December 13, 2016 | Author: Felix Bruce | Category: N/A
1 Pharmacy practice review: a counselling and action resource Quality use of prescription PPIs How are you managing? Adu...
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Pharmacy practice review: a counselling and action resource Quality use of prescription PPIs How are you managing…? Adult patients using prescription proton pump inhibitors (PPIs)?
Recognised by the: • Australian Association of Consultant Pharmacy (AACP) for 8 points. • Pharmaceutical Society of Australia (PSA) CPD&PI Program for 8 points. • Pharmacy Board of South Australia for up to 8 ENRICH credits. • Society of Hospital Pharmacists of Australia (SHPA) CPD for 8 hours of content as a group 2 activity.
Best practice in the management of prescription PPIs This activity will assist you to: • Clarify the duration of PPI therapy and dosage regimens used for different clinical indications.
• Determine which concurrent medications may induce or exacerbate dyspepsia/ulceration and identify potential medication-related problems.
• Reflect on priorities for patient counselling and identify counselling points for patients prescribed PPIs.
• Recognise alarm symptoms and ensure immediate referral when appropriate.
• Discuss the potential benefits of lifestyle modifications and tailor lifestyle advice based on symptom presentation and precipitating factors.
• Encourage patients to speak to their GP about symptom control and their suitability for a step-down strategy with PPIs.
• Communicate potential rare but serious side effects of PPIs.
• Self-assess your abilities and practice against standards relevant to your role to determine training/development needs.
• Demonstrate provision of quality care.
1. Use best practice standards and guidelines
5. Monitor progress
4. Review and reflect
Discuss expectations of treatment Do my patients know their indication for PPI therapy? with a PPI Do I discuss treatment expectations with patients who Clarify indication and dosage regimen present an initial prescription for PPI therapy? Am I familiar with potential step-down strategies for certain indications? Individualise counselling Gather information and check medication records to prioritise patients for counselling
Am I gathering enough information to tailor counselling to the individual? Am I discussing the potential benefits of lifestyle modification in relation to symptom presentation and precipitating factors? Do I provide additional written materials to support counselling?
Determine the need for referral or review Refer patients to their GP for review where appropriate
Do I engage in discussion about symptom control with patients on long-term therapy? Do I recommend GP review for patients who may be suitable for a step-down strategy? Are patients with alarm symptoms considered for immediate referral?
Provide quality care in pharmacy practice
Do I know which concurrent medications may induce or exacerbate GI symptoms? Can I identify potential medication-related problems? Am I offering consumer medicine information (CMI) as recommended by guidelines?
2. Review current practice
3. Consider implementing changes to pharmacy practice
Are my patients informed of potential rare but serious side effects?
Guide
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Additional information to assist you to review your management. Use this information to complete the forms for patients over 18 years of age with a prescription for a PPI. Do not complete the form while talking to the patient. Complete as soon as possible after your selected episode of care to reflect on your interaction with the patient. This activity has been designed to assist you to review your management of patients prescribed a PPI by their doctor. Do NOT include patients supplied pantoprazole as a Pharmacist Only medication in this activity. Pantoprazole 20 mg is available as a Pharmacist Only medicine in Australia for symptomatic relief of heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux disease (GORD). The Pharmaceutical Society of Australia has a protocol for the providing pantoprazole as a Pharmacist Only medicine.1
Current Management Dosing schedule Determine what dosing schedule the patient’s GP has prescribed – regular daily or symptom driven therapy.
