April Blackmon NURS7440/7550. Gardasil. Auburn University/Auburn Montgomery

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April Blackmon Health Promotion Paper NURS7440/7550 Gardasil Auburn University/Auburn Montgomery

2 Introduction Human papillomavirus or HPV is a virus that will affect an estimated 75%- 80% of males and females in his or her lifetime (CDC, 2012). For most the virus clears itself; however, HPV can cause very serious consequences; cervical, vaginal and vulvar cancers in females. Other types of HPV may cause genital warts in both males and females. The human papillomavirus can be transmitted during any type of genital contact in someone that has HPV; intercourse isn t necessarily the only transmission. According to the Centers for Disease Control and Prevention (CDC, 2010), 6 million new cases of genital HPV occur in the United States each year. Another study estimates that 74% of those cases appear in 15-26 year old male and females. The virus invades human epithelial cells, including oral mucosa, esophagus, larynx, trachea, conjunctiva of eyes and the anal and genial areas. The time between exposure to the virus and having any symptoms can be three four months; however, the virus can be transmitted to someone else during this time (Contraceptive Technology, 2009). HPV is transmitted from skin to skin contact; traditional methods of protecting oneself from sexually transmitted disease may not eliminate the risk in this type of situation. Persons at risk for contracting HPV include: multiple partners, early age of first intercourse, history of other sexually transmitted diseases, partners number of sexual partners and drug and alcohol use related to risky sexual behavior (Contraceptive Technology, 2010).

HPV in Men The human papillomavirus (HPV) will cause an estimated 250,000 cases of genital warts and an estimated 7,500 cancers in males this year (FDA, 2012). There are two very important reasons to vaccinate boys and young men. One reason is to reduce or lessen the rates of HPV infection in the male population; therefore, reducing or protecting unvaccinated women (Contraceptive Technology, 2009). The author of this article refers to this phenomenon as herd immunity, idealizing that if large amounts of girls or young women are unvaccinated that boys and young men could play a significant role in lowering HPV infections among both groups; male and female (Contraceptive Technology, 2009). Another reason to vaccinate boys and young men with Gardasil is to protect them against genital warts and some less common HPV- related malignancies, such as, penile, anal, mouth and or throat cancers (Contraceptive Technology, 2010). There is also the gay community that may benefit from Gardasil injections. Men that have sex with men and whom are vaccinated with Gardasil are significantly less likely to develop high- grade precancerous anal lesions than a comparison group whom did not receive Gardasil (FDA, 2012). Gay men will benefit most from the vaccine s protection from anal cancer, because this group has a higher risk than that of heterosexual men.

4 Gardasil Vaccine Gardasil is the only human papillomavirus (HPV) vaccine that helps protect against four types of HPV. In girls and young women ages 9-26, this vaccine will protect against two types of HPV that cause 75% of cervical cancer cases and two more types that can cause 90% of genital wart cases. In boys and young men ages 9-26, Gardasil helps to protect against 90% of genital warts cases (AAP, 2010). This vaccine covers HPV types 6,11,16 and 18 (FDA, 2012). Gardasil is given as three injections over six months. Parents may begin the vaccine series as early as age 9. It is imperative that the primary care practitioner begins to educate parents about the importance of these vaccines. Many parents are not aware that boys may be vaccinated with Gardasil. The purpose of this project will be to educate parents and young adults about the importance of vaccinating both boys and girls with Gardasil even if he or she is not sexually active. Delivery of Importance/Target Population The author of this paper is proposing a handout for the primary care setting to be given to parents of school age children and young adults up to age 26. The goal is to vaccinate every child/young adult that comes in to the clinic regardless of sexual history. The handout describes the HPV issue and problems related to contracting the disease, who is eligible to receive the vaccine and stress the importance of boys and girls both receiving Gardasil. The primary care practitioner and physician in the clinic chosen are both in agreement to this proposed

