SHARED CARE GUIDELINE For

Transcription

1 SHARED CARE GUIDELINE Fr Lithium therapy Implementatin Date: Review Date: This guidance has been prepared and apprved fr use within Gateshead, Suth Tyneside and Sunderland in cnsultatin with Primary and Secndary Care Trusts and Lcal Medical Cmmittees. The guideline sets ut the details f the transfer f prescribing and respective respnsibilities f GPs and specialist services within shared care prescribing arrangements. It is intended t prvide sufficient infrmatin t allw GPs t prescribe these treatments within a shared care setting Further cpies are available frm Lynn Dbsn SOTW Medicines Management Team Sunderland Teaching Primary Care Trust Lftus Huse Clima Avenue Sunderland Enterprise Park Sunderland Tyne & Wear SR5 3XB Tel: Lynn.Dbsn@stw.nhs.uk Apprved by: Cmmittee NHS Suth f Tyne & Wear Date

2 Lithium Preparatins: Lithium shuld be prescribed by brand and frm because f the differences in biavailability between the prducts. Nt all preparatins are biequivalent; care must be taken t make sure that the patient receives the same preparatin each time a new prescriptin is supplied. Changing the preparatin requires the same precautins as initiatin f treatment. Lithium Carbnate Tablets Lithium Citrate Liquid Brand name Tablet Strength Amunt f lithium Brand name Liquid strength Amunt f lithium Priadel 200mg MR 5.4mml/200mg Priadel 520mg/5ml 5.4mml/5ml (scred) 400mg MR (scred) 10.8mml/400mg Camclit 250 Camclit mg (scred) 400mg MR 6.8mml/250mg Li-liquid 509mg/5ml 1.018g/5ml 5.4mml/5ml 10.8mml/5ml Lisknum (scred) 10.8mml/400mg 450mg MR (scred) Lithium citrate liquid shuld be given TWICE DAILY. Nte differences in amunt f lithium (mml lithium) between tablets and liquid. i.e. between lithium carbnate and lithium citrate; lithium carbnate 200mg lithium citrate 509mg Cnditins(s) t be treated prphylaxis in biplar disrder treatment-resistant depressin (lithium used in additin t an antidepressant) management f acute manic r hypmanic episdes Aim f treatment T shw a psitive respnse t the patient s mental health. This will be achieved by maintaining lithium levels within the therapeutic range and mnitring therapy t minimise ptential harm. cntrl f aggressive behaviur r intentinal self harm Patients excluded frm shared care Eligibility criteria fr shared care Initiatin Duratin f treatment Dsage and lithium levels. Unstable disease state. Patients wh refuse t accept the NPSA lithium infrmatin pack. Dse stable and ptimal serum lithium range determined. The specialist team will initiate, mnitr and regularly review the patient s therapy until the ptimum dse and serum lithium cncentratin have been determined Fr as lng as benefit is maintained. The specialist team will be respnsible fr treatment discntinuatin. Patients are usually started n lithium carbnate MR at a dse f mg daily. Fr elderly patients half t a quarter f this dse is ften used. The dse is titrated t achieve a therapeutic serum level, usually mml/L. In biplar disrder aim fr mml/l nrmally, r mml/l if the patient has relapsed previusly n lithium r has sub-syndrmal symptms. Smetimes lwer levels f the range are used fr resistant depressin and Page 2