All PPIs have similar clinical efficacy and safety profiles.2 Table 1. Dose comparison of prescription only proton pump inhibitors Proton pump inhibitor
Standard dose* Low dose*
esomeprazole Nexium
20 mg daily
lansoprazole Zoton
30 mg daily
15 mg daily
omeprazole Acimax, Losec, Meprazol, Omepral, Probitor
20 mg daily
10 mg daily
pantoprazole Somac
40 mg daily
20 mg daily
rabeprazole Pariet
20 mg daily
10 mg daily
†
PPIs produce prolonged acid suppression so dosing is usually once daily for patients requiring regular therapy. If higher dose PPI therapy is required for GORD, twice-daily dosing may be more effective than once-daily dosing.3
20 mg daily
A symptom-driven dosing schedule, taking medication only when symptoms occur, may be used for the maintenance management of uninvestigated GORD/dyspepsia, peptic ulcer, non-ulcer dyspepsia, endoscopy-negative reflux disease, and GORD with mild-to-moderate oesophagitis, once initial healing has occurred.5
* Standard dose refers to the initial therapeutic trial dose used to provide symptom relief and heal erosive disease.3 Low-dose refers to the lower dose recommended for maintenance therapy for gastro-oesophageal reflux disease.4 † Esomeprazole 20 mg is recommended as the initial therapeutic trial dose to provide symptom relief and heal erosive disease.3 Esomeprazole 40 mg daily is a PBS-listed restricted benefit for healing of GORD, and may be appropriate if there is endoscopically proven erosive disease in a previously untreated patient.3
Indication and episode of care Table 2. Clinical indication and duration of therapy Clinical indication
Recommended duration of PPI therapy
Uninvestigated GORD/dyspepsia
4–8 weeks. GP may determine ongoing need by a trial of withdrawal of PPI.5,6
Step-down strategy appropriate? Yes
Endoscopically confirmed peptic ulcer disease Up to 8 weeks - if confirmed H. pylori positive and Yes successfully treated with eradication therapy.5 4–8 weeks - if confirmed H. pylori negative and not currently using NSAID/aspirin. Investigated non–ulcer dyspepsia
4–8 weeks5
Yes
7
Yes
Endoscopy–negative reflux disease
4–8 weeks
Mild to moderate oesophagitis (Los Angeles Grades A and B)
4–8 weeks. GP may determine ongoing need by a trial of withdrawal of PPI.6
Yes
Severe oesophagitis (Los Angeles Grades C and D)
Continuous PPI therapy is indicated as relapse is likely.6
No
Barrett’s oesophagus, Zollinger–Ellison syndrome, scleroderma or strictures
Continuous standard or higher daily dose of PPI therapy is indicated.2,3,5
No
Prophylaxis of NSAID–induced dyspepsia/ulceration
Continuous PPI therapy.5,8
No Yes – if NSAID treatment is stopped
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Indication and episode of care (continued…) Alarm symptoms Urgent referral is warranted if patients develop gastrointestinal alarm symptoms or cardiac-type chest pain (e.g. chest pain radiating to the chin or left shoulder).
Patients may not be familiar with their exact indication. Encourage patients to understand their indication for therapy and learn about their medicines. Step-down strategy If there is a good response to an initial course of 4–8 weeks of prescribed PPI therapy and patients do not have significant pathology such as severe oesophagitis, strictures, scleroderma, Barrett’s oesophagus, or Zollinger– Ellison syndrome, they may be suitable for a step-down strategy (see Table 2).
Alarm symptoms1,5,6 Dysphagia (difficulty swallowing) Odynophagia (painful swallowing) Nocturnal choking Haematemesis (vomiting of bright red blood) Melaena (tar/black stools) Unexplained weight loss Abdominal mass Anaemia
Table 3. Types of step-down strategy2,5,6 Treatment withdrawal Some patients do not experience a clinically significant relapse of symptoms after withdrawal of effective initial therapy. A trial withdrawal of PPI therapy may be appropriate for some patients.
Adherence to therapy Determine whether patients have been taking their PPI as prescribed by their doctor.
Symptom-driven therapy PPI is used at the lowest effective dose on days when symptoms are troublesome. Some patients may prefer to use a PPI intermittently as a fixed 2–4 week course.
Survey data suggests that many patients use their PPIs intermittently.9,10 If this has not been recommended by the patient’s doctor, it requires further investigation.
Reduced dose
For patients who require long-term therapy with a PPI (see Table 2) routinely check pharmacy medication history as part of the dispensing process and assess and monitor adherence.11 Explain the importance of adherence to help reduce the risk of relapse or further complications.
If PPIs are required continuously, the PPI is used at the lowest effective dose that maintains control of dyspeptic symptoms. An H2 antagonist may be used as an alternative.
“We all forget to take our medicines sometimes… How many doses have you forgotten in the last week?”
Step-down strategy is not suitable for: • Severe oesophagitis • Strictures • Scleroderma
Use of a PPI only when required may be appropriate for patients who have been using their PPI for more than 8 weeks for conditions that do not require long-term continuous therapy (see Table 2). However a symptom driven dosing schedule should only be used if patients have first discussed and confirmed the appropriateness of this with their GP.
• Barrett’s oesophagus • Zollinger–Ellison syndrome • Prophylaxis of NSAID–induced dyspepsia/ulceration Patients on long-term PPI therapy may be under specialist management.
Adherence to Helicobacter pylori eradication
See Possible suitability for a step-down strategy (page 5).
Medication adherence is extremely important when PPIs are used with antibiotics for H. pylori eradication.2 Poor adherence and antibiotic resistance are the most important predictors of H. pylori treatment failure.2,12 Preparing patients for potential common side effects of PPIs and the antibiotics prescribed improves adherence and increases the probability that the entire course will be completed.12 When counselling patients prescribed H. pylori eradication treatment, discuss the importance of adherence and the possibility of a cure without the need for long-term medication.2
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Indication and episode of care (continued…) Other medications Assess if any of the patient’s concurrent medicines can induce or exacerbate dyspepsia/ulceration, or if the patient is using any other medication that can interact with a PPI. Consider the clinical implications and contact or refer to the prescriber if appropriate.
