Pregabalin Prescribing in Primary Care Audit Results 2012/13

Executive summary Pregabalin Prescribing in Primary Care Audit Results 2012/13 Pregabalin is extensively used across Aneurin Bevan Health Board (ABHB). It is the second highest medicine in terms of primary care prescribing expenditure ( 794k per quarter Dec 12) and ABHB has the highest cost per 1000 patients in Wales, 37% greater than the National average. An audit of pregabalin usage was therefore included within the Clinical Effectiveness and Prescribing Programme (CEPP) within primary care, to audit this medicine s use in relation to: Which conditions were being treated? Adherence to local and National guidance Source of Initiation Dosage regimes and dosage optimisation This audit was completed in 84 GP practices and included 3266 patients taking pregabalin. 69% of prescribing was for neuropathic pain, 22% for generalised anxiety disorder (GAD) and 9% for diabetic neuropathic pain (DNP). The results are summarised in the table below. Generally across all indications there were relatively low levels of documented adherence to local and National guidelines, and within the treatment indications for neuropathic pain and diabetic neuropathic pain there was poor documented evidence of assessment of efficacy at maximally tolerated doses. Indication % Initiated in % Adherence % Initiated in % Adherence % Initiation (n=3266) Secondary Care to Guidance Primary Care to Guidance Unknown Neuropathic 52% 34% 46% 35% 2% Pain (69%) GAD (22%) 67% 38% 32% 16% 1% DNP (9%) 45% 19% 52% 11% 3% Dosage optimisations led by Prescribing Support technicians aiding the completion of the audit resulted in savings in excess of 139K, which indicated a lack of awareness on the flat, twice daily, pricing structure of this product. There was evidence, from completion of audit summary sheets in GP practices by the clinicians, that practices were made more aware of the issues around pregabalin prescribing, especially in relation to adherence with NICE guidelines, dose optimisation strategies and medication reviews for patients

taking pregabalin. 92% of GP practices intended to discuss these issues within their practice meetings. In summary, this was an extensive primary care audit which raised the awareness of clinicians of National and local guidelines. It is clear that implementation of guidance needs to be improved across the whole Health Board, in order that the prescribing of pregabalin reflects the positioning of the drug within existing guidance. It is intended to repeat this audit to assess any improvements in prescribing in 2013/14. Sponsored by: Prepared by: Jonathan Simms Clinical Director of Pharmacy Mike Curson Senior Primary Care Pharmacist Date 28 th February 2013 2

Introduction The objective of this review is to measure current prescribing of pregabalin for neuropathic pain and generalised anxiety disorder against the Aneurin Bevan Health Board (ABHB) Guidelines for the diagnosis and management of Neuropathic Pain 4, ABHB guidelines for Diabetic Peripheral Neuropathic Pain 4 and the National Institute for Health and Clinical Excellence (NICE) Clinical Guideline 113: Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults 9. ABHB spent 2.7 million on pregabalin in primary and secondary care during 2011, an increase of 25% compared to 2010, Although the trend in pregabalin prescribing has increased across all of the Welsh Health Localities, ABHB has the highest cost per 1000 patients in Wales and is 37% greater than the Welsh national average. 3

Method and Results. Data was collected, utilising the audit pack Appendix 1, for 3,266 patients taking pregabalin over 84 GP Practices in Aneurin Bevan Health Board who were receiving the treatment for the following conditions: Neuropathic Pain 2,264 patients Diabetic Neuropathic Pain 282patients Generalised Anxiety Disorder 720 patients 11% of patients were on a three times a day (TDS) dosage which was changed to an equivalent twice a day (BD) dosage along with other dose optimisations e.g. 25mg 2 BD to 50mg 1BD which collectively realised annual savings in excess of 139,000. ABHB Pregabalin Prescribing 2012/13 Neuropathic pain Diabetic Neuropathic pain Generalised Anxiety Disorder 22% 9% 69% Pregabalin for Neuropathic Pain In March 2010 NICE published guidance for the pharmacological management of neuropathic pain CG96 1 specifying pregabalin as one of the first-line treatment options. However in June 2010 the Drug and Therapeutics Bulletin 2 published an article questioning the validity of this recommendation stating that gabapentin was excluded as a treatment option based on indirect comparisons suggesting that, in relation to pregabalin, it offers less net benefit, is less cost-effective and requires more complex dosing and titration. Furthermore there were concerns over the economic modelling, on which CG96 was based to conclude that pregabalin was more cost-effective than gabapentin. It has been suggested that the drug costs used in the Health Technology Assessment (HTA) 3 were based exclusively on gabapentin generic tablets rather than the less expensive generic capsules and the costs of pregabalin assumed twice daily (rather than the more costly three times daily) dosing. As a result of this in July 2011, NICE in collaboration with the 4

