Lithium continuing care guideline summary (refer to full guidelines for further information)

Transcription

1 Lithium continuing care guideline summary (refer to full guidelines for further information) Formulary status YELLOW: Specialist initiation with GPs continuing care once patients are on a stable dose Lithium Initiated by Secondary Care (Mental Health) Lithium must be prescribed by brand due to its narrow therapeutic index and the difference in bioavailability between the brands. Brand of choice is Priadel Indications include: mania, prophylaxis of bipolar disorder, treatment-resistant depression Check patient has been given a copy of the Lithium Booklet. Monitoring Required - Secondary Care (Mental Health) Baseline egfr, thyroid function (TSH) tests, calcium, bodyweight, height, pulse, blood pressure and ECG if indicated. Exclude pregnancy. Discuss adequate contraception, if relevant. Check Lithium levels 5-7 days after initiation and repeat weekly until stable (sample taken hours post-dose). Once stable, monitor levels every 3 months in first year, then every 6 months. Recheck levels 7 days after dose changes and weekly until stable. STABLE MENTAL HEALTH Prescribing will only be transferred when the consultant and GP are in agreement that the patient s condition is stable Transfer to Primary Care The psychiatrist will send the GP a link to NEP Continuing Care Guidelines within a copy of the patient s care plan including diagnosis, current test results, list of concomitant medication and professional healthcare contact details. The brand, form, strength and dosage of lithium must be clearly stated on any correspondence. To ensure both the GP and psychiatrist receive a copy of any blood test results the name and address of both parties should be specified on the sample forms. Monitoring Required - Primary Care Check serum lithium levels every 3 months in first year, then every 6 months (more frequently if patient is physically unwell, taking interacting medications) Check egfr, TSH, calcium, weight every 6 months (more frequently if clinically indicated). Check FBC and assess cardiac function if clinically indicated. An annual health check should also include blood (plasma) glucose, lipid profile, cardiovascular (including BP and pulse), liver function, diet, level of physical activity, smoking / alcohol and contraceptive advice (if relevant). Lithium doses may need to be altered to maintain a level within the target range mmol/l (sample taken hours post-dose). Individual patients may have a target level just below ( mmol/l) or just above ( mmol/l) refer to guideline. Recheck levels 7 days after dose changes and weekly until stable. If lithium toxicity is suspected or level >1.5mmol/l STOP lithium immediately and assess patient. Repeat serum lithium, U&Es and creatinine levels and seek hospital advice. Levels >2.0mmol/l consider referral to A&E. Circumstances in which patients may be referred back to secondary care or secondary care (mental health) advice sought: Problematic side effects, including signs of toxicity (ataxia, tremor, cognitive impairment) Deteriorating renal, thyroid function or hypercalcaemia Deterioration of mental state, or where level of risk to self or others is increased Pregnancy Erratic / non-compliance or patient request to discontinue lithium Advice on drug interactions To consider the appropriateness of continuing / stopping lithium in people who have been stable for the last 4-5 years

2 POLICY DOCUMENT Document Title Continuing Care Guideline for Lithium Therapy Reference Number Policy Type Continuing Care Guidelines Electronic File / Location Intranep Location N:\Pharmacy\Intranet ared%20care.aspx Status FINAL Version No / Date Version 2.0 June 2016 Author(s) Responsible for Writing and Monitoring Dr R Gupta, Consultant Psychiatrist R Parekh, AD for Pharmacy C Banham, Pharmacy Manager J Dattani, Lead Pharmacist for Mid Essex Approved By and Date Medicines Management Group, July 2016 Implementation Date 6 July 2016 Review Date 6 July 2019 Copyright North Essex Partnership University NHS Foundation Trust (2016). All rights reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. All matters or concerns regarding fraud or corruption should be reported to: Chris Rising, Senior Manager (chris.rising@bakertilly.co.uk ), Mark Kidd (mark.kidd@rsmuk.com), Mark Trevallion, LCFS Lead (mark.trevallion@bakertilly.co.uk ) or the National Fraud and Corruption Line on Lithium continuning care guidelinesgui201608v1.0final Page 2 of 19

