SHARED CARE GUIDELINE FOR LITHIUM 1. Aim/Purpose of this Guideline 1.1. This guideline applies to medical, nursing and pharmacy staff in the safe and appropriate prescription and administration of lithium. 2. The Guidance 2.1. See below for the Shared Care Guideline. Page 1 of 10
CORNWALL & IoS HEALTH COMMUNITY SHARED CARE GUIDELINE LITHIUM This shared care guideline (SCG) sets out details for the sharing of care of patients prescribed lithium. Lithium has been managed in primary care for many years and this SCG aims to support the safe and effective use of lithium as recommended by Safer Lithium Therapy NPSA/2009/PSA005. SCGs highlight some relevant prescribing issues but should be used in conjunction with relevant guidance (eg NICE, NPSA, BNF, ABPI summary of product characteristics), and do not replace them. INDICATIONS Lithium is licensed for the treatment of acute manic or hyomanic episodes, recurrent depression where other antidepressants have failed, in the prophylaxis of bipolar disorder, and control of aggressive behaviour or intentional self harm. PREPARATIONS AND DOSAGE Lithium should be prescribed by brand name, because of its narrow therapeutic range and differences in product bioavailability. te that not all lithium products are modified release (MR) The Priadel brand is recommended within Cornwall & IoS. This is available as Priadel MR 200mg and Priadel MR 400mg tablets; both contain lithium carbonate and both are scored tablets and can be halved. Particular care is needed with Priadel 520mg/5ml SF liquid, which actually contains lithium citrate where 5ml = 200mg lithium carbonate (= 5.4mmol Li+). Using a single brand (Priadel) throughout Cornwall healthcare community should help to reduce medication errors. CONTRAINDICATIONS AND PRECAUTIONS include: Hypersensitivity to lithium or any excipients Clinically significant renal disease Untreated hypothyroidism or Addison s Cardiac disease Low sodium (eg dehydration, low sodium diet) Women of childbearing potential discuss risks of teratogenicity (cardiac, Ebstein s anomaly) Pregnancy or breastfeeding seek specialist advice first to review risks and benefits t recommended for children, adolescents Initiation of lithium Initiation will be on the advice of a specialist, who will give the diagnosis and target lithium level for each patient, with ongoing guidance as necessary. The specialist will discuss potential risks and benefits of lithium with the patient and give written information (eg NPSA lithium folder). Baseline and ongoing blood results are more easily checked in primary care; any abnormal results should be discussed with the specialist before proceeding. Lithium should be started at low dose, (eg 400mg at night in healthy adults, 200mg at night in elderly), titrating up to the target therapeutic level as indicated by weekly serum lithium levels. The recommended therapeutic range in bipolar disorder is usually 0.6 0.8mmol/L in healthy adults, but lower (eg 0.4mmol/L) in elderly or frail patients. MONITORING The safe and effective use of lithium requires regular monitoring of lithium level, renal and thyroid function. Baseline monitoring Renal - Urea, electrolytes, creatinine, e-gfr Thyroid function TSH, T4 Full blood count Calcium ECG if existing cardiac disease or risk factors BMI Exclude pregnancy, consider contraception as appropriate, as risk of teratogenicity with lithium. Serum Lithium monitoring : 5-7 days after initiation, then weekly after each dose change until the level is stable within the therapeutic range for that patient, then after one month, then if stable every 3 months for the first year. After the first year, measure plasma lithium levels every 6 months, or every 3 months for people in any of the following groups: older people (65 years and over); people taking drugs that interact with lithium; people who are at risk of impaired renal or thyroid function, raised calcium levels or other complications; people who have poor symptom control; people with poor adherence; people whose last plasma lithium level was 0.8 mmol per litre or higher. Lithium samples should be taken 12 hrs post-dose, so a once-daily dose at night of Priadel tablets is recommended for simplicity of blood sampling. Patients taking lithium twice daily (eg Priadel liquid is licensed for twice daily dosage), should delay the morning dose until after the blood sample has been taken, again 12 hrs after the dose the preceding night. Ongoing monitoring of other parameters: Every 6 months renal function (Including e-gfr: potential for lithium toxicity if renal dysfunction; lithium can cause diabetes insipidus or more rarely reduce egfr). The decision whether to continue lithium depends on clinical efficacy, and degree of renal impairment; prescribers should consider Page 2 of 10
