Depression & Generalised Anxiety Disorder Treatment Summary (Primary and acute care) v1.6 Step 1 •Screening for depression •During the last month have you been feeling down, depressed or hopeless? •During the last month have you often been bothered by having little interest or pleasure in doing things? •If yes, during the last month, have you often been bothered by: Feelings of worthlessness? Poor concentration? Thoughts of death •Screening for Anxiety •During the past four weeks, have you been bothered by feeling worried, tense, or anxious most of the time? •Are you frequently tense, irritable, and having trouble sleeping? Step 2 Step 3 •Treatment of mild depression/generalised anxiety disorder •Offer watchful waiting/active monitoring, guided self-help (e.g. internet based CBT), group CBT or referral to community psychology services (IAPT) (mandatory in all children) . •Short periods of exercise may be helpful. •Offer antidepressants if there is a history of major depression, symptoms persist after other interventions or symptoms are protracted (more than 2 years). •Pharmacologic treatment of depression (Treatment threshold: PHQ-9 ≥12/27) •Consider psychology (IAPT) or an antidepressant or both. •1st line: citalopram or fluoxetine 20mg OD . Start 10 mg OD in elderly and *children. •2nd line antidepressant: If no response after 6 weeks, switch to an alternative SSRI (sertraline 100mg OD) or mirtazapine 30mg OD.3rd line: If still no response within 6 weeks, switch to venlafaxine immediate release (75mg BD or greater) or consider augmentation strategy. Also consider referring to mental health services. Augmenting in adults sooner may bring about remission in more patients. For GPs with special interest in mental health, consider adding a second antidepressant (e.g. venlafaxine+mirtazapine or sertraline+(mirtazapine or venlafaxine). For specialists, consider adding the following to an antidepressant: lithium (>0.4mmol/L), an antipsychotic i.e. risperidone (1-2mg/day), olanzapine (2.5-5mg/day ) or quetiapine (150-300mg/day) or liothyronine. Prescribing in children should be initiated by a specialist. •Pharmacologic treatment of generalised anxiety disorder •1st line: sertraline 200 mg/day (unlicensed) or paroxetine 20 mg/day •2nd line : If no response consider switching to an alternative SSRI or venlafaxine 75mg/day •3rd line: Pregabalin 200 to 450 mg/day in 2 divided doses Considerations when choosing an antidepressant Seizures: avoid TCAs, use SSRIs Renal, liver impairment, children or elderly: start low & increase slowly, consider mirtazapine or a SSRI with a shorter half-life. Increased risk of bleeding: mirtazapine 1st line. Consider adding a PPI when using other antidepressants. CVD: mirtazapine 1st line. CVE: sertraline 1st line. All SSRIs (escitalopram and citalopram especially) increase the QTc interval. Where possible avoid other QTc prolonging drugs or monitor ECG. All antidepressants may increase the risk of suicidal ideation in children and young adults, monitor closely. Fluoxetine should be used 1st line. Hyponatraemia: trazodone (lower risk) & agomelatine (non-formulary), elderly/those with a low BMI are prone. Monitor sodium. BPSD: Use an antidepressant when there are significant depressive features. *Referral Practitioners without a special interest in mental health are advised to refer all patients with severe, chronic, resistant depression, patients at high risk of suicide or any children and adolescents with depression to mental health services. Advice & Support Psychiatric Medicines Information (020 3513 4566) OR your local Mental Health Team. For professionals: www.bnf.org.uk www.medicines.org.uk www.nhsevidence.nhs.uk For patients & carers: www.medicationandchoice.org/swlstg-tr (medicines & comparison charts) www.nhschoices.nhs.uk www.swlstg-tr.nhs.uk/advice-support/ 1 Homeless Persons Units: www.homelesslondon.org Employment: www.adviceguide.org.uk Depression and anxiety disorder treatment Introduction This guidance is intended to give clinicians in South West London information concerning the treatment of depression and anxiety in line with local prescribing policy and national treatment and technology appraisals and guidance. Screening questions (See summary) Screening questions are useful tools to assess whether a patient should be further investigated for depression and anxiety. Those with long term physical health conditions should be targeted as these are associated with higher levels of depression than the general population. Diagnosis 1. Assessment of depression: Severity of depression is likely