3 CONTENTS Item No Item Page No 1 Introduction 3 2 Aim 3 3 Scope 4 4 Reference to other standards, policies or procedures 4 5 Responsibilities Consultant 5 & General Practitioner 6 & Patient / Carer 8 6 Procedure Indications and licensing Administration Brand prescribing 8 & Monitoring standards Monitoring guidance 10 & 11 7 Prescribing in specialist groups Pregnancy Children Elderly Renal impairment 13 & 14 8 Side effects Toxicity 14 & Cautions Interactions Contraindications 15 & 16 7 Summary of Changes 16 APPENDICES App. No Appendix Page No 1 Lithium monitoring form 17 2 Initial letter to GP 18 3 Second letter to GP to start continuing care 19 4 NEP Algorithm for Prescribing & monitoring Calcium 20 Lithium continuning care guidelinesgui201608v1.0final Page 3 of 19

4 CONTINUING CARE GUIDELINE PROCESS FOR LITHIUM 1. INTRODUCTION This is a document that provides information allowing patients to be managed safely across primary care, secondary care and across the interface. It is a partnership /agreement between Secondary care, Primary care and the patient which sets out responsibilities for each party. The patients should be clearly explained about the intentions for shared care and should give their agreement. There should be good communication and cooperation between the parties involved in ensuring patient safety and management. The doctor who is prescribing the medication should have clinical responsibility for the drug and the consequence of its use. 2. AIM The aims and objectives of these continuing care guidelines are to ensure that lithium therapy is initiated, prescribed, dispensed and monitored appropriately and according to the National Patient Safety Alert (NPSA) guidelines and NICE guidance. This is to ensure that patients on lithium therapy are managed safely across the interface of primary and secondary care. Arrangements should be put in place to ensure that: 1. Patients who are prescribed lithium are monitored in accordance with NICE guidance 2. There are reliable systems to ensure blood test results are communicated between laboratories and prescribers 3. At the start of lithium therapy and throughout their treatment patients receive appropriate on-going verbal and written information and a record book to track lithium blood levels and relevant clinical tests. 4. Prescribers and pharmacists (hospital and community) check that blood tests are monitored regularly and that it is safe to issue a repeat prescription and/or dispense the prescribed lithium. 5. Systems are in place to identify and deal with medicines that might adversely interact with lithium therapy. 3. SCOPE All practitioners within NEP and third parties dealing with Lithium therapy in respect to NEP patients. Lithium continuning care guidelinesgui201608v1.0final Page 4 of 19

5 4. REFERENCES TO OTHER STANDARDS, POLICIES OR PROCEDURES NICE guidance on Bipolar Affective disorder [Nice Guidance CG185 published in Sept 2014] NICE guidance on Antenatal and Postnatal mental health [Nice Guidance CG192 published in December 2014] The Maudsley Prescribing Guidelines.12th edition. British National Formulary. Close monitoring of patients prescribed Lithium NSPA Dec Lithium monitoring app, available on the App Store. 5. RESPONSIBILITIES 5.1 Initiation of Lithium Therapy - Consultants Responsibilities Lithium therapy will usually be initiated by a consultant psychiatrist. A GP may consider restarting lithium (preferably in consultation with a psychiatrist) for the same diagnosis if the patient has previously benefited but has relapsed since discontinuation. Baseline investigation will be undertaken before initiating lithium (Table 1). A lithium monitoring book will be provided containing a lithium alert card complete with relevant details e.g. baseline checks, current dose, target lithium level. Appropriate on-going verbal and written information will be provided to the patient. Clinicians are to update the lithium monitoring booklet where appropriate. It must be ensured that the first blood test is done and checked. Monitoring of side effects is to be agreed by both parties. A comprehensive referral letter to the GP is to be provided also indicating when the patient should be referred back to the consultant (see Appendices 1 and 2). Conditions of assuming responsibility by the GP agreed and a continuing care document is to be sent. Patients on CPA (Care Programme Approach) should remain with Secondary Care unless agreed by GP and stated on the CPA. Both parties should ensure that results are shared by both sectors and means of doing this should be agreed. Criteria for transferring prescribing and/or discharging to GP Prescribing responsibility will only be transferred when the consultant and the GP are in agreement that the patient s condition is stable or predictable. The patients will only be referred to the GP once the GP has agreed each individual case and the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined below. Lithium continuning care guidelinesgui201608v1.0final Page 5 of 19

