HUMAN PAPILLOMAVIRUS (HPV) VACCINATION PROGRAM GARDASIL TM

Cristi Froyman 4 th Year Pharmacy Intern University of Saskatchewan

Mikki Millar RN (NP) Primary Care Nurse Practitioner Cypress Health Region

WHAT IS HPV? Common virus: Human Papillomavirus Common virus: Human Papillomavirus Many different types of HPV Many different types of HPV Types 6, 11, 16, and 18Types 6, 11, 16, and 18 Can cause diseases of the genital area Can cause diseases of the genital area cervical cancercervical cancer precancerous lesionsprecancerous lesions genital wartsgenital warts

PREVALENCE OF HPV Infects half of all sexually active women aged 18 to 22 in North America Infects half of all sexually active women aged 18 to 22 in North America ~75% of sexually active Canadians will have at least one HPV infection during their lifetime ~75% of sexually active Canadians will have at least one HPV infection during their lifetime Most common in women aged years Most common in women aged years

HOW DO PEOPLE GET HPV? Affects both men and women Affects both men and women Sexual contact with an infected person Sexual contact with an infected person INTERCOURSE IS NOT NECESSARY! INTERCOURSE IS NOT NECESSARY! HPV is easily transmitted HPV is easily transmitted may not show any signs or symptomsmay not show any signs or symptoms can pass the virus on without even knowing itcan pass the virus on without even knowing it

WHAT DISEASES ARE ASSOCIATED WITH HPV? Cervical cancer Cervical cancer Vulvar cancer Vulvar cancer Vaginal cancer Vaginal cancer Precancerous lesions Precancerous lesions Genital warts Genital warts

WHAT IS CERVICAL CANCER? Cancer of the cervix: the lower part of the uterus that connects to the vagina Cancer of the cervix: the lower part of the uterus that connects to the vagina

Cervical Cancer Continued… Is the second most common type of cancer in Canadian women ages 20 to 44 Is the second most common type of cancer in Canadian women ages 20 to 44 Over 1350 Canadian women were diagnosed with cervical cancer in 2001, and 400 women died from it Over 1350 Canadian women were diagnosed with cervical cancer in 2001, and 400 women died from it

Cervical Cancer Continued… May be caused by certain types of HPV May be caused by certain types of HPV Usually the HPV goes away on its own within 1 or 2 years Usually the HPV goes away on its own within 1 or 2 years If infected with these types, and the virus does not go away on its own If infected with these types, and the virus does not go away on its own abnormal cells  pre-cancerous  cancerousabnormal cells  pre-cancerous  cancerous

Progression to Cancer

CERVIX HealthyCancerous

POSSIBLE SYMPTOMS Early cervical cancer may not cause noticeable signs or symptoms Early cervical cancer may not cause noticeable signs or symptoms Signs and symptoms may include: Signs and symptoms may include:  Vaginal bleeding not during period  Unusual vaginal discharge  Pain  Pain during sexual intercourse

SCREENING FOR CERVICAL CANCER Tests that examine the cervix: Pap Smear: a piece of cotton, a brush, or a small wooden stick is used to gently scrape cells from the cervix and vagina to be viewed under a microscope Pap Smear: a piece of cotton, a brush, or a small wooden stick is used to gently scrape cells from the cervix and vagina to be viewed under a microscope Colposcopy: a thin, lighted tube is inserted through the vagina into the cervix to look for abnormal tissue Colposcopy: a thin, lighted tube is inserted through the vagina into the cervix to look for abnormal tissue Biopsy: a sample of abnormal tissue is cut from the cervix and viewed under a microscope to look for cancer Biopsy: a sample of abnormal tissue is cut from the cervix and viewed under a microscope to look for cancer

SCREENING FOR CERVICAL CANCER Pelvic Exam: an exam of the vagina, cervix, uterus, fallopian tubes, ovaries, and rectum. The doctor or nurse inserts one or two lubricated, gloved fingers of one hand into the vagina and the other hand is placed over the lower abdomen to feel the size, shape, and position of the uterus and ovaries. A speculum is also inserted into the vagina and the doctor or nurse looks at the vagina and cervix for signs of disease. Pelvic Exam: an exam of the vagina, cervix, uterus, fallopian tubes, ovaries, and rectum. The doctor or nurse inserts one or two lubricated, gloved fingers of one hand into the vagina and the other hand is placed over the lower abdomen to feel the size, shape, and position of the uterus and ovaries. A speculum is also inserted into the vagina and the doctor or nurse looks at the vagina and cervix for signs of disease. Endocervical Curettage: a spoon-shaped instrument is used to collects cells or tissue from the cervical canal Endocervical Curettage: a spoon-shaped instrument is used to collects cells or tissue from the cervical canal

CERVICAL CANCER TREATMENT Cryosurgery: pre-invasive cancer cells frozen off Cryosurgery: pre-invasive cancer cells frozen off Laser Surgery: pre-invasive cancer cells burned off Laser Surgery: pre-invasive cancer cells burned off Cone Biopsy: cone-shaped piece of tissue removed Cone Biopsy: cone-shaped piece of tissue removed Simple Hysterectomy: uterus is removed Simple Hysterectomy: uterus is removed