to be greater when more symptoms are present with functional and social impairment, and a longer duration of symptoms. Assess for these symptoms to make a diagnosis of depression using the ICD 10: 2. Anhedonia – loss of interest in pleasurable CORE SYMPTOMS: activities 1. Persistent pervasive low mood 3. Decreased energy d) Negative image about self and the future ADDITIONAL SYMPTOMS: e) Ideas/acts of self-harm or suicide a) Reduced attention and concentration f) Disturbed sleep b) Reduced self-esteem and self confidence g) Disturbed appetite c) Ideas of guilt and unworthiness MILD EPISODE: At least 2 core symptoms and 2 other additional symptoms MODERATE EPISODE: At least 2 core symptoms and 3 other additional symptoms Both mild and moderate episodes can be present with/without somatic symptoms. SEVERE EPISODE: All 3 core symptoms and 4 or more additional symptoms with severe intensity. 2. Assessment of Anxiety disorder: The symptoms must be present for most days for at least several weeks at a time and usually for several months. Generalised and free floating anxiety. Persistent symptoms of apprehension, motor tension and autonomic over activity. Frequent need for reassurance and recurrent somatic symptoms may be prominent. However, if the person does not fulfil these criteria (sub-threshold symptoms), they should not be dismissed as they may still have potential for considerable morbidity. Assess the risk of suicide Ask all suspected patients with depressive symptoms about suicidal ideation and current intent at assessment, follow-up and on initiation and dose changes of antidepressants. Suggested questions are below. In depression the more actions a patient has taken to attempt suicide and the fewer barriers there are to stop them undertaking the act, the higher risk of suicide (in personality disorder the clinical picture may be more complicated). Those depressed with a diagnosis of bipolar disorder are known to have a higher risk of suicide than those with depression alone. o Do you ever think about suicide? o Have you made any plans for ending your life? o Do you have the means for doing this available to you? o What has kept you from acting on these thoughts? Risk factors for suicide1 Social characteristics Male gender Young age (< 30 years) Advanced age Single or living alone (poor social support & no responsibility for children) 2 History Prior suicide attempt(s) Family history of suicide History of substance abuse Recently started on antidepressants Clinical/diagnostic features Hopelessness Psychosis Anxiety, agitation, panic attacks Concurrent physical illness Severe depression Rating scales objectively rate the severity of symptoms of depression and anxiety and help to empower patients. Suggested scales are: Depression self-administered Scale (PHQ-9): ≥12 (max 27) threshold for treatment, download free: www.depression-primarycare.org Anxiety Scale (Covi): ≥9 clinically relevant anxiety Consider co-morbidities, social and cultural factors Consider coexisting psychological and psychiatric disorders, such as bipolar disorder, dementia, eating disorders, obsessive compulsive disorder, post-traumatic stress disorder and alcohol abuse. Grief reaction may present as depression. The first line of management should be bereavement counselling rather than medicines. Dementia may present as depression as they share symptomatology (disorientation, memory loss, and distractibility). o Approximately a third of people with dementia develop depressive symptoms. Pseudodementia describes cognitive impairment due to depression in the elderly. o A primary diagnosis of depression is suggested by: o Preservation of a reasonable memory. o Personal or family history of depression. o A successful trial of treatment for depression which alleviates symptoms of dementia. Parkinson’s Disease is associated with mild dementia in approximately a third of people, and tends to become more severe in the end stages. Approximately half of people with Parkinson’s disease develop depression during their illness. Consider underlying medical conditions with known associations with depression: o Chronic diseases (e.g. chronic pain, diabetes and cardiac disease). o Cerebrovascular disease (stroke, subarachnoid haemorrhage). o Endocrine disorders (hypothyroidism, Cushing’s syndrome, adrenal insufficiency, hyperparathyroidism, hypopituitarism). o Cancer (e.g. pancreatic) o Autoimmune conditions. Consider the effect of substances of abuse and psychiatric side effects of medical drugs: o Carbon monoxide poisoning. o Substance misuse (e.g. alcohol, anabolic