6 The hospital will provide the patient with a minimum initial supply of 2 weeks therapy on discharge. Areas of responsibility In general the various responsibilities will be shared as outlined below, but for an individual patient there may be some variation in the detail (e.g. on who does which blood tests) but this must be clearly agreed between the consultant and the GP. It should be clearly explained to patients about the intentions for continuing care and their consent given. There should be good communication and cooperation between the parties involved to ensure patients are safely managed. All patients to have been counselled and have an up to date lithium monitoring book. All patients will continue with hospital prescribing until the patient has stable dose and only routine monitoring required (Table 1). The consultant/specialist will send a full referral letter giving details of patient s response to therapy. The letter will list any drugs or investigations recommended by the consultant and previous test results. The consultant will request that the GP consider taking over the monitoring requirements as per continuing care guidelines, which is considered safer than splitting the prescribing and monitoring across care sectors. The patient will continue to be monitored until deemed stable to be discharged from mental health services. 5.2 Lithium Therapy - General Practitioner Responsibilities Reply to the request for continuing care within 2 weeks and clarify with the hospital specialist who is to take responsibility for issuing the blood tests and monitoring. Whoever issues the blood requests must act upon the results. Ensure patient brings their monitoring book with them, whenever requesting a further supply of lithium. Check lithium dose and blood results prior to deciding if safe to continue to prescribe. Update patient s monitoring book where appropriate. Check with the relevant pathology lab if patient has been tested but no results are available. Prescribe lithium by brand. Ensure patient understands that branded product is lithium. Use of phrases such as 'as directed' should be avoided and should state specific instructions, for example, take one tablet (400mg) at night. Lithium continuning care guidelinesgui201608v1.0final Page 6 of 19

7 Prescriptions are recommended to be provided as acute prescription or with appropriate safeguarding. Where repeat prescriptions are necessary, it is recommended that 28-day prescription is adopted unless not deemed appropriate. Ensure patients are aware of their blood testing requirements. Measure lithium plasma levels every 3 months (see below for further information regarding lithium levels) and check they are within desired therapeutic range as advised by the consultant. Samples should be taken 12 hours post dose (trough). Patients should be encouraged to know acceptable levels and their most recent results. Respond to out of range results as outlined in the guidance. Measure thyroid function and renal function every 6 months. Provide appropriate on-going verbal and written information to patient. Monitor for drug interactions. Monitor for side-effects or adverse effects as specified later. Perform/request additional tests and investigations during maintenance therapy if abnormal results obtained or as stated by the consultant. Consider referral back to consultants for review of stable patients on lithium for 3 years. Lithium patients discharged from Mental Health Services can be referred urgently to the Access and Assessment teams /Community Mental Health Teams. Response to results: If Lithium levels are above or below the range, confirm with patients the timing of the blood test and adherence with lithium. Lithium levels below the range should be discussed with the specialist services contact and consideration given to increasing the dosage. Levels above the range should also be discussed urgently with the specialist service contact and consideration given to referring patients to A&E or stopping the lithium for a period of time and restarting at a lower dose once the lithium level is within the normal range. All lithium levels above the range should be rechecked urgently and consider urgent medical review. Review patient and look for signs of toxicity and side-effects. The patient lithium monitoring booklet must be updated at each visit. If the hospital has the monitoring responsibility, the hospital is responsible for contacting the patient if any action is required. If the GP has the monitoring responsibility, the GP is responsible for contacting the patient if any action is required. Lithium continuning care guidelinesgui201608v1.0final Page 7 of 19

8 5.3 Patient/ Carer Responsibilities Report any adverse effects to their GP and/or specialist. Ensure that they have a clear understanding of their treatment. Report any changes in disease symptoms to GP and/or specialist. Alert GP and/or specialist of any changes of circumstance which could affect management of disease e.g. plans for pregnancy. Take/ administer the medication as prescribed. Undertake any monitoring as requested by the GP and/or specialist. Ensure that their monitoring booklet is kept up to date and taken to all appointments. Inform their GP in sufficient time to obtain repeat prescriptions. Keep monitoring booklet safe and bring to hospital/gp appointments. Show monitoring booklet to pharmacist when collecting medication. 6. PROCEDURE 6.1 Indications and Licensing Management of acute mania or hypomanic episodes. Management of refractory depressive disorders where Lithium is used for augmentation of antidepressants. Prophylaxis of Bipolar Affective disorder. 6.2 Administration The usual starting dose is 400mg at night (200mg in the elderly). Once daily dosing at night is preferred due to monitoring of plasma lithium levels. The dose of lithium is adjusted to achieve a lithium concentration of 0.4-1mmol/litre. 6.3 Brand Prescribing Lithium should be prescribed by brand name because of its narrow therapeutic range and difference in product bioavailability. Not all products are modified release (MR). The brand Priadel is recommended within NEP and is available as 200mg and 400mg tablets. Priadel contains lithium carbonate and are scored tablets which can be halved. Particular care is needed with Priadel 520mg / 5ml Lithium continuning care guidelinesgui201608v1.0final Page 8 of 19