Drug interactions PPIs are considered to have a relatively low potential for metabolic interactions with other drugs, however there are some interactions of clinical importance that pharmacists should be aware of.3 (See Table 5, page 6.)
Main drugs or drug classes that may induce or exacerbate dyspepsia/ulceration2,13,14 (This list is not exhaustive.) anticholinergic effect drugs (e.g. tricyclic antidepressants, antipsychotics, oxybutynin) beta blockers bisphosphonates (e.g. alendronate) calcium-channel blockers (e.g. verapamil) clopidogrel corticosteroids dopaminergic drugs (e.g. levodopa) iron nitrates (e.g. isosorbide mononitrate) NSAIDs – conventional including aspirin and COX-2 selective slow-release potassium tetracyclines (e.g. doxycylcine) theophylline
Patient symptom profile Factors that may aggravate patients’ reflux or dyspepsia symptoms include spicy or fatty foods, chocolate, caffeine, alcohol and possibly smoking.6 Some patients experience more symptoms during the day, others experience mainly nocturnal symptoms.3 Discuss the patient’s symptom profile with them so that you can tailor counselling and lifestyle advice. “Some people find certain foods make their symptoms worse. Are there any foods that aggravate your symptoms?”
PPIs may be prescribed for prophylaxis of NSAID-induced dyspepsis/ulceration.
Review of hospital discharge prescriptions Confirm indication for ongoing use if the PPI was initiated during the current admission Critically ill patients are sometimes prescribed a PPI or an H2 antagonist for stress ulcer prophylaxis.3 Local practice and drug choice varies.3,15 Stopping stress ulcer prophylaxis should be considered when the patient is no longer in the acute illness phase and has begun to recuperate.3
Communication to community health care providers Communicating medicines information to patients and community health care providers helps to ensure continuity in medication management.20 Ideally this should include: • a verified list of all the medicines at the beginning of the episode of care • any changes made during the episode of care • a detailed rationale explaining any changes in medication management during the episode of care • specific needs regarding medication management.20
PPI treatment is sometimes unintentionally continued after discharge.16,17 If PPIs are prescribed inappropriately on discharge from hospital it may lead to inappropriate long-term use in primary care.18,19 Review of discharge prescriptions provides an opportunity to prevent unintentional continued therapy.
Ensure the patient’s medication list includes the indication, dose and intended duration of PPI therapy.
Counselling encounter Purpose of PPI therapy Initial therapy should help relieve symptoms and allow healing of inflammation or ulcers to occur. If maintenance therapy is needed in the absence of significant pathology, the primary purpose is to control symptoms. In severe oesophagitis, strictures, scleroderma, Barrett’s oesophagus or Zollinger–Ellison syndrome, PPIs are used continuously to reduce the risk of relapse or further complications.
How to take PPIs are most effective for GORD if taken 15–30 minutes before food.6 Mainly day-time symptoms — best taken before breakfast. Mainly night-time symptoms — best taken before the evening meal.3
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Counselling encounter (continued...) Treatment expectations and anticipated duration of treatment PPIs are very effective, but it may take several days for the patient to benefit from the full treatment effect. Adjuvant therapy with an antacid may be required to manage symptoms of GORD/dyspepsia during this time.1,21
Offer written advice – use the patient information leaflets provided
Patient Information Leaflet Medicines for heartburn and reflux one of a group Your doctor has prescribed you inhibitors. of medicines called proton pump which Proton pump inhibitors are medicines the stomach reduce the amount of acid that of the makes. This can allow inflammation and help relieve oesophagus (food pipe) to heal reflux. They can the symptoms of heartburn and ulcers (ulcers in the also treat and help heal gastric in the stomach) or duodenal ulcers (ulcers of the stomach). duodenum - the tube leading out stop you digesting Proton pump inhibitors do not food in the normal way.
medicine for? How long will I need to take this pump How long you need to take a proton your doctor has inhibitor for will depend on why for a number of prescribed it. They can be used to take your different medical conditions. Continue tells you to. medicine for as long as your doctor
Encourage modifications to lifestyle: • weight loss (if overweight or obese) • moderate alcohol consumption • quiting smoking • avoiding late large meals • refraining from lying down shortly after meals • raising the head of their bed may help patients experiencing night-time symptoms that disturb sleep.1,3 listed below. You are taking one of the medicines Active ingredient esomeprazole lansoprazole omeprazole
Brand names Nexium Zoton Acimax, Losec, Meprazol, Omepral, Probitor
pantoprazole rabeprazole
Somac Pariet
effective Proton pump inhibitors are very several days for medicines, however it can take people find that their full effect to be felt. Some helps relieve using an antacid for a day or two when they first heartburn and reflux symptoms start taking a proton pump inhibitor.
