POMH-UK QUALITY IMPROVEMENT PROGRAMME LITHIUM MONITORING. Thomas R. E. Barnes

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1 POMH-UK QUALITY IMPROVEMENT PROGRAMME LITHIUM MONITORING Thomas R. E. Barnes

2 LITHIUM Evidence-based guidelines support the use of lithium in the prophylaxis of bipolar disorder, protecting against both depression and mania BALANCE study confirmed the effectiveness of lithium for relapse prevention in bipolar disorder Geddes et al. Lancet 2010;375: Lithium shown to reduce suicidality in this condition Grof & Müller-Oerlinghausen. Bipolar Disord 2009;11 (Suppl. 2): Slow onset of action in acute mania Narrow therapeutic range Baldessarini & Tondo. Bipolar Disord 2008;10: Serum levels <0.4 mmol/l are unlikely to be effective in majority of patients Serum levels >1.0 mmol/l increasingly associated with signs and symptoms of toxicity including confusion, seizures and renal damage

3 Common side effects LITHIUM SIDE EFFECTS Include tremor, thirst, increased urination, diarrhoea, vomiting, weight gain, impaired memory, poor concentration, drowsiness, muscle weakness, hair loss, acne Signs of toxicity Include diarrhoea, vomiting, fever, unsteady walking, fainting, decreased level of consciousness, slurred speech, rapid heart rate Chronic lithium therapy Decreased thyroid function (goitre and hypothyroidism) Nephrogenic diabetes insipidus (polyuria and polydipsia) Chronic kidney disease and renal failure:?lower target lithium plasma level for long-term maintenance can reduce risk of severe nephrotoxicity Lithium in pregnancy Lithium readily crosses the placenta. Inconsistent evidence for increased risk of foetal cardiac and other malformations, miscarriages and prematurity, as well as foetal goitre and hypothyroidism Neurotoxicity with combination of lithium + haloperidol/other antipsychotics Characterised by weakness, lethargy, fever, tremulousness and impairment of consciousness, with risk of residual neurological deficits

4 POMH-UK QUALITY IMPROVEMENT PROGRAMME LITHIUM MONITORING PRACTICE STANDARDS for audit 1. The following tests/measures should be completed before initiating lithium treatment Renal function tests; urea and electrolytes (U&Es) including creatinine (or e-gfr or creatinine clearance) Thyroid function tests (TFTs) Weight or BMI or waist circumference 2. The following tests/measure should be conducted during maintenance treatment Serum lithium level every 3 months U&Es and TFTs every 6 months Weight or BMI or waist circumference during the last year

5 LITHIUM MONITORING QIP Audits Baseline 2008 Re-audit 2010 Supplementary 2011 Supplementary 2013 Number of Trusts participating Number of patients ,373 3,646 5,683 6,400

6 % OF PATIENTS WITH A DIAGNOSIS OF BIPOLAR DISORDER PRESCRIBED MEDICATION IN ADDITION TO LITHIUM Other drugs prescribed 2008 (n=1,919) 2010 (n=2,060) 2011 (n=3,276) 2013 (n=3,610) Valproate 14% 13% 13% 13% Carbamazepine 6% 5% 4% 4% Lamotrigine 4% 5% 6% 7% An antidepressant 36% 35% 41% 40% An oral FGA 12% 9% 9% 8% An oral SGA 43% 45% 46% 48% A depot/lai 5% 5% 6% 6% Any antipsychotic 57% 58% 58% 59% No other mood stabiliser, antidepressant or antipsychotic 20% 21% 17% 18% One of the above 46% 46% 50% 46% Two of the above 28% 29% 29% 31% Three or more of the above 5% 5% 5% 6%

7 INFORMATION PROVIDED AT INITIATION OF LITHIUM TREATMENT Pre-treatment (N=397) (N=478) (N=626) (N=714) Side effects of lithium 62% 53% 70% 68% Signs/symptoms of lithium toxicity 45% 38% 61% 57% Risk factors for lithium toxicity 42% 33% 57% 54% Women <50 years of age (N=140) (N=169) (N-189) (N=225) Teratogenic potential of lithium 27% 24% 48% 47% 100% Renal function tests Thyroid function tests 80% 60% Pre-treatment screening tests 40% 20% 0%

8 PATIENT LITHIUM PACK Change intervention POMH-UK collaborated with the National Patient Safety Agency (NPSA) on the development of an information booklet for patients taking lithium Information about lithium treatment Patient-held record book for blood test results Wallet-sized lithium treatment card that can be shown to healthcare professionals 170,000 distributed in first three years

9 BASELINE: NUMBER OF SERUM LITHIUM TESTS OVER THE PAST YEAR Patients receiving lithium for more than 1 year: n=2, % % 80% Proportion of patients 70% 60% 50% 40% 30% 20% 10% 0% TNS Trust code 4 or more 2 or 3 1 None

