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Title: Manitoba%20RSV%20Prophylaxis%20Program:%20Past,%20Present%20and%20Future


1
ManitobaRSV Prophylaxis Program Past, Present
and Future
  • Aaron Chiu
  • Section of Neonatology
  • Department of Paediatrics
  • University of Manitoba

2
Questions for consideration
  • Who should be given palivizumab?
  • Why are we giving palivizumab?
  • What is the cost?

3
Objectives
  • Review RSV burden of disease, later disease
  • Review palivizumab
  • Eligibility Criteria
  • Program how it works
  • Regional challenges
  • Outreach program
  • 2005-06 Program statistics
  • Manitoba approach to 33-35 wks infants
  • 2006-07 Program and Eligibility Criteria

4
Disclosure
  • Abbott Canada provides
  • Yearly funding to run the program
  • Funds for nursing staff to run clinics
  • No part of funding from Abbott goes to physician
    remuneration
  • No physician remuneration from MB Health
  • I do not directly hold shares in Abbott

5
Quiz
  • Which of the following is true?
  • Infection with RSV confers immunity for the rest
    of the season
  • Immunization with palivizumab decreases
    likelihood of becoming infected with RSV
  • Palivizumab, like RSV-IVIG is contraindicated in
    infants with congenital heart disease
  • A single dose of palivizumab is sufficient to
    provide immunity for the next month

6
Answer
  • Which of the following is true?
  • Infection with RSV confers immunity for the rest
    of the season
  • Immunization with palivizumab decreases
    likelihood of becoming infected with RSV
  • Palivizumab, like RSV-IVIG is contraindicated in
    infants with congenital heart disease
  • A single dose of palivizumab is sufficient to
    provide immunity for the next month

7
RSV
  • Most common cause of LRTI in young children
  • Infection does not result in immunity
  • Re-infection common
  • Common presentation bronchiolitis

8
Burden of RSV Illnesses
  • Wheezing later
  • Morbidity and Mortality
  • Apnea
  • Hospitalization 1-2 require hospitalization

9
Infants at risk significant RSV
  • Preterm infants with BPD/CLD
  • Children with other lung diseases
  • Aboriginal
  • Premature Infants
  • Hemodynamically significant cardiac disease
  • Pulmonary hypertension

10
Childrens Hospital RSV Burden
05-06 04-05 03-04 02-03 01-02
Total HSC 63 219 159 216 115
HSC not admit 6 12 10 24 14
HSC admitted 57 207 149 192 101
Non-HSC 22 114 105 106 54
Total 85 333 264 322 169
Courtesy of Infection Prevention Control Karen
Olekson
11
Childrens Hospital RSV Burden
Year ICU Days
05-06 25
04-05 223
03-04 140
02-03 85
01-02 170
Courtesy of Infection Prevention Control Karen
Olekson
12
Immunoprophylaxis
  • Palivizumab

13
Immunoprophylaxis
  • Passive Immunization
  • RespiGam (RSV-IVIG)
  • Synagis
  • RespiGam manufactured by Genesis Bio-pharm
  • Synagis manufactured by MedImmune
  • In Canada Abbott Laboratories Ltd. has license
    for distribution

14
Palivizumab
  • Humanized, mouse monoclonal antibody against F
    protein of RSV
  • Immunoglobulin G-1
  • Against F glycoprotein of RSV
  • 50-100 times more potent than RSV-IVIG

15
Palivizumab
Adapted from B. Law presentation 2004
16
IMpact-RSV Trial
  • 1502 infants (1002 palivizumab, 500 placebo)
  • Participants
  • 35 wks GA and lt 6 months age
  • 24 months or younger and clinical diagnosis of
    BPD requiring ongoing medical treatment (oxygen
    steroids, bronchodilators, diuretics) within past
    6/12

Pediatrics 1998102531-537
17
IMpact-RSV Trial
  • Primary Outcome
  • Hospitalization with tested positive RSV
  • Positive RSV test while hospitalized for non-RSV