3 ccasinally belw the lwer therapeutic level are used fr elderly patients. It is imprtant t determine the ptimum range fr each patient. Initially lithium levels need t be measured weekly until a stable therapeutic level is achieved then every ne t tw mnths fr 6 mnths and every three mnths thereafter. Usual Dse Range Maximum Dse Cst (Drug Tariff January 2011) Adverse effects (Side effects may be shrt term and are ften dse dependent. They may be prevented r relieved by a mderate reductin in dse.) Signs f serius txicity NB May ccur at nrmal levels Cnditins that affect Lithium Levels Cntra-indicatins Renal impairment and liver disease Pregnancy and breast feeding Mnitring Bld levels shuld be taken 12 hurs pst dse althugh in practice hurs (preferably 12-14hurs) between the dsage and the sample is acceptable as lng as the interval is specified fr each measurement and is cnsistent. 200mg 1200mg at night Guided by serum lithium cncentratin The brands f lithium tablets range frm arund 2.30 t 4.80 per 100 tablets The brands f lithium liquid are apprximately 5.80 fr 150ml Fr full prescribing infrmatin n Lithium, please refer t the Summary f Prduct Characteristics available frm the electrnic medicines cmpendium at: Mild gastrintestinal effects, particularly nausea, vertig, muscle weakness can ccur initially but frequently disappear after stabilisatin. Fine hand tremrs, plyuria and mild thirst may persist. Refer back t the hspital if severe. Oedema can ccur but shuld nt be treated with diuretics. If severe r persistent, refer back t the hspital specialist. Hypercalcaemia, hypthyridism and abnrmal renal functin tests arise mre cmmnly in patients taking lithium. Weight gain and skin cnditins such as acne and rashes and exacerbatin f psriasis can ccur. Memry Impairment/ slwing and fatigue. Nausea, vmiting, blurred visin, carse tremr, slurred speech, muscle weakness, cnfusin, ECG changes, ataxia, cnvulsins, and drwsiness are signs f lithium txicity. If these ccur, cntact the initiating specialist urgently and cnsider stpping the lithium. If symptms are severe, cnsider referring patient t acute hspital A&E department. Persistent vmiting r diarrhea can lead t salt and water depletin and lithium txicity: Drastic changes in diet: can affect fluid balance and cause serum lithium levels t change. Knwn hypersensitivity t lithium, clinically significant renal disease, untreated hypthyridism, cardiac disease, Addisn s disease r breast feeding Lithium is cntra-indicated in clinically significant renal disease. N dsage adjustment is required in liver disease. Cntact specialist team fr advice. Lithium shuld nly be used during pregnancy when it is cnsidered essential. A decisin shuld be made whether t discntinue lithium therapy r t discntinue breast-feeding, taking int accunt the imprtance f the drug t the mther and the imprtance f breast-feeding t the infant. Lithium has a narrw therapeutic range and regular mnitring (serum lithium levels every 3 mnths, thyrid and renal functin every 6 mnths) as described belw is essential t ensure patient safety. Page 3

4 Specialist Respnsibilities: T assess the patient, establish the diagnsis, perfrm baseline tests (where recent results are nt prvided by the patient s GP) befre lithium initiatin and determine an individual patient management strategy. T initiate, mnitr and regularly review the patient s therapy until the ptimum dse and serum lithium cncentratin have been determined. New patients must be prvided with the NPSA lithium infrmatin pack. Care must be taken that the patient is fully infrmed abut their treatment, drawing specific attentin t the signs f lithium txicity (page 18 imprtant infrmatin fr patients ). The patient must understand what they shuld d if they experience signs f txicity. Particular emphasis shuld als be placed n what can make the level f lithium in my bld t high (page imprtant infrmatin fr patients ). The sectin n taking sme ther medicines mentins befre buying a medicine t treat pain, yu shuld check that it is safe t take with lithium. It des nt specifically mentin the interactin with ibuprfen and this shuld be verbally re-enfrced t the patient. All relevant infrmatin in the lithium therapy recrd bk, imprtant infrmatin fr patients, and lithium alert card must be cmpleted by the initiating prescriber. If the patient refuses t accept the NPSA lithium infrmatin pack, the benefits f the pack shuld be reiterated t the patient. If the patient still declines t use the pack, this fact shuld be cmmunicated t the GP and dcumented in the patient s clinical ntes. Patients wh refuse t accept the NPSA infrmatin pack are nt candidates fr shared care. T request that the patient s GP takes ver prescribing when apprpriate. T prvide the GP with details f the patient s management plan including: Indicatin fr prescribing. The prpsed therapeutic range f serum lithium levels fr that patient. The last recrded lithium, renal and thyrid results. Timing f the next utpatient visit and / r frequency f subsequent fllw-up. Details f the patient s care manager. The brand f lithium used, the strength and dse When the patient received the last supply f treatment When he/she will require the next supply. Details f any ptentially interacting medicatin that the patient is currently prescribed, with further advice if necessary. T be available fr advice if the patient s cnditin changes T ensure that prcedures are in place fr re-assessment. T review the verall management f the patient as necessary and ntify the GP f any changes in therapy that may arise in future. Ntificatin t the GP if the patient des nt attend appintments fr specialist review within 1 mnth, plus specific infrmatin n the planned curse f actin. If the patient refuses t attend their reviews the specialist will cntact the GP t disslve the shared care arrangement. At this pint the GP will n lnger prescribe lithium fr the patient and care fr this indicatin will revert fully t the specialist. Page 4

