Funding Proposal for an HPV Immunization Clinic in Middlesex-London Health Unit in Southwestern Ontario, Canada

Funding Proposal for an HPV Immunization Clinic in Middlesex-London Health Unit in Southwestern Ontario, Canada

 

1.0 Executive Summary

The paper proposes to estimate the funding/budget to be allotted for the integration of an HPV immunization clinic within the confines of Middlesex-London Health Unit. The HPV mass vaccination in various provinces in Canada including Ontario was approved in July 2006. By August 2007, the school-based vaccination was then permitted but only for Grade 8 female students, the time whereby Ontarians are at the onset of sexual knowledge. HPV infection is a highly communicable disease that eventually leads to cervical cancer. Although cervical cancer was ranked at 11th most diagnosed disease in Canadian women, the state estimated that 1, 350 women will be diagnosed this year and that about 390 will die of the disease. Albeit the diverse contradictions regarding the HPV immunization program for Grade 8 students, still many believed that HPV is a life-saver. This paper responds to that rationale proposing the establishment of the HPV immunization clinic which will target 9 to 26 years of age living in Middlesex and London areas which is estimated to be 53, 000.  

2.0 The Scenario

2.1 HPV and HPV Infection

            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.

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).

2.2 HPV Immunization: The FDA-approved preventive medicine

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.

2.3 In Canada: HPV Infection and Cervical Cancer Epidemiology

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 about 400 in Canada and with an estimated 371, 000 new cases of invasive cervical cancer diagnosed 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 made possible by the ongoing periodic Pap smear testing and cytological testing. 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.

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). In July 2006, human papillomavirus or HPV vaccination was approved for use in Canada for females aged 9 to 26 years. 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.

2.4 The Detriments of HPV Immunization Program for Grade 8 Female Students

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 $135 per injection ($405 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 $300 million for mass-HPV vaccination and established a committee to look at the feasibility of implementing the agendum since research had determined that it would cost $2 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. To wit, there are 351, 920 Ontarians who are 9 years and under and approximately 1.277 million who are between 10 and 26 years. Evidently, the schools-based inoculation is not sufficient, as well as the budget allotted, to cater to the number of females that should receive the shots too.

LIppman et al (2007) 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 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 vaccination 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 sickness 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. There are also parents who wish to conform to ethical, religious and social values prior to subjecting their daughters to inoculation while others are still under researching of the possible consequences that may manifest after two to four years (Anderssen and Alphonso, 2007). Distinctly, 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 $600 (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 corner/clinic 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 Middlesex-London Health Unit.

The purpose of establishing the HPV preventive clinic in Middlesex-London 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 activities of the person to be inoculated. There are approximately 103 Grade 8 students in Middlesex and 2600 in London who will receive the shots while the approximately 1, 581 females from Middlesex and 51, 428 from London who will not receive it. 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 which will target the 53, 009 females who will have to pay the three shots. The project will consist of funding a preventive HPV clinic within the Middlesex-London Health Unit and the pertinent health authorities specializing in HPV immunization program within Ontario.

3.1 Background on Middlesex-London Health Unit

            Middlesex-London Health Unit serves both London and Middlesex which is located in Central London. This health unit Provides public health services that promote health and prevent disease for area residents through all of life’s stages, staff support and encourage people to make healthy choices, and work with the community to ensure that public health standards are being met in the areas of parental/child health, chronic disease and injury prevention, communicable diseases, sexual health, environmental health, dental health, epidemiological investigation, and practical public health research and evaluation. There are six divisions: the clinic, dental division, environmental health and chronic disease prevention, family health services, library, nutritionists and dieticians and the immunization and travel immunization clinics (thehealthline.ca, 2008).   

            The immunization clinic provides vaccination services Influenza, Diphtheria, Pertussis (whooping cough), Tetanus, Polio, Haemophilus Influenza type B (Hib), Measles, Mumps, Rubella, Hepatitis B, Pneumococcal (high risk), Tuberculin (TB) Skin Test. This clinic also reviews the immunization records so as to determine the vaccination requirements and provides counseling regarding the vaccines. In addition, the clinic distributes brochures and fact sheets. On the other hand, the travel immunization vaccine specializes in vaccination for foreign ailments while also providing travel advice, immunizations and pre-travel medical assessments (thehealthline.ca, 2008).