steroids, cannabis, cocaine & opiates). o Centrally-acting antihypertensives (such as methyldopa), lipid-soluble beta-blockers (e.g. propranolol), central nervous system depressants, opioid analgesics, retinoids (e.g. isotretinoin), interferons & steroid withdrawal. Consider socio-cultural differences in presentation: eg: Asian women presenting with somatic symptoms rather than mood symptoms. Treatment Mild depression or sub threshold symptoms Antidepressants are not recommended and are considered ineffective unless the symptoms inhibit treatment of a physical health condition, there is a history of major depression, symptoms persist after other interventions or symptoms are protracted (more than 2 years).2&3 Watchful waiting, guided self-help4 (e.g. internet based CBT), group CBT or referral to community psychology services (IAPT) may be useful.5 Evidence for exercise is conflicting, short periods of exercise may be enough to have an effect.6 Those with anxiety disorders alone should be offered psychological therapies before initiation of antidepressants. IAPT services (hyperlinks below) All accept self-referral from patients with borough based GPs and referrals from GPs for the treatment of anxiety and depression. Wandsworth 0203 513 6264 Sutton & Merton 0800 032 4207 Richmond 020 8548 5550 Kingston 0203 513 3000 Moderately severe depression or anxiety Non-pharmacological interventions via referral to local psychological therapist or IAPT should be considered along with antidepressant medicines. 3 1st line antidepressant treatment for working age adults are citalopram or fluoxetine, 20mg each morning. These doses treat acute depression and prevent return of symptoms. Treatment may take up to 2 weeks to begin to have a therapeutic effect and should be continued for 6 months after abatement of symptoms in 1st episode depression. Long term treatment may be considered in chronic or relapsing depression. NICE recommends continuation for at least 2 years where there is a risk of relapse. Short-term (2 weeks) hypnotics may be prescribed for insomnia: zopiclone 3.75-7.5mg ON PRN or promethazine 25-50mg ON PRN. After six weeks of no response to 1st line antidepressant, consider switching to a 2nd SSRI (sertraline 100mg OD) or mirtazapine 30mg OD. Those with anxiety alone or generalised anxiety disorder requiring treatment should have a 1st line antidepressant (SSRI). Paroxetine 20mg or sertraline 200mg (unlicensed) should be prescribed 1st line. If no response consider switching to an alternative SSRI or venlafaxine 75mg/day. Patients who have not responded to a first and second antidepressant or do not tolerate antidepressants may have a trial of pregabalin (prescribed twice daily, titrated to 200 mg to 450 mg/ day). Depression as a ‘behavioural and psychological symptom of dementia should be treated taking in to consideration co-morbidities in line with recommendations for treating elderly patients. Agitation in BPSD with a background of depressive symptoms may improve when treated with SSRIs (citalopram or sertraline).7 See the “Medicines for behavioural and psychological symptoms in dementia (BPSD) guidance” for further information. Considerations when initiating an anti-depressant Antidepressants increase the risk of seizures, there is a paucity of evidence to choose one antidepressant over another; avoid tricyclic antidepressants. All antidepressants increase the risk of hyponatraemia (excluding agomelatine); trazodone may be lower risk. Elderly/those with low BMI are more prone and require sodium level monitoring. Antidepressants may accumulate in renal & liver failure. Start low and increase the dose slowly. Antidepressants that affect serotonin increase the risk of bleeding (especially when combined with anticoagulants or NSAIDS). Mirtazapine is the 1st line option where there is an increased risk of bleeding. Mirtazapine may still slightly increase the INR when given with warfarin. Other antidepressants may increase the risk of bleeding; consider adding a PPI when prescribing other antidepressants in patients with a high risk of bleeding (e.g. peptic ulcer in elderly or other comorbidities). Avoid TCAs in those with a known history of overdose. Mirtazapine is the drug of choice in cardiovascular disease, avoid TCAs which increase the risk of MI in the first 3 months of treatment.8 Cardiac side-effects are also less common with moclobemide. Citalopram and escitalopram (non-formulary in South West London except by recommendation from Tier 4 OCD services) are known to cause QTc elongation. They should not be prescribed in combination