5 GP Respnsibilities T cntact the specialist immediately and discuss exceptinal cases if he/she is unwilling t accept shared care prescribing. T invite all patients with a histry f enduring serius mental illness t be included n the practice SMI register. Fr patients n SMI registers, t ffer a check f general physical health and the accuracy f prescribed medicatin, including a medicatin review, at least every 12 mnths. Existing patients must be prvided with the NPSA lithium infrmatin pack and any necessary infrmatin updated. Care must be taken that the patient is fully infrmed abut their treatment. T prescribe a length f supply suitable fr the patient, this will usually be up t mnthly repeat prescriptins. In certain circumstances it may be justifiable t cnsider lnger prescriptin lengths prvided it is clinically apprpriate and safe t d s. Prescribers shuld check that bld tests are being mnitred and that it is safe t issue a repeat prescriptin. T mnitr serum lithium levels every 3 mnths. Bld levels shuld be taken 12 hurs pst dse althugh in practice hurs between the dsage and the sample is acceptable as lng as the interval is specified fr each measurement and is cnsistent. It is recmmended that befre rutine mnitring, the ICE system is checked s that tests are nt unnecessarily duplicated. Where it is anticipated the level may be in the txic range (i.e. patients shwing signs f txicity), mark the sample as urgent. Any levels abve 1.0mml/l shuld be telephned thrugh t the prescriber and any apprpriate actin taken within 24 hurs f the sample being taken frm the patient. Nn-urgent lithium levels which are subsequently fund t be in the txic range shuld be telephned thrugh t the prescriber and any apprpriate actin taken within 24 hurs f the result being analysed / phned thrugh. T mnitr thyrid, renal functin (U & Es and serum creatinine and egfr) every 6 mnths and btain apprpriate advice if necessary. All lithium results and any ther apprpriate test results shuld be made available t the relevant specialist if still under their care. NB. All results must als be entered in the lithium therapy recrd bk. It is recmmended that blds fr rutine lithium mnitring shuld nrmally be taken n Mnday t Thursday mrnings. This will give the best chance f cntact with the apprpriate specialist during nrmal wrking hurs in the event f abnrmal results. A rbust recall system must be in place fr anyne wh fails t attend lithium mnitring. If there are any signs f serius lithium txicity (which can ccur at therapeutic levels), t stp lithium immediately (fllwing cnsultatin with the specialist if pssible) and measure lithium levels, urea and electrlytes, and egfr T mnitr medicatin cncrdance T be vigilant fr adverse effects, perfrming additinal tests where clinically relevant (see enclsed lithium infrmatin sheet) T cmmunicate cpies f relevant nn-psychiatric secndary and tertiary care referrals and crrespndence t the Psychiatrist if still under their care. T cntact secndary care when necessary including: -Any spntaneus deteriratin in mental state that cannt be managed by the GP. -Patient experiencing intlerable adverse effects. -Patient has signs f txicity r deteriratin in renal / thyrid functin. -Cncerns abut apparent nn-cncrdance r lack f efficacy. -Unusual prescribing circumstances e.g. pregnancy, initiatin f ptentially interacting medicatin. -Requests t stp lithium. -When cnsidering dse changes -High lithium levels Page 5

