This review will look at current practice in relation to points 1,3, 4 and 5 from the GP practice perspective. The audit standards are:

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1 NHS Dumfries & Galloway - Medicines Management Audit Review of drug monitoring lithium October 2010 Lithium is a long-term treatment used clinically for bipolar disorder. Lithium has a narrow therapeutic/toxic ratio and maintaining patients within the appropriate therapeutic margin requires scheduled monitoring. A NPSA alert in Dec 2009 (NPSA/2009/PSA005) states that all prescribers check that blood tests are monitored regularly and it is safe to issue a repeat prescription. The monitoring should be in line with NICE guidance i.e. Lithium blood level measured every three months as standard, renal function tests and thyroid function tests every six months. In addition, yearly health checks and monitoring of weight are recommended. This pattern is more stringent than the audit standards in the QOF guidance for GMS contract (MH 4 & 5). Doses are adjusted to achieve serum-lithium concentration of mmol/litre (lower end of range for maintenance therapy and elderly patients)(bnf 59). In addition, it is recommended lithium is prescribed by brand to avoid variations in bioavailability between products. The National Patient Safety Agency (NPSA) have asked all NHS Organisations to ensure 1. Patients prescribed lithium are monitored in accordance with NICE guidance; 2. There are reliable systems to ensure blood test results are communicated between laboratories and prescribers; 3. At the start of lithium therapy and throughout their treatment patients receive appropriate ongoing verbal and written information and a record book to track lithium blood levels and relevant clinical tests*; 4. Prescribers and pharmacists check that blood tests are monitored regularly and that it is safe to issue a repeat prescription and/or dispense the prescribed lithium; 5. Systems are in place to identify and deal with medicines that might adversely interact with lithium therapy. This review will look at current practice in relation to points 1,3, 4 and 5 from the GP practice perspective. The audit standards are: 100% of patients should have their Lithium prescribed by brand. 100% of patients should have Lithium within the therapeutic range in the last 3 months. 100% of patients should have thyroid function checked in the last 6 months. 100% of patients should have their renal function checked within 6 months. 100% of patients should have their weight and BMI taken in the last year. 100% of patients should have been offered written information on Lithium and a book to record their lithium results* * The NPSA has developed a patient information booklet, lithium alert card and record book for tracking blood tests. Search for all patients prescribed the following on repeat prescription within the last 6 months: Lithium carbonate Camcolit Liskonum Priadel Patients with terminal condition

2 Other as defined by GP! " " # Implementation of audit in selected GP practices is as follows: $ Protocol to be discuss with all GPs in the practice to ensure that agreement to proceed is reached Computer search of all patients according to the inclusion criteria Review of patient s medical notes and repeat prescribing records against audit standards GPs to determine if appropriate monitoring and appropriate action is being taken on these results for their individual patients Patients to be invited for review as determined by the audit e.g. who are overdue for monitoring, whose results require further action etc. GPs, and practice staff, to ensure a robust system for routine recall of patients is in place. Admin staff in practices to be made aware of importance of drug monitoring. Patients should receive appropriate written and verbal information about their treatment, their blood results and current dose. They should be informed of the known side effects and symptoms of toxicity. They should have a record book to track blood tests. The written information recommended by the NPSA will be made available through the Prescribing Support Team for current patients. The information should be issued to new patients from their mental health team/hospital pharmacy or community pharmacy. % " # The findings of this review should be written into a short report detailing whether the NPSA standards are being met and/or what changes to practice processes are being made in order that they are met. Review to be undertaken by: GP Authorisation: Date:

3 Lithium Medication Review Form Date: Practice: Actions Patient Name & CHI Drug, Dose Prescribed Prescribed by Brand? Date and value for latest Lithium level Is Lithium in range? Was this taken within last 3 Is it being checked every 3 Date and value of latest thyroid function tests Are values within range? Was this taken within last 6 Is it being checked every 6 Date and value of latest renal function tests Are values satisfactory? Were these taken within last 6 Are they checked every 6 Has the patient s weight /BMI been taken in the last year? Is it checked each year? Have their been any significant changes to weight/bmi? Compliance: Is the patient ordering their Lithium on a regular basis? Are there any relevant drug interactions? Any reason to exclude the patient from the recommended monitoring? Has patient been given the NPSA patient information leaflet? Alert Card? Lithium Record Book? Are these accurate/consistent with recent consultations/letters? If no, change record to specify brand Investigate any trends, adjust dose as necessary Invite patient for testing every 3 months Change recall system Hypothyroidism may require levothyroxine treatment Invite patient for testing every 6 months Change recall system Declining egfr may indicate need for dose adjustment or withdrawal of treatment Invite patient for testing every 6 months Change recall system If no, record weight at next blood test Change recall system Investigate any unusual increases (?hypothyroidism) or decreases (?worsening depression etc.) If no, or results, behaviour etc. suggest poor compliance contact patient to discuss Assess using patient s repeat and acute medication lists with help of BNF +/- Stockley s drug interactions. Pay particular consideration to drugs affecting renal function or sodium levels. If in doubt of potential importance of interaction contact a Prescribing Support Pharmacist. Ask about use of OTC medicines when patient is at clinic. Give out at next review or post to patient

