Community Pharmacy Contract 2011/12 to 2012/13 All Wales Multi-Disciplinary Audit Service Specification Essential Service 8 – Clinical Governance This audit was endorsed by the All Wales Medicines Strategy Group (AWMSG) at their meeting on the 16th March 2011. Please send the Pharmacy details, audit sheets, issues log and the reflective action plan to your local Medicines Management team on or before the date specified by your Health Board. Your Medicines Management team will compile the local information and forward to the Welsh Medicines Partnership (wmp@wales.nhs.uk) who will provide a national perspective. Contents Page Introduction 3 Background 4 General Prescribing Points / Good Practice Guidance 4 References 8 Overall Aim 9 Method 9 Preparation 10 Reporting 10 Pharmacy Details 11 Audit Sheets 12 Issues Log 16 Reflective Action Plan 18 Appendix A 19 Appendix B 21 2 Introduction By auditing elements of your practice you can assess current performance against identified standards and acknowledge any shortfalls that require attention. Audits can also help to educate and inform professionals, staff and patients about the standards associated with the subject of the audit, especially where the audit requires their participation. Audits have been shown to promote changes to practice because of this. Under the terms of the New Pharmacy Contract under Essential Service 8 – clinical governance, every pharmacy should participate in one practice-based audit and one multidisciplinary audit each year. The subject of the multidisciplinary audit is determined by the Local Health Board (LHB) and will involve elements of auditing your own and other health care professionals’ practice, and may include other health care professionals auditing your practice as well. For the year 2011-12 / 2012-13 the LHB has decided that a multidisciplinary audit of proton pump inhibitor (PPI) prescribing should be carried out by community pharmacists. The objectives of the audit are: To help identify and subsequently address the key prescribing issues in PPI use in primary care. To increase awareness of community pharmacists with regard to these issues. To provide pharmacists with the opportunity to identify ways in which they can support local GP practices in educating patients about the use of PPIs, and identify concordance issues. To raise GP/practice staff awareness of the support that pharmacists can provide in the management of patients on PPIs. To reduce the inappropriate prescribing of PPIs and minimise waste. 3 Background Dyspepsia is defined as any symptom of the upper gastrointestinal tract, present for four weeks or more, including upper abdominal pain or discomfort, heartburn, acid reflux, nausea or vomiting1. It is estimated that around 40% of the adult population will have symptoms of dyspepsia 1, the most common causes being gastro-oesophageal reflux disease (GORD), peptic ulcer and non-ulcer (or functional) dyspepsia, with a large proportion of these patients being prescribed a PPI. PPI use is continuing to increase across Wales. One possible explanation for this is that they are continued when they are no longer indicated 2, as for many indications, such as peptic ulcer disease, treatment courses are intended for short term use only1. It has also been suggested that a reduction in cost, together with reduced concerns of their safety has led to a more liberal use of PPIs for a wide variety of upper gastrointestinal symptoms with a substantial proportion, if not majority, of patients now prescribed PPIs having no true indication for treatment3. The All Wales Medicines Strategy Group (AWMSG) has introduced two National Indicators for PPIs for the financial year 2011/12 which look at both the overall PPI usage and the choice of PPI4. General Prescribing Points / Good Practice Guidance Is there a legitimate indication for a PPI? PPIs should only