6 Cmmunicatins Specialist t GP T request that the patient s GP takes ver prescribing when apprpriate. T prvide the GP with details f the patient s management plan including: Indicatin fr prescribing. The prpsed therapeutic range f serum lithium levels fr that patient. The last recrded lithium, renal and thyrid results. Timing f the next utpatient visit and / r frequency f subsequent fllw-up. Details f the patient s care manager. The brand f lithium used, the strength and dse When the patient received the last supply f treatment When he/she will require the next supply Details f any ptentially interacting medicatin that the patient is currently, with further advice if necessary. T ntify the GP f any changes in therapy that may arise in future. Ntificatin t the GP if the patient des nt attend appintments fr specialist review within 1 mnth, plus specific infrmatin n the planned curse f actin If the patient declines t use the NPSA lithium infrmatin pack, this fact shuld be cmmunicated t the GP and dcumented in the patient s clinical ntes. Bth the specialist and the GP must ensure that systems are in place t ensure the safe prescribing and mnitring f lithium in such cases. GP t Specialist If unwilling t accept shared care prescribing. lithium results and any ther apprpriate test results shuld be made available t the relevant specialist if still under their care. T cmmunicate cpies f relevant nn-psychiatric secndary and tertiary care referrals and crrespndence t the Psychiatrist if still under their care. Cntact details Specialist: T cntact secndary care when necessary including: -Any spntaneus deteriratin in mental state that cannt be managed by the GP. -Patient experiencing intlerable adverse effects. -Patient has signs f txicity r deteriratin in renal / thyrid functin. -Cncerns abut apparent nn-cncrdance r lack f efficacy. -Unusual prescribing circumstances e.g. pregnancy, initiatin f ptentially interacting medicatin. -Requests t stp lithium. -When cnsidering dse changes -High lithium levels Agreed Date Expiry date Page 6

7 Fr full prescribing infrmatin n lithium, please refer t the Summary f Prduct Characteristics available frm the electrnic medicines cmpendium at: Prescribing Ntes Preparatins Lithium shuld be prescribed by brand and frm because f the differences in biavailability between the prducts. The brand shuld be stated in bth the lithium therapy recrd bk and n the lithium alert card. Nt all preparatins are biequivalent, care must be taken t make sure that the patient receives the same preparatin each time a new prescriptin is supplied. The manufacturers recmmendatins vary slightly fr each brand hwever the infrmatin in this guideline is cnsidered t be best practice. Pharmaclgy The mechanism f actin f lithium is unknwn. It is thught that lithium may affect inic channels r the sertinergic system. Serum Levels The dse is titrated t achieve a therapeutic serum level, usually mml/L. In biplar disrder aim fr mml/l nrmally, r mml/l if the patient has relapsed previusly n lithium r has sub-syndrmal symptms. Smetimes lwer levels f the range are used fr resistant depressin and ccasinally belw the lwer therapeutic level are used fr elderly patients. Initially lithium levels need t be measured weekly until a stable therapeutic level is achieved then every ne t tw mnths fr 6 mnths and every three mnths thereafter. Bld levels shuld be taken 12 hurs pst dse althugh in practice hurs between the dsage and the sample is acceptable as lng as the interval is specified fr each measurement and is cnsistent. Thyrid Functin Lng-term lithium therapy can cause hypthyridism r hyperthyridism. Hypthyridism is the mst cmmn and can be treated with levthyrxine (wmen are at a greater risk). Thyrid functin shuld be checked every 6 mnths. If hyper r hypthyridism is suspected then TFTs need t be mnitred mre frequently as the thyrid dysfunctin can reslve spntaneusly. Managing Serum Lithium Levels (always check that the time at which the bld sample was taken is apprpriate.) If the level is lw (typically < 0.4 mml/l) Patient is well and levels are cnsistently lw but within the desired specified range fr that patient d nt alter dse. If the patient s cnditin is nt well cntrlled and the pattern f lithium levels has been brdering n the lwer end f the range Assess medicatin cncrdance Increase dse if apprpriate, but nly after discussin with specialist. Recheck levels in 5 days If the lw level is incnsistent with the trend i.e. a ne ff : Assess cncrdance Page 7

