $92 million annually in addictions prevention and treatment programming. This investment includes funding to support a network of 55 treatment centres, as well as drug and alcohol prevention services in over 550 community-based prevention programs.
Of note, in 2013-14 Health Canada worked in close partnership with the Ministry of Health in Ontario as well as the Chiefs of Ontario, and invested $2 million to support first nations communities in Ontario where the problem of prescription drug abuse is most acute.
Health Canada's investments in addictions and treatment programs are part of a larger effort to provide first nations and Inuit with a comprehensive system of mental wellness services.
Health Canada also administers the non-insured health benefits program, NIHB. It provides coverage for a limited range of medically necessary goods and services, including prescription drugs, to eligible first nations and Inuit.
Over the last decade, the non-insured health benefits program has introduced a wide range of client safety measures to prevent and respond to potential misuses of prescription drugs to help ensure that First Nations and Inuit clients can get the medications they need without being put at risk.
Examples of these measures include sending automated real-time warning and rejection messages to pharmacies to alert them to situations of potential misuse when a client attempts to fill a prescription that requires a pharmacist's intervention before the claim can be processed. It also includes placing restrictions on the coverage of drugs of potential abuse, including those that present health risks or risk of diversion, and introducing dose limits that limit the amount of a particular drug that a client can receive per day.
To detect patterns of potential inappropriate prescribing and dispensing and other safety concerns, the NIHB program has a formal surveillance program called a prescription monitoring program, PMP.
Though the PMP was originally introduced in 2007 to focus on clients who have been double doctoring, it has since been expanded to address clients who are on high doses of one or more drugs of concern.
Clients whose drug utilization profiles indicate that they are at high risk of misusing certain drugs—opioids, stimulants, or benzodiazepines—are placed in the PMP. Clients listed in the PMP face restrictions in terms of the approval process for these drugs.
Since November 2012, the NIHB has been using the findings of the surveillance work to engage prescribers to gain insight into the reasons behind high doses of opioids and benzodiazepines, and work with them to impose restrictions, taper doses, and encourage the use of alternative non-opioid medications as appropriate.
Preliminary results of these initiatives indicate that the impact is positive. In the last 12 months the number of high-dose benzodiazepine clients has decreased by 36%, and the number of high-dose opioid clients has decreased by 7.5%.
Going forward, the non-insured health benefits program will continue to monitor the use of opioids and other drugs of concern. It will continue to adjust existing limits and introduce new restrictions and measures as appropriate.
NIHB will also continue to work closely with physicians, other prescribers, pharmacists, and other public drug plans in our efforts to ensure the safe use of prescription drugs among first nations and Inuit clients.
Madam Chair, I would like to close my remarks today by spending a few moments talking about the Controlled Drugs and Substances Act and Health Canada's role in the national anti-drug strategy.
The Controlled Drugs and Substances Act, or the CDSA, provides a legislative framework for the control of substances that can alter mental processes and that may cause harm to the health of an individual or to society when diverted to an illicit market or used illicitly. The CDSA has a dual purpose to protect public health and maintain public safety. It prohibits activities such as the production, sale and possession of substances such as opioids, unless authorized for legitimate medical, scientific or industrial purposes through regulations or exemptions. It includes offences and penalties that range from a fine to life imprisonment.
The CDSA has a number of regulations that are relevant to the discussion of prescription drug abuse. The regulations provide a framework to facilitate the use of prescription drugs for medical treatment.
Compliance and enforcement also form an important part of the drug control objectives of the CDSA. Health Canada is active across the regulated supply chain to verify compliance with the CDSA and its regulations.
For example, licensed dealers comply with regulations setting out reporting and record-keeping requirements, as well as security measures aimed at minimizing diversion. Pharmacists are required to maintain records of controlled substances purchased and are accountable for prescriptions dispensed.
As a final comment, I would like to highlight some of the lessons learned under the national anti-drug strategy, a strategy based on three key areas of action—prevention, treatment and enforcement—which I believe are informative in identifying actions to address prescription drug abuse.
Under this strategy, we have seen marked progress in discouraging youth from using illicit drugs and in supporting innovative treatment services for individuals addicted to illicit drugs.
For example, the government led a successful mass media campaign entitled “DrugsNot4Me” to raise awareness among youth and parents about the dangers of illicit drugs. This campaign saw impressive results. Youths are now more likely to say that they would refuse to take illegal drugs, and more parents engage their teens in discussions about the risks of taking drugs.
The government has also made significant progress, working in partnership with law enforcement, to prevent the production and diversion of illicit drugs.
The national anti-drug strategy and its successes provide a strong foundation upon which to support action to prevent prescription drug abuse. In light of the recent Speech from the Throne commitment to expand its scope, work is under way to assess how the prevention, treatment, and enforcement successes of the national anti-drug strategy can be applied to addressing this issue.
Thank you, Madam Chair.
