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Switching factor products: nurses’ experience with NovoEight

Debra Pollard
Debra Pollard
, 
Kate Khair
Kate Khair
 y 
Mike Holland
Mike Holland
   | 17 jun 2020
The Journal of Haemophilia Practice's Cover Image
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Article Category: Clinical Practice
Publicado en línea: 17 jun 2020
Páginas: 59 - 69
DOI: https://doi.org/10.17225/jhp00156
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© 2020 Debra Pollard et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Focusing on the introduction of NovoEight, a survey of haemophilia nurse specialists on their experience of managing factor product switches reveals the hidden workload involved© Shutterstock
Focusing on the introduction of NovoEight, a survey of haemophilia nurse specialists on their experience of managing factor product switches reveals the hidden workload involved© Shutterstock

Patient selection (‘p’ indicates nurse in a paediatric centre)

NURSEWHO DECIDED ON WHICH PATIENTS TO SWITCH?WHEN DID THE PATIENTS FIRST LEARN THAT THEY WOULD SWITCH?MAIN CRITERIA USED TO SWITCH PATIENTSREASONS FOR NOT SWITCHINGHOW MANY PATIENTS REFUSED TO SWITCH?
HNS1pDoctor/NurseRoutine visitHigh usersInfusion volumeBreakthrough bleedsPresence of an inhibitor0
HNS2pMDTRoutine visitProduct withdrawalConsistency across regionHigh usersPresence of an inhibitorCommunication difficulties0
HNS3MDTRoutine visitHigh usersProduct withdrawalNone0
HNS4MDTRoutine visitHigh usersProduct withdrawalSwitch to recombinantClinical reasonsHistory of an inhibitorPatient anxiety0
HNS5MDTRoutine visitVolume target (ReFacto FuseNGos patients)New mild and moderate patientsPresence of an inhibitor0
HNS6NurseRoutine visitHigh usersProduct withdrawalNone0
HNS7MDTRoutine visitHigh usersThose pending surgeryPresence of an inhibitorPatient anxiety1 who was new to prophylaxis1 inhibitor concern
HNS8pMDTRoutine visitHigh users<50 exposure daysThose pending surgeryPresence of an inhibitor2 inhibitor concern
HNS9Doctor/NurseRoutine visitHigh usersProduct withdrawalPatients who had switched too often2 inhibitor concern
HNS10MDTLetter (unless due in clinic)Product withdrawalLeast switched patientsSiblings<50 exposure daysThose pending surgeryPresence of an inhibitorCommunication difficulties0
HNS11NurseLetter/phone callHigh usersPresence of an inhibitor0
HNS12DoctorRoutine visitProduct withdrawalThose coming off study drugsPresence of an inhibitor0

Workload associated with switching

NUMBER OF PATIENTS SWITCHEDWAS A PK ASSESSMENT UNDERTAKEN?HOW WERE TROUGH VALUES POST-SWITCH?WERE PRE-AND POST-SWITCH INHIBITOR SCREENS UNDERTAKEN?WHO MANAGED THE WORKLOAD?PROCESS FOR USING UP PREVIOUS PRODUCTOVERALL ASSESSMENT OF WORKLOAD (ALL ACTIVITY)
HNS1p30NurseData ManagerAssessed by phoneMinimal (low patient numbers)
HNS2p3On 1 patientComparableUsual 6 monthsNurseInstruct patientMinimal (low numbers)
HNS315On 1 patientImprovedUsual 6 monthsNurseData Manager1 day per week for 4 months
HNS4300Usual 6 monthsNurseInstruct patient1 day followed by bulk switch
HNS560Only for severe patientsNurseData ManagerMinimal if well planned
HNS6~100Usual 6 monthsNurseData Manager1–2 days
HNS7~400Usual 6 monthsNurseData ManagerTrust3–4 days
HNS8p100Usual 6 monthsNurseHome delivery companyMinimal (absorbed into general workload)
HNS918Only where practicalComparablePrior to switch and FUNurseData ManagerSubstantial but absorbed into general workload across the team
HNS1080Usual 6 monthsNurseData ManagerTrust and Haemtrack3 days
HNS11~200Usual 6 monthsNurse
HNS12~25YesComparable6–12 dosesDoctorNurseData ManagerTrust2–3 days

