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Public Health Wales Antidepressant therapy in primary care Antidepressant therapy in primary care Quality improvement toolkit Author: Primary Care Quality and Information Service Date: January 2013 Version: 1 Status: Final Intended audience: Public (Internet) / NHS Wales (Intranet) / PHW (Intranet) Purpose and summary of document: This document is for use by general practitioners treating and advising patients with Depression. The purpose of this toolkit is to support practices to review and reflect on the service they provide and the information they record following patient consultations for Depression. This audit may be of particular interest to clinicians who have seen the recent WeMeReC Bulletin (Antidepressant therapy in primary care) and the accompanying education module, and reinforces its main points and supplements learning opportunities provided by the case studies. This toolkit provides patient review criteria and guidance on how to complete a straightforward audit. Also included is a review section designed to prompt reflection and comment on the results of the audit process. Completion of this audit would constitute a suitable piece of Continuing Professional Development that could be included within the appraisal process. Publication / distribution: Publication in PHW document database (Primary Care Quality and Information Service) Link from PHW e-bulletin Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 1 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care Contents Page Number Background 4 Management Summary 4 Aim of Audit 7 Audit Objectives 7 Patients to be Included 7 Methodology 7 Audit Criteria 8 Case Review - Data Collection Sheet 9 Case Review – Data Collection Summary 10 References 11 Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 2 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care Background – NICE describe Depression as a broad and heterogeneous condition, characterised by low mood and/or loss of pleasure in most activities. Severity is defined by the number and severity of symptoms and degree of functional impairment 1 Management Summary Antidepressant drugs – The 2009 NICE Guideline (NICE CG90) recommends that antidepressants should not be used routinely to treat sub-threshold depressive symptoms or mild depression (because the risk–benefit ratio is poor), but consider them for patients with: a past history of moderate or severe depression or mild depression which complicates the care of the physical health problem or First presentation of sub-threshold depressive symptoms that have been present for a long period (typically at least 2 years) or Sub-threshold depressive symptoms / mild depression that resist other interventions. When prescribing for a patient with depression and chronic physical illness consider: the presence of additional physical health disorders the side effects, which may impact on the underlying physical disease (in particular, SSRIs may result in / exacerbate hyponatraemia, especially in older people) The lack of evidence to support the use of specific antidepressants for patients with particular chronic physical health problems interactions with other medications 1 Key Points Antidepressants should not be prescribed routinely for mild depression 1 A generic SSRI is usually first-line 2 SSRIs are safer than TCAs in overdose 1 Hyponatraemia should be considered in patients developing drowsiness, confusion, or convulsions while taking an antidepressant 2 (see appendix A). NSAID’s should not normally be offered to patients taking SSRI’s 4 (see appendix D). Response at 4 to 6 weeks is a good predictor of overall response 5 When switching antidepressants, cross-tapering is preferred to abrupt cessation 5 Concomitant use of some antidepressants is contraindicated; a drug-free interval would prevent interactions 5 The incidence of discontinuation reactions appears to increase with higher doses, longer duration of therapy, and shorter half-life 2 In pregnancy caution should be exercised with all medication, but the SSRI’s Sertraline and Citalopram are not known to be harmful 6 (although Citalopram should be avoided in breast feeding) 3 Paroxetine and sertraline can be safely given to a woman who is breastfeeding, provided the infant is healthy and his or her progress is monitored; SSRI’s are better tolerated than TCAs and more likely to be prescribed at recommended doses for an adequate period of time 1 If for a good clinical reason a tri-cyclic antidepressant (TCA) is used, imipramine and nortriptyline are preferred for the treatment of depression in breastfeeding women 2 Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 3 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care Definitions of depression severity DSM-IV (see www.nice.org.uk/CG90niceguideline). Sub-threshold depressive symptoms (appendix A): Fewer than 5 symptoms (as below). Mild depression: Few or no symptoms in excess of the 5 required to base a diagnosis, and symptoms result in only minor functional impairment. Moderate depression: Symptoms / functional impairment between ‘mild’ and ‘severe’. Severe depression: Most symptoms. Markedly interfere with functioning. Can occur with or without psychotic symptoms 1 DSM-IV major/minor depressive disorder: Depressed mood by self-report or observation by others Loss of interest or pleasure in activities Fatigue/loss of energy Worthlessness/excessive or inappropriate guilt Recurrent thoughts of death, suicidal thoughts, or actual suicide attempts Diminished ability to think/concentrate or indecisiveness Psychomotor agitation or retardation Insomnia / hypersomnia Significant appetite and / or weight loss ASSESSMENT - Stepped care treatment of depression 2 Assessment of depression is based on the DSM-IV criteria and should include the number and severity of symptoms, duration of current episode, and illness trajectory (See appendix B) 1 Step / focus of care Responsible for care Interventions 1 All known and suspected presentations of depression GP, practice nurse Assessment, support, psychoeducation, active monitoring and referral for