BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE. RHEUMATOLOGY SHARED CARE GUIDELINE for DMARDs

Transcription

1 BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE RHEUMATOLOGY SHARED CARE GUIDELINE fr DMARDs There are currently 6 Disease-mdifying anti rheumatic drugs (DMARDs) in rutine use by the Lutn & Dunstable NHS Trust and Bedfrd Hspital Rheumatlgy Departments. Methtrexate (ral r Subcutaneus injectin) Sulfasalazine Leflunmide Azathiprine Mycphenlate Hydrxychlrquine Overarching Principles f Shared Care Guidelines The intrductin f these shared care guidelines fr cmmnly used DMARDs facilitates the fllwing aspects f patient care: Patients can be seen and initiated n the mst apprpriate DMARD treatment regimen under the care f a Rheumatlgy Specialist team. The nging rutine prescribing and bld test mnitring can be taken ver by the patient s wn GP (at a mutually acceptable time as agreed between the GP and the Specialist - typically smewhere between 4 and 12 weeks after treatment started, depending n lcal GP practice preference). GPs can cntact the Rheumatlgy Specialist team directly fr advice and supprt n an nging basis. Patients will cntinue t be reviewed by the Rheumatlgy Specialist team at scheduled ut-patient appintments (frequency will vary n an individual basis). T initiate shared care: All shared care arrangements rely upn clear cmmunicatin between the Specialist, GP and the individual patient and / r their carer. A member f the Specialist Rheumatlgy team shuld cntact the patient s GP and discuss the cncept f shared care at the pint f initiatin f DMARD therapy. If a GP is nt able t participate fully with the shared care agreement, they are under n bligatin t d s. In such an event, the ttal clinical respnsibility fr the patient fr the diagnsed rheumatlgical cnditin will remain with the Specialist team.

2 Timing f Implementatin f Shared care arrangements: Due t practical reasns, there is currently a difference in practise between BCCG and LCCG as t when GPs will cnsider accepting prescribing and bld test mnitring respnsibilities fr DMARDs. Lcal arrangements are: BCCG GPs can cnsider accepting prescribing and bld test mnitring respnsibility under shared care arrangement frm week 4 nwards (NB: This may be prir t the patient being treated with a stable dse f the chsen DMARD). LCCG GPs can cnsider accepting prescribing and bld test mnitring respnsibility under shared care arrangement nly when the patient has reached a stable maintenance dse. (NB: The time t reach a stable dse will vary depending n the DMARD chsen and individual patient factrs.) Bld Test Mnitring and Prescribing f DMARDs by GPs As part f the shared care agreement, the GP as the prescribing clinician is respnsible fr the drug and the cnsequences f its use. The GP is therefre respnsible fr checking the bld test results PRIOR t the issue f a prescriptin f the specific DMARD. (This includes checking the bld test results even if the bld tests are requested by the Specialist at any pint). In situatins when bld tests are rdered by the Specialist, the Specialist must ensure that a cpy f the results are sent t the GP (either electrnically r paper cpy) in a timely manner t enable the GP t check the results prir t issuing a prescriptin. Frequency f Bld Test Mnitring: The British Rheumatlgy Sciety (BSR) have published a guideline:- Guidelines fr diseasemdifying anti-rheumatic drug (DMARD) therapy (2017) utlining the frequency f bld test mnitring. The BSR guidelines have in general, adpted a harmnised apprach acrss the 6 DMARDs (where pssible) in rder t standardise the frequency f bld test mnitring. Details f frequency are specified in Appendix 1. NB: Patients are ften prescribed mre than ne DMARD e.g. methtrexate and sulfasalazine. In general, mnitring f patients n mre than ne DMARD shuld be based n the DMARD which requires the mst frequent mnitring. Individual Respnsibilities: Hspital Specialist Team At Initiatin f therapy phase Cntact the GP t request share care. Infrm GP that a cpy f the Rheumatlgy Shared care guideline plus the relevant DMARD drug Prescribing infrmatin sheet are dwnladable frm the GP Ref website. Cnfirm diagnsis and indicatin fr drug treatment. Assess the patient fr any c-mrbidities, including evaluatin fr respiratry disease and screening fr ccult viral infectin e.g. varicella, when chsing the mst apprpriate DMARD therapy. Discuss ptential benefits and side-effects f treatment with patient. Explain the bld test mnitring schedule and the imprtance f attending fr regular bld tests t the patient. Carry ut baseline mnitring requirements. Send a cpy f the baseline test results t the GP fr infrmatin (electrnically r paper cpy as apprpriate).

