Health Committee on Dec. 2nd, 2013

[The Chair, Conservative, Ben Lobb]

Good afternoon, ladies and gentlemen. Welcome to the health committee. We have a quorum so we are going to get under way here.

We have another large contingent here to provide information and their expert experience for our study addressing prescription drug abuse.

We ask that you do a 10-minute presentation, or shorter, to the committee. There is translation if you need it. Then there will be several rounds of questions to follow.

We have five different groups. We'll start with the Royal College of Dental Surgeons of Ontario. Please go ahead.

[Dr. Peter Trainor, President, Royal College of Dental Surgeons of Ontario]

Thank you, Mr. Chairman, and members of the committee.

I am Dr. Peter Trainor, president of the Royal College of Dental Surgeons of Ontario. I am also president of the Canadian Dental Regulatory Authorities Federation.

The college is the regulatory body for the dental profession in Ontario. We regulate the practice of over 9,000 dentists. These dentists work in both general practice as well as specialty practices. To put that into a different perspective, we regulate about half the dentists in Canada. Our legislative mandate as a provincial health care regulator is very clear: it is public safety and protection. Everything that we do is seen through the single lens of public protection, and we have been doing that for a long time. RCDSO has been regulating the dental profession since 1868. Dentists have a long history of safely and effectively using and prescribing medications to their patients in the treatment of oral health disease. It is an essential component of the modern practice of dentistry, and this is why our college is very pleased to have the opportunity to be before this committee today.

Joining me today is Irwin Fefergrad. Mr. Fefergrad is a lawyer by profession. He is the registrar and chief executive officer of the college. He is certified by the Law Society of Upper Canada as a dual specialist in civil litigation and health law. He is also the executive director of the Canadian Dental Regulatory Authorities Federation.

Also with me is Dr. David Mock, a dentist as well as a specialist in oral pathology and oral medicine. Dr. Mock is an expert in pain management and as such is the associate director of the Wasser Pain Management Centre at Mount Sinai Hospital in Toronto. He is the former dean of the faculty of dentistry at the University of Toronto, the largest dental school in the country. Dr. Mock is also a member of our governing council.

Our college, due to concern about the management of chronic pain, has held a one-day symposium strictly dedicated to this very important topic. As an outcome of that symposium, a working group was established to study acute and chronic pain. Dr. Mock is the chair of that working group.

Dr. Mock, as well as Dr. David Segal, an oral surgeon on the RCDSO council, are also members on the working group of the Canadian Centre of Substance Abuse. Dr. Mock co-chairs that working group, and they have produced a statement on the national document First Do No Harm. The working group is composed of both professional as well as lay people developing competencies for health care providers.

With that brief introduction, I would like to turn the presentation over to Mr. Fefergrad.

[Irwin Fefergrad, Registrar, Chief Executive Officer, Royal College of Dental Surgeons of Ontario]

Thank you very much for having us. Good afternoon.

As the registrar of the college, I have responsibilities under the statute to protect the public, the public interest, and the health and safety of the public of Ontario. Our mandate does not include advocacy for the profession; it does not include anything involving protection for the profession. As a regulatory body, we are governed by statute, as Dr. Trainor has said, and that is our mantra.

The issue of drug prescription, particularly with opioids, has been in the forefront not only of the college, as Dr. Trainor has outlined and as Dr. Mock will explain in a minute, but it has also been at the forefront of the thinking of the government of Ontario. It produced a document through the Health Professions Regulatory Advisory Council, which is the Minister of Health and Ontario's key statutory advisory committee.

I have copies of it here and will make brief reference to it. I apologize that it is in English only—

but it is not my document. It comes from the Ontario government.

I have not translated it. It is an Ontario document and I've just given you what the Ontario government has produced. I hope that for this session you will look at it. I think it has an impact on what you might be doing, analyzing, and discussing.

I understand there is a procedure that you have. Again, I apologize. This is not a document that the college produces. If you see our magazine, you will see that features of it are bilingual. If you looked at our website, you will see that features of it bilingual. But this is from the Government of Ontario.

I've given it to the clerk, Mr. Chair.

[The Chair, Conservative, Ben Lobb]

Thank you.

Does that conclude your presentation or is there more to that?

[Irwin Fefergrad]

No, I want to refer to the document.

[The Chair, Conservative, Ben Lobb]

Okay, carry on.

What we'll do, just for your information, is to have it translated and then distributed to the committee. Okay?

[Irwin Fefergrad]

Thank you very much.

