Transcript presentation (x format)

Session FR5-162
Kimberly Cauthon, PharmD, CGP
Anita Mosley, PhD, PharmD
Feik School of Pharmacy
University of the Incarnate Word
Learning Objectives

Objective 1:
List the CDC
recommended
immunizations for
young adults
Objective 2:
Discuss when and how
students should be
treated for latent
tuberculosis infection
We have no actual or potential conflicts of interest in relation to this activity.
2
Student Case Study

 A 19 year-old female student is matriculating into the
sophomore class of your university. She is moving into
the dorms.
 She brings her immunization records signed by her
physician.
 She requests a tuberculosis (TB) test today.
 She moved to the United States from India 4 years ago.
 She has no major health conditions and no drug allergies.
 Her medications are YAZ birth control pills.
3
Student Immunization Record
Immunization
Date Received
Varicella
MMR
Hepatitis A
Hepatitis B
Influenza
IPV
1/15/2000, 6/16/2000
1/15/2000, 3/15/2000
1/15/1996, 1/14/1997
1/2/1995, 2/1/1995, 1/15/1996
10/2/12
3/3/1995, 5/1/1995,
1/15/1996, 1/16/1999
3/3/1995, 5/1/1995, 7/1/1995,
1/15/1996, 1/16/1999
DTaP

4
CDC Recommended Adult
Immunization Schedule

 What immunizations is our student missing per the
recommended adult immunization schedule - 2014?
 Immunization Schedules updated annually
 No major changes from the 2013 schedule
http://www.cdc.gov/vaccines/schedules/index.html
http://www.acha.org/topics/vaccine.cfm
5
Adult Immunization
Schedule 2014

6
Adult Immunization
Schedule 2014

7
Screening for Vaccine
Contraindications

Based on the immunizations our student needs,
which of the following screening questions
must be asked?
Yes or No
Are you sick today?
What are your allergies? Do you have allergies to
medications, food, a vaccine component, or latex?
Have you ever had a serious reaction after
receiving a vaccination?
What are your medical conditions?
Have you received any vaccinations within the
past 4 weeks?
http://www.immunize.org/clinic/screening-contraindications.asp
http://www.cdc.gov/vaccines/schedules/index.html
8
Screening for Vaccine
Contraindications
Based on the immunizations our student needs,
which of the following screening questions
must be asked?

Yes or No
In the past 3 months, have you taken medications
that weaken your immune system or have you
had radiation treatments?
During the past year, have you received a
transfusion of blood or blood products or been
given immune (gamma) globulin or an antiviral
drug?
Are you pregnant or is there a chance you could
become pregnant during the next month?
Have you had a seizure, brain, or other nervous
system disorder?
9
Immunization
Administration

 True/False – The student can receive all the needed
vaccinations at the same time.
10
http://www.cdc.gov/vaccines/recs/vac-admin/default.htm
Influenza Vaccination

 What percentage of all influenza related
hospitalizations were within the age range of 18 – 64
years of age for the 2013-14 season?
A.
B.
C.
D.
20%
40%
60%
80%
Morb Mortality Wkly Rep. 2014; 63(7): 137-142.
11
New Influenza Vaccine
Abbreviations

Abbreviation
Explanation
IIV
Inactivated influenza vaccine
RIV
Recombinant hemagglutinin influenza
vaccine
Live, attenuated influenza vaccine
LAIV
ccIIV
3 or 4
Cell culture-based inactivated influenza
vaccine
Addition of 3 or a 4 at the end of an
abbreviation indicates if the vaccine is
trivalent or quadrivalent
Morb Mortality Wkly Rep. 2013; 62(RR07): 1-43.
12
Influenza Vaccines

 True/False – The influenza vaccine is 100% effective.
 True/False – The intranasal flu vaccine is a safe
choice for patients allergic to eggs.
Morb Mortality Wkly Rep. 2013; 62(23): 473-479.
Morb Mortality Wkly Rep. 2013; 62(RR07):1-43.
http://www.immunize.org/catg.d/p4072.pdf
13
Influenza Vaccines
Trade Name
Dose
FluMist (LAIV4)
0.2 mL
Fluarix (IIV3&4)
0.5 mL
Fluzone (IIV3&4)
FluLaval (IIV3&4)
Afluria (IIV3)
Fluvirin (IIV3)
Fluzone (IIV3)
0.1 mL
Route
Information
 Quadrivalent replaces
trivalent
Intramuscular  Quadrivalent options
(IM)
available in addition to
trivalent options
Nasal