vaccination topic. Both the physician and practitioner are also on board with screening each child and young adult that comes into clinic. An assessment is conducted to each child/young adult age 9-26 at the time of check- in and the patient/parent will be given the option to receive the vaccine. If the patient/parent refuses the vaccine, it will be documented in the patient s chart and can be reassessed at a later visit. Handouts will be available, as well as, self- protection information provided to the patient/parent. Each parent will be educated that even if his or her child is not sexually active this vaccine can still prevent HPV later in the child s life. Researchers have determined that HPV is found in almost 100% of cervical cancers worldwide (Contraceptive Technology, 2011). This is unique to cervical cancer, no other cancer has been found to have one dominant source. Screening/How to Implement Each child/young adult that comes in to clinic for a sick or well visit will be asked if he or she would like to receive the Gardasil vaccine. At this time the nurse stresses the importance of the vaccine series and delivers a self- protection message to the patient/parent. Parents/young adults will be reminded that HPV is the most common sexually transmitted disease in the United States (FDA, 2012). Each person will also be educated about HPV; and other problems associated with HPV including cancers. Gardasil is not a live vaccine and can be administered with other vaccines or during illness. Education on the vaccine series will also be provided: first vaccine during routine or sick visit, second vaccine to be administered one month after the

6 first with a maximum of 24 weeks in between and the last vaccine to be administered six months after the first dose with a maximum of ten months. If the schedule is interrupted, the series does not need to be restarted (Contraceptive Technology, 2010). The vaccine is administered intramuscularly in the upper arm or thigh. Education on side effects will also be included in the self- protection message; and include: pain, swelling, itching, bruising and redness at the injection site, headache, fever, nausea, dizziness, vomiting and fainting (FDA, 2012). Vasovagal syncope appears to be the most common adverse effect and for this reason the patient is asked to wait 15 minutes after receiving the vaccine before leaving the clinic. Any questions that the patient/parent may have will be answered at the screening time and handouts will be given. The perfect opportunity would be to conduct this screening in a pediatric office where all patients would meet the age criteria. Learning Theory The best learning theory for this type of project would be constructivism, developed by Jean Piaget and John Dewey. This theory explains learning as a process in which the learner actively constructs or builds new ideas or concepts based upon current and past knowledge experiences (Chauhan, 1993). During the screening, information pamphlets are given to the patient/parent, this pamphlet includes: a self- protection message, how HPV is transmitted and other problems that HPV may cause. It is imperative that each person understands the severity of HPV. With the

knowledge provided in this screening session one may learn new information to put with information he or she already has regarding HPV. The learner may then construct the best evidence for his or herself from that interaction with the nurse, past experiences and new ideas. The goal of screening is to protect each person from contracting HPV; with Gardasil the highest risk strains may be prevented. If each child and young adult, in this clinic setting, are vaccinated it would significantly decrease the amount of HPV diagnosed each year. Since implementation of this topic in late August 2012, 8 out of 10 children and young adults, or 80% have been vaccinated. This number will hopefully increase as more people become aware of the severity of HPV. Conclusion Researchers have identified 100 different strains of HPV, 40 of which can infect anal and genital areas (FDA, 2012). Gardasil targets the two most common HPV high- risk strains, 16 and 18; these two strains are responsible for 70% of cervical cancers and 88% of anal cancers. All available information found regarding HPV states that the vaccine is roughly 90% effective in preventing HPV (FDA, 2012). Knowledge about Human Papilloma Virus has developed vastly in the last 10 years and is certain to continue. Healthcare providers and patients or parents of young patients will need to stay well informed with changes in practice in order to achieve improved health outcomes for children and young adults.

8 References: American Association of Pediatrics (AAP). Is HPV vaccine safe for children? Available at http://www.aap.org/en- professional- resources/publications- and- journals.aspx. Retrieved on November 9, 2012. CDC. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). Retrieved on November 3, 2012. Chauhan, S.S. Advanced educational psychology. 5 th edition. New Delhi:Vikas Publishing House PVT LTD; 1993. Food and Drug Administration. Product approval- prescribing information. Gardasil vaccine, Merck & Co, Inc: Food and Drug Administration 2010. Available at http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts. Retrieved on November 9, 2012. HPV vaccination in men How to boost uptake. (2011). Contraceptive Technology Update 32(4), 44-45.

HPV vaccine update: will there be more options for women and men? FDA committee gives nod to Cervarix use in females, Gardasil in males. (2010). Contraceptive Technology Update, 30(11), 121-123. Science eyes HPV vaccine use in men will shot be approved for U.S. males? Vaccine prevented 90% of external genital lesions caused by 4 HPV types. (2009). Contraceptive Technology Update, 30(8), 85-88.