PARLIAMENT of CANADA
Home Parliamentary Business Senators and Members About Parliament Visitor Information Employment
 

Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 5 - Evidence - February 6, 2014


OTTAWA, Thursday, February 6, 2014

The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:29 a.m. to study prescription pharmaceuticals in Canada.

Senator Kelvin Kenneth Ogilvie (Chair) in the chair.

[Translation]

The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.

[English]

My name is Kelvin Ogilvie. I'm chair of the committee and a senator from Nova Scotia. I will invite my colleagues to introduce themselves, starting on my right.

Senator Seidman: I'm Judith Seidman from Montreal, Quebec.

Senator Stewart Olsen: Carolyn Stewart Olsen from New Brunswick.

Senator Seth: Asha Seth, Ontario.

Senator Beyak: Senator Lynn Beyak, Dryden, northwestern Ontario.

Senator Enverga: Senator Enverga from Ontario.

Senator Segal: Hugh Segal, Kingston-Frontenac-Leeds.

Senator Cordy: Jane Cordy from Nova Scotia.

Senator Chaput: Maria Chaput, Manitoba.

Senator Moore: Good morning. Wilfred Moore from Nova Scotia.

The Chair: I will remind everyone that we are dealing with our order of reference on prescription pharmaceuticals in Canada, Part 4. We are looking at the nature of unintended consequences. This is our second meeting dealing with the subject of addiction, misuse and abuse.

We have two witnesses this morning, and I will introduce them as I invite them to speak. By earlier agreement, I'm going to invite forward first Dr. Sproule, Clinician Scientist, Pharmacy, Centre for Addiction and Mental Health. She joins us by video conference. I'm pleased to welcome you. I invite you to make your presentation.

Beth Sproule, Clinician Scientist, Pharmacy, Centre for Addiction and Mental Health: Thank you for the invitation, and I appreciate the opportunity to present to the committee.

By way of background, I've been a pharmacist for 30 years and I've been working specifically in the area of prescription drug abuse for over 20 years. I mention that for two reasons: First, this isn't a new problem; and, second, I mention it to give you an idea that it has involved a number of different drugs, but the picture has been changing more recently — in the past 10 to 15 years or so. It first came to my attention as a pharmacist, particularly working at the Addiction Research Foundation in Toronto, which is now part of Centre for Addiction and Mental Health, or CAMH. That was its name back in the 1980s and 1990s. As a pharmacist, it came to my attention with people seeking OTC codeine and large numbers of prescriptions for opioids.

With the problem regarding prescription pharmaceuticals as it relates to abuse and addiction, I want to say that our focus has been on psychotropics, which are the particular prescription drugs that affect the brain in a certain way. A lot of prescription drugs can be abused. The focus of our research and the focus of our current crisis or problem being addressed is on certain types of prescription pharmaceuticals — namely, those that work in the brain similarly to other substances of abuse, meaning they tap into the area of the brain related to reward, causing a high or good feelings. These classes of drugs include the opioid analgesics — the big one everyone is talking about — but also sedative hypnotics such as the benzodiazepines, which have been around and have been an issue for many year, and the stimulant drugs like amphetamines, Ritalin and methylphenidate-type medications.

Although they act in the brain similarly to other substances of abuse, whether alcohol, cocaine or other agents, there are unique features with the problem associated with prescription pharmaceuticals. One of those is around trying to understand and find solutions to the problem. You can't just cut off the supply; they need to be available for those who need the medications, because they are beneficial. Also, some people who have an addiction also need the medications. So we have to try to deal with that dichotomy where the drug that's causing somebody a problem is also something they need for health reasons.

One of the biggest unique features and challenges of this problem is how the health care system is intertwined with the problem. Some characterize this problem as involving dichotomous groups, where you have these prescription drugs that are widely available and there's a small population trying to divert the system and trying to get a hold of these medications to use them recreationally. Then they end up having a problem or becoming addicted to them. Then everybody else is a legitimate user, but it's not that simple.

Although most people who use the medications don't have problems, as far as we can tell, some do, and this number has been increasing, particularly in the last decade or so and particularly when we look at opioids. Some of the evidence for that is the increasing numbers of people seeking treatment specifically for addiction to prescription opioids. This is evidenced at CAMH, for example, where we have witnessed over the past decade an increasing number of people coming to both our medical withdrawal unit and into our methadone and Suboxone programs. Primarily, people seeking treatment for opioid dependence are doing so for prescription opioids. Regarding those using heroin, the number seeking treatment has remained low and stable over the years compared to prescription opioids.

The increasing problem is also evidenced by the increasing number of overdoses, particularly for opioids. Of particular concern is the proportion of those overdoses that cause death that are inadvertent or accidental. This information that comes out of the coroner's office is quite important in helping to ensure that we improve our systems and maximize the safety of these medications, while at the same time ensuring their accessibility for people who need them.

The evidence for this is also found in the increasing number of youth who are using prescription opioids, as seen from a number of student surveys in different parts of Canada. Looking at people who are using prescription opioids, you can think of people using them recreationally or therapeutic users who develop a problem. It seems from our experience at CAMH and from research we've done that there's a large proportion of people who have this mixed therapeutic use and problematic use. It seems to be particularly risky for those who have a history of problems with other substances, those with mental health problems and those who have chronic pain. This combination of both therapeutic use and having a problem with the drug makes it very difficult to diagnose, to identify in practice and to treat.

In the couple minutes I have left, I thought I would mention some of the directions that are useful for helping to rectify this problem. It's clear that a comprehensive strategy is needed. Just doing isolated interventions is not going to work. It's a complex problem that needs interventions and action on numerous fronts. This is outlined in the First Do No Harm strategy that you're probably aware of — the national strategy that has a number of recommendations in different areas, including prevention, education, treatment, monitoring, surveillance and enforcement.

To highlight a couple of those, there has been particular interest in prescription monitoring programs, something that, as a pharmacist, I have an interest in and can see the value in. They are widely used and mandated in the U.S., for example, and several provinces in Canada have them to help in detecting the problem and intervening when problematic prescribing or use is detected. Research is still needed as to what is the best structure for these types of programs, the best type of intervention, the best communication strategy between programs, who should have access to this data, and how information can be shared with enforcement. There are a number of questions, but it's quite a promising area.

Other important areas are around education and health care professional education, with prescribers and pharmacists in particular having more education in both pain and addiction, particularly addiction. There has been very little in that area to date.

I'd like to highlight the role of the pharmacists in things like take-back programs, allowing people to bring back unused medications to pharmacies and potentially having support for that. It is a cost for pharmacists to safely dispose of that and broadening it will help with being able to take back medications, even if it's not your patient.

One other thing I'd like to highlight is access to treatment and ensuring that when people recognize that they may be having a problem with their prescription drugs, there is access to treatment, both pharmacological and non- pharmacological. There are various issues related to that.

One final thing is the whole approach of formulation strategies in trying to reduce the harm associated with different products and the various strategies that can be used on a formulation basis.

Most important, I'd like to emphasize the need for monitoring and surveillance in this area because for any interventions we have at this point, we need to know the scope of the problem, characterize the problem, implement the interventions. The only way to evaluate the impact of that would be to have a comprehensive monitoring and surveillance system in place. Thank you.

The Chair: Thank you very much, Ms. Sproule.

I'm going to turn now to Cameron Bishop, Acting Country Manager for Reckitt Benckiser Pharmaceuticals in Canada. I want to give an explanation. The invitation went out to the National Advisory Council on Prescription Drug Misuse, and Mr. Bishop is an advisory member of that organization. They recommended that he be here, and he kindly accepted the invitation.

You're in several capacities, but the topic is common. Mr. Bishop, the floor is yours.

Cameron Bishop, Country Manager (Acting), Reckitt Benckiser Pharmaceuticals (Canada): Thank you. I'm pleased to appear before you today for Reckitt Benckiser Pharmaceuticals in Canada but also as a member of the National Advisory Council on Prescription Drug Misuse, which is coordinated through the Canadian Centre on Substance Abuse. I am most pleased to be part of that council and to serve as one of its two co-chairs on the legislation and regulation subcommittee with Dr. Mel Kahan of Women's College Hospital in Toronto.

