Jacqueline Costello, DNP, MSN Ed, APRN, CPNP - PowerPoint Presentation

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Jacqueline Costello, DNP, MSN Ed, APRN, CPNPPediatric Nephrology & HypertensionEast Carolina University/Brody School of Medicine

Immunization Recommendations for Pediatric Patients with Chronic Kidney Disease, Nephrotic Syndrome & Renal Transplant: A Literature Review & Quality Improvement Project

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Jacqueline Costello

No Disclosures

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AcknowledgementsGuillermo Hidalgo, MD, FASN Division Head Pediatric NephrologyEast Carolina University/Brody School of Medicine

Nancy Darden-Saad, BSN, RN, CCRC

ECU Pediatric Specialty Care Clinic-Research Nurse

ECU Pediatric Nephrology Clinic Staff

ECU Pediatric Specialty Clinic & General Pediatric Clinic

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Objectives

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BackgroundDuring the first several years of life children have immature immune systems, thus putting them at risk for infection. Pediatric patients with CKD, predominantly stages 3-5, receiving traditional management, dialysis, or transplant have an increased risk of infx

due to their faulty immune response.

Immunizations can prevent

infx

& morbidity/mortality.

(Esposito,

Mastrolia

, Prada,

Pietrasanta

, &

Principi, 2014, Hogg, Furth, Lemley, Portman, Schwartz, Coresh, et al. 2003)

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CDC/ACIPImmunization schedules updated every January by the Center for Disease Control (CDC), the Advisory Committee on Immunization Practices (ACIP).

CDC sets United States (U.S.) immunization schedules based on recommendations of the ACIP.

ACIP membership candidates are screened carefully.

(Neu, 2012)

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CDC/ACIPACIP:15 expert membersSelection

Application, Interview & Nomination process

Secretary of the U.S. Dept. of Health and Human Services (DHHS)

14 with expertise in pediatrics, internal medicine, family medicine, immunology, virology, infectious disease, vaccinology,

nursing

, public health , and/or preventive medicine

One consumer representative providing perspectives on social and community aspects

(CDC, 2013)

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CDC/ACIPACIP develops vaccine recommendations for children and adults.Recommendations include:Age(s) vaccine should be administeredNeeded number of doses

Interval between doses

Precautions & contraindications

(CDC, 2013)

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CDC/ACIPACIP reviews the following for each vaccine:Safety & effectiveness (specific ages given)Severity of diseaseNumber of children who contract disease w/o available vaccine

How well it works at different ages

(CDC, 2013)

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SignificanceChildren with chronic kidney disease (CKD), nephrotic syndrome (NS) and renal transplant (RT) candidates and recipients are at an increased risk for developing infections.Immunizations are an essential preventative approach for disease management.

In the U.S., approximately ¼ of young children are not properly immunized.

Children with CKD, NS, and RT continue to have reduced coverage.

(Fu, L., Weissman, M., McLaren, Thomas, C., Campbell, J.,

Mbafor

, J., Doshi, U. & Cora-Bramble, D. 2012)

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Question

Are children diagnosed with chronic kidney disease, nephrotic syndrome or renal transplant candidates and/or recipients receiving age-appropriate immunizations based on current recommendations?

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Vaccine Safety

https://www.youtube.com/watch?v=Xf9-N4wLhA4&feature=youtu.be

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PurposeUnderstand the impact of immunizations along with safety concerns and efficacy for this distinct pediatric population & how to assist the Primary Care Provider (PCP) as well as the specialist in providing age-appropriate recommendations for children with CKD, NS and /or RT.

(Fu et al. 2012)

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Aim/GoalPrimary aim was to educate PCP’s and specialty care providers caring for this pediatric population.Primary goal was to increase awareness and provide education related to age-appropriate immunizations to PCP’s for children with CKD.Secondary goal was to ensure children with NS & RT were up-to-date on pneumococcal vaccines.

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Conceptual FrameworkPediatric Nephrology

(www.healthychildcare.org)

School Nurses

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Pediatric Medical Home (PMH)Care that is…

Accessible

Comprehensive

Continuous

Compassionate

Coordinated

Culturally effective

Family Centered

Promotes the holistic care of children

Emphasizes need for collaboration

Focus on overall well-being

(Duderstadt, 2008; NAPNAP, 2009; Trivedi, Patterson & Neto, 2011)

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What do you think?

Pediatric nephrology patients are seen more by the specialist than they are by the PCP?