CERVICAL CANCER TREATMENT Radical Hysterectomy: Radical Hysterectomy:  uterus, and tissues next to the uterus, the upper part of the vagina, and lymph nodes from the pelvis are removed Pelvic Exenteration: Pelvic Exenteration:  uterus, lymph nodes, bladder, vagina, rectum, and part of colon removed Radiation Therapy Radiation Therapy Chemotherapy Chemotherapy

WHAT IS VULVAR CANCER? Vulva: the outside part of the vagina Vulva: the outside part of the vagina  Labia majora: two prominent skin folds  Labia minora: two small, hairless skin folds  Clitoris: found below the spot where the two labia minora meet labia minora meet Cancer of the vulva most often affects the inner edges of the labia majora or the labia minora, but it can also occur on the clitoris Cancer of the vulva most often affects the inner edges of the labia majora or the labia minora, but it can also occur on the clitoris

Vulvar Cancer Continued…

VAGINAL CANCER

WHAT ARE GENITAL WARTS? Flesh-colored growths that appear in or around the genital area: Flesh-colored growths that appear in or around the genital area:

Genital Warts Continued… Caused by different types of HPV than cervical cancer Caused by different types of HPV than cervical cancer Can occur on the penis, in and around the vagina, or in and around the anus/rectum Can occur on the penis, in and around the vagina, or in and around the anus/rectum 2 out of 3 people who have sexual contact with a person who has genital warts will also get them 2 out of 3 people who have sexual contact with a person who has genital warts will also get them It can take weeks, months or years after contact with an infected partner for warts to occur It can take weeks, months or years after contact with an infected partner for warts to occur Lifetime risk of getting genital warts is > 10% Lifetime risk of getting genital warts is > 10%

TREATMENT FOR GENITAL WARTS They can be treated They can be treated  HOWEVER…25% of warts will come back within 3 months if HPV is still present in the body Treatment depends on the size, amount, and location of the warts Treatment depends on the size, amount, and location of the warts  applying a solution directly to the warts  freezing or burning  laser therapy  surgery

PROTECTION AND PREVENTION Protection: Protection:  avoid genital contact  always use condoms Prevention: Prevention:  GARDASIL

HUMAN PAPILLOMAVIRUS VACCINE

WHAT IS GARDASIL? New vaccine New vaccine Protects against HPV Protects against HPV Helps guard against diseases caused by: Helps guard against diseases caused by:  HPV Types 16 and % of cervical cancer cases  HPV Types 6 and % of genital warts cases

GOAL PROTECT BEFORE EXPOSURE! PROTECT BEFORE EXPOSURE! BEFORE SEXUALLY ACTIVE! BEFORE SEXUALLY ACTIVE!

CAN THE GARDASIL VACCINE CAUSE HPV? NO! NO! Made of virus-like particles prepared from HPV Types 6, 11, 16, and 18 Made of virus-like particles prepared from HPV Types 6, 11, 16, and 18 Particles do not contain viral DNA Particles do not contain viral DNA  cannot infect cells  cannot reproduce

WHO SHOULD BE VACCINATED WITH GARDASIL? Girls and women ages 9 to 26 years Girls and women ages 9 to 26 years To prevent infection caused by the Human Papillomavirus types 6, 11, 16, and 18 To prevent infection caused by the Human Papillomavirus types 6, 11, 16, and 18 GARDASIL works when given before a person has any contact with HPV Types 6, 11, 16, and 18 (before sexually active) GARDASIL works when given before a person has any contact with HPV Types 6, 11, 16, and 18 (before sexually active)

HOW IS GARDASIL GIVEN? Injected into the upper arm or thigh muscle Injected into the upper arm or thigh muscle 3 separate 0.5-mL injections over 6 months: 3 separate 0.5-mL injections over 6 months:  First dose: At a date you and your doctor or healthcare professional choose  Second dose: 2 months later  Third dose: 6 months after the first dose

Dosing Schedule Continued… Getting all 3 doses will allow you to get the full benefits of GARDASIL Getting all 3 doses will allow you to get the full benefits of GARDASIL All 3 doses should be given within 1 year All 3 doses should be given within 1 year

WHY IS IT IMPORTANT TO BE VACCINATED EARLY? To help prevent illness before there is any contact with HPV Types 6, 11, 16, and 18 To help prevent illness before there is any contact with HPV Types 6, 11, 16, and 18 To protect against future cervical cancer and genital warts To protect against future cervical cancer and genital warts

WHAT IF I ALREADY HAVE HPV? Vaccination is still beneficial Vaccination is still beneficial GARDASIL covers 4 types of HPV GARDASIL covers 4 types of HPV It is unlikely that you have been infected with all 4 types of HPV It is unlikely that you have been infected with all 4 types of HPV

IMPORTANT INFORMATION ABOUT GARDASIL GARDASIL is not for women who are pregnant GARDASIL is not for women who are pregnant GARDASIL will not treat diseases GARDASIL will not treat diseases GARDASIL will not protect against diseases caused by other types of HPV GARDASIL will not protect against diseases caused by other types of HPV

POSSIBLE SIDE EFFECTS OF GARDASIL Pain, swelling, itching, and redness at the injection site Pain, swelling, itching, and redness at the injection site Fever Fever Nausea Nausea Dizziness Dizziness

ARE PAP TESTS STILL NECESSARY AFTER BEING VACCINATED? YES! YES! Vaccination with GARDASIL does not take the place of Pap tests: Vaccination with GARDASIL does not take the place of Pap tests:  may not fully protect everyone  does not prevent all types of cervical cancer It is important to continue regular cervical cancer screenings It is important to continue regular cervical cancer screenings Pap tests have been proven to help save lives. Pap tests have been proven to help save lives.