3 Hspital Specialist Team At Initiatin f therapy phase cnt. Prvide patients with the relevant advice relating t the particular DMARD(s) being initiated e.g. cntraceptin / varicella- zster immunity / alchl cnsumptin / cyttxic waste dispsal. Advise patient t infrm all healthcare prfessinals (e.g. GPs, A&E clinicians, cmmunity pharmacists) that they are taking DMARD therapy and that regular bld test mnitring is being undertaken. Advise patient t shw a cpy f the mst recent clinic letter cntaining details f their current dse t the cmmunity pharmacist when presenting a prescriptin fr DMARD therapy. Prvide patient with any relevant patient infrmatin leaflet(s) fr example: Natinal patient Safety agency (NPSA) patient infrmatin leaflet Arthritis Research UK patient infrmatin leaflet In-huse develped patient infrmatin leaflet (if applicable) Prvide patient with a patient-held mnitring & dsage recrd bklet (NPSA bklet r lcally agreed equivalent bklet) and prvide replacement bklets when required (if applicable.) NB: It has been agreed lcally that bld tests d nt need t be written in a patient-held mnitring bklet as bld test results can be accessed electrnically by lcal GPs and the Specialist Rheumatlgy Team If electrnic access is nt available, a decisin as t whether t recrd the results in the patient bklet shuld be agreed between the Specialist team/ the GP and the patient n an individual basis. Check fr pssible drug interactins with existing medicatin, befre initiating DMARD therapy. (Refer t individual SPCs / electrnic BNF) Pssible drug interactins shuld als be checked if prescribing any new medicatins r when stpping any cncurrent medicatins at any pint. Ensure that the hspital pharmacy cmputer sftware has the latest cmputer sftware updates relevant t the chsen DMARD, e.g. methtrexate alerts and prmpts. (as per NPSA advice) Initiate DMARD therapy and prescribe until the shared care agreement begins (this typically invlves the Specialist prviding the first 6 t 12 weeks (depending n BCCG LCCG cmmissining psitin) supply f medicatin and then, the GP taking ver bth prescribing and bld test mnitring respnsibilities). The initial prescriptin issued by the Specialist team shuld be fr a 6 week supply f medicatin, and any subsequent prescriptins shuld be fr a maximum f a 4 week supply at a time. Infrm the GP f the prescriptin details i.e. dse and frequency. Aviding phrases such as as directed Infrm the GP if the patient is receiving any additinal immunsuppressants r bilgic drugs and the GP shuld ensure that this infrmatin is added t the patient s medical recrd. Ensure that patient/ carer is trained in the administratin and dispsal f subcutaneus methtrexate (if applicable). Infrm the patient t reprt any side-effects t the Specialist r GP (Clinicians shuld refer t the individual drug Summary f Characteristics (SPCs) and current electrnic BNF fr full details f side effects). Bld Test Mnitring (See Summary f Bld Test mnitring schedule fr the different DMARDs Appendix 1) If the GP agrees t share care frm week 4 : Specialist shuld infrm patient that they will require regular bld tests whilst taking DMARD therapy. Specialist shuld prvide an initial prescriptin fr the first 6 weeks f therapy and issue the patient with 2 bld test frms (ne fr blds at week 2 and ne fr blds at week 4). Specialist t check the bld test results at week 2: If satisfactry, Specialist t advise patient t have a repeat bld test at week 4 and explain that the GP will take ver and that the GP shuld check the week 4 bld test results. If the week 4 results are satisfactry, the GP will then cntinue t prescribe and mnitr bld tests in the lng term as per the bld test schedule (appendix 1). Advise the patient that subsequent bld test mnitring frms shuld be btained frm their GP practice. If the GP agrees t share care frm when the patient is n a stable dse (typically frm arund 12 weeks): Specialist shuld infrm patient that they will require regular bld tests whilst taking DMARD therapy. Specialist shuld prvide prescriptins fr the DMARD medicatin until shared care with the GP is implemented. Specialist t issue bld test frms and t check the results fr the duratin f time until the GP agrees t share care. Once shared care is implemented, the GP will then cntinue t prescribe and mnitr bld tests in the lng term as per the bld test schedule (appendix 1). Advise the patient that subsequent bld test mnitring frms shuld be btained frm their GP.