I won't take a lot of time, but the conclusions of the Ontario report were, at page 231, that dentists prescribe medication, particularly prescribe opioids, safely.

At page 214, the government's counsel reviews the professional misconduct regulation on prescribing, and says:

Dentists...have a detailed professional misconduct regulation. It includes “prescribing, dispensing or selling a drug for an improper purpose, or otherwise using improperly the authority to prescribe, dispense or sell drugs” as grounds for disciplinary action.

I would also urge the committee to look at pages 215, 216, 217, and 218 of the report. It outlines the education in the pharmacological area at the universities, and concludes:

Dental programs have extensive general pharmacology courses at levels comparable to medical students. All programs offer courses in general medicine relating to how common illnesses impact dental care.

It goes on to analyze what the programs are about and then it compliments the college for its ongoing education in drug education.

Finally, at page 218 of the report, it concludes that we are responsible as a regulatory body looking at the public interest in regulating the profession. There's a comment on online adverse drug interaction programs providing timely and reliable information on drugs, and the minister's counsel feels that this is a very important availability for each and every dentist at chair-side to avoid contraindicated medication prescriptions.

I will tell you, in conclusion, as the registrar, that we are very proud of the way the dentists in Ontario have used their prescription privileges. That's not to say that every dentist is perfect. That's why we have a regulatory body. But it's to say that, overwhelmingly, dentists are very responsible with the current knowledge and its use for prescription medication.

We don't rest on our laurels. I'll turn matters over to Dr. David Mock, former dean of the University of Toronto dental school, who's now on our council. He will tell you about some of the initiatives we are making collaboratively with our friends and colleagues at the College of Physicians and Surgeons of Ontario, who are here, and others on a national and provincial basis.

[Dr. David Mock, Professor, Royal College of Dental Surgeons of Ontario]

Thank you. To begin, I have a slight correction to make on the credentialing.

Dr. David Segal and I were on the larger federal body for the CCSA that produced the First Do No Harm document, which I'm sure you've seen. But that was a large national body and the two of us were just members of the committee. I'm now co-chairing with Dr. Norman Buckley from McMaster a working group subcommittee to develop competencies, guidelines, and educational material for health professionals, patients, students, and the general public with respect to the whole issue of substance abuse.

As an outcome of the meeting that was just described at the RCDSO, I'm chairing a committee there looking at producing guidelines for dental surgeons in Ontario on chronic and acute pain, concentrating primarily on establishing guidelines for the prescription of drugs in general and, more specifically, opioids. In turn, that committee is going to make recommendations on additional educational programs for dentists in practice to make sure they're up to date on the whole issue of prescribing, and in particular prescribing opioids. The program at the university has been described to you. I was actually the one who described it when we met with HPRAC.

I'd certainly be glad to answer any questions. I will say that dentists across Canada are very well educated on the issue. In fact, as the general public has become more and more aware of the potential for substance abuse and the problems with that, particularly with prescription drugs, the educational programs are being augmented to ensure that our students and graduates are also aware of the issues and how to deal with them.

[The Chair, Conservative, Ben Lobb]

Thank you very much. You're pretty close to being right on time, so that's very good.

Next up is the Canadian Pharmacists Association.

[Phil Emberley, Director, Pharmacy Innovation, Canadian Pharmacists Association]

Good afternoon.

I'm Dr. Phil Emberley. I'm the director of pharmacy innovation at the Canadian Pharmacists Association and also a practising pharmacist. CPhA represents over 35,000 Canadian pharmacists from coast to coast, practising in community and hospital pharmacies, family practice clinics, industry, and other settings.

I'm joined today by my colleague and peer, Mr. Mark Barnes, who is a pharmacist, owner, and VP of business development and public relations of a pharmacy in Ottawa that provides treatment to patients addicted to opiates. In a couple of minutes, Mark will share with you the services he provides, as well as the impact he has on his clients.

As front-line health professionals, pharmacists see first-hand the devastating impact of prescription drug abuse—in particular, opioid painkillers—as it shatters careers, relationships, and indeed lives. Many patients who become addicted to opioids start them as prescribed therapy for an actual ailment.

Ensuring access to pain medications for patients who have legitimate needs while working to prevent misuse, abuse, and diversion of opioids is a complex balancing act for prescribers and pharmacists. There are no easy answers to mitigating the prescription drug abuse problem in Canada. However, pharmacists can play an important role in helping patients to avoid the pitfalls of prescription drug abuse and in providing treatment for those who are addicted to opiate medications.

