:
Good morning, Mr. Chair, members of the committee, staff, and witnesses.
It is my privilege to assist you today, both as a physician and as a representative of the Office of the Chief Coroner for Ontario.
The issue of prescription drug misuse, especially in regard to opiates, is one of great significance to our office and to physicians as a whole. There is no doubt that this is a complex public safety concern of import and urgency. The Office of the Chief Coroner for Ontario investigates all non-natural deaths and some specified natural deaths in the province, totalling about 17,000 deaths a year.
The coroner's investigative mandate is threefold: to determine the identity of the decedent, the place and date of death, the medical cause of death, and the manner of death; to determine if an inquest is necessary; and to make recommendations to prevent deaths in similar circumstances, where appropriate. In Ontario, the coroner has powers of entry, inspection, and seizure that allow for a thorough examination of the circumstances of death, and for the compilation of detailed information about individual deaths and about broader population trends.
The Office of the Chief Coroner recognized the growing number of prescription opioid deaths a number of years ago. Opioid-related mortality in Ontario doubled between 1991 and 2004. This was in large part due to the misuse of sustained-released oxycodone. By 2008, the number of opioid deaths had grown to surpass the number of deaths of drivers in motor vehicle collisions. It has since continued to increase. The rate of death from opioids is more than twice that from HIV, and approaching that from sepsis. In Ontario, more than 500 people die from opioid toxicity each year. If deaths attributed to alcohol plus opioids are included, the number exceeds 700.
Accidental prescription drug deaths affect a broad range of age, from children to the elderly. Studies have shown that accidental drug deaths are more likely to be due to opioids, while suicides more often involve other prescription drugs. The source of drugs in declining order is: prescription, then a combination of prescription and illicit purchase, and then illicit purchase. The likelihood of the source of drugs being from a person's prescription increases with increasing age.
Our investigations and the studies of others indicated that a number of factors had contributed to the development of this crisis. These included: liberalization of the utilization of opioids for the treatment of non-cancer pain; lack of knowledge on the part of health care providers with respect to potential toxicity; lack of dosage guidelines; lack of effective means for monitoring who was prescribing and who was using opioids; aggressive marketing campaigns by manufacturers; and law enforcement restrictions due to health privacy legislation.
It was clear from our review that the problem cases were not coming from the cancer care sector. The problems were related to the treatment of chronic non-cancer pain, to illicit diversion of legally obtained opioids, and improperly prescribed opioids or improperly utilized opioids. The Office of the Chief Coroner identified the following issues in opioid-related deaths that required further investigation: the management of chronic non-cancer pain; the diversion or abuse of opioids, specifically oxycodone; access to prescribing information; and legislative hurdles to sharing of information.
The Office of the Chief Coroner for Ontario has endeavoured to share our information and experience with policy-makers, prescribers, and dispensers. We have participated in a number of efforts to address these issues, such as the College of Physicians and Surgeons of Ontario's report, “ Avoiding Abuse, Achieving a Balance: Tackling the Opioid Public Health Crisis”; the National Opioid Use Guideline Group's “Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain”; the National Advisory Committee on Prescription Drug Misuse's report “First, Do No Harm: Responding to Canada's Prescription Drug Crisis”; the public health division of the Ministry of Health and Long-Term Care's “A Review of the Impacts of Opioid Use in Ontario, Interim Summary Report”; and the Institute for Safe Medication Practices Canada's report “Death Associated with Medication Incidents”.
I know you are aware of these reports, each of which sets out the problem and suggested solutions much better than I can in this brief presentation.
In addition to these collaborations, the Office of the Chief Coroner identified two related deaths that became the subject of an inquest focusing on the issue of prescription opioid misuse. The inquest was broad in its scope and examined addiction, access to drugs, prescribing and dispensing, enforcement, and legislative challenges. The jury made 48 recommendations that can be categorized and summarized as follows.
Regarding drugs, the jury recommended: the removal of sustained release products with more than 100 milligrams of morphine equivalent per dose, and the removal of products with more than 40 milligrams of oxycodone; the review of all approved opioids; the inclusion of dose recommendations in monographs; and a review of tamper-resistant formulations.
Regarding monitoring and data, the jury recommended the development of a database accessible to prescribers and dispensers in Ontario through eHealth and through the Narcotics Safety and Awareness Act.
In regard to treatment, the jury advocated for resources for comprehensive pain and addiction treatment programs and facilities.
In regard to education, the recommendation was for renewed public and professional education, including the development and maintenance of national guidelines and relevant research.
In regard to legislation and enforcement, the jury recommended the funding of provincial and municipal drug enforcement units, a clarification of privacy issues, and recommended mandatory sharing of information between health care providers and between police and health care providers.
