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Care Homes Independent PharmacistPrescribing Study (CHIPPS):Experiencesfrom non-randomised feasibility StudyChristine Bondon behalf of CHIPPS teamChief Investigator:David Wright UEA

Background Medicines use in care homes is suboptimal One person should assume overall responsibility formedicines management Pharmacist independent prescribing (PIP) provides anopportunity for pharmacists to assume this role National programmes investing in increased pharmacistroles Evidence needed to develop services1/22/20182

CHIPPS programme: AimTo develop and deliver a cluster randomisedcontrolled trial to assess the effectiveness and costeffectiveness of pharmacist independentprescribers (PIPs) assuming responsibility formedicines management within care homescompared to usual care31/22/20183

CHIPPS overviewWP1: Systematic Review (SR) of evidence on medicineoptimisation, stakeholder views, service spec.WP2:Identification and evaluation of potential out comemeasuresWP3: Development of Health Economic approachesWP4: Develop and test trainingWP5: Non‐randomised feasibility studyWP6: RCT with internal pilot1/22/20184

Objectives of feasibilitystudy test and refine servicespecification (developed inprevious work packages) test feasibility of data collection assess service and researchacceptability via a qualitativeprocess evaluation evaluate potential outcomemeasures estimate the size of eligiblepopulation explore recruitment andretention assess participation and followup rates1/22/2018and identify reasons for missingdata determine suitability ofoutcome measures used tomeasure resource use in a carehome setting assess appropriateness of PIPtraining package5

PIP role Optimise (doses,monitoring) Repeat prescriptions Maintain records Initiate Rx for minor ailments PharmaceuticalCare Plan Care homestaff Assess andaddress need Processes formedicines22 January, 2018MedicationreviewPrescribingTraining andsupportCommunication Care homes GP practice Communitypharmacy6

MethodGP/PIPFoursitesCH (s)10residents22 January, 20187

MethodGP/PIPFoursitesCH (s)10residents Registered PIP Trained and competent 16 hours per month Working with GP 65 years and older At least one regular med. Not end of life3 month intervention22 January, 20188

Results ‐ Patient recruitmentAssessed for eligibility (n 127)Norfolk ‐ 35, Belfast ‐ 18, Grampian ‐ 48, Leeds ‐ 2636 (28%) residents excluded[7 (5.5% by GP) and 29 (22.8%) did not meet inclusioncriteria]91 (71.7%) residents approached[33 (36.3%) declined, 5 (5.5%) were not contacted]53 ( 58.2% ) agreed13 ( 24.5% ) on waiting listRecruited (n 40)Norfolk ‐ 10, Belfast ‐ 10, Grampian ‐ 10, Leeds ‐ 10Followed‐up (n 40; 100%)Lost to follow ‐up (n 0; 0%)1/22/20189

PIP ActivitiesGPpracticeCarehomePIP22 January, 201810

PIP ActivitiesPractice meetingsMed. ReconciliationGPpracticeCare planningRepeat RxMonitoringReferralPIP22 January, 201811

PIP ActivitiesMed.reconciliationMed. managementMedicine roundsMedicine relatedissuesCare homeTrainingMet residents andrelatives to discussgeneral health andmeds.22 January, 2018PIP12

Quantitative data22 January, 201813

Case Study – Male 89 yearsMedication atbaseline Risperidone 1mg bd Mirtazapine 30mg nocte Memantidine 10mg nocte Paracetamol 1g qds prn Diazepam 5mg prn Ranitidine 150mg bd Lamotrigine 25mg mane 50mgnocte Nebivolol 2.5mg od Lactulose 10ml odPIP intervention Staged reduction ofrisperidone to250mcg bd Reduced diazepam to2mg bd prn Stopped ranitidineand started Peptac10mls qds prn Started Vitamin D odOutcome measures EQ‐5D (proxy) BL 0.666, VAS 45% FU 0.788, VAS 80% MMSE BL unable to complete FU 15/30 Falls BL 2 FU 0 Drug Burden Index BL 1.97, FU 1.171/22/201814

Qualitative outcomesInterviewsGP, CH manager and staff, Patients/relatives, PIP Overall very positive Few changes suggestedFocus groups PIP Service pressures impacting on time to meet care home staff Pharmaceutical Care Plans were time consuming Difficulty meeting GP (CCG employed pharmacist) Suggested time insufficient (20 hours cf 16 hours per month)1/22/201815