As Ms. Sproule just pointed out, the National Advisory Council on Prescription Drug Misuse released its strategy in spring 2013 entitled First Do No Harm: Responding to Canada's Prescription Drug Crisis. For the most part, though, I will confine my remarks to the recommendations contained in the report under the legislation and regulation committee.

I should probably give a quick overview of Reckitt Benckiser so you know where we're coming from.

Reckitt Benckiser Pharmaceuticals is an addiction treatment company, and to my knowledge the only one in Canada. We manufacture one product called Suboxone sublingual tablets. They are the first opioid medication approved for the substitution treatment of opioid dependence in an office-based setting. However, above and beyond that, we have a different approach to how we operate in that we focus on working in partnership with government and key stakeholders on everything from industry reform, legislative and regulatory recommendations and breaking down barriers to treatment for patients.

For those of you not familiar with Suboxone, it was approved by Health Canada in May 2007. It is a fixed-dose combination of buprenorphine, which is a partial agonist, and naloxone, an opioid antagonist. It is indicated for medication-assisted treatment in adults who are opioid dependent and is available in two strengths, a 2-milligram tablet with 0.5 milligrams of naloxone, and an 8-milligram tablet with 2 milligrams of naloxone. The intention of Suboxone's naloxone component is to deter intravenous and intranasal misuse. When you take Suboxone sublingually, then the naloxone component has poor bioavailability. However, if you crush it and take it intravenously or snort it, naloxone becomes 100 per cent bioavailable and precipitates withdrawal symptoms in patients dependent on full opioid agonists.

As committee members will know, opioid dependence is a chronic relapsing medical condition of the brain and it is 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 existed 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 indicated to be 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 also includes a diversity of prescription opioids including oxycodone, fentanyl, codeine, morphine and hydromorphone. As a result, there has been an increase in demand for opioid dependence treatment across Canada.

I'm often asked who are the people living with prescription drug addiction, and I say it's pretty much the people in front of you right now. It's everyone sitting around this table today, from the soccer mom who got in a car accident, broke her back, was prescribed oxycodone and found herself addicted. Then down the road when she had been dismissed by her doctor from the clinic because the doctor in question ``doesn't treat patients like her,'' she found herself turning to prostitution while her kids were at school so that she could get access to oxycodone.

They are also the returning soldiers from Afghanistan, or Iraq in the case of the United States, who used prescription opioids to numb the pain of watching comrades blown up by a land mine or because of soft tissue injuries, then came home to Canada with addiction to opioids and/or PTSD. These are the faces of the unintended consequences of prescription drugs, individuals who by way of voluntary action wound up with an involuntary addiction.

These are real stories and they speak not just to a problem that is confined to the alleys and gutters of Canada but rather one that is widespread, growing and at crisis levels. We as a society, through lack of access to treatment and sometimes policies that criminalize disease versus treating it in the context of a public health crisis, too 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, in jail or dead.

While we must expand treatment in all its forms in Canada, so too must we battle the stigma of addiction that allow Canadians struggling with this condition to avoid treatment because of the perception and the sometimes reality that if you admit 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.

I'm now going to present recommendations from the legislation and regulation committee of the National Advisory Council on Prescription Drug Misuse. 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.

Mr. Chair, in view of the legislation and regulation committee, the federal government should do the following: First, they should require that all prescription opioids carry the warning, be they painkillers or treatments for addiction, that there is the possibility of addiction, misuse or death with the drugs in this class even if used as prescribed. That would require amending Part C of the Food and Drug Regulations. Prescription painkillers should be limited to severe pain only as opposed to moderate pain. All labeling should reflect what the clinical trials of the drug actually showed.

Second, they should mandate that federal drug plans require physicians to apply for exceptional status approval should they wish to prescribe opioids over the 200 milligram daily dose level. This is the watchful dose under the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain.

Third, they should propose changes to Health Canada's existing drug approval process for both generic and branded manufacturers to require denial of approval if a conflict of interest is found. They should also require that generic manufacturers complete clinical trials to ensure the safety of their product is comparable to the brand.

I touched on conflict of interest, and what I'm talking about is if a maker of a prescription painkiller also manufactures a treatment for that addiction, or if a company manufactures an addiction treatment and then markets a painkiller that can result in an addiction that can be treated by the same addiction treatment the company is marketing. 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 in place to stipulate that it first stop selling the products with addictive properties.

Health Canada should deny drug approval to any company that does not have safety provisions built into its prescription pain killers that reduce abuse and diversion. All companies that manufacture generic or branded prescription pain medications or addiction treatments must be required to contribute funding to a surveillance system for prescription drug abuse, misuse and diversion as well as for general drug safety awareness. The Minister of Health should be empowered to deny or revoke a notice of compliance for a prescription painkiller or addiction treatment manufacturer if the manufacturer fails to comply with any of the provisions I've outlined above.

Fourth, we propose that federal plans delist high-dose opioid formulations, add weak-dose opioids and mandate that only tamper-resistant formulations in child-resistant packaging be placed on provincial and federal formularies.

Fifth, the federal government should also require mandatory review every two years by Health Canada of the product monographs of companies that manufacture prescription drugs with high abuse potential, including opioids, stimulants, et cetera.

Sixth, they should review regulatory requirements relevant to opioid medication, for example, section 56 of the Controlled Drugs and Substances Act, and implement changes as required to remedy any barriers that might exist to treatment.

Seventh, they should increase the transparency of all clinical trials by requiring that the pharmaceutical industry provide all data related to these trials and for Health Canada to make that data public. They should add a further offence under the Food and Drugs Act for misleading the federal regulator.

Eighth, require that all federal drug formularies cover naloxone.

Ninth, require that all companies, both branded and unbranded, that manufacturer or distribute opioids, sedatives, hypnotics or stimulants comply with full drug submission requirements before listings, and that would include the provision for branded and unbranded clinical trials, and give that data to Health Canada.

Tenth, review international evidence and existing programs on risk mitigation strategies to identify and develop effective risk mitigation strategy standards and models for pharmaceutical companies that must be adopted by industry players. I refer the committee to the FDA, which has those standards in place in the United States.

Eleventh, there should be annual reporting to Health Canada, Parliament, and all provincial ministries of health and provincial medical colleges on all aspects of a branded or unbranded company's risk mitigation strategies.

Twelfth, the federal government should implement stringent financial and regulatory penalties for branded and unbranded companies that fail to report and/or comply with their Health Canada-approved product risk mitigation strategies.

There is one that I wrote this morning and neglected to put in: Establish a national take-back day for prescription drugs. We need to get old drugs out of the medicine cabinets and into a place where they can be disposed of safely. To that end, the federal government should request the Canadian Centre on Substance Abuse to work with key stakeholders nationwide to develop national standards for the take-back and disposal of these medications, because none exist now.

That concludes our committee's recommendations. We look forward to working with senators and all parliamentarians to implement them. I'd be happy to meet with any member of this committee to discuss how we might be able to do that.

The Chair: Thank you, Mr. Bishop. I note for the record that you mentioned your company's relationship with naloxone, and you came back to it in a recommendation. That's on the table. That's clear and everything is fine. I now open the meeting to questions from senators.

Senator Seidman: I'm breathless from that long list of recommendations. You, sir, mean business, and I appreciate that very much.

Ms. Sproule, you represent the Centre for Addiction and Mental Health, which is a major institution in this area. I notice that it is described as providing clinical care, education and health promotion services and that it also conducts policy development and research. You said that you're a pharmacist. Is that correct?

Ms. Sproule: That's right, yes. I'm a pharmacist.

Senator Seidman: That's the basis for my question.