be started or continued where there is a valid documented indication. The use of PPIs for mild or vague symptoms and any ‘diagnostic’ use must be short term2. Can the PPI be stopped? For example, has the treatment course finished or has a non-steroidal anti-inflammatory drug (NSAID) been discontinued therefore prophylaxis will no longer be necessary. Many patients presenting with dyspepsia are diagnosed as having non-ulcer dyspepsia. Initial therapeutic strategies for uninvestigated dyspepsia include testing and treating for Helicobacter. pylori or a one month full-course of a PPI. All patients on a long term PPI should have an annual review to discuss continuing need for medication and/or stepping down treatment, unless there is an underlying condition or co-medication that necessitates ongoing treatment1. Has the patient been tested and treated for H. pylori where appropriate? Up to 95% of duodenal ulcers and 80% of gastric ulcers are associated with H. pylori1. Eradication of H. pylori can prevent the 4 recurrence of peptic ulcers and reduce the need for long term acid-suppression therapy1. Could any medications that can cause dyspepsia be withdrawn? PPIs are the first line therapy for GORD. Once initial symptoms are controlled treatment should be stepped down. If long term treatment with a PPI is required, the lowest possible dose to control symptoms should be used. On demand or intermittent use of medication is encouraged1. When stepping down or stopping therapy, consider prescribing antacid/alginate for rebound acid hypersecretion. National Institute for Health and Clinical Excellence (NICE) recommends that a PPI (with the lowest acquisition cost) should be co-prescribed in patients treated with an oral NSAID/COX-2 inhibitor6. However, before using an NSAID which requires concurrent use of a PPI, it should be established whether all other strategies to optimise pain control have been considered 7. Where a PPI needs to be continued can the dose be reduced? Some medications can contribute to the symptoms of dyspepsia (examples include calcium antagonists, nitrates, theophyllines, bisphosphonates and NSAIDs)1. Existing medication should be reviewed and if a causative medication identified withdrawal should be considered5. Have other strategies to optimise pain control been considered before using an NSAID that requires concurrent use of a PPI? There is currently no evidence that H. pylori should be investigated in patients with GORD1. PPI withdrawal may induce rebound acid hypersecretion 2,8. This may explain the continued use of PPIs in patients and the inability to discontinue treatment. Patients should therefore be informed of this potential risk when both stepping down and stopping therapy. Consideration should also be given to implementing strategies that may reduce it such as intermittent dosing (where clinically appropriate), or the use of antacid / alginate therapy7. Have lifestyle measures been discussed and patient advised to avoid precipitating factors? Lifestyle advice should include1: Healthy eating and avoidance of food/drink which exacerbate symptoms. Avoiding reclining or lying down shortly after meals, and large, late meals. 5 Potential risks are associated with PPIs particularly in patients with multiple risk factors for fractures, hospital and community-acquired pneumonia or Clostridium difficile infection (CDI). In general PPIs are well tolerated. However, there have been a number of recent reports which have documented concerns relating to possible adverse events relating to their use. These include a small increase in the risk of both hospital-acquired and community-acquired pneumonia9,10 and possible increase in fracture risk11. This should be taken into consideration when prescribing a PPI in those patients with other risk factors for these conditions7. The Health Protection Agency and Department of