Manitoba RSV Immunoprophylaxis Program (MB RSVIP) Annual Report

Transcription

1 Manitoba RSV Immunoprophylaxis Program (MB RSVIP) Annual Report Version 2.0 May 2008 Page 1 of 12

2 MB RSVIP Program Team Program Team: Dr Aaron Chiu Director of program Dr Joanne Embree Assistant Director of program and ID Consultant Rose Paulley RSV Program Coordinator Sherree Anderson RSV Program Administration Children s Hospital RSV Clinic Nurses: Ruth Reimer Cory Kress Lise Bourrier Debbie Cote Amy Yakimoski Kris Sneesby St. Boniface Representatives: Darlene Mihalchuk Coordinator ACF SBGH Naomi Granke Newborn F/U program SBGH Pharmacy Representatves: Ron Eros Pharmacy Site Manager for Paediatrics Helen Ferens CK4 Pharmacy HSC Lydia Smart Pharmacy Tech HSC / Tamara Mose - Pharmacy Tech HSC Luke Mackenzie Coordinator, Department of Pharmacy SBGH Roxanne Burton Pharmacy Tech SBGH Jill Thurston Pharmacy Tech SBGH Julie Muise Pharmacy Tech SBGH Community/Outreach Advisors: Dr Bruce Martin Director of Northern Medical Unit Dr Dave Williams - FNIHB Celina Denechezhe FNIHB Other Representatives: Lea Legge Paediatric Nurse Clinician, Variety Heart Centre Paul Brenneman - Abbott Laboratories Version 2.0 May 2008 Page 2 of 12

3 Summary This is the second annual report for the Manitoba RSV Immumoprophylaxis Program (MB RSVIP). This past year, the transition from a regional program to a Provincial program continued; and along with transition, the number of challenges and obstacles increased. Effective 2007, the Program will review all requests initiated from Manitoba and will grant approval in place of the Canadian Blood Services. Synagis is the agent used for immunoprophylaxis against RSV. Numerous clinical studies show Synagis is useful in preventing severe RSV infection in at risk infant. Its efficacy is in decreasing hospitalization from RSV infection with no evidence that it decreases the incidence of RSV infection. The MB RSVIP is unique in its approach to RSV immunoprophylaxis in many aspects. The Program actively identifies Manitoban infants eligible for immunoprophylaxis. Our collaboration with the provincial NICUs, paediatric subspecialists, community paediatricians and family physicians, and health care providers in remote communities allows comprehensive identification of infants and children traditionally eligible based on the standard criteria of prematurity, bronchopulmonary dysplasia and hemodynamically significant heart disease. In addition, the Program coordinates and organizes immunoprophylaxis for all enrolled patients throughout the province. Eligible inpatients receive immunoprophylaxis during hospitalization in the NICUs and the Children`s Hospital in Winnipeg. Weekly outpatient immunoprophylaxis clinics are held at the Children s Hospital of Winnipeg for enrolled patients residing in or near Winnipeg. Infants followed by the ACF Paediatrics group at St. Boniface receive RSV immunoprophylaxis in their physician s offices. The Program also arranges immunoprophylaxis to those residing in more remote regions through extensive collaboration with local physicians, nurses, nursing stations and community health care units. Of note, the greatest increase in drug usage this past year was in patients receiving Synagis in outreach communities. The eligibility criteria for were expanded from previous years. The standard criteria for prematurity (< 33 weeks gestational age), chronic lung disease (BPD), and hemodynamically significant heart disease remained unchanged. For , we expanded enrolment for infants born weeks gestational age. In the prior year, we enrolled week gestation infants residing in remote northern Manitoban and Nunavut communities (defined by postal codes). This year, we expanded coverage to include all weeks gestational age infants (regardless of residence) with sufficient risk factors placing them at high risk of hospitalization from RSV infection. Near term infants (35 weeks gestation) that were not admitted to a special care nursery may not have been automatically referred to the Program. Infants from Ontario did not qualify for eligibility under the weeks criteria due to differences in provincial eligibility. For the season, the eligibility for our Program will remain the same. As in previous year, the Program began on a fixed date: November 15, The predictability of the fixed date made it easy to start the Program and ensured eligible and enrolled infants received at least 1 dose of immunoprophylaxis before the Christmas/New Year Break. The Program ended March 15, 2007 after a brief but active RSV season. We plan to maintain a similar fix start date for subsequent seasons. The RSV season was more typical than the previous year, with a significant increase in infants hospitalized for RSV compared to the uncharacteristically mild season. The number of patients enrolled into the Program also increased. Version 2.0 May 2008 Page 3 of 12