You presented a lot of really good ideas that need thinking about. I thank you for that. I'd like to ask you about the role of pharmacists in monitoring and de-prescribing or re-evaluating medications. Right now, we're in the fourth part of a four-part study, and we're looking specifically in this case at unintended consequences as they relate to addiction, misuse and abuse of prescription drugs. Clearly, we want to come up with some kind of recommendations in this area.

I'm just going to cut to the chase with you. We have talked about the role of pharmacists in monitoring. They play a special role but they also play a certain role in oversight of patients who are on many different medications prescribed by many different physicians. I notice that you talked about this complicated issue of therapeutic use and addiction and how they're intertwined. You said that specifically in relation to mental health, problems with other substances and chronic pain.

It's a complicated issue; I agree with you. I'd like to know, given your special vantage point, what you see as the role of pharmacists in dealing with this complicated issue.

Ms. Sproule: Thanks for the question. It is a complicated question but one that I have a keen interest in. One of my other hats is one at the Leslie Dan Faculty of Pharmacy at the University of Toronto where I'm Director, Division of Pharmacy Practice, so I have lots of ideas and a particular view about what the pharmacist's role is or could be.

The clinical model for pharmacy services is around identifying and resolving patients' drug-related problems. This is a huge area of drug-related problems. There are a couple of issues around trying to optimize what pharmacists could be doing in this area. I think we need to improve training so that pharmacists, in addition to other health care professionals, feel more comfortable in identifying and dealing with addiction issues. It's complex, and the current specific training is for pharmacists that provide, for example, methadone or the buprenorphine-type services. It needs to be broader than that for people using opioids.

Definitely pharmacists have a role. The role is optimized in certain settings of pharmacy practice. For example, in hospital settings or where pharmacists are in family health team settings, it's a little more difficult in community pharmacy settings or mainstream settings because they don't necessarily have the opportunity to sit down with the patient and systematically review their medications. They don't have that private area for those conversations to develop a relationship. It becomes a challenge for the pharmacist working in a community pharmacy who has many different physicians and prescribers to develop relationships with as they co-care for a patient. That becomes a challenge, whereas in a family health team setting, you're part of a team and you work with the same people.

Even with those limitations, the way that pharmacy is currently happening in community pharmacy provides a lot of opportunity for pharmacists to intervene. Regardless, we need to monitor the medications and communicate the risks to the patient, especially now that we have the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain. There is real guidance in terms of when they should be concerned, even if they don't have full information about the clinical situation of the patient, just by awareness of the daily dose.

As Mr. Bishop mentioned with the 200-milligram watchful dose, we need to be questioning, warning, helping to explain to the patients why there is that watchful dose, what the risks are with using these medications balanced with what their expectations should be as far as how well these medications are going to work for their chronic pain. It will not alleviate the pain completely. We need to help patients manage those expectations and then, on a more practical level, ensure that they are storing the medications properly. Even if they trust their own children, their friends may be over and everything needs to be securely locked and brought back to the pharmacy once they are finished.

With the fentanyl patch, we must have a mechanism to return the used patches before people get more. These kinds of safety mechanisms are definitely possible, especially because of the easy access that the public has to pharmacists as a health care professional in general.

Also, in some provinces, for example, in Ontario, and then provinces that have prescription monitoring programs, but particularly in Ontario because of the way our new narcotic monitoring system is set up, there are alerts that go directly to the pharmacist as they are filling a prescription. That alert indicates if there may have been dispensing on multiple previous occasions from different physicians and different pharmacies. It gives pharmacists that information right at the point of care. There are other prescription monitoring systems that have that point-of-care access as well, so pharmacists, as they're dispensing, have a real role to play there as well.

Certainly, the most challenging is trying to figure out when a patient has crossed the line from okay use to problematic use. Mostly that's a problem because it is not a line; it's a grey area and a very difficult assessment and diagnostic process that happens over time.

Pharmacists, I agree, have a key role in the health care system and are at the interface between the actual giving of the medication and the patients, and as a profession we could be taking this on more head-on and contributing to the solution.

Senator Seidman: This is a really productive and interesting approach. I think we've had this feeling over the previous three parts of our study that there is an important role for pharmacists to play. I know Quebec has recently changed the law so that pharmacists can actually prescribe or renew prescriptions for conditions that patients have already been treated for in some ongoing way.

In community settings, where you say there are complications, they do have a larger role to play; however, the issue has been how to reimburse pharmacists for the extra time that that takes. I see that as a potential issue.

We've talked about the pharmacists, but I would like to ask a question that has to do with Health Canada. What role do you think Health Canada can play? Are there regulations that we ought to consider?

Ms. Sproule: Yes, I do think Health Canada has a role, very broadly speaking, in that it can help support the strategy that I and Mr. Bishop referred to, which is the number of recommendations that are in the strategy. There are a number of recommendations that have oversight and, as Mr. Bishop said, a regulatory role.

In looking at how medications are approved, there is the issue of the generic version of control-release oxycodone that was approved after OxyContin was removed from the market. Perhaps you've already discussed that within this committee, but there is a need to look at how that happened and what changes may be needed so Health Canada can have more of a role in controlling that type of thing.

Health Canada definitely has a role in the monitoring and surveillance area. There are national surveys that have been evolving over several years. Having a mechanism to have more space for questions about prescription drug abuse would be really helpful, as well as participating in the monitoring and surveillance piece. That could be development and support of prescription monitoring programs across the country, helping operationally to develop a repository of information from different data sources such as coroners' data, treatment data and national survey data. How can we organize and standardize all of these sources? Those are recommendations that are in the strategy as well.

Those are the key areas around monitoring the problem and monitoring the post-marketing of new entities and current drugs, as well as the approval process.

Senator Stewart Olsen: Dr. Sproule, my first question would be directed to you. You mentioned that you are seeing an increasing number of users of prescription drugs having problems and they are coming in for treatment. How do you think they understand that they have the problem?

I go back to the fact that there are a lot of people who take a lot of these prescription drugs without any idea that they are becoming addicted. What is their trigger for when they find they are addicted?

Ms. Sproule: That's an excellent question and there is not an easy answer. I can tell you that one of the studies I have conducted, with the support of Health Canada, is a Pathways to Prescription Opioid Addiction study, where we interviewed over 350 people from Ontario, New Brunswick and Newfoundland and Labrador. We looked at people who had received treatment for prescription opioid addiction and, over the course of their lifetime, looked at how they ended up having a problem and the sequence of events.

Related to your question, one of the key highlights was that we were able to divide the users. This was not a random sample, but among the people who participated in the interviews there was a certain set of people who were younger and were using the prescription opioids recreationally only. They only had periods in their life where they used recreationally. Then there was a larger cohort of people who had had periods using therapeutically or recreationally or both.

What was clear is this: The time frame between initiating regular use of the prescription opioid and coming to their own realization that they were having a problem was prolonged in those with the therapeutic use period of several years, and they were older when they realized they were having a problem.

The triggers were more difficult to get at, but it was generally related to increasing problems in their life, increasing stressors, behavioural indicators of an addiction where you're losing control, you're unable to fulfill your obligations in life, your relationships are breaking down, and these types of things that are associated with an addition.

It is a challenge and, as I say, there is not sort of a line that people cross. It seems to be a process, and it gets to the point where they think they have a problem. Then there's another delay for them to seek treatment actually.

Senator Stewart Olsen: I put a lot of emphasis on patient responsibility as well, or user responsibility, and I think there might be more information about what the symptoms of an addiction would be. I don't think we go there. We warn of addiction, but I don't think we have done a good enough job telling patients about the warning signs. What are your thoughts on that?

Ms. Sproule: I agree completely. When I'm teaching at the university I tell the pharmacy students and pharmacists elsewhere that when people are getting prescribed opioids and coming into the pharmacy you need to be careful with the message that you send. Pharmacists are also concerned about under-treated pain, and some patients do not take the medication because they're concerned about becoming addicted. I emphasize that they need to have a conversation and explain what addiction is. Every patient needs to be assessed individually for their level of risk for addiction, and then that education and counselling need to ensue.