Intradermal
 Continues to be the only
intradermal option
 Associated with equal
rates of erythema,
induration, swelling, and
pruritus compared to
intramuscular
14
http://www.immunize.org/influenza/
Influenza Vaccines
Trade
Name
Dose
Route
Flucelvax
(ccIIV3)
0.5
mL
IM
Flublok
(RIV3)
0.5
mL
IM

Information
 Manufactured in mammalian
animal cells instead of eggs
 Seed virus was initially
cultured in chicken eggs
 Egg free
 Recombinant hemagglutinin
 Produced in an insect cell line
 No neuraminidase present
 Has shorter expiration date - 16
weeks from production date;
other vaccines expire June 30,
2014
15
http://www.immunize.org/influenza/
Meningococcal
Vaccination

 True/False - MCV4 is the preferred vaccine formulation
for the college age group.
 True/False – The meningococcal vaccine is 60% effective
for serogroups A, B, and C.
Morb Mortality Wkly Rep 62(2): 2013.
http://www.immunize.org/meningococcal/
16
Meningococcal Vaccines
Abbreviation
Explanation
MCV4
Meningococcal conjugate vaccine
• Quadrivalent
• Serogroups A, C, Y, W-135
Meningococcal polysaccharide vaccine
• Same serogroups as MCV4

MPSV4
Brand
Name
Vaccine
Type
Dose &
Route
Description
Menactra
MCV4
0.5 mL IM
Meningococcal polysaccharide
diphtheria toxoid conjugate vaccine
Menveo
MCV4
0.5 mL IM
Meningococcal oligosaccharide
diphtheria CRM197 conjugate
vaccine
Menomune
MPSV4
0.5 mL
subcutaneous
Meningococcal polysaccharide
vaccine
Morb Mortality Wkly Rep 62(2): 2013.
http://www.immunize.org/meningococcal/
17
Meningococcal
Recommendations

 First year college students up through the age of 21
years who are living in residence halls
No History of
Vaccination
One dose of MCV 4
Previous
Vaccination
One dose of MCV4 if
the previous dose
was given when the
student was < 16
years
http://www.cdc.gov/vaccines/schedules/index.html
18
Human Papillomavirus
(HPV)

 True/False – Gardasil is the preferred HPV vaccine
for college age students.
 True/False – HPV vaccines are almost 100% effective
in prevention of cervical cancer if the patient is
vaccinated prior to sex.
19
http://www.cdc.gov/vaccines/schedules/index.html
HPV Vaccination

 CDC recommendation
is up to 26 years of age
 Off-label if given
above 26 years of age
 No safety issues
documented
 Preferred to be given
before sexually active
 Do not withhold if
sexually active
 Vaccination endorsements
 American College Health
Association
 American Academy of
Pediatrics
 American Academy of Family
Physicians
 American College of
Obstetricians and
Gynecologists
http://www.cdc.gov/vaccines/schedules/index.html
http://www.immunize.org/press/recommend_hpv_vaccination.asp
20
HPV Vaccine
Formulations

 No recommendation on the interchangeability of the
HPV vaccines
 No HPV or Pap test screening is required to receive
the HPV vaccine
Brand
Name
HPV Types
Gardasil
Cervarix
Dose &
Route
Dosing Series
Gender
Quadrivalent 0.5 mL IM
– 6 , 11, 16,
18
0, 2, 6 months
Females &
Males
Bivalent – 16
and 18
0, 1, 6 months
Females Only
0.5 mL IM
https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
https://www.gsksource.com/gskprm/htdocs/documents/CERVARIX-PI-PIL.PDF
21
Tetanus, Diphtheria, and
Acellular Pertussis (Tdap)
Vaccines