3.2 The HPV Immunization Clinic in Middlesex-London Health Unit

3.2.1 General Information

The clinic will occupy the space complementary to the immunization clinic with an area of 150 sq/meters. The HPV immunization clinic will be open between 8 am until 5 pm and immunizations will be given from 8-11 am and 1-4 pm. HPV Immunization Clinic will implement the following regulations: 1) No immunizations are given on the last Friday morning of each month in the HPV clinic. 2) No appointment is necessary for routine immunizations; individuals will be attended on a first come, first serve basis. 3) No one will be denied of HPV immunization because of an inability to pay. 4) Children under 18 years must be accompanied by a parent or guardian or have a signed consent from the parent/guardian.     

3.2.2 Goals and Objectives

            The goal of the clinic is to mobilize the internal mechanisms, staff and resources in Middlesex-London Health Unit to respond to reducing the toll of cervical cancer deaths in Ontario and provide mass HPV immunization to residents at a time convenient to them in order to minimize HPV infections and death. The main objective are: to provide HPV vaccines safely in order to prevent spread of HPV infections and protect the community; to manage and track the storage, allocation and distribution and administration of HPV vaccines; to administer secure, efficient and appropriate management of supplies and clinical equipments; and to document the administration of HPV vaccines, report any adverse effects and monitor the safety and effectiveness of the HPV immunization program in Middlesex and London. 

3.2.3 Priority Groups

Group 1: Public Health Agency of Canada, Canadian Cancer Society, Health Canada, Canadian Task Force on the Periodic Health Examination and Canadian Task Force on the Preventive Health Care

            Group 2: Middlesex-London Health Unit and the HPV Immunization Staff

            Group 3: Persons at Risk – Females Aged 9 to 26

3.2.4 Supplies

            HPV vaccine supplies will be stored in compliance with the MOHLTC vaccine storage and handling guidelines.

3.2.5 Staff Resources and Roles

            There will be a total of five staff working within the HPV Immunization Clinic: one doctor, two public nurses, a medical technologist and one janitorial staff. Alternative skilled immunizers other than Middlesex-London Health Unit nurses may need to be considered. The doctor will perform the vaccination and the medical technologist will ensure that HPV vaccines are safe. The nurses with appropriate HPV competencies will be required to ensure consent and safely administer immunizations and will perform an ongoing Vaccine vs. Target Scheduling.           

4.0 Funding Arrangements for HPV Immunization Clinic

Cost-sharing between province of Ontario and the municipalities for Middlesex-London Health Unit is divided at 75% for the province and 25% for the municipalities (4% for Middlesex County and 21% for City of London. Nonetheless, the 2007 approved budget was divided into: province of Ontario – 66% and municipalities – 34% (Middlesex County at 6% and City of London at 28%). In accordance with the Section 72 of Health Protection and Promotion Agency (HPPA), the obligated municipalities “shall ensure that the amount paid is sufficient to enable the board of health to provide or ensure the provision of health programs and services” (McLaughlin et al, 2007); therefore, establishment of the HPV immunization clinic will be funded by the municipalities.

4.1 Budget for the Facilities of HPV Immunization Clinic  

Five Clinic Tables @ $879.88                                                                         $4, 399.40

Storage Area for Supplies @ approximately $ 2, 298.00                               $ 2, 298.00

Equipment for Sterilization (Fridge Storage) @ $720.00                               $720.00

Vaccine Preparation Area @ approximately $1, 769.00                                $1, 769.00

Wheelchair Accessibility (Provided by the Middlesex-London Health Unit)  --------------

Washroom Accessibility @ approximately $ 2, 367.00                                  $ 2, 367.00

Alarm System (Provided by the Middlesex-London Health Unit)                  --------------

Emergency Transportation Route (-do-)                                                        --------------

Onsite Parking (-do-)                                                                                      --------------

Backup Generator (-do-)                                                                                --------------

                                                                                                TOTAL                        $11, 553.40

4.2 Budget for Clinic Set-up and Design

            Adequate Ventilation (Provided by the Middlesex-London Health Unit)        --------------

            Telephone Access (-do-)                                                                                --------------

            Space for Reception/Screening Area @ approximately $2, 867.00              $3, 867.00

            Clinic Reception/Consent Signing Area @ approximately $3, 675.00           $4, 675.00

