Respiratory Syncytial Virus Prophylaxis For High-Risk .
Respiratory Syncytial Virus Prophylaxis for High-RiskInfants Program Reference ManualRespiratory Syncytial Virus Prophylaxisfor High-Risk Infants Program ReferenceManualDrug Programs Delivery BranchDrugs and Devices DivisionMinistry of HealthEffective Fall 2020
Table of ContentsContentsRespiratory Syncytial Virus Prophylaxis for High-Risk Infants Program ReferenceManual . 1Table of Contents . 2Introduction . 3Section 1 Active Season for the RSV Program . 4Section 2 Criteria for Coverage . 7Section 3 Patient Enrolment into the RSV Program. 9Section 4 How to Apply for Special Clinical Circumstances. 10Section 5 How to Order a Drug Product . 11Section 6 Frequently Asked Questions . 12Section 7 Forms. 17Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual2
IntroductionThrough the Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program(RSV program), the Ministry of Health (MOH) covers the full cost of the drugpalivizumab to prevent a serious lower respiratory tract infection caused by theRespiratory Syncytial Virus (RSV) in infants who are less than two years of age at thestart of the RSV season and who are at high risk for RSV disease.Palivizumab – immunization practices and product managementPalivizumab is a monoclonal antibody that provides passive immunization against therespiratory syncytial virus and is not expected to interfere with routine vaccinations.However, like other vaccinations, palivizumab has the potential to induce an adverseevent including but not limited to fevers. For proper monitoring of adverse events,palivizumab can be administered 24 hours before or after a routine vaccination.Immunization practices that are described in the Canadian Immunization Guide shouldbe followed. Part I of the Guide titled “Key Immunization Information” identifies thesepractices in the section “National Guidelines for Immunization Practices”. In addition, itis important to document the respective lot numbers of doses of palivizumab that areadministered to patients.The ministry requests that all health care providers be mindful of the costs such thatdrug wastage is minimized. It is noted that vial sharing is practiced in many jurisdictionsand there is literature evidence to demonstrate cost savings associated with thispractice. The September 2003 Statement on the Recommended Use of MonoclonalAnti-RSV Antibody (Palivizumab) from the National Advisory Committee onImmunization (NACI) recommended that prescribers should arrange for more than onepatient to receive palivizumab within six hours in order to minimize product wastage andpromote vial sharing.The ministry is aware that the total number of vials requested for any given clinic datemay be less than the calculated number of vials based on total body weight of theinfants due to sharing of vials. The dose of palivizumab is 15 mg per kg of bodyweight.Clinics should not accumulate any extra vials at the end of the season to minimize thepossibility of drug spoilage during the off-season (summer months) due to unforeseencircumstances.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual3
Section 1 Active Season for the RSV ProgramThe drug palivizumab is only provided during the active season to infants who meet theministry’s eligibility criteria for funding. The active season is generally from November toApril, with variations in various regions of Ontario.1.1 Season Start and EndStartDue to the seasonality of the RSV virus, palivizumab should only be administeredduring the active RSV season which for eastern, central and southern Ontario generallybegins in mid-November. Ontario’s RSV Advisory Group recommends that the first dosebe administered to eligible infants on or around the third week of November. Please seethe Important Dates for the Season section for further information.For northern Ontario (e.g. Sudbury and further north), the RSV season generally startslater in the year (e.g. December or January).The RSV season may begin earlier in certain communities. Prescribers can request anearlier start of the RSV season for that region if they believe RSV activity hascommenced by providing supporting evidence.EndFor most of Ontario, the prophylaxis season will finish at the end of March. Fornorthern Ontario (e.g. Sudbury and further north), the end of the season is generally inApril or May.However, if continued prophylaxis is required on or after the end of the season OR ifregional RSV activity persists, the requesting prescriber must confirm the RSV activitylevel in the infant’s area of residence. The status of the regional activity must be statedon the request as per the definition below.Regional activity can be confirmed by contacting the local or regional hospital’s pediatricinfectious disease department to inquire on the status of the season. The RSV seasonis considered on-going when there are TWO or more LOCAL RSV relatedhospitalizations per week for two consecutive weeks (Law et al. 2004).The ministry will communicate to the community the official start date and a declarationto the end to the RSV season.1.2 Dosing ScheduleOntario’s RSV Advisory Group recommends palivizumab be administered according tothe following general dosing schedule for central and southern Ontario:Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual4