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Literature Review

The goal of the literature review was to increase knowledge related to immunizations for high risk pediatric patients in order to assist PCP’s and specialty care pediatric providers in verifying age-appropriate immunizations are up-to-date.

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Sheth & AssociatesHepatitis B vaccine in pediatric dialysis patientsAnnual HbSAb data/median duration immunity (106.3 months) pre-dialysis

Median duration post dialysis 37.1 months

Significant difference based on timing of vaccine

Duration

HbSAb

titers not well established

US studies show decrease 5-15

yrs

post vaccination in children

Healthy Adult studies - immunity >90% (titers last >10

yrs) (CKD 5D 64%)Decline not understood (older age, malnutrition, low initial AB response)

(Sheth, Peksin & Du, 2014)

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Sheth & AssociatesPoor seroconversion rates in pediatric CKD Altered immune status, CKD stage, age & nutritional status Modify vaccine response ( doses or additional doses)

Protective immunity shortened

75-91% of

peds

dialysis pts found to be protected at 1

yr

Infx

in vaccinated dialysis pts r/t waning of vaccine-induced

HbSAb

Findings support CDC recommendations for annual screening in dialysis pts

(Sheth,

Peksin & Du, 2014)

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Sheth & Associates

(Sheth,

Peksin

& Du, 2014)

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Messengill & FerrisAddressed the educational gap and importance of delaying or preventing the progression of CKD in children.Follow CDC immunization schedule

Dialysis patients at risk for HB infection r/t suboptimal vaccine responses or a rapid decline in immunity

(Massengill, S. & Ferris, M. 2014)

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Esposito & AssociatesDiscuss risk for infx & vaccine administrationCKD patients suffer with malnutrition, increased intracellular Ca, Fe overload & uremic toxins

Infx

are the 2

nd

leading cause of morbidity & mortality

Highest incidence in those less than 2

yrs

old on dialysis

US hospitalization rates for

infx

were 500-600 per 1000 pt-yrs for ESRD

(Banerjee, Dissanayake & Abeyagunawardena, 2016, Esposito et al. 2014)

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Esposito & AssociatesSafety:Potential Risks:Graft rejection post RTReduced dialysis efficacy

Acceleration of renal function decline

Live vaccine induced

infx

(Banerjee et al. 2016, Esposito et al. 2014 )

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Esposito & AssociatesImmunogenicity:CKD with conservative tx or on dialysis – no significant difference for immune response than Healthy children.

NS may have reduced antibody production & remain unprotected.

Duration of protection is shorter for CKD and dialysis patients.

RT patients have greater risks for mod/severe impaired immune response & can remain unprotected.

(Banerjee et al. 2016, Esposito et al. 2014)

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Esposito & AssociatesEfficacy:Very few studies in pediatric CKD population.Available data shows effectiveness. HB infx in ESRD patients has almost completely disappeared.

Varicella prior to RT reduces disease risk.

(Esposito et al. 2014. Banerjee et al. 2016)

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Esposito & AssociatesVaccine Preventable Infections: General pediatric population (herd immunity) Children w/CKD (poor coverage)Barriers

Frequent hospitalizations

Cost (Foreign countries)

Limited knowledge

Concerns about safety, immunogenicity & efficacy

(Banerjee et al. 2016, Esposito et al. 2014 )

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Esposito & AssociatesVaccine Approaches:Vaccinate children with CKD according to the normal scheduleNeed influenza & pneumococcal vaccinesDialysis pts need titers regularly

Transplant candidates should receive age-appropriate vaccines

Monitor periodically & give boosters

(Banerjee et al. 2016, Esposito et al. 2014)

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(Esposito et al. 2014)

Vaccines

for

CKD

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Vaccines on IS therapy

(Banerjee et al. 2016)

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CDC Immunization Schedule

(CDC, 2018)

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CDC Immunization Schedule - Medical Conditions

18 yrs. & younger

(CDC, 2018)

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Why do parents want alternative vaccine schedules?Safety concernsSide effects or outcomes (i.e., autism)Concerns r/t vaccine additives Concerns vaccine will affect immune systemConcerns about fever & pain

Perceived low risk for getting disease

Wish to be involved in child’s medical care

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Let’s talk about alternative vaccine schedules….

https://www.youtube.com/watch?v=Phy1h1cxgSQ

http://www.chop.edu/centers-programs/vaccine-education-center/vaccine-schedule/altering-the-schedule

Recommended Article from Dr.

Offit

:

Offit

PA, Moser CA.

 

The problem with Dr. Bob's alternative vaccine schedule

 

Pediatrics.

