SHARED CARE PROTOCOL AND INFORMATION FOR GPS Drug Name: Lithium Clinical Indications: Treatment and prophylaxis of mania; bipolar disorder; augmentation therapy in treatment resistant depression Version: 3 Date Approved: January 2013 Review Date: January 2015 Lithium for Treatment and prophylaxis of mania; bipolar disorder; augmentation therapy in treatment resistant depression AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of Lithium can be shared between the specialist and general practitioner or non-medical prescriber in primary care (GP). GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In that case, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe drugs for this treatment, the GP should reply to this request as soon as practicable. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. For patients detained under The Mental Health (Care and Treatment) (Scotland) Act 2003, lithium must be included in the T2 or T3 Treatment Plan. Patients with bipolar disorder or treatment resistant depression are under regular specialist follow-up. This provides an opportunity to discuss and to monitor drug therapy. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. Lithium is a well-established treatment for mood disorders including bipolar disorder, mania and recurrent or resistant depression it has a narrow therapeutic window and monitoring of blood levels is essential for its safe use. National Patient Safety Agency (NPSA) In December 2009 the NPSA made the following recommendations in a Patient Safety Alert Patients prescribed lithium are monitored in accordance with NICE guidance on the management of bipolar disorder There are reliable systems to ensure blood test results are communicated between laboratories and prescribers At the start of lithium therapy and throughout their treatment patients receive appropriate ongoing verbal and written information and a record book to track lithium blood levels and relevant clinical tests. Record book available from Clinical Management, Stratheden Hospital (01334 696004). Prescribers and pharmacists check that blood tests are monitored regularly and that it is safe to issue a repeat prescription and/or dispense the prescribed lithium Systems are in place to identify and deal with medicines that might adversely interact with lithium therapy.
RESPONSIBILITIES and ROLES Specialist responsibilities 1 Confirm diagnosis 2 Assessment of baseline mental state 3 Discuss the benefits and side effects of treatment with the patient and advise patient of signs of toxicity. 4 For patients detained under The Mental Health (Care and Treatment) (Scotland) Act 2003, ensure that lithium is included in the T2 or T3 Treatment Plan. 5 Undertake baseline investigations- renal function, thyroid function, calcium and baseline ECG if existing cardiac disease or risk factors 6 Ensure that a baseline weight is recorded 7 Consider any drug interactions 8 Consider any pre-existing conditions which require particular caution with lithium 9 Discuss the shared care arrangement with the patient. 10 Provide patient with Lithium Therapy NPSA booklet [Record book available from Clinical Management, Stratheden Hospital (01334 696004)] and complete initial details. 11 Initiate treatment with Lithium or advise GP on initiating treatment. Prescribe using brand name, usually Priadel. 12 Ensure that serum lithium monitoring is carried out during initial titration and after dose changes either in secondary care or by arrangement with the GP 13 Counsel female patients to take contraceptive precautions during treatment. Record in GP referral letter that contraceptive advice has been given 14 Ask the GP whether he or she is willing to participate in shared care. 15 Complete Shared Care Lithium Treatment Plan 16 Review the patient's condition and monitor compliance and response to treatment regularly where indicated. The need for continued lithium therapy should be assessed regularly and patients should be maintained on lithium after 3-5 years only if benefit persists. 17 Advise GP of the necessary ongoing monitoring and the frequency. 18 Monitor any other parameters considered necessary, or advise GP on which to monitor. 