1.0 Executive Summary


2.0 The Case for Change


            In July, 2006, human papillomavirus or HPV vaccination was approved for use in Canada for females aged 9 to 26 years. According to the Public Health Agency of Canada (PHAC), these DNA-based viruses are transmitted by skin-to-skin and fomites contact which infect the skin and mucous membranes of human and animals and that there are over a hundred types of HPV. Among the 130 HPV types, about 30 to 40 types are usually transmitted through sexual contact and infect the anogenital region of both women and men, others cause the skin and genital warts while others infect the genitals but shows no noticeable sign of infection. Apart from this, HPV could cause serious health consequences including cancer (i.e. cervical, penile and anal) in the anogenital region. Nonetheless, the types that cause anogenital warts do not usually cause cancer.


As such, the various types of HPV are often classified into low and high risk depending on their association with cancer. Low-risks are seldom associates with cancer while the high risks subset of sexually-transmitted HPV might potentially lead to precancerous lesions onto progressing to invasive cancer. Nearly all cases of cervical cancer, HPV infection is one of the major component in the development of this cancer. Cervical cancer is the second leading cause of death from cancer in women worldwide and the leading cause of cancer-related deaths in developing countries. Affecting more than 50% of the sexually active adults, the HPV-caused cervical cancer can kill about 290, 000 women worldwide including 3, 500 in the US (Bridges, 2006) with an estimated 371, 000 new cases of invasive cervical cancer diagnosed and with about 400 in Canada each year.


Representing the 10% of all cancers in women, there is 9.7% annual incidence rate with 2.5% annual mortality rate in Canada. There are an estimated number of new cases with 1, 450 and 430 is the number of estimated death (refer to Table 1). Over the last four decades, there had been a decline in age-standardized incidence and mortality rates in Canada. Statistically, Canadian provinces have higher survival rate of 5-year survival compared to the US (Franco, Duarte-Franco and Ferenczy, 2001). The Canadian Cancer Society ranks cervical cancer as the 11th most diagnosed disease in women. Alain Desroches of PHAC states that the projected figures for this year are: 1, 350 women will be diagnosed with cervical cancer and about 390 will die of the disease. The emphasis, however, is on the significant decline in cervical cancer – an estimated 7.5 per 100, 000 in 2006 from 15.4 per 100, 000 in 1977.   


The World Health Organization (WHO), through its International Agency for Research on Cancer (IARC) classified HPV infection in three categories: carcinogenic – HPV types 16 and 18; probably carcinogenic – HPV types 31 and 33; and possibly carcinogenic – HPV types except 6 and 11. As Franco, Duarte-Franco and Ferenczy (2001) put it, clinical and subclinical HPV infections are today’s most common STDs and that asymptotic cervical HPV infection could be detected in 5% to 40% of the women at their reproductive age making HPV infection a central causal factor in cervical cancer in the continuum of lesion grades (refer to Fig. 1). Current studies suggest that 10 to 29% of women in Canada are infected with HPV, making it the most common sexually transmitted infection in Canada. For females four of the common types of HPV can be prevented by means of vaccination, deemed important since HPV infections are incurable.


To immunize against strains of HPV, Merck, a pharmaceutical giant, roll out an HPV vaccine called Gardasil. Gardasil is designed to prevent HPV infection types 16, 18, 6 and 11. HPV types 16 and 18 were believed to cause about 70% of cervical cancer cases; the HPV type 16 was also found to be associated with a form of throat cancer (oropharyngeal squamous-cell carcinoma). While HPV types 6 and 11 are known to be the leading causes of about 90% of genital wart cases. The effectiveness of Gardasil vaccine is very high in preventing these four types of HPV strains and the vaccine can still protect the infected person with one of the four HPV types against the other types up to four years after the vaccination. Cervarix is another promising vaccine being tested by GlaxoSmithKline but is not yet approved by the Food and Drug Administration. This bivalent vaccine targets two HPV types: 16 and 18 and is also given in three doses over a 6-month period. The National Cancer Institute asserts that “widespread vaccination has the potential to reduce cervical cancer deaths around the world by as much as two-thirds, if all women were to take the vaccine and if protection turns out to be long-term. In addition, the vaccines can reduce the need for medical care, biopsies, and invasive procedures” (Steinbrook, 2006).    


The approved mass-vaccination in Canada is intended for primarily for females aged 9 to 13 and then later recommended for females 14 to 26 years of age by the National Advisory Committee on Immunization. Provided that HPV is a sexually-transmitted infection, the vaccination is administered to female before the onset of sexual activities for most females in Canada in order to ensure maximum benefit. For the second age bracket, there is still the potential for benefit since they may not yet have been infected and even if they are already infected, it is still unlikely that they possess all the four strains of HPV that the vaccine covers. The vaccine is not approved for girls below 9 and women over 26 because it is not known how effective the vaccine is in younger girls and no data for these age groups yet exists, respectively. Dr. Shelley Deeks, senior medical specialist in the immunizations and respiratory infections division at the PHAC, there is a high possibility of school-based HPV vaccination programs.


