Norfolk lithium database

Stephen BazireChief 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) Mania and severe depression or mania alone Mean age of onset 21, peak 15 - 19 years 0.8% US adults

Bipolar II 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

Sub-syndromal mania (hypomania)

Mania

Depression

Mania

Subsyndromaldepression

Remission

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 0.4-0.8mmol/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)

Surgeries showed huge variation Norfolk & Norwich Pathology lab one-year survey

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

Test?

Yes

2nd reminder & blood form

No

No

GP ALERT& Recall 3

Test?

Yes

Letters sent out each week

Registration Welcome and

consent 7 4-week consent 2 12-week consent 1 26-week 0

* average 2002-2010

Blood reminder letters

13-week 87 17-week 17 GP alert 5

Outcomes(Lithium database started in 2002)

Tests per year

1999 2003 2004 2009

n= 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 Run by 0.8wte Band 5 plus cover

Covers Trust catchment area 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. Database programme written that PCTs/Trusts could purchase and run themselves

2. NWMHFT runs national data collection from Path Labs, local PCTs/Trusts access that and send own reminders out

3. 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