HTA group were due to publish a review of the economic modelling but have recently announced the clinical guideline will now be fully revised in order to address ongoing uncertainties of cost effectiveness of some of the recommended treatment options. In September 2010 the Gwent Partnership Medicines and Therapeutics Committee discussed local implementation of NICE CG96 and based on the concerns above produced interim local guidance for the pharmacological management of neuropathic pain in a non-specialist setting 4 which reflects the current recommendations from the NHS Clinical Knowledge Summaries 5. This was supported by a letter to all prescribers in September 2010 from the Medical Director and the GPMTC chair 6. The Scottish Medicines Consortium has also restricted pregabalin for the treatment of peripheral neuropathic pain in adults to patients who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments for peripheral neuropathic pain. There is also a recommendation that treatment should be stopped if the patient has not shown sufficient benefit within 8 weeks of reaching the maximally tolerated therapeutic dose. 7 Of the 2,264 patients prescribed pregabalin for neuropathic pain 46% were initiated by the GP, 52% initiated by secondary care and 2% unknown due to limited documentation recorded as the patients are new to the practice. 35% of those initiated by the GP were prescribed in line with the local guidance compared to 34% of those initiated in secondary care. In both cases the majority of patients had no documentation of previous gabapentin use. Although it was not a requirement of the audit it was observed that there was a high incidence of side effects documented for those patients who had previously taken gabapentin. Diabetic Peripheral Neuropathic pain (DPN) NICE CG96 1 for the pharmacological management of neuropathic pain in adults recommends duloxetine as first line treatment for people with painful diabetic neuropathy with pregabalin and amitriptyline recommended as second line treatment options. However due to the concerns regarding the exclusion of gabapentin, ABHB have produced local guidance 8 which includes gabapentin and places pregabalin as a 4 th line treatment option. Of the 282 patients prescribed pregabalin for diabetic neuropathic pain 52% were initiated by the GP, 45% initiated by secondary care and 3% unknown due to limited documentation recorded as the patients are new to the practice. 11% of those initiated by the GP were prescribed in line the local guidance compared to 19% of those initiated in secondary care. In both cases the majority of patients had no documentation of previous duloxetine or gabapentin use. For both neuropathic pain and DPN, it was difficult to ascertain whether a true assessment of efficacy at maximal tolerated dose had been carried out. Reviews had been carried out but not systematically. 5

Pregabalin for generalised anxiety disorder (GAD) In January 2011 NICE published guidance for the management of generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults in primary, secondary and community care CG113. 9 The guidance recommends offering drug treatment or a high-intensity psychological intervention for patients with GAD and marked functional impairment or those whose symptoms have not responded adequately to step 2 psychological interventions. If a patient chooses drug treatment a selective serotonin reuptake inhibitor (SSRI) should be used first-line and although it does not have a UK marketing authorisation NICE recommends sertraline as a cost-effective choice. The guidance goes on to state that if sertraline is ineffective offer an alternative SSRI or a serotonin noradrenaline reuptake inhibitor (SNRI). If the person cannot tolerate SSRIs or SNRIs then pregabalin could be considered. Of the 720 patients prescribed pregabalin for generalised anxiety disorder 32% were initiated by the GP, 67% initiated by secondary care and 1% unknown due to limited documentation recorded. 16% of patients initiated by the GP were prescribed in line with the local guidance compared with 38% of those initiated in secondary care with the remainder having no documentation of having being prescribed an SSRI or an SNRI previously although very few patients had neither before being initiated on pregabalin. Audit Summary Sheet (Part 2) (Comments) Within the review Practices were asked to: identify anything that they could do to improve pregabalin prescribing in neuropathic pain and generalised anxiety disorder; explain how the audit data will be discussed and relevant changes to practice taken forward. Of the 84 Practices who returned the completed summary results are as follows: 1. Is there anything that the practice has identified that they can do to improve prescribing in this area? No of practices Adhere to NICE / ABHB Guidelines 46 Dose optimise from TDS to BD 36 Consider using LANSS pain assessment tool 7 Issue on acute prescriptions only 4 Medication reviews for Pregabalin patients 25 Stop prescribing for anxiety disorder 3 Lack of information from Secondary Care pain clinics as to why Gabapentin is not used first line (More information required from Secondary Care) 3 6