If symptoms continue you should see your doctor.
If your doctor has prescribed lansoprazole (Zoton), it is recommended that you wait at least one hour after taking lansoprazole (Zoton) before you use an antacid.
In the absence of complicated pathology, introduce the concept that medication may be needed for 4–8 weeks initially and, depending on patient response, it may be possible to stop therapy or reduce to the lowest dose that maintains control of their symptoms.
Starting your medicine
a prescription for To start with, you may be given or inflammation 4–8 weeks. This will allow ulcers to heal and help relieve your symptoms. this time, you If your symptoms are better after “stepped may be able to have your treatment down”. You may be able to: inhibitor • stop taking the proton pump • use a lower dose the medicine • manage your symptoms by using symptoms. only on the days that you have for everybody. These options are not suitable and you If your symptoms are well controlled your treatment think you may be able to have It is very ‘stepped down’, talk to your doctor. before important to speak to your doctor you take your making any changes to the way medicine.
this medicine Some patients will need to use long term such as severe People with certain conditions Barrett’s oesophagitis, strictures, scleroderma, syndrome need oesophagus or Zollinger–Ellison pump inhibitor. long-term treatment with a proton cause gastric or People using a medicine that can pump inhibitor duodenal ulcers may take a proton In this case, the to help prevent an ulcer developing. the same period proton pump inhibitor is used for cause the ulcer. of time as the medicine that can
Please turn over
Patients using a PPI to prevent NSAID–induced dyspepsia/ulceration should be counselled to use their PPI for the duration of NSAID therapy.
Possible suitability for a step-down strategy Encourage patients to speak to their GP about their suitability for a step-down strategy if: • they do not have an indication that requires long-term PPI therapy, and • their symptoms are well controlled, and • they have been using a PPI for > 8 weeks.
Possible adverse effects Discuss potential adverse effects of PPIs without causing unnecessary alarm. PPIs are generally well tolerated. Common adverse effects include headache, nausea, vomiting, diarrhoea, abdominal pain, constipation and flatulence.2 Table 4. Rare but serious adverse effects
“If your heartburn/reflux symptoms are well controlled – ask you doctor whether you may be suitable for a step-down in therapy. You may be able to use a lower dose of medicine, or only use medicine on the days you have symptoms, or stop your PPI treatment altogether. These options are not suitable for everybody so it important to ask your doctor what is the best plan for you.”
Acute interstitial nephritis Serious hypersensitivity reaction reported with all PPIs.22 Symptoms are non-specific, e.g. weight loss, fatigue, malaise, nausea and vomiting and onset may be delayed by as much as 12 months.22,23 Renal function typically improves after withdrawal of the PPI, but there may be residual chronic kidney disease.24 Clostridium difficile infection 2–3-fold increase in risk of C. difficile infection in patients using a PPI.25,26 Other risk factors include antibiotic use, age ≥ 75 years and renal failure.25,27,28
Providing written information Consumer medicine information (CMI) can be used to supplement verbal counselling.33 CMI may be offered to the patient each time a product is dispensed. Whether this is appropriate is a matter for professional judgement.
Community-acquired pneumonia Increased rate of community-acquired pneumonia29,30 Hip fracture
CMIs should generally be provided: • when a medicine is first provided to the patient • on provision of a medicine when: – a significant change to the CMI has been notified by a sponsor (medicine manufacturer) – the dosage form has been changed (e.g. to a once-daily formulation) – brand substitution occurs and providing the CMI is deemed appropriate • with each supply of a medicine for which there are valid reasons for regular reinforcement of information • at the patient’s/carer’s request • when the patient has special needs • at regular intervals for long-term medicines.33
Associated with increased risk of hip fracture with higher doses and increased duration of therapy.31,32
Lifestyle advice Lifestyle modifications have not been demonstrated to have significant effects in healing oesophagitis, however they may be useful in controlling symptoms in some patients.3,6 Advise patients to avoid food and drinks that exacerbate their dyspeptic symptoms. A written record of episodes of reflux and foods consumed beforehand may increase patients’ awareness of specific triggers. Note that patients are unlikely to adhere to excessively restrictive diets.
