November 19, 2012 The Honourable Leona Aglukkaq, P.C., M.P.

Federal Minister of Health 70 Colombine Driveway, Tunney's Pasture Ottawa, ON K1A 0K9 Dear Minister Aglukkaq: We, the undersigned, are clinicians from across Canada, who regularly treat patients with chronic non-cancer pain (CNCP) and/or addiction. One of the treatment options for moderate to severe CNCP is the use of long-term opioid therapy. This treatment has been very controversial in recent years as a result of the misuse of opioids by a small segment of the population. This has resulted in harms related to opioid abuse and addiction including the risk of accidental death from overdose. The risk of harm is highest in those who snort or inject an oral opioid because of the resulting rapid and higher serum levels. We understand that Health Canada will decide on November 25th whether or not to approve generic forms of controlled-release (CR) oxycodone for the Canadian market. These generic products will use the older controlled release formulation, similar to the now discontinued OxyContin, which was easy to tamper with by crushing. The resulting crushed powder can be snorted directly or easily dissolved in water for injection. The generic formulations will lack the tamper-resistant characteristics of the currently available CR-oxycodone formulation (OxyNEO), which is difficult to crush and forms a thick hydrogel when placed in water thus discouraging snorting and injecting. This formulation is already demonstrating less popularity among those attending U.S. addiction treatment programs (Cicero, NEJM 2012; Butler, J of Pain 2012). This preliminary data is also supported by anecdotal information from clients attending some Canadian addiction programs. We are in favour of maintaining access to affordable treatments for our patients with CNCP, and we understand the important role that generic products have in reducing overall drug costs. However, this is a unique case where the costs of approving the generic may be much higher than the savings from the drug costs alone. The recent paper by Skinner (copy attached) from the Canadian Health Policy Institute estimates that the total social costs of drug misuse related to the generic oxycodone formulations, could be as much as five times more than any direct formulary savings from the generic versions. If there were some foolproof way to stratify patients into low risk vs. high risk, perhaps we could provide the generics versions to low risk patients and reserve the tamper-resistant formulations for the higher risk patients. Unfortunately, even with various screening and monitoring strategies, it is always a challenge in practice to be confident that a given patient is using pain medication appropriately. Even if our patients are using medication appropriately, there is always a concern about access to household medication and misuse by our youth. In making a risk-benefit decision about long-term opioid therapy, a clinicians confidence is improved if the prescribed formulation is more difficult to tamper with and misuse. From a societal safety point of view, a tamper-resistant opioid formulation would be preferred to an easy to tamper with opioid. Although a determined person can always find a way to defeat any currently available tamper-resistant technology, it requires a complicated, multi-step process which makes it unlikely that a casual drug misuser, such as a young person who is experimenting, will go through the trouble of trying to tamper with the OxyNeo formulation. The other risk of approving a generic CR-oxycodone could be that with ongoing cost pressures in both public and third party formularies, a provincial formulary committee or a formulary manager may deem the generic and tamper-resistant formulations to be interchangeable. Thus a clinician who specifically prescribes a tamper-resistant opioid for a higher risk patient will be understandably upset if the pharmacist automatically substitutes the less

CPM Centres for Pain Management

6400 Millcreek Drive, Unit 9 Mississauga, Ontario L5N 3E7 Ph: 905-858-1368 Fax: 905-858-2144

expensive, easier to tamper, generic equivalent. For all of these reasons and in the interests of patient and public safety for all Canadians, we wish to add our opinion to those of the Provincial Ministers of Health, the Ontario Chiefs of Police urging Health Canada not to approve at this time, any new generic formulations of controlled-release oxycodone using the older, easier to crush formulation. We remain available to consult further with Health Canada as needed, regarding this important issue. Yours truly,