Health Guidance on managing CDI recommends that PPIs should only be used when there is a clear clinical indication 12. They also state that consideration should be given to stopping PPIs in recurrent cases of CDI. The combination of clopidogrel and omeprazole or esomeprazole, should be avoided unless considered essential. Weight reduction (if overweight or obese). Smoking cessation. Moderation of alcohol consumption. Current evidence regarding interactions between clopidogrel and PPIs is not consistent. However, the MHRA has advised that the combination of clopidogrel and omeprazole or esomeprazole should be avoided unless considered essential13. Where it is necessary to continue on treatment with a PPI, is the patient on the most cost-effective, appropriate PPI? NICE recommendations state that the least expensive PPI should be used1. There is no evidence that there is any difference in clinical efficacy between PPIs at equivalent doses5, although prescribers should be aware that there are some slight variations in the indications for use, interactions and cautions 14. Generic omeprazole and lansoprazole capsules or pantoprazole tablets should be used as first line therapies. Community pharmacists are ideally placed to offer advice and support to patients with dyspepsia. The NICE dyspepsia guideline includes a flowchart outlining the potential role of community pharmacists in the management of dyspepsia1. Community pharmacist involvement could include: Advice on lifestyle choices, such as healthy eating and weight reduction. 6 Smoking cessation. Advice on the use of over-the-counter medication for symptom relief Referring patients to their GP, for instance where ALARM signs may be present or medication has not provided adequate symptom relief. ALARM signs include dyspepsia with gastrointestinal bleeding, difficulty in swallowing, unintentional weight loss, abdominal swelling and persistent vomiting1. Advice about medication that could cause dyspepsia. Medicines Use Review – advice on how to adjust medication to control symptoms. 7 References 1. North of England Dyspepsia Guideline Development Group. Dyspepsia: managing dyspepsia in adults in primary care. Full Clinical Guideline No. 17. 2004. Available at http://guidance.nice.org.uk/CG17. Accessed Sept 2010. 2. WeMeReC Bulletin. Stopping medicines – proton pump inhibitors. Online content. October2010. Available at: http://www.wemerec.org/Documents/enotes/StoppingPPIsenotes.pdf. Accessed Nov 2010. 3. McColl KEL, Gillen D. Evidence that proton-pump inhibitor therapy induces the symptoms it is used to treat. Gastroenterology 2009; 137: 20-39. 4. All Wales Medicines Strategy Group. National Prescribing Indicators 2011/12. http://www.wales.nhs.uk/sites3/Documents/371/Indicator%20paper%202011% 2D12%20website.pdf Accessed Mar 2011. 5. National Prescribing Centre. The management of dyspepsia in primary care. MeReC Briefing. 2006. Issue number 32. Available at http://www.npc.co.uk/ebt/merec/therap/dysp/resources/merec_briefing_no32.pd f. Accessed Nov 2010 6. National Institute of Health and Clinical Excellence. Osteoarthritis. The care and management of osteoarthritis in adults. Clinical Guideline 59. 2008. Available at http://www.nice.org.uk/CG59. Accessed Nov 2010. 7. Thompson A. Emerging Concerns with PPI therapy. The Pharmaceutical Journal 2010; 285:239-240. www.pjonline.com 8. Reimer C, Søndergaard B, Hilsted L et al. Proton–pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy. Gastroenterology 2009; 137:80-87. 9. Herzig SJ, Howell MD, Ngo LH et al. Acid-suppressive medication use and the risk for hospital-acquired pneumonia. Journal of the American Medical Association 2009; 301:2120-2128. 10. Sarkar M Hennessy S, Yang YX. Proton-pump inhibitor use and risk for community-acquired pneumonia. Ann Intern Med 2008; 149:391-398. 