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Table 5. Interactions with PPIs (including suspected and possible interactions)2,34–36 PPIs
Esomeprazole (Nexium)
Lansoprazole (Zoton)
Omeprazole (Acimax, Losec, Meprazol, Omepral, Probitor)
Pantoprazole (Somac)
Rabeprazole (Pariet)
Interacting drugs (This is not an exhaustive list. See table below for mechanism of interaction and management options.)
citalopram, clarithromycin, clopidogrel, diazepam, erythromycin
clarithromycin, clopidogrel, erythromycin, methotrexate, theophylline
clarithromycin, clopidogrel, clozapine, diazepam, erythromycin, methotrexate, phenytoin
methotrexate
clopidogrel, digoxin
Antiretrovirals: delavirdine and protease inhibitors (e.g. atazanavir, indinavir) Azole antifungals: ketoconazole, itraconazole (capsule only) Ginko biloba, St John’s wort Warfarin (isolated cases of raised INR reported with all PPIs) People who are known to be poor metabolisers of CYP2C19 (1% to 6% of Caucasians, 1% to 7.5% of Blacks and 12% to 23% of Oriental and Indian Asians) are more dependent on CYP3A4 for the metabolism of PPIs. PPI level may be raised in patients concurrently using CYP3A4 inhibitors (e.g. clarithromycin).
Selected interacting drugs Pharmacokinetic effects
Management
Azole antifungals: ketoconazole, itraconazole (capsule only)
Decreased absorption of some antifungals due to the increase in gastric pH. Decreased levels of azole antifungals.
Avoid combination when possible. Give ketoconazole or itraconazole with an acidic drink (e.g. a cola beverage) to minimise the interaction.
clopidogrel
Decreased metabolism of clopidogrel pro-drug (limited data). Decreased activity of clopidogrel (possible).
Be aware of the potential for reduced efficacy of clopidogrel. Review ongoing need for PPI therapy. Available data suggests no special precautions necessary for pantoprazole.
clozapine
Increased metabolism of clozapine (suspected mechanism). Monitor clinical response, dosage adjustment may be necessary. Decreased levels of clozapine (possible).
Complementary medicines: Ginko biloba, St John’s wort
Increased metabolism of PPIs. Decreased levels of PPIs
Be aware of the potential for reduced efficacy of PPI therapy. Consider avoiding combination especially when consequences may be serious (eg. patients with healing ulcers).
diazepam
Decreased metabolism of diazepam. Increased levels of diazepam.
Advise patient of potential interaction. Monitor patient for increased benzodiazepine effects (sedation, unstable gait, etc). Reduce dose of benzodiazepine if necessary.
Macrolides: clarithromycin erythromycin
Decreased metabolism of PPIs. Increased levels of PPIs.
No special management considerations. Interaction may be valuable in H. pylori eradication regimens. No special precautions necessary for roxithromycin, unlikely to interact.
methotrexate
Decreased renal and (possible) hepatic clearance of methotrexate. Increased levels of methotrexate.
Consider an alternative to PPI (e.g. H2 antagonist) when using high dose methotrexate for chemotherapy. If PPI treatment necessary: • Discontinue PPI therapy 4–5 days before high dose methotrexate. • Monitor methotrexate concentration carefully. Increase rescue treatment with calcium folinate if needed.
phenytoin
Decreased metabolism of phenytoin. Increased levels of phenytoin.
Monitor plasma phenytoin level especially when higher doses of PPIs are used i.e. omeprazole 20 mg did not affect plasma phenytoin level, whereas 40 mg caused slight increase. No special precautions necessary for rabeprazole or pantoprazole.
Protease inhibitors: e.g. atazanavir, indinavir
Decreased absorption of some protease inhibitors due to the increase in gastric pH. Decreased levels of protease inhibitors.
Avoid combination.
warfarin
Decreased metabolism of warfarin. Increased INR (possible).
Monitor INR.
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Summary of planned actions Identify any further actions that need to be implemented for the patient. Use the enclosed Counselling checklist and action plan to detail planned actions for individual patients that you may wish to implement or address at the next episode of care. You may prefer to use patient records or specific documentation that you already use.
Flag your dispensary software to identify patients for further counselling or planned actions to be delivered.
Pharmacist competencies Participation in this activity may help you address the following competency standards.37 Functional Area (areas of responsibility for practising pharmacists) Competency Unit (areas of professional performance) 1: Practice pharmacy in a professional and ethical manner
1.2: Practise to accepted standards 1.3: Pursue lifelong professional learning and contribute to the development of others
2: Manage work issues and interpersonal relationships in pharmacy practice
2.1: Apply communication skills 2.3: Address problems
3: Promote and contribute to optimal use of medicines
3.1: Participate in therapeutic decision making 3.2: Provide ongoing pharmaceutical management
4: Dispense medicines
4.2: Evaluate prescribed medicines 4.3: Supply prescribed medicines (element 3: assist patient understanding and adherence)
6: Provide primary health care
6.1: Assess primary health care needs 6.2: Address primary health care needs of patients 6.3: Promote good health in the community
7: Provide medicines and health information and education
7.3: Disseminate information (element 2: provide information to assist patient care, and element 3: educate members of the general public)
8: Apply organisational skills in the practice of pharmacy
8.1: Plan and manage work time 8.4: Work in partnership with others
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Confidentiality and privacy What will happen to your patient data
What will happen to your personal details
• Your de-identified patient data forms are scanned and returned to you.
