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 Minister of Health 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.