Wendy Rosenthal, Pharm.D.

Transcription

1 Wendy Rosenthal, Pharm.D. This program has been supported by an educational grant from Merck Pharmaceuticals PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education

2 Speaker: Wendy Rosenthal is the president of MedOutcomes, Inc. She received her Doctor of Pharmacy degree from the Medical University Of South Carolina and her bachelor of Science in Pharmacy from the University of Georgia. Dr. Rosenthal has spoken nationally on the topics of Pharmaceutical Care and disease state management. In addition, she has authored a number of papers and text books on these subjects. Speaker Disclosure: Dr. Rosenthal has no actual or potential conflicts of interest in relation to this program. This program has been supported by an educational grant from Merck Pharmaceuticals PharmCon is accredited by the Accreditation Counci for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

3 Accreditation: Pharmacists: L01-P Pharmacy Technicians: L01-T Target Audience: Pharmacists and Pharmacy Technicians CE Credits: 1.0 Credit hour or 0.1 CEU for pharmacists/technicians Expiration Date: 7/29/2011 Program Overview: The area of immunizations is exploding with the introduction of new products, administration recommendations, and opportunities for pharmacist involvement. This program will provide pharmacists with the basics regarding adult vaccines and how they can expand their role in this area. Objectives: Describe the impact of Influenza, Herpes Zoster, and HPV infections. Specify the indication, administration, adverse effects, and contraindications for Influenza, Herpes Zoster, and HPV vaccines. This program has been supported by an educational grant from Merck Pharmaceuticals

4 Basics of Immunity

5 Active immunity produced by vaccine Immunity and immunologic memory similar to natural infection but without risk of disease Epidemiology and Prevention of Vaccine-Preventable Diseases 9 th ed

6 Live attenuated Weakened form of the original Must replicate in body to be effective Generally require one dose Severe reactions possible Examples: measles, varicella, intranasal influenza Epidemiology and Prevention of Vaccine-Preventable Diseases 9 th ed

7 Inactivated Composed for whole viruses or bacteria or fractions Cannot replicate Generally require more than one dose Antibody titer diminishes over time Examples: pneumococcal, HPV, influenza Epidemiology and Prevention of Vaccine-Preventable Diseases 9 th ed

8 Vaccine Adverse Reactions Local Pain, swelling, redness at injection site Usually mild & self-limited Systemic Fever, malaise, headache Live attenuated vaccines: may produce mild symptoms after incubation period of 7 21 days Allergy Due to vaccine components

9 True or False? There is an inverse relationship between the levels of vaccinepreventable diseases & safety concerns.

10 Contraindications & Precautions Condition Allergy to component Severe illness Pregnancy Immunosuppression Live C P C C Inactivated C P V V C=contraindication P=precaution V= vaccinate if indicated

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13 Spreads by contact with infected respiratory droplets Incubation period: 1 5 days Adults are infectious for 1 day prior & 5 days following symptom onset Symptoms Sudden onset of fever, muscle aches, headache, malaise, nonproductive cough, sore throat & rhinitis Symptoms resolve in 3-7 days; cough & malaise may persist for > 2 weeks

14 Almost 16 million cases per year in the U.S. among people <20 years of age About 4.5 million per year in the U.S. among the elderly Influenza-related pulmonary and circulatory deaths : average 36,000 Rates of death/100, aged 0 49 years 7.5 aged years 98.3 aged 65 years JAMA. 2003;289:

15 Single-stranded RNA virus Three strains Type A Moderate to severe illness All age groups Subtypes determined by surface antigens: hemagglutinin & neuraminidase Type B Milder diseases Primarily affects children Type C Rarely reported in humans

16 Antigenic Shift Occur only in type A Drastic changes in hemagglutinin or neuraminidase Responsible for epidemics & pandemics Antigenic Drifts Occur in all three types Minor change in surface antigens May result in epidemic

17 Contains surface proteins of virus strains Most likely to circulate in the coming winter Generally two type A and one type B Epidemiological data reviewed and strains chosen 6 9 months before distribution

18 vaccine A/Brisbane/59/2007 (H1N1)-like virus A/Brisbane/10/2007 (H3N2)-like virus B/Florida/4/2006-like virus vaccine A/Brisbane/59/2007 (H1N1)-like virus A/Brisbane/10/2007 (H3N2)-like virus B/Brisbane/60/2008-like virus