19 Communicate promptly with the GP when treatment is changed or needs to be changed by the GP, any results of the monitoring undertaken, and assessment of adverse events. 20 Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. 21 Evaluate any adverse events reported by patient, carer or GP 22 Report adverse events to the MHRA via Yellow Card Scheme. 23 Ensure that clear backup arrangements exist for GPs to obtain advice and support. General Practitioner responsibilities 1 Reply to the request for shared care as soon as practicable. 2 Prescribe Lithium at the dose recommended. Prescribe using brand name, usually Priadel 3 Adjust the dose as advised by the specialist. 4 Consider any drug interactions 5 Monitor Lithium serum levels, calcium, renal and thyroid function as in monitoring section 6 Monitor weight/bmi 7 Update Shared Care Treatment Plan 8 Confirm patient has NPSA booklet and update information 9 Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect treatment. 10 Refer patient to specialist if his or her condition deteriorates. 11 Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises. 12 Report adverse events to the specialist and to the MHRA via the Yellow Card Scheme. Patient's role 1 Attend regular appointments for assessment and blood sampling 2 Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 3 Share any concerns in relation to treatment. 4 Report any adverse effects to the specialist or GP. 5 Ensure hand-held record in NPSA booklet is regularly updated
BACK-UP ADVICE AND SUPPORT Sector Consultant Psychiatrist Pharmacy Services 01383 565343 or local clinical pharmacist SUPPORTING INFORMATION Licensed indications (From SPC Priadel- indications for other products may vary) Management of acute manic or hypomanic episodes Management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful Prophylaxis against bipolar affective disorders Control of aggressive behaviour or intentional self-harm Dosage and Administration Lithium has a low therapeutic/toxic ratio and should be started at a low dose and titrated up to achieve therapeutic levels as indicated by serum lithium monitoring. The recommended therapeutic range is 0.5 1.0mmol/L (0.5 0.8mmol/L in elderly patients). Dosage must be individualised depending on serum lithium levels and clinical response. The dosage necessary to maintain serum lithium levels within the therapeutic range varies from patient to patient. The minimum effective dose should be sought and maintained. Contraindications and precautions for use Contraindications Hypersensitivity to lithium or to any of the excipients; Cardiac disease. Cardiac insufficiency. Severe renal impairment. Untreated hypothyroidism. Breast-feeding. Patients with low body sodium levels, including for example dehydrated patients or those on low sodium diets. Addison's disease. Brugada syndrome or family history of Brugada syndrome. See SPC or BNF for complete list of precautions Pregnancy Lithium therapy should not be used during pregnancy, especially during the first trimester, unless considered essential. Women of child-bearing potential should use effective contraceptive methods during treatment with lithium Women taking lithium who are planning a pregnancy or who become pregnant must be referred to psychiatric services for advice. Breastfeeding Lithium is excreted in breast milk with resultant risk of toxicity in the infant. Manufacturers advise to avoid. Withdrawal Unless due to serious adverse reaction, withdrawal should be gradual and take place under the supervision of a Consultant in Psychiatry. Abrupt discontinuation increases the risk of relapse. See BNF section 4.2.3