What interviewees saidthe pharmacist was able tospend more time with theresident looking at themedications, speaking tothe staff who knew theresidents really well andgetting a detailed historywhich we know the GPshaven’t got the time to do(CHMan)the nurses would give youthe impression that theydon’t want any changes butwhen you chat to them (thepatient/rel.) they were happyto stop things (Ph)1/22/2018I think you know overall it just hadled to better patient care, bettermedicines management you knowfor those patients and nursinghomes.(GP)they’ve got their fingers on the pulseof the medicines that’s coming outand everything like that and the GP seesthat many people that he wouldn’t knowwhat to give ya. (Pt.)16

In conclusion PIPs were valued Existing working relationship with GP important Patient outcomes show trend to improvementResearch programme has systematically informed changes to service specification confirmed design of definitive RCT identified optimal outcome measures provided foundation for health economic assessment provided reassurance that trial is feasible17

CHIPPS Research teamhttps://www.uea.ac.uk/chippsD. WrightR. HollandD.P. AlldredA. ArthurG. BartonA. BlythC. BondA. Daffu‐O’ReillyJ. DesboroughJ. FordC. HandfordH. HillC. HughesJ. InchL. IrvineV. MaskreyK. MasseyM. SpargoP. MyintN. NorrisF. NotmanF. PolandL. ShepstoneI. SmallAM. SwartC. SymmsD. TurnerJ. WilliamsA. ZermanskyProfessor of Pharmacy Practice, University of East AngliaHead of Medical School and Professor of Public Health Medicine, University of LeicesterAssociate Professor of Pharmacy Practice, University of LeedsProfessor of Nursing Science, University of East AngliaProfessor of Health Economics, University of East AngliaResearch Fellow, University of East AngliaProfessor of Primary Care, University of AberdeenResearch Fellow, University of LeedsSenior Lecturer in Pharmacy Practice, University of East AngliaConsultant in Older Peoples' Medicine, NNUH NHS Foundation TrustPublic and Patient Involvement in Research, Norfolk and SuffolkConsultant, Director Healthcare Homes, EssexProfessor of Primary Care Pharmacy, Queens UniversityResearch Fellow, University of AberdeenResearch Fellow in Health Economics, University of East AngliaResearch Fellow, University of East AngliaPublic and Patient Involvement in Research, Norfolk and SuffolkResearch Fellow, Queen’s University BelfastProfessor of Old Age Medicine, University of AberdeenProfessor of Education, University of East AngliaResearch Fellow, University of AberdeenProfessor of Social Research Methodology, University of East AngliaProfessor of Medical Statistics, University of East AngliaDeputy Head of Prescribing Pharmaceutical Medicine, NHS Commissioning BoardProfessor of Medicine and Epidemiology, Director Norwich CTU, University of East AngliaSponsor’s Representative, Norfolk & Suffolk Primary and Community Care Research Office, NHS South Norfolk Clinical Commissioning Group, NorfolkSenior Research Fellow Health Economics, University of East AngliaClinical Trial Manager, Norwich CTU, University of East AngliaGP and Visiting Honorary Senior Research Fellow, University of Leeds

AcknowledgementThis presentation summarises independent research fundedby the National Institute for Health Research (NIHR) underits Programme Grants for Applied Research Programme(Grant Reference Number RP‐PG‐0613‐20007) ( 2M over 5years ). The views expressed are those of the author(s) andnot necessarily those of the NHS, the NIHR or theDepartment of Health.The CHIPPS Research team acknowledges the support of theNational Institute of Health Research Clinical ResearchNetwork (NIHR CRN) and Chief Pharmaceutical Officers forNHS England, NHS Scotland, NHS Northern Ireland1/22/201819

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Care home staffI think the pharmacist was ableto spend more time with us andthe resident looking at themedications that they were on,speaking to the staff who knewthe residents really well andgetting a detailed history whichunfortunately we know the GPshaven’t got the time to do (CHMAN)The pharmacist doesn’tknow her history, thepharmacist doesn’t and Isaid but there will be atime, yes she may alwayshave to remain on sometype of antipsychotic dose .(CHMAN)1/22/2018I’ve been struggling withgetting the monthly scriptand the systems the cyclesalready started . this iswhat the care homes need(CHN) .we’ve been looking atsomebody who we wantsome pain relief, it didn’tarrive, it was supposed toarrive on Friday .butone word from XXXX (PIP)and there it is. CHMan22