Dose number one (week number 0) to be given starting usually in the third weekof November. Please see the Important Dates for the Season section for moreinformation.Dose number two (week number three) to be given in the month of DecemberDose number three (week number seven) to be given in the month of JanuaryDose number four (week number 11) to be given in the month of FebruaryDose number five (week number 15) to be given in the month of MarchThe season and prophylaxis start date for northern Ontario is generally delayed incomparison to southern Ontario and consequently, the suggested dosing scheduleshould be adjusted accordingly.In general, the interval between the 1st and 2nd dose should be 21-28 days. Theintervals between the 2nd, 3rd, 4th, and 5th doses should be 28-35 days.Based on human pharmacokinetic modeling, the 5th dose of palivizumab will providesufficient antibody levels to protect for at least six weeks. As such, the 5th dose willprovide the child protection through the end of April or into the month of May ifthe usual dosing schedule is followed.The RSV program covers the cost of up to five doses of palivizumab administeredduring the active RSV season to infants at high-risk for RSV infection. A sixth dose willNOT be covered by the RSV program except in isolated circumstances which willrequire approval by the ministry. These requests should be submitted to AbbVie as perthe usual process and will be adjudicated by the ministry.1.3 Important Dates for the SeasonPlease observe the following dates for the 2020/21 season: Start of Season/First Dose: November 16, 2020.Ontario’s RSV Advisory Group recommends that the first dose be administered toeligible infants on or after the week of November 16th, 2020. For logistical reasons,some clinics may have to commence prophylaxis the week prior to November 16th. Itis important to note that under such circumstances the total number of dosespermissible for the season should remain the same. End of Season: April 1st, 2021 First shipment of palivizumab by the manufacturer: On or after November 2nd,2020.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual5
1.4 Changes from the Previous SeasonSection Additions5.2 End of Season Ordering This section details the process of vial usage and strategy of end of season ordering.Frequently Asked Questions (FAQs) ChangesThe following questions were added to the FAQs: How should communication of coverage of palivizumab be given to caregivers ofinfants who may qualify?Should RSV prophylaxis continue if an infant has a positive test for RSV during theactive RSV season?What supporting documentation is required when an infant has a septal defect?Please see the FAQs section for further information.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual6
Section 2 Criteria for CoverageThe ministry covers the full cost of palivizumab for infants who meet the followingcriteria: Are residents of OntarioHave a valid Ontario Health NumberAre less than two years of age at the start of the RSV seasonAre at high risk for RSV diseaseMeet at least one of the clinical criteria.The clinical criteria for funding of palivizumab are: Infants born prematurely at 32 completed weeks gestation and aged 6months at the start of, or during, the local RSV season; orInfants 33 – 35 completed weeks gestation and aged 6 months at the start of,or during the local RSV season, who DO NOT live in remote communities ANDhave a Risk Assessment Tool Score of 49 to 100; orInfants 33 – 35 completed weeks gestation and aged 6 months at the start of,or during the local RSV season, and who LIVE IN remote communities definedby lack of immediate access to medical care ( 30 min) (i.e., Level I hospital)AND/OR inability to access pediatric services in a timely manner ( 90 minutes);orChildren 24 months of age with Down Syndrome / Trisomy 21; orChildren 24 months of age with bronchopulmonary dysplasia/chronic lungdisease (BPD/CLD) and who required oxygen and/or medical therapy specificallyfor chronic lung disease within the 6 months preceding the RSV season; orChildren 12 months of age with hemodynamically significant (HS) cyanotic oracyanotic congenital heart disease (CHD): requiring corrective surgery or are oncardiac medication for congestive heart failure or diagnosed with moderate tosevere pulmonary hypertension. Children 12 – 24 months of age withongoing HS CHD will be considered on a case-by-case basis.Infants and children with other specific medical illnesses that place them at high risk ofhospitalizations and complications from a RSV infection may also be considered forprophylaxis, if they meet necessary requirements. The enrolment forms for these infantsand children will be reviewed on a case-by-case basis by the ministry's medicalconsultant(s) with expertise in RSV prophylaxis. Please see the Special ClinicalCircumstances section for further information.Multiple Birth SetsIf a high-risk infant of a multiple birth set is approved for the season, the siblings in thesame set are also eligible for funding for prophylaxis. Enrolments for the siblings in thesame multiple birth set should be submitted on a separate form at the same time as theRespiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual7
