Nova Scotia Guidelines for Respiratory Syncytial Virus Infection Prophylaxis ( )

Transcription

1 5850/5980 University Avenue PO Box 9700 Halifax, NS B3K 6R8 Canada Tel: Oct 14 Nova Scotia Guidelines for Respiratory Syncytial Virus Infection Prophylaxis ( ) 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 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 1 st 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 1 st, 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 1 st, *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 (26 th Ed) 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).

2 Risk Factor Yes Value No Value Score Small for gestational age (birth weight less than the 10 th 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 RSV- Hospitalization Score Action TOTAL SCORE Low Risk 0-48 Will not be approved 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%. Moderate Risk Case by case- With Evaluation High Risk Approved 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 Oct

3 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) or a fax can be sent to their attention at (902) 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 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. Oct

4 2. Palivizumab funding will be limited to 5 doses per season as outlined in Table 1. The initial dose should be given between December 1 st and January 6 th 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) ). Infants in the region of Cape Breton may receive palivizumab through a clinic at the Cape Breton Regional Hospital (902) 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 intramuscularly 1 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) 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. Oct

5 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) 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. 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) for a copy of this document, or information. Oct

6 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) or Fax: (613) Toll free for consumers and health professionals: Tel: , Fax: 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 Canadian Communicable Disease Report, Statement of the recommended use of monoclonal anti- RSV 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: 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: Oct