Side Effects See SPC or BNF for complete list of adverse effects Side effects may be short term and are usually dose dependent. They can often be prevented or relieved by a moderate reduction in dose. Type of adverse effect GI disturbances e.g. nausea, diarrhoea, dry mouth Weight gain Oedema Fine tremor Polyuria (frequent urination) Polydipsia (frequent thirst) Hypothyroidism Signs of toxicity: Blurred vision, muscle weakness, drowsiness, coarse tremor, dysarthria, ataxia, confusion, convulsions, nausea & vomiting, ECG changes. Action to be taken Ensure patient aware of need for fluid replacement Monitor Advise to avoid crash diets & sugary drinks. Monitor may respond to dose reduction. Consider slight reduction in dose Advise re: fluid intake. May require investigation for diabetes insipidus if persistent Consider thyroid replacement if clinically indicated Stop lithium immediately, measure lithium, creatinine, urea and electrolytes. Refer to hospital if clinical condition warrants MONITORING Serum Lithium monitoring Serum lithium must be monitored 5-7 days after initiation, then weekly until steady state is reached, then 3 monthly when stable (more frequently, typically 2 monthly in the elderly). More frequent monitoring is required following alteration of dosage; on development of intercurrent disease; in those with or at risk of cardiac, renal or thyroid disease; signs of manic or depressive relapse; following significant change in sodium or fluid intake; if an interacting drug is being taken or if signs of lithium toxicity occur. Lithium serum levels should be measured 12 hours after the previous dose. Patients taking lithium once daily at night should have the level measured in the morning 12 hours after the previous night time dose. Patients taking lithium twice daily should have the level measured in the morning 12 hours after the previous night time dose. The morning dose must be postponed until after the sample has been taken. Cardiac, renal, thyroid and calcium monitoring- minimum requirements Baseline ECG for those with existing cardiac disease or risk factors. Renal function- baseline and then every 6 months. Calcium- baseline and then every 6 months Thyroid function -TSH and T4 baseline and then every 6 months More frequent monitoring may be indicated in those with or at risk of cardiac, renal or thyroid disease. Weight should also be monitored Drug Interactions Refer to SPC or BNF appendix 1 for complete list Some medicines may result in increased lithium levels and risk of toxicity, e.g. diuretics (especially thiazides), NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, SSRIs and other psychotropic medicines. Increased risk of ventricular arrhythmias with amiodaraone (avoid). Cost REFERENCES Priadel Tablets 200mg 100 tablets 2.30 Priadel Tablets 400mg 100 tablets 3.35 Priadel Liquid 150ml 5.61 BNF Edition 63 March 2012 NICE Clinical Guideline 38 Bipolar Disorder 2006 SIGN Guideline 82 Bipolar Affective Disorder 2005
ADDITIONAL INFORMATION Preparations are NOT Bioequivalent Two salts of lithium are available (lithium carbonate and lithium citrate) which contain different amounts of lithium (mmolli + ) and are not interchangeable. Lithium carbonate (tablets) 200mg lithium citrate (liquids) 509mg Lithium must always be prescribed by trade name Priadel tablets are the most frequently prescribed lithium preparation in Fife and Priadel liquid the most commonly prescribed liquid lithium preparation. *See Appendix 1- Equivalent doses of Priadel liquid and Priadel tablets. Alternative preparations Lithium preparations vary widely in bioavailability therefore any change of preparation (even those containing the same salt) requires the same precautions as initiation of treatment i.e. weekly monitoring. LITHIUM CARBONATE TABLETS Trade Name Tablet Strength Available Amount of Lithium (Li + ) Priadel 200mg m/r (scored) 400mg m/r (scored) 5.4mmol/200mg 10.8mmol/400mg Camcolit 250 Camcolit 400 250mg (scored) 400mg m/r (scored) 6.8mmol/250mg 10.8mmol/400mg Liskonum 450mg m/r (scored) 12.2mmol/450mg LITHIUM CITRATE LIQUID Trade Name Liquid Strength Available Amount of Lithium (Li + ) Priadel * 520mg/5ml 5.4mmol/5ml Li-liquid 509mg/5ml 5.4mmol/5ml Li-liquid 1018mg/5ml 10.8mmmol/5ml Dosing frequency depends on preparation prescribed Liquid preparations and Liskonum tablets should be prescribed twice daily Other lithium preparations are usually prescribed as a single dose at night. Interpretation of serum lithium level (Range: 0.5 1.0mmol/L, elderly 0.5 0.8mmol/L) Level Action to Be Taken < 0.5mmol/L & patient is well and pattern Do not alter dose. of levels has been low but within specified range for that