Poor information from Mental Health clinics as to why SSRis and SNRIs are unsuitable for anxiety disorders (More information required from Secondary Care) Pregabalin added without tricyclic being stopped. No documented reason for the concomitant therapies. Would like Health Board to query with Secondary Care on behalf of practice). Use specific directions not as directed 1 Inform new GPs of audit results and Guidance 1 Carry out 4 weeks assessment on new patients 14 Re-audit in 12 months 5 Improve documentation on PMR 5 Contact Secondary Care where ABHB guidance has not been adhered to 1 Patient education on use of drug 1 3 1 Individual GPs given list of patients where prescribing was not in accordance with guidelines for review and reflection Would like enhanced service with shared care protocol for monitoring Secondary Care prescribing 2 1 Discuss guidelines within the practice 1 Alerts added to PMR to discuss pregabalin 2 Stop initiation of Pregabalin 1 Switch Pregabalin patients to Gabapentin 3 Attempt to switch new patients initiated in Secondary Care from Pregabalin to Gabapentin 1 2. How will this information be discussed with all relevant members of the practice team and any relevant changes to practice taken forward? No of practices Discuss at practice meeting 77 Distribute copy of audit results to all partners 12 Agree pain management strategy 1 Formulary adjustments (dosage defaults) 1 ABHB / NICE Guidance to all clinicians 23 ABHB prescribing support team to assist in dose optimisation 2 Template made with guidelines for all doctors 1 Practice to arrange local pain specialist to talk at clinical meeting 1 Acknowledgements to GP practice staff and Medicines Management Technicians for their help and support in carrying out this audit. 7

References: 1. http://guidance.nice.org.uk/cg96 2. DTB 2010;48:61 doi:10.1136/dtb.2010.04.0029 3. HTA Report 05/30/03 - The Efficacy and Cost-Effectiveness of Different Treatment Pathways for Neuropathic Pain: systematic review and economic modelling of postherpetic neuralgia and painful diabetic neuropathy 4. http://www.wales.nhs.uk/sites3/documents/814/neuropathicpainguidance- ABHBsept2010.pdf 5. http://www.cks.nhs.uk/neuropathic_pain_drug_treatment/management/scenario_neur opathic_pain_drug_treatment/management 6. http://www.wales.nhs.uk/sites3/documents/814/implementationofnicecg96- MDLetterSept10.pdf 7. http://www.scottishmedicines.org.uk/smc_advice/advice/157_05_pregabalin Lyric a_/pregabalin Lyrica_ 8. http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=48819 9. http://guidance.nice.org.uk/cg113 8

Appendix 1 Review of Pregabalin Prescribing in Primary Care Aim The objective of this review is to measure current prescribing of Pregabalin for neuropathic pain and generalised anxiety disorder against the Aneurin Bevan Health Board (ABHB) Guidelines for the diagnosis and management of Neuropathic Pain, ABHB guidelines for Diabetic Peripheral Neuropathic Pain and the National Institute for Health and Clinical Excellence (NICE) Clinical Guideline 113: Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults. Process Run a search to identify all patients over 18 years who have been prescribed Pregabalin or Lyrica in the last 6 months. Exclude those patients with a read code for Epilepsy (F25%) Collect data for patients prescribed Pregabalin for neuropathic pain on data collection sheet (appendix A) Collect data for patients prescribed Pregabalin for diabetic peripheral neuropathic pain on data collection sheet (appendix B) Collect data for patients prescribed Pregabalin for generalised anxiety disorder on data collection sheet (appendix C) Complete the audit summary table (appendix D) The practice should submit a copy of the audit summary sheet to the locality Prescribing Advisor, as evidence of completion by 31st December 2012. Dose Optimisation ABHB has a standard operating procedure for changing pregabalin TDS dose regimes to BD regimes when prescribed for neuropathic pain or generalised anxiety disorder This is a separate cost saving scheme which may have already been implemented in your practice with support from the locality prescribing teams Following data collection if patients are identified with a TDS regime and have not previously been offered a BD regime please contact your locality prescribing team for support with the switch. 9