            Immunization Line-up Area @ approximately $2, 068.00                              $3, 068.00

            Immunizing Area @ approximately $2, 633.00                                              $3, 633.00

            Post Immunization Supervision Area @ approximately $2, 564.00               $3, 564.00

            Recovery Area @ approximately $2, 748.00                                                 $3, 748.00

            Private Rest Area for Staff @ approximately $2, 547.00                              $3, 547.00

                                                                                                            TOTAL                        $26, 102.00

4.3 Budget for HPV Immunization Supply

4.3.1 Budget for Immunization Supplies

            Blood Pressure Kits (5) @ $17.49 each                                                         $87.45

            Stethoscope (1) @ $775.77                                                                            $775.77

            Screening Questionnaire (Laminated, 1 per table) (5) @ $1.78 each           $8.90

            Epinephrine Kit (1) @ $85.99                                                                         $85.99

            Communication Binder (1) @ $16.00                                                             $16.00

            Coordination Binder (1) @ $23.00                                                                  $23.00

            Adverse Reaction Reporting Forms (100) @ $.86 each                                $86.00

 

            3cc syringes with 25 G. 1 inch-needle (box of 100) (5) @ $15.00                $75.00

            Alcohol swabs (200 per box) (5) @ $4.00                                                      $20.00

            Gloves (100 per box) (1 vinyl) @ $118.00                                                     $118.00

            Gloves (100 per box) (1 latex) @ $49.00                                                       $49.00

            Alcohol hand sanitizers (5) @ $9.77 each                                                      $48.85

            Yellow/white garbage bags (5) @ $33.75                                                       $168.75

            Cotton balls (2000 per bag) (2) @ $26.45 each                                             $52.90

            Band aids (100 per box) (5) @ $4.00 each                                                    $20.00

            Immunization consent and records (200) @ $1.78 each                               $356.00

            Biohazard sharps containers (3) @ $9.00                                                      $27.00

            Tables (5) @ $61.00 each                                                                              $305.00          

Chairs (20) @ $28.00                                                                                     $560.00

            Antiseptic wash solution (5) @ $7.00                                                             $35.00

            Signage for directions (Customized) (7) @ $70.00                                        $70.00

                                                                                                            TOTAL                        $2, 988.61      

4.3.2 Clerical Supplies

            Pens/Pencils (1 box) @ $13.00                                                                      $13.00

            Highlighters (1 set) @ $4.00                                                                           $4.00

            Permanent Black Marker (1) @ $1.00                                                           $1.00

            Masking Tape (1 roll) @ $8.98                                                                       $8.98

            Paper Towels (8 x 400) (5) @ $33.00 each                                                   $165.00

            Scissors (1) @ $7.69                                                                                      $7.69

            Tape (1) @ $1.03                                                                                            $1.03

            Clipboards (4) @ $4.99                                                                                   $19.96

            Stapler and Staples (1 and 1 5000/box) @ $11.00 and @ $2.00                   $13.00

            File boxes (5) @ $17.00                                                                                 $85.00

            Flip Chart (1) @ $29.00                                                                                  $29.00

                                                                                                            TOTAL                        $347.66

4.4 Budget for Marketing

            Information Material (Brochures, Charts, Fact Sheets) @ $3, 000.00          $3, 000.00

            Infomercial @ $8, 000.00                                                                               $5, 000.00

                                                                                                            TOTAL            $8, 000.00

4.5 Budget for First 300 HPV vaccines

            HPV vaccines (1st shot) @ $135.00                                                               $40, 500.00

                                                                                                            TOTAL                        $40, 500.00

4.6 Administrative Budget

             1 Doctor @ $7, 634.50                                                                                  $7, 634.50

            2 Nurses @ $2, 100.00                                                                                   $4, 200.00

            1 Medical Technologist @ $4, 982.00                                                            $4, 982.00

            1 Janitor/Janitress @ $1, 485.00                                                                    $1, 485.00

                                                                                                            TOTAL                        $18, 301.00    

5.0 Evaluation

5.1 Cost-benefit analysis

Cost for HPV Immunization Clinic at Middlesex-London Health Unit

·         Clinic Facilities                                                                     $11, 553.40

·         Clinic Set-up and Design                                                     $26, 102.00