with other QTc prolonging medicines and in high doses unless in line with South West London recommendations. o All SSRIs have reports to the MHRA that they cause QTc prolongation. Mirtazapine (as yet) does not. Venlafaxine is known to cause QTc prolongation in overdose at the same rate as SSRIs. o Having cardiovascular disease does not contraindicate the use of QTc prolonging antidepressants, close monitoring is advised. They should be avoided in those at high risk of torsades e.g. untreated electrolyte abnormalities or malignant arrhythmias. Pregnancy & Lactation: See National guidelines Agomelatine, bupropion, duloxetine, escitalopram and reboxetine are non-formulary in South West London for the treatment of depression and anxiety. If alcohol or use of illicit substances are considered to be a primary factor in contributing to depression or anxiety consider referring to local Drug and Alcohol Teams before initiating treatment. The majority of symptoms of depression and anxiety resolve when there is abstention from drugs and alcohol. Severe, chronic or resistant depression Practitioners without a special interest in mental health are advised to refer all patients with severe, chronic, resistant depression or are at high risk of suicide to mental health services. Treatment of chronic or resistant depression may involve augmenting an antidepressant with a second antidepressant or other agents such as: lithium, an antipsychotic (risperidone, olanzapine or quetiapine) or 4 liothyronine (not advised as augmenting agent by NICE). Evidence suggests that of the formulary antidepressants sertraline may be the most effective and augmenting sooner may bring about remission in more patients. Further information, advice & support on medicines (See summary) Mental health services contacts Kingston Wandsworth Merton OP CMHT Merton assessment (18-75) Sutton OP CMHT Sutton assessment (18-75) Kingston Hospital OP Liaison St George’s Hospital Liaison Merton CAMHs Sutton & Merton CMH & ID Sutton CAMHs Kingston Hospital Liaison St Helier Hospital Liaison Children & young people (under 18 years) Depression Children & young people should only be offered antidepressants in conjunction with psychological therapies (as this may be a more effective treatment than antidepressant alone) initiated in secondary care.9&10 Fluoxetine is the antidepressant of choice in those aged 8 and above.11 Start at 10mg each day (20mg/5mL liquid) increasing to 20mg each day after a week if necessary. Doses of 40-60mg each day are rarely needed. Those with lower body weight or intellectual disabilities may require lower doses. Poor or no response to fluoxetine & psychological therapies may warrant switching antidepressants after exclusion of other contributing factors. Sertraline (start at 25mg each day and gradually increase to the adult dose over 2-4weeks) and citalopram (start at 10mg each day and gradually increase to 20mg each day over 2-4weeks) are second line agents. Venlafaxine may be prescribed as a third line agent, but is associated with more side-effects then SSRIs.12 All antidepressants with the exception of fluoxetine have regulatory warnings over the risk of suicide, aggression and paucity of evidence of therapeutic benefit in children and young people with depression.13,14,15,16&17 Children and young people should be monitored for the appearance of suicidal behaviour, self-harm or hostility on initiation and dose changes of antidepressants. Evidence supports the use of sertraline in those 6 years and above. TCAs are not effective in pre-pubertal children.18 Anxiety & generalised anxiety disorder in children and adolescents Management largely follow the treatments for adults. Medicines used to treat anxiety in children and adolescents should only be tried after failure of non-pharmacological interventions. Switching & stopping antidepressants All antidepressants have a risk of discontinuation effects. These may range from anxiety symptoms to flulike symptoms and ‘electric shock’ effects. Discontinuation effects are not harmful but can be very uncomfortable. Antidepressants should be tapered down thereby reducing the risk of discontinuation effects. Switching antidepressants may involve cross tapering or stopping one antidepressant before starting another. Advice should be sought before attempting to switch: See the Maudsley Prescribing Guidelines (free via NHSevidence) or contact Specialist Medicines Information 020 3513 6829 for advice. 