Pediatrics 1998102531-537
18
IMpact-RSV Trial - Outcome
Placebo Palivizumab (Synagis) P-value NNT
RSV Hospitalization 10.6 4.8 lt0.001 18
Prem without BPD 8.1 1.8 lt0.001 16
Prem with BPD 12.8 7.9 0.038 21
lt 32 weeks (84) 11 5.8 0.003 20
32-35 wks (16) 9.8 2 0.002 13
ICU Admissions 3 1.3 0.026 44
Pediatrics 1998102531-537
19
IMpact-RSV Trial - Outcome
Placebo Palivizumab (Synagis) P-value NNT
RSV Hospitalization 10.6 4.8 lt0.001 18
Prem without BPD 8.1 1.8 lt0.001 16
Prem with BPD 12.8 7.9 0.038 21
lt 32 weeks (84) 11 5.8 0.003 20
32-35 wks (16) 9.8 2 0.002 13
ICU Admissions 3 1.3 0.026 44
Pediatrics 1998102531-537
20
IMpact-RSV Trial - Outcome
Placebo Palivizumab (Synagis) P-value NNT
RSV Hospitalization 10.6 4.8 lt0.001 18
Prem without BPD 8.1 1.8 lt0.001 16
Prem with BPD 12.8 7.9 0.038 21
lt 32 weeks (84) 11 5.8 0.003 20
32-35 wks (16) 9.8 2 0.002 13
ICU Admissions 3 1.3 0.026 44
Pediatrics 1998102531-537
21
Eligibility Criteria
22
Quiz
  • Which of the following is true?
  • There is standardized eligibility criteria for
    palivizumab across Canada.
  • Each province has its own eligibility criteria.
  • Parents/guardians of non-eligible patients can
    purchase palivizumab on their own.
  • An infant born at 29 weeks gestation in Canada
    would receive palivizumab regardless of which
    tertiary centre he/she is born in.

23
Answer
  • Which of the following is true? None
  • There is standardized eligibility criteria for
    palivizumab across Canada.
  • Each province has its own eligibility criteria.
  • Parents/guardians of non-eligible patients can
    purchase palivizumab on their own.
  • An infant born at 29 weeks gestation in Canada
    would receive palivizumab regardless of which
    tertiary centre he/she is born in.

24
CPS Recommendations (1999)
  • Priority for palivizumab given to patients at
    highest risk of developing severe RSV infection
  • lt24 months with BPD requiring oxygen in past 6
    months preceding RSV season
  • Infants 32 weeks gestation or less who are 6/12
    months of age or less at start of RSV season
  • Consideration for children 33-35 in isolated
    communities where hospital care is not readily
    accessible

Recommendations reaffirmed in 2005
25
AAP Recommendations (2003)
  • immunoprophylaxis should be reserved for use in
    infants and children at greatest risk of RSV
    infection because of the high cost of this
    intervention

Pediatrics 20031121442-1446.
26
AAP Recommendations (2003)
  • Parental education important
  • Eliminate exposure to cigarette smoke
  • Limit participation in child care
  • Limit exposure to crowds and infected individuals
  • Importance of hand hygiene in all settings
    including the home

Pediatrics 20031121442-1446.
27
AAP Recommendations (2003)
  • lt320 weeks gestation
  • 280 weeks
  • 28-320 weeks up to 6 months age
  • lt 2 years age if CLD requiring medical therapy
    (oxygen, bronchodilator, diuretic, steroid)
  • lt 2 years age with hemodynamically significant
    congenital heart disease

Pediatrics 20031121442-1446.
28
AAP Recommendations (2003)
  • 321-350 weeks gestation, lt 6 months at start of
    season, if 2 or more risk factors
  • Child care attendance
  • School-aged siblings
  • Environmental air pollutants,
  • Congenital abnormalities of the airways
  • Severe neuromuscular disease

Pediatrics 20031121442-1446.
29
AAP Recommendations (2003)
  • Uncertain
  • Immunocompromised children
  • Cystic fibrosis
  • Prevention of nosocomial RSV disease