CORNWALL & IoS HEALTH COMMUNITY SHARED CARE GUIDELINE seeking advice from a renal specialist and psychiatrist. TFT (potential hypothyroidism, which can be treated as usual with thyroxine) BMI (potential weight gain) Annually corrected calcium (potential for increased calcium, hyperparathyroidism). ECG if cardiac disease or risk factors (potential for arrhythmias, bradycardia though these are not common). More frequent monitoring may be indicated in those with or at risk of, cardiac, renal or thyroid disease. SIDE EFECTS SEE SUMMARY OF PRODUCT CHARACTERISTICS Weight gain (avoid sugary drinks), oedema, mild GI disturbances e.g. mild nausea, diarrhoea (but see acute toxicity below), fine tremor, dry mouth, metallic taste, polydipsia, polyuria, exacerbation of psoriasis or acne. Longer term - hypothyroidism, hypercalcaemia & hyperparathyroidism, renal impairment & diabetes insipidus, bradycardia, arrhythmias Signs of Lithium Toxicity may be present even at a therapeutic lithium level. Raised lithium levels or signs of toxicity require lithium to be reduced or stopped, at least until blood levels fall to therapeutic range and the cause of lithium toxicity has been investigated. Because Priadel tablets are modified release, do repeat lithium levels. Risk factors for toxicity often involve change in sodium levels or how the body handles sodium. COMMON / SIGNIFICANT DRUG INTERACTIONS Lithium levels may be increased by:- Diuretics avoid diuretics, particularly thiazides. NSAIDs caution with when needed or OTC NSAIDs. Avoid NSAIDs or monitor lithium levels closely. ACE inhibitors and Angiotensin II antagonists Dehydration, sweating, low salt intake Stopping concurrent theophylline Lithium levels can be decreased by excessive fluid intake, acetazolamide, or adding theophylline. Risk of serotonin syndrome with other serotonergics eg SSRIs (although this can be a therapeutic combination in resistant depression), triptans, certain opioids e.g. tramadol, pethidine. Serotonin syndrome (restlessness, sweating, shivering, tremor, myoclonus, confusion) can be mild or potentially fatal, and resolves rapidly on stopping serotonergic drugs. Risk of neurotoxicity with concurrent diltiazem, verapamil, methyldopa, carbamazepine, phenytoin, antipsychotics or SSRIs. Again, lithium + antidepressant or lithium + antipsychotic is usually a synergistic therapeutic combination, but problems can occur rarely. REFERENCES Summary of Product Characteristics. NICE Clinical Guideline 185: Bipolar disorder: assessment and management (Sept 2014). Maudsley Prescribing Guidelines 12 th Ed. As a general guide :- Serum level 1.3mmol/l or above : blurred vision, muscle weakness, ataxia, increasing GI disturbances (anorexia, nausea, diarrhoea), drowsiness, confusion, coarse tremor, dysarthria, poor co-ordination, muscle twitching. Fine tremor is a normal side effect, but a coarse tremor may indicate toxicity. Action: Withhold lithium, advise patient to drink water, seek specialist advice, daily lithium level. Serum level 2.0mmol/l or above (severe lithium toxicity). hyperreflexia or hyperextension of limbs, convulsions, disorientation, syncope, renal failure, circulatory failure, coma. Action: Stop lithium immediately and seek urgent acute medical care Request for other formats Please ask if you would like to receive this leaflet in large print, braille, on CD or in any other languages. If you would like the leaflet in an alternative format please contact the NHS Kernow Communications Team at communications@kernowccg.nhs.uk or call 01726 627800 For a planned withdrawal of lithium when not due to an urgent medical situation, withdraw gradually over at least one month, preferably longer. Stopping lithium suddenly can significantly increase the risk of relapse. Page 3 of 10