high-risk infant - irrespective of the discharge date(s) of the individual infants. UnderSection 1 of the form, please specify the set (e.g. twins, triplets) and provide the multiplenumber (e.g. child 1, 2, 3) in the box titled, “Multiple Birth Infant Number”. Althoughthere is no specific space available on the form, you may also wish to indicate theReference Number of the approved infant of the multiple birth set, if available.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual8
Section 3 Patient Enrolment into the RSV Program3.1 Enrolment ProcessAll enrolments will initially be processed by the Synagis Coordinator at AbbVie Canada.All enrolment forms and Medical Justification Forms (if applicable) should be faxed tothe Synagis Coordinator at 1-888-703-6967.To protect personal health information, NO personal health identifiers (e.g. name,address, Ontario Health Number, parent names) are to be provided on the formsor any supporting documents.The RSV season reference number will be provided by the Synagis Coordinator if theenrolment request is approved. The ministry’s RSV program coordinator will reviewenrolment requests for the BPD/CLD and CHD criteria and have requests submittedunder Special Clinical Circumstances reviewed by external medical experts in RSVprophylaxis. The ministry’s medical experts may directly contact the enrolling prescriberfor additional information if necessary.The turn-around time is one business day for most requests. For requests submittedunder the BPD/CLD or CHD criteria and the Consideration of Special ClinicalCircumstances category, the average turn-around time is three business days.3.2 Enrolment FormTo protect personal health information, NO personal health identifiers (e.g. name,address, Ontario Health Number, parent names) are to be provided on the enrolmentform. Fields for the infant’s full name, Ontario Health Number, and other personalidentifiers have been removed.Please see Section 7 of this document for links to the enrolment form.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual9
Section 4 How to Apply for Special Clinical CircumstancesThe Special Clinical Circumstance Medical Justification Form (Medical JustificationForm) has been developed to facilitate submission of enrolment requests for high-riskinfants who do not satisfy the enrolment criteria for approval. This form must becompleted and must accompany enrolment requests submitted for Consideration ofSpecial Clinical Circumstances.Infants who are over 2 years of age at the start of the active RSV season will not beapproved for funding. However, enrolment requests for high-risk infants who do notsatisfy the above clinical criteria will be considered by the ministry’s medical experts inRSV prophylaxis. A completed Medical Justification Form must accompany theenrolment request.The Medical Justification Form must state the infant’s specific medical illness, providesufficient clinical details regarding the risk for severe RSV disease and specify whetheran infectious disease specialist, neonatologist or a respirologist has been consulted. Ifspecialist support cannot be obtained because of limited accessibility, this should beclearly stated on the Medical Justification Form. The request will then be considered bythe ministry’s expert clinicians in RSV who may contact the requesting physician foradditional information. When providing clinical findings/status of the infant, please be asthorough as possible to avoid delays in the review process. It is important that nopersonal health identifiers (e.g. infant’s name, address, health card number, andparents’ names) be provided on the Medical Justification Form.To assist the ministry’s expert clinicians in contacting the requesting physician ifrequired, please include a direct phone line (back-office number) on the enrolmentform, if available.Please see Section 7 of this document for the link to the Medical Justification Form.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual10
Section 5 How to Order a Drug Product5.1 Ordering Process from Abbvie CanadaAll shipment orders for palivizumab will be directed to the Synagis Coordinator (fax: 1888-703-6967). The Synagis Order Form can be found in Section 7 of this documentor by calling the Synagis Coordinator at 1-888-704-8270.The first dose can be ordered in Section 7 of the Enrolment form and will be shippedupon approval of enrolment. All subsequent shipments should be ordered on theSynagis Order Form.The first dose and all subsequent doses can be ordered on the Synagis Order Form ifa shipment of the first dose is not required at time of enrolment request.If there are any vials left over from last season, please use those vials prior to orderinganother shipment of palivizumab. During mid-season (mid-January), the ministry asksthat you take note of the number of vials of palivizumab in your inventory and take thisinto account when ordering another shipment of palivizumab for the remainder of theseason. The intent is to reduce inventory to zero by season end.Except for orders placed on Fridays, weekends and statutory holidays, shipmentsgenerally occur within 24 hours. However, it is recommended that an order be placedfive business days prior to the infant’s date of injection to avoid any unforeseencircumstances.Please note that the first shipment of palivizumab