These jury recommendations mirror the findings of the other reports referenced.
The problem of prescription drug misuse is complex. There is no simple solution. The answer lies in a nationally coordinated, multipronged approach. This is a difficult task that will become more difficult the longer we delay. The evidence is in, the analyses are done, and a pathway has been charted. What is needed now is a unified political and professional will to move forward and to keep the resolution of this public safety crisis as a priority. If we do so, I am confident that many premature deaths can be prevented.
Thank you.
:
Mr. Chairman, and members of the committee, I'm pleased to appear before you today for Reckitt Benckiser Pharmaceuticals Canada, and as a member of the National Advisory Council on Prescription Drug Misuse. It's being co-ordinated through the Canadian Centre on Substance Abuse.
I’m proud to be part of that council and to serve as one of its two co-chairs of the legislation and regulation committee with Dr. Mel Kahan of Women’s College Hospital in Toronto.
The National Advisory Council on Prescription Drug Misuse, as you all know, released its strategy in spring 2013. For the most part, I will confine my remarks to the top-line recommendations contained in the report under the legislation and regulation committee.
Before that, however, let me give you a bit of background on Reckitt Benckiser Pharmaceuticals.
We are only an addiction treatment company, to my knowledge, the only one in Canada. We manufacture one product, NSuboxone. It's a combination of buprenorphine and naloxone. They are sublingual tablets. They are the first opioid medication for the substitution treatment of opioid dependence in an office-based setting.
However, above and beyond that, we also have a very different approach in how we operate in that we have a focus on working, obviously, with government and key stakeholders on everything from industry reform efforts, legislative and regulatory recommendations, and of course, breaking down barriers to treatment for patients.
NSuboxone was approved by Health Canada in May 2007. It is a fixed-dose combination of buprenorphine, which is a partial agonist, and naloxone, which is an opioid antagonist. It is indicated for medication-assisted treatment in adults who are opioid-dependent, and is available in two strengths: 2 milligrams of buprenorphine with 0.5 milligrams of naloxone and 8 milligrams of buprenorphine with 2 milligrams of naloxone.
For those who don't know what the naloxone component is for, it is to deter intravenous and intranasal misuse. Naloxone has poor bioavailability when it's taken orally or sublingually. However, if NSuboxone is taken intravenously, naloxone is 100% bioavailable and precipitates withdrawal symptoms in patients dependent on opioid agonists.
As Dr. Skinner pointed out—and as I'm sure other witnesses have—opioid dependence is a chronic relapsing medical condition of the brain, a well-recognized clinical and public health problem in Canada.
A 2009 study by Popova et al indicated that between 321,000 to 914,000 non-medical prescription opioid users were among the general population in Canada. Further, the estimated number of non-medical prescription opioid users, heroin users, or both, among the street drug using population was about 72,000, with more individuals using non-medical prescription opioids than heroin in 2003.
Historically, heroin has been the main source of opioid dependence; however, the current reality of illicit opioid use has become much more diverse and complex. In Canada, illicit opioid use includes a diversity of prescription opioids including: oxycodone, codeine, fentanyl, morphine, and hydromorphone. As a result, there has been an increase in demand for opioid dependence treatment across Canada.
Mr. Chairman, the individuals living with prescription drug addiction are—and it has always surprised me since I started this job—just like you, me, and everybody sitting around the table. They are a soccer mom who got into a car accident, broke her back, was prescribed Percocet, and found herself addicted. Then down the road, when she had been dismissed from the clinic by her doctor because the doctor in question wouldn't “treat patients like her”, she turned to prostitution while her kids were at school so that she could afford her Percocet. They are the returning soldier from Afghanistan—or Iraq, in the case of the United States—who used prescription opioids, either for soft tissue injuries or to numb the pain of watching their comrades in arms blown up by a landmine, then came home with an addiction to those opioids, and at times with PTSD.
These are the faces of prescription drug addiction, individuals who by way of voluntary action wound up with an involuntary addiction.
I have met a lot of addicted patients and I have yet to meet one of them, whether they use heroin, or whether they use prescription opioids, who told me that they took that first hit because their goal in life was to be an addict. Nobody in their right mind would want that for a life.
The stories I shared are real stories. They speak to a problem that is not just confined to the alleys and gutters of Canada, but rather one that is widespread, growing, and at crisis levels.
We as a society, however, through lack of access to treatment and at times policies that criminalize disease versus treating it in the context of what it is, a public health crisis, often force men and women like that soldier and that soccer mom down the slide from a contributing member of society to one on the margins, in the gutter, or in jail, or worse yet, dead.