19 Trivalent Inactivated Vaccines (TIV): Fluzone (Sanofi Pasteur) Approved for > 6 mo of age Fluvirin (Chiron) Approved for > 4 years of age Fluarix (GlaxoSmithKline) Approved for > 18 years of age FluLaval (GlaxoSmithKline) Approved for > 18 years of age Afluria (CSL Limited) Approved for > 18 years of age Cold-adapted Influenza Vaccine Trivalent : FluMist (MedImmune) Approved for 2 to 49 years of age

20 Inactivated influenza vaccine 70 90% effective among healthy persons <65 yo 30 40% effective among frail elderly 50 60% effective in preventing hospitalization 80% effective in preventing death Cold-adapted influenza vaccine-trivalent 87% effective in pediatric population Among healthy adults, 18 37% fewer days of healthcare provider visits

21 Persons at Increased Risk for Complications Persons aged 50 years Residents of nursing homes and chronic-care facilities Adults with chronic heart or lung disorders, including asthma Adults with: Chronic metabolic disease (e.g., diabetes) Renal dysfunction Hemoglobinopathies Immunosuppression (e.g., HIV) Adults with conditions that can compromise respiratory function Cognitive disorders Spinal cord injuries Seizure disorders Other neuromuscular disorders Women who will be pregnant during the influenza season MMWR. 2008

22 Persons Who Can Transmit the Virus to Those at High Risk Health care workers Employees of chronic-care facilities or residences for persons in groups at high risk Persons providing home care to persons in groups at high risk Household members (including children) of persons at high risk Household contacts and out-of-home caretakers of children aged <2 years MMWR. 2008

23 Healthy Individuals 2 49 Years of Age Who wish to decrease their risk of influenza Who are in close contact with persons at high risk for influenza-related complications

24 Influenza vaccination as personal protection versus Immunization for the greater public good

25 Inactivated vaccine Staggered administration based on need High risk/health care workers can get as early as Sept, Oct or Nov is ideal Nursing homes October or later Healthy November or later Cold-adapted trivalent Starting in October

26 Soreness at injection site Fever, malaise, myalgia Immediate allergic reaction Sneezing or cough (intranasal)

27 Inactivated vaccine Egg allergy History of anaphylactic reaction to components of the vaccine Cold-adapted trivalent vaccine Egg allergy History of anaphylactic reaction to components of the vaccine Aged <2 years or >50 years Persons with chronic diseases Pregnant women

28 True or False? You can contract influenza from the IM vaccine.

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30 Varicella Zoster Virus (VZV) Varicella (Chicken Pox) Herpes Zoster (Shingles)

31 Reactivation of dormant varicella zoster virus Likelihood for reactivation related to: Age Immune status Additional predisposing factors Local irradiation, trauma & surgery

32 90% of U.S. population has serologic evidence of varicella 50% of persons who live to age 85 will develop herpes zoster Estimated 1 million cases occur yearly in U.S.

33 Symptoms Sharp, stabbing pain & tenderness along the nerve Lesions appear 3 5 days later Papules vesicles pustules Heal in 7 10 days Present on only one side of the body Contagious until dry crusts appear: 5 10 days Pain can occur during the prodrome and/or eruptive phase

34 Based on pain research, which of the following is correct? 1. Labor pain > HZ pain 2. HZ pain > labor pain 3. HZ pain = labor pain

35 Serious complications Postherpetic neuralgia (PHN) 90% pain-free 1 month after acute attack; 95% pain-free at 3 months & 97% pain-free after 12 months Incidence & duration directly correlate with patient age Results from varicella-induced neuronal destruction & immflammation Difficult to treat Scarring, bacterial superinfection, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss

36 Live, attenuated varicella-zoster virus Indication: prevention of HZ in individuals 60 and older Stimulates the patient s immune system to reestablish memory cells Dose: 0.65 ml subq

37 Advisory Committee On Immunization Practices (ACIP) recommendations Routinely administer to all people 60 years of age and older This includes those who have had a previous episode of the disease Patients need not be asked about history of varicella or have varicella immunity determined by serologic testing

38 Must be kept frozen at -15º C (+5º F) Reconstitute straight from freezer and use immediately Adverse effects: injection site reactions

39 History of anaphylactic reaction to gelatin, neomycin, or other component of the vaccine Immunodeficiency (leukemia, lymphomas, other bone marrow or lymphatic neoplasms, HIV) Immunosuppressive therapy Active, untreated tuberculosis Pregnancy

40 Efficacy Efficacy with respect to incidence of zoster was 63.9% among those yo compared with 37.6% in those 70 years and older Reduced incidence of postherpetic neuralgia by 67% Duration of time patients experienced pain was significantly lower in those who received the vaccine N Engl J Med 2005:352;