GPs.I think pharmacists areincreasingly a crucial resourcewithin primary care and therehave been moves over the lastcouple of years to bring in morepharmacists to GP practices on afull time basis.because XXXX (PIP) is going in and dealingwith maybe some of the issues that wewould have dealt with in the past, thatthere’s the potential that you see yourpatients less and you have less of a closerelationship with some patients in thenursing homes so that would be apotential negative going forward1/22/2018so we see it as a very positivething. XXX (PIP) brings a lot ofknowledge and time‐efficiency tous and we work I guess side byside is the best way to put it.I think you know overall it just hadled to better patient care, bettermedicines management you knowfor those patients and nursinghomes.23

Pharmaciststhe nurses would give youthe impression that theydon’t want any changes butwhen you chat to them (thepatient/rel.) they were happyto stop thingseverybody is getting themonitoring but they don’t doanything with theresults .the one on lithiumthat was not in range was abig one for me1/22/2018 and I think that’s fine ifyou have a good workingrelationship with that GPpractice .I’ve made a point oftalking to the HCA you getan awful lot of valuableinformation particularlythings to do withconstipation nurses saythey have terribleconstipation but HCA showsyou the records that say no24

Patients and relativesSo, what do you think about having apharmacist in a care home? yeah, it’s a good idea do you think so, why do you think it’s a goodidea?Well then the people can get individualmedicines what they need. do you think there’s a greater benefit of likechatting to a pharmacist compared to a GP?Yeah they’ve got their fingers on the pulse ofthe medicines that’s coming out and everythinglike that and the GP sees that many people thathe wouldn’t know what to give ya.So when the GP comes to see you do you evertalk about your medicines or anything like that?I never see a GP. (Patient)1/22/2018Sometimes I find whenyou go through GPs ittakes much longer if, youknow, if you ask them toreduce something, thetime then they pass iton. I found with Clare,after her phone call, it’simplemented straightaway, you know, there’sno hanging around,which is good, I like that.Can’t think of much else,that’s about all, really(Relative)25

Quantitative outcomesOutcome measureBaselineFollow upFalls13/30 (43%)6/30 (20%)ADRs0/30 (0%)0/30 (0%)MMSE mean & SD20.21 [SD 7.55] (n 14/30)20.91 [SD 6.4] (n 12/28)Barthel mean & SD7.30 [SD 5.9]7.07 [SD 5.9]Drug Burden Index mean & SD0.92 [SD 0.84]0.805 [SD 0.74]Number of STOPP incidences139 (n 29)83 (n 28)Number of START incidences80 (n 29)58 (n 28)EQ‐5D‐5L Mobility31EQ‐5D‐5L Self‐Care32EQ‐5D‐5L Usual Activities32EQ‐5D‐5L Pain/ Discomfort22EQ‐5D‐5L Anxiety/ Depression220.6660.761EQ‐5D‐5L Index22 January, 201826

Results – PatientCharacteristicsCharacteristicMale10/30 (33.3%)Age mean85 years (SD 6.6)Age range67‐96 yearsNursing/ Residential22 (73%) nursing8 (27%) ResidentialNo.meds. per patientMean 9.1 (Range 1‐22)1/22/201827

Patients and relativesSo, what do you think about having apharmacist in a care home? yeah, it’s a good idea do you think so, why do you think it’s a goodidea?Well then the people can get individualmedicines what they need. do you think there’s a greater benefit of likechatting to a pharmacist compared to a GP?Yeah they’ve got their fingers on the pulse ofthe medicines that’s coming out and everythinglike that and the GP sees that many people thathe wouldn’t know what to give ya.So when the GP comes to see you do you evertalk about your medicines or anything like that?I never see a GP. (Patient)1/22/2018Sometimes I find whenyou go through GPs ittakes much longer if, youknow, if you ask them toreduce something, thetime then they pass iton. I found with Clare,after her phone call, it’simplemented straightaway, you know, there’sno hanging around,which is good, I like that.Can’t think of much else,that’s about all, really(Relative)28

PIP role 22 January, 2018 6 Care homes GP practice Community pharmacy Care home staff Assess and address need Processes for medicines Optimise (doses, monitoring) Repeat prescriptions Maintain records Initiate Rx for minor ailments Pharmaceutical