vials from the manufacturer will beavailable around the first week of November. Please see the Important Dates section formore information.Caution: To maintain cold chain, palivizumab must be stored in refrigerated conditionsbetween 2 and 8 C in its original container. Please ensure that the drug is storedproperly upon receipt.5.2 End of Season OrderingDuring the RSV season, a surplus of palivizumab vials may be generated due to thepractice of administering multiple doses from the the same vial for multiple patients. Asthe end of season nears, there may remain some extra vials of palivizumab that havenot yet been administered. At the end of the season, each ordering site should takenote of their inventory and only order enough additional palivizumab vials such that anyand all stock is used and depleted by the end of season date.Respiratory Syncytial Virus Prophylaxis for High-Risk Infants Program Reference Manual11
Section 6 Frequently Asked QuestionsWho is eligible for RSV prophylaxis with palivizumab?To be eligible for the program, the infant must be a resident of Ontario, insured underthe Ontario Health Insurance Plan (OHIP) and meet the program’s listed clinical criteria.Prior to the start of each prophylaxis season, the ministry updates the program’seligibility requirements and RSV Reference Manual.When is the start date for RSV prophylaxis in Ontario?The RSV prophylaxis start date is determined by the ministry and usually begins in thethird week of November for southern, central and eastern Ontario. Northern Ontario’sprophylaxis season traditionally starts later by a month or more. Prior to the start ofeach prophylaxis season, the ministry will communicate the start date through the RSVReference Manual. The RSV season is influenced by local RSV activity and seasonalfactors. The ministry uses this information in consultation with the Ontario RSV AdvisoryGroup to determine the start date. However, the RSV season in any given regional areamay be delayed as it relates to the actual local RSV activity. Ministry funding ofpalivizumab is provided between the start and end date of the RSV prophylaxis season.When is the end date for RSV prophylaxis in Ontario? Can palivizumabbe given after season end?The end date to the RSV prophylaxis season is normally around April 1st and iscommunicated through the RSV Season End communiqué. For some areas of NorthernOntario, the RSV season typically ends near the end of April to early May. However, thedate may change based on RSV activity trend in various regions of Ontario and trackingthrough the Public Health Agency of Canada (PHAC) Respiratory Virus DetectionSurveillance System reports.Doses of palivizumab should not be given after the RSV season has ended as declaredby the ministry. If doses are required after the season end, the RSV program mayconsider those requests on a case-by-case basis but only where the local RSV seasonis definitely active and
Multiple Birth Sets If a high-risk infant of a multiple birth set is approved for the season, the siblings in the same set are also eligible for funding for prophylaxis. Enrolments for the siblings in the same multiple birth set should be submitted on a separate form at the same time as the
Respiratory syncytial virus (RSV) is a common cause of acute respiratory illness in older adults, with the risk of serious infection increasing with age.1–4 The virus circulates along with many other winter respiratory viruses, most notably
vaccine trial. We performed a nested phylogeographic analysis of respiratory syncytial virus (RSV) positive samples and classified virus samples into distinct subgroups. The geographic coordinates of household of residence were obtained for study participants using GPS and used to link phylogenetic results to the geographic
The respiratory syncytial virus (RSV) is considered the leading cause of lower respiratory tract infections in chil-dren worldwide [1,2]. RSV also infects adults and is a major pathogen in older adults and immunocompromised individuals [3]. RSV strains are separated into two major groups (A and B) on the basis of antigenic and genetic variability.
Learning At Home: Nursing Management of Respiratory Syncytial Bronchiolitis 2 Respiratory Syncytial Virus
The phylogenetic analysis indicated the genotypes GA2, GA5, SAA1 (Group A), SAB1, SAB3 and BA (Group B) for RSV and Group B, subgroup B1, for MPV. Key-Words: Respiratory syncytial virus, metapneumovirus, genotypes, infants, clinical.
The followings are the types of computer viruses: a) Boot sector virus b) Program virus c) Multipartite virus d) Polymorphic virus e) Stealth virus f) Macro virus. Q4. What is a Boot sector virus? It is a computer virus designed to infect the boot sector of the disk. It modifies or
BAB 5 PENYAKIT YANG DISEBABKAN OLEH VIRUS DAN FITOPLASMA 159 5.1 Virus Belang Kacang Tanah Peanut Mottle Virus (dicetak miring) 159 5.2 Virus Bilur Kacang Tanah (Peanut Stripe Virus) 166 5.4 Nekrosis Tunas (Bud Necrosis) 184 5.5 Virus Roset Kacang Tanah (Groundnut Rosette Virus) 195 5.6 Virus Kerdil Kacang Tanah (Peanut Stunt Virus) 206
Bruksanvisning för bilstereo . Bruksanvisning for bilstereo . Instrukcja obsługi samochodowego odtwarzacza stereo . Operating Instructions for Car Stereo . 610-104 . SV . Bruksanvisning i original