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE These are suggested ways in which the responsibilities for the management of patients prescribed lithium can be shared between the specialist and the general practitioners. The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility for prescribing these drugs. If a specialist asks the GP to prescribe this drug the GP should reply to this request as soon as practical. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient and be accepted by them. In its guidelines on responsibility for prescribing (circular EL(91)127) between hospitals and GPs, the DH has advised that legal responsibility for prescribing lies with the doctor who signs the prescription. In line with the NPSA alert Safer Lithium Therapy, all health professionals involved with patients taking lithium should assist in educating those patients and support them in assuming some responsibility for their safe treatment. Specialist: Provide diagnosis, rationale for lithium therapy and advise on target lithium level for each patient. Advise GP on baseline tests and request notification of any abnormal results before proceeding with lithium. Discuss lithium treatment with the patient in advance, including potential benefits and side-effects, warning signs of lithium toxicity, the requirement for regular blood tests, likely duration of treatment. Provide patient with written information and patient lithium record card (eg NPSA folder of lithium information and record card). Encourage patient to be actively involved in monitoring lithium levels and to show lithium record to doctors, pharmacists and others involved in monitoring lithium. For women of childbearing potential, discuss the risk of teratogenicity and risk in breastfeeding where appropriate. Refer to GP and/or other sources for advice on contraception as appropriate. Ask GP and patient for a full list of prescribed and non-prescribed medicines and consider potential drug interactions with lithium. Risk assess patient and determine appropriate quantity of supply, eg weekly or monthly supplies. See patient again at one month, review current blood level and advise on any side-effects Check that patient understands the need for adherence and regular blood tests, and signs of lithium toxicity and what action to take. Encourage the patient to be actively involved in maintaining and monitoring the safe and effective use of lithium. Evaluate and advise on adverse events noted by GP or patient. Promptly communicate to GP any necessary changes to treatment. Advise GP on when and how to discontinue. Specialist reassessment should occur after 5 years to review need for treatment. General Practitioner: Reply to request for shared care as soon as practical. The general practitioner will prescribe the medicine in consultation with, and receiving advice from, the specialist service. To provide the patient with monthly repeat prescriptions, or smaller quantities if necessary. Specify the brand (Priadel) on the prescription; incorrect dosing can occur if the patient changes preparations To monitor for side-effects and drug interactions, seeking specialist advice as necessary. To discuss with specialist if a patient needs a drug which is likely to affect lithium levels. Undertake baseline tests and notify the specialist of any abnormalities before proceeding to prescribe. To check serum lithium levels according to recommendations on page 2. To monitor lithium levels closely and to reduce the dose or discontinue treatment as appropriate in serious diarrhoea, vomiting or intercurrent infection (especially if sweating profusely). To check patients for side effects and signs of lithium toxicity at each appointment. Toxicity can occur without apparent increase in serum level, and it is important to treat the patient not the level. Signs of neurotoxicity which can occur at therapeutic levels include paraesthesia, ataxia, tremor and cognitive impairment. To undertake continuation monitoring as set out above, take appropriate action if these tests are abnormal and to communicate all abnormal test results to specialist and seek advice as necessary. To stop lithium if signs of toxicity occur and contact the consultant psychiatrist for advice. Refer back to secondary care for specialist advice if the treatment is ineffective or the patient is non-compliant or if the patient develops unacceptable side effects (this is particularly important where patients develop signs of renal impairment.) To continue patient education and encourage the patient to take responsibility for maintaining their treatment safely. Page 4 of 10