9 sugar free liquid, which actually contains lithium citrate where 5ml = 200mg lithium carbonate (=5.4mmol Lithium). Using a single brand (Priadel) throughout the locality should help to reduce medication errors. Camcolit tablets are film coated immediate release. (Note from 1 st October 2015 Camcolit 250mg tablets changed name to Lithium Carbonate Essential Pharma 250mg film-coated tablets. The name of Camcolit 400mg modified release tablets remains unchanged). Care should be taken, including additional monitoring, when changing brands for formulations. Tablets contain lithium carbonate 200mg lithium citrate 520mg. 6.4 Monitoring Standards When starting lithium Advise patients that poor adherence or rapid discontinuation may increase risk of relapse. Ensure that the patient is given appropriate information on taking lithium safely, including monitoring booklet which is to be requested and issued from NEP Pharmacy with the medication. Establish a continuing care arrangement with the patient s GP for prescribing and monitoring adverse effects. When stopping lithium Gradually reduce the dose over at least 4 weeks and preferably up to 3 months, even if the person has started taking another anti-manic drug. During dose reduction and for 3 months after stopping Lithium, monitor closely for early signs of mania or depression. 6.5 Monitoring Guidance The safe and effective use of lithium requires regular general physical monitoring (see Table 1) and lithium levels (see Table 2). Table 1 - General Checks Lithium continuning care guidelinesgui201608v1.0final Page 9 of 19

10 Checks Baseline (Pre- Treatment) After Treatment Commenced Weight / BMI Every 6 months Urea & Electrolytes Every 6 months (more frequent in renal impairment see below) egfr Every 6 months (more frequent in renal impairment - egfr<50ml/min) Calcium Every 6 months (more frequent if raised) Thyroid Functions Every 6 months (more frequent if impairment) FBC Every 6 months ECG People with cardiovascular risk factors. Repeat only if appropriate. Pulse Annual Blood pressure Annual Table 2 Lithium Checks Blood samples for lithium levels should be taken hours (ideally 12 hours) post dose. For patients on liquid preparations taking it twice daily, patients should be advised to delay the morning dose until after the blood sample and taken 12 hours post the night time dose. Checks Stabilising Treatment Maintenance Lithium Levels 5-7 days after starting GENERAL Lithium continuning care guidelinesgui201608v1.0final Page 10 of 19

11 treatment One week after every dose change Then monitor weekly until dose and level is stable to 4 weeks. Once stable: Every 3 months in first year, then Every 6 months thereafter SPECIAL GROUPS Every 3 months in following groups: 1. Older adults 2. Risk of impaired renal or thyroid function 3. Raised calcium levels 4. Poor symptom control 5. Poor adherence 6. Last plasma level 0.8 mmol /l or higher 7. Taking interacting drugs PREGNANCY (see advice below on prescribing in pregnancy) Every 4 weeks up to 36 weeks of pregnancy then weekly till labour starts. Do not give lithium during labour. After delivery measure levels 12 hours after last dose. Lithium to be given after receipt of blood assay results and dose adjusted according to lithium levels (minimum of 24h after last dose). Target Levels Levels <0.4mmol/l subtherapeutic Aim for 0.6mmol/l-0.8mmol/l (first time treated with lithium) mmol/l previously on lithium who have relapsed 6.6 Lithium Prescribing in Special Groups Pregnancy Do not offer lithium to women who are planning a pregnancy or pregnant, unless antipsychotic medication has not been effective. If antipsychotic medication has not been effective and lithium is offered to a woman who is planning a pregnancy or is pregnant, ensure: Lithium continuning care guidelinesgui201608v1.0final Page 11 of 19