Roman D. Jovey, MD Medical Director, CPM Centres for Pain Management Physician Director, Addictions and Concurrent Disorders Program Credit Valley Hospital Mississauga, Ontario References: Butler SF, Cassidy TA, Chilcoat H, Black RA, Landau C, Budman SH, Coplan PM. Abuse Rates and Routes of Administration of Reformulated Extended-Release Oxycodone: Initial Findings From a Sentinel Surveillance Sample of Individuals Assessed for Substance Abuse Treatment. J Pain. 2012 Nov 3. doi:pii: S15265900(12)00803-6. 10.1016/j.jpain.2012.08.008. [Epub ahead of print] Cicero TJ, Ellis MS, Surratt HL. Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 2012 Jul 12;367(2):187-9. Skinner BJ. Net societal economic impact in Canada from withholding regulatory approval for generic OxyContin. Toronto: Canadian Health Policy. Sept 12, 2012 (attached) The following physicians have endorsed this letter electronically: Newfoundland Lydia Hatcher, MD, CCFP, FCFP, CHE, CAPM Clinical Associate Professor of Family Medicine Memorial University of Newfoundland St. Johns NFLD Nova Scotia: A J Clark, MD FRCPC Pain Management Unit 4th Floor Dickson, QEII, Health Sciences Centre Halifax, Nova Scotia

CPM Centres for Pain Management

6400 Millcreek Drive, Unit 9 Mississauga, Ontario L5N 3E7 Ph: 905-858-1368 Fax: 905-858-2144

Quebec: Aline Boulanger, MD, FRCP Professor of Anesthesia Director, Pain Clinic Centre Hospitalier de lUniversite de Montreal Montreal, Quebec Mark A. Ware, BA MBBS MRCP(UK) MSc Associate Professor Departments of Family Medicine and Anaesthesia McGill University Montreal, Quebec Ontario: Joel Bordman, MD Medical Director, Complex Pain Program First Step Medical Clinics Medical Director, Interdisciplinary Pain Program Austin Rehab Group Toronto, Ontario Geoff Davis, MD Assistant Clinical Professor of Medicine Northern Ontario School of Medicine Thunder Bay, Ontario Allan Gordon MD FRCP(C) Neurologist and Director Wasser Pain Management Centre Mount Sinai Hospital Toronto, Ontario Alan Kaplan, MD, CCFP(EM) FCFP Family Physician Richmond Hill, Ontario Angela Mailis Gagnon, MD, MSc, FRCPC(PhysMed) Director, Comprehensive Pain Program, and Senior Investigator, Krembil Neuroscience Centre, Toronto Western Hospital, University Health Network, and Professor, Dept. of Medicine, University of Toronto Robert McKay, MD Pain and Addiction Clinician Windsor, Ontario Dwight Moulin, MD, FRCP Professor and Earl Russell Chair, Pain Medicine University of Western Ontario London, Ontario

CPM Centres for Pain Management

6400 Millcreek Drive, Unit 9 Mississauga, Ontario L5N 3E7 Ph: 905-858-1368 Fax: 905-858-2144

Mary Redmond, MD, FRCSC Pain Management Clinician Ottawa, Ontario Sol Stern, BSc, MSc, MD, MCFP Lead Family Physician, Argus Medical Family Health Organization Oakville, Ontario Ellen Thompson, MD, FRCP Pain Clinic CPM Centres for Pain Management Ottawa, Ontario Eddie Wasser, MD Pain Management Clinician Jacobs Pain Centre North York, Ontario Erica L. Weinberg, MD Pain and Palliative Care Physician Richmond Hill, Ontario Manitoba: Howard Intrater, MD, FRCP Medical Director, Pain Clinic Winnipeg Health Sciences Centre Winnipeg, Manitoba Saskatchewan: Dr. P.R. Butt, MD, CCFP, FCFP Assoc. Prof., Department of Family Medicine, University of Saskatchewan, Saskatoon, SK. Alberta: Ian Forster, MD Medical Director and Consultant in Addiction Medicine Lifemark Health Institute Edmonton, Alberta Rob Hauptman, MD Pain Consultant, HealthPointe Clinic Treasurer Chronic Pain Section Alberta Medical Association Past President Pain Society of Alberta Assistant Clinical Professor University of Alberta Brian Knight, MD, FRCPC Facility Chief, Anaesthesiology Covenant Health, Misericordia Hospital Edmonton, Alberta