·         HPV Immunization Supply                                                   $3, 336.27

            Immunization Supplies – $2, 988.61  

            Clerical Supplies – $347.66

• Marketing                                                                              $8, 000.00
• HPV Vaccines                                                                       $40, 500.00
• Administrative                                                                       $18, 301.00

                                                                               TOTAL        $96, 803.67

 

Benefits of  HPV Immunization Clinic at Middlesex-London Health Unit

• Cost-related Benefits

1)    Reduced maintenance since the clinic will operate under the umbrella organization of the Middlesex-London Health Unit

2)    Reduced staff costs since the clinic requires lesser staff, less overtime and lest costly skills

3)    Reduced operational costs since the clinic operates within the confines of the Middlesex-London Health Unit; there will be no rent, power and license fees  

• Service-related Benefits

1)    Improved service delivery due to HPV infection education, improved service delivery, acquiring medical explanations and informed decision-making

2)    Enhanced services delivery because of tailored services, geographic access to the services and greater equity of access

3)    Better educated communities   

• Qualitative Benefits

1) Long-term and with high customer satisfaction because of the improved and enhanced delivery of services and better educated people

 

5.2 Risk analysis

Risks for HPV Immunization Clinic at Middlesex-London Health Unit

• Supplies Transport Abuse

1)    Supplies and equipments are subjected to daily transportation to the HPV immunization clinic site. There might be the inherent constraints on unloading clinic materials and restocking the clinic supplies and equipments.

• Clinic Operations

1)    The location of the clinic must be ideally customized so that it can accommodate the flow and movement of people

2)    The HPV Immunization Clinic may require a separate entrance and exit which will inclusively cater to the disabled

• Infection Control

1)    The number of people visiting the clinic may require to have infection control and routine precautions must be applied

• Biohazard Waste Disposal

1) The janitor/janitress must be knowledgeable on the Middlesex-London policies about handling and disposing clinic biohazards waste materials apart from infection control measures

 

6.0 Appendices

 

 

Table 1 Average Annual Incidence and Mortality Rates for Cervical Cancer and Estimated New Cases and Deaths in 2000 in Canada (Source: Franco, Duarte-Franco and Ferenczy, 2001)

 

 

Figure 1 Etiological model of human papillomavirus (HPV) infection and cervical cancer, illustrating probable role of remote behavioural risk factors for persistent infection and of coexisting factors that mediate lesion progression (Source: Franco, Duarte-Franco and Ferenczy, 2001)

 

7.0 References

 

Anderssen, E. and Alphonso, C. (2007). Should your daughter get the HPV vaccine? Globe and Mail (14 September).

 

Bridges, A. (2006). FDA Panel Endorses Cervical Cancer Vaccine. Washington Post. The Associated Press.

 

Franco, E. L., Duarte-Franco, E. and Ferenczy, A. (2001). Cervical cancer: epidemiology, prevention and the role of human papillomavirus infection. Canadian Medical Association Journal, 164(7).

 

Human Papillomavirus (HPV) Vaccines: Questions and Answers. National Cancer Institute. Retrieved on 17 June 2008 from cancer.gov.

 

Kirkey, S. (2007). Panel urges widescale HPV vaccination. CanWest News Service. CanWest Publishing, Inc. Retrieved on 17 June 2008 from canada.com.

 

Laucius, J. (2007). Cancer vaccine to be made available to Ontario school girls. Ottawa Citizen.

 

Lippman, A., Melnychuk, R., Shimmin, C. Boscoe, B. M. (2007). Human papillomavirus, vaccines and women’s health: questions and cautions. Canadian Medical Association Journal, 177(55).

 

Mclaughlin, T., Pollett, G. L., Warshawsky, B. W. and Millson, J. (2007). Middlesex-London Health Unit 2007 Budget. Presentation to Board of Control. Retrieved on 18 June 2008 from http://council.london.ca.

 

Middlesex-London Health Unit. (2008). Retrieved on 18 June 2008 from http://thehealthline.ca.

 

Public Health Division. Simcoe Muskoka District Health Unit. Retrieved on 17 June 2008 from http://www.simcoemuskokahealth.org. 

 

Steinbrook, R. (2006). The potential of human papillomavirus vaccines. New England Journal of Medicine, 354(11):1109–1112.  

 

 

 

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