11. U.S Food and Drug Administration (FDA). FDA Drug Safety Communication. Possible increased risk of fractures of the hip, wrist and spine with the use of proton pump inhibitors. May 2010. Available at http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatient sandproviders/ucm213206.htm. Accessed Nov 2010. 12. Health Protection/Department of Health. Clostridium difficile infection: how to deal with the problem. 2009. Available at http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1232006607827. Accessed Nov 2010. 13. Drug Safety Update April 2010, vol 3 issue 9: 4. Available at http://www.mhra.gov.uk/home/groups/plp/documents/publication/con076503.pdf. Accessed Nov 2010. 14. British National Formulary. BNF 60. September 2010. 8 Overall Aim To assess current prescribing and use of PPIs with reference to the NICE guideline and the AWMSG key priorities. Method Identify 20 patients receiving prescriptions for high acquisition cost (HAC) PPIs. This is to try and ensure that patients requiring a PPI are prescribed the most cost-effective preparation according to NICE guidelines. However, if you find that you do not have enough patients on HAC PPIs to complete the audit for 20 patients, for the remainder you may use patients receiving prescriptions for low acquisition cost (LAC) PPIs. For a definition of HAC and LAC PPIs see Appendix B. Complete data collection for each patient. This may be as part of a Medicines Use Review (MUR) if you wish. You may find that you will not be able to answer all the questions for every patient, but part of the purpose of the audit is to identify gaps in the management of these patients, which can then be addressed by a multidisciplinary approach. If you do not know the answer to any of the audit questions then please indicate this on the audit form. Retain the patient details record at the pharmacy. Return anonymised data collection sheets to the LHB by the return date. Similar audits will also be taking place in GP practices. The information gained from the audits will help the LHB to assess what resources are needed, and how best to manage these patients. This will help the LHB comply with NICE guidance and AWMSG key priorities. All dispensary staff should be made aware of the audit to help recognise when an appropriate PPI prescription is presented and to alert the audit team. To avoid duplication you will need to assign each PPI patient an ID number. We suggest giving the first patient presenting a prescription for a PPI the number 1 and noting the patient details, such as name, address, Patient Medication Record PMR ID number or NHS number, against their ID number on the appropriate sheet in Appendix A. Assign number 2 to the next different patient to be included in the audit and continue sequentially until the audit is completed. Appendix A should be retained in the pharmacy at the end of the audit. 9 Preparation Take time to read the audit forms and appendices thoroughly, then plan who needs to be involved and what needs to happen, including what you want them to do. For example: Will the pharmacist need to complete the audit forms or can they be delegated to support staff with the pharmacist supporting them and checking the content? Communicate the process to those who need to know e.g. reception staff, dispensers, healthcare assistants, etc. Decide the period over which you will carry out the audit. How will you review the results and develop the action plan? Who will be responsible for posting the forms once the audit is completed? How will you audit delivery patients or care home patients? A grid format has been designed to minimise the workload associated with the survey of prescriptions. If you have any questions regarding the process please contact the Medicines Management Team at the LHB. Reporting When you have finished the audit: 1. Copy the audit. 2. Send the original audit to the Health Board including the reflective action plan by 01/04/12. 