Flu information pack 2015/16: guidance

Transcription

1 Introduction Forthe2015/16winterinfluenza(flu)season,theDepartmentofHealth(DH)hasadvisedthatthe following strains are likely to circulate and should be included in the trivalent seasonal influenza (northern hemisphere winter) vaccine, based on the World Health Organization (WHO) recommendation: AnA/California/7/2009(H1N1)pdm09likevirus AnA/Switzerland/ /2013(H3N2)likevirus AB/Phuket/3073/2013likevirus AnyquadrivalentvaccineswhichincludetwoinfluenzaBvirusesshould containtheabovethreevirusesandab/brisbane/60/2008likevirus. Targetgroups Forthe2015/16fluseason,thefollowingpatientgroupsareeligibleforfluvaccinationunderthe NHSthroughthecommunitypharmacyseasonalinfluenzavaccinationAdvancedService(England): 1) Thoseaged65yearsorover,includingthosereaching65yearsofageby31March2016 2) Those aged 18 years and over to under 65 years with one or more serious medical condition(s) a. For example, chronic respiratory disease, chronic heart disease, chronic kidney disease at stage three, four or five, chronic liver disease, chronic neurological disease,diabetes,weakenedimmunesystemorsplenicdysfunction 3) Allpregnantwomenatanystageofpregnancy 4) Thoseinlongstayresidentialcarehomesorotherlongstaycarefacilities a. Excludesprisons,youngoffenderinstitutions,universityhallsofresidence 5) Carers a. Individualswhoreceiveacarer sallowanceorthosewhoarethemaincarerofan elderlyordisabledindividual 6) Householdcontactsofimmunocompromisedindividuals a. Anyone living in close contact with immunocompromised individuals during most daysoverthewinterperiodshouldbeconsideredforvaccination Forthe2015/16fluseason,thefollowingpatientgroupsarealsoeligibleforfluvaccinationunder thenhsthroughotheravenuessuchasgpsurgeriesand/orlocallycommissionedservices: All two, three and four year olds (not five years or older) on 31 August 2015 through GP surgeries Allchildreninschoolyearsoneandtwothroughalocallycommissionedservice Primary schoolaged children in areas that were part of the primary schools pilot in the 2014/15influenzaseason Thoseagedsixmonthstounder65yearswithoneormoreseriousmedicalcondition(s) Theabovelistisnotexhaustive.Healthprofessionalsshouldapplytheirclinicaljudgementtodecide whetherapatientneedstohavethefluvaccine,takingintoaccounttheriskoffluexacerbatingany underlyingdiseaseandtheriskofillnessfromflu,andreferthepatienttoanappropriateservice provider. For further information about the flu plan please refer to the DH letter and Flu plan: Winter2015to2016.

2 Children(eligibilitythroughGPsurgeriesand/orlocallycommissionedservices) In July 2012, the JCVI issued a statement that recommended extending the flu vaccination programmetochildrenagedbetweentwoyearstolessthan17years;thisprocesswasrolledout gradually. In2015/16,alltwo,threeandfouryearoldswillcontinuetobeeligibleforfluvaccinationthrough GPsurgeries,andvaccinationwillcontinuetobeofferedtothosechildrenwhoparticipatedinthe primaryschoolpilotsin2014/15.inaddition,the2015/16seasonwillseetherolloutextendedto childreninschoolyearsoneandtwo,throughlocallycommissionedschemes. Forthe2015/16influenzaseason,therearetwotypesofvaccinesavailableforchildrenuptothe ageof17;aliveattenuatednasalvaccine(fluenztetra)andtheinactivatedinfluenzavaccine.for further information on the suitability of these vaccines for specific age ranges in children, please referto Whichfluvaccineshouldchildrenhave? publishedbypublichealthengland. Pregnancyandbreastfeeding Pregnancy Thefollowingshouldbeconsideredforfluvaccinationinpregnancy: Allpregnantwomenarerecommendedtoreceivetheinactivatedfluvaccineregardlessof whichtrimestertheyarein;pregnancyincreasestheriskofcomplicationsfromflu Ideally,fluvaccinationshouldbeofferedtopregnantwomenbeforeflustartscirculating Womenwhobecomepregnantduringthefluseasonshouldstillbeofferedthevaccine Fluduringpregnancycanleadtoprematurebirthandsmallerbirthsizeandweight Fluvaccinationduringpregnancymayprovidebabieswithpassiveimmunitytofluduring theirfirstfewmonthsoflife Inactivated flu vaccine can be administered safely and effectively during any trimester of pregnancy FluenzTetraintranasalvaccine thereislimiteddataontheuseofthisvaccineinpregnant women;therefore,itsuseisnotrecommendedduringpregnancy Intanza suspension for injection 15mcg/strain the vaccine is licensed for use in people aged60yearsandover,sothespccontainsnoinformationonitsuseduringpregnancy Breastfeeding The Summaries of Product Characteristics (SPCs) for all of the UK licensed flu vaccines for the 2015/16seasonstatetheyaresuitableforuseduringbreastfeeding,withtheexceptionof: FluenzTetra thisshouldnotbeusedduringbreastfeeding Intanza suspension for injection 15mcg/strain the vaccine is licensed for use in people aged60yearsandover,sothespccontainsnoinformationonitsuseduringbreastfeeding Vaccineadministration Beforeafluvaccineisadministered,thevaccinatorshouldmakesurethat: Thepatienthasnocontraindicationstothevaccine Thepatientisprovidedwithallappropriateinformationaboutthevaccinetogiveinformed consent