4 Shared care Respnsibilities: Shared care can cmmence anytime frm 4 weeks after DMARD therapy has been initiated by the Specialist Team. (exact timing will vary depending n individual GP practises). Specialist Rheumatlgy Team GP Cnfirm that the GP will take ver the prescribing and bld test mnitring frm week 4 (r at ther time as agreed with GP). Infrm the GP f the frequency f bld tests that are required. (See Summary f bld test mnitring schedule Appendix 1) Agree hw the bld test results shuld be cmmunicated between the Specialist team and the GP (i.e. electrnically r paper cpy), ensuring that bld test results can be accessed in a timely manner by bth parties. Mnitr the patient s verall health and well-being. Update the patient s medical recrd t reflect the results f immunity screening and any vaccinatins given prir t DMARD therapy. Ensure that the patient s medical recrd is updated if the patients is als being prescribed an additinal immunsuppressant r bilgic agent by the Specialist Rheumatlgy team (as these are ften slely prescribed by secndary care clinicians). Prvide GP with advice n actin required in the event f abnrmal bld results / side effects when requested by the GP. NB: If a clinically urgent bld test abnrmality/ side effect ccurs, the Specialist Rheumatlgy Team shuld prvide advice within ne wrking day. NB: When advising the GP n a plan f actin t be taken, ensure that the length f time that will elapse befre the patient can be reviewed in the Specialist clinic is cmmunicated with the GP. Agree t take ver Prescribing fr the specified DMARD at an agreed date (can be anytime frm week 4 as per agreement). (NB: GPs shuld nte that sme patients, in particular thse cmmenced n methtrexate may nt yet be n a stable maintenance dse by week 4. In such cases, the Specialist team will prvide the GP with written details f the dse escalatin schedule.) Arrange t review the patient at Out-Patients as apprpriate Mnitr the patient s respnse t therapy. Infrm the GP f any changes made t the dsage / rute f administratin etc. At the agreed date (can be anytime frm week 4), agree t take ver bld test mnitring respnsibility at the specified frequency as directed by the Specialist team. (See Summary f bld test mnitring schedule Appendix 1) Mnitr the patient fr any side-effects t the specified DMARD therapy and infrm the GP if any ccur. Reprt any serius side-effects t the MHRA. (Refer t individual SPCs / electrnic BNF fr full details n side effects.) Check fr pssible drug interactins when prescribing any new medicatins r when stpping any cncurrent medicatins. (Refer t individual SPCs/ electrnic BNF) Ensure that the GP practice (and dispensaries, if a dispensing practice) cmputer sftware has the latest sftware updates relevant t the chsen DMARD, e.g. methtrexate alerts & prmpts. (as per NPSA advice) Decide when t stp therapy and infrm bth the patient and the GP. Mnitr the patient fr any side-effects t the specific DMARD therapy and refer back t the Specialist shuld any serius side-effect ccur. Reprt side effects t MHRA if apprpriate. (Refer t individual SPCs/ electrnic BNF fr full details n side effects.) Bld Tests : Reiterate the imprtance f attending fr regular bld test mnitring t the patient. Advise patients t attend fr a bld test apprximately. ne week befre their next prescriptin is due t ensure that the results can be reviewed befre the next prescriptin is requested fr issue. Ensure that bld test results are taken at the required frequency AND check the results prir t the issue f a subsequent prescriptin. (See Summary table f bld test mnitring frequency, Appendix 1 and individual drug prescribing infrmatin sheets)

