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Shared Care Prescribing Agreement Lithium for Affective Disorders Section A: To be completed by the hospital consultant initiating the treatment GP Practice Details: Patient Details: Name: ……………………………………… Name: ……………………………………………… Address: …………………………………… Address: …………………………………………… Tel no: ……………………………………… DOB: ……/………/………… Fax no: …………………………………… Hospital number: ………………………………… E-mail: …………………………… NHS number (10 digits): ………………………… Mental Health Team details: Mental Health Team details contd: Consultant name: …………………………… Fax no:……………………………………… Clinic name: …………………………………. Tel no: ……………………………………… Address:...................................................... ………………………………………………. ………………………………………………….. NHS.net e-mail: …………………………… Diagnosis: Drug (brand) name & dose to be prescribed by GP: ……………………………………………………………. Licensed indication yes/no …………………………………………………… Next hospital appointment: …………/……..…/…………….. Dear Dr:…………………………………. Your patient is prescribed ………………………………………… (Insert specific brand name and dose) for the above diagnosis and they are stabilised on this treatment. I am requesting your agreement to sharing the care of this patient from ……………………..…. (Insert date) in accordance with the attached Shared Care Prescribing Guideline (Title: Lithium for Affective Disorders; Approval date:…………..). Please take particular note of Section 2 where the areas of responsibilities for the consultant, GP and patient for this shared care arrangement are detailed. Patient information has been given outlining aims and potential side effects of this treatment. A lithium booklet has been supplied and a lithium care plan has been opened. The patient has given me consent to treatment under a shared care prescribing arrangement (with your agreement) and has agreed to comply with instructions and follow up requirements. Please monitor the following in accordance with the attached schedule: Every three months*:(*NICE recommendations): lithium blood level (sample taken 12 hours after last dose) Every six months: thyroid function & eGFR Annually: weight, serum calcium, BP, pulse, lipids, fasting blood glucose, HbA1c and LFTs Test Lithium level (mmol/l) Result Test Date Test Result Test Date U&E (Na, Ca, Cr & eGFR) TFT Weight (kg) (or BMI) Mental Health Team please ensure the latest blood results are attached with this agreement Lithium level must not be above: …..………………..(mmol/l) or below:………………………………(mmol/l) Other relevant information: ……………………………………………………………………………………….. Section B: To be completed by the GP and returned to the hospital consultant Please sign and return your agreement to shared care within 14 days of receiving this request Tick which applies: □ I accept sharing care as per shared care prescribing guideline and above instructions □ I would like further information. Please contact me on………………………………. □ I am not willing to undertake shared care for this patient for the following reason: ………………………………………………………………………………………………………………………….. GP name: ………………………………………….………. GMC no: …………………………………………….... GP signature: ……………………………………………… Date: ……...…/…………../…....….. Date original approved: February 2004 Version 201705 Date last review: June 2016 Date next review : June 2019 Working in partnership with SHARED CARE PRESCRIBING GUIDELINE Lithium for Affective Disorders NOTES to the GP The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility for prescribing this drug. The questions below will help you confirm this: Is the patient’s condition predictable or stable? Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this shared care prescribing guideline? Have you been provided with relevant clinical details including monitoring data? If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for you to accept prescribing responsibility. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant within 14 days, outlining your reasons for NOT prescribing. If you do not have the confidence to prescribe, we suggest you discuss this with your local Trust/specialist service, who will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility, you still have the right to decline. Your CCG pharmacist will assist you in making decisions about shared care. It would not normally be expected that a GP would decline to share prescribing on the basis of cost. The patient’s best interests are always paramount Participating Primary Care Organisations Kingston CCG Dr Anthony Hughes, GP on behalf of Medicines Management Committee Seema