For example, someone might say they are concerned about being addicted because they don't like to take tablets and they're not going to take them, or they could be concerned because they've had a past problem. You can't just reassure them with, ``No, your doctor has prescribed them and you need to take them'' kind of attitude.

Assessing their history in terms of smoking, taking other substances in the past, mental health problems; explaining the risks to them; explaining the behaviours that you might see, some of the things that they might be feeling around loss of control over taking their medication, which, again, in a therapeutic setting is challenging. If you ask patients about some of the criteria around addiction, ``Do you take more than prescribed or do you ever have trouble cutting down?'' the answer is, ``Yes, but it is because of my pain.'' Diagnostically, it is quite a challenge. I agree completely that patients need to be more informed of both the risk of addiction and the risk of inadvertent overdose.

The Chair: I will go now to Mr. Bishop, because he referred to specific recommendations in this area.

Mr. Bishop: Yes, senator, I think that is absolutely in line with what we have suggested. There are a number of different components. I always look back at my wife; two years ago she had an appendectomy — three little incisions. If you were to see my wife — I'm a lucky man; she is Miss Canada 2005. I've done pretty well for myself. I don't know how, but I did. She comes from a good family, but she does have a hereditary history of addiction on her mother's side. They prescribed 40 Percocets for a day's surgery. She wound up taking four. When I went to the pharmacist to pick them up — and this goes back to what Dr. Sproule said earlier about education for the pharmacist but also for the doctors — I said to the pharmacist, because he didn't know what I do from a career perspective, ``This is Percocet. That's an opioid?'' He said, ``That's right.'' I said, ``This can cause addiction.'' He said, ``No, no. Addiction is not a concern with this drug.''

There were 40 Percocets in there. By day three of my wife's taking them, I remember coming into the bedroom, and she said to me, ``My gosh, look at how lovely I look.'' I said, ``After three days in bed, with an appendectomy, you look fantastic.'' She said, ``But look at my hands and look at my feet.'' I said, ``I don't know what I'm looking at.'' She said, ``Look at the jewels on my hands and my feet. I can't get them off the bed; they're so heavy.''

She knew enough to take them back. I'm not saying that she would definitely have wound up addicted if she had finished off the 40, but I would say that she was enjoying it four pills in, and that's all she took.

What you say in terms of flagging it, this is why we need plain labelling. We need to put it on there so people can understand it, so that people like my wife will look at that and say, ``Oh, God. If I'm having hallucinations like this, I should probably put these away and switch to an Advil.''

Senator Stewart Olsen: I agree. Just a comment: I really like your recommendations. I think they put an expectation of responsibility right where it needs to be. I also like the fact that you respect the patients or the users enough to have an expectation that if you tell them something, they are smart enough to know what you're getting at. We tend to be paternalistic in medicine. I don't think even young people who are taking drugs recreationally want to become addicted. They need to be educated as well. Thank you very much for your time.

Senator Cordy: Thank you very much to both of you. These have been excellent presentations. I love it when people come in with recommendations specifically related to what the federal government can do, because in Canada we always have this jurisdictional problem. Thank you very much. I know it's a lot of work when you're itemizing things to bring forward to a committee.

About 10 years ago, this committee did a study on mental health and mental illness. People forget that part of that was about addictions. This study is certainly an excellent follow-up to that.

Mr. Bishop, you spoke about the stigma of addiction. In our report we talked about the stigma of mental illness and addiction. In your presentation you spoke about the fact that there is no stereotype of who can be addicted.

How do we deal with the stigma of addiction, first of all? And second, I want to follow up on Senator Stewart Olsen's question about recognizing that there is a problem and that one has a problem with an addiction.

Dr. Sproule, you talked about the access to treatment for people who recognize that they have a problem. First of all, there is the stigma and how we deal with that, and then how, if we have the stigma, we get people to in fact recognize that they have an addiction so that they will access treatment. The second part of that question is how much access to treatment do we have in Canada for those who are addicted to prescription drugs? It is sort of one question with a gazillion parts.

Mr. Bishop: With regard to the stigma, by way of background, I am not a clinician at all. I have no scientific background. But I certainly had my biases when I started this job. We do a preceptorship, where we are lucky enough to sit with an addiction physician and meet their patients for half a day. The first time I went, I was thinking I was going to get shivved, because that's what your perception is. You look at the people on TV who are in the Downtown Eastside who are injecting heroin into their veins, using water from a dirty puddle, sitting in the back alley, turning tricks, whatever.

The stigma, for me, is that's how people are looked at, at the very base end. If you were to look at addiction, and this slide, and my elbow is where people are, and everybody around this table is up here. Because we have shame in the education and treatment components, we allow people to go all the way down that slide, so that by the time they get here, where my wrist is, they have no hope left.

It does start with education. The example I gave you with regard to the soccer mom, in particular, this is a lovely lady who is also a social worker, as white collar as you can get. She is now on welfare, she lives in her parents' basement, and her kids were taken by social services. As gently as I can say this, her doctor was her official dealer, without being a dealer.

It does come to the education and acceptance from the physician as well. Sometimes, through no fault of your own, perhaps a voluntary action and a voluntary prescription have resulted in an involuntary addiction. That's okay, but I think physicians have to feel not less pressure, but less stigma that, ``Oh, my God, I've caused this problem,'' because then they're not going to turn it over to their patients.

At the same time, we have to start putting addiction in the context of what it is. We've done it for mental illness and even for HIV/AIDS. Everybody around this table is susceptible to addiction. There is no rhyme or reason. Once we change the face from the person in the Downtown Eastside, who is equally worthy of treatment and dignity, once we change that as the primary face and we start talking about it as though it's normal, I think we will go a long way.

In terms of where we are at for treatment in this country broadly, one of the best things I like about our company is that it does not require me to say that our treatment is better than everyone else's. We believe that treatment is treatment is treatment, for patients. There is no one-size-fits-all patient or treatment.

Is it where it should be? No. I believe that anything, whether it's a psychosocial support, withdrawal, or medication- assisted therapy in line with psychosocial support, is valid. But if you look across the country, it is sporadic. If you look at the federal level, where they have direct responsibility for the men and women in our military and for our First Nations, we need to do a better job of saying, ``It's okay to come forward. You are still heroes and you are still people of this land. We accept you and we will help you get well.''

Right now, the way we fund the different treatments, from the formulary perspective, we tend to zero in on an area that is in the news. Right now it's northern Ontario, for example, among the First Nations addiction community. But that story is repeated out and not well published in every province across the country.

I look at treatment and think, ``Gosh, it's better than nothing,'' but it's certainly not at the level that it could be, from a medication standpoint, from a training standpoint, from a stigma standpoint, or any standpoint. We have to do a better job. Hopefully you can help convince people that we should.

The Chair: Thank you.

Senator Cordy: I just wondered, Dr. Sproule, if you would like to comment on the access to treatment aspect, which you mentioned in your presentation as well.

Ms. Sproule: I think the access to treatment is really quite important just because of, from what we gather, the number of people who currently have a problem. Moving forward, we really want to emphasize prevention, and I am hopeful that this will be reduced. However, we do have significant number of people who have problems now. From the access to treatment point of view for addictions, psychosocial interventions are the mainstay, and those are expensive treatments. So I think that access to those types of treatments and folks who can deal with this unique problem are really important. For example, some of the therapists at CAMH have told us that when they're dealing with patients whose problem is prescription opioids, a different set of psychosocial issues comes to the fore. A lot of them are around their relationships with their doctors and even how they view themselves. It is related to stigma — ``I'm not really a drug addict; I've only been using what has been prescribed to me.'' Those types of issues need to be dealt with.