patient. < 0.5mmol/L & patient unwell & pattern of Assess compliance, increase dose if appropriate, and recheck levels on lower end of specified range for level in 5 days. that patient. < 0.5mmol/L & is inconsistent with the Assess compliance, consider other factors e.g. drug interactions, trend. excess fluid intake, brand change, and recheck level. > 1.0mmol/L with no signs of toxicity. If there is an explanation for the high level e.g. dehydration, timing of level, interacting medicines, brand change, correct where possible and recheck level. > 1.0mmol/L with no signs of toxicity and Decrease dose, encourage fluids, recheck in 5 days. the trend is for high end of range. > 1.0mmol/L with no signs of toxicity and Recheck level, check e GFR, and urea, creatinine and no explanation for high level. If patient shows signs of toxicity Blurred vision, muscle weakness, drowsiness, coarse tremor, dysarthria, ataxia, confusion, convulsions, nausea & vomiting, ECG changes electrolytes. Stop lithium immediately, measure lithium, egfr, creatinine, urea and electrolytes. Refer to hospital if clinical condition warrants
Appendix 1 Equivalent doses of Priadel Liquid and Priadel Tablets All liquid lithium preparations contain Lithium Citrate and all tablet preparations contain Lithium Carbonate. These are not interchangeable. Priadel is the most frequently prescribed brand of lithium in Fife. Each 5ml of Priadel liquid contains 520mg of lithium citrate which is equivalent to 204mg of lithium carbonate. Priadel Tablets contain lithium carbonate. Confusion between Lithium Carbonate and Lithium Citrate is a common cause of error. Equivalent doses of Priadel tablets and liquid Priadel Tablets Priadel Liquid 200mg 5ml 400mg 10ml 600mg 15ml 800mg 20ml 1g 25ml 1.2g 30ml 1.4g 35ml Priadel liquid should be given in divided doses, ideally twice daily The following table shows what quantity of Priadel liquid should be prescribed if switching between Priadel l tablets and Priadel liquid. Priadel tablets Priadel liquid 200mg daily 2.5ml twice daily 400mg daily 5ml twice daily 600mg daily 7.5ml twice daily 800mg daily 10ml twice daily 1g daily 12.5ml twice daily 1.2g daily 15ml twice daily 1.4g daily 17.5ml twice daily All Lithium preparations must be prescribed by brand name (usually Priadel ) as bioavailability varies. Any change in formulation (e.g. tablets to liquid) or brand requires the same monitoring of lithium levels as initiation of treatment If there are any queries about changing between the different preparations of Priadel or any of the other lithium preparations please contact your local clinical pharmacist for advice or alternatively contact pharmacy services on 01383 565343
SHARED CARE LITHIUM TREATMENT PLAN PATIENT SPECIFIC DETAILS CONSULTANT To be completed at time of discharge/outpatient review and sent to GP NAME ADDRESS DOB/CHI Current indication: (e.g.bipolar prophylaxis / augmentation) Desired Therapeutic range: (0.5 1.0mmol/L, elderly 0.5 0.8mmol/L) Dosage Regime: Brand used: Last level/date: / Level next due: PHYSICAL & BLOOD MONITORING TO BE CARRIED OUT BY: Psychiatrist Lithium Clinic Day Care Unit GP Other Frequency of lithium monitoring (minimum 3 monthly/2 monthly in elderly) Completed by (sign & print name) MINIMUM MONITORING REQUIREMENTS FOR ESTABLISHED LITHIUM TREATMENT Date NB more frequent monitoring may be required if clinical indications arise and in higher risk patients, e.g. those on interacting drugs (see BNF), those with or at risk of renal / thyroid / cardiac disease. BASELINE ECG DONE? Yes/No/Not required LITHIUM minimum 3 monthly NB sample at approx. 12 hours post dose. Ensure time interval is same at each measurement, if varies, state clearly on form. RENAL AND THYROID FUNCTION CALCIUM 6 monthly 6 monthly PSYCHIATRIC REVIEW GP s should consider patients for formal review by psychiatrist after 2 5 years of lithium therapy to assess ongoing benefit.
Results Current dose regimen and Brand Date of next blood level Date of current blood level Serum Lithium Level (mmol/l) Renal function (egfr) Thyroid function Calcium Weight/ BMI Comments e.g. dose alteration, side effects, mood rating, non-compliance