3. Retain Appendix A in the pharmacy at the end of the audit - this will contain patient information on which MUST be retained in the pharmacy. Failure to participate in this audit will constitute a breach of the terms of service of the New Pharmacy Contract i.e. this audit is a requirement of the New Pharmacy Contract. 10 COMMUNITY PHARMACY MULTIDISCIPLINARY AUDIT PPI 2011/2012 Pharmacy Name Pharmacy Address Pharmacy Tel. No. Local Health Board Local Health Board Contact PLEASE RETURN THE FOLLOWING COMPLETED FORMS TO THE MEDICINES MANAGEMENT TEAM AT THE LHB: Pharmacy Details Multidisciplinary Audit Sheets Issues Log Reflective Action Plan 11 COMMUNITY PHARMACY CONTRACT: MULTIDISCIPLINARY AUDIT 2011/2012 – PPIs SHEET 1 PATIENT AUDIT ID NO. 1 2 3 4 PRESCRIPTION/PATIENT MEDIATION RECORD (PMR) REVIEW NAME OF PPI PRESCRIBED DOSE AND DIRECTIONS LENGTH OF TREATMENT AT CURRENT DOSE RECORD OF STEP-DOWN OR GAPS IN TREATMENT? (Y/N) RECORD OF ANY OTHER PREVIOUS PPI PRESCRIPTION? (PLEASE STATE) RECORD OF ANY OTHER (PREVIOUS OR CURRENT) DYSPEPSIA TREATMENT? (PLEASE STATE) CONCOMMITENT TREATMENT WITH AN NSAID/ASPIRIN? (STATE WHICH) CONCOMMITENT TREATMENT WITH CLOPIDOGREL? (Y/N) RECORD OF OTHER MEDICATIONS THAT COULD CAUSE DYSPEPSIA? (Y/N) PATIENT CONSULTATION DOES THE PATIENT KNOW THE INDICATION FOR THE PPI? (PLEASE STATE) ARE THE PATIENT’S SYMPTOMS CONTROLLED? (Y/N) DOES THE PATIENT KNOW HOW TO RECOGNISE ALARM SYMPTOMS? (Y/N) HAS THE PATIENT HAD A MEDICATION REVIEW TO DICUSS THEIR PPI IN THE PAST 12 MONTHS? DOES THE PATIENT UNDERSTAND ABOUT HEALTHY EATING/LIFESYLE FACTORS? (Y/N) HAS THE PATIENT HAD A PPI LEAFLET? (Y/N) ACTIONS HAVE YOU IDENTIFIED ANY ISSUES FROM THIS AUDIT? (Y/N) WHAT ACTION HAVE YOU TAKEN (IF ANY) – E.G. MUR/GP REFERRAL/PATIENT EDUCATION? IF YOU DO NOT KNOW THE ANSWER TO ANY OF THE QUESTIONS PLEASE STATE ‘NOT KNOWN’ 12 5 COMMUNITY PHARMACY CONTRACT: MULTIDISCIPLINARY AUDIT 2011/2012 – PPIS SHEET 2 PATIENT AUDIT ID NO. 6 7 8 9 PRESCRIPTION/PATIENT MEDIATION RECORD (PMR) REVIEW NAME OF PPI PRESCRIBED DOSE AND DIRECTIONS LENGTH OF TREATMENT AT CURRENT DOSE RECORD OF STEP-DOWN OR GAPS IN TREATMENT? (Y/N) RECORD OF ANY OTHER PREVIOUS PPI PRESCRIPTION? (PLEASE STATE) RECORD OF ANY OTHER (PREVIOUS OR CURRENT) DYSPEPSIA TREATMENT? (PLEASE STATE) CONCOMMITENT TREATMENT WITH AN NSAID/ASPIRIN? (STATE WHICH) CONCOMMITENT TREATMENT WITH CLOPIDOGREL? (Y/N) RECORD OF OTHER MEDICATIONS THAT COULD CAUSE DYSPEPSIA? (Y/N) PATIENT CONSULTATION DOES THE PATIENT KNOW THE INDICATION FOR THE PPI? (PLEASE STATE) ARE THE PATIENT’S SYMPTOMS CONTROLLED? (Y/N) DOES THE PATIENT KNOW HOW TO RECOGNISE ALARM SYMPTOMS? (Y/N) HAS THE PATIENT HAD A MEDICATION REVIEW TO DICUSS THEIR PPI IN THE PAST 12 MONTHS? DOES THE PATIENT UNDERSTAND ABOUT HEALTHY EATING/LIFESYLE FACTORS? (Y/N) HAS THE PATIENT HAD A PPI LEAFLET? (Y/N) ACTIONS HAVE YOU IDENTIFIED ANY ISSUES FROM THIS AUDIT? (Y/N) WHAT ACTION HAVE YOU TAKEN (IF ANY) – E.G. MUR/GP REFERRAL/PATIENT EDUCATION? IF YOU DO NOT KNOW THE ANSWER TO ANY OF THE QUESTIONS PLEASE STATE ‘NOT KNOWN’ 13 10 COMMUNITY PHARMACY CONTRACT: MULTIDISCIPLINARY AUDIT 2011/2012 – PPIS SHEET 3 PATIENT AUDIT ID NO. 11 12 13 14 PRESCRIPTION/PATIENT MEDIATION RECORD (PMR) REVIEW NAME OF PPI PRESCRIBED DOSE AND DIRECTIONS LENGTH OF TREATMENT AT CURRENT DOSE RECORD OF STEP-DOWN OR GAPS IN TREATMENT? (Y/N) RECORD OF ANY OTHER PREVIOUS PPI PRESCRIPTION? (PLEASE STATE) RECORD OF ANY OTHER (PREVIOUS OR CURRENT) DYSPEPSIA TREATMENT? (PLEASE STATE) CONCOMMITENT TREATMENT WITH AN NSAID/ASPIRIN? (STATE WHICH) CONCOMMITENT TREATMENT WITH CLOPIDOGREL? (Y/N) RECORD OF OTHER MEDICATIONS THAT COULD CAUSE DYSPEPSIA? (Y/N) PATIENT CONSULTATION DOES THE PATIENT KNOW THE INDICATION FOR THE PPI? (PLEASE STATE) ARE THE PATIENT’S SYMPTOMS CONTROLLED? (Y/N) DOES THE PATIENT KNOW HOW TO RECOGNISE ALARM SYMPTOMS? (Y/N) HAS THE PATIENT HAD A