 True/False – An adult Tdap booster has been
recommended since 2005 due to waning protection
and increased incidence of acellular pertussis.
New Engl J Med. 2012; 367(11): 1012-9.
http://www.cdc.gov/vaccines/pubs/pinkbook/index.html
22
Tdap Vaccines

 If there is no record of a Tdap dose
 Give a single dose of Tdap followed by one dose of Td
every 10 years
 Tdap can be administered regardless of the interval
since the last tetanus and diphtheria toxoidcontaining vaccine
 Vaccine formulations include Boostrix and Adacel
 Dose is 0.5 mL IM
http://www.cdc.gov/vaccines/schedules/index.html
http://www.immunize.org/packageinserts/pi_tdap.asp
23
Student Case Continued

 The student had positive TST, normal chest x-ray
and a negative sputum test (she reports having never
received the BCG vaccine)
 She is diagnosed with latent TB infection
 Should she be treated?
 What is appropriate treatment?
24
Risk Factors

 True/False – The student’s use of oral contraceptives
increases her likelihood of having LTBI.
http://www.cdc.gov/TB/education/corecurr/index.htm
25
Latent Tuberculosis
Infection (LTBI)

 Over 11 million people in the U.S. estimated to have
LTBI (4% of population)
 5%-10% will develop TB disease if untreated
 Treatment of LTBI essential to controlling and
eliminating TB disease
 Reduces risk of progression of LTBI to active TB
disease
N Engl J Med 2004;350(20):2060-2067
26
Groups at Increased Risk
of LTBI

Infants, children and adolescents who have close contact with high-risk
adults
Employees of long-term care facilities, hospitals, clinics and medical
laboratories
Foreign-born persons from countries with high prevalence of TB,
especially within 5 years of arrival in the US
High-risk racial and ethnic minorities, as defined locally
Individuals who have close contact with someone known or suspected to
have active TB
Residents and employees of congregates living facilities, including prisons
and jails, nursing homes, hospitals, and homeless shelters
Some medically underserved, low-income populations
Am Fam Physician. 2009;79(10)879-886
N Engl J Med. 2011;364:1441-1448
27
Number of TB Cases in
U.S.-born vs. Foreign-born Persons,
United States, 1993–2012*

No. of Cases
20,000
15,000
10,000
5,000
U.S.-born
2012
2011
2010
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
0
Foreign-born
* Updated as of June 10, 2013
http://www.cdc.gov/tb
28
Risk Factors

 True/False – Individuals with a history of untreated
TB have an increased risk of progression from LTBI
to active TB disease.
http://www.cdc.gov/TB/education/corecurr/index.htm
29
Groups at Increased Risk of
Progression from LTBI to Active TB

Children younger than 4 years old
Individuals with advanced, untreated HIV infection
Individuals infected within the past two years
Individuals who inject illicit drugs or use other locally identified highrisk substances
Individuals with a history of untreated TB
Individuals with the following clinical conditions or other
immunocompromising conditions:
• Disorders that require long-term use of immunosuppressant
medications including corticosteroids or TNF- inhibitors
• Body weight 10% or more below ideal
• Chronic renal failure
• Poorly controlled diabetes
Am Fam Physician 2009;79(10)879-886
N Engl J Med 2011;364:1441-1447
30
Treatment

 True/False – If active TB disease is suspected but not
confirmed, an appropriate course of action would be
to proceed with treatment for LTBI.
31
http://www.cdc.gov/TB/education/corecurr/index.htm
When to Treat LTBI

Initiate of treatment of LTBI only after the possibility of
active TB disease has been excluded
 Medical History
 Chest Radiograph
 Bacteriologic Examination of Specimens
32
http://www.cdc.gov/TB/education/corecurr/index.htm
Isoniazid (INH)
Treatment Regimens

 9-month daily regimen is preferred - 270 doses
 Effective for HIV-infected individuals taking antiretroviral
therapy (ART)
 Can be given twice weekly via DOT - 76 doses
 Preferred for children 2–11 years of age
 6-month regimen also generally acceptable - 180 doses
 Can be given twice weekly via DOT - 52 doses
 Shorter regimen not recommended for children,
immunosuppressed individuals, individuals whose x-rays
suggest previous TB
 Dosing: 5 mg/kg (maximum: 300 mg/dose) once daily or
15 mg/kg (maximum: 900 mg/dose) twice weekly
33
http://www.cdc.gov/TB/education/corecurr/index.htm
Isoniazid-Rifapentine (RPT)
LTBI Treatment Regimen