Pediatrics 20031121442-1446.
30
NACI Recommendations (2003)
  • Infants born 32 week gestation and lt 6 months
    age at start of during season (IA)
  • Children lt 24 months at with BPD/CLD requiring
    oxygen or medical therapy within past 6 months
    (IA)
  • Children lt 24 months with hemodynamically
    significant heart disease (IA)
  • Consideration for children both at lt 35 weeks
    gestation who are lt 6 months at start of season
    who live in remote northern communities (IIIF)

CCDR September 15, 2003 Volume 29ACS-7,8
31
Different Criteria Across Canada
  • British Columbia
  • lt 2 yo with BPD/CLD requiring oxygen and/or
    medical therapy
  • ? 28 wks gestation, and lt 6 months age at start
    of season
  • 29-35 weeks gestation and lt 6 monhts at start of
    season with additional risk factors
  • lt 2 yo with hemodynamically significant CHD
  • Quebec BMT

32
Economics of Palivizumab
33
Quiz
  • Assuming an ex-premature infant remains at 4 kg
    during the entire RSV season, what is the cost
    (Cnd) to provide the standard 5 doses of
    Synagis?
  • 500
  • 1200
  • 2500
  • 4500
  • 8500

34
Answer
  • 4500
  • Cost is 1500/100 mg vial or 750/50 mg
  • Approximately 15/mg
  • Usual dose is 15 mg/kg or 225/kg/dose
  • Usual 5 doses or 1125/kg/season (assuming no
    increase in weight)

35
Quiz
  • During the 2004-05 season, what is the total cost
    of palivizumab ordered through CBS?
  • 4 million
  • 10 million
  • 13 million
  • 19 million
  • 23 million

36
Quiz
  • During the 2004-05 season, what is the total cost
    of palivizumab ordered through CBS?
  • 4 million
  • 10 million
  • 13 million
  • 19 million
  • 23 million
  • Does not include Hema-Quebec

37
Economics of Synagis
  • Worldwide annual sales 1 billion US
  • MedImmune partnered with Abbott since 1998
  • Abbott received commission based on amount of
    drug sold
  • Concern about conflict with 2 drugs in market
    Synagis and Numax
  • MedImmune will sale and promote Synagis as of
    July 1, 2006
  • Abbott Laboratories has rights to market and
    distribute Synagis (and Numax) outside of USA

MedImmune Press Release - August 31, 2005
38
Palivizumab Packaging
  • 100 mg and 50 mg vials
  • 100 mg upto 6.7 kg infant
  • 50 mg upto 3.3 kg infant
  • No preservative
  • Opened vials must be used within 6 hours
  • Potential for drug wastage
  • Rationale for cohorting patients into clinic days
    (Thursday)
  • Pharmacy reconstitute and pharmacy and clinic
    staff draws up dose to limit wastage

39
ManitobaRSV Prophylaxis Program (RSVP)
40
Program Structure
  • RSV (immuno)prophylaxis Program since 1998
  • 2 main hospital sites in Winnipeg involved with
    neonates and paediatrics
  • In-patient
  • Out-patient clients
  • Evolving to be a true provincial program

41
MB RSV Prophylaxis Program
  • Capture, register and follow all prems with
    fulfill Program criteria
  • Follow upon discharge to community
  • Winnipeg (hospital) vaccination clinics
  • Arrange for vaccinations outside of Winnipeg
  • Arrange shipment of Synagis to outreach sites
  • Record compliance with doses provided to each
    patient reminders if necessary
  • Education to outreach communities about RSV and
    RSV Prophylaxis
  • Meeting with entire team each fall to prepare for
    season review of program, changes

42
Tertiary NICU Catchment Area
  • Winnipeg is referral centre for
  • Manitoba
  • Western Nunavut
  • Northwestern Ontario

43
MB RSV Prophylaxis Program
  • Database of almost all preterm infants born in
    Manitoba and catchment area
  • Regionalization of Synagis clinics within the
    city of Winnipeg to 2 major sites running clinics

44
Out-Reach Liaisons
  • Established Regional Medical Units
  • Northern Medical Unit
  • First Nations-Inuit Health Branch
  • First Nations Reserves
  • Nurse Practitioners
  • Local medical clinics
  • Physicians