4 " " & ' These tables have been adapted from the NPSA standard operating procedure for the dispensing of Lithium. They provide an overview of clinical information relevant to monitoring patients who take Lithium. They were intended as a reference for Pharmacists when referring issues to a GP. They are not intended as a complete reference and GPs may wish to consider other issues when reviewing their patients.

5 Lithium blood level CLINICAL INFORMATION Test Clinical reason Frequency of test Normal range What to check for Blood levels are an indication of Once blood levels are Determined by prescriber and Levels below or above the patient s clinical efficacy or potential stable, normally every 3 documented in the patient s lithium target blood level range. Also, the toxicity. months. Monitoring therapy record book. Potential trend in blood levels. Progressively Levels should be within target should be increased with range between 0.4mmol/L increasing lithium levels are a range, not sub therapeutic or potential drug drug 1mmol/L. NICE suggests consequence of deteriorating renal toxic. Toxicity has been seen at interactions, such as the mmol/l as the optimum range. function. Be more vigilant with levels 1.2 mmol/l, but it is very introduction of thiazide elderly patients, or patients dependent on renal function. In diuretics. However, some patients who are experiencing side effects which elderly renally compromised young with excellent renal function could be signs of toxicity. patients, levels <1 mmol/l have may require up to 1.2mmol/L. been toxic. A change in formulation should be treated as initiation of therapy for monitoring i.e weekly until stable. Higher levels are required for patients with acute exacerbations of mania. Thyroid function tests (TFTs) Lithium is associated with longterm risk of hypothyroidism. Every 6 months. Laboratories vary in the method of testing and in the units of reporting, thus the normal range may vary. TSH values which are increasing and/or free T4 values that are decreasing. Approximate normal reference ranges are: Thyroid-stimulating hormone (TSH) mU/L Free thyroxine (FT4) 9-26pmol/l FreeT4 is depressed with hypothyroidism. Patients with a sustained increase in TSH of greater than twice the upper limit of normal (~10 mu/l)

6 Test Clinical reason Frequency of test Normal range What to check for which is confirmed by repeat testing after 2 weeks should be treated with levothyroxine. A patient with a TSH which is around double the normal upper limit (~10 mu/l) or between the upper normal limit and double the normal upper limit (~5.5mU/L - ~10mU/L) may require additional monitoring and possible treatment with levothyroxine. Estimated glomerular filtration rate (egfr) Weight/BMI Measures the level of kidney function. Lithium associated with long-term risk of chronic renal impairment. Commonly patients do gain weight; however, loss of weight is linked to worsening depression. Weight gain may be linked to hypothyroidism and viewed as a complication of lithium therapy. Every 6 months Every 12 months as part of a general health check. Every 6 months when prescribing medication for children, adolescents or during an acute manic episode. Assays vary between laboratories. Values below 60 ml/min/1.73 m 2 are noteworthy, >90 ml/min/1.73 m 2 is considered normal. Renal function deteriorates with age. Varies between patients An egfr which is decreasing and/or results imply dosing adjustments should be considered. Trends in change in weight, or sudden changes in weight, in particular rapid weight gain.

7 Sample Letter Patient Address Dear Mr/Mrs As part of a review of prescribing, NHS Dumfries and Galloway are currently reviewing all patients prescribed lithium tablets. In order to benefit from your long-term medication without unwanted effects it is important to have regular blood tests. Your next health check and blood test is due on.please make an appointment to see your GP. If necessary your dosage will be adjusted. It is important to be aware of the possible side effects of any treatment. A patient information leaflet is attached. You should also have a lithium alert card and a record book for tracking blood tests. These are available from Should have any queries; please contact the Surgery on the number above or, alternatively, you can contact a member of the Prescribing Support Team on Yours sincerely Name Prescribing Support Technician On behalf of the Doctors

8 The Patient Safety Alert, Safer Lithium Therapy is available at Downloadable versions of the Patient Information Leaflet, Alert Care and Patient Record Book are also available via this link. The NPSA Standard Operating Procedure Supplying Lithium Therapy is available at NICE Clinical Guideline 38, Bipolar Disorder: the management of bipolar disorders in adults, children and adolescents in primary and secondary care. July Accessed 30 th July BNF advice can be accessed at