To oversee the appropriate completion of the NPSA lithium therapy record book. To review the patient in accordance with the patient s care plan, if appropriate. To make a clear statement in the primary care notes showing where monitoring is being carried out. To inform care team if patient is non-adherent with treatment plan. Patient / carer: Attend appointments and have recommended tests at recommended Intervals. Carry the lithium alert card in case urgent medical treatment is needed. Keep the lithium record book up-to-date and show it to healthcare professionals as required, eg prescribers, pharmacists. Wherever possible, to be aware of due dates for regular monitoring, and utilise the lithium record book (or equivalent) Be aware of possible side-effects, especially signs of high lithium level and report these promptly to professional(s) involved with their care. Share any other concerns about lithium (e.g. incomplete understanding of treatment) with professional involved with their care. Maintain their usual adequate diet and fluid intake. Seek advice before self-medicating with over the counter medicines, eg check with a pharmacist. Seek advice and support from GP or specialist immediately if pregnant or planning a pregnancy Store medicines safely at home. BACK-UP ADVICE AND SUPPORT IS AVAILABLE FROM THE RELEVANT CLINICAL TEAM Page 5 of 10
3. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Compliance with prescribing and administration in accordance with this guideline (or other safe practice) Head of Prescribing Support Unit specific tool As required according to clinical incident reports Via Medicines Practice Committee Relevant Clinical Staff Relevant Clinical Staff 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website. 4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 6 of 10
Appendix 1. Governance Information Document Title Lithium Shared Care Guideline Date Issued/Approved: May 2016 Date Valid From: June 2016 Date Valid To: June 2019 Directorate / Department responsible (author/owner): M Wilcock, Head of Prescribing Support Unit, Pharmacy Department, RCHT Contact details: 01872 253548 Brief summary of contents Some clinical issues and details of prescribing responsibilities for GP and specialists Suggested Keywords: Target Audience Executive Director responsible for Policy: Shared care RCHT CCG CFT Medical Director Date revised: May 2016 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: v2.0 Cornwall Area Prescribing Committee Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Karen Jarvill, Associate Director CSCS t Required {Original Copy Signed} Internet & Intranet Intranet Only Clinical / Pharmacy ne ne Page 7 of 10
Version Control Table Date Version May 13 V2.0 Minor updating May 16 V3.0 Minor updating Summary of Changes v 17 V3.1 Correction to footer page 1 Changes Made by (Name and Job Title) M Wilcock, Head of Prescribing Support Unit B Luft, Deputy chief Pharmacist, CFT M Wilcock, Head of Prescribing Support Unit All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 8 of 10
Appendix 2.Initial Equality Impact Assessment Screening Form Name of service, strategy, policy or project (hereafter referred to as policy) to be assessed: Lithium Shared Care Guideline Directorate and service area: Pharmacy Is this a new or existing Procedure? Existing Name of individual completing assessment: Dan Thomas, Pharmaceutical Services Contracting Team, NHS Kernow 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? Telephone:01726 627953 To provide information on prescribing of lithium to enable General Practitioners to take over prescribing responsibility from secondary care. 2. Policy Objectives* To promote a consistent level of shared care between primary and secondary care (in relation to CPFT catchment area) 3. Policy intended Confident and competent prescribers, enabling medicines to be Outcomes* access in a primary care setting. 4. *How will you measure If the guideline is not well received, publicised and adopted, then the outcome? some GPs may not enter into shared care arrangements. 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? b) If yes, have these *groups been consulted? General practitioners, hospital specialists and community pharmacists from understanding local guidance around use of these medicines. Patients/carers, from being able to access medicines from their GP. C). Please list any groups who have been consulted about this procedure. Cornwall & IoS Area Prescribing Committee 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes Rationale for Assessment / Existing Evidence Age Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Page 9 of 10
Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity no no no no Sexual Orientation, no Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. 9. If you are not recommending a Full Impact assessment please explain why. Signature of policy developer / lead manager / director Date of completion and submission Names and signatures of members carrying out the Screening Assessment 1. Dan Thomas 2. Mike Wilcock Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date Page 10 of 10