8 Cnsider ther factrs e.g. drug interactins, excess fluid intake, brand change Recheck the level If the level is within therapeutic range (typically mml/l) If the patient is well and tlerating lithium d nthing If the patient is well but cmplaining f side effects e.g. plydipsia, plyuria, liaise with the psychiatrist t cnsider reducing the dse and check if there has been:- A change in diet e.g. salt restrictin r crash diets can cause bld lithium t rise. Initiatin f interacting medicines by dctr r use f OTC prducts If the patient is clinically unwell liaise further with psychiatrist. If the level is high ( > 1.00 mml/l), but with n signs f txicity, same day actin is required. If there is an explanatin fr the high level e.g. dehydratin, timing bld sampling fr lithium levels, interacting medicatin, brand change; crrect where pssible and recheck level. If the level is part f a pattern f levels which have brdered n being t high: Decrease the dse, after discussin with specialist Encurage fluids Recheck level in 5 days If there is n clear explanatin fr high levels, liaise with the psychiatrist t cnsider temprary discntinuatin/rechecking the lithium level and investigatin f renal functin If the patient is elderly, liaisn with the psychiatrist shuld be cnsidered t discuss temprarily discntinuing lithium and reducing the maintenance dsage. Signs f Txicity can ccur at nrmal levels. Cnsider stpping lithium immediately. It is imprtant t cnsult with the specialist as sn as pssible, check lithium, serum creatinine U&Es. High Risk Patients Certain high-risk patients may require mre frequent mnitring. These include thse: Over 65 years ld On interacting medicatin (see enclsed infrmatin sheet) With r at risk f renal / thyrid / cardiac disease. Page 8

9 Lithium interactins with ther medicines 1.1 Because f lithium s relatively narrw therapeutic range, interactins with ther drugs can be very imprtant. Prescribers must have a system fr checking, identifying and acting n any cncurrent medicatins that may interact with lithium. It is gd practice t check the BNF fr interactin ptential when a new medicine is cmmenced fr a patient stabilised n lithium. 1.2 In rder t minimise ptential txic effects f lithium interactins prescribers shuld ensure that patients are aware f pssible signs and symptms indicating a txic lithium level. 1.3 The mst prblematic interactins with ther medicines include Thiazide diuretics ACE inhibitrs eg ramipril, lisinpril Nn-steridal anti-inflammatry drugs (NSAIDs) Up t 4 fld increases in lithium plasma level may ccur. Hwever the effect is variable and cannt be predicted. Ideally cmbinatins f lithium with these medicatins shuld be avided. Hwever if this is nt pssible then lithium levels shuld be clsely mnitred. The lithium dse in patients stabilised n lithium may need t be reduced in anticipatin f an interactin hwever this will depend n individual patients: their clinical cnditin and whether lithium levels are already near r at the tp f the desired therapeutic range. NSAIDs are f particular cncern because these may be btained by the patient withut prescriptin (eg ibuprfen). Patients shuld be advised t chse alternative painkillers (paracetaml is a suitable first line alternative); and that the interactin risk can still ccur with ccasinal use f NSAIDs. 1.4 Other medicines may increase lithium levels. Evidence f interactin is restricted t case reprts. Increased lithium level mnitring is recmmended fr: Angitensin II receptr antagnists eg candesartan, lsartan Antibacterials eg metrnidazle, tetracyclines, c-trimxazle Diuretics eg lp, triamterene, spirnlactne Methyldpa 1.5 Medicines may als lwer lithium levels the mst imprtant nes being: Xanthines eg aminphylline, thephylline Sdium cntaining drugs eg antacids, urinary alkalinisers Acetazlamide lithium levels shuld be clsely mnitred. The lithium dse may need t be increased 1.6 Medicatins may interact by increasing the txic effects f lithium withut a change in plasma level. These include Amidarne Antiepileptics eg carbamazepine, phenytin, tpiramate Antipsychtics eg clzapine, flupentixl, lanzapine, halperidl, phenthiazines, sulpiride, zuclpenthixl Calcium channel blckers eg verapamil, diltiazem, nifedipine Antidepressants eg SSRIs, venlafaxine, tricyclics 1.7 A detailed summary f pssible interactins which may ccur with lithium are listed in the fllwing table: Page 9