5 Submission to SWL Medicines Decision Making Groups Date of Meeting: Person presenting at meeting: Agenda No: Attachment: Title of Document: Depression & anxiety disorder treatment guidance Purpose of Report: For discussion and comment & Approval for primary care or acute care health providers Report Author: Submitting Team/Organisation: Carl Holvey Mental Health Interface Prescribing Forum Contact details: Carl.holvey@nhs.net 020 3513 4566 Executive Summary: (precise purpose of document) To aid clinicians working in primary care and acute care organisations to prescribe for depression and generalised anxiety disorder. This documented is to be shared across healthcare organisations in South West London to ensure there is consistency and a shared understanding of the treatment of depression. Key sections for particular note (paragraph/page), areas of concern etc: Recommendation(s) for the committee: Approve and communicate the publication across the organisation. Committees which have previously discussed/approved/declined the report and/or Leads who have been consulted and key outcomes See below Financial Implications: Nil Other Implications if applicable: (including patient and public involvement/Legal/Governance/Risk/Diversity/ Staffing) This guide has been seen by patient and care representatives as part of South West London and St George’s NHS Trust. How will this document be disseminated and to whom? The Mental Health Interface prescribing forum proposes joint education meetings in depression and physical health of those with severe and enduring mental illness between primary and secondary care to aid dissemination of this guide. 6 Working in Partnership Depression & anxiety disorder treatment guidance for primary care or acute care health providers 7 Version 1.6 TWC21a Ratified by SWLStG Drug & Therapeutics Committee (& other CCG/participating body organisations) Date ratified 12/2/2014 Contributors Sedina Agama, Chief Pharmacist, Merton CCG Gursharon Bains, Primary Care Pharmacist, Kingston CCG Carl Holvey, Principal Clinical and Deputy Chief Mental Health Pharmacist, Kingston CCG & South West London & St George’s NHS Trust Hetal Naik, Pharmacist, Merton CCG Shaistah Qureshi, Senior Pharmacist Richmond CCG Dr Nova Hart, Consultant Psychologist Fiona White, Nurse Practitioner, Merton CCG Dr Chris Keers, Sutton CCG Dr Andrew Otley, Merton CCG Dr Anthony Hughes, Kingston CCG Dr Shubra Rao, SWLStG, Adult & ID Psychiatrist Dr Alice Lomax, SWLStG, Psychiatrist Dr Jim Bolton, SWLStG, Liaison Psychiatrist Dr Maurice Zwi, SWLStG, Child & Adolescent Psychiatrist Dr Sim Roy-Chowdhury, East London NHS FT, Consultant Clinical Psychologist and Psychotherapist Responsible committee Drugs and Therapeutics Committee Mental Health Interface Prescribing Forum Date of implementation - Date of last review - Date of next review 12/2/16 Target audience Clinicians treating depression & anxiety in primary care or Acute Care Equality impact assessment & Governance This policy is written by South West London and St George’s NHS Trust for CCGs and acute care. They are responsible for the monitoring and implementation of this policy. Review will occur at the South West London Mental Health Interface Prescribing forum. Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared The CCGs receive prescribing review information on prescribing antidepressants as part of the London wide QIPP initiative Each CCGs will have their own lead. See London procure partnershi p website. QIPP data is send quarterly by the London Procurement Partnership to CCGs and NHS Provider Trusts. Each CCG and organisation are responsible for reviewing and reporting to their prescribing lead group. The Mental Health Interface Prescribing forum will suggest possible actions required for CCGs or acute provider organisations to aid compliance with this policy. The medicines ratification body in each organisation is responsible for ensuring action s identified and carried out from review of compliance of this policy. Each CCG and organisation are responsible for acting on their own results from compliance with this policy. ASSOCIATED DOCUMENTS South West London Mental health formulary SWLStG Shared care of psychotropics & discharge of patients Psychotropic Physical monitoring of Mental health medicines for GPs summary All shared mental health prescribing policies for South West London are available: http://www.swlstg-tr.nhs.uk/for-health-professionals/ Equality Impact Assessment Tool Yes/No 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race No Ethnic origins (including gypsies and travellers) No Nationality No Gender No Culture No Religion or belief No Sexual orientation including lesbian, gay and bisexual people No Age No Disability - learning disabilities, physical disability, sensory impairment and mental health problems No 2. Is there any evidence that some groups are affected differently? No 3. If you have identified potential discrimination, are any No 8 Comments Yes/No Comments exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? No 5. If so can the impact be avoided? N/A 6. What alternatives are there to policy/guidance without the impact? 