2009 Jan;123(1):164-9.

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A QI Project is Born

Based on the literature review a quality improvement project (QIP) was developed to ensure children with CKD stage 5, NS and RT were appropriately immunized.

Focus was on

pneumococcal

, measles-mumps-rubella (MMR) & Varicella vaccines.

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Pneumococcal VaccinesPPSV 23

Purified capsular polysaccharide antigen from 23 types of pneumococcus.

Account for 60% –70% against invasive disease.

Not effective for children under 2 years old.

Less effective in preventing pneumococcal pneumonia.

PCV 13

More than 90% effective against invasive disease caused by vaccine serotypes in children.

45% effective against vaccine-type non-

bacteremic

pneumococcal pneumonia in adults older than 65 years.

75% effective against vaccine-type invasive disease in adults older than 65 years.

(CDC, 2017)

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Pneumococcal Vaccine HistoryPPSV23 recommended for children:Nephrotic syndrome - 1989 CKD -1997Poorly immunogenic in infants - 24 months and older

PCV 7 - 2000

Studies revealed adequate antibody response in children with CKD, dialysis, and solid organ transplant recipients

PCV 13 - 2010

recommended by AAP & ACIP - replaces PCV7

(Neu, 2012)

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(CDC, 2017)

(CDC, 2017)

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IRB ProcessAn expedited IRB application was submitted through East Carolina University (ECU) to allow access to patient records. The ECU IRB determined the QI study was exempt & it was approved.

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Timeline

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North Carolina Immunization Registry (NCIR)NCIR is a secure, web-based clinical tool which is the official source for North Carolina immunization information. NCIR takes the place of outdated handwritten charting of immunizations administered in the state. Access to NCIR via the North Carolina Identity Management (NCID) system is limited to North Carolina Immunization Program medical providers and affiliates. 

(http://www.immunize.nc.gov/providers/ncir.htm)

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North Carolina Immunization Registry (NCIR)The primary purposes of the NCIR are:To give patients, parents, health care providers, schools and child care facilities timely access to complete, accurate and relevant immunization data.

To assist in the evaluation of a child's immunization status and identify children who need (or are past due for) immunizations.

To assist communities in assessing their immunization coverage and identifying areas of under-immunization.

To fulfill federal and state immunization reporting needs.

(http://www.immunize.nc.gov/providers/ncir.htm)

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ICD 10 CodesList of clinic patients with the following diagnoses:Nephrotic Syndrome (n = 45)CKD stage 5 D or ESRD (n = 5)Renal Transplant (n = 6)

n = 56 patients identified initially

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Immunization Review

We reviewed immunization records in our EHR

Reviewed NCIR

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What we found

Parameter

NS/CKD/Dialysis/RT patients (n = 56)*

PCV 13 needed

18 (32%)

PPSV 23 needed

43 (77%)

PCV 13 & PPSV 23 needed

15 (27%)

Moved/Aged out/Pregnant

18 (32%)

*n = 38 excluding moved/aged out/pregnant pts

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Interventions

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CDC GuidelinesPCV & PPSV23

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CHOP Pediatric Nephrology PCV & PPSV23 Algorithm

(Malone, et al. 2016)

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OutcomesOutcome metricPercentage of NS/CKD/RT pts >2 yrs vaccinated Fully vaccinated defined as:

At least one PCV13 and a PPSV 23 (last 5

yrs

or 2 total doses)

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Outcomes

Parameter

Peds Specialty Clinic

PCP

Outpt Dialysis

Total

PCV 13

10 (26%)

10 (26%)

0

20 (52%)

PPSV 23

10 (26%)

5 (13%)

3 (8%)

18 (47%)

Total

20 (52%)

15 (39%)

3 (8%)

38 (100%)

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PCP of record incorrect

Patient not seen at PCP in years

Inpatient immunizations received not entered in NCIR by PCP

Outpatient Dialysis Center immunizations not entered in NCIR

Military Treatment Facilities (MTF’s) use their own EHR and Do Not participate in State registry programs

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Future PlansOngoing:

We have started reviewing “all” required/recommended immunizations for dialysis patients.

Continue to review immunization records for our patient population periodically.

Utilization of the recommendation letter will be discontinued.

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Future Plans

Ongoing:

Provide family with Rx to give to PCP/Health Dept.

MTF’s will update their system and send records to our clinic & will we enter them into NCIR.

Outpt dialysis center immunizations will be entered into NCIR by PSC staff.

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How can we help?