3 Thepatientfullyunderstandsthevaccinationprocedure Thepatientisinformedofanypossibleadversereactionsandhowtomanagethem Skin that looks dirty is washed with soap and water; clean skin does not require further cleaning InformationonvaccineadministrationcanbefoundintherelevantSPCsandin TheGreenBook: immunisationagainstinfectiousdisease:chapter19influenza and TheGreenBook:immunisation againstinfectiousdisease:chapter4immunisationprocedures Vaccination techniques overview (IMPORTANT: This is NOT a substitute for proper vaccination traininginstructionfromaqualifiedprovider itisyourpersonalandprofessionalresponsibilityto ensurethatyouhavetheappropriatetrainingtobeabletoadministerthefluvaccinescompetently) Intramuscular (IM) Deep subcutaneous (SC) Intranasal route(using FluenzTetra) Ininfants,childrenandadults,a25mm23G(blue)or25mm25G(orange) needleshouldbeused Inpretermorverysmallinfantsa16mmneedleissuitableforIMinjection Largeradultsmayrequirealongerlengthneedle,forexample,a38mmneedle Injectionsshouldbeadministeredwiththeneedleata90degreeangletothe skinandtheskinshouldbestretched,notbunched Injectionsshouldpreferablybeadministeredintothedeltoidmuscleofthe upperarminolderchildrenandadults;theanterolateralthighininfantsunder oneyearofage Useofa25mmneedlecanreduceanylocalvaccinereactogenicity Injectionsshouldbeadministeredwiththeneedleata45degreeangletothe skinandtheskinshouldbebunched,notstretched Injectionsshouldpreferablybeadministeredintothedeltoidsiteinolder childrenandadultsortheanterolateralthighininfantsundertheageofone year VaccinesthatarenormallyadministeredbytheIMrouteshouldonlybegiven bydeepscinjectiontoindividualswithableedingdisorder,inordertoreduce theriskofbleeding FluenzTetranasalspraysuspensionisaliveattenuatedfluvaccineandisonly licensedtobeadministeredbynasaladministration itdeliversa0.1mldose intoeachnostril Administrationdoesnotneedtoberepeatedifthepatientsneezesorblows theirnosefollowingadministration ItisnotknownwhetherFluenzTetrawillbeeffectiveifgiventoachildwitha heavilyblockedorrunnynose;insuchcasesitmaybeappropriatetopostpone administrationuntilthenasalcongestionisresolved,oradministeranim vaccineinstead Intradermal Injectionsshouldonlybeadministeredusinga26G,10mm(brown)needle Ifconsiderableresistanceisfeltandaraised,blanchedblebshowingthetipsof thehairfolliclesisapparent,thisindicatesthattheinjectionhasbeencorrectly administered Ifnoresistanceisfelt,theneedleshouldberemovedandreinsertedbefore furthervaccineisgiven