12 The woman knows that there is a risk of foetal heart malformations when lithium is taken in the first trimester, but the size of the risk is uncertain The woman knows that lithium levels may be high in breast milk with a risk of toxicity for the baby Lithium levels are monitored more frequently throughout pregnancy and the postnatal period (see table 2 lithium level monitoring) If a woman taking lithium becomes pregnant, consider stopping the drug gradually over 4 weeks if she is well. Explain to her that: Stopping medication may not remove the risk of foetal heart malformations There is a risk of relapse, particularly in the postnatal period, if she has bipolar disorder. If a woman taking lithium becomes pregnant and is not well or is at high risk of relapse, consider: Switching gradually to an antipsychotic or Stopping lithium and restarting it in the second trimester (if the woman is not planning to breastfeed and her symptoms have responded better to lithium than to other drugs in the past) or Continuing with lithium if she is at high risk of relapse and an antipsychotic is unlikely to be effective. If a woman continues taking lithium during pregnancy: Check plasma lithium levels as above ( Table 2) Adjust the dose to keep plasma lithium levels in the woman's therapeutic range Ensure the woman maintains an adequate fluid balance Ensure the woman gives birth in hospital Ensure monitoring by the obstetric team when labour starts, including checking plasma lithium levels and fluid balance because of the risk of dehydration and lithium toxicity Stop lithium during labour and check plasma lithium levels 12 hours after her last dose. Restart lithium at least 24 hours after last dose and only after reviewing the blood assay results (as dose may need to be readjusted) Children The use in children is not recommended. The decision to give prophylactic lithium requires specialist advice, and must be based on careful consideration of the likelihood of recurrence in the individual child, and the benefit of treatment weighed against the risks. Serum- lithium concentration needs to be monitored and should therefore not be prescribed unless facilities for monitoring serum-lithium concentration are available. Lithium is approved to treat mania in children yrs. However adherence to treatment and regular blood tests may be challenging in adolescents. Although Lithium can be used to treat severe aggressive behaviour in conduct disorder, it is not licensed for this purpose Elderly Patients Elderly patients are particularly liable to lithium toxicity and may exhibit adverse reactions at serum levels ordinarily tolerated by younger patients. Lithium continuning care guidelinesgui201608v1.0final Page 12 of 19

13 Caution is also advised since lithium excretion may be reduced in the elderly due to age related decrease in renal function (see also Renal Impairment section). Elderly patients or those below 50kg in weight, often require lower lithium dosage to achieve therapeutic serum lithium levels and serum concentrations of lithium need to be reduced in the elderly population and particularly so in the very old and frail elderly. The summary of product characteristics (SPC) for Priadel tablets states that for prophylaxis, the dosage needed to reach a blood lithium level of mmol/L is generally in the range 600mg 1200mg/day. Reduced lithium clearance is expected in patients with hypertension, congestive heart failure or renal dysfunction. The most clinically significant pharmacokinetic drug interactions associated with lithium involve drugs which are commonly used in the elderly. Some examples of these are ACE inhibitors, Angiotensin II Receptor Antagonists, diuretics and NSAIDs that can increase serum lithium concentration. Especially troublesome is the interaction between lithium and diuretics as lithium toxicity is made worse by sodium depletion; therefore concurrent use of diuretics (particularly thiazides) is hazardous and should be avoided Renal impairment Since lithium is primarily excreted via the renal route, significant accumulation of lithium may occur in patients with renal insufficiency. Therefore, if patients with mild or moderate renal impairment are being treated with lithium, serum lithium levels should be closely monitored, and the dose should be adjusted accordingly. Renal impairment is classified according to NICE CG182 using egfr and ACR (albumin:creatinine ratio). For further information on this, please see the NICE guideline. As a guide, based on NICE CG182: Mild moderate egfr reduction = ml/min = G3a NICE classification Moderate severe egfr reduction = mol/min = G3b NICE classification A classification of G3 (a or b) is equivalent to the previous CKD 3 classification. If very regular and close monitoring of serum lithium levels and plasma creatinine levels is not possible, lithium should not be prescribed in this population. Lithium is contraindicated in patients with severe renal insufficiency egfr ml/min (G4 NICE classification) Lithium is a nephrotoxic drug and the possibility of hypothyroidism and renal dysfunction arising during prolonged treatment should be borne in mind and periodic assessments made. Patients should be warned to report if polyuria or polydipsia develop. In patients who develop polyuria and/or polydipsia, renal function should be monitored in addition to the routine serum lithium assessment. Cases of Renal tumours; microcysts, oncocytomas and collecting duct renal carcinoma have been reported in patients with severe renal impairment who received lithium for more than 10 years. Acute renal failure has also been reported rarely with lithium toxicity. 6.7 Side Effects of Lithium Most common side effects include fine tremor, stomach upset, polyuria and polydipsia. Other side effects include metallic taste in mouth, weight gain, ankle oedema, hypothyroidism and rashes. Some skin conditions such as psoriasis and acne can be aggravated. Lithium continuning care guidelinesgui201608v1.0final Page 13 of 19

