Pan-canadian public health network council report and policy recommendations on the use of antivirals for prophylaxis during an influenza pandemic

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References

¹ Record of Decisions, Conference of F/P/T Ministers of Health, May 12-13, 2006

² Guidelines regarding the response to outbreaks of avian influenza, including the potential use of antivirals, have already been developed and published by PHAC: Human Health Issues related to Avian Influenza in Canada is available at: http://www.phac-aspc.gc.ca/publicat/daio-enia/index.html.

³ Canada does not currently have a containment strategy, as our planning assumption is that the pandemic virus will emerge outside of the country. It is anticipated that PHAC will lead the development of the containment strategy, which would involve the use of antivirals for early treatment of cases and prophylaxis of contacts in the context of commitments under the North American Plan for Avian and Pandemic Influenza, and in accordance with the World Health Organization interim protocol on this issue, which was posted in May 2007. WHO Interim Protocol: Rapid Operations to Contain the Initial Emergence of Pandemic Influenza is available at: http://www.who.int/csr/disease/avian_influenza/RapidContProtMay07.pdf.

⁴ Common Briefing Note to Conference of F/P/T Deputy Ministers of Health, June 16, 2006: Background.

⁵ Record of Decisions, Conference of F/P/T Ministers of Health, May 12-13, 2006

⁶ Common Briefing Note to Conference of F/P/T Deputy Ministers of Health, June 16, 2006: Appendix A – Plan to Develop National Policy Recommendations on the Provision of Antivirals for Prophylaxis During an Influenza Pandemic

⁷ Reports can be consulted on the Canadian Agency for Drugs and Technologies in Health’s website at: http://cadth.ca/index.php/en/hta

⁸ Gravenstein 2005 was a duplicate of the Peters et al study.

⁹ In this trial there was a significant difference in one of the secondary outcome measures: lab-confirmed influenza with fever. Nonetheless, in keeping with the principle that at least two trials are needed to support an indication based on the primary outcome measure, the product monograph for Relenza^® specifically states “Relenza^® has not been proven effective for prophylaxis of influenza in the nursing home setting.”

¹⁰ John PA, Ioannidis, Lau J. Completeness of Safety Reporting in Randomized Trials: An Evaluation of 7 Medical Areas. JAMA, 2001;285:437-443.

¹¹ See Canadian Pandemic Influenza Plan (2006) Annex G: Clinical Care Guidelines and Tools, p. 17

¹² McDonald HP, Garg AX, Haynes RB. Interventions to Enhance Patient Adherence to Medication Prescriptions: Scientific Review. JAMA 2002;288:2868-2879.

¹³ Shepard CW, Soriano-Gabarro M, Zell ER et al. Antimicrobial postexposure prophylaxis for anthrax: adverse events and adherence. Emerg Infect Dis 2002 Oct;10:1124-1132.

¹⁴ Personal communication, Nikki Shendo, World Health Organization

¹⁵ Bosman, A. et al, Executive Summary, Avian Flu Epidemic 2003: Public Health Consequences. RIVM report 630940004/2004

¹⁶ Skowronski, D. et al, Protective measures and human antibody response during an avian influenza H7N3 outbreak in poultry in British Columbia, Canada. In press CMAJ

¹⁷ Hayden FG. Perspective on AV use during pandemic influenza. Phil Trans R Soc London 2001;356:1877-84.

Treanor JJ, Hayden FG. Vrooman PS, et al. Efficacy and safety of the oral NI oseltamivir in treating acute influenza: a RCT. J Am Med Assoc 2000;283:1016-24.

¹⁸ Whitley RJ, Hayden FG, Reisinger KS, et al. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J 2001;20:127-33. Kiso M, Mitamura K, Sakai-Tagawa Y, Shiraishi K, Kawakami C, Kimura K, Hayden FG, Sugaya N, Kawaoka. Resistant influenza A viruses in children treated with oseltamivir: descriptive study. Lancet 2004;364:759-765.

¹⁹ DeJong MD, Thanh TT, Khanh TH, Hien VM, Smith GJD et al. Brief Report: Oseltamivir resistance during treatment of Influenza A (H5N1) infection. New Engl J Med 2005;353:2667-2672.

²⁰ Heyman DL Resistance to Anti-Infective Drugs and the Threat to Public Health. Cell, 2006;124:671-5.

²¹ Alexander ME, Feng Z, Gardham M, Moghadas S, Rost G, Wu J, Yan P. Emergence of Drug Resistance: Dynamical implications for pandemic influenza. Proc R Soc Lond (in press).

1Exptx = expectant therapy

²² Williams v. Canada (Attorney General) [2005] O.J. No. 3508 (S.C.J).

²³ Eliopoulos v. Ontario (Minister of Health and Long Term Care, (3 November 2006), Toronto C44577 (Ont. C.A.).

²⁴ Supra note 2. It should be noted that the Plaintiff in this has sought leave to appeal this decision to the Supreme Court of Canada, however, the reasoning of the Court of Appeal is consistent with earlier and very relevant SCC decisions.

²⁵ Just v. British Columbia [1989] S.C.J. No. 121 (QL), Brown v. British Columbia (Minister of Transportation and Highways) [1994] 1 S.C.R. 420 at p. 441

²⁶ Supra note 4, Just at 11.

²⁷ Ibid, Brown at 441.

²⁸ Ibid, Just at 11.

²⁹ Ibid, Just at 11.

³⁰ Jamal Estate v. Scarborough Hospital – Grace Division [2005] O.J. No. 3506 (S.C.J.) (QL); Abarquez v. Ontario, [2005] O.J. No. 3504 (S.C.J.).

³¹ R.S.O. 1990, c.0.1.

³² Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (U.K.), 1982, c.11. I am indebted to Judy Hunter, Counsel Health Canada and Public Health Legal Services, for much of the analysis contained in the Charter section: see General Guidance on the allocation of antivirals from a Charter perspective. Memorandum dated February 22, 2006.

³³ Law v. Canada (Minister of Employment and Immigration), [1999] 1 S.C.R. 497 [hereinafter referred to as Law].

³⁴ Ibid at paras. 62-75.

³⁵ R. v. Therens, [1985] 1 S.C.R. 613 at 645; R.W.D.S.U. v. Dolphin Delivery, [1986] 2 S.C.R. 573; B.C.E.G.U. v. B.C., [1988] 2 S.C.R. 214; R. v. Swain, [1991] 1 S.C.R. 933 at 968; Irwin Toy v. Quebec, [1989] 1 S.C.R. 927 at 981.

³⁶ Slaight Communications v. Davidson, [1989] 1 S.C.R. 1038; Ross v. New Brunswick School Board No. 15, [1996] 2 S.C.R. 825.

³⁷ Little Sisters Book and Art Emporium v. Canada (Minister of Justice), [2000] 2 S.C.R. 1120, at para. 141; Weatherall v. Canada (A.G.), [1993] 2 S.C.R. 872.

³⁸ R. v. Oakes, [1986] 1 S.C.R. 103 [hereinafter referred to as Oakes] at 139.

³⁹ RJR-MacDonald v. Canada, [1995] 3 S.C.R. 199 at paras. 156-58.

⁴⁰ McKinney v. University of Guelph, [1990] 3 S.C.R. 229; Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982.

⁴¹ The courts have stated that financial considerations are somewhat relevant to determining the standard of deference. Reference re: Remuneration of Judges, [1997] 3 S.C.R. 3; Krock v. Canada, [2001] F.C.J. No. 896 (FCA).

⁴² Oakes, supra note 15, at 139.

⁴³ R. v. Parker, 49 O.R. (3d) 481 (Ont. C.A.); R. v. Monney, [1999] 1 S.C.R. 652, at para. 55; Chaoulli v. Quebec (A.G.), 2005 SCC 35 at paras. 111-124 [hereinafter referred to as Chaoulli].

⁴⁴ R. v. Nova Scotia Pharmaceutical Society, [1992] 2 S.C.R. 606, at 626-27; Ontario v. Canadian Pacific Ltd., [1995] 2 S.C.R. 1028, at 1070-72.

⁴⁵ Rodriguez v. British Columbia (A.G.), [1993] 3 S.C.R. 519, at 594-95; R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571, at para. 135; Chaoulli supra note 20, at paras. 129-30 and 232.

⁴⁶Chaoulli supra note 20 at para 130.

⁴⁷ R.S.C., 1985, c.P-21.

⁴⁸ S.C., 2000, c.5. Québec, Ontario, Alberta and British Columbia have enacted their own pieces of legislation which are deemed substantially similar to PIPEDA and thus PIPEDA does not apply in those jurisdictions; the provincial legislation applies to organizations that conduct commercial activities.

⁴⁹ C.C.S.M. c. P33.5, s.22(2)(b).

⁵⁰ S.O. 2004, c. 3 Sched A, s.40(1).

⁵¹ Supra, note 4.

⁵² Health Act, R.S.B.C. 1996, c.179.

⁵³ Food and Drugs Act, R.S.C. 1985, c.F-27, s. 15.and Food and Drugs Regulations, C.R.C., c.870, Part C, Division I s. C.01.041 (1.1) [hereinafter referred to as FDR].

⁵⁴ Ibid at s. C.01.001.

⁵⁵ Supra, note 30 at s. C.01.001.

⁵⁶ R.S., 1985, c.F-27.

⁵⁷ C.R.C., c.870, Section C.08.002.

⁵⁸ The Workers’ Compensation Act, C.C.S.M.A. c.W200.

⁵⁹ Workers’ Compensation Act, R.S.P.E.I. 1988, c. W-71.

⁶⁰ Workers’ Compensation Act, S.N.S. 1994-95, c.10.

⁶¹ S.C. 1996, c.23.

⁶² Maddox PJ. 1998. Administrative ethics and the allocation of scarce resources. Online Journal of Issues in Nursing. (December 31, 1998).

⁶³ Christian MD, et al. 2006. Development of a triage protocol for critical care during an influenza pandemic. CMAJ 175(11): 1377-1381.

⁶⁴ Idem (see references 1 and 2).

⁶⁵ Childress JF, Faden RR, Gaare RD, et al. 2002. Public health ethics: mapping the terrain. J Law Med Ethics 30: 170-178.

⁶⁶ Seedhouse D. 1998. Ethics: the Heart of Healthcare. Chapter 7: Theories of ethics. Wiley Publishers.

⁶⁷ Childress JF. 2005. Just care: Rationing in a public health crisis. Update 20(3): 1-7.

⁶⁸ University of Toronto Joint Centre for Bioethics Pandemic Influenza Working Group. Stand on Guard for Thee: Ethical considerations in preparedness planning for pandemic influenza. Nov 2005.

⁶⁹ Romanow RJ. 2002. Building on Values: The Future of Health Care in Canada (Final Report). Commission on the Future of Health Care in Canada. www.healthcarecommission.ca.

⁷⁰ Kluge E-HW. 2000. Social values, socioeconomic resources, and effectiveness coefficients: An ethical model for statistically based resource allocation. In: R Cohen-Almagor (ed), Medical Ethics at the Dawn of the 21st Century. Ann NY Acad Sci 913: 23-31.

⁷¹ We are currently collecting more data pertaining to the status of the F/P/T stockpiles.

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