Rationale for Audit ABHB spent 2.7 million on pregabalin in primary and secondary care during 2011, an increase of 25% compared to 2010, Although the trend in pregabalin prescribing has increased across all of the Welsh Health Localities, ABHB has the highest cost per 1000 patients in Wales and is 37% greater than the Welsh national average. Pregabalin for Neuropathic Pain In March 2010 NICE published guidance for the pharmacological management of neuropathic pain CG96 1 specifying pregabalin as one of the first-line treatment options. However in June 2010 the Drug and Therapeutics Bulletin 2 published an article questioning the validity of this recommendation stating that gabapentin was excluded as a treatment option based on indirect comparisons suggesting that, in relation to pregabalin, it offers less net benefit, is less costeffective and requires more complex dosing and titration. Furthermore there were concerns over the economic modelling, on which CG96 was based to conclude that pregabalin was more costeffective than gabapentin. It has been suggested that the drug costs used in the Health Technology Assessment (HTA) 3 were based exclusively on gabapentin generic tablets rather than the less expensive generic capsules and the costs of pregabalin assumed twice daily (rather than the more costly three times daily) dosing. As a result of this in July 2011, NICE in collaboration with the HTA group were due to publish a review of the economic modelling but have recently announced the clinical guideline will now be fully revised in order to address ongoing uncertainties of cost effectiveness of some of the recommended treatment options. In September 2010 the Gwent Partnership Medicines and Therapeutics Committee discussed local implementation of NICE CG96 and based on the concerns above produced interim local guidance for the pharmacological management of neuropathic pain in a non-specialist setting 4 which reflects the current recommendations from the NHS Clinical Knowledge Summaries 5. (Reproduced overleaf). This was supported by a letter to all prescribers in September 2010 from the Medical Director and the GPMTC chair 6. The Scottish Medicines Consortium has also restricted pregabalin for the treatment of peripheral neuropathic pain in adults to patients who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments for peripheral neuropathic pain. There is also a recommendation that treatment should be stopped if the patient has not shown sufficient 10

benefit within 8 weeks of reaching the maximally tolerated therapeutic dose. 7 Diabetic Peripheral Neuropathic pain NICE CG96 1 for the pharmacological management of neuropathic pain in adults recommends duloxetine as first line treatment for people with painful diabetic neuropathy with pregabalin and amitriptyline recommended as second line treatment options. However due to the concerns regarding the exclusion of gabapentin mentioned above, ABHB have produced local guidance 8 which includes gabapentin and places pregabalin as a 4 th line treatment option. The increased level of pregabalin prescribing within ABHB seems to suggest that local guidance is not being followed. A review of prescribing will establish if this is the case. Recognising and Treating Neuropathic Pain in Primary and Secondary Care The LANSS Scoring Tool should be used to assist diagnosis and hence make a decision whether a treatment for neuropathic pain should be initiated. 11

RECOGNISING AND TREATING NEUROPATHIC PAIN IN PRIMARY & SECONDARY CARE SIGNS AND SYMPTOMS Can be spontaneous, continuous, intermittent, superficial or evoked Pain will often be described as burning, sharp, shooting, lanciating, itching, pins and needles, indescribable in terms of normal reference (patients often get distressed as they are not voice their pain in a way that they think is normal and are therefore worried they will not be believed). Can be made worse by temperature, or touch USE OF LANSS SCORING TOOL TO ASSIST DIAGNOSIS 1. Do you have pins and needles / numbness / tingling? 2. Does painful area change colour? 3. Does skin in painful area feel sensitive to touch? 4. Do you get feelings like an electric shock? 5. Do you get a feeling of burning where the pain is? 1. Test with cotton wool for allodynia 2. Is there an altered sensation to a needle prick? Yes (5) No (0) Yes (5) No (0) Yes (3) No (0) Yes (2) No (0) Yes (1) No (0) Yes (5) No (0) Yes (3) No (0) Total score < 12 = neuropathic pain unlikely. > 12 = likely neuropathic pain. USE OF PHARMACOLOGICAL AGENTS FOR NEUROPATHIC PAIN ONLY IF LANSS SCORE > 12 NON FOCAL NEUROPATHIC PAIN DIABETIC PERIPHERAL NEURALGIA FOCAL NEUROPATHIC PAIN AMITRIPTYLINE GABAPENTIN capsules PREGABALIN IF NO BENEFIT REFER FOR PAIN CLINIC REVIEW DULOXETINE NB: Consider CARBAMAZEPINE for trigeminal neuralgia CAPSAICIN cream 0.075% (Axsain) LIDOCAINE PLASTER (Versatis ) Post Herpetic Neuralgia ONLY Other off label uses should be initiated by ABHB Pain Clinic GPs may initiate as rescue analgesic (while waiting for a referral to Pain Clinic) in a very small subgroup of people with localised pain who are unable to take oral medication because of medical conditions and/or disability ANY VARIATION FROM THIS FLOWCHART REQUIRES THE REASON(S) TO BE CLEARLY DOCUMENTED IN THE PATIENT NOTES AND COMMUNICATED WHERE APPROPRIATE Full guidance with dose regimes can be found at: http://www.wales.nhs.uk/sites3/documents/814/neuropathicpainguidance ABHBsept2010.pdf http://www.wales.nhs.uk/sites3/documents/814/dpnp RevisedALOGORITHM%5B21June2011%5D.pdf 12