Although the vaccine is safe and effective: the question remains: Who will shoulder the cost? The vaccine requires 3 doses to be given over the course of 6 months and cost about 5 per injection (5 in total for three shots). Sharon Kirkey (2007) maintains that “the recommendations are made at a national level but it will be up to the provinces and territories to decide how and whether to make the vaccine available at no cost.” In lieu with this, Health Canada committed 0 million for mass-HPV vaccination and established a committee to look at feasibility of implementing the agendum since research had determined that it would cost billion for inoculating 5 million girls aged nine to 13 alone. The Canadian Cancer Society thinks that the HPV vaccine should be available and affordable especially for those who are not covered in the school-based programs.


LIppman et al contend that an HPV vaccination program could be successfully implemented in Canada if it is publicly funded and that lack of financial capability must not prevent any girl or woman from receiving the FDA-approved vaccine. Canadian government support for HPV vaccinations should not continue existing health inequities but rather reduce such health inequities through comprehensive and evidence-based approaches. In protecting and promoting Canadian women’s health as well as preventing deaths from cervical cancer, the focus must be domestic, processual and long-term. For instance, the HPV vaccination is made available in various provinces of Canada including Nova Scotia, Nevada, Alberta and Ontario. Nonetheless, according to Lippman et al (2007), there is no epidemic of cervical cancer in Canada and that the incidence and mortality varies between different groups of women and that the decline in the five-year survival rate may due to the following factors: ability to pay, access to diagnosis and treatment and eligibility set by the school boards.      


3.0 Information about the Proposed Project


            Since the provincial vaccination programs are basically school-based, there are categories that are being excluded in the process including the out of school youth and out of school youth but otherwise have the capacity to pay. The process also excludes students not in Grade 8 who missed vaccination due to personal reasons or is sick during that time since the Ontario government is only funding the HPV vaccine at no cost to all females in Grade 8 through school clinics. As such, the no-cost vaccines have not been offered retroactively. Girls and women who wished to get the vaccine but are older will have to pay to buy the Gardasil vaccine from a pharmacy and have the immunizations at a doctor’s office which will cost about 0 (Laucius, 2007).  


            There are 36 public health units in Ontario Canada. The public health system is administered by the Public Health Division which functions to “advice to corporate management on public health issues; a provincial epidemiology service and response to control outbreaks of disease both communicable and non-communicable; and management of transfer payments for public health programs.” Notable is that the cost of public health programs and services are accumulated between the province and the local municipalities equating to less than 2% of the total healthy care budget. HPV vaccination clinics are basically administered inside school facilities; there are no specialized units committed to providing HPV education and health services.


This paper proposes to build a consulting room/health centre within a public health unit. In strengthening Ontario’s public health system, the McGuinty government includes cervical cancer prevention through life-saving HPV immunization program in line with other health initiatives. To further promote Ontarian women’s health and reduce the toll of cervical cancer cases, there must be a public facility devoted for proving information regarding HPV, safer sex practices, healthy living and others. Among the 36 health units, 6 belonged to Southwestern Ontario: Brant County Health Unit; Chatham-Kent Public Health Services; Huron County Health Unit; Middlesex-London Health Unit; Region of Waterloo, Public Health; and Wellington-Dufferin-Guelph Public Health The proposal chooses the Brant County Health Unit.


The purpose of establishing the HPV preventive clinic in Brant County Health Unit is to optimize public participation regarding the HPV vaccination whereby medical histories and thorough examination of the vaccine recipient is possible. The clinic shall also purport proper orientation regarding the preventive vaccine and sexually communicable infections as well as to complement gynecological efforts. In lieu with these aims, the planned outcomes of the project are: HPV infection education, improved service delivery, acquiring medical explanations and informed decision-making.


The project will consist of funding a preventive HPV clinic within the Brant County Health Unit and the pertinent health authorities specializing in HPV immunization program within Ontario. This will not include the design of the organizational structure, the internal change management plan, the marketing of the clinic and the procurement strategies.


[Gantt Chart here].


4.0 Funding Arrangements


5.0 Evaluating the Options


5.1 Cost-benefit analysis


Examples of Possible Cost



  • Direct Project Cost

  • Acquisition Costs

  • Implementation Costs

  • Whole of Life Ownership Costs

  • Social and Environmental Costs 


 


Examples of Possible Benefits



  • Cost-related Benefits

  • Service-related Benefits

  • Qualitative Benefits


 


5.2 Risk analysis



  • Project type proposed under option

  • Organisational impact

  • Stakeholder impact

  • Scope

  • Technology

  • Project organisation

  • Knowledge and support


 


6.0 Appendices


 


 



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