Buckley, Director & Chief Pharmacist Richmond CCG Dr Kate Moore, Vice Clinical Chair Emma Richmond, Chief Pharmacist Merton CCG Dr Andrew Otley, Mental Health Lead Sedina Agama, Chief Pharmacist Wandsworth Dr Nicola Jones, Clinical Chair Nick Beavon, Chief Pharmacist Sutton CCG Dr Chris Kears, Mental Health Lead Sarah Taylor, Chief Pharmacist Date original approved: February 2004 Version 201705 Participating Hospital Trusts SWL & St. George’s Mental Health NHS Trust Helen Miller (DTC Chair & Consultant Psychiatrist) Dianne Adams (DTC secretary & Chief Pharmacist) Date last review: June 2016 Date next review : June 2019 2 1. CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE 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 in each individual case and the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined below. The hospital will provide the patient with a minimum initial supply of 2 weeks medication. 2. 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 GP Consultant GP Formulate diagnosis and initiate Prescribe specific dosage, form and brand of lithium ensuring treatment plan monitoring results indicate it is safe to do so, adjusting dosage as required. Priadel MR® 200mg and 400mg tablets are the formulary Follow Mental Health Trust guidelines choice for lithium carbonate tablets. If liquid is prescribed note, for prescribing and monitoring lithium therapy SWLStG uses only the high strength lithium citrate liquid 1.018g/5ml (equivalent to 400mg lithium carbonate/5ml). Provide verbal and written information to the patient and answer their questions Measure lithium plasma levels every 3 months in accordance about lithium with NICE guidelines (or at any other time if signs of toxicity) and Establish willingness for adherence to send a copy of the results to the CMHT. lithium treatment (to avoid abrupt If monitoring results not available at the time of prescribing, cessation of treatment) prescribe only a limited supply (e.g. maximum 14 days) and Perform baseline physical health arrange for blood tests. checks (including body weight and ECG), Measure thyroid function and renal function every 6 months in renal and thyroid function, serum calcium, accordance with NICE guidelines and send a copy of the results to creatinine, eGFR and sodium (recorded in the CMHT. the electronic care notes). FBC should be Update the patient’s lithium monitoring booklet with all results done if indicated and changes in treatment when presented by patient Initiate lithium treatment and establish Perform annual health checks including record of body weight in desired dose / blood level accordance with NICE guidelines (including serum calcium) Provide lithium treatment monitoring Monitor mental state booklet and complete with relevant Monitor adherence to medication details. Open lithium care plan Assess for adverse effects (Healthcare professionals are asked Provide information on the new lithium to report suspected adverse reactions via the Yellow Card Scheme app (NHS Health Monitor for Lithium). at: www.mhra.gov.uk/yellowcard) The app will: provide information on the Be alert for medicines that interact with lithium; if any are added, do’s and don’ts with lithium, record blood stopped or have their dosage changed re-check the lithium level test results, set reminders for forthcoming and observe for any signs of toxicity or of relapse of symptoms. blood tests, record sleep and mood data Contact mental health community team or medicines and results can be emailed the to the GP information for advice on: dosage adjustment to maintain lithium and Consultant. level, management of adverse effects or patients who refuse blood Check on going monitoring of lithium tests. occurs Refer patient back to CMHT if concerns over mental state or Communicate to GP: concerns over poor compliance with treatment, refusal for Dosage, form & brand of lithium to be monitoring and of physical health issues that affect dosing or prescribed (this must be specified in all treatment. correspondence, prescriptions and the patient’s lithium record) Current lithium plasma level Desirable plasma level range to be maintained Frequency of follow-up appointments with CMHT and communicate treatment changes to the GP promptly within Trust recommended times. Date original approved: February 2004 Version 201705 Date last review: June 2016 Date next review : June 2019 3 N.B. results of all tests and investigations should be copied by / to both consultant and GP Patient and Carers responsibilities