NON FOCAL NEUROPATHIC PAIN FOCAL NEUROPATHIC PAIN AMITRIPTYLINE * start at 10mg and titrate by 10mg a week until 75mg daily (in divided doses or as a single dose at bedtime) is reached. Maximum tolerated dose should be used for 4 weeks before benefits can be judged. Care with drug interactions and use in the elderly If satisfactory improvement continue the treatment; improvement sustained consider reducing dose If amitriptyline* gives satisfactory pain reduction but adverse effects not tolerated consider oral imipramine* STOP IF NO BENEFIT slowly over 4 weeks CAPSAICIN cream 0.075% (Axsain) GABAPENTIN capsules start at 300mg nocte (100mg if patient very frail or very susceptible to sedative medications).titrate up according to side effects to a maximum of 1800mg per day. Once on maximum tolerated dose wait for 2 weeks to assess effect 30 to 40% pain relief would be considered as a significant decrease. IF NO BENEFIT LIDOCAINE PLASTER (Versatis ) licensed for post herpetic neuralgia used 12 hours on and 12 hours off Can be cut to cover area (possibly allowing more economic use) No more than 3 patches should be applied an any one time Do not use on broken skin One month trial required before assessing efficacy NB: Consider CARBAMAZEPINE for trigeminal neuralgia IF NO BENEFIT or NOT TOLERATED (due to adverse effects or difficulty adhering to dosage schedule) PREGABALIN start at 75mg nocte. If tolerated increase to 75mg BD. This can then be titrated according to side effects to a maximum of 600mg daily in two divided doses. Once on maximum tolerated dose wait for 2 to 4 weeks to assess effect 30 to 40% pain relief would be considered significant. IF NO BENEFIT REFER FOR PAIN CLINIC REVIEW Topical lidocaine (Versatis ) may play a role as a rescue analgesic (while waiting for a referral to a specialist pain service) in a very small subgroup of people with localised pain who are unable to take oral medication *In these recommendations, drug names are marked with an asterisk if they do not have UK marketing authorisation for the indication in question. Informed consent should be obtained and documented. 13

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Pregabalin for generalised anxiety disorder (GAD) In January 2011 NICE published guidance for the management of generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults in primary, secondary and community care CG113. 9 The guidance recommends offering drug treatment or a high-intensity psychological intervention for patients with GAD and marked functional impairment or those whose symptoms have not responded adequately to step 2 psychological interventions. If a patient chooses drug treatment a selective serotonin reuptake inhibitor (SSRI) should be used first-line and although it does not have a UK marketing authorisation NICE recommends sertraline as a cost-effective choice. The guidance goes on to state that if sertraline is ineffective offer an alternative SSRI or a serotonin noradrenaline reuptake inhibitor (SNRI). If the person cannot tolerate SSRIs or SNRIs then pregabalin could be considered. ABHB guidance for drug treatment of GAD is reproduced on the following pages. Anecdotally GPs have seen an increase in pregabalin prescribing requests for GAD from secondary care. A review of prescribing will establish if prescribing is compliant with current guidance. 15