4 Fluvaccinecontraindications Fluvaccineshouldnotbegivento: Thosewhohavehadaconfirmedanaphylacticreactiontoapreviousdoseofthefluvaccine Thosewhohavehadaconfirmedanaphylacticreactiontoanycomponentofthefluvaccine (exceptovalbumin seesectionon Patientswithaneggallergy ) FurtherinformationonspecificfluvaccinecontraindicationscanbefoundintherelevantSPCs. Precautions Apersonwhoisunwellmayhavetheirfluvaccinationpostponeduntiltheyarefullyrecovered,to avoidconfusionbetweensymptomsoftheillnessandanysideeffectsofthevaccine.thereisno needtopostponetheadministrationofafluvaccinetopatientswithaminorillnessthatpresents withoutfeverorsystemicdisturbance. Adversedrugreactions FollowingadministrationoftheinactivatedfluvaccineviatheIMorintradermalroutethepatient mayexperience: Pain,swellingorrednessatthesiteofinjection Mildflulike symptoms such as headache, low grade fever, shivering, fatigue or myalgia; thesesymptomsusuallydisappearwithinonetotwodayswithouttreatment Followingadministrationoftheliveintranasalfluvaccine,thepatientmayexperience: Nasalcongestion,rhinorrhoea,lossofappetite,weaknessandheadache(common) Urticaria,bronchospasm,angiooedemaandanaphylaxis(immediately) Patients and healthcare professionals are advised to report serious adverse reactions using The YellowCardSchemeandinparticularthosevaccinesthathaveablacktrianglesymbol()suchas FluenzTetranasalspraysuspensionandFluarixTetrasuspensionforinjectioninprefilledsyringe. Black Triangle drugs are recently licensed and monitored intensively by the Medicines and HealthcareproductsRegulatoryAgency(MHRA). Doseinformation Information on vaccine dosage and schedules can be found in The Green Book: immunisation againstinfectiousdisease:chapter19:influenza andtherelevantspcs. TheJCVIhasadvisedondifferentdosageschedulesoffluvaccineforchildren;thiscandependon: Ageofthechild Clinicalindications Typeoffluvaccineoffered Previousadministrationofafluvaccine TheJCVIadvice,in TheGreenBook:immunisationagainstinfectiousdisease:Chapter19:Influenza, maydifferfromsomeofthespcs.

5 Administrationofothervaccines Thefollowingshouldbeconsideredwhenadministeringothervaccines: Inactivatedfluvaccinescanbegivenatthesametimeasothervaccines Live attenuated vaccines can also be given at the same time as other live or inactivated vaccines JCVIhasadvisedthatnospecificintervalsneedtobeobservedbetweenadministrationof theliveattenuatedintranasalfluvaccineandotherlivevaccines IMandintradermalinjectionvaccinesshouldbegivenatseparatesitesandpreferablyina different limb;if they are given in the same limb they should be administeredat least 2.5cmapart Vaccinestorage Vaccines should be stored as recommended in their SPC, in the original packagingbetween2cand8candprotectedfromlight Whenstoredintherefrigerator,vaccinesmustbestoredwithspacearoundthemsothatair cancirculate;theyshouldnotbeplacedtooclosetothesideorbackwallsoftherefrigerator becausethismayresultinthevaccinesfreezingmakingthemunusable Thecoldchainmustbemaintainedandmonitoreduntilthetimethevaccineisadministered tothepatient The pharmaceutical refrigerator they are stored in must be regularly serviced and maintainedandundergocalibrationandelectricaltestingsothatitisfitforpurpose Ifvaccinesneedtobetransported,avalidatedmedicalgradecoolboxorcoolpackmustbe usedandthetemperaturemustbemonitoredregularly Further information on vaccine storage can be found in The Green Book: immunisation against infectiousdisease:chapter3:storage,distributionanddisposalofvaccines Wastedisposalandspillages Expired stock and any equipment used during the vaccination process, including any empty vials, syringesandneedles,shouldbedisposedofcorrectlyintheappropriatesharpscontaineraccording tolocalauthorityregulationsandtheguidanceinthe HealthTechnicalMemorandum0701:Safe managementofhealthcarewaste bythedepartmentofhealth. Thesharpscontainershouldbesealedandreplacedonceitistwothirdsfull,oronce thecontentshavereachedthelevelindicatedonthecontainerbythemanufacturer. The container should not be accessible to unauthorised individuals and should be disposedofinaccordancewithlocalcontractualprocedures. Anyspillagesofvaccinesshouldbeclearedupquicklyusingpapertowelsandwearinggloves;local written procedures should be followed, together with the Control of Substances Hazardous to Health(COSHH)safetydatasheetssuppliedbythevaccinemanufacturers. Furtherinformationondealingwithspillagesandwastedisposalcanbefoundin TheGreenBook: immunisationagainstinfectiousdisease:chapter3:storage,distributionanddisposalofvaccines