14 6.7.1 Signs of toxicity Toxicity is likely above 1.5mmol/litre, however can occur within range i.e. in the elderly. Symptoms include blurring of vision, anorexia, vomiting, diarrhoea, drowsiness, giddiness, ataxia, coarse tremor and lack of co-ordination, muscle twitching and weakness. At very high levels, above 2 mmol/litre hyper-reflexia, hyperextension of limb, increased disorientation progressing to coma and ultimately death. Monitor for symptoms of neurotoxicity, including paraesthesia, ataxia, tremor and cognitive impairment, which can occur at therapeutic doses. On rare occasions within normal range, symptoms of lithium toxicity can occur. Elderly patients are particularly liable to lithium toxicity. If any of the symptoms are experienced by the patient, then lithium therapy should be stopped immediately and lithium levels checked urgently. Consider urgent medical referral and psychiatric advice, and refer back to consultant psychiatrist Cautions Cautions are vomiting, diarrhoea and inter-current infection (especially if sweating profusely) which may require dose reduction or discontinuation. Elderly patients may exhibit adverse reactions at serum levels ordinarily tolerated by younger patients and lithium excretion may be reduced Interactions Lithium is excreted through the renal route (it is not metabolised). Lithium toxicity is made worse by sodium depletion, therefore concurrent use of diuretics particularly thiazides is hazardous and should be used with caution and monitored appropriately. Interactions which increase lithium concentrations: NSAIDs ACEIs Diuretics Tetracyclines Metronidazole Interactions which may decrease lithium concentrations: Theophylline Sodium bicarbonate containing products Interactions causing neurotoxicity: Antipsychotics Lithium continuning care guidelinesgui201608v1.0final Page 14 of 19

15 SSRIs Carbamazepine Methyldopa If no other alternative can be found and interacting medications are used, then lithium levels need more frequent monitoring (on initiation and discontinuation) Contra-indications / precautions Avoid if there is hypersensitivity to lithium or to any of the excipients. Avoid in patients with low body sodium levels, including for example dehydrated patients or those on low sodium diets. Avoid in patients with cardiac disease or family history of QT prolongation. Avoid in patients with conditions with sodium imbalance such as Addison s disease. Avoid in patients who are breastfeeding. In patients with renal impairment egfr < 50ml/min (avoid if possible or reduce dose and monitor serum-lithium carefully). In patients with untreated hypothyroidism (Patients are to be euthyroid before initiation of lithium therapy) Contact Details NEP Pharmacy Units E & F Chelford Court 37 Robjohns Road Widford Industrial Estate Chelmsford CM1 3AG Tel: (01245) SUMMARY OF CHANGES Date Page No Summary of Changes May 2016 June 2016 All All None new document Formatting changes change of font and presentation, added numbering system and rearranged the order of the document, no changes to content. Lithium continuning care guidelinesgui201608v1.0final Page 15 of 19

16 APPENDIX 1 - LITHIUM MONITORING FORM Dates inc Dose of Lithium Lithium Levels TFT egfr U&E Calcium T4 TSH Ur C N K BMI / Weight Side Effects Lithium continuning care guidelinesgui201608v1.0final Page 16 of 19

17 APPENDIX 2 - INITIAL LETTER [Address] [Date] Dear Dr [Name] Re: Patient: [Drug name] Continuing Care Guidelines [Name, address, Remedy No, NHS No.] I have seen this patient in clinic and believe that [he / she] is suitable for treatment with [drug name]. I have initiated this patient on [drug name, form, dose, frequency] and will be monitoring and prescribing for this patient at our clinics until such time that the patient is deemed stable, which is likely to be in the region of [No.] months. I would like to seek your agreement for you to take over the prescribing and monitoring of this patient s treatment after this stabilisation period as per agreed Continuing Care Guidelines. A copy of these guidelines can be found at Please complete the form below and either fax it back to the safe haven fax number below or scan and it from a secure nhs.net account to our secure nhs.net account below. I thank you in anticipation. Yours sincerely [Name] [Job title] Fax back to: [Name of NEP consultant and safe haven fax no.] [Clinical Commissioning Group and safe haven fax no.] Scan and from [NEP consultant secure nhs.net address] nhs.net to: [Clinical Commissioning Group secure nhs.net address] [*Delete as applicable]: *I agree to take over prescribing and monitoring responsibility for this patient as per Continuing Care Guidelines from such date as the patient is deemed stable. or *I am not willing to undertake continuing care for this patient because [reason]. [Patient name] [NHS No] Yours sincerely, [Dr] [Date] [Practice address] Lithium continuning care guidelinesgui201608v1.0final Page 17 of 19