GWENT GUIDANCE (BASED ON NICE CG113 http://guidance.nice.org.uk/cg113) Drug Treatment for Generalised Anxiety Disorder (GAD) If a person with GAD chooses drug treatment Discuss the treatment options and any concerns the person with GAD has about taking medication. Explain fully the reasons for prescribing and provide written and verbal information on: the likely benefits of different treatments the gradual development, over 1 week or more, of the full anxiolytic effect importance of taking medication as prescribed and the need to continue treatment after remission to avoid relapse differences in drug side effect, withdrawal syndrome and drug interaction profiles the risk of activation with SSRIs and SNRIs, with symptoms such as increased anxiety, agitation and problems sleeping BENZODIAZEPINES SHOULD ONLY BE USED AS A SHORT TERM MEASURE (10 TO 14 DAYS) DURING CRISES. DO NOT OFFER AN ANTIPSYCHOTIC FOR THE TREATMENT OF GAD IN PRIMARY CARE Offer trial of SSRI (see ABHB options below) Note increased risk of bleeding in elderly and those on NSAIDs/aspirin consider a gastro protective drug. Advise those <30yrs of age of risks of suicidal ideation and self harm monitor weekly for first month. Review the effectiveness and side effects every 2 to 4 weeks during the first 3 months of treatment and every 3 months thereafter. If effective advise the person to continue for at least 1 year to avoid relapse. SSRI INEFFECTIVE SSRI NOT TOLERATED Offer trial of alternate SSRI (see ABHB options on page 2 Offer trial of SNRI (see ABHB options on page 2) Provide information and consider one of the following strategies: monitoring the person s symptoms closely (if the side effects are mild and acceptable to the person) OR reducing the dose of the drug OR stopping the drug and, according to the person s preference, offering either an alternative DRUG OR a high intensity psychological intervention m/r venlafaxine INAPPROPRIATE, INEFFECTIVE or NOT TOLERATED Consider trial of PREGABALIN initially 150mg daily in 2 divided doses, increased if necessary at 7 day intervals in steps of 150mg daily; max. 600mg daily in 2 divided doses Pregabalin INEFFECTIVE or NOT TOLERATED Consider SPECIALIST REFERRAL if the person with GAD has severe anxiety with marked functional impairment in conjunction with: a risk of self harm or suicide OR significant comorbidity, such as substance misuse, personality disorder or complex physical health problems OR self neglect OR an inadequate response to the drug pathway above. 16

SSRIs in ABHB Formulary SERTRALINE Licensed status for GAD OFF LABEL obtain & document informed consent CITALOPRAM OFF LABEL obtain & document informed consent. FLUOXETINE OFF LABEL obtain & document informed consent. Dose in adults over 18 years Initially 25mg daily increased after 1 week to 50mg daily; if response is partial and if drug tolerated, dose increased in steps of 50mg at intervals of at least 1 week to max. 200mg daily. Initially 10mg once daily increased gradually if necessary in steps of 10mg daily, usual dose 20 30mg once daily; max. 40mg once daily (20mg once daily in the elderly) Initially 20mg daily, increased after 3 4 weeks if necessary, and at appropriate intervals thereafter; max 60mg daily (elderly usual max 40mg) PAROXETINE LICENSED CSM advise that the recommended dose for GAD is 20mg daily. There is no evidence that a higher dose is more effective. SNRIs in ABHB Formulary VENLAFAXINE 28 day cost (Oct 2011) 50mg 6.60 100mg 13.91 20mg 1.85 20mg 1.42 20mg 1.74 GAD License Dose 28 day cost (Oct 2011) Only M/R capsules (XL) LICENSED for moderate to severe GAD. 75mg once daily, increased if necessary at intervals of at least 2 weeks. Discontinue if no response after 8 weeks; max 225mg once daily. DULOXETINE LICENSED Initially 30mg once daily, increased if necessary to 60mg once daily; max 120mg daily. 75mg M/R 22.08 225mg M/R 33.60 30mg 22.40 60mg 27.72 Comment Recommended by NICE as the SSRI to try first as it had the lowest probability of discontinuation due to side effects and the second highest in terms of achieving a conditional response (among the drugs considered by NICE). Licensed for depressive illness, OCD, Panic disorder, PTSD and social anxiety disorder. Caution advised in patients susceptible to QTinterval prolongation. Licensed for depressive illness and Panic disorder. Long duration of action due to long half life. Treatment break of 2 weeks recommended if switching from fluoxetine to another SSRI. Licensed for major depression & OCD. Associated with a withdrawal syndrome, gradual dose reduction is advised on cessation of treatment. Also licensed for major depression, OCD, Panic disorder, Social anxiety disorder & PTSD. Comment Caution advised in patients with heart disease. Associated with a withdrawal syndrome, gradual dose reduction is advised on cessation of treatment. Also licensed for major depression. 17