6 Vaccineexcipients Eggallergy Aninactivatedfluvaccinewithanovalbumin contentoflessthan0.12mcg/ml (i.e.containinglessthan0.06mcgper0.5mldose)canbegiventopatientswith eggallergy Patientsovertheageof18yearswitheggallergycanusetheovalbuminfreeflu vaccine,optaflususpensionforinjection,inprefilledsyringe ChildrenwithaneggallergycanbesafelyadministeredwithFluenzTetrainany setting;unlesstheyhavesevereanaphylaxistoeggthathaspreviouslyrequired intensivecare Children for whom Fluenz Tetra is contraindicated should be offered an inactivated flu vaccine with a low ovalbumin content of less than 0.12mcg/ml (<0.6mcg/0.5ml) All patients (adults and children) with severe anaphylaxis to egg should be referredtospecialistsforimmunisationinhospital DetailsoftheovalbumincontentoffluvaccinesavailableintheUKforthe2015/16 fl useasoncanbefoundin Influenzavaccines:2015to2016fluseason, TheGreen Book:immunisationagainstinfectious disease:chapter19influenza and thenpa Pharmacy Services factsheet Flu information pack : vaccine information andtherelevantspcs. Antibiotics Mostoftheinfluenzavaccinesfor2015/16containtracesofcertainantibiotics andcautionmustbeexercisedinpatientswithhypersensitivitytoanyofthese All flu vaccines are contraindicated in patients who have had a confirmed anaphylacticreactiontotheseantibiotics Further information can be found in the NPA Pharmacy Services factsheet Flu informationpack201516:vaccineinformation andtherelevantspcs. Latex An individual should not be offered a flu vaccine that is supplied in a vial or syringethatcontainslatexiftheyhaveasevereallergytolatex Mostoftheinfluenzavaccinesarelatexfreebutthefollowingvaccinesmaynot besuitableforpatientswithalatexallergy: o FluarixTetrasuspensionforinjectioninprefilledsyringehaslatexpresentin thetipcapoftheprefilledsyringe o Agrippalsuspensionforinjectioninprefilledsyringehasnolatexpresentin thesyringecap;however,thesafeuseofagrippalsuspensionforinjectionin patients who are sensitive to latex has not been established, so the manufacturer, Novartis Vaccines Ltd, is unable to recommend its use in patientswhoaresensitivetolatex Further information on individual vaccines can be found in the NPA Pharmacy Services factsheet Flu information pack : vaccine information and the relevantspcs. Thiomersal Thiomersalisamercurybasedcompoundandcertainvaccinesusethiomersalas apreservativeduringmanufacturing

7 Gelatine None of the influenza vaccines for 2015/16 contain thiomersal as an added preservative. Further information can be found in the NPA Pharmacy Services factsheet Flu informationpack201516:vaccineinformation UKlicensedfluvaccinesforthe2015/16seasonareallfreefromgelatine,withthe exceptionoffluenztetrawhichcontainshydrolysedgelatinederivedfrompork(the gelatine is highly purified and is used to stabilise the live vaccine). Further informationcanbefoundinthenpapharmacyservicesfactsheet Fluinformation pack201516:vaccineinformation andtherelevantspcs. Since Fluenz Tetra nasal spray contains gelatine derived from pork, patients from certainfaithgroupsmayhaveconcernsaboutthisvaccine ssuitability. Jewish IndividualsfromtheJewishcommunitymayfindthefollowingstatement,byRabbi AbrahamAdleroftheKashrusandMedicinesInformationService,helpfulindeciding whether to have the vaccine or not: It should be noted that according to Jewish laws,thereisnoproblemwithporcineorotheranimalderivedingredientsinnon oral products. This includes vaccines, including those administered via the nose, injections,suppositories,creamsandointments. Patientswhoareunsurewhethertohavethevaccineornotarerecommendedto consultwiththeirlocalrabbiforfurtheradviceorguidance. Muslim TheBritishMuslimCouncilhasbeenconsultedbyPublicHealthEngland(PHE)over this matter. Some individuals in the Muslim community consider that porcine gelatineisforbidden;however,theymaybeabletoacceptmedicinalproductswhich containgelatinewhenthereisnosuitablealternativeandtheproductislifesaving. ThereisnootherlivefluvaccineavailableinEuropethatdoesnotcontainporcine gelatine. PHE and the DH have recommended that for vaccination of healthy children,thereisnosuitablealternativetofluenztetranasalspraysuspension.only children in clinical risk groups, who cannot receive Fluenz Tetra nasal spray suspension,shouldreceivetheinjectableinactivatedvaccine. PHE strongly recommend that children receive the live vaccine Fluenz Tetra nasal spray suspension to give them the best protection against flu and to reduce the spread of flu to more vulnerable people, for example, young infants, pregnant womenandthosewithunderlyingmedicalconditions. Patientswhoareunsurewhethertohavethevaccineornot,arerecommendedto consultwiththeirlocalimamforfurtheradviceorguidance.