CPM Centres for Pain Management

6400 Millcreek Drive, Unit 9 Mississauga, Ontario L5N 3E7 Ph: 905-858-1368 Fax: 905-858-2144

British Columbia: Anna Borowska, MD FRCPC Consultant in Pain Medicine and Sleep Disorders Consultant in Psychiatry Complex Pain Centre St Paul's Hospital, Vancouver David G. Hunt, MD FRCPC Consultant In Pain Medicine Complex Pain Centre St Paul's Hospital, Vancouver Brenda Lau, MD FRCPC FFPMANZCA MM Canadian Royal College Taskforce on the specialty of Pain Medicine Chair, Fraser Health Authority Regional Pain Services Pain Specialist, St. Paul's Hospital and JPOCSC Pain Clinics Vancouver, B.C. Herman Lau, MD FRCPC Consultant in Pain Medicine Physical and Rehabilitation Medicine Complex Pain Centre St Paul's Hospital, Vancouver William McDonald MD FRCPC Interventional Pain Management Internal Medicine and Anaesthesia Complex Pain Centre St Paul's Hospital, Vancouver Michael Negraeff, MD, FRCPC, FFPMANZCA Anesthesiologist and Pain Specialist Department of Anesthesiology Vancouver General Hospital Viem Nguyen MD FRCPC Physical and Rehabilitation Medicine Complex Pain Centre St Paul's Hospital, Vancouver Christian Rucker, MD ASAM Consultant for Chronic Pain and Addiction Vancouver General Hospital May Ong MD FRCPC Consultant in Pain Medicine Internal Medicine Clinical Pharmacology Complex Pain Centre St Paul's Hospital, Vancouver

CPM Centres for Pain Management

6400 Millcreek Drive, Unit 9 Mississauga, Ontario L5N 3E7 Ph: 905-858-1368 Fax: 905-858-2144

Roger Shick MD FRCPC Consultant in Pain Medicine Consultant in Psychiatry Complex Pain Centre St Paul's Hospital, Vancouver Pam Squire, MD CCFP DCAPM ISAM CPE Pain Clinician Assistant Clinical Professor, UBC Vancouver, British Columbia Stephen Wiseman MD FRCPC Physician Leader Consultant in Psychiatry Complex Pain Centre St Paul's Hospital, Vancouver CC: Director General Health Canada Therapeutic Products Directorate Health Products and Food Branch Address Locator: 3106B Ottawa, ON K1A 0K9 Honourable Susan Sullivan Minister of Health and Community Services Confederation Building P.O. Box 8700 St. Johns, NL A1B 4J6 Honourable Dave Wilson Minister of Health and Wellness 4th Floor, Joseph Howe Bldg 1690 Hollis Street P.O. Box 488 Halifax, NS B3J 2R8 Honourable Rjean Hbert Minister of Health & Social Services Ministre de la Sant et des Services sociaux 15e tage, 1075, chemin Sainte-Foy Qubec (Qubec) G1S 2M1 Honourable Deb Matthews Ontario Minister of Health 80 Grosvenor St., 10th Floor, Hepburn Block Toronto, ON M7A 2C4 Honourable Theresa Oswald Minister of Health Room 302, Legislative Building

CPM Centres for Pain Management

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Winnipeg, MB R3C 0V8 Honourable Dustin Duncan Minister of Health Room 302, Legislative Bldg 2405 Legislative Drive, Regina, SK S4S 0B3 Honourable Fred Horne Alberta Minister of Health & Wellness 208 Legislature Building 10800 - 97 Avenue Edmonton, AB T5K 2B6 Honourable Dr. Margaret McDiarmid BC Minister of Health PO BOX 9050 STN PROV GOVT Victoria BC V8W 9E2 Honourable Thomas Mulcair (MP, Outremont) Leader of the NDP House of Commons Ottawa, Ontario K1A 0A6 Honourable Bob Rae (MP, Toronto Centre) Leader of the Liberal Party House of Commons Ottawa, Ontario K1A 0A6

CPM Centres for Pain Management

6400 Millcreek Drive, Unit 9 Mississauga, Ontario L5N 3E7 Ph: 905-858-1368 Fax: 905-858-2144