The other thing around access to treatment is pharmacological. This is one of the few areas of addiction where, for opioid dependence in particular, we have very good treatments. One is Suboxone, which Mr. Bishop's company produces, and the other is methadone, which has been around for quite a while in Canada, available in clinics and offices. However, there is still limited access for some patients based on where they live. There may not be a methadone prescriber or a methadone dispensing pharmacy in the area. That's where options like Suboxone can be offered, but, again, there may not be prescribers. It's not just prescribing the drugs. You need to know how to deal with the problem with the person who has an addiction. It is a little bit different from prescribing other opioids. Of course, coverage is sort of a provincial formulary issue for the most part, with third-party payers. Obviously, methadone is less expensive, but, for a lot of reasons, if people have access to Suboxone, it would be good for that to be treated not just as second line but to be more available for people as well. So the issue is the access, the actual number of bodies around that are willing and able to provide the treatment, and then the access from a financial point of view.

Senator Enverga: Thank you for all the presentations.

Mr. Bishop, you mentioned in one of your recommendations that Health Canada should deny drug approval to any company that does not have safety provisions. Can you explain about the safety provisions?

Mr. Bishop: I go back to the naloxone component that is part of buprenorphine. In the interests of full disclosure, it is no secret that if you take buprenorphine alone, it is an opioid. It is a partial opioid, but it is an addictive property. You can become addicted to everything from food to sex to whatever, but if there's a way to prevent it, that should be explored. When we created Suboxone, we added the naloxone component so that if people wanted to snort it because they wanted to see if they could get a high from the buprenorphine side, then it would induce withdrawal if they're dependent on the opioids.

That technology exists. It could be put into fentanyl patches. It could be put into oxycodone, as we've seen. There are a variety of different ways to do it, but adding a naloxone component would be an absolute must. It exists. That's the thing I find so funny, senator. We have these drugs that are being approved. I'm not going to fault the minister because she has approved this, that or the other thing because she needs to be empowered to have the tools to say, ``No, it is not enough,'' but I struggle with the fact that Health Canada doesn't look at it and say, ``We have this generic version of oxycodone. We know that there are other products on the market that are abuse deterrent. Why are we approving these things without those tools in there?'' I struggle with that, so I think we need to empower them to put those tools in in the first place.

Senator Enverga: How many of the drug manufacturers do not have the tools or the safety provisions?

Mr. Bishop: I will have to beg ignorance on that one; I don't know the answer to that. Dr. Sproule, do you know?

Ms. Sproule: Could you repeat the question?

Senator Enverga: Knowing that there are safety provisions that we can put in medications, how many of the drugs that we have right now have safety provisions?

Ms. Sproule: Most don't. There are specific examples, Suboxone being one of them. The other big example is the tamper-resistant products. There are different product formulation strategies. Adding an antagonist is one strategy, which is the naloxone strategy, but OxyNEO and Concerta are other products that are abuse-deterrent because they prevent the crushing and potentially injecting that way. It is definitely only very few that you could target.

Senator Enverga: Can you possibly let us know the reason that they are not being put in?

The Chair: We don't want to speculate too far here. We want to go on the positive side and look at recommendations. We are not speculating with regard to motive.

Mr. Bishop: I'll just say that I'm sure that everybody wants to make sure that patients are being treated.

The Chair: We will have officials here as witnesses later, and questions can be put to them directly. I want to come back and clarify. Your recommendation was very clear. You felt that where there is an opportunity for safety to be built in, it should be required. So that's the generic issue, senator, and he has made a broad recommendation there.

Senator Seth: Thank you for this. It is a complicated, unsolved topic that we will probably keep on discussing. There will be no final result, but we will keep on trying. CAMH calls itself a teaching hospital with regard to prescription drug abuse and misuse, and, recently, a program was launched called VISION 2020: tomorrow.today. Of course this campaign is meant to unlock CAMH's full potential as a 21st century academic health science centre. How is this vision applied in the treatment of prescription abuse and misuse?

Ms. Sproule: Yes, CAMH does have a number of initiatives that are directed toward the prescription drug abuse area. We have ongoing programs that have specifically targeted the problem of opioid dependence in particular for several years. Part of it is focused on things like reducing stigma, particularly around treatment, methadone treatment, for example. There is a website that was developed called methadonesaveslives.ca. That provides good information on how well methadone works for opioid dependence and on the role of prescription drugs that are currently a major part of the picture of opioid dependence. Helping to reduce stigma and people being accepting of treatment is one area. We have a number of educational initiatives through our program as well. That includes several series of webinars every year that health professionals and the public are invited to participate in. There are a number of courses, both in-house and online, offered through CAMH, including safe prescribing for opioids, that reflect the Canadian opioid guideline for safe prescribing. It includes, in Ontario, a mandatory opioids treatment course that all methadone prescribers and all pharmacists dispensing methadone are mandated to take. In that opioid dependence treatment course, there is a core course online, plus an in-person workshop that includes both methadone and buprenorphine training, along with a number of allied courses that come together to create a certificate program that's affiliated with the University of Toronto. That is in addition to a number of training opportunities, people coming for clinical placements and that type of thing at CAMH.

Certainly on the education front, that's where there's been a large initiative from CAMH. In addition, on the treatment side and on the research side there is support, for example, for my research program, and there are a few other researchers at CAMH as well focusing on different aspects of this issue, in addition to also putting out some policy statements, both provincially and federally, around the issue.

Senator Seth: Ms. Sproule, I think you were talking about a prescription monitoring program. How do you monitor? I'm talking with regard also to health professionals. Do we have any tools where we can monitor? Can you explain that?

Ms. Sproule: Yes. I was mentioning prescription monitoring programs; sorry if I didn't explain it well enough. I was referring to the formal programs implemented around collecting data on all monitored drugs that are dispensed in a province or territory, for example. Some provinces have this and some don't. Everything that's dispensed, an administrative database goes to a central place where retrospectively or at the point of care you can see what else the patient has had prescribed or dispensed, not just in that pharmacy. Normally, pharmacy records are just in-house. They are only located in that particular pharmacy. So this creates a way of sharing information, no matter where they have it prescribed and where they have it dispensed.

Different programs can be set up around that to use that information. Some provinces, for example, do monitor that, look at physician prescribing and, for example, an intervention, if they send out letters to prescribers that are outside the norm for the prescribers in their province or their area. If they get a letter like that from their regulatory college, it has quite a big impact. The idea is that it could be quite helpful.

The information at point of care is thought to be quite helpful because you can question things on the spot and help clarify with the patient and the prescriber what the situation might be if something has been flagged.

The challenge with monitoring programs is what the threshold is for when something should be flagged, because you can't have too many flags; you don't want to miss people. There are still a lot of questions around them, but the general feeling is at least having a handle on who's prescribing what and which patients are getting what is the base of what's needed. We are still working on the best way to use that information. That's a formal prescription monitoring program.

Clinical monitoring as a clinician of an individual patient involves assessing how well the medication is working for the particular pain problem, for example, and also its use. From a pharmacist's point of view, we keep track of early refills or signs of intoxication or problems. It's monitoring on an individual basis versus a program.

Senator Seth: Thank you.

Senator Moore: Ms. Sproule, in your remarks, you mentioned increasing inadvertent overdoses and deaths and you said something about a coroner's report. You also commented about the increase in use of opioids by youth and some numbers there.

Do you have any reports or studies that you could give to our clerk that would help us in trying to analyze or get a handle on the situation?

Ms. Sproule: Yes, I absolutely can do that. There are several published reports. There are two key ones in the coroner's data area. One was published in 2009 by Irfan Dhalla that showed the increase, using coroner's data and Ontario drug benefit data, which showed a correlation between increase in prescribing and an increase in overdose deaths.

Last year, a researcher called Madadi published a report that also looked at the characteristics of people who had overdosed with opioids as part of the picture. One of the most interesting things from that paper was showing for each individual type of opioid the proportion of overdose deaths that were inadvertent, and the medication with the highest inadvertent overdose death was methadone.

On the youth front, CAMH has a long-running student survey that has been monitoring student drug use for over 30 years. There's definitely data we can provide you that shows that prescription drug use is right up there with alcohol and cannabis in youth.