MEDICATION REVIEW TO DICUSS THEIR PPI IN THE PAST 12 MONTHS? DOES THE PATIENT UNDERSTAND ABOUT HEALTHY EATING/LIFESYLE FACTORS? (Y/N) HAS THE PATIENT HAD A PPI LEAFLET? (Y/N) ACTIONS HAVE YOU IDENTIFIED ANY ISSUES FROM THIS AUDIT? (Y/N) WHAT ACTION HAVE YOU TAKEN (IF ANY) – E.G. MUR/GP REFERRAL/PATIENT EDUCATION? IF YOU DO NOT KNOW THE ANSWER TO ANY OF THE QUESTIONS PLEASE STATE ‘NOT KNOWN’ 14 15 COMMUNITY PHARMACY CONTRACT: MULTIDISCIPLINARY AUDIT 2011/2012 – PPIS SHEET 4 PATIENT AUDIT ID NO. 16 17 18 19 PRESCRIPTION/PATIENT MEDIATION RECORD (PMR) REVIEW NAME OF PPI PRESCRIBED DOSE AND DIRECTIONS LENGTH OF TREATMENT AT CURRENT DOSE RECORD OF STEP-DOWN OR GAPS IN TREATMENT? (Y/N) RECORD OF ANY OTHER PREVIOUS PPI PRESCRIPTION? (PLEASE STATE) RECORD OF ANY OTHER (PREVIOUS OR CURRENT) DYSPEPSIA TREATMENT? (PLEASE STATE) CONCOMMITENT TREATMENT WITH AN NSAID/ASPIRIN? (STATE WHICH) CONCOMMITENT TREATMENT WITH CLOPIDOGREL? (Y/N) RECORD OF OTHER MEDICATIONS THAT COULD CAUSE DYSPEPSIA? (Y/N) PATIENT CONSULTATION DOES THE PATIENT KNOW THE INDICATION FOR THE PPI? (PLEASE STATE) ARE THE PATIENT’S SYMPTOMS CONTROLLED? (Y/N) DOES THE PATIENT KNOW HOW TO RECOGNISE ALARM SYMPTOMS? (Y/N) HAS THE PATIENT HAD A MEDICATION REVIEW TO DICUSS THEIR PPI IN THE PAST 12 MONTHS? DOES THE PATIENT UNDERSTAND ABOUT HEALTHY EATING/LIFESYLE FACTORS? (Y/N) HAS THE PATIENT HAD A PPI LEAFLET? (Y/N) ACTIONS HAVE YOU IDENTIFIED ANY ISSUES FROM THIS AUDIT? (Y/N) WHAT ACTION HAVE YOU TAKEN (IF ANY) – E.G. MUR/GP REFERRAL/PATIENT EDUCATION? IF YOU DO NOT KNOW THE ANSWER TO ANY OF THE QUESTIONS PLEASE STATE ‘NOT KNOWN’ 15 20 ISSUES LOG Patient ID number 1 Issue Identified Action Taken 2 3 4 5 6 7 8 9 10 16 Patient ID number 11 Issue Identified Action Taken 12 13 14 15 16 17 18 19 20 THIS SECTION MUST BE COMPLETED AND RETURNED WITH THE AUDIT 17 REFLECTIVE ACTION PLAN Did you identify any areas in your practice where you can make changes to help improve the management and care of patients on PPIs? Yes No If yes, what changes will you make in the future? Did you identify areas in the practice of others, such as GPs, nurses, pharmacists or hospital doctors/nurses, where they can make changes to help improve the management and care of patients on PPIs? Yes No If yes, how will you communicate this to them? What help, if any, do you need from the LHB to achieve this? Has your practice or knowledge of this therapeutic area improved as a result of this audit? Yes No REMINDER - YOU MAY WANT TO CONSIDER THIS AUDIT ACTIVITY AS AN ENTRY IN YOUR RPSGB CPD PORTFOLIO. 18 Appendix A – Use this form to allocate an Audit ID No. to each PPI patient. Multidisciplinary audit 2011/2012 Patient’s Audit ID No. Patient Details e.g. name and address or NHS Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 19 Patient’s Audit ID No. Patient Details e.g. name and address or NHS Number 15 16 17 18 19 20 DO NOT INCLUDE THIS FORM IN ANY RETURNS BUT RETAIN IN THE PHARMACY FOR CONTRACT VALIDATION PURPOSES. THE LHB CLINICAL GOVERNANCE TEAM MAY NEED TO ACCESS THE INFORMATION AT SOME STAGE FOR FOLLOW UP PURPOSES. 20 Appendix B – Definition of HAC and LAC PPIs Low Acquisition Cost PPIs Lansoprazole Capsules 15mg and 30mg Omeprazole Capsules 10mg and 20mg Pantoprazole Tablets 20mg and 40mg High Acquisition Cost PPIs Esomeprazole (Nexium®) - all formulations/strengths Rabeprazole (Pariet®) - all formulations/strengths Pantoprazole Liquid Special all strengths Protium® - all formulations/strengths Lansoprazole Gran Sach 30mg Lansoprazole Orodispersible Tablets 15mg and 30mg Lansoprazole Liquid Special – all strengths Zoton® FasTab® 15mg and 30mg Omeprazole capsules 40mg Omeprazole Liquid Special all strengths Omeprazole Dispersible tablets 10mg, 20mg and 40mg Omeprazole tablets 10mg, 20mg and 40mg Losec® – all formulations/strengths Omeran® – all strengths Zanprol® – all strengths Mepradec® – all strengths 21