7. Can we reduce the impact by taking different action? achieving the N/A N/A References 1 National Institute for Clinical Excellence. Depression: The treatment and management of depression in adults. Clinical Guideline 90. Amended October 2009. www.nice.org.uk. 2 Barbui C, Cipriani A, Patel V et al. (2011) Efficacy of antidepressants and benzodiazepines in minor depression: systematic review and meta-analysis. British Journal of Psychiatry 198: 11–16 Full text: www.bjp.rcpsych.org/content/198/1/11.full.pdf+html 3 Gartlehner G, Hansen RA, Morgan LC et al. (2011) Comparative benefits and harms of second-generation antidepressants for treating major depressive disorder: an updated meta-analysis. Annals of Internal Medicine 155: 772–85 Full text: www.annals.org/content/155/11/772.full.pdf+html 4 Cuijpers P, Donker T, Johansson R et al. (2011) Self-guided psychological treatment for depressive symptoms: a meta-analysis. PLoS ONE 6: e21274 Full text: www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0021274 5 van t’Hof, Cuijpers P, Waheed W et al. (2011) Psychological treatments for depression and anxiety disorders in low- and middleincome countries: a meta-analysis. African Journal of Psychiatry 14: 200–7 Full text: www.ajop.co.za/Journals/july2011/Psychological treatments.pdf 6 Krogh J, Nordentoft M, Sterne JAC et al. (2011) The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials. Journal of Clinical Psychiatry 72: 529–38. www.article.psychiatrist.com/dao_1login.asp?ID=10007122&RSID=35271304530341 7 Pollock BG et al. Comparison of Citalopram, Perphenazine, and Placebo for the Acute Treatment of Psychosis and Behavioural Disturbances in Hospitalized, Demented Patients. Am J Psych 2002; 159(3):460-465. 8 Ray, W.A. et al: Cyclic Antidepressants and the Risk of Sudden Cardiac Death; Clin. Pharm. Ther. 2004; 75(3): 234-41. Tata et al 2005. General population based study of the impact of tricyclic and selective serotonin reuptake inhibitor antidepressants on the risk of acute myocardial infarction Heart 2005;91:465-471 http://heart.bmj.com/cgi/content/full/91/4/465 9 NICE Clinical Guideline 28, September 2005. Depression in children and young people. Identification and management in primary, community and secondary care. www.nice.org.uk. 10 Reference guide to consent for examination or treatment (2001). Accessed on www.dh.gov.uk 1st June 2010. 11 Duff G. Safety of venlafaxine in children and adolescents under 18 years in the treatment of depressive illness. 19th September 2003. 12 March et al. Fluoxetine, cognitive-behavioural therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) Team. JAMA 2004; 292: 807-820. 13 Goodyer et al. A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors. The ADAPT trial. Health Technology Assessment 2008; Vol. 12: No. 14 14 Dubicka B, Elvins R, Roberts C et al. Combined treatment with cognitive–behavioural therapy in adolescent depression: metaanalysis. Br J Psychiatry 2010; 197:433–40. 15 Bridge JA, Iyengar S, Salary CB et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA 2007; 297:1683–96. 16 Hughes CW, Emslie GJ, Crismon ML et al. Texas Children’s Medication Algorithm Project: update from Texas Consensus Conference Panel on Medication Treatment of Childhood Major Depressive Disorder. J Am Acad Child Adolesc Psychiatry 2007; 46:667–86. 17 MHRA Citalopram and escitalopram: QT interval prolongation—new maximum daily dose restrictions (including in elderly patients), contraindications, and warnings. Drug Safety Update Vol 5 Issue 5, Dec 2011: A1. 18 Cochrane Database of Systematic Reviews: Plain Language Summaries. Tricyclic drugs for depressed children and adolescents. First published: June 18, 2013; Review content assessed as up-to-date: April 12, 2013. References in relation to Equality Impact Assessments (section 4.5) Health and Social Care Act 2001 The Human Rights Act 1998 The Equal Pay Act (as amended) 1970 Promoting Equality and Human Rights in the NHS - A Guide for Non-Executive Directors of NHS Boards (2005) Department of Health NHS Act 2006 The Equality Act 2010 NHSLA template on policy for policies June 2007 9