Senator Moore: Mr. Bishop, you mentioned that one of your recommendations requires that all federal drug formularies cover naloxone. Just for my benefit and the public who may be watching this hearing, what do you mean by a formulary?

Mr. Bishop: You mean define ``formulary''? I apologize. It is where the drugs are listed, what drugs are covered by, whether it's the provincial government or what have you. That is what the formulary is.

Senator Moore: So it's a registry of drugs and the respective conditions they are prescribed for?

Mr. Bishop: Some of them. It depends. Some formularies will have written that it will be under a certain heading. It might say ``cardiovascular,'' but it depends on the class of drug or if there are criteria attached to it and where on the formulary it sits. If it has criteria, then it would be in a different area of the formulary and it could only be prescribed using the criteria.

Senator Moore: These formularies are distributed to all qualified pharmacists in the provinces?

Mr. Bishop: Yes. Where the pharmacies operate, they would have access to the various formularies, and when they treat patients covered under federal ones, they would use the federal formularies, and the provincial ones accordingly.

Senator Moore: Your second recommendation is to mandate that federal public drug plans require physicians to apply for exceptional-status approval should they wish to prescribe opioids in dosages over 200 milligrams per day. To whom would they apply, and what would be the qualifications of the people who would hear those applications? Have you worked that through?

Mr. Bishop: We have not. It has been a discussion point that we have had a lot of debate around on our committee.

What I would suggest is if we could get to a point where we look at section 56 and any barriers that exist there, that is the methadone exemption. What we envision is taking similar language that exists for the methadone exemption and applying it to the physicians who may want to go over and above the 200 milligram. What happens now is that if you want your methadone exemption, it is Health Canada that gives it, but it's done through the provincial colleges.

What would be required in this case would be that, if you could add something to section 56 pertaining to this, Health Canada would still issue the exemption but it would go through the colleges as is done right now for the methadone exemption, but it would have to require certain levels of training and application before you are actually able to get it.

[Translation]

Senator Bellemare: We are fortunate to have Ms. Sproule as a witness. She is known for saying that Canada is one of the largest consumers of opioids per capita and that consumption has increased significantly between 2000 and 2009. I do not have any medical training, but I am an economist and statistics interest me. When I see statistics like that, I have to wonder where the data for these statistics came from.

Are you able to explain to us why per capita consumption is so high in Canada? Are we seeing similar trends with stimulants? Since this phenomenon seems to also be significant in Canada, are we consuming more than in other countries, and if so, why?

[English]

Ms. Sproule: Thank you for the question. I wish I had good answers for all of them, but I can tell you that where the statistics come from is the International Narcotics Control Board, and they get information from several countries around the world; there are over 200 listed in there. They have converted usage statistics into a per capita statistic.

From 2000 into 2011, actually, the per capita consumption in Canada steadily increased. In the middle of that point, we started out in 2000 as ranked fifth, and now we rank second only to the U.S. The U.S. is quite a bit higher. Even though we're second, there are several countries that are similar, but out of 200, we do rank second and have consistently.

The question about why is harder to answer, though. It could be that we're better at treating pain than other countries. Usage statistics alone don't provide enough information about why we're having an increased problem, but it's suggestive that, as we know for other substances, increasing availability correlates with an increasing number of people who have problems. Certainly we're concerned about increased prescribing and the relationship to that.

We do have evidence that an increase in prescribing of higher doses is linked to an increasing number of overdose deaths, for example. That's where this watchful dose we've been talking about, the 200 milligrams of morphine equivalence, comes from. The risk benefit crosses a line, particularly around that dose, from the evidence we have now.

Unfortunately, there are a lot of questions around statistics and what is actually happening in Canada where we don't have that information. That's why I've been talking about the monitoring and surveillance piece. Similarly to Mr. Bishop for the First Do No Harm strategy, I'm leading the monitoring and implementation team to help try and rectify that and to move the strategy along to help implement that.

Mostly we have information about use and less about the number of problems and what the impact of our interventions might be.

Senator Bellemare: For other kinds of substances, like Ritalin and other stimulants, has there also been an increase in Canada? Do you have data on the situation in Canada for those substances?

Ms. Sproule: No, it's less clear for the stimulants and the benzodiazepines. It's definitely smaller than for opioids. Opioids are definitely the leader in the amount of problems.

With respect to stimulants, most of the research from the U.S., for example, has been in college students, that type of thing, who end up having a problem with stimulants. The numbers are quite a bit lower.

For example, in a small study that Health Canada funded that I did before we had our monitoring system in Ontario, we looked at regular users of opioids, stimulants and benzodiazepines using community pharmacy data. We invited people to call us so we could get an idea of what their regular use entailed and if there were any problems. We only had one person who called in about stimulants. The magnitude is quite a bit lower, but it's still a problem for those who are using and wind up having an issue. I don't have the exact numbers, but it's definitely magnitudes lower than for opioids.

The Chair: Mr. Bishop wanted to come in on this.

Mr. Bishop: Dr. Sproule made a good point that we might be really good at treating pain, and that might be the underlying cause.

I take two examples, first the one that Senator Stewart Olsen was talking about in helping patients recognize when they're becoming addicted. Then again I use the example of my wife, who went in for day surgery and got 40 Percocets, used four or five of them and then returned them.

We are really good at treating pain with medication. We're less good, however, in ensuring there are physiotherapy and other sorts of non-pharmacological ways to treat that pain. We start to see these climbing, and unfortunately, we sometimes have it in our head that we have this sickness care system; we'll just give you the pills, you'll be fine, don't worry, you'll feel better. But we have less of a preventive piece and a wellness model that would promote less pharmacological and more on the get well part.

Senator Bellemare: If I could add a comment and a question, I thought with the demography, because we're getting older, maybe that's why we have more opioid use issues. Is that a hypothesis that can explain these facts? Other countries are getting older, too, but so is Canada.

Ms. Sproule: In our studies and certainly with the people seeking treatment at CAMH, the mean age is in the forties, as well as in the number of studies we've done overall. From our student surveys, though, we know there's also a population of younger people using opioids more recreationally.

We are seeing a change in that yes, people are needing it therapeutically — those numbers are increasing — but the other cohort of young people initiating experimental use with them is a newer phenomenon that is also part of the picture.

Senator Chaput: Thank you. Most of my questions have been asked, but I have one on student drug use and younger Canadians' addictions, 15 years and older.

In the education strategy, what is being done with regard to the high schools? I would even say Grades 6, 7 and 8 because that's where they are now. We have the schools, the universities and also the community colleges where we get young people who are interested in trades. There are a lot of young ones there.

What is presently being done to educate them? After all, they are the parents of tomorrow.

The Chair: Dr. Sproule, do you want to comment first?

Ms. Sproule: Sure. I can't say I'm an expert or fully aware of all the initiatives that may be happening there. I know that from a prevention and public education point of view, another group that was part of the national strategy did look at that. In particular, they were looking at the most effective way of sending that message, whether it's through schools or social media, and what the best form of social media is. These types of things are being looked at and lessons are being learned, like don't put a government logo on a social media message because that won't attract viewers.

From a school's point of view, my impression is that a large part of the substance abuse initiatives are also taken on by enforcement, with police officers having an education component going into schools. I know they're including prescription opioids in their general message as well, definitely. I think those are the main points I can make on that.

Mr. Bishop: I have a couple things to add. I agree with everything that Dr. Sproule just said. Certainly government- sponsored awareness programs are fine, except that people my age and younger — and I'm 35 — honest to God, don't waste your money because nothing bugs me more than government giving me tips on how to be cool without doing drugs or alcohol. If I haven't figured it out by now, I don't think the government is going to be able to help me.

In terms of the schools, though, our office here in Ottawa is located just down the road, about 10 minutes away from a high school where about four, maybe five kids in the last year at that same high school have died of fentanyl overdose. I found with what we're hearing from the different physicians in there, they are doing awareness, but it always comes after the fact. You can't bring five teenagers who are dead back after the fact.