Your personal details are:
• Your individual results are kept confidential and are provided to you only.
• recorded for NPS evaluation
• Your data are aggregated with those of other participants and the aggregate results (which do not identify any individual patient or pharmacist):
• provided to a mail house for processing • provided to the Pharmaceutical Society of Australia for CPD&PI credit point allocation, if appropriate
– are provided to all participants
• provided to your pre-registration course co-ordinator to confirm completion, if appropriate
– may be used in NPS evaluation and reports.
• available from NPS by request in writing.
At the close of the review cycle (i.e. after individual results are returned to participants), all potentially identifying data are removed from NPS records. Your individual review results will then no longer be available.
Please note: You are responsible for advising NPS of any changes of address during the review cycle.
Further information Therapeutic enquiries Contact Marissa Scuderi Phone (02) 8217 8700
References 1. Pharmaceutical Society of Australia. Provision of pantoprazole as a Pharmacist only medicine for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease. 2008. http://www.psa.org.au/site.php?id=38 (accessed 23 January 2009). 2. Australian Medicines Handbook. 2009. 3. Therapeutic Guidelines: Gastrointestinal, version 4. 2006. 4. Department of Veterans’ Affairs. PPIs in GORD: Reduce the dose - keep the benefits. Therapeutic Brief 7. http://www.dva.gov.au/health/veteransmates (accessed 13 January 2009). 5. National Institute for Clinical Excellence. Dyspepsia: management of dyspepsia in adults in primary care. Clinical Guideline No. 17. 2004 http://www.nice.org.uk/ download.aspx?o=CG017NICEguideline (accessed 23 January 2009). 6. Gastroenterological Society of Australia. Gastrooesophageal reflux disease in adults: guidelines for clinicians. 2008 http://www.gesa.org.au/pdf/ RefluxDisease4Ed08.pdf (accessed 30 October 2008). 7. Clinical Knowledge Summaries. Dyspepsia-proven GORD. 2008. http://www.cks.library.nhs.uk /dyspepsia_proven_gord (accessed 10 February 2009). 8. Gastroenterological Society of Australia. NSAIDs and the gastrointestinal tract. 2008 http://www.gesa.org.au /pdf/booklets/GesaNSAIDSClinical.pdf (accessed 10 February 2009). 9. Hungin AP, et al. Factors influencing compliance in long–term proton pump inhibitor therapy in general practice. Br J Gen Pract 1999;49:463–4. 10. Van Soest EM, et al. Persistence and adherence to proton pump inhibitors in daily clinical practice. Aliment Pharmacol Ther 2006;24:377–85. 11. Essential CPE: Medication adherence. Canberra: Pharmaceutical Society of Australia, 2006. 12. Stenstrom B, et al. Helicobacter pylori. The latest in diagnosis and treatment. Aust Fam Physician 2008;37:608–12.
13. Myler’s side effects of drugs. Amsterdam: Elsevier. 2006. 14. Gowan J. Dyspepsia - a primary care issue? Australian Pharmacist 2008;27:632–5. 15. Robertson MS, et al. Acute stress ulceration prophylaxis: point prevalence surveys in intensive care units in Victoria, 1997 and 2005. Crit Care Resus 2008;10:18. 16. Wohlt PD, et al. Inappropriate continuation of stress ulcer prophylactic therapy after discharge. Ann Pharmacother 2007;41:1611–6. 17. Murphy CE, et al. Frequency of inappropriate continuation of acid suppressive therapy after discharge in patients who began therapy in the surgical intensive care unit. Pharmacotherapy 2008;28:968–76. 18. Zink DA, et al. Long-term use of acid suppression started inappropriately during hospitalization. Aliment Pharmacol Ther 2005;21:1203–09. 19. Grant K, et al. Continuation of proton pump inhibitors from hospital to community. Pharm World Sci 2006;28:189–93. 20. Australian Pharmaceutical Advisory Council. Guiding principles to achieve continuity in medication management. Canberra: Commonwealth of Australia, 2005. 21. Tytgat GN, et al. New algorithm for the treatment of gastro-oesophageal reflux disease. Aliment pharmacol Ther 2008;27:249–56. 22. Sierra F, et al. Systematic review: Proton pump inhibitor-associated acute interstitial nephritis. Aliment Pharmacol Ther 2007;26:545-53. 23. Geevasinga N, et al. Proton pump inhibitors and acute intersitital neprhritis. Clin Gastroenterol Hepatol 2006;4:597–604. 24. Brewster UC, Perazella MA. Proton pump inhibitors and the kidney: critical review. Clin Nephrol 2007;68:65–72. 25. Dial S, et al. Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile– associated disease. JAMA 2005;294:2989–95.