But there also remain areas where further work and efforts must be addressed. First and foremost, pharmacists want to do what is best for the health of their patients, and their goal is to steer patients away from harmful situations such as prescription drug abuse. As drug experts, pharmacists fully understand how drugs work and how addictions occur, including the factors that lead to medication abuse and misuse.

In recent years, provincial governments have expanded the professional scope of pharmacists. In most jurisdictions, pharmacists can now provide medication reviews to their patients. A medication review allows pharmacists to become more familiar with a patient's diagnoses, the indication for treatment, and their response to medication.

This service can also be used to flag potentially problematic medication use, as well as to provide an opportunity to better educate patients on how to take their medication safely. For example, stopping some narcotics abruptly can cause harm to patients and even lead to emergency room visits in some cases. Medication reviews are an ideal setting for pharmacists to educate patients on how to safely stop a medication.

The CPhA recommends that all jurisdictions, including the federal government, as a provider of health services, support pharmacist medication review programs.

The Canadian Pharmacists Association is also an accredited provider of continuing education. While there is medical, nursing, and pharmacy training that educates to optimize the prescribing of psychoactive drugs, there is an opportunity to do much more. Health providers need better education in order to weigh the risks and benefits of opioid treatment and in order to educate patients on the safe use of these medications.

Health professionals also need to be able to recognize evidence of and potential for the misuse of these medications. National and inter-professional education programs need to be developed that ensure all health care providers are fully up to date on the current treatment regiments for chronic pain and mental health disorders.

I'll now pass the floor over to Mark, who will describe some of his experiences with patients who have problems with prescription drugs.

[Mark Barnes, Pharmacy Manager and Owner, Westboro Pharmasave, Respect Rx Pharmasave, Canadian Pharmacists Association]

I want to describe to you situations—just two, unfortunately, due to time constraints—that will give you a better understanding of the type of person or patient we can see on a daily basis at the pharmacy. That way you guys can understand exactly how a pharmacist can make a difference in identifying but also treating or preventing addiction to opioids especially.

I'll describe one patient. We'll call him Adam. He was a successful person, well-adjusted, from university, and a successful accountant living in Ottawa, doing quite well, with two children. He had a sports injury, went into treatment, and was prescribed short-acting narcotics. This led to overuse of the narcotic, then misuse of the narcotic, and eventually seeking the drug on the street.

He came to me at the pharmacy at a very young age, with two small children and a wife he was hiding his addiction from. He started into a methadone program that was unsuccessful at the pharmacy level.

I approached Adam and asked him why he was not continuing to take his methadone on a regular basis: what was going wrong? He said he was hiding his problem from his wife and trying to maintain a job. He was busy, dropping his kids off at day care at 8 a.m. and couldn't get to the pharmacy on time.

I simply provided him the option of coming 15 minutes earlier to the pharmacy. After a connection we made, he got compliant, he got better, and he finished using methadone.

Five months later, he called me from Disney World and said, “Thank you for making a difference to me. This is the first vacation I have had in five years with my family.”

This was not a person who you would normally think would have a problem with addiction. This was a person who was successful, well-adjusted, with no financial problems and no other comorbidities. He was simply prescribed medication post-injury.

The second patient I'll describe to you is probably the type of patient you're more familiar with, a product of the system. At five years old he was abused physically—as a child he was woken up in the morning by his parents dunning his forehead with a cigarette—which led to his being in and out of child care services. Obviously he then became addicted to drugs and alcohol, became HIV-positive and hepatitis C-positive. He presented to me at the pharmacy and we got to know each other well. He described the situation to me and said, “Listen, I never had a chance from the start.”

I simply asked him what he was doing now, and he told me that he was on a treatment program and doing quite well. He taught me how addiction can work. He's now reaching out to children. He's teaching them how to be safe from HIV. He's teaching them about proper needle exchanges. He's teaching kids how not to do drugs, to stay away from drugs. He volunteers at local churches. He tries to educate where possible. He's successful.

Will he ever stop using methadone? Maybe not. But it's important that you guys realize that addiction itself does not have any boundaries. It can affect many different classes of people in society, from the homeless to the well-adjusted.

It's important that everyone here today understands that pharmacists see these patients on a daily basis and can make a difference every day to keep them in the treatment and see them progress through treatment.

[Phil Emberley]

Thank you, Mark.

It's important that we address problematic drugs and that we take steps to prevent their misuse and diversion. This includes public policy that prevents the marketing of drugs known to be problematic.