5 Specialist Rheumatlgy Team GP Bld Tests: Cntinued Seek advice frm the Specialist as t whether mre frequent bld tests are required e.g. fllwing any dse adjustments, in certain patient grups e.g. thse with renal impairment, thse n mre than ne DMARD. Recrd bld test results in the GP medical recrd. Send a cpy f the bld tests t the Specialist fr infrmatin unless previusly agreed electrnic access is available. NB The Specialist will nt rutinely review the bld test results - this prcess is t allw the Specialist t review bld test results in the event when a GP cntacts them fr advice and als when reviewing the patient in utpatient clinic. Refer any patient wh fails t attend fr regular bld test mnitring back t the Specialist team. Cntact the Specialist fr advice with regards any actin that shuld be taken in the event f abnrmal bld results / side effects. NB: If a clinically urgent abnrmality, the Specialist Rheumatlgy Team shuld prvide advice within ne wrking day. Subsequent Prescriptins: Prvide subsequent prescriptins and ensure that repeat prescriptins requests fr all DMARDs (with the exceptin f Hydrxychlrquine) are retained separately fr prescriber review prir t authrisatin as they are regarded as high risk drugs which require a review f bld test results by the GP prir t issuing f a prescriptin. Prvide a maximum f 4 weeks supply at a time. This is applicable t all DMARDs. When prescribing methtrexate tablets, nly prescribe the 2.5mg strength tablets. (This has been agreed lcally as a way t reduce cnfusin and t reduce the risk f dispensing errrs.) Prescribe any cncmitant medicatin as specified by the Specialist (if applicable) e.g. fr patients n methtrexate, prescribe flic acid as directed by the Specialist team. Re-iterate any relevant advice e.g. infrmatin with regards cntraceptin / varicella zster immunity / alchl / waste dispsal - see the individual drug Prescribing drug infrmatin sheets (Appendix 2). Discuss drug therapy and management plan f any pregnant patients/any patients cnsidering pregnancy r anyne wishing t breastfeed with the Specialist Rheumatlgy team. Infectins Initiate prmpt anti-infectin treatment when indicated n the basis that the patient may be immunsuppressed t sme degree. During a serius infectin, DMARD therapy (except Hydrxychlrquine) shuld be temprarily discntinued until the patient has recvered frm the infectin. NB Serius infectin = warrants admissin t hspital r requires parenteral antimicrbial therapy. Fr patients wh are nn--immune and expsed t measles r chickenpx, cntact the Specialist Rheumatlgy team asap fr cnsideratin f apprpriate immunglbulin therapy. If patient cntracts chickenpx r shingles, cntact Specialist and treat with acyclvir.

6 Patient Respnsibilities Cmmunity Pharmacist Respnsibilities Discuss ptential benefits and side-effects f treatment with the Specialist and GP and share any cncerns they have in relatin t their treatment. Reprt any side-effects t the Specialist r GP. Reprt immediately, any breathlessness, dry cugh, whites f eyes becming yellw, severe itching f skin, rash, dark urine, infectins (including fever, chills r severe sre thrats), new unexplained bleeding r bruising, muth ulcers, vmiting and diarrhea (particularly if ccurs at the start f treatment, r if it is severe, at any stage in treatment). Be familiar with side effects and bld test mnitring requirements fr individual DMARDs. (Refer t Individual SpCs / electrnic BNF and Individual Prescribing drug infrmatin sheets.- Appendix 2) Check with patient that a recent bld test has been taken and the results checked by the GP / Specialist team befre dispensing DMARD medicatin. Cntact the prescribing clinician (GP / Specialist) if in any dubt abut the dsage prescribed r if any cncerns relating t bld test mnitring and bld test results Infrm all healthcare prfessinals (e.g. GP s, A&E clinicians, cmmunity pharmacists) that they are taking DMARD therapy and that regular bld test mnitring is being undertaken. Prvide adequate cunselling n the use f the specified DMARD(s). Advise patients t take flic acid as specified by the prescriber ensuring that flic acid is NOT taken n the same day as methtrexate (if applicable). Shw a cpy f the mst recent clinic letter cntaining current prescriptin details e.g. dse and frequency t the cmmunity pharmacist when presenting a prescriptin fr DMARD therapy. Be familiar with the NPSA guidance n methtrexate Participate in the mnitring f therapy (including having bld tests carried ut at agreed intervals) and assessment f utcmes. Ensure that a bld test is taken in advance f running ut f medicatin t allw time fr the results t cme back. Patients wh are nn-immune t measles and r varicella-zster shuld ntify GP and / r Specialist f any inadvertent expsure t a persn with measles / chicken px s that passive immunity can be given with the apprpriate immunglbulin therapy. T acknwledge advice given e.g. regarding cntraceptin, alchl, varicella, cyttxic waste dispsal. T use adequate cntraceptin and reprt any suspected pregnancy t the GP / Specialist Team. T infrm GP / Specialist f all medicines (including OTC preparatins) currently being taken. T fllw cyttxic waste dispsal prcedure as advised by Specialist team (if applicable)