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42 DNA tumor virus Skin virus About 40 genital types 15 to 18 of these associated with cancer Sexually transmitted disease Intercourse Genital, oral & skin to skin contact

43 Cervical dysplasia and cancer Genital warts Anogenital cancers (vulvar, penile, vaginal) Head & neck cancers (esophagus, pharynx)

44 High-Risk HPV Types Types 16, 18, 31, and 45 Low-Risk Types 6 and 11 Manifestations Low-grade cervical changes High-grade cervical changes Cervical cancer Anogenital and other cancers Benign low-grade cervical changes Condylomata acuminata (Genital warts)

45 HPV clearance 80 90% of infections resolve in 2 years Average duration of infection 9 13 months Unclear if eradicated or latent HPV persistence 10 20% of infections persist Major risk factor for cancer Clearance & persistence are age related

46 6.2 million new cases of sexually transmitted HPV occur in the U.S. each year 20 million people in the U.S. currently have a detectable genital HPV infection 50% of sexually active men and women acquire genital HPV infection at some point in their lives $1.6 billion in direct annual medical costs for treating symptoms of genital HPV infection

47 What % of women tested positive for HPV DNA within 12 months of intercourse with FIRST male sex partner? 1. 5% 2. 13% 3. 28% 4. 42%

48 1 million new cases annually; two thirds in women Present in 15% of general population Transmitted during vaginal or anal sex with infected partner May appear within several weeks, months or years after sex or not at all Occur predominantly at sites of friction Penis, scrotum, vulva, vagina, cervix, perineum & perianal area

49 Condylomata acuminata Cauliflower-like appearance Skin colored or pink Smooth papules Dome-shaped Skin colored Flat papules Slightly raised, smooth surface Skin colored More common on internal structures Keratotic warts Resemble common warts

50 Can spontaneously disappear without treatment May remain unchanged or increase in size and/or number Treatment options Provider applied topical medications Patient applied topical medications Freezing, laser and surgical excision Recurrence rates of 30-40%

51 Gardasil Quadrivalent vaccine containing HPV-like particles of HPV types 6,11,16 & 18 Cervarix Bivalent vaccine containing HPV-like particles of HPV types 16 & 18

52 Approved for use in females aged 9 to 26 for prevention of the diseases caused by HPV types 6,11,16 & 18: Cervical cancer Vaginal cancer Vulvar cancer Genital warts And the following precancerous or dysplastic lesions: Cervical adenocarcinoma in situ (AIS) Cervical intraepithelial neoplasia (CIN) grade 2 & 3 Vulvar intraepithelial neoplasia (VIN) grade 2 & 3 Vaginal intraepithelial neoplasia (VaIN) grade 2 & 3 Cervical intraepithelial neoplasia (CIN) grade 1

53 Approved for use in males aged 9 to 26 for prevention of genital warts caused by HPV types 6 &11

54 Approved for use in females aged 10 to 25 for prevention of the diseases caused by HPV types 16 & 18: Cervical cancer And the following precancerous or dysplastic lesions: Cervical intraepithelial neoplasia (CIN) grade 2 Cervical intraepithelial neoplasia (CIN) grade 1

55 Gardasil Given as 3 separate IM injections over 6 months 1st dose: at elected date 2nd dose: 2 months after 1st dose 3rd dose: 6 months after 1st dose Cervarix Given as 3 separate IM injections over 6 months 1st dose: at elected date 2nd dose: 1 month after 1st dose 3rd dose: 6 months after 1st dose

56 As of , 12,424 adverse events reported since approval 94% classified as nonserious 6% classified as severe Most common events Syncope Local reactions at injection site Nausea Headache Vasovagal syncope High baseline risk among target population 15 waiting period following administration FDA & CDC: effective & benefits continue to outweigh risks

57 Reported in approx 20% of study vaccine recipients Pain at injection site Fatigue Headache GI symptoms Arthralgia

58 Advisory Committee On Immunization Practices (ACIP) recommendations Routinely administer to all girls when they are years old Immunize females who have not previously received the vaccine At their discretion, physicians could vaccinate girls as young as 9

59 HPV vaccine is a prophylactic vaccine Individuals infected with 1 or more vaccine-related HPV types prior to vaccination will achieve protection from the remaining vaccine HPV types

60 HPV vaccine is not recommended for women who are pregnant, think they may be pregnant or plan to become pregnant during the 6 month vaccination course Immunocompromised individuals may have a reduced immune response

61 In the typical American household, which family member has the most accurate & up-to-date immunization record on file? 1. The parents 2. The children 3. The pets

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