References: 10. http://guidance.nice.org.uk/cg96 11. DTB 2010;48:61 doi:10.1136/dtb.2010.04.0029 12. HTA Report 05/30/03 - The Efficacy and Cost-Effectiveness of Different Treatment Pathways for Neuropathic Pain: systematic review and economic modelling of post-herpetic neuralgia and painful diabetic neuropathy 13. http://www.wales.nhs.uk/sites3/documents/814/neuropathicpainguidance-abhbsept2010.pdf 14. http://www.cks.nhs.uk/neuropathic_pain_drug_treatment/management/scenario_neuropathic_pain_drug_treatme nt/management 15. http://www.wales.nhs.uk/sites3/documents/814/implementationofnicecg96-mdlettersept10.pdf 16. http://www.scottishmedicines.org.uk/smc_advice/advice/157_05_pregabalin Lyrica_/pregabalin Lyrica_ 17. http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=48819 18. http://guidance.nice.org.uk/cg113 18

Appendix A: Data collection sheet Pregabalin for Neuropathic Pain Patient ID Strength & Dose Initiated by GP 2nd ry care TDS dose which could be switched to BD Previously tried or is currently prescribed Previously tried Gabapentin Efficacy Reviewed after 4 weeks of max Pregabalin prescribed in line with (Exclude patients who Amitriptyline tolerated dose? ABHB have previously been Neuropathic offered this switch and declined Read code Pain Guideline 8B30) Yes No Yes No Yes No Yes No Yes No 19

Appendix B: Data collection sheet Pregabalin for Diabetic Neuropathic Pain Patient ID Strength & Dose Initiated by GP 2nd ry care TDS dose which could be switched to BD Previously tried or is currently prescribed Previously tried Gabapentin Efficacy Reviewed after 4 weeks at max Pregabalin prescribed in line with (Exclude patients who Duloxetine tolerated dose? ABHB have previously been Neuropathic offered this switch and declined Read code Pain Guideline 8B30) Yes No Yes No Yes No Yes No Yes No 20

Appendix C: Data collection sheet Pregabalin for Generalised Anxiety Disorder Patient ID Strength & Dose Initiated by GP 2nd ry care TDS dose which could be switched to BD Previously tried SSRI Previously tried SNRI Documented reason for not prescribing Pregabalin prescribed in line with NICE (Exclude patients who SSRI / SNRI Guideline have previously been (if no previous CG113 offered this switch and declined Read code trial) 8B30) Yes No Yes No Yes No Yes No 21

Appendix D: Audit Summary Sheet (Part 1) Review of Pregabalin in neuropathic pain and generalised anxiety disorder Practice Name Date of data collection No. Patients % of Patients Pregabalin for Neuropathic Pain Number of patients reviewed Number of patients with TDS dose which could be switched to BD dose Number initiated by GP Number initiated by secondary care (SC) Number where prescribing is line with ABHB guidance Number where pregabalin used before other recommended treatments Number where pregabalin has not been assessed after 4 weeks of max tolerated dose GP SC GP SC Pregabalin for Diabetic Neuropathic Pain Number of patients reviewed Number of patients with TDS dose which could be switched to BD dose Number initiated by GP Number initiated by secondary care (SC) Number where prescribing is line with ABHB guidance Number where pregabalin used before other recommended treatments Number where pregabalin has not been assessed after 4 weeks of max tolerated dose GP SC GP SC 22

Pregabalin for generalised anxiety disorder Number of patients reviewed Number of patients with TDS dose which could be switched to BD dose Number initiated by GP Number initiated by secondary care (SC) Number of patients where pregabalin has been initiated in line with NICE CG 113 Number of patients where pregabalin has been used before other recommended treatments and no reason provided GP SC GP SC Submit a copy of audit summary sheet part 1 and 2 to the locality pharmacy team by 31 st December 2012 23

Appendix D: Audit Summary Sheet (Part 2) 1. Is there anything that the practice has identified that they can do to improve prescribing in this area? (Please specify below) 2. How will this information be discussed with all relevant members of the practice team and any relevant changes to practice taken forward? (Please specify below) Practice: Date: Signed: Designation: 24