For example, last year OxyContin lost its patent and was approved for generic manufacture despite its known notoriety as a drug of abuse. We need a regulatory mechanism that prohibits generic drugs with high risk of harms, such as OxyContin, from easily gaining approval and entering the market.

Potential for abuse of new brand and generic drugs must be an important determinant for whether such drugs are authorized for sale in Canada. The fact that crushable forms of generic OxyContin still exist in Canada poses a major risk to the public and leaves pharmacies more vulnerable to robberies.

Many jurisdictions across Canada have implemented controls that reduce the diversion of narcotic and controlled substances. One example is Ontario's narcotics monitoring system, or ONMS, which acts as a centralized database for storing the history of monitored drug prescribing and dispensing activities across the province. ONMS is capable of reviewing previous history of monitored drug use, and can provide real-time alerts to pharmacies if drug abuse is suspected.

Several other provinces have triplicate prescription programs. While these controls are important, the most effective would be implementation of electronic health records—in particular, drug information systems and electronic prescribing in all jurisdictions. Pharmacists, physicians, and other prescribers would be able to see records of all narcotic and controlled drugs prescribed and dispensed for patients. Knowing a patient's controlled drug history and behaviours would support both pharmacists and prescribers in monitoring use and applying their professional judgment.

Ultimately, as gatekeepers, pharmacists make the final decision on whether or not to dispense a narcotic or controlled substance, based on their careful assessment of the patient, the prescription, and the prescribed medication. With the proper tools and policies in place, we can better enable pharmacists to do their job in this respect.

Thank you. We would be happy to entertain questions later.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Next up is the Federation of Medical Regulatory Authorities of Canada.

You have 10 minutes. Go ahead, please.

[Dr. Rocco Gerace, President, Federation of Medical Regulatory Authorities of Canada]

Thank you very much.

I'm Rocco Gerace, and I'm pleased to be here as the chair of the Federation of Medical Regulatory Authorities of Canada.

With me is Louise Marcus, who is the director of professional affairs.

FMRAC is the voice, both nationally and internationally, of the provincial and territorial medical regulatory authorities.

My background is in the practice of emergency medicine and clinical toxicology. I practised for many years using opioids on an acute-care basis, and currently I'm the registrar of the College of Physicians and Surgeons of Ontario.

In describing the problem, we know that opioids are critical in the treatment of pain, whether that's acute pain, chronic pain, or terminal pain. There's no doubt that health professionals are very keen, along with their patients, to ensure that pain is treated. But treatment of pain is fraught with uncertainty, especially when it comes to opioids. The use of opioids ranges from underuse to overuse, and the dosing can be difficult. So we need to create a balance. We have to encourage the judicious use of these agents without creating an atmosphere of fear. There's no doubt that if we approach this too aggressively there will be fear among the prescribers.

We know there is overuse of these drugs in Canada. We are amongst the largest users in the world, second only to the United States. The problem is multifactorial, involving prescribers, dispensers, and, in some cases, the public by way of diversion. Misuse has terrible effects on the individual, sometimes creating addiction, which is occasionally fatal, but I'm sure I don't have to talk about the societal impact of overuse of these agents.

Just to describe what we see in the case of doctors, I'm pleased to say that the majority of doctors prescribe these drugs appropriately. But having said that, we are seeing increasing numbers of reports related to inappropriate prescribing at the regulatory level. These have a number of outcomes. We see some doctors, who want to treat appropriately, who deviate slightly from standards. These doctors really need an educational approach to help them do the job better. Occasionally we see pervasive inappropriate prescribing. The only outcome for these doctors is a regulatory approach, ultimately removing their ability to prescribe these agents. Rarely we see intentional overprescribing for the purposes of diversion. We look at this as criminal behaviour and feel that these individuals should be prosecuted to the full extent of the law. But I think it's important to remember that doctors want to do a good job in prescribing these drugs and in treating their patients' pain.

I'll describe briefly what has been done around the regulatory community. We've provided links to this activity in the material we've circulated.

First of all, at the national level, the regulatory authorities brought together experts to develop standards for opioid use. We have provided this reference. The document has been internationally validated. What these Canadian guidelines do is give evidence-based guidance for the appropriate use of opioids. Flowing from the document have been things like an opioid manager, a tool that helps doctors in the appropriate use of opioids. It also provides the regulators and others with a measure of the standard of care so that when we look at individual doctors prescribing, we know the sorts of outcomes we might have.

The second area is activity in Ontario, which I'm just going to allude to. This was a multi-stakeholder task force to consider what we might do as a community to deal with what we've described as a public health crisis. In this stakeholder consultation, we brought together multiple health professionals, patients, educators, law enforcement officials, and members of the provincial government. I'm just going to highlight a couple of the areas, and we will leave with you a copy of our report.