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Case Study4 yr old Hispanic female presents to PCP for 4 yr Well Visit and immunizations. She is accompanied by her Mom who does not speak English. Mom has brought her current medications to the clinic visit. Current medications include.

Prograf

2mg twice a day,

Cellcept

200 mg twice a day, Prednisone 10 mg daily, Zyrtec 5mg Q HS &

Prevacid

15mg twice a day. PMH: Seasonal allergies, Nephrotic Syndrome (Clinical Remission). Followed closely by pediatric nephrology.

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Which immunizations do we give today?DTaP #5, IPV #4, MMR #2, Varicella #2DTaP #5, IPV #4

MMR #2, Varicella #2

DTaP #5, IPV #4, MMR #2

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What did she actually get?DTaP #5, IPV #4, MMR #2, Varicella #2At that time on prednisone, tacrolimus & cellceptTiters drawn (2 yrs. post immunization administration)

Rubella IgG 12.30 (immune >0.99)

Rubeola Ab, IgG, EIA >300.0 (immune >29.9)

Mumps Abs, IgG 57.1 (immune >10.9 )

Varicella Ab, IgG 2,956 (immune >165)

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Case Study16 yr old AA female with C3 nephropathy currently on eculizumab every 3 weeks at home. Presents for follow up, doing well. Review of immunizations show PCV 7 series given at PCP during childhood. PPSV23 vaccine received March 2014 (13

yrs

old) upon discharge from hospital when initially diagnosed. Before she leaves today you will give her a PPSV 23 booster?

True

False

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The Children’s Hospital of Philadelphia (CHOP)

https://www.youtube.com/watch?v=qcnSFBepU94

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When Parents Ask Do we still need Vaccines?Per Dr. Offit - Yes!!https://www.youtube.com/watch?v=pxyTU5d542Y&list=PLUv9oht3hC6TTY-k6FbWQDWS-aR-KGRGZ&index=16

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Resources for Health Care Professionals (HCP)- ChildrenVaccines for Children (VFC): Federally funded program providing no cost vaccines to children who may not get vaccinated due to financial concerns. www.cdc.gov/vaccines/programs/vfc/index.html

.

Vaccine Conversations with parents for providers: Materials including resources for HCP’s, parental handouts, & communication strategies and tips for effectively addressing questions from parents, along with info for parents choosing to not vaccinate.

www.cdc.gov/vaccines.conversations

.

Influenza Resources: Flu vaccine is recommended yearly for everyone 6 months old and above. Info and resources for parents, patients and HCP’s.

www.cdc.gov/flu/professionals/ondex.htm

.

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Resources for Health Care Professionals - AdolescentsAdolescent Vaccine Information: Includes fact sheets on specific adolescent vaccines, trainings and a video to increase vaccine coverage in this age group. www.cdc/vaccines/who/teens/for-hcp.html

.

HPV Vaccine Resources: Ready-to-use tools to assist HCP’s and staff in communicating with parents about the HPV vaccine.

www.cdc.gov/hpv/commit-cause.html

.

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Resources for Health Care Professionals - AdolescentsYou Are The Key To Cancer Prevention: (CE) Presentation providing up-to-date info on HPV, includes info about infection/disease, vaccines and communicating with patients and parents. www.cdc.gov/vaccines/ed/hpv/index.html

.

Meningococcal Resources: Disease and vaccine information and resources for parents, patients and HCP’s.

www.cdc.gov/meningococcal

.

Influenza Resources: same as for children.

www.cdc.gov/flu/professionals/index.htm

.

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Resources for Parents - ChildrenCDC Vaccine Website for Parents: Provides parents & guardians with credible, balanced information regarding risks and benefits for vaccinating children. www.cdc.gov/vaccines/parents/

.

Fact Sheets r/t Vaccine-Preventable Diseases: Info for parents on the 14 preventable diseases (with timely vaccine administration). Available in basic & in-depth information for each disease. Also available in Spanish.

www.cdc.gov/vaccines/hcp/patient-ed/conversations/prevent-diseases/provider-resources-factsheets-infants.html

.

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Resources for Parents - ChildrenVaccine Safety: Information regarding basic vaccine safety & how vaccine safety is monitored. www.cdc.gov/vaccinesafety/.

Vaccines on the Go: What You Should Know - The Children’s Hospital of Philadelphia Free App, Includes vaccine schedules, safety, games and videos.

http://www.chop.edu/centers-programs/parents-pack/vaccines-go-what-you-should-know

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Resources for Parents & Patients - AdolescentsAdolescent Vaccines (Parents): Fact sheet for parents on recommend preteen & teen vaccines. www.cdc.gov/vaccines/hcp/conversations/prevent-diseases/provider-resources-factsheets-teens.html

.