Practical guide to switching factor concentrate post-tender

TENDER OUTCOME1 DECEMBER 2017PRODUCTS AND VOLUMES ESTABLISHED NATIONALLY.ENSURE CENTRE AND REGIONAL ALLOCATION ARE KNOWN.ESTABLISH A TIMELINE FOR ACHIEVING THE CENTRE’S ALLOCATED VOLUMES
Staff PreparationKnowledge of productsLiaise with laboratory to ensure assay implications are assessed and safeKnow data requirements for selecting patients and ongoing monitoring of product useObtain supply of reconstitution device demo kits and patient product informationNotify home delivery companies as soon as possible that there will be product change
CommunicationPatients/ParentsDiscuss upcoming tender at clinic appointments and prepare for the possibility of switching productsExplain that whilst inhibitor risk used to be a concern with product switching, the experience since the first national tender in 2004, and internationally where switching is more routine, has revealed no evidence of increased risk following a switch.Terms such as “different brand” can be useful in explaining the difference between products. Some patients will be aware that many drugs are produced by more than one pharmaceutical company and have different branding. The brand is changed from time to time if the NHS can get a better price.Consider a letter to all patients on home treatment about the tender, raising the possibility that they may be asked to switch. This can help to raise awareness that the tenders happen regularly and, if not on this occasion, you may be required to switch another time.A telephone consultation may be appropriate for some patients who are selected to switch. This may be all that is needed if they are familiar with the reconstitution device. Discuss running down stock of current product and managing transition to the new.Patients/parents should be advised to finish their supply of existing product before starting the new one – and not to mix brands togetherRemind to choose the right product name when entering data onto HaemtrackCentres who use Partnership Agreements – consider changing product information to generic recombinant factor VIII or IX
Pharmacy/Blood BankEnsure new product entered onto their systemsLiaise re. adjusting stock levels
Home Delivery CompanyAs soon as the Centre is aware, inform about product changes. Limit deliveries to no more than 4 weeks’ supply. If within their service specification with the Centre, they may be requested to assist with home stock check.
Key Care PersonnelInform those involved in the individual's care about change of product, e.g. shared care centres, local hospital, GP, residential care.Ensure all staff involved in administering clotting factor concentrate know how to safely and efficiently reconstitute and administer product, e.g. on-call doctors, ward or A&E staff.Educational materials should be available e.g. where products are stored, on hospital intranet, given to staff at handover alongside any product.
Selecting PatientsDraw up list of potential patients to switchExamine product use of individuals on home treatment/high users over at least a year, adjusting for those who have had surgeryAim to keep household members on same productInclude patients who are currently:

Highusers

On a product that will no longer be available e.g. Helixate

On a plasma-derived product and due to switch to recombinant

 Review list with MDTConsider any reasons for reluctance to switch e.g.

Pendingsurgery

Under 50 exposure days

Children and parents new to managing home treatment

Likely anxiety e.g. extreme worry about treatment safety and the consequences of changing treatment – often with family history of transfusion transmitted disease or inhibitors.

Communication issues e.g. learning difficulties, language

Agree list of propose patientsAs an MDT decide on a consistent approach to patients who may decline switch.
Managing StockHospitalPlan for transitionReview stock levels and revise re-order levelsLiaise with local network hospitals re revision of their stock holding
Home TreatmentStock check existing product – patient/home delivery.company – and plan to run down supplyChange prescriptions for home delivery
Post-SwitchDataReview trends in individual use – Haemtrack validationReview overall volumes used monthly – at 3 months consider if further patients need to switch to make target volumes
Clinical MonitoringEncourage patients to ring Centre with concernsRespond to any unexpected factor response results, reports of any adverse events or perceived lack of efficacy. Report any confirmed adverse events including lack of efficacy on HCIS &/or EUHASS.Inhibitor screen/PK if indicatedOtherwise no extra measures beyond standard clinical care are recommended by UKHCDO
eISSN:
2055-3390
Idioma:
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Calendario de la edición:
Volume Open
Temas de la revista:
Medicine, Basic Medical Science, other, Clinical Medicine, Pharmacy, Pharmacology
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