8 NPAseasonalfluvaccinationprivatePatientGroupDirectionservice TheNPAprovidesaseasonalfluvaccinationprivatePatientGroupDirection(PGD)serviceaswellas fullandrefreshervaccinationtraining. Thefullvaccinationtrainingprogrammecovers: VaccinationtechniquesforadministeringalltypesofvaccinesincludingIM,intranasal,and SCrouteofadministeringvaccines Basiclifesupportandanaphylaxismanagement PLUSonline(distancelearning)trainingmodulesforthefollowing: 1) Influenza 2) Basiclifesupportandanaphylaxismanagement 3) Vaccinationtechniques Members interested in providing a private PGD service and/or vaccination training can obtain furtherinformationfromthepharmacyservicesteamby: Telephone: consultandtreat@npa.co.uk Professionalindemnityforvaccinationservices NPAprofessionalindemnityinsurancecoversmemberstoprovidePGDservice(privateand/orNHS) whichmayincludevaccinationservices,bothfromtheregisteredpharmacypremisesaswellasfrom offsite providedthatallthepgdandservicerequirementsarefulfilledcorrectly. Itremainsthepersonalandprofessionalresponsibilityofthepharmacist,inallcases,toensurethat theyaretrained,confidentandcompetenttoofferthefluvaccinationservice(nhsand/orprivate) includingmanagementofanaphylaxisandresuscitationtechniques;thepharmacistmustdecidefor themselveswhethertheyshouldundergothefullvaccinationtrainingortheonlinerefresher. NPAresourcestosupportyourfluvaccinationservice(NHSand/orprivate) Fluinformationpack2015/16:vaccineinformation Fluinformationpack2015/16:vaccineorderingandavailability Fluinformationpack2015/16:pharmacystaffguide Chaperonepolicy DealingwithneedlestickinjuriesandbiohazardspillagesSOP HandhygieneSOP VaccinecoldchainSOP TemplatefluserviceSOPtosupportthedeliveryoftheNHSNationalFluVaccination AdvancedServiceforcommunitypharmacists(comingsoon) TheseresourcesareaccessibletodownloadfromtheNPAwebsite:

9 References Contraindicationsandspecialconsiderations:TheGreenBook,Chapter6: considerationsthegreenbookchapter6 DepartmentofHealth(2013)HealthTechnicalMemorandum07 01:Safemanagementof healthcarewaste: healthcarewaste Fluplan:winter2015to2016: GreenBook Immunisationagainstinfectiousdisease: Immunisationprocedures:TheGreenBook,Chapter4: chapter4 Influenzavaccines:2015to2016flu: Influenzavaccineandporcinegelatine: guidanceforhealthprofessionals JCVIstatement: routineannualinfluenzavaccinationprogramme Nationalfluprogrammetrainingslidesetforhealthcareprofessionals: forhealthcareprofessionals NHSpublichealthfunctionsagreement2015to2016: to2016 Protocolforordering,storingandhandlingvaccines: vaccines Storage,distributionanddisposalofvaccines:TheGreenBook,Chapter3: vaccinesthegreenbookchapter3 SummaryofProductCharacteristics: Thenationalfluimmunisationprogramme2015/16: WorldHealthOrganization Influenza: Disclaimer:Theinformationpublishedis,tothebestofourknowledge,correctatthetimeof publication.however,noresponsibilitywillbeacceptedforanyconsequencesofdecisionsmade usingthisinformation.