4 The season also saw challenges in product ordering, inventory and supply. We extend our thanks to Abbott Canada, to Canadian Blood Service, and to the Manitoba Provincial Blood Coordinating office in their assistance in resolving this issue and in developing stricter inventory control for subsequent years. We give our many thanks to all the physicians, nurses, pharmacists, and allied health professional for their continuing support. Their dedication and collaboration has made our Program a success and the model for other jurisdictions. We look forward to the challenges of this continuously evolving program for the upcoming season including the relocation of our office to the Children s Hospital: Manitoba RSV Immunoprophylaxis Program CE308N 820 Sherbrook Ave Winnipeg, MB Phone: (204) Fax (204) address is: rsvprogram@exchange.hsc.mb.ca Dr. Aaron Chiu Medical Director RSV Prophylaxis Program Disclosure: the MB RSVIP is administered by the Section of Neonatology, Department of Paediatrics. The Program is a not-for-profit program and receives an unrestricted grant from Abbott Canada. The funds are used to pay for nursing and secretarial staff that administer the program and staff the clinics. Physicians and other allied health personnel do not receive compensation for participation in the program. Version 2.0 May 2008 Page 4 of 12

5 Eligibility Criteria 1. Prematurity: born < 33 0 weeks gestation and < 6 months of age at start of RSV season (May 1, 2006). 2. Chronic Lung Disease: Infants < 2 years of age with chronic lung disease (i.e. BPD) and who have received oxygen therapy within the 6 months preceding the start of the RSV season. 3. Congenital Cardiac Condition: Children < 24 months of age with hemodynamically significant heart disease (based on degree of physiologic cardiovascular compromise. ELIGIBLE NOT ELIGIBLE pulmonary artery hypertension uncomplicated or small ASD Tetralogy of Fallot patent ductus arteriosus cyanotic heart disease uncomplicated VSD congestive heart failure (ongoing therapy) pulmonic stenosis congenital heart disease (any type) in association with prematurity or chronic lung disease Gestational Age Category: post, corrective cardiac surgery [should receive 1 dose post-cardiopulmonary bypass] uncomplicated aortic stenosis mild coarctation of the aorta cardiomyopathy, untreated i. Infants less than 6 months of age at the start of the RSV season living in or will reside in remote Northern communities are eligible. ii. (NEW this season) Infants with sufficient risk factors (see below) placing them at high risk for hospitalization for RSV infection (score 65). 5. Special Requests: Scoring Tool Questions Yes No Small (<10 th percentile) for gestational age 12 0 Male Gender 11 0 Birth during season (November approx. March) 25 0 Family history without eczema 12 0 Subject or siblings attend day-care 17 0 More than five individuals in the home counting the subject 13 0 Two or more smokers in the household 10 0 Other infants were considered on an individual basis. Letters of support were required from the attending paediatrician/physician as well as from the paediatric subspecialist (typically respirology, infectious disease, or cardiology. All requests were reviewed and approved by the Program before submission to Canadian Blood Services. Version 2.0 May 2008 Page 5 of 12

6 Program Enrolment Season (May 1, 2006 April 30, 2007) 1) Gestational Age Criteria a. 32 Weeks Gestation (Registered By Manitoba or Received Dose) Gestational Age Total Manitoba Other Northern Non-Northern Nunavut Ontario Total b Weeks Gestation Total weeks gestational age infants 367 Born before season (May 1 October 31, 2006) 197 Born During Season 122 Born after season ended (March 16 April 30, 2007) 48 Born Before Season (May 1 October 31, 2006) 197 Born before season and not enrolled 184 (Enrolled in NU) (4) Nunavut Resident enrolled in Manitoba 1 Manitoban Born before season and enrolled (all but 1 from Northern MB) 12 Born During Season (November 1, 06 February 28, 2007) 122 Born During Season and Not Enrolled 84 Saskatchewan Resident Enrolled in Manitoba 1 Nunavut Resident enrolled in Manitoba 5 Manitoban Born During Season and Enrolled 34 Born After Season Ended (March 1 April 30, 2007) none enrolled 48 Version 2.0 May 2008 Page 6 of 12

7 b Weeks Gestation (continued) Total week Gestation Infant Enrolled 53 Remote Residency Category 39 Northern Manitoba Remote 32 Nunavut Resident Enrolled by Manitoba 6 Saskatchewan Resident Enrolled by Manitoba 1 Non-Northern Manitoba Referrals Received 102 Ontario Patients (Low Risk: Moderate Risk: High Risk = 6:2:2) 10 Manitoba Patients 92 Non-Northern Manitoba Risk Scores 92 Low Risk (0-48) 56 Moderate Risk: (49-64) no enrolled 22 Moderate Risk: (49-64) 2 of whom enrolled with scores 63, 64 2 High Risk: (65-100) 12 Gestational Age Total Enrolled in Program Registered with CBS Not Registered with CBS Percentage enrolled out of total week gestation cohort = 53/367 = 14.4% 2) Chronic Lung Disease Criteria (BPD) Total First Year in Program Second Year in Program Enrolled Total Number of Chronic Lung Disease = 6 3) Haemodynamically Significant Heart Disease Total First Year in Second Year in Repaired During Program Program Season Enrolled Total number of Cardiac Cases Enrolled = 39 Version 2.0 May 2008 Page 7 of 12