 INH and RPT given in 12 once-weekly doses under DOT
 Offers equal option to 9 months daily INH, but does not
replace other treatment options for LTBI
 Recommended for treating LTBI in otherwise healthy
people ≥12 years of age who had recent contact with
infectious TB, or who had a tuberculin skin test
conversion or a positive blood test for TB infection
 12-dose regimen is not recommended for children <2
years, HIV-infected persons on ART drugs, patients with
presumed INH or RIF resistance, women who are or
might become pregnant during treatment
http://www.cdc.gov/TB/education/corecurr/index.htm
34
Dosing for INH-RPT LTBI
Treatment Regimen

 Isoniazid: 15 mg/kg rounded up to the nearest 50 or
100 mg, with a 900 mg maximum
 Rifapentine:





10.0-14.0 kg:
14.1-25.0 kg:
25.1-32.0 kg:
32.1-49.9 kg:
> 50.0 kg:
300 mg
450 mg
600 mg
750 mg
900 mg maximum
35
http://www.cdc.gov/TB/education/corecurr/index.htm
Rifampin (RIF)

 Alternative to INH
 4 months daily - 120 doses
 Should not be used in HIV-infected persons being
treated with some antiretroviral therapy (ART)
 Dosing: 10 mg/kg/day (maximum: 600 mg/day)
36
http://www.cdc.gov/TB/education/corecurr/index.htm
LTBI Treatment Options
Medication
Duration
Dosing
Frequency
Minimum
Doses
Isoniazid
9 months
Daily
270
Twice weekly*
76
Daily
180
Twice weekly*
52
Isoniazid
6 months

Isoniazid &
Rifapentine
3 months
Once weekly*
12
Rifampin
4 months
Daily
120
*Directly Observed Therapy
http://www.cdc.gov/tb
37
LTBI

 Which LTBI treatment regimen would you
recommend for this student?
38
Adverse Reactions to LTBI
Medications

 Peripheral neuropathy – INH
 Fatal hepatitis
 Elevated liver enzymes
 GI distress – nausea, vomiting
 Discolored fluids or stools – RIF
 Rash or pruritus
http://www.cdc.gov/TB/education/corecurr/index.htm
39
Drug-Drug Interactions

 RIF and RPT are strong inducers of cytochrome P450 enzymes and P-glycoprotein transport systems
resulting in interactions with a large number of
medications including oral contraceptives and HIV-1
protease inhibitors
 INH might affect the serum concentrations of some
anti-seizure medications including carbemazepine
and phenytoin
N Engl J Med 2011;365(23):2155-2166
40
Drug-Drug Interactions

 Are there any changes to her current medications
that you would recommend?
41
Monitoring

Baseline laboratory monitoring of ALT, AST, and
bilirubin during treatment of LTBI is indicated only
for students
 with a history of liver disorder
 with a risk of chronic liver disease
 who regularly use alcohol
 with HIV infection
 who are pregnant or up to three months
postpartum
42
Monitoring (continued)

At least monthly, evaluate for
Adherence to prescribed regimen
Signs and symptoms of TB disease
Signs and symptoms of adverse
effects, especially hepatitis
Jaundice, loss of appetite, fatigue,
and/or muscle and joint aches
43
Summary/Recommendations

Recommend
Immunizations for
Young Adults
LTBI Initiation and
Treatment
• Download the CDC
Recommended Adult
Immunization
Schedule every year
• Screen, educate, and
immunize students
• Rule out active TB
infection before
starting LTBI
treatment
• Discuss the pros and
cons of the LTBI
treatment options
with each patient
44
References