Carry lithium monitoring booklet or updated lithium app to required appointments and allow Health Care professionals involved in their care to see the booklet/app info. 3. COMMUNICATION AND SUPPORT Hospital contacts: Out of hours contacts & procedures: (the referral letter will indicate named consultant) ENTER CONTACT DETAILS OF YOUR LOCAL CMHT The on-call Psychiatrist and Pharmacist can be contacted via the hospital switchboard on 020 3513 5000. Tel: Fax: Nhs.net e-mail: Specialist support/resources available to GP including patient information: Additional information on any aspect of lithium treatment is available during working hoursfrom Mental Health Medicines Information 020 3513 6829 Patient information leaflets & lithium monitoring booklets for patients are available from Springfield Hospital Pharmacy 020 3513 6204. Information leaflets, choice of treatment for illnesses & illness leaflets (funded by SWLStG): http://www.choiceandmedication.org/swlstg-tr/ 4. CLINICAL INFORMATION Place in therapy: Therapeutic summary: Dose & route of administration: Duration of treatment: Monitoring Requirements: The NPSA Patient Safety Alert states that NHS providers “should ensure that patients prescribed lithium are monitored in accordance with NICE guidance” In accordance with NICE CG 185 (Sept 2014): Healthcare professionals in secondary care should ensure, as part of the care programme approach, that people with bipolar disorder receive physical healthcare from primary care after responsibility for monitoring has been transferred from secondary care. Date original approved: February 2004 Version 201705 One of the drugs of first choice for established recurrent illness insteadof or in addition to antipsychotics and/or antidepressants as appropriate. Treatment and prophylaxis in mood disorders – exact mechanism of action unknown Dose - established for each individual patient to produce the desired blood level (usual therapeutic range 0.4 – 1.0mmol/l but specific target level will be individual for each patient). Route of administration – oral (see notes on formulations in “practical issues” section below). For prophylaxis, likely to be for several years General monitoring of the patient’s mental state, adherence to treatment and for any adverse effects of their medication. Every three months*:(*NICE recommendations) o lithium blood level (sample taken 12 hours after last dose) Every six months*: o measure thyroid function o measure renal function (eGFR) Annually*: o physical health check including measure of body weight, serum calcium, BP, pulse, lipids, fasting blood glucose, HbA1c and LFTs In addition, measure lithium blood levels if signs of toxicity or relapse of illness appear, or if any medication is added / removed which may affect lithium blood levels (See interactions section) Request on each laboratory form that a copy of all results be sent to both consultant & GP. For those patients using the lithium app can email the results directly to the GP and Specialist Consultant Date last review: June 2016 Date next review : June 2019 4 4. CLINICAL INFORMATION contd. Summary of adverse effects: (See summary of product characteristics (SmPC) for full list, visit www.medicines.org.uk ) N.B. because of potential risk to unborn child, women of childbearing age should be clearly informed of the risks of pregnancy and should be encouraged to discuss with you any possible pregnancy, plans to breastfeed (or plans to conceive) as early as possible. Clinically relevant drug interactions: N.B. included are the “potentially hazardous” interactions as listed in the BNF – see latest BNF / SmPC for more complete information N.B. increased lithium plasma level/decreased lithium excretion brings the risk of lithium toxicity N.B. the effect of adding these drugs to lithium treatment is described here – the opposite effect is likely if the drug is withdrawn N.B. care may also be needed if one interacting drug is switched for another (e.g. change in diuretic) Practical issues: Adverse effect Frequency Management Lithium toxicity (signs: vomiting, diarrhoea, polyuria, increased thirst, coarse tremor, ataxia, muscle pain / weakness, drowsiness, confusion) Unknown (affected by dosage, drug interactions, physical illness, salt & fluid balance) Stop lithium, measure lithium blood level urgently, rehydrate, contact CMHT, DO NOT force diuresis, consider A+E referral Impaired renal function (identified by monitoring) Unknown contact CMHT Impaired thyroid function