further assessment and interventions 2 Mild to moderate depression; persistent sub-threshold depressive symptoms Primary care team, primary care mental health worker Low-intensity psychosocial interventions, psychological interventions, medication and referral for further assessment and interventions 3 Moderate / severe depression; mild to moderate depression With poor response to initial interventions; persistent sub-threshold depressive symptoms Primary care team, primary care mental health worker Medication, high-intensity psychological interventions, combined treatments, and referral for further assessment and interventions Severe and complex depression Mental health specialists including crisis teams Risk to life; severe self-neglect Inpatient care, crisis teams 4 Medication, high-intensity psychological interventions, electroconvulsive therapy, crisis service, combined treatments, multi-professional / in-patient care. Adapted version; Original idea from NICE guideline and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 4 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care TREATMENT may be psychological (e.g. active monitoring; cognitive behavioural therapy) or pharmacological (e.g. antidepressants). For more information refer to WeMeReC Bulletin, Managing Depression in Primary Care, September 2010 Antidepressants may be considered for people with; History of moderate or severe depression Sub-threshold depressive symptoms (present for at least two years) Mild depression resistant to other interventions Mild depression complicating the care of a chronic physical health problem People suffering depression typically prefer psychological and psychosocial treatments to medication 1 (See appendix C) These include; Cognitive behavioural therapy (CBT) Behavioural activation Inter-personal therapy (IPT) MONITORING (WeMeReC) Patients to be reviewed within 2 weeks of starting treatment and regularly thereafter, typically at 2 to 4 week intervals Patients <30 years; or at increased risk of suicide to be seen more frequently. Treatment to continue for at least 4 weeks at a therapeutic dose (6 weeks in elderly patients) to determine efficacy; if effective, to be continued as below. Continuation and maintenance therapy Patients benefiting from treatment should continue for at least 6 months after remission of symptoms as evidence indicates that this will greatly reduce the risk of relapse. If the risk of relapse is significant or if the consequences of relapse are likely to be severe, treatment should be continued for at least 2 years, at an effective maintenance dose. Psychological interventions, such as individual CBT or mindfulness-based cognitive therapy, can also be beneficial in some people to prevent relapse. Stopping antidepressants To avoid or reduce discontinuation symptoms the dose of antidepressant should be reduced gradually, usually over a period of at least 4 weeks (unnecessary with fluoxetine – unless previously at higher doses) Reduce the dose over longer periods for drugs with a shorter half-life (e.g. paroxetine and venlafaxine). Advise the patient to see their practitioner if they experience significant discontinuation symptoms. People with depression who benefit from treatment with antidepressants are advised to continue with treatment for at least 6 months after remission, extending to at least 2 years for people at higher risk of harm if they relapse. (NICE Quality Standards 2011) Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 5 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care Aim of Case Review To improve the care of patients who take anti-depressant medication for depression. Review Objectives To establish that the severity of depression is recorded in all reviewed cases To confirm that the treatment provided is, in all cases reviewed consistent with the available guidance and is appropriate to the severity of the patient’s condition Patients to be included in the Case Review; Patients who take Anti-depressant medication for Depression (READ Code E2B1.) in the last 6 months, or in the last 12 months, whichever the practice decides. Patients to be excluded Those patients not managed entirely by the practice throughout the review period Methodology Identify a suitable review period (patients reviewed in the 12 months from ...) Use retrospective data gathered prior to the audit start date Compile a list of patients from the practice records of those taking anti-depressant Medication; exclude; 1) Those taking antidepressants for conditions other than depression, such as neuralgia 2) Those patients not managed entirely within the practice Select a suitable number (suggest 10) of patients, manually review the case notes and record the findings against the stated criteria using the collection sheet provided (See appendix F) Collate, using the data summary sheet (page 9) and analyse results of the data collection Reflect on the results of the audit and agree those recommendations that you consider appropriate, which may include recalling patients who do not meet the criteria (See appendix G) Decide on a date to re-audit. PCQIS suggests that the audit is repeated 6-12 months from the date that the current audit is completed IMPORTANT The results and subsequent recommendations should be viewed as a development opportunity, and it is for the practice to decide how best to utilise the findings. Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 6 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care Criteria - By reviewing selected medical records, reflect on the patient’s history with regard to their depression treatment, and answer the following; 1. Assessment 1a. Is there a record of an assessment of mood at, or just prior to the date of diagnosis? 1b. If yes, was a rating scale used to assess mood? 1c. If yes to 1a, was an appropriate READ Code ascribed at that time (see Appendix)? 1d. Were alternative or adjunctive treatments (e.g. psychological or talking therapies) considered at diagnosis? 1e if yes to 1d would the patient have been able to access such services within a reasonable period of time? 1f. If yes to 1b did using a rating scale help to reach a diagnosis or manage the patient? 