Influenza resources: Info and resources about the flu and flu vaccine for patients and parents in English & Spanish fact sheets, brochures and other materials, infographics, GIF images, widgets and more.

www.cdc.gov/flu

.

Vaccine Quiz for Teens & Adults: Web-based interactive quiz to help teens and adults discover which vaccines they may need.

www.cdc.gov/nip/adultimmsched/

.

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ReferencesBanerjee, S., Dissanayake, P. V., & Abeyagunawardena

, A. S. (2016). Vaccinations in children on immunosuppressive medications for renal disease.

Pediatric Nephrology, 31:

1437-1448.

Becherucci

, F.,

Roperto

, R.M.,

Materassi

, M., &

Romagnani, P. (2016). Chronic Kidney disease in children. Clinical Kidney Journal,9(4), 583-591.Centers for Disease Control (CDC). https://www.cdc.gov/vaccines/vpd/vaccines-age.htmlCenters for Disease Control (CDC). https://www.cdc.gov/pneumococcal/surveillance.htmlDuderstadt, K. G. (2008). Medical home: Nurse practitioners’ role in health care delivery to vulnerable populations. Journal of Pediatric Health Care, 22

(6), 390-393. Retrieved from EBSCOhost.

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ReferencesEsposito, S., Mastrolia, M.V., Prada, E., Pietrasanta

, C., &

Principi

, N. (2014). Vaccine administration in children with chronic kidney disease.

Vaccine

32: 6601-6606.

Fu, L., Weissman, M., McLaren, Thomas, C., Campbell, J.,

Mbafor

, J., Doshi, U. & Cora-Bramble, D. (2012). Improving the quality of immunization delivery to an at-risk population: A comprehensive approach.

Pediatrics

129:e496-503.Hogg, R.J., Furth, S., Lemley, K.V., Portman, R., Schwartz, G.J., Coresh, J. et al. (2003). National kidney foundation’s kidney disease outcomes quality initiative clinical practice guidelines for chronic kidney disease in children and adolescents: evaluation, classification, and stratification. Pediatrics, 111: 1416-1421.

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ReferencesMalone, K., Clark., S., Palmer, J., Lopez, S., Pradhan,. Furth, S., … Laskin, B. (2016). Pediatric Transplant, 20(6)

: 783- 789.

Mantan, M.,

Pandharikar

, N., Yadav, S.,

Chakravarti

, A. &

Ethi

, G. R. (2013).

Seroprotection

for hepatitis B in children with nephrotic syndrome. Pediatric Nephrology, 28:2125-2130. Massengill, S.M. & Ferris, M. (2014). Chronic Kidney Disease in Children and Adolescents. Pediatrics in Review, 35 (1):16-29.

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ReferencesNAPNAP Position Statement on Pediatric HealthCare/Medical Home: Key Issues on Delivery, Reimbursement, and Leadership. (2009). Journal of Pediatric Health Care, 23, 23A-24A. Retrieved from EBSCO

host.

Neu, A.M. (2012). Immunizations in children with chronic kidney disease.

Pediatric Nephrology

, 27: 1257-1263.

North Carolina Immunization Registry (NCIR). http://www.immunize.nc.gov/providers/ncir.htm

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ReferencesPediatric Medical Home. http://www.healthychildcre.org.Pittet, L.F. &

Posfay-Barbe

, K.M. (2013). Immunization in transplantation: review of the recent literature

. Pediatric Transplantation

,

18

 (5):543-548.

Sheth, R.D.,

Peskin

, M.F. & Du, X.L. (2014). The duration of hepatitis B vaccine immunity in pediatric dialysis patients.

Pediatric Nephrology, 29:2029-2037.

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ReferencesTrivedi, H. K., Pattison, N. A. & Neto, L. B. (2011). Pediatric medical home: Foundations, challenges, and future directions. Pediatric Clinics of North America,58(4), 787-801. Retrieved from EBSCOhost

.

Vaccine Education Center at The Children’s Hospital of Philadelphia (

http://www.chop.edu/service/vaccine-

education-

center/home.html)

World Health Organization (WHO). Pneumococcal position statement: 6 APRIL 2012, 87th YEAR / 6 AVRIL 2012, 87e ANNÉE No. 14, 2012, 87, 129–144 http://www.who.int/wer

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Questions?

Thank you