45
RSVPP Enrolment Process
46
RSVPP Enrolment Process
  • Identification
  • Consent
  • Referral to Canadian Blood Services
  • CBS Approval and ID
  • Rx Palivizumab
  • In hospital
  • In clinic (HSC, St. B)
  • Other other clinics, nursing stations, MD offices

47
Patient Identification
  • Direct
  • Staff identify eligible newborns
  • All admissions to the three nurseries are
    reviewed
  • Indirect
  • Referral from physicians

48
Consent
  • Verbal consent obtained
  • Role of primary physician

49
Canadian Blood Services
  • CBS runs program
  • Hema-Quebec for Quebec
  • CBS established criteria for funding approval
  • CBS grants approval and provides patient ID for
    tracking
  • CBS bills the referral province for cost

50
Sites of Vaccination
  • Winnipeg Hospital Clinics
  • Childrens Hospital
  • St. Boniface Hospital
  • Regional
  • Physicians office
  • Health Unit/Nursing Stations

51
RSVPP Statistics
52
Program Enrollment
Year Total 32 wks BPD CHD 33-35 wks Other Outreach
99-00 45 41 4 0 0 ? 14
00-01 158 144 14 0 0 ? 44
01-02 154 145 9 0 0 ? 56
02-03 181 177 4 0 0 ? 72
03-04 177 143 5 29 0 ? 63
04-05 186 142 6 30 0 8 67
05-06 231 180 2 25 10 14 72
53
2005-2006
  • Total eligible for program 273
  • Total number enrolled 231 (85)
  • Infants lt 33 wks and lt 6 months at season start
  • N 203
  • Enrolled 170 (84)

54
Reasons for Non-Enrollment
Non Eligible (gt6 months old when season began) 2
Cardiac corrected prior to season start 16
Refused by family 8
Family cannot be located 8
No consent or No reply from MD/Family 3
Baby discharged resides in USA 1
Deceased 4
55
Who Initiated Enrollment
  • Program 223 (97)
  • Outreach Communities 8 (3)

56
Outreach Infants and Location of Vaccinations
Community All Hospital Hospital and Community
MB 3 13 38
ONT 2 2 6
SK 0 1 0
AB 0 0 8
BC 0 0 2
Nunavut 1 7 12
72 infants in the program received at least one
dose outside of hospital clinics
57
Shipping of Synagis to Outreach Sites
  • 2004-05 Season
  • Attempt made to ship from HSC Pharmacy in
    Winnipeg to all outreach sites
  • Failure
  • 2005-06 Season
  • Shipping directly from Montreal (Abbott)
  • UPS Supply Chain Solutions (Winnipeg)
  • Winnipeg HSC Pharmacy (rare cases)
  • Success!

58
Outreach Sites
  • Manitoba - 18 sites
  • Altona, Berens River, Brandon, Boundry Trails,
    Cross Lake, Dauphin, Easterville, Koostatak,
    Minnedosa, Norway House, Pine Falls, Shamattawa,
    Steinbach, Swan River, The Pas, Thompson, Vita,
    Waywayseecappo
  • Ontario - 4 sites
  • Kenora, Pikangikum, Sioux Lookout, Thunder Bay
  • Nunavut - 4 sites
  • Arviat, Baker Lake, Coral Harbour, Rankin Inlet

59
Synagis Utilization 2005-06 (794 doses)
Location Doses Doses
Hospital In-Patient HSC Site 150 81
Hospital In-Patient St. Boniface 59 81
Hospital Out-Patient HSC Site 421 81
Hospital In-Patient St. Boniface 14 81
Outreach - Manitoba 104 18
Outreach - Ontario 14 18
Outreach - Nunavut 26 18
Edmonton (Post-op Cardiac) 6
60
Quiz
  • What was the cost of palivizumab used for the
    Manitoba RSV Prophylaxis Program for 2005-2006?