I don't know what the answer is, but I do know that we have to do a better job of making people feel it's okay, if they're approached at a party, to say, ``You know what, I took this from my parents' medicine cabinet, and it's not a good thing.'' I don't know how to do it.

However, I have the greatest respect for the men and women in uniform who are police officers. I'm not sure, but enforcement should probably not be the ones going in to inform kids because automatically the stigma is, ``You will do something wrong if you do this.'' We know that to be true, but having a police officer show up in uniform to provide that education could give the wrong message, namely, ``I'd better just take this and shut my mouth because I do not want to go to jail.''

I think there's a role for the police, but we also need to do a better job of bringing the issue of addiction forward. We need to bring forward the Philip Seymour Hoffmans and the Cory Monteiths of the world who struggle in silence to speak to it, not necessarily just police officers and certainly not necessarily government.

Senator Chaput: Who is best to do the work, if it's not the governments or the police officers? Who can do it?

Mr. Bishop: We have a responsibility on the National Advisory Council on Prescription Drug Misuse to make those recommendations, and I know there has been a lot of debate there. I'm not sure everyone is aligned yet on the best way forward.

What I will say to you is this: I think it will require everybody from the layperson to industry to physicians to pharmacists to everybody coming together to do it because you cannot deal with this in silos. Right now, that's what we're trying to do. I don't have a final answer for you, but I know it will take the collective to make a recommendation.

Senator Chaput: Could it be a pharmacist or a doctor?

Mr. Bishop: I'll leave Dr. Sproule to answer that, except to say that, again, this returns to the education piece and the stigma going around it. Yes, it could be, but we have to get the right stakeholders to come forward in that community to say: ``You know what? I treat these patients; I'm going to give you the lowdown on what's happening and I'm not ashamed of treating them and neither should my patients be ashamed for coming forward.''

Senator Seidman: Mr. Bishop, you've done very well answering my colleagues, and most of my questions have been fairly well answered.

You have made recommendations that would include all stakeholders — the prescribers, the physicians and pharmacists, industry, the regulators, government, Health Canada and patients or all of us, consumers. We live in a society that's very drug-oriented, and perhaps it's a culture that we need to deal with.

I do want to ask you about your second recommendation. I believe Senator Moore has already touched on it, but I want to ask you about it with specific reference to Suboxone. My understanding is that Suboxone doesn't have to have the requirement of exemption under section 56. I find that quite curious. In fact, all that is needed is a 60- to 90-minute online training program for a physician to be able to prescribe it.

In light of your second recommendation where you make it very clear that there should be a need for application for exceptional status for a physician to prescribe, I'd like you to reconcile what seems like a contradiction.

Mr. Bishop: It really depends on the jurisdiction you're in right now. You're quite right that Suboxone doesn't require an exemption. However, depending on where you are — B.C. comes to mind, Manitoba and some other jurisdictions — you actually have to have your methadone exemption in order to prescribe Suboxone. It varies, and I'm happy to share with you the provinces where it differs.

Regarding section 56, I'm going to ask Dr. Sproule to jump in, at least from her perspective, too.

As for the Suboxone piece, first of all, we offer a six-hour training course online; it's Suboxone CME. We recommend that everyone go into that training course but that they also have a full understanding of the opioid dependence practice. Would I suggest it be added to the exemption piece? That's why in a further recommendation we said let's look at it. Is section 56 acting as an impediment or a driver towards treatment? There may be an opportunity to do something there.

What I will say is that whatever we do, it has to be standardized across the country. We have a transient population. If you're in Newfoundland and fly up to Fort McMurray for work, and you're on Suboxone in Newfoundland, you may not be able to get it up in Fort McMurray because you don't have a doctor with a methadone exemption, and, if you do, they haven't taken the Suboxone training.

The pharmacological properties of Suboxone are materially different than those of methadone. Methadone is a good drug for some patients, but people don't seem to realize sometimes that the optimal dose of methadone could kill you as a patient. It could take anywhere from six weeks to six months to titrate up to the right dose. With Suboxone, the maximum dose you can ever be on is 24 milligrams, and you can titrate up to that in two days. Because of the parameters within it, there is a baby-sitter, so to speak, in terms of not causing the respiratory depression you would see from other drugs.

It is an opioid, but I'm not sure it would fit into section 56. Again, I'm a creature of the committee that I'm on, and if that is the recommendation, it's obviously one we would support. But for now, the pharmacological properties of Suboxone and methadone are materially different, which is why the methadone requirement is so much more substantial.

Dr. Sproule, is that fair?

Ms. Sproule: The short answer is yes. Because of the pharmacological properties, namely, the ceiling effect, that there is with buprenorphine, there isn't the same risk of overdose, and it has some features that make it safer than methadone, which is why it doesn't require an exemption. The main reason methadone needs the exemption is that it is a challenging drug to use and to prescribe safely. We refer back to methadone having the highest proportion of inadvertent overdoses in Ontario. Those happen by just increasing the dose of methadone too quickly. So that is true.

Having said that, also, as I mentioned earlier, to prescribe either buprenorphine or methadone, it's more than just knowing the drug. You have to know the patients, the problems and the management issues around helping people who have addiction.

Senator Seidman: The reason I asked the question is precisely because this is a demonstration of how complicated it is. There are a lot of stakeholders involved here, and there are potential conflicts of interest. I think it's important to understand that, for example, the College of Physicians and Surgeons of Ontario has stated very clearly that while a methadone exemption is not necessary to prescribe buprenorphine, the college recommends that physicians who wish to treat opioid dependence should have or should obtain a section 56 exemption.

We're dealing with a lot of stakeholders, and it only exemplifies how complicated the issue is.

Senator Cordy: I'd like to talk about the collection of data because we heard from you, Dr. Sproule, that Canada is number two in terms of use of opiates, and, Mr. Bishop, we heard from you that there are between 321,000 and 914,000 non-medical opioid users, which is quite a gap.

Yesterday, our witnesses said that there's a lot of data collected on use or abuse of pharmaceuticals but that the data is, in fact, not being compiled or analyzed. Could you touch on the collection and the analyzing of data we have available to us here in Canada?

Mr. Bishop: I will let Dr. Sproule answer that because she heads up monitoring and surveillance.

Ms. Sproule: I'm not sure specifically what they may have been referring to yesterday, but there is a lot of information collected clinically in regular practices and doctors' offices and pharmacies and treatment facilities, at CAMH, for example, but having it easily retrievable and translating that into viable statistics is a challenge. That will improve as more and more health systems become electronic.

That is certainly going to be the case at CAMH. Up until now, every time we wanted to go in and look at what was happening, we had to physically go and do individual chart reviews from patient charts. We are implementing a totally electronic system in a few months.

I think that that may be what they were referring to.

There are systems in the U.S. that integrate clinical information that are then automatically collected anonymously to be able to be analyzed for that purpose. There is a system that can be used in addiction treatment facilities where when you are gathering all the initial information from a patient, including the different types of drugs they're using and how much, that can all be de-identified and then put into a database to analyze trends across the country around what are people seeking treatment for, which drugs, and looking for trends. For example, a few years when the U.S. changed their OxyContin product — it's still called OxyContin, but it's same as our OxyNEO — the change in people seeking treatment was detected quite early by using that type of system.

Right now, I think what they may have been referring to was that we have a fragmented system. There are diverse pieces of information, again more about use than actually how many people are having a problem, but even people seeking treatment. For example, in Ontario there is a system called DATIS that CAMH helps organize, and that collects data but just from publicly funded addiction treatment centres. So again, it is not the whole picture.

I think that's the challenge: Does one just physically collate and have a repository for this information? And the other challenge in the field around collecting data is the different definitions that are used, even comparing surveys and information around what do you mean by ``misuse'' and ``abuse.'' Everybody uses a slightly different definition and it can be interpreted differently. So it is very hard to even compare across jurisdictions many times.

The Chair: I will just further clarify that yesterday they were talking about a very broad data collection including results out of coroners' offices, police services and so on. The point was made similar to what you've just made.