The recommendations we made are equally valid today. We've suggested that we create a coordinated and accessible system for the treatment of pain and addiction. We do know that in the community there is not adequate access to either treatment of pain or treatment of addiction.

You've heard about the importance of technology. We felt it was important to move forward with greater use of technology so that all providers have real-time access to the drugs their patients are receiving.

Key in our recommendations is the ongoing education of health care providers, individual patients, and the public at large. We feel it is important that all of these stakeholders are aware of the benefits and risks of opioids.

Finally, we felt that there needed to be a mechanism to empower all of the stakeholders to reduce diversion by facilitating an exchange of information, whether it be with regulatory bodies or law enforcement. Certainly, criminal activity has to be stopped.

In closing, I want to say that this is a very complex problem. I'm fond of quoting H.L. Mencken, a journalist in the U.S. from early last century. He said, “For every complex human problem there is a solution which is simple, straightforward and wrong.” This issue of opioid use is complicated. We all have to work together to find solutions that will be applicable across the country.

On behalf of the federation, I appreciate the interest of the committee and the federal government. It's only with the involvement of all of the stakeholders that we're going to come up with meaningful solutions to this difficult problem. I assure you that the medical regulatory community across the country would be pleased to help in any way it can.

Those are my comments. Thank you.

[The Chair, Conservative, Ben Lobb]

Thank you very much, Mr. Gerace.

I think the Toronto Maple Leafs have been using that slogan for a few years, and that could be the problem. Maybe we've uncovered the problem.

[Dr. Rocco Gerace]

I hope I can disavow myself of the Toronto Maple Leafs.

Thank you.

[The Chair, Conservative, Ben Lobb]

Okay.

Next up we have the Canadian Generic Pharmaceutical Association.

For 10 minutes, please.

[Jim Keon, President, Canadian Generic Pharmaceutical Association]

Thank you.

Good afternoon.

On behalf of the Canadian Generic Pharmaceutical Association, I would like to thank the Chair and the honourable members for this opportunity to participate in your study of addressing prescription drug abuse.

I am the president of the CGPA, and I am joined today by Dr. Colin D'Cunha, director of global medical affairs with Apotex Inc. Dr. D'Cunha is also a former chief medical officer for the Province of Ontario and an adjunct professor at the University of Toronto medical school.

I will begin with a little bit about our industy.

The generic pharmaceutical industry operates the largest life sciences companies in Ontario, Quebec, and Manitoba. We are Canada's primary pharmaceutical manufacturers and exporters, and are among the top research and development spenders across all industrial sectors.

Generic pharmaceutical companies directly employ more than 12,000 Canadians in highly skilled research, development, manufacturing, and other scientific positions. Our industry's most important role is in controlling health care costs in Canada. Generic drugs are dispensed to fill 65% of all prescriptions; approximately two out of three prescriptions in Canada are now filled with generics. However, we account for less than one quarter of the $22 billion spent in Canada on prescription medicines—two thirds of prescriptions by volume, less than a quarter by cost.

Prescription medications are generally safe, but only when they are taken as prescribed and for the intended purpose. When they are abused, they can cause an array of adverse health effects. Prescription and over-the-counter drugs may be abused by taking a drug for a purpose other than prescribed, taking a drug in a higher quantity or in a manner other than prescribed, and taking a medication prescribed for somebody else.

This committee has heard disturbing statistics from earlier witnesses with respect to the prevalence of prescription drug abuse in Canada. This is a cause for concern for all pharmaceutical stakeholders, and for all Canadians. We commend the Government of Canada and the committee for its efforts to review the appropriate roles throughout the supply chain of all stakeholders in addressing prescription drug abuse.

We hope our testimony today will help you in this regard.

On the role of the pharmaceutical industry, this afternoon I want to highlight three ways in which the generic pharmaceutical industry is supporting efforts to address prescription drug abuse. First, it provides essential information about the safety profile, proper prescribing, and use of prescription medicines; second, it operates a safe and secure supply chain for our medicines that prevents opportunities for diversion; and third, it supports the safe disposal of unused or expired prescription medications.

The first item is information. To give you a little background, the brand-name companies that develop new medicines generally promote their products to doctors during the period of patent exclusivity. Generics typically enter the market 12 to 15 years after the original-brand product has been introduced. By that time, after 12 to 15 years of use, the characteristics of the medication, including its therapeutic benefits as well as side effects, are well known and understood by doctors and pharmacists, who have been prescribing and dispensing the product to their patients for many years. As a result, generic companies do not promote or detail their medicines to doctors. There are, however, several ways in which generic pharmaceutical companies support enhanced knowledge about the products we sell.