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ACHA Guidelines. Recommendations for institutional prematriculation immunizations. March
2013. Available at: http://www.acha.org/topics/vaccine.cfm. Accessed April 25, 2014.
ACHA Guidelines. Tuberculosis screening and targeted testing of college and university
students. April 2014. Available at: http://www.acha.org/Topics/tb.cfm. Accessed April 25, 2014.
Baxter R, Bartlett J, Rowhani-Rahbar, et al. Effectiveness of pertussis vaccines for adolescents and
adults: case-control study. BMJ. 2013; 347: f4249.
Brokhof MM, Foster SL, Hayney MS. New options for influenza vaccines: quadrivalent,
recombinant, and cell culture – vaccine update. J Am Pharm Assoc. 2013; 53(5): 545-549.
Capua T, Katz JA, Bocchini JA. Update on adolescent immunizations: selected review of US
recommendations and literature. Curr Opin Pediatr. 2013; 25: 397-405.
Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices.
Influenza activity – United States, 2012-13 season and composition of the 2013-14 influenza
vaccine. Morb Mortality Wkly Rep. 2013; 62(23): 473-479.
Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices.
Prevention and control of influenza with vaccines – United States, 2013 -2014. Morb Mortality
Wkly Rep. 2013; 62(RR07):1-43.
Centers for Disease Control and Prevention. Core Curriculum on Tuberculosis. Available at:
http://www.cdc.gov/TB/education/corecurr/index.htm. Accessed April 25, 2014.
46
References

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


Centers for Disease Control and Prevention. Epidemiology and prevention of vaccinepreventable diseases. The Pink Book: Course Textbook. 12th ed. 2012 May. Available at:
http://www.cdc.gov/vaccines/pubs/pinkbook/index.html. Accessed April 25, 2014.
Centers for Disease Control and Prevention. Prevention and control of meningococcal disease –
recommendations of the Advisory Committee on Immunization Practices. Morb Mortality Wkly
Rep 62(2): 2013.
Centers for Disease Control and Prevention. Recommended adult immunization schedule.
Available at: http://www.cdc.gov/vaccines/schedules/hcp/adult.html. Accessed March 6,
2014.
FDA licensure of quadrivalent (HPV4, Gardasil) for use in males and guidance from the
Advisory Committee on Immunization Practices. Morb Mortality Wkly Report. 2010; 59 (20): 630632.
Froeschle J. Meningococcal disease in college students. Clin Infect Dis. 1999; 29:215-16.
Hauck FR, Neese BH, Panchal AS, El-Amin W. Identification and management of latent
tuberculosis infectin. Am Fam Physician. 2009;79(10)879-886.
Healthy People 2020 Topics and Objectives. Available at:
http://www.healthypeople.gov/2020/topicsobjectives2020/ Accessed April 25, 2014.
Heartland National Tuberculosis Center. Model Tuberculosis Prevention Program for College
Campuses. 2nd ed. 2011.
http://www.heartlandntbc.org/products/model_tb_prevention_program_college_campuses.pd
f. Accessed April 25, 2014.
Horsburgh CR. Priorities for the treatment of latent tuberculosis in the United States. 2004; 350:
2060-7.
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References


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
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

Horsburgh CR, Rubin EJ. Latent tuberculosis infection in the United States. N Engl J Med. 2011;
364: 1441-1448.
Klein NP, Bartlett J, Rowhani-Rhabar A, et al. Waning protection after fifth dose of acellular
pertussis vaccine in children. N Engl J Med. 2012; 367: 1012-9
Malik H, Khan FH, Ahsan H. Human papillomavirus: current status and issues of vaccination.
Arch Virol. 2014; 159: 199-205.
Meningococcal: Questions and Answers. Immunization Action Coalition. Available at:
http://www.immunize.org. Accessed March 6, 2014.
Panatto D, Amicizia D, Lai PL, Gasparini R. Neisseria meningitidis B vaccines. Expert Rev
Vaccines. 2011; 10(9): 1337-1351.
State Information. Meningococcal Prevention Mandates for Colleges and Universities. Available
at: http://www.immunize.org/laws/menin.asp. Accessed March 6, 2014.
Sterling TR, Villarino ME, Borisov AS, et al. Three months of rifapentine and isoniazid for latent
tuberculosis infection. N Engl J Med. 2011; 365: 2155-66.
48