While we must expand treatment in Canada in all of its forms, so too must we battle the stigma of addiction that allows Canadians struggling with this condition to avoid treatment because of the perception, and at times the reality, that if you admit that you have a problem with abuse or dependence, then you are somehow not worthy of being part of what we define as normal. Our treatment and view of individuals who battle substance abuse in all its forms is too often one of the lowest common denominators. In many respects it is the soft bigotry of low expectations.
Mr. Chairman, in the context mentioned above, I will now present to you the recommendations from the legislation and regulation committee of the National Advisory Council on Prescription Drug Abuse. Taken together these recommendations would help put Canadian public health, patient safety, and patient dignity at the forefront while seeking to mitigate the unintended consequences of prescription opioids.
The recommendations are as follows:
One, amend the general labelling requirements under part C of the food and drug regulations to require that all prescription opioids carry the warning—and these prescription opioids should be either painkillers or addiction treatments—that there is a possibility of addiction, misuse, or death with drugs in this class even if the drugs are used as prescribed. Also, the labels on painkillers should be restricted to severe pain only. As well, all labelling should reflect what the clinical trials actually showed.
Two, the federal government should mandate that federal public drug plans require physicians to apply for exceptional status approval should they wish to prescribe opioids over the 200 milligram a day dosage level. This is the watchful dose under current Canadian guidelines.
Three, the federal government should move to change Health Canada's existing drug approval process for both generic and branded pharmaceuticals to require the denial of approval if a conflict of interest is found, for example, if the maker of a prescription opioid painkiller also manufactures a treatment for that same addiction that can result from the painkiller, or if a company manufactures a treatment and then goes on to market a painkiller.
Ideally, no company should be permitted to drive volume of one product with another. If a company wishes to manufacture and sell addiction treatment, regulations must be put into place to stipulate that it first stop selling the products that have addictive properties.
Four, Health Canada should deny drug approval to any company that does not have safety provisions built into its prescription painkillers that aim to reduce abuse and diversion. All companies that manufacture generic or branded prescription medications or addiction treatments must be required to contribute funding to surveillance systems for prescription drug abuse, misuse, and diversion, as well as to general drug safety awareness.
As well, the should be empowered to deny notice of compliance to any pharmaceutical company that manufactures painkillers or addiction treatment if that company fails to comply with the provisions that I've outlined above.
Additionally, the federal government should propose that plans delist high-dose opioid formulations, that they should add weak dose opioids, and mandate only tamper-resistant formulations and child-resistant packaging be placed on formulary.
Five, they should require mandatory review every two years by Health Canada of the product monographs of companies that manufacture prescription drugs with high abuse potential, and that would include opioids, stimulants, etc.
Six, the federal government needs to review regulatory requirements relevant to opioid medication—I'm referring to section 56 of the Controlled Drugs and Substances Act—and implement changes as required to remedy barriers that may exist to treatment.
Seven, they should increase the transparency of all clinical trial data by requiring industry to provide all data related to clinical trials, and for Health Canada to make that information public.
Further to that, they should also add an offence to the Food and Drugs Act for misleading the federal regulator.
Eight, they should require that all federal drug formularies cover naloxone.
Nine, they should require that all companies, both branded and unbranded, that manufacture or distribute opioids, sedatives, hypnotics, or stimulants comply with full drug submission requirements before listing. This would include the conducting of clinical trial testing for generic manufacturers.
Ten, they need to review international evidence and existing programs for risk evaluation and mitigation strategies to identify and develop effective risk mitigation strategy standards and models for pharmaceutical companies that must be adopted by industry players.
Eleven, they should require annual reporting to Parliament, Health Canada, all provincial ministries of health and provincial medical colleges on all aspects of a branded or unbranded company's risk mitigation strategy activities.
Twelve, they should implement stringent financial and regulatory penalties for branded and unbranded companies that fail to report and/or comply with their Health Canada-approved risk mitigation strategies.
Last, they should establish a national take-back day—and I think Mark will agree with this—for prescription drugs. Let's get the old drugs out of the medicine cabinet and into a place where they can be disposed of safely. To that end, the federal government should request that the Canadian Centre on Substance Abuse work with key stakeholders across the country to develop the national standards for the take-back and disposal of these medications, because currently none exist.
That concludes the recommendations of RBP and its committee. We look forward to working with parliamentarians to implement these. I'd be happy to meet with any member of this committee to discuss how we can work together to get this done.
Thank you very much.
:
Good morning. By way of introduction, my name is Mark Mander. I am the chief of police with the Kentville Police Service, and I'm the chair of the Canadian Association of Chiefs of Police drug abuse committee.
On behalf of CACP president Chief Constable Jim Chu, I would like to express our sincere appreciation to this committee for allowing us the opportunity to contribute to this critical issue. I would also like to congratulate Mr. Lobb on his reappointment as chair of this very important committee, as well as the other members for their appointments.