61
Answer
  • Total dose used 55,722 mg
  • Total cost of drug (assuming no wastage) 835,830
  • Assuming 50 wastage, total cost of palivizumab
    used 1,671,660

62
Program Outcome 2005-06
  • Number of Infants enrolled in Program
    hospitalized for RSV admission
  • One
  • Infant admitted at beginning of season and had
    yet to receive a dose

63
Program Outcome 2005-06
  • Number of infants hospitalized for RSV who were
    eligible for Program but was not enrolled
  • None

64
33-35 weeks gestation cohort
  • 2005-06 (Last Season)

65
Impact-RSV Trial - Outcome
Placebo Palivizumab (Synagis) P-value NNT
RSV Hospitalization 10.6 4.8 lt0.001 18
Prem without BPD 8.1 1.8 lt0.001 16
Prem with BPD 12.8 7.9 0.038 21
lt 32 weeks (84) 11 5.8 0.003 20
32-35 wks (16) 9.8 2 0.002 13
ICU Admissions 3 1.3 0.026 44
Pediatrics 1998102531-537
66
Issues Against Immunoprophylaxis
  • Large cohort, significant costs
  • Lack of direction from expert groups (CPS, NASI)

67
Ottawa General Level III 1995-96
Cost in Canadian Dollars
Average Cost 15,980
68
Issues For Immunoprophylaxis
  • Benefit in preventing hospitalization
  • Evidence to suggest increased morbidity after
    RSV-associated infection/hospitalization
  • Increased hospitalization, need for RT visits,
    medical visits, hospital stay
  • Lack of Canadian expert guidelines
  • Acknowledgment of potential benefit to some
  • First Nations
  • Residents of Northern communities

69
Decision
  • Look at available evidence
  • Find a way to apply evidence in practical and
    pragmatic manner
  • Made in Manitoba solution
  • Major protection from palivizumab decrease rate
    of RSV hospitalization

Sampalis. J Pediatr 2003143S150-156.
70
PICNIC 33-35 week Cohort
  • Risk Factors for Hospitalization
  • Birth Nov, Dec, Jan
  • Male Gender
  • SGA (birth weight lt 10ile)
  • Attending day care
  • Any preschool siblings
  • 2 smokers in household
  • gt 5 individuals in home (include subject)
  • Eczema in first degree relative

Law et al. Pediatr Infect Dis J 200423806-14.
71
PICNIC 33-35 weeks gestation cohort
Risk Factor for RSV Hospitalization OR Risk Score
Born Nov, Dec, Jan 4.88 25
Male 1.91 11
SGA (bwt lt 10ile) 2.19 12
Subject attend day care 12.32 17
Any preschool siblings 2.76 17
2 smokers in household 1.71 10
gt5 individuals in home 1.69 13
Eczema in 1st degree relative 0.42 12 (no FHx)
Law et al. Pediatr Infect Dis J 200423806-14.
Langley et al. CPS Abstract 2006
72
Risk Score 33-35 weeks gestation cohort
Risk of RSV Hospitalization Risk of RSV Hospitalization Risk of RSV Hospitalization
Level of Risk Score Range in Risk Group
Low Risk 0-48 70.4
Moderate Risk 49-64 25.6
High risk 65-100 4.0
Langley et al. CPS Abstract 2006
73
Risk Score 33-35 weeks gestation cohort
Risk Factor OR Risk Score
Born Nov, Dec, Jan 4.88 25
Male 1.91 11
SGA (bwt lt 10ile) 2.19 12
Subject attend day care 12.32 17
Any preschool siblings 2.76 17
2 smokers in household 1.71 10
gt5 individuals in home 1.69 13
Eczema in 1st degree relative 0.42 12 (no FHx)
SUM 65
74
Manitoba Approach to 33-35
  • Criteria
  • Born during RSV season
  • Infants residing in remote North
  • Definition remote North
  • requiring air medical transport for urgent
    medical care

75
Manitoba Approach to 33-35
  • No formal cost analysis
  • Assumption cost of medical transport justifies
    use of palivizumab in this cohort
  • Cost of typical air medical transport
  • Estimate of 5000-10,000
  • Nunavut cost of medical transport and
    hospitalization
  • 40,000

76
Pragmatic Definition Remote North
  • Communities north of Winnipeg were reviewed
  • Communities south of Winnipeg not included due to
    greater availability of regional hospitals
  • Based on likelihood of air medical transport
  • Communities 500 N Latitude or greater
  • North of Eriksdale Poplar Field - Arborg

77
(No Transcript)
78
Postal codes of communities were compiled for
inclusion list
79
Postal Code
  • RO (rural code) select
  • R7N - Dauphin
  • R8 Thompson, Flin Flon
  • R9 The PAS
  • P Northern Ontario
  • X - Nunavut

80
Comparison to Childrens RSV Data
05-06 04-05 03-04 02-03 01-02
R0 (rural) 16 79 38 48 25
R1 (Portage, Selkirk) 0 3 2 5 3
R2/3 (Winnipeg) 39 114 89 143 70
R4 (Headingly) 0 0 0 1 0
R5 (Steinbach) 0 1 2 0 1
R6 (Winkler, Morden) 0 1 1 0 1
R7 (Brandon, Dauphin) 0 1 0 3 0
R8 (Thompson) 2 1 2 2 0
R9 (The Pas) 0 1 1 2 0
P (Northern Ontario) 2 14 4 9 4
X (Nunavut) 4 3 18 2 11
Courtesy of Infection Prevention Control Karen
Olekson
81
33-35 weeks gestation cohort
  • 2006-07 Current Season

82
Childrens RSV Data
05-06 04-05 03-04 02-03 01-02
R0 (rural) 16 79 38 48 25
R1 (Portage, Selkirk) 0 3 2 5 3
R2/3 (Winnipeg) 39 114 89 143 70
R4 (Headingly) 0 0 0 1 0
R5 (Steinbach) 0 1 2 0 1
R6 (Winkler, Morden) 0 1 1 0 1
R7 (Brandon, Dauphin) 0 1 0 3 0
R8 (Thompson) 2 1 2 2 0
R9 (The Pas) 0 1 1 2 0
P (Northern Ontario) 2 14 4 9 4
X (Nunavut) 4 3 18 2 11
Courtesy of Infection Prevention Control Karen
Olekson
83
Countries with Guidelines for Palivizumab use in
33-35 week GA Infants
  • Italy
  • Japan
  • Poland
  • Germany
  • Hungary
  • Spain
  • Latin American
  • USA

84
Canadian Criteria for Palivizumab use in 33-35
weeks GA infants (2005-2006)
Province Criteria - Risk Factors
Quebec lt 6 months day care OR 3 risk factors
Saskatoon 2 or more risk factors
BC lt 6 months 3 risk factors
S. Ontario Risk Score gt 49 ( Moderate- High Risk)
Ottawa 2 or more risk factors
New Brunswick Risk Score gt 49 ( Moderate- High Risk)
Alberta lt 6 months 3 risk factors
85
Palivizumab Utilization 33-35 wks (05-06)
Province 33-35 wks enrolled (Total 582)
BC 13
Alberta 71
Saskatchewan 12
Manitoba 10
Ontario 241
Quebec 221
New Brunswick 14
86
Risk Score 33-35 weeks gestation cohort
Risk Factor for RSV Hospitalization Risk Score
Born Nov, Dec, Jan 25
Male 11
SGA (bwt lt 10ile) 12
Subject attend day care 17
Any preschool siblings 17
2 smokers in household 10
gt5 individuals in home 13
Eczema in 1st degree relative 12 (no FHx)
Overall Sensitivity 68.2
Langley et al. CPS Abstract 2006
87
Risk Score 33-35 weeks gestation cohort
Risk of RSV Hospitalization Risk of RSV Hospitalization Risk of RSV Hospitalization
Level of Risk Score Range in Risk Group
Low Risk 0-48 70.4
Moderate Risk 49-64 25.6
High risk 65-100 4.0
Langley et al. CPS Abstract 2006
88
Total Score vs Predicted Probability of RSV
Hospitalization
Langley et al. CPS Abstract 2006
89
Risk Score 33-35 weeks gestation cohort
Risk of RSV Hospitalization Risk of RSV Hospitalization Risk of RSV Hospitalization Risk of RSV Hospitalization
Level of Risk Score Range in Risk Group Predicted Probability
Low Risk 0-48 70.4 1.7
Moderate Risk 49-64 25.6 7.1
High risk 65-100 4.0 18.7
Langley et al. CPS Abstract 2006
90
Eligibility Criteria for 330-356 wk GA
  • Reside in remote North
  • Eligibility will be assessed based on place of
    primary residence (address and postal code)
  • Not residing in remote North
  • Eligibility based on scoring of risk factors
  • Infants in High Risk Category will be considered
  • Risk factor
  • Born Nov 2006-March 2007
  • Male
  • Small for gestational age
  • Patient or sibling attending daycare
  • gt 5 individuals living in household (including
    patient)
  • 2 smokers in household
  • No family history of eczema

91
Plans for 2006-07 Season
  • Collection of data all infants lt36 week
  • Active enrolment of 33-35
  • Residing in Remote North
  • Risk factors scoring in high risk range for RSV
    hospitalization

92
Eventual Plan
  • Linkage of
  • preterm birth database
  • participation in RSV Prophylaxis Program
    (including compliance and dose scheduling)
  • air medical transport for illness
  • admission for RSV ve bronchiolitis

93
2006-2007 RSVP Program
  • Eligibility Criteria and Start Date

94
Start Date
  • November 15, 2006
  • Unless sudden start of RSV Season
  • If season start early
  • Start in-patient program immediately
  • Outpatient clinics once space available and
    families notified

95
Why Fixed Start Date?
  • Previous moving start date
  • Pros
  • tailor to season
  • Limit to 5 doses
  • Cons wait for 2 admissions for 2 consecutive
    weeks
  • Infants already infected season started before
    first vaccination
  • Initial admissions can be quite sick
  • New recommendation allow up 7 doses per season

96
Standard Eligibility Criteria
  • lt330 weeks gestational at birth and 6 months
    age at start of season
  • 24 months of age with BPD/CLD and who have
    required oxygen within the past 6 months
    preceding season
  • 24 months of age with hemodynamically
    significant heart disease

97
Eligibility Criteria for 330-356 wk GA
  • Reside in remote North
  • Eligibility will be assessed based on place of
    primary residence (address and postal code)
  • Not residing in remote North
  • Eligibility based on scoring of risk factors
  • Infants in High Risk Category will be considered
  • Risk factor
  • Born Nov 2006-March 2007
  • Male
  • Small for gestational age
  • Patient or sibling attending daycare
  • gt 5 individuals living in household (including
    patient)
  • 2 smokers in household
  • No family history of eczema

98
Other Category
  • Other infants 2 years of age considered on
    individual basis
  • Will require letters of support from
    paediatrician AND respirologist, infectious
    disease specialist, cardiologist (or other
    specialists)

99
Parental Education
  • Eliminate exposure to cigarette smoke
  • Limit participation in child care
  • Limit exposure to crowds and infected individuals
  • Importance of hand hygiene in all settings
    including the home

100
MB RSV Prophylaxis Program Team
  • Program Team
  • Rose Paulley
  • Sherree Anderson
  • Dr. Joanne Embree
  • Childrens Clinic Nurse
  • Ruth Reimer
  • Cory Kress
  • Lise Bourrier
  • Debbie Cote
  • Debby Shaski
  • St. Boniface
  • Darlene Mihalchuk
  • Naomi Granke
  • Pharmacy Representative
  • Ron Eros
  • Helen Ferens
  • Lydia Smart
  • Luke Mackenzie
  • Roxanne Burton
  • Community/Outreach Rep
  • Dr. Bruce Martin
  • Dr. Dave Williams
  • Celina Denechezhe
  • Liason
  • Lea Legge (cardiology)
  • Paul Brenneman (Abbott)

101
Forms
  • Referral Form
  • Pocket Card

102
Objectives
  • Review RSV burden of disease, later disease
  • Review palivizumab
  • Eligibility Criteria
  • Program how it works
  • Regional challenges
  • Outreach program
  • 2005-06 Program statistics
  • Manitoba approach to 33-35 wks infants
  • 2006-07 Program and Eligibility Criteria
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