26. Leonard J, et al. Systematic review of the risk of enteric infection in patients taking acid suppression. Am J Gastroenterol 2007;102:2047–56. 27. Dial S, et al. Risk of Clostridium difficile diarrhea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. CMAJ 2004;171:33–8. 28. Muto CA, et al. A large outbreak of Clostridium difficile–associated disease with an unexpected proportion of deaths and colectomies at a teaching hospital following increased fluoroquinolone use. Infect Control Hosp Epidemiol 2005;26:273–80. 29. Laheij RJ, et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA 2004;292:1955–60. 30. Gulmez SE, et al. Use of proton pump inhibitors and the risk of community-acquired pneumonia: a population-based case-control study. Arch Intern Med 2007;167:950–5. 31. Yang YX, et al. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA 2006;296:2947–53. 32. Targownik LE, et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ 2008;179:319–26. 33. Consumer medicine information and the pharmacist. Canberra: Pharmaceutical Society of Australia, 2007. 34. Baxter K, ed. Stockley’s Drug Interactions. 8th edn. London: Pharmaceutical Press, 2008. 35. Juurlink DN, et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ 2009;180(7) doi:10.1503/cmaj.082001 36. Ho PM, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009;301:937–44. 37. Competency standards for pharmacists in Australia. Canberra: Pharmaceutical Society of Australia, 2003.
April 2009 The information contained in this material is derived from a critical analysis of a wide range of authoritative evidence. Any treatment decisions based on this information should be made in the context of the clinical circumstances of each patient.
NPSA0879
National Prescribing Service Limited ACN 082 034 393 An independent, non-profit organisation for Quality Use of Medicines, funded by the Australian Government Department of Health and Ageing. Level 7 / 418A Elizabeth Street Surry Hills NSW 2010 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email:
[email protected] l web: www.nps.org.au
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Pharmacy Practice Review: Quality use of prescription PPIs NPS office use only
Do not complete this form while talking to the patient. Complete as soon as possible after the episode of care.
Use a black biro to mark a cross (X) in the box beside your response. If you make a mistake, use white correction fluid.
Current management 1.
2.
Who was involved in this episode of care:
Which PPI is the patient using? active ingredient (Brand name)
3.
the patient relative/carer/support person
other
15 mg/day
30 mg/day
60 mg/day
other
10 mg/day
20 mg/day
40 mg/day
other
pantoprazole (Somac)
20 mg/day
40 mg/day
80 mg/day
other
rabeprazole (Pariet)
10 mg/day
20 mg/day
40 mg/day
other
Meprazol, Omepral, Probitor)
Symptom driven
Was the current PPI prescription? an initial prescription for PPI therapy
Ensure understanding of purpose, anticipated duration and possible adverse effects of PPI therapy
ongoing therapy (unchanged)
Consider reinforcing 1 or 2 points from previous counselling, e.g. potential benefits of lifestyle change
a change to current therapy (e.g. increase/decrease dose, change to a different PPI)
Ensure understanding of how to take PPI and treatment expectations
SA M
not determined/not known
What was the clinical indication(s) for treatment with a PPI? (Mark all that apply) GORD/reflux/dyspepsia/heartburn
prophylaxis of drug–induced dyspepsia/ulceration
Specify
mild to moderate oesophagitis
aspirin
COX-2 selective NSAID
peptic ulcers (including NSAID or H. pylori–induced ulcers)
conventional NSAID
other __________________________________
H. pylori eradication not determined not known
Discuss the importance of knowing indication for therapy
other__________________________________________________________________________
severe oesophagitis
Barrett’s oesophagus
strictures, scleroderma
Zollinger–Ellison syndrome
These patients require long-term use of PPI
< 4 weeks
4–8 weeks
not determined
not known
> 8 weeks
Has this patient achieved control of symptoms? yes no
below
not determined
Prompt patient to discuss symptom control and review management with their GP.
not known
Has this patient’s treatment previously been stepped-down? yes no not determined
not known
Patients without an indication for long-term PPI and good symptom control may be suitable for step-down strategy. Advise to discuss management with their GP.
Are alarm symptoms present? (See Guide p.3) yes
9.
Go to Q8
How long has the patient been using a PPI? not applicable (initial prescription)
8.
Not known
PL
Indication and episode of care
7.
What is the dosing schedule of PPI?
E
40 mg/day
omeprazole (Acimax, Losec,
hospital pharmacist intern pharmacist
Regularly each day
20 mg/day
lansoprazole (Zoton)
6.