The CACP, through its 20 public safety and justice related committees, contributes primarily through the justice and human rights, and public safety and national security committees of the House of Commons. For your own background, the CACP represents in excess of 90% of the police community in Canada, which includes federal, first nations, provincial, regional, and municipal police leaders and services. Our mandate is the safety and security of all Canadians through innovative police leadership.
In 2007 the CACP adopted a drug policy that was developed through the drug abuse committee. This policy sets out the position of the CACP on this very important national issue that has a direct impact on Canadians on a day-to-day basis.
Let me provide a brief overview of our drug policy. We believe in a balanced approach to the issue of substance abuse in Canada consisting of prevention, education, enforcement, counselling, treatment, rehabilitation, and where appropriate, alternative measures and diversion of offenders to counter Canada’s drug problems. We believe in a balanced continuum of practice distributed across each component.
In addition, the policy components must be fundamentally lawful and ethical, must consider the interests of all, and must strive to achieve a balance between societal and individual interests. We believe that to the greatest extent possible, initiatives should be evidence based.
You in your deliberations have no doubt heard and will continue to hear the countless stories of families who have painfully and helplessly seen their loved ones succumb to the abyss of substance abuse or even die as a result. Some of these deaths have been from a single experimentation with prescription narcotics. We need to continue to listen to and learn from their voices, as they are the ones who have suffered from what is termed the “unintended consequences” of prescribing.
In 2004 the Canadian Association of Chiefs of Police, through resolution 08-2004 called upon the federal, provincial and territorial ministers of health to prioritize the implementation of safeguards, in consultation with Canadian policing and pharmaceutical representatives, to prevent the further diversion of prescription drugs to the illicit drug trade.
In this resolution we expressed concern that the illicit use of prescription drugs is a serious health concern and that this could be mitigated through safeguards, which would include enhanced inspections of distributors, enhanced inspections of pharmacies, and the monitoring of excessive doses prescribed in prescriptions. In 2012 we reiterated our position through another resolution.
This problem has grown to impact many communities across Canada. My policing colleagues across this country are increasingly concerned about the number of young people abusing prescription narcotics often accessed from family medicine cabinets and friends. We are concerned about the increase in pharmaceutical-related crimes, including pharmacy robberies, prescription drug diversion, break and enters, trafficking, double doctoring, prescription theft and forgery, drug-impaired driving, as well as theft-related offences committed to fuel the financial needs of people seeking drugs. Most concerning is the large number of deaths that have a direct link to prescription drug abuse. Some of our first nations communities have been hit the hardest, where addiction rates are said to be many times the norm.
While we know that drugs are intrinsically linked to crime, we cannot, however, simply enforce our way out of this problem. We require a national community response to address this crisis.
For us, the way forward has been written. The “First Do No Harm: Responding to Canada’s Prescription Drug Crisis” strategic plan was developed through extensive consultation and work by many stakeholders under the expert guidance and leadership of Michel Perron of the CCSA team.
For the implementation of this strategy to be successful, however, there is a need for continued resourcing. Most important, the federal, territorial, and provincial governments must lead the way by working together to adopt this plan and ensure that it remains a priority over the next number of years.
For policing, the most critical path in this strategy is monitoring and surveillance so we can ensure we are collecting and acting upon the most current and relevant data. Having a nationally coordinated prescription monitoring program is the natural first step.
In the plan for law enforcement, we have undertaken a number of things.
First is to determine the extent of the impact of prescription drugs on law enforcement resources and public safety. Currently we are undergoing a study, which is being facilitated by Public Safety Canada, to determine some of that data.
Second, we want to raise awareness among key law enforcement and justice bodies.
Third, and Cameron referred to this, is to promote safe storage and disposal of prescription drugs. Based on a model used by the DEA in the United States, and the experience of some extensive work in Ontario, the CACP along with Public Safety Canada held a national prescription drug drop-off day on May 11, 2013. Police recorded receiving just over two tonnes of pharmaceutical products on that one day. We plan on continuing this program. This year’s date has been set; it's May 10.
Fourth, we want to identify the gaps in tools or training for criminal justice professionals to better address the illicit use of prescription drugs.
Fifth, we want to ensure death investigations across Canada are conducted in an evidence informed and consistent manner. This process is currently under way as well.
Sixth, we want to identify and address barriers to immediate access to and sharing of relevant information. We feel the prescription drug monitoring program is the way we can do that.
In closing, prescription drug abuse cuts across a multitude of service providers and stakeholders. The CACP is but one of the players. We are willing to step up and do our part in resolving this national crisis.
Thank you.