PAP TESTS Cervical cancer screenings Cervical cancer screenings Look for abnormal cells in the lining of the cervix before they have the chance to become precancerous or cervical cancer Look for abnormal cells in the lining of the cervix before they have the chance to become precancerous or cervical cancer

ABNORMAL PAP TESTS The more severe the abnormality, the more likely it is that cervical cancer could develop in the future The more severe the abnormality, the more likely it is that cervical cancer could develop in the future Abnormal Pap? Don’t panic—it does not always mean that you are at risk for cancer or even have HPV Abnormal Pap? Don’t panic—it does not always mean that you are at risk for cancer or even have HPV Your doctor or healthcare professional may repeat the Pap test or do other tests as needed Your doctor or healthcare professional may repeat the Pap test or do other tests as needed

WHO SHOULD GET PAP TESTS? Women 21 years or older Women 21 years or older Females under 21 years of age who have been sexually active for three years or more Females under 21 years of age who have been sexually active for three years or more No age limit! No age limit!

HOW OFTEN? Once you become sexually active Once you become sexually active One year later One year later Every 2 to 3 years Every 2 to 3 years  if 2 normal pap tests and not on any birth control or hormones Every year Every year  if on birth control or hormones

Pap tests are an important part of taking control of your health—and taking care of yourself!

GARDASIL is not included on any provincial vaccination programs GARDASIL is not included on any provincial vaccination programs However, a doctor can provide a written prescription for the three required shots However, a doctor can provide a written prescription for the three required shots One Dose = $ ( x 3 doses) One Dose = $ ( x 3 doses) Total cost / person = $ Total cost / person = $508.56

Gordon Stueck has chosen to sell the GARDASIL vaccine at cost + expense of refrigeration of the product Gordon Stueck has chosen to sell the GARDASIL vaccine at cost + expense of refrigeration of the product $ x 3 = $ $ x 3 = $469.26

The benefit of vaccination with GARDASIL far outweighs the expense!

In the long run, vaccination with GARDASIL will save the health care system money In the long run, vaccination with GARDASIL will save the health care system money The overall yearly cost of invasive disease and death in Canada from cervical cancer has been estimated to be ~ $270 million The overall yearly cost of invasive disease and death in Canada from cervical cancer has been estimated to be ~ $270 million

Travel time for treatments Travel time for treatments Emotional turmoil and uncertainty associated with further testing and delays Emotional turmoil and uncertainty associated with further testing and delays More frequent monitoring is required if infected with HPV More frequent monitoring is required if infected with HPV  Ex: Colposcopy every 6 months with HPV type 16 and 18 TESTS ARE NOT PLEASANT! TESTS ARE NOT PLEASANT! CONSIDER…

SUMMARY Human Papillomavirus infection can cause cancer and genital warts Human Papillomavirus infection can cause cancer and genital warts It is important to protect yourself from HPV infection It is important to protect yourself from HPV infection Using condoms or abstaining from genital contact may help prevent infection Using condoms or abstaining from genital contact may help prevent infection GARDASIL is a new vaccine that protects against HPV types 6, 11, 16, and 18 GARDASIL is a new vaccine that protects against HPV types 6, 11, 16, and 18 Pap tests are still important after vaccination Pap tests are still important after vaccination

References: 1) Merck. Gardasil [Online]. [cited 2007Jan 04]; Available from: URL: 1) Merck. Gardasil [Online]. [cited 2007Jan 04]; Available from: URL: 2) Cervical cancer vaccine approved in Canada. CBC News [Online] Jul 18. [cited 2007 Jan 04]; Available from: 2) Cervical cancer vaccine approved in Canada. CBC News [Online] Jul 18. [cited 2007 Jan 04]; Available from: URL: URL: 3) Compendium of Pharmaceuticals and Specialties. Gardasil Product Monograph [online version (e-CPS)]. CPhA, ) Compendium of Pharmaceuticals and Specialties. Gardasil Product Monograph [online version (e-CPS)]. CPhA, [cited 2007 Jan 04]; Available from: URL: [cited 2007 Jan 04]; Available from: URL: 4) American Cancer Society. Cancer Reference Information [Online]. [cited 2007 Jan 09]; Available from: URL: http. 4) American Cancer Society. Cancer Reference Information [Online]. [cited 2007 Jan 09]; Available from: URL: http.

Cristi Froyman 4 th Year Pharmacy Intern University of Saskatchewan

Mikki Millar RN (NP) Primary Care Nurse Practitioner Cypress Health Region