Norfolk lithium database Stephen Bazire Chief Pharmacist Norfolk and Waveney Mental Health NHS Foundation Trust Hon Prof, School of Pharmacy, UEA Famous people thought to have had bipolar disorder Adam Ant (musician) Frank Bruno (sportsman) Lord Byron (writer) Winston Churchill (politician) Kurt Cobain (musician) Ray Davies (musician) Charles Dickens (writer) Ernest Hemingway (writer) Linda Hamilton (actor, Terminator) John Keats (writer) Otto Klemperer (musician) Paul Merton (comedian) Spike Milligan (writer and comedian) Marilyn Monroe (actress) Florence Nightingale (nurse) Edgar Allan Poe (writer) Axl Rose (musician) Robert Schumann (musician) Tony Slattery (comedian and actor) Robert Louis Stevenson (writer) Mark Twain (writer) Vincent van Gogh (artist) Tennessee Williams (writer) Virginia Woolf (writer) Prof. Kay Redfield Jamison “Lithium moderates the illness but therapy teaches you how to live with it” Prof. Kay Jamison 1995 Bipolar spectrum Bipolar I (classical manic-depression) Bipolar II Mania and severe depression or mania alone Mean age of onset 21, peak 15 - 19 years 0.8% US adults depression with at least one hypomanic episode 0.5% US adults, slight gender difference (F > M) May be genetically distinct from Bipolar I Bipolar III (Pseudounipolar Bipolar Disorder) Recurrent depression and mixed states antidepressants may induce hypomanic switching and/or mixed states Bipolar disorder is multidimensional Mania Sub-syndromal mania (hypomania) Mania Remission Subsyndromal depression Depression Acute and maintenance drug therapy Licensed and widely used as mood stabilisers: Lithium Carbamazepine (non-response to lithium) Olanzapine (manic episode) Licensed for mania/hypomania and relapse prevention Valproate semisodium Antipsychotics Quetiapine Olanzapine Risperidone Acute and adjunctive treatments: Antipsychotics Benzodiazepines Antidepressants Unlicensed/being investigated: Lamotrigine (bipolar depression) Gabapentin Topiramate Other atypicals including risperidone and clozapine Calcium-channel blockers Cannabis Lithium - the gold standard Cade JFJ, Lithium salts in the treatment of psychotic excitement Med J Aust 1949;36:349-52 Effective in mania Reduces number of relapse Reduces severity of relapses Reduces mortality Reduces suicide Reduces incidence of Alzheimer’s Disease Putative therapeutic plasma range Plasma levels Prophylactic therapy plasma levels 0.40.8mmol/L Analysis of RCTs by NICE revealed that: 0.6-1.0mmol/L had lowest relapses 0.4-0.6mmol/L higher level of relapse Generally higher levels needed in acute mania POMH-UK audit showed monitoring was poor across the UK The risks of not monitoring 102 litigation claims involving lithium prescribing and monitoring 53 due to inadequate monitoring 13 deaths (suicides excluded) 7 cases of renal failure 6 cases of neurological sequelae (MDU November 2003) Norfolk lithium database project Norfolk-PCG/NMHC Clinical Liaison group 2000 Prescribing sub-group Lithium prescribing and monitoring: Initial prescribing and monitoring responsibilities Variations in therapeutic plasma levels quoted between N&N and JPH Inconsistent approach to continuing monitoring Issuing guidelines doesn’t work Eagles et al, Acta Psychiatr Scand 2000, 101, 349-53 Lithium monitoring - Norfolk and not very good Lithium guidelines existed but not widely followed Survey showed poor monitoring against Royal College of Psychiatrists guidelines (except Coast) Norfolk & Norwich Pathology lab one-year survey Surgeries showed huge variation 32% of patients had only had one level less that 30% of patients had adequate monitoring Shared care responsibility not recognised Plasma levels quoted JPH 0.4-0.8mmol/L, N&N 0-1.0mmol/L If you want a job done properly, do it yourself… Norfolk-wide lithium database was set-up to: Maintain register of all people taking lithium in Norfolk Send blood test reminders to all patients every 3 months Send up to three reminders third alerting the GP directly Ensure adequate information, education & access to specialist advice Be integral with a full shared-care agreement Shared care agreement showing secondary and primary care responsibilities It is the GP’s responsibility to act should a plasma level by out of range after stabilisation Standard process of Norfolk lithium database 11 wkly recall letter & blood form Yes Yes Test? No 2nd reminder & blood form Test? No GP ALERT & Recall 3 Letters sent out each week Registration Welcome and consent 4-week consent 12-week consent 26-week * average 2002-2010 7 2 1 0 Blood reminder letters 13-week 87 17-week 17 GP alert 5 Outcomes (Lithium database started in 2002) Tests per year n= 1999 2003 2004 2009 1457 1283 1249 1288 3+ 46% 79% 77% 81% 2 22% 13%* 16%* 1 32% 8%* 7%* 0 ?? 0.5% * Includes new starters and discontinuers Structure Based in Pharmacy at Hellesdon hospital Covers Trust catchment area Run by 0.8wte Band 5 plus cover Norfolk and NE Suffolk Programme is at the limits of capacity NPSA Alert December 2009 1. Monitoring according to NICE Guidelines 2. Reliable systems for test results between labs and prescribers 3. Initiation with appropriate verbal and written information 4. Blood tests monitored regularly, no repeats without safety assured 5. Systems to detect interactions To be implemented by December 2010 Could Norfolk system be extended? Currently no Current database uses Access, no further capacity Could be considered with web-based system if rewritten Post-PHEN/Waltham Abbey meetings update (1.7.10) NWMHFT has allocated funds to commission P1 (software company in Norwich, maintains current database) to formulate proposals and options: Draft Specification and vision Options include: 1. 2. 3. Database programme written that PCTs/Trusts could purchase and run themselves NWMHFT runs national data collection from Path Labs, local PCTs/Trusts access that and send own reminders out NWMHFT runs everything, with contact person locally Due to report back to PHEN (Eastern Region Chief Pharmacists/Prescribing Advisors Network) on 20.7.10 Some issues being considered Confidentially Continuity Would PCTs or mental health Trusts run this? Would still need a contact person locally (at least initially) to roll-out implementation Accessing and updating changes in GPs That for each PCT/Trust, there will be patients getting blood tests done at Path labs in different PCTs Makes tracking all patients difficult e.g. some patients from the edges of Norfolk get bloods done in Ipswich and Bury St Edmonds Would make a national/regional data source more efficient Stephen Bazire 1.7.10