Senator Cordy: Mr. Bishop, you spoke about the watchful dose, 200 milligrams per day, but you didn't mention how many days a prescription can be. You spoke about your wife. I spoke about a friend who got 50 tablets of OxyContin after surgery. Would that be overstepping the boundaries to say how many you should prescribe? That seems to be a pretty big problem.

Mr. Bishop: One of the things that our committee has said — again, we have not formalized that aspect of it, but we are united on that recommendation. However, on the days of prescribing, there is debate that if it's over and above 90 days, then you have to reapply. That seems to be where we are leaning, that it should be a 90-day window on the exemption and then you would have to reapply.

Unfortunately, it is a bit of a bureaucratic hurdle. However, I'm not sure when we lose 500 people to opioid overdose in Ontario alone that we don't want to create a couple of barriers here or there. Right now we seem to be trending over to the 90-day limit for a physician to be able to prescribe that, and then at the end of that to have to reapply.

Senator Enverga: Now that I know we can apply safety provisions for opioid pain relievers, can we do the same with stimulants and sedatives?

Ms. Sproule: Yes. It depends. The naloxone example is very specific for opioids, because it's an antagonist. We do not have that for stimulants or for benzodiazepines. There really is not a good antagonist-type analogous drug for stimulants.

For benzodiazepines there is an analogous antagonist that's available, but again, with the pharmacology and the way these drugs work, it's not practical, because if you were to induce withdrawal as an antagonist in someone who is physically dependent on them, you can induce a seizure, which is unlike opioids. With opioids, the withdrawal symptoms can be miserable but not usually considered life threatening, whereas that's not the case with benzodiazepines. So adding a substance does not work as well with other drugs, but certainly other formulation strategies, particularly making them crush-resistant, is possible. An example of that is Concerta, a stimulant product in Canada.

Senator Chaput: My question has to do with the younger Canadians' addictions, the data, and the answer could be sent in writing.

Do you have any data on younger Canadians' additions regarding the regional differences between provinces and then between regions in a province and also rural and urban areas, if there are differences? Do you have data that you could send to the committee?

Mr. Chair, if you agree.

The Chair: Certainly. And the request is back to you.

Mr. Bishop: Yes.

The Chair: If you would send it to our clerk that would be very helpful.

This has been a fascinating discussion of a very important issue, and it's quite interesting to hear the different approaches to certain aspects. This is the second session on this, and there have been some, not nuance differences, but some clear differences in response with regard to the issues dealing particularly with the limits on prescriptions and so on.

I want to touch on a couple of things. I want to come back first to one of last areas where, Mr. Bishop, you pointed out the problematic aspect of government advertising programs to act as educational vehicles. Now, the reality is that it won't matter who in the end has decided to carry out this public educational piece. Government will be expected to pay for it, so it has to be involved in some way.

I think you gave a very good summary in the end when you pointed out the need to bring together groups and individuals who work in these areas at the front lines and with the groups that are most affected. Therefore, I'd like you to think a bit more about that aspect, because they will go to government for funding, and there has to be an accountable way of spending in government. But the key issue is the one that both of you have mentioned, and that is that the campaigns chosen must actually be recognizable and acceptable, at least viewable, by the audiences intended.

If you could give that some additional thought and perhaps send us in writing how you think that might work so that the bringing together of the groups that would come — you can mention examples if you want — that's not so important — but then in the end how would you choose the organizations that will develop the actual modules that will go out, because at some point it has to come up with a recommendation.

I will just leave that, perhaps, unless you have a quick comment.

Mr. Bishop: I hear what you're saying on the government side, but one of the things we have talked about on the national advisory council is that I don't know it has to be government.

The Chair: We're talking about spending now.

Mr. Bishop: Look at the NHL. It has a litany of problems when it involves soft-tissue injuries, chronic-concussion syndrome. As I have outlined in the recommendations, industry should be required to pay into drug awareness initiatives; government already pays a great deal of money when it comes to drugs and all that kind of stuff, but there are other stakeholders who may not be evident.

Dr. Irfan Dhalla sent me a paper a couple of months ago about chronic concussion injuries and soft tissue injuries in the NFL in the United States. We know what's happened up here in Canada. We've seen that. And right there, you've got built-in heroes for a lot of young Canadians, but you also have — I'm not a big expert on the NHL, but I think you've got a little bit of money there.

This is where the private-public partnerships could really pay some dividends and get government out of it, and do something that is going to be cost-neutral.

The Chair: A public-private partnership has government; it's not out of it. But you have made some good points. I really like the idea of having the heroic side of things as part of the visibility, for obvious reasons. Thank you.

Now I want to come to an issue that is really very important and at the core, at least of the problem with people becoming accidently addicted through medical treatment as opposed to those who are out on the street seeking these kinds of drugs. We have heard that there could be some limitations on prescribing, possibly in terms of length and in terms of maximum dosage prescribed in particular products.

We need to be careful here, because we're dealing with the issue mostly of pain. You have made a very good argument that there needs to be a recognition of the magnitude of the pain and the various ways of dealing with that that are non-prescription in terms of pharmaceuticals. In terms of that education piece, that has to go through the medical system, because that's where it starts. You have given clear examples — and we are familiar with them — where that's not occurring and that awareness is not there. Many of us have heard exactly the examples you gave today in terms of saying, ``Here is this; go away and do that'' when there are many alternatives to treating certain kinds of pain.

But at the extreme, I suspect that many people in this room have dealt with friends or family who have been dying of cancer. We have the other end of spectrum where we have some rather unusual barriers to prescribing a sufficient painkiller to mitigate pain in a palliative care situation.

This is really a complex kind of problem. It's too deep to get into the argument; I know some of the dimensions of this. What I'd like to ask both of you is to think about this in real terms. Remember that, on the one hand, the initial contact point is the physician who writes the first prescription. On the other end are the people who have pain ranging from pain that can be treated by a number of different possibilities through to those dealing with terminal pain issues.

And we're dealing ultimately with regulation.

So this is not a simple issue. But we have heard you can't limit, on the one hand, and we've heard that there should be some guidelines at the very least, on the other. I wonder if you witnesses could both think about this and, based on your respective experiences, write to our clerk with any ideas you have following this meeting.

The final thing I want to touch on in this regard, and you have referred to it very directly and inferred it in some of your answers, is this: We know that the electronic gathering of information is one of the keys to the future in terms of responding to many of the questions our colleagues have asked in terms of seeking data, extents, levels of prescription and so on.

Dr. Sproule, I want to mention directly that in our previous studies we have been very impressed with the extent to which pharmacists are organized across the country — or at least communicate; I shouldn't say ``organized'' as that may convey other issues. Regardless, you are capable of communicating, and you are very good with technology. You are all pretty much fully online, electronically in terms of data and so on.

We have heard many suggestions that pharmacists can play — and largely this has come from pharmacists themselves — an even larger role, certainly in the data gathering and in advising patients that they see. You mentioned earlier, Dr. Sproule, that perhaps in rural area, it's not easy to have instruction. But in some rural areas, the pharmacist does indeed deal with all of the prescriptions of most their patients, and they often voluntarily provide feedback and information.

I again want to ask you as a take-away question to think about the problem of gathering information, both in terms of the volume and distribution of specific pharmaceuticals in the areas we are talking about today and then the collection of data on adverse reactions, which of course you've largely talked about today, because addiction is a huge adverse reaction. Please give that some thought, unfettered by committee room and other distractions, and if you could write any thoughts you have on this back to our clerk. This is an area we've been pushing in all of our reports, and we are continuously seeking specific, identifiable actions that can be taken, and the best organizations that can do it.

With that I want to thank you both for a remarkable meeting today, an extremely informative meeting with useful data. The recommendations in the report you referred to — we have seen that it's a remarkable document. The additional points you have made today and the extent of your responses to us have been excellent. I want to thank my colleagues once again for questions that have elicited a tremendous amount of information in the response.

(The committee adjourned.)