8 4) Other/Special Request Total CF CDH VACTERL Neuromuscular or Miscellaneous Down s Syndrome Enrolled Total number of Other/Special Request Enrolled = 20 5) Total Enrolment for Season CATEGORY 32 weeks gestation weeks gestation 53 Chronic lung disease 6 Congenital heart disease 39 Other/Special 20 TOTAL 277 Total number of children ENROLLED for season = 277 6) Children Meeting Eligibility Criteria But Were Not Enrolled: Deceased before or during season 19 Families declined to participate 12 Families cannot be located 2 No Replies from Primary Care Physicians 9 Version 2.0 May 2008 Page 8 of 12

9 OUTREACH COMMUNITY PROGRAM Manitoba has an extensive out-reach program coordinating the ordering and shipping of Synagis and the monthly dosing in patients residing far from the Winnipeg hospital clinics. Our program encompasses all of Manitoba, and assists with North-Western Ontario & Central Nunavut regions. There is also liaison with programs in other provinces to accommodate patient transfers in and out of province due to ongoing medical care or family relocation. Listed below are the sites in where Synagis was shipped for the RSV Season. MANITOBA OUTREACH SITES (24) Boundary Trails Pelican Rapids Brandon Cranberry Portage Cross Lake Dauphin Ebb & Flow Flin Flon Lac Brochet Moose Lake Nelson House Norway House Opaskwayak Pine Falls Portage La Prairie Sandy Bay Somerset South Indian Lake St Theresa Point Steinbach Swan River The Pas Thompson Wasagamach ONTARIO OUTREACH SITES (4): Fort Francis Kenora Sioux Lookout Thunderbay NUNAVUT OUTREACH SITES (8): Baker Lake Chesterfield Inlet Clyde River Coral Harbor Rankin Inlet Repulse Bay Whale Cove Many enrolled patients who reside in a remote community travel into Winnipeg to receive their monthly injection. Families from Northern Manitoba and Northwestern Ontario regularly travelled to the Children s Hospital RSV Clinic or St. Boniface ACF Pediatric Clinic. Version 2.0 May 2008 Page 9 of 12

10 RSV POSITIVE CASES IN RSVIP ELIGIBLE INFANTS For season, Manitoba s first RSV positive child admission to Children s Hospital was on September 29, 2006 and the last was on May 10, Children s Hospital had 149 RSV positive admissions, 14 of theses children were eligible for the RSV-IP Program: 3 had not been identified and enrolled into the program: - All 3 subsequently enrolled after admission (2 as special requests, 1 as cardiac) 3 were indentified but not yet enrolled: - 1 identified but had not consented - 1 identified but supporting letter from specialist was requested and not yet received - 1 considered too unstable to receive doses 1 enrolled but did not attend their clinic appointments 7 enrolled and received doses: - 5 received 1 dose of Synagis - 1 received 2 doses of Synagis - 1 received 3 doses of Synagis RSV-Related Length of Stay for RSVIP Enrolled Patients Of the 12 enrolled (or subsequently enrolled) children who were admitted to hospital, 4 children were admitted to either PICU / NICU and the other 8 children were admitted to paediatric wards. LOCATION PICU NICU Pediatric Ward Total Hospital Days LENGTH OF STAY 26 days 12 days 100 days 138 days Two children required ventilation for a total of 34 days. Two children had other medical issues which resulted in prolonged hospitalization stays not related to RSV infection. Version 2.0 May 2008 Page 10 of 12

11 UTILIZATION OF SYNAGIS Total Utilization (Approximate) Location # Patients #Doses Unknown (mg) (mg) % change Inpatient % HSC In-patient % St Boniface In-patient % Winnipeg Hospital Clinic % HSC Clinic % ACF Clinic % Outreach Program % *Manitoba Ontario Nunavut Edmonton Cardiac Post-op Total ,923 55, % * Two patients were not registered in this category and received Synagis dose(s). Doses Received Number Who Received Synagis (mg) Used (Approximate) 1 Dose 2 Doses 3 Doses 4 Doses 5 Doses Version 2.0 May 2008 Page 11 of 12

12 Comparison to National Data NATIONAL MANITOBA * * Variation * * Variation Actual 28 weeks % % weeks % % weeks % % 53 BPD % % 4 BPD % CHD % % 33 CHD % % 6 Other % % 20 Total % % 277 *Information supplied by Abbott Canada Manitoba Utilization Yearly Trend weeks weeks CLD CHD Other ????? TOTAL % increase 20% 24% 5% -2% 17% -2% 251% Drug (mg) 66,923 55,722 % increase 20% Remaining Vials 447 COST (est.)* 2,008,000 1,700,000 1,200, ,000 *Based on $15/mg and 50% wastage. This report is for informational purposes only. Publication in part or whole must be approved by the MB RSV Program. Version 2.0 May 2008 Page 12 of 12