First of all, the drug labels and packaging of our products give health care professionals the information they need to prescribe and dispense drugs appropriately. Health Canada is currently undertaking an important initiative to make drug labels and packaging information easier for the general public to read and understand—and we're participating in that exercise.

Second, we have our product monographs. A product monograph is a factual, scientific document on the drug product that describes the properties, claims, indications, and conditions of use for the drug, and contains any other information that may be required for the optimal, safe, and effective use of the drug. It includes appropriate information respecting the name of the drug, its therapeutic or pharmacological classification, its actions or clinical pharmacology, and its indications and clinical uses. A product monograph also includes many other important pieces of safety information, including contraindications, warnings, precautions, and adverse reactions. In accordance with Health Canada requirements, the generic company must follow the information in the product monograph of the equivalent brand-name product. We are not able to have different information in our product monographs.

The third area where the generics engage in active efforts for patient information is risk management plans. Companies develop risk management plans, or RMPs, for particular medicines in consultation with Health Canada. These plans include information about a medicine's safety profile, how its risks will be prevented or minimized in patients, plans for studies, and other activities to gain more knowledge about the safety and efficacy of the medicine, risk factors for developing side effects, and measuring the effectiveness of these risk minimization efforts.

Monitoring the use and effect of medicines is an essential focus for any pharmaceutical company. All pharmaceutical companies in Canada are required to monitor the use and effect of a given medication and to detect, assess, understand, and prevent any adverse reactions or any other medicine-related problems that arise. These activities and the science behind it are known as pharmacovigilance in the pharmaceutical industry. Our member companies prepare safety reports to meet regulatory obligations. We'd be happy to discuss this whole area of adverse drug reaction more with the committee. We also conduct ongoing monitoring and literature reviews on a global basis to identify any adverse drug reaction case reports.

The second area identified where generic companies operate to help prevent prescription drug abuse is in the supply chain. Having a safe and secure supply chain is a high priority for generic pharmaceutical companies. Generic pharmaceutical companies supply Health Canada with approved medicines to meet the demands of the Canadian market. The standards are the same for both imported and domestically manufactured products, and for both brand and generic products. Almost all generic medicines in Canada today are distributed through sale to wholesale distributors, who are licensed by Health Canada. These wholesalers must meet stringent standards for the safe and secure distribution of the medicines across Canada. It is the wholesalers who distribute the medicines to pharmacies in Canada.

There are four primary aspects of the pharmaceutical supply chain. They are the regulatory review approval process, the manufacturing process, procurement and delivery, and front-line delivery. I will not go through those, but Dr. D'Cunha and I would be pleased to answer any questions you may have with respect to the pharmaceutical supply chain this afternoon.

The final area I'm going to cover is the safe disposal of prescription medications. Unused portions of medications provide opportunities for abuse. Those that are left at home or are tossed in the garbage can make their way into the wrong hands and be abused. Improper storage at home may also provide opportunities for abuse. For this reason, as well as environmental concerns, the generic pharmaceutical industry educates consumers about the proper disposal of medication.

All CGPA member companies participate in the Health Products Stewardship Association. The HPSA program objective is to divert expired and/or unused health products from landfills and sewers, as well as to ensure safe and effective collection and disposal. There is no charge for the public to return medications. All costs for the collection and proper disposal of pharmaceutical products are paid by HPSA members from the pharmaceuticals and health products industries. In addition, the Government of Canada initiated the first National Pharmaceutical Take-Back Day in May 2013, where the public was encouraged to take unused medications to police and RCMP stations for safe and proper disposal. We commend the government for this initiative and we're pleased to participate in a stakeholder round table.

I will stop there, and I thank you again for the opportunity for the generic pharmaceutical industry to participate in your study. Dr. D'Cunha and I would be pleased to answer any questions

[The Chair, Conservative, Ben Lobb]

Great, thank you very much.

Our last witness to testify here today is from the National Association of Pharmacy Regulatory Authorities.

Ms. Bouchard, go ahead.

[Carole Bouchard, Executive Director, National Association of Pharmacy Regulatory Authorities]

Thank you, Mr. Chair.

Good afternoon, honourable members, ladies and gentlemen.

It is a great pleasure for the National Association of Pharmacy Regulatory Authorities to appear today before your committee.