2. Initial Review 2a. Was the drug, chosen on initiation the most appropriate at the time? 2b. Was the patient invited for review within 1 month of initiation? 2c. If yes to 2b, did the patient attend? 2d. If yes to 2c, is there a recorded review of tolerability / therapeutic effect of the medication? 3. Ongoing review 3a. Was the patient invited for a further review within 2 months of initiation? 3b. If yes to 3a, did the patient attend? 3c. If yes to 3b; is it recorded that the patient’s depression symptoms were reviewed at this time? 3d. If yes to 3c, Was any rating scale used in the assessment of progress? 3e. If, at review, the patients symptoms had not improved; was the medication dose increased or the agent changed? 3f. If no to 3e is it clear from the record why not? 3g. If the patient is on an Anti-Depressant, or another therapy for depression, for more than 6 months, is there a record of having received planned follow-up at least every 6 months? 4. Ongoing Medication 4a. Is the patient’s current medication the most appropriate? 4b. Was the patient ever prescribed more than one anti-depressant drug simultaneously? 4c. If yes, is it clear from the record why a further anti-depressant drug was prescribed? 5. Discontinuation of Medication 5a. Have any of the patients medications been discontinued within the last 6 weeks? 5b. If yes did this decision correlate with established guidance regarding the duration of treatment and discontinuation (pp6)? 5c. If no to 5b, was there a documented reason for the alternate management? Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 7 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care Case Review – Data Collection Table Please indicate Yes / No as appropriate Patient Criteria 1a 1b 1c 1d 1e 1f 2a 2b 2c 2d 3a 3b 3c 3d 3e 3f 3g 4a 1 2 3 4 5 6 7 8 9 10 Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 8 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS 4b 4c 5a 5b 5c Public Health Wales Case Review – Data Collection Summary. Antidepressant therapy in primary care Start date of the review _________ End date of the review ________ Criteria Description – Review 1, Assessment 1 Patients taking Anti-Depressant Medication for Depression during the chosen time period; Number in Sample 1a Of Is there a record of an assessment of mood at, or just prior to the date of diagnosis? 1b If yes, was a rating scale used to assess mood? 1c If yes to 1a, was an appropriate READ Code ascribed at that time (see Appendix)? 1d Were alternative or adjunctive treatments (e.g. psychological or talking therapies) considered at diagnosis? 1e if yes to 1d would the patient have been able to access such services within a reasonable period of time? 1f If yes to 1b did using a rating scale help to reach a diagnosis or manage the patient? Number % Number % Comments from Review 1; Description – Review 2, Initial Review Criteria 2a Was the drug, chosen on initiation the most appropriate at the time? 2b Was the patient invited for review within 1 month of initiation? 2c If yes to 2b, did the patient attend? 2d If yes to 2c, is there a recorded review of tolerability / therapeutic effect of the medication? Comments from Review 2; Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 9 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Criteria Antidepressant therapy in primary care Description – Review 3, Ongoing Review Number 3a Was the patient invited for a further review within 2 months of initiation? 3b If yes to 3a, did the patient attend? 3c If yes to 3b; is it recorded that the patient’s depression symptoms were reviewed at this time? 3d If yes to 3c, Was any rating scale used in the assessment of progress? 3e If, at review, the patient’s symptoms had not improved; was the medication dose increased or the agent changed? 3f If no to 3e is it clear from the record why not? 3g If the patient is on an Anti-Depressant, or another therapy for depression, for more than record of having received planned follow-up at least every 6 months 6 months, is there a Comments from Review 3; Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 10 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS % Public Health Wales Antidepressant therapy in primary care Description – Review 4, Ongoing Medication Criteria 4a Is the patient’s current medication the most appropriate? 4b Was the patient ever prescribed more than one anti-depressant drug simultaneously? 4c If yes, is it clear from the record why a further anti-depressant drug was prescribed? Number % Number % Comments from Review 4; Description – Review 5, Discontinuation of Medication Criteria 5a Have any of the patients medications been discontinued within the last 6 weeks? 5b If yes did this decision correlate with established guidance regarding the duration of treatment and discontinuation (pp6)? 5c If no to 5b, was there a documented reason for the alternate management? Comments from Review 5; Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 11 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS Public Health Wales Antidepressant therapy in primary care References 1 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline (CG) 90; Depression; The treatment and management of depression in adults (Oct 2009). 2 Welsh Medicines Resource Centre (WeMeReC); Antidepressant therapy in primary care (December 2010) 3 Clinical Knowledge Summaries (2011); Depression, antenatal and post natal management; which antidepressant should I prescribe for a woman who is breastfeeding? 4 National Institute for Health and Clinical Excellence. Depression in adults with a chronic physical health problem: treatment and management. NICE Clinical Guideline 91, October 2009 5 Taylor D et al. The Maudsley Prescribing Guidelines;10th Edition. London: Information Healthcare, 2009 6 BNF, 2012; http://www.medicinescomplete.com/mc/bnf/current/PHP2413selective-serotonin-re-uptake-inhibitors.htm Author Primary care quality and information service Version; 1 Date Jan 2013 Status; Final 12 Intended audience: Public (Internet) / PHW (Intranet / Internet) / PCQIS