Unknown contact CMHT (identified by monitoring) ACE inhibitors and Angiotensin-II antagonists – increased lithium blood level (monitor lithium closely until stabilised) Analgesics – decreased lithium excretion by azapropazone, diclofenac, ibuprofen, indometacin, ketorolac (avoid concomitant use), mefenamic acid, naproxen, parecoxib, piroxicam, rofecoxib, and probably other NSAIDs (risk of lithium toxicity-monitor lithium closely until stabilised) Antidepressants – SSRIs may increase risk of CNS effects Antipsychotics – increased risk of EPSE / neurotoxicity with clozapine, haloperidol, phenothiazines, sulpiride; increased risk of ventricular arrhythmias with amisulpride, sertindole, thioridazine Acetazolamide – increased lithium excretion (monitor lithium closely until stabilised) Diuretics – decreased lithium excretion/increased lithium blood level. Loop diuretics safer than thiazides (monitor lithium closely until stabilised) Methyldopa – neurotoxicity without increased lithium blood level (monitor patients for sign of toxicity) Steroids – may alter lithium excretion and should therefore be avoided Tetracyclines Formulations of lithium Different brands and formulations of lithium are likely to produce different lithium blood levels The brand & formulation of lithium should remain unchanged for a patient & should be specified on each prescription, in all correspondence and on the patient’s lithium monitoring booklet Take extra care when prescribing lithium in liquid form, as different brands contain very different concentrations of lithium (e.g. Li-Liquid (Rosemont) is available in 2 strengths) SWLStG only uses the high strength lithium citrate liquid 1.018g/5ml (equivalent to 400mg lithium carbonate/5ml) If the lithium level is outside the desired range for this patient If level is above 1.0mmol/l contact the patient to arrange urgent assessment and to ensure that they take no more lithium and monitored for signs of toxicity. Otherwise: Confirm correct dosage is being prescribed / taken Date original approved: February 2004 Version 201705 Date last review: June 2016 Date next review : June 2019 5 Confirm blood sample taken 12 hours post-dose Check for drug interactions (N.B. some over-the-counter drugs may interact e.g. ibuprofen) Check hydration and salt intake or loss Assess physical & mental state of the patient Adjust the dosage if indicated and repeat level after 5-7 days Potential risk in pregnancy Because of the potential risk to the unborn child, women of child-bearing age should: Be clearly informed of the risks of pregnancy Be encouraged to discuss with you any possible pregnancy as early as possible Be encouraged to discuss with you any plans to conceive as early as possible Contact Mental Health Medicines Information (020 3513 6829) or the Perinatal Mental Health Service for advice. Key references: NPSA Patient Safety Alert NPSA 2009/PSA005 “Using lithium safely” Drug & Therapeutics Bulletin 1999, 37, 22 “Lithium for maintenance treatment of mood disorders” (Cochrane review), Burgess S et al In: The Cochrane Library, Issue 3, 2001 British National Formulary May 2016. https://www.medicinescomplete.com/mc/bnf/current/whatsnew.htm#ne ws607(accessed 7th June 2016) NICE clinical guideline 185 - Bipolar disorder: the assessment and management of bipolar disorder in adults, children and young people in primary and secondary care. September 2014, Last updated: February 2016 SWLStG Lithium prescribing and monitoring. TWC21j. Stockley’s Drug Interactions: https://www.medicinescomplete.com/mc/stockley/current/x170953.htm?q=lithium%20tetracycline&t=interactions&ss=interactions&tot =1&p=1#_hit (accessed 7th June 2016) Lithium App. Download the Apple IPhone version of the Lithium App here: https://itunes.apple.com/us/app/nhs-physical-healthmonitor/id1040946243?mt=8 Download the Android version of the Lithium App here: https://play.google.com/store/apps/details?id=com.incentivated.nhs.Healt hMonitor Date first prepared: January 2004 Date reviewed: January 2013, January 2015, June 2016 Date review approved: February 2013, February 2015, June 216 Next review date: June 2019 Date original approved: February 2004 Version 201705 Prepared by: Carl Holvey, Principal Pharmacist SWLStG MH Trust Reviewed by: Caroline Mollison, Pharmacist, SWLSTG MH Trust June 2016 Approved by (Approval date): S W London Mental Health Prescribing Forum: S W London & St Georges Mental Health NHS Trust June 2016 Date last review: June 2016 Date next review : June 2019 6