Our association understands that the committee has recently begun a study on the government's role in addressing prescription drug abuse, and wishes to dedicate today's meeting to best practices and federal barriers regarding practice and training of health care professionals.

We thank you for the opportunity to come to present our view on this important topic.

Let me first explain who we are. NAPRA is the National Association of Pharmacy Regulatory Authorities. It is a not-for-profit organization that represents all provincial and territorial pharmacy regulatory authorities whose mandate is the protection of the public. Our membership also includes the Canadian Forces' pharmacy services.

Our members play a key role to ensure that optimal regulatory practices are in place for a safe practice environment for the benefit of all Canadians. Over 36,000 pharmacists are licensed by our members to practise pharmacy across the country, and operate within specific regulatory practices and requirements. Our members have also started to license another group, pharmacy technicians, in certain jurisdictions in Canada, as this group is now becoming regulated.

In my presentation today I will be sharing information on four key areas with the committee: a general perspective of prescription drug abuse; our association's contribution so far to the matter; the role of health care practitioners and their regulatory authorities; and to conclude, the most urgent area for improvement by the federal government from a regulatory lens.

First of all, I would like to share our perspective on prescription drug abuse. When we refer to prescription drug abuse in our presentation we have in mind the drugs that, generally speaking, have abuse liability potential such as analgesics, stimulants, tranquilizers, and hypnotics.

Prescription drugs approved by Health Canada have been reviewed for their safety, efficacy, and quality and are made available to health care practitioners to help patients cope with their medical conditions and associated symptoms. They have a place in the therapeutic drug arsenal. However, these drugs have abuse liability potential and when taken or used inappropriately can cause problems.

The issue of prescription drug abuse is not new, but it seems to have been forgotten or underestimated during the development of what is currently the national anti-drug strategy, led by the Department of Justice. That needs to change. I am confident that the committee has already heard details from previous witnesses on the overall situation in Canada and worldwide regarding this matter. Canada is not unique in dealing with this issue. It is a topic of interest to the United Nations Commission on Narcotic Drugs.

I'm sure each of us has seen at least once the harm experienced by a person as a result of prescription drug abuse. This is a sad situation for the person and his or her family, which could have been avoided.

This leads to the second point in my presentation regarding our association's contribution on the matter to date. Over the past few years NAPRA has participated in a series of meetings and workshops held by the Department of Public Safety and the Canadian Centre on Substance Abuse. We understood that all of this work was to serve as a foundation for the launch of the development of a renewed anti-drug strategy for Canada. We accepted being a part of the National Advisory Council on Prescription Drug Misuse. This undertaking was important to NAPRA and its members, in order to examine the problem a bit more closely and to elaborate a strategy to improve the situation in Canada.

We are pleased to have contributed to this work that led to the release of the report entitled First Do No Harm: Responding to Canada's Prescription Drug Crisis, which contained several recommendations, as you know. The report established a vision and outlined a road map for action.

NAPRA, through its president, continues its work with the National Advisory Council on Prescription Drug Misuse.

This leads naturally to the third key area of my presentation, which is the role of health care practitioners and the regulatory authorities in prescription drug abuse. Health care practitioners are regulated professionals who abide by a code of ethics and follow standards of practice developed by their regulatory authorities, and that is to ensure consistency across Canada in the practice of public protection.

Pharmacists are no different. They comply with the standard of practice that involves providing drug therapy management services. They are the medication management experts and their goal is to ensure optimal drug therapy for patients. They work collaboratively with the patient and other health care providers in defining the health-related needs and drug therapy problems to be resolved. They prepare care plans. They undertake implementation, monitoring, and follow-up. Pharmacies are able to identify issues, provide education or other information, and refer patients to other care providers when appropriate.

Drugs that have abuse liability potential are no different from the other drugs. When it comes to the job or work of the pharmacist, we look for the most appropriate drug therapy for the medical condition symptoms the patient is being treated for, and we monitor the patient's use of drug therapy to identify any issues such as side effects or misuse.

When needed, regulatory authorities take action to correct any problems that may come with the practice of their members. They also provide a series of guidelines and standards to support best practices in the every day work of pharmacists. They collaborate with other stakeholders on initiatives that aim to improve patient safety and public protection. Although regulatory authorities and pharmacists do their best to curtail prescription drug abuse by many interventions and means, they lack tools and authority when it pertains to drugs that have abuse liability potential. These drugs are, for the most part, found in Canada in the Controlled Drugs and Substances Act, which is federal legislation.