18 APPENDIX 3 - SECOND LETTER TO START CONTINUING CARE [Address] [Date] Dear Dr [Name] Re: [Drug name] Continuing Care Guidelines Patient: [Name, address, Remedy No, NHS No.] Thank you for agreeing to continuing care for the above named patient as per my initial letter dated [date]. I have been monitoring and prescribing for this patient for [no.] months and the patient is deemed stable as per agreed Continuing Care Guidelines. The patient is doing well and is currently on [details of dosage regimen]. I would like to discharge this patient to you for prescribing and general wellbeing of the patient within the parameters of the Continuing Care Guidelines. I have prescribed for this patient for a further 14 days. Yours sincerely [Name] [Job title] [Contact number] [Care coordinator & contact no.] [Community team & contact no.] Lithium continuning care guidelinesgui201608v1.0final Page 18 of 19

19 APPENDIX 4 NEP ALGORITHM FOR PRESCRIBING & MONITORING LITHIUM Traffic Light Classification YELLOW Lithium Initiated by Secondary Care (Mental Health) Prescribe by Brand Name (usually Priadel ) Indications include: mania, prophylaxis of bipolar disorder, treatment-resistant depression Check patient has been given a copy of the Lithium Booklet. Monitoring Required - Secondary Care (Mental Health) Baseline egfr, thyroid function (TSH) tests, calcium, bodyweight, height, pulse, blood pressure and ECG if indicated. Exclude pregnancy. Discuss adequate contraception, if relevant. Check Lithium levels 5-7 days after initiation and repeat weekly until stable (sample taken hours post-dose). Once stable, monitor levels every 3 months in first year, then every 6 months. Recheck levels 7 days after dose changes and weekly until stable. Patients with bipolar disorder should be advised that erratic compliance / rapid discontinuation of lithium may increase risk of relapse. Stable mental state Prescribing will only be transferred when the consultant and GP are in agreement that the patient s condition is stable. Transfer to Primary Care The psychiatrist will send the GP a link to NEP Continuing Care Guidelines within a copy of the patient s care plan including diagnosis, current test results, list of concomitant medication and professional healthcare contact details. The brand, form, strength and dosage of lithium must be clearly stated on any correspondence. To ensure both the GP and psychiatrist receive a copy of any blood test results the name and address of both parties should be specified on the sample forms. Monitoring Required - Primary Care Check serum lithium levels every 3 months in first year, then every 6 months (more frequently if patient is physically unwell, taking interacting medications) Check egfr, TSH, calcium, weight every 6 months (more frequently if clinically indicated). Check FBC and assess cardiac function if clinically indicated. An annual health check should also include blood (plasma) glucose, lipid profile, cardiovascular (including BP and pulse), liver function, diet, level of physical activity, smoking / alcohol and contraceptive advice (if relevant). Lithium doses may need to be altered to maintain a level within the target range mmol/l (sample taken hours post-dose). Individual patients may have a target level just below ( mmol/l) or just above ( mmol/l) refer to guideline. Recheck levels 7 days after dose changes and weekly until stable. If lithium toxicity is suspected or level >1.5mmol/l STOP lithium immediately and assess patient. Repeat serum lithium, U&Es and creatinine levels and seek hospital advice. Levels >2.0mmol/l consider referral to A&E. Circumstances in which patients may be referred back to secondary care or secondary care (mental health) advice sought: Problematic side effects, including signs of toxicity (ataxia, tremor, cognitive impairment) Deteriorating renal, thyroid function or hypercalcaemia Deterioration of mental state, or where level of risk to self or others is increased Pregnancy Erratic / non-compliance or patient request to discontinue lithium Advice on drug interactions To consider the appropriateness of continuing / stopping lithium in people who have been stable for the last 4-5 years Approved BY NEP MMG July To be revised July 2019 Lithium continuning care guidelinesgui201608v1.0final Page 19 of 19