10 PROPORTION OF PATIENTS FOR WHOM THE AUDIT STANDARDS WERE MET IN 2010 AND 2011 Total national sample Trust Treatment initiation (n=626) Maintenance treatment (n=5,057) Treatment initiation Maintenance treatment Renal tests Renal function (2 or more tests) Renal tests Renal function (2 or more tests) Thyroid tests Thyroid (2 or more tests) Thyroid tests Thyroid (2 or more tests) Body weight measures Body weight (1 or more measures) Bodyweight measures Bodyweight (1 or more measures) Serum lithium (4 or more tests) Serum lithium (4 or more tests) Re-audit 2010 Supplementary 2011 Re-audit 2010 Supplementary 2011 Re-audit 2010 Supplementary 2011 Re-audit 2010 Supplementary 2011

11 Baseline 2008 Re-audit 2010 Supplementary 2011 Supplementary 2013 WEIGHT/BMI/WAIST CIRCUMFERENCE DURING MAINTENANCE TREATMENT Baseline (2008: n=2,976), re-audit (2010: n=3,169), first supplementary audit 7c (2011: n=5,057) and supplementary audit 7d (2013: n=5,686) 100% 80% 60% 73% 69% 58% 56% 0 tests 40% 20% 0% 24% 24% 14% 17% 13% 14% 18% 20% 1 test 2 or more

12 Baseline 2008 Re-audit 2010 Supplementary 2011 Supplementary 2013 Baseline 2008 Re-audit 2010 Supplementary 2011 Supplementary 2013 Baseline 2008 Re-audit 2010 Supplementary 2011 Supplementary 2013 MONITORING OF MAINTENANCE TREATMENT WITH LITHIUM 100% 80% 60% 40% 20% 0% 10% 11% 22% 23% 38% 36% 30% 30% Serum lithium 4% 5% 16% 17% 32% 30% 48% 48% 0 tests 1 tests 2 or 3 tests 4 or more Thyroid function tests 18% 20% 8% 10% 26% 25% 33% 31% 0 tests 1 test 100% 80% 60% Renal function tests 19% 22% 10% 7% 20% 20% 26% 25% 49% 49% 66% 65% 2 or more 40% 20% 55% 53% 70% 73% 0%

13 TNS MOST RECENTLY RECORDED LITHIUM LEVEL (MMOL/L) FOR PATIENTS WHO HAVE BEEN RECEIVING LITHIUM FOR >1 YEAR IN EACH TRUST AT SUPPLEMENTARY AUDIT: Greater than mmol/l Most recent previous audit Less than 0.4 mmol/l No lithium level reported

14 Proportion of patients MOST RECENTLY RECORDED LITHIUM LEVEL FOR PATIENTS WITH MOOD DISORDER TREATED FOR >1 YEAR Baseline (n=2,776), re-audit (n=2,906), first supplementary audit (n=4,517) and 100% 90% 80% second supplementary audit (n=4,524) 70% 60% 50% 40% 30% 20% % 0% Plasma lithium level

15 egfr AND LITHUM MONITORING Data from the 2013 supplementary audit suggested that: Less than half of patients have egfr results documented before starting lithium At least a third of patients established on lithium treatment have no documented egfr in the past year Stages GFR (ml/min/1.73m 2 ) Description Management 1 90 Normal renal function Measure egfr and blood pressure annually Mildly reduced kidney function If heavy proteinuria present, refer to nephrology If proteinuria (not heavy) present, monitor albumin to creatinine ratio annually Health advice as appropriate: smoking cessation, aerobic exercise, weight loss, limiting alcohol and sodium intake 3a Moderately reduced 3b kidney function Severely reduced kidney function 5 <15 Established renal failure Check egfr every 3 months Monitor albumin to creatinine ratio annually Control blood pressure Stage 3b: measure Hb, refer to nephrology, discuss lithium discontinuation if heavy proteinuria or proteinuria + haematuria present, or if egfr has rapidly declined Involvement of specialist renal service Monitoring for any deterioration in egfr, treatment of complications and preparation for dialysis where appropriate

16 LITHIUM MONITORING QIP: CONCLUSIONS Data from mental health Trusts participating in the POMH-UK QIP over time showed that the proportion of patients monitored in line with NICE standards increased markedly between baseline and supplementary audits Serum lithium levels within the therapeutic range were maintained in the majority of patients A significant minority of patients prescribed lithium had a subtherapeutic blood level and so may be at high risk of relapse The proportion with no documented monitoring of renal or thyroid function halved Practice informing patients about potential lithium side effects, signs and symptoms of lithium toxicity, and risk factors for toxicity showed some improvement between baseline and the supplementary audits Analysis of the clinical audit data revealed areas where there were gaps between the practice standards and routine clinical practice