This brings me to the last area of my presentation, which will focus on the most urgent area for action by the federal government.

The Controlled Drugs and Substances Act, CDSA, came into effect in the late nineties. This piece of legislation introduced a series of new provisions that were overdue for Canada at that time. However, since the legislation was enacted, the regulations under the statute have not been improved. As the statute create total prohibition, the regulations are necessary to define the type of activities and control for prescription drugs that have drug abuse liability potential.

The health care environment and the role of health care practitioners have changed significantly since the late sixties, but the regulatory framework for narcotic and controlled drugs, which dictates how these drugs are imported, distributed, sold, prescribed, dispensed, and destroyed, has not changed.

This situation is creating problems for stakeholders, such as health care practitioners, regulatory authorities, and law enforcement, as the outdated framework is not responsive to the current needs and environment. In addition, the ongoing monitoring of these activities for compliance is quasi nonexistent.

Our association is supportive of interventions that will focus, among other things, on education, prevention, treatment, monitoring, surveillance, enforcement, and research. However, above all, we believe that the federal government needs to take leadership, in partnership with affected stakeholders, in redesigning the regulatory framework in Canada so that it can be updated and adapted to the current environment. For instance, current regulations speak about filing paper copies of prescriptions, where it is now possible to maintain proper accountabilities and controls through electronic means while maintaining public protection. Regulatory authorities have been struggling with situations where actions were required to stop or prevent a problem of drug abuse, but were limited in their actions due to the lack of authority pertaining to federal regulation. One aspect of this is the lack of information exchange, authorities, and systems between federal authorities and provincial and territorial regulatory authorities.

In redesigning the regulatory framework, we believe that the government needs to develop the most adequate framework for current and future environments, one that provides the best accountability framework for the management of this category of drug, and eliminates barriers preventing health care practitioners, including pharmacists, from practising to their full scope of practice.

We believe that the government must clarify its intentions regarding the scope of federal involvement with this category of drug. Any regulatory framework requires not only monitoring, in addition to a compliance and enforcement plan, but also must have available the educational resources for carrying out both plans. They also need to ensure that exchange of information is possible between regulators for the purpose of curtailing prescription drug abuse. They need to develop a means of monitoring, nationally, drug prescriptions that could lead to abuse, and implement new technologies or other e-health initiatives across the country.

A good example is the effort being made by the United States with the establishment of a prescription monitoring program that connects state-level programs, entitled InterConnect.

It should also be mentioned that it is necessary for the government to have a role in post-market surveillance. Drug abuse, drug overdose, and inappropriate prescribing are all examples of situations that require monitoring by Health Canada to a much greater and significant extent to what has been done over the past several years.

The government also needs to be quicker in scheduling drugs under the CDSA. By not doing so, the government leaves a series of drugs not scheduled, sometimes for a long period of time. For a drug not scheduled, it often means a lot of confusion among stakeholders and health care professionals regarding the control that applies to the drugs in question. For example, many provincial prescription monitoring programs, which we call triplicate programs, will not add a drug to the list of monitored drugs until Health Canada lists that drug—

[The Chair, Conservative, Ben Lobb]

Excuse me, Ms. Bouchard, is there much left to your presentation?

[Carole Bouchard]

I'm almost finished.

[The Chair, Conservative, Ben Lobb]

Okay, thank you very much.

[Carole Bouchard]

Therefore, those drugs need to be scheduled very quickly to be able to add them to the monitoring. So a quicker scheduling process should also apply for drugs that may be abused, and it requires urgent review and scheduling in situations where new trends of abuse emerge, for example, over-the-counter health products.

In conclusion, I wish to reiterate that the consequences of prescription drug abuse are important for the health of Canadians and can also create other problems such as drug shortages. When a drug is overused or used inappropriately, it can reduce the supply of the drug to a point that the drug is suddenly not available for legitimate use. We know there is a lot to do in this area and we will contribute to the work of the National Advisory Council on Prescription Drug Misuse.

We believe that primary action needs to start with redesigning the legislative framework.

Thank you again, Mr. Chair, and committee members, for the opportunity for our association to appear before you today.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

We have a great group of individuals here who have provided us with some great opening remarks.

For our members, we do have a large panel here today. We should be able to get through everybody's questions if we keep it to our time. So please don't be offended if I cut you off at seven minutes or five minutes. Also, as discussed previously, because we do have a large panel, if you can direct your questions to those you'd specifically like to answer, that would be very helpful to keep the flow of the meeting going.

For the first seven minutes, we have Ms. Davies.