10 These medicines can cause clinically significant increases in lithium levels. Evidence f interactin is well dcumented. Cncurrent use is nt recmmended. Drug Imprtance Cmment ACE inhibitrs Thiazide diuretics Nn-steridal antiinflammatry drugs NSAIDs Nt clinically imprtant in every patient Can get up t 4-fld increases in plasma lithium levels. Increase in lithium level can ccur ver several weeks Nt clinically imprtant in every patient Can get up t 4-fld increases in plasma lithium levels Increase in lithium level usually apparent in the first 10 days Nt clinically imprtant in every patient Increase in lithium level may develp after a few days r up t several mnths Resulting effect can vary frm 10% t > 4- fld increase in plasma lithium level. Page 10 Cncurrent use nly with cautin and clse mnitring. Avid if pssible. This is an established well-dcumented and ptentially serius interactin. Avid if pssible. Other diuretics may be safer. Cnsider a lithium dse reductin Patients taking lithium shuld be warned nt t take ver-the-cunter NSAIDs (eg ibuprfen). Prescribing NSAIDs shuld be avided if pssible These medicines can cause clinically significant interactins with lithium in sme patients. Cautin and clse mnitring is recmmended. Drug Imprtance Cmment Amidarne Increased risk f hypthyridism Increased mnitring f thyrid functin. Aminphylline /thephylline Angitensin II receptr antagnists Antibacterials: (Metrnidazle/ tetracyclines/ c-trimxazle) Antiepileptics: (carbamazepine, phenytin tpiramate) Antipsychtics: (clzapine, flupentixl, lanzapine, halperidl, phenthiazines, sulpiride, zuclpenthixl) Ca channel blckers: (verapamil, diltiazem, nifedipine) Diuretics: (lp, triamterene, acetazlamide spirnnlactne) Antidepressants: (SSRIs, venlafaxine, tricyclics) Methyldpa Sdium cntaining medicines: (antacids, urinary alkalinisers) Reduced plasma cncentratin f lithium by apprx % Case reprts f increase in plasma levels. Case reprts f increase in plasma levels +/r lithium txicity Case reprts f neurtxicity (withut increase in lithium plasma level). Interactin less well established with phenytin & tpiramate. Case reprts f increased risk f EPSEs and pssibly neurtxicity Case reprts f neurtxicity (withut increase in lithium plasma level). Case reprts f decrease in plasma levels with acetazlamide Case reprts f increased plasma levels and txicity with lp diurestics, triamterene and spirnlactne Case reprts f symptms f sertnin syndrme with SSRIs and venlafaxine Case reprts f neurtxicity, sertnin syndrme and neurleptic malignant syndrme with tricyclics Case reprts f increase in plasma levels +/r lithium txicity Excessive sdium intake assciated with reduced plasma cncentratin f lithium Increased mnitring f plasma levels with cncurrent use Increased mnitring f plasma levels with cncurrent use, particularly during the first cuple f mnths. Increased mnitring with cncurrent use In sme cases ther factrs assciated with infectin eg fever, pr fluid intake may have cntributed t txicity. Mnitr cncurrent use fr signs f neurtxicity. Mnitr cncurrent use fr signs f neurtxicity Mnitr cncurrent use fr signs f neurtxicity Cnsidered t be safer in cmbinatin with lithium than thiazide diuretics (see table abve) hwever increased mnitring f plasma levels is advised with cncurrent use Mnitr cncurrent use fr signs f neurtxicity References: British Natinal Frmulary 59 March 2010 Stckley s Drug Interactins [nline] Pharmaceutical Press (medicinescmplete.cm accessed ) Increased mnitring with cncurrent use Antacids cntaining aluminium/magnesium hydrxide are a safer alternative

11 Appendix 2 Shared Care Request Frm Sectin 1 Cnsultant Cnsultant t cmplete FIRST SECTION f frm GP t cmplete SECOND sectin and RETURN t Secndary Care Trust Clinician Team Hspital address Cntact Phne Number Patient s name Address This patient is stabilised n Dse Prescriptin fr 28 days supply given n Cmpliance aid YES/NO Mnitred by Designated cmmunity pharmacy Their treatment has been explained t them and a review has been arranged fr.. Appintments t cntinue every mnths

12 Sectin 2 Patient s name Address I ACCEPT the prpsed Shared Care Agreement fr this patient t start I d NOT ACCEPT the prpsed Shared-Care Agreement fr this patient My reasns fr nt accepting: Please cmplete this sectin Signed date.. Please return t the Secndary Care Trust Clinician team at : Page 12