4.
What is the current DAILY dose of PPI? e.g. omeprazole 20 mg twice a day = 40 mg/day
esomeprazole (Nexium)
5.
community pharmacist accredited pharmacist
AND
no
not determined
not known
Confirm with patient that prescriber is aware, if not refer immediately.
Was the patient using their PPI therapy as prescribed? not applicable (initial prescription Go to Q10 over page) yes, takes every day or as prescribed no, has not been using PPI as prescribed not determined
Discuss importance of adherence to: • allow for healing in short-term disease management • prevent relapse or complications in indications for long-term PPI therapy.
i Used for > 8 weeks without indication for long-term PPI therapy: • Patient may be suitable for step-down strategy. Advise to discuss management with their GP.
not known Please turn over to complete form
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Indication and episode of care (continued) 10. Was the patient using any medication that may induce/exacerbate dyspepsia/ulceration? (See Guide p.4) yes
no
not determined
not known
11. Was the patient using any medication that may interact with a PPI? (See Guide p.6) yes
no
not determined
not known
12. Did you determine if there are any factors (e.g. certain foods) that exacerbate the patient’s symptoms? yes
no
nothing identified
Advise patients to try to avoid foods or activities that aggravate their symptoms.
Hospital discharge prescriptions Review of discharge prescriptions when PPI was INITIATED during CURRENT admission (All other episodes of care go to Q15 below)
i Community pharmacists: Detailed information on discharge prescriptions may not be readily available. Advise patient to discuss management with GP.
13. Was there a clear indication for ongoing PPI use after discharge from hospital? yes
no
not known
Was the need for ongoing PPI therapy after discharge discussed with/reviewed by prescriber? yes
no
not known
Outcome continued PPI on discharge
stepped-down PPI on discharge (e.g. dose reduction, or change to symptom-driven use)
ceased PPI on discharge
patient advised to discuss ongoing need with GP
other_________________________________________________
E
14. Was the indication, dose and intended duration of treatment after discharge documented/communicated to community health care providers (e.g. GP, pharmacist)? i Communication improves continuity in medication management. yes no not applicable (PPI ceased) not known
PL
Counselling encounter
15. Indicate what verbal counselling was provided at this episode of care (Mark all that apply)
Ensure understanding of indication for PPI therapy.
purpose of PPI therapy
Provide instruction on dose and ideal timing dependent on symptom presentation. Clarify how to use PPIs for symptom-driven therapy.
how to take PPI medicine response to therapy
SA M
Discuss time to effect and outline treatment expectations.
anticipated duration of treatment
Advise 4–8 weeks of treatment will heal and control symptoms for some indications.
possible adverse effects of PPIs
Discuss potential for adverse effects of PPIs e.g. common: headache, nausea; rare: acute kidney problems, Clostridium difficile infection, community-acquired pneumonia, hip fracture.
potential benefits of lifestyle changes
Provide specific lifestyle advice tailored to patient’s symptom profile and precipitating factors.
possible suitability for a step-down strategy
Encourage patients that do not have an indication that requires long-term PPI therapy, with well controlled symptoms, to speak to their GP about their suitability for a step-down strategy.
use of concomitant medicines that may cause GI symptoms
Discuss potential for medicines (prescribed, OTC or complementary) to exacerbate symptoms.
potential for interactions with other medicines
Remind patients to always check with GP or pharmacist before commencing any new medicines (prescribed, OTC or complementary).
16. What written material was provided to support verbal counselling? none
CMI for PPI
NPS patient information leaflet
referral to website for information
Pharmacy Self Care Card
patient medication list
other_______________________
17. Approximate time for counselling on PPI treatment at this episode of care: no counselling given
< 2 minutes
2–5 minutes
6–10 minutes
> 10 minutes
Summary of planned actions 18. Mark any further actions to be implemented/have been implemented for this patient: refer patient to prescriber for review
alarm symptoms present
contact prescriber directly to discuss management
patient may be suitable for review/ step-down in therapy
check adherence at next episode of care contact carer/relative/support person
use of medicine that may induce/ exacerbate GI symptoms
advice on specific lifestyle issues
HMR/RMMR
provide specific counselling or resources at next episode of care
potential drug interactions
other _______________________________________________ _________________________________________________________
refractory symptoms other __________________________
Consider recording specific details of further actions in patient profile on computer for future reference.
Other planned actions: ________________________ ____________________________________________________ ____________________________________________________ ____________________________________________________ ____________________________________________________ ____________________________________________________ ____________________________________________________ NPSA0879
OKA6982 NPS PPI PhPR Patient Info Pad V3.qxd:6982
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Patient Information Leaflet Medicines for heