Download Nova Scotia Guidelines for Respiratory Syncytial Virus Infection

5850/5980 University Avenue
PO Box 9700
Halifax, NS B3K 6R8
Canada
Tel: 902-470-8888
www.iwk.nshealth.ca
Nova Scotia Guidelines for Respiratory Syncytial Virus
Infection Prophylaxis (2014-2015)
General Considerations
The most important measures for prevention of respiratory syncytial virus (RSV) infection continue to be
careful hand washing and avoidance of exposure to crowded settings, such as child care centres and busy
public areas where infection could be acquired. Tobacco smoke increases the risk of respiratory disease
in children, therefore, it is strongly recommended that exposure to tobacco smoke is avoided.
Recently the American Academy of Pediatrics revised its guidelines for palivizumab in premature
infants, restricting its use to those less than 29 weeks gestation. The IWK Health Centre Utilization
Monitoring Program (IWKUMP) will review the evidence for this change in policy for the 2015-2016
season.
Indications for use of Palivizumab (SYNAGIS®)
1. Children with BPD/CLD:
Seasonal administration of palivizumab should be considered for children 24 months of age with
bronchopulmonary dysplasia (BPD) / chronic lung disease (CLD) and who have required oxygen
within 6 months preceding the RSV season (i.e. June 1st – November, 2014) or other pulmonary
disorders requiring oxygen therapy (e.g. recurrent aspiration).
2. Premature infants with or without BPD/CLD:
a. Seasonal administration of palivizumab should be considered for infants born at 32 weeks, 0
days* or earlier gestation with BPD/CLD and who are ≤ 6 months of age at the beginning of the
RSV season. i.e. must be born on or after June 1st, 2014.
b. Seasonal administration of palivizumab may benefit infants born at 32 weeks, 0 days or earlier
gestation, even if they do not have BPD/CLD and who are ≤ 6 months of age at the beginning of
the RSV season. i.e. must be born on or after June 1st, 2014.
*In Nova Scotia, the definition of 32 weeks gestation or earlier will be ≤32 weeks, 0 days, as per
the Red Book 2003 Report of the Committee on Infectious Diseases (26th Ed)2.
3. Moderately premature infants (32 1/7 weeks- 35 6/7 weeks gestation) and aged ≤ 6 months at the start
of, or during, the local RSV season can be considered for prophylaxis. Information about risk factors
is collected from the family by the physician requesting palivizumab using the Pediatric Investigators
Collaborative Network on Infections in Canada (PICNIC) scoring tool, and then reviewed by the
IWK Health Centre Utilization Monitoring Program (IWKUMP) (Refer to Table).
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Risk Factor
Yes
th
Value No
Value
Small for gestational age (birth weight less than the 10
percentile for gestational age)
12
0
Sex is male
11
0
Birth month in November, December or January
25
0
Immediate family (mother,father,sibling) have a history without
eczema
(without eczema = Yes)
12
0
Infant to attend daycare OR siblings attend daycare
17
0
More than five individuals in the home including the infant (ie,six
or more)
13
0
Two or more smokers in the household
10
0
Risk of RSVHospitalization
Score
Action
Low Risk
0 - 48
Will not be approved
Moderate Risk
49 - 64
Case by case- With Evaluation
High Risk
65 – 100
Approved
Score
TOTAL
SCORE
“Note: The overall risk of RSVassociated hospitalization(RSV-H) in
the first year of life is ~ 1%.
Moderately premature(32-35wk GA)
infants have a RSV-H of ~ 3.5%.”
4. Young children with Congenital Heart Disease (CHD):
a. Palivizumab will be considered for children 24 months of age or younger at the start of the RSV
season diagnosed with “hemodynamically significant” congenital heart disease (CHD).
b. The presence of hemodynamically significant CHD will be determined by a pediatric cardiologist.
The IWK Children’s Heart Centre will be consulted prior to distribution of palivizumab for these
requests.
c. Hemodynamically significant is defined as:
 Children with left to right shunts who require medication
 Children with congenital heart disease for whom surgery is pending
 Children with ongoing cyanosis
d. Palivizumab is not recommended for use in children with minor or hemodynamically nonsignificant congenital or acquired heart disease, including:
 Small patent arterial ducts
 Small atrial septal defects
 Small ventricular septal defects (not requiring medication use and/or with no significant LA
or LV dilation on echo)
 Those children with fully repaired congenital heart disease
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Guidelines for RSV Infection Prophylaxis (2014-2015)
e. Patients given palivizumab for cardiac indications who subsequently undergo cardiopulmonary
bypass, will be given a “post pump” dose if they have ongoing risk factors. Patients for whom
the cardiac operation results in their no longer meeting criteria for palivizumab will not be given a
post-pump dose. All patients started on a course of palivizumab will still complete the full course
(5-6 doses) for that season, regardless of the type of repair they have.
5. “Other” children considered to be at high risk for contracting RSV:
a. The requesting physician and an Infectious Disease Specialist or Respirologist should supply a
letter along with the Nova Scotia ordering requisition to AbbVie providing medical justification
for ordering palivizumab.
b. Eligible requests will be approved by an Infectious Disease physician at the IWK Health Centre.
c. If physicians are unsure whether a patient is eligible, the Pediatric Infectious Diseases physician
on call at the IWK Health Centre is willing to provide a consult and can be contacted at (902)
470-8888 or a fax can be sent to their attention at (902) 470-7846. Examples of children who
could be considered high risk are those with severe combined immunodeficiency syndrome or
those with severe hypotonia preventing adequate clearance of respiratory secretions or those with
severe chronic lung disease not due to prematurity.
Requests for Palivizumab (Synagis®)
Note: A “check-box” was added this year to the Nova Scotia RSV Prophylaxis Request Form 2014-2015
for the care provider to indicate that the parent/guardian was informed and consented to their child’s
demographic information being shared with AbbVie Corporation in Montreal for the purpose of ordering
“product” (ie. palivizumab prophylaxis ). This will meet the needs of the privacy requirement for the
Personal Health Information Act (PHIA).
The demographic information is required by the Department of Health and Wellness to monitor
costs/utilization of palivizumab and by the Provincial Palivizumab Working Group committee for a
yearly review prior to establishing provincial prophylaxis guidelines yearly and to contribute to the
national body of evidence/knowledge/practice regarding RSV prophylaxis.
1. In all cases, to order palivizumab, the requesting physician should fax a Nova Scotia RSV
Prophylaxis request form to AbbVie Corporation (AbbVie). The request form now includes an area to
indicate if this is the first time product is requested (i.e. “initial” dose) or if it is a request for
additional product (i.e. “subsequent” dose). For subsequent requests, the patient reference number
assigned by Abbott upon “initial” request must be provided. This will insure each infant/child has a
unique reference number and only one file. As palivizumab is sold on a “non-returnable” and “nonrefundable” basis, pharmacies or offices having inventory from last season should still submit a
request form to AbbVie but reduce doses requested so remaining inventory may be used first to
eliminate expiry of product. Those requests that are for “other” children considered to be at high risk
for contracting RSV should be faxed to AbbVie along with the two appropriate letters providing
medical justification for ordering the product.
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Guidelines for RSV Infection Prophylaxis (2014-2015)
2. Palivizumab funding will be limited to 5 doses per season as outlined in Table 1. The initial dose
should be given between December 1st and January 6th and every 4 weeks to a maximum of 5 doses.
This seasonal approach is based on when infants are deemed to be most at risk for contracting the
disease in Nova Scotia (January to May). Nova Scotia epidemiology experts will continue to monitor
this defined season. Table 1 outlines the number of doses required dependent on the date of request
for palivizumab.
Table 1. Guidance for number of doses depending on request date
Request Date
December
January
February
March
April
Number of Doses
(Dose is 15 mg/kg as per
package insert)
Five Doses
Four Doses
Three Doses
Two Doses
One Dose
3. It is recommended that palivizumab be delivered to hospital pharmacy services due to strict storage
requirements, and be administered to patients through same-day, centralized clinics wherever
possible. Infants in Halifax (formerly the Halifax Regional Municipality) may receive palivizumab
through the IWK RSV Prevention Clinic. Infants in Colchester County and the Municipality of East
Hants may receive palivizumab through the Colchester East Hants Health Center (contact the
Maternal/Child Unit at (902) 893-5544). Infants in the region of Cape Breton may receive
palivizumab through a clinic at the Cape Breton Regional Hospital (902) 567-7844.
4. Requests for indications that meet the provincial guidelines and do not require medical consultation
will be immediately dispensed by AbbVie.
5. Requests that require medical consultation (“cardiac indications” and “other children considered at
high risk for contracting RSV”) will be faxed to the IWK Health Centre Utilization Monitoring
Program (IWKUMP) by AbbVie. The IWKUMP will refer these requests for consultation to the
appropriate clinical specialists at the IWK Health Centre and once approved will request dispensing
of palivizumab by AbbVie.
Administration of Palivizumab (SYNAGIS®)
1. The dose of palivizumab is 15mg/kg, administered intramuscularly1 preferably in the anterolateral
aspect of the thigh. The two vial sizes available are 50 mg and 100 mg.
2. AbbVie has developed a reconstitution video with recommendations for reconstitution and
withdrawal of maximum volumes of palivizumab from the vials. On request, a copy can be obtained
by contacting Karen Chestney at (902) 470-2723.
3. Palivizumab does not contain a preservative and should be administered within 3 hours of
reconstitution. Once reconstituted, the product should stand at room temperature for a minimum of 20
minutes until the solution clarifies.
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Guidelines for RSV Infection Prophylaxis (2014-2015)
4. Administration of palivizumab in the Neonatal Intensive Care Unit (NICU):

Infants in neonatal intensive care incubators will be eligible for product administration if at
any time they are deemed stable to be cared for in a crib or a cot.

Those in cribs/cots will be eligible to receive palivizumab as infection risks remain higher for
this group of infants.

It is recommended that NICU policies be reviewed so in future those infants in cribs/cots may
not have to receive palivizumab until just before being discharged from hospital where
exposure to the general public presents a risk.
5. In all cases where palivizumab is administered, the lot number and final disposition of the product
should be accurately documented. Palivizumab that is outdated or destroyed should have the
quantity, lot number and expiry date recorded and reported to the IWK Health Centre at (902)
470-2723. The Program will do a follow up at the end of season to collect information on inventory
in the province.
6. Palivizumab does not interfere with response to vaccines.
Epidemiology of RSV
In the fall of 2004 a laboratory-based surveillance system for RSV was initiated in Nova Scotia which
included seven surveillance reporting centre’s across the province. An accurate and up to date place to
find out about respiratory activity is to review the Respiratory Watch, where surveillance results are
published each week by the Nova Scotia Department of Health and Wellness.
http://www.gov.ns.ca/hpp/cdpc/respiratory-watch.asp.
Storage Guidelines for Physician Offices and Hospital Pharmacies:*
1. All sites where this publicly funded product is handled must:
a) have a maximum-minimum refrigerator thermometer in all refrigerators containing product.
b) check refrigerator temperatures at least once a day (on office opening).
2. Individuals and institutions handling this publicly funded product are required to comply with the
guidelines presented in this section. If a site is unable to maintain refrigerator temperatures between
+2°C and +8°C alternative appropriate storage should be arranged.
3. Store palivizumab in the refrigerator at +2°C to +8°C immediately following receipt.
4. Do not store palivizumab on the door shelves of the refrigerator, in vegetable bins or on the shelf
below the freezer as temperatures in these areas will fluctuate. Store on the middle shelves of the
refrigerator.
* For more details on storage please refer to the cold chain maintenance document found in the Nova
Scotia Immunization Manual or contact the IWK Pharmacy Department at (902) 470-8165 for a
copy of this document, or information.
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Guidelines for RSV Infection Prophylaxis (2014-2015)
Adverse Incident Reporting
Any suspected adverse incident can be reported to the Canadian Adverse Drug Reaction Monitoring
Program at:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
[email protected]
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The
Canadian Compendium of Pharmaceuticals and Specialties.
The IWK Health Centre will request a report from Health Canada on any adverse reactions within
Canada during the previous RSV season and review this information with the palivizumab working
group annually.
References:
1. Abbott Laboratories Limited (November 19, 2009). Product Insert Synagis® (palivizumab) 50 mg and
100 mg Intramuscular Injections.
2. American Academy of Pediatrics (2003). Red Book 2003 Report of the Committee on Infectious
Diseases, 26th Edition, pp 523-528
3. Canadian Communicable Disease Report, Statement of the recommended use of monoclonal antiRSV antibody, 15 September 2003, Volume 29, ACS-7,8
4. Canadian Pediatric Society Infectious Diseases and Immunization Committee and the Fetus and
Newborn Committee. Palivizumab and respiratory synctial virus immune globulin intravenous for
the prophylaxis of respiratory syncytial virus infection in high risk infants. Paediatrics & Child
Health 1999;4:474-480
5. Canadian Pediatric Society Position Statement. Use of palivizumab in children with congenital heart
disease. Paediatrics & Child Health 2009; Vol 14 No 8
6. Feltes TF, Cabalka AK, Meissner HC et al. Palivizumab prophylaxis reduces hospitalization due to
respiratory syncytial virus in young children with hemodynamically significant congenital heart
disease. J Pediatr 2003; 143:532-40
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