7 BACK-UP ADVICE AND SUPPORT GP queries shuld be directed t the Rheumatlgy cnsultants. Patient queries shuld be directed t the Rheumatlgy Specialist Nurses All urgent requests shuld be answered within ne wrking day. CONTACT DETAILS The Lutn & Dunstable Hspital Cnsultants Dr Daniel Fishman, Dr Muhammed Nisar, Dr Tanya Baqai Dr Balaji Ramabhadran, Dr Vanessa Quick, Dr Marian Chan Tel: / Fax: Specialist Nurses Nicki Wd, Julie Begum, Sue O Cnnr : Nurse Advice Line: Bedfrd Hspital Cnsultants : Dr S Rae Specialist Nurse Marice Lenard Dr Eirini Giavri Nurse Advice Line : Dr M Wajed Tel: Tel: Secretary Fax: Written : Octber 2016 Updated : September 2018 Review date: September 2020

8 Appendix 1 Summary f Bld Mnitring Schedule fr DMARDs (Reference: The bld test schedule is based n current clinical practise and the BSR Guidelines - Guidelines fr disease-mdifying anti-rheumatic drug (DMARD) therapy (2017). Bld Tests required each time : FBC, creatinine/calculated GFR, ALT and/r AST and albumin DMARD (Single drug) Methtrexate (MTX) Azathiprine (AZA) Leflunmide (LEF) Bld Test Mnitring Schedule every 2 weeks until n a stable dse fr 6 weeks, then mnthly bld tests fr 3 mnths then every 12 weeks* lnger-term *Mre frequent mnitring is apprpriate fr patients at a higher risk f txicity. Sulfasalazine (SSZ) every 2 weeks until n a stable dse fr 6 weeks, then mnthly bld tests fr 3 mnths then every 12 weeks.* Other Mnitring Leflunmide Mnitr BP and weight at each mnitring visit. Azathiprine Assess baseline Thipurine methyltransferase (TPMT) status. *Mre frequent mnitring is apprpriate fr patients at a higher risk f txicity. Rutine bld test mnitring is nly required fr the first 12 mnths f therapy, after which time n rutine mnitring is needed. Mycphenlate (MMF) every 2 weeks until n a stable dse fr 6 weeks, then mnthly bld tests fr 3 mnths then every 12 weeks* lnger-term *Mre frequent mnitring is apprpriate fr patients at a higher risk f txicity. Hydrxychlrquine (HCQ) Cmbinatin therapy Leflunmide and Methtrexate (LEF/MTX) N rutine labratry mnitring required. every 2 weeks until n a stable dse fr 6 weeks, then mnthly bld tests lnger- term* Baseline frmal phthalmic examinatin (ideally including bjective retinal assessment e.g. using ptical cherence tmgraphy (OCT), within ne year f starting therapy. Annual eye assessment (ideally including OCT) if cntinued fr > 5 yrs. *Mre frequent mnitring is apprpriate fr patients at a higher risk f txicity. Patients wh have been stable fr 12 mnths can be reviewed by the Specialist team and cnsidered fr reduced frequency f mnitring n an individual basis. Other cmbinatins Mnitring f patients n mre than ne DMARD shuld be based n the DMARD which requires the mst frequent mnitring. Please nte : Fr all DMARDs : If the dse is increased at any time, bld test mnitring shuld increase t every 2 weeks until n a stable dse fr 6 weeks then mnthly fr 3 mnths, then revert back t previus schedule (as specified abve). *Mre frequent mnitring is apprpriate fr patients at a higher risk f txicity.

9 Appendix 2 Prescribing Infrmatin sheets fr GPs: Cntents: Methtrexate (ral r Subcutaneus injectin) (Fr patients under the care f the Lutn & Dunstable hspital nly) Methtrexate (ral r Subcutaneus injectin) (Fr patients under the care f Bedfrd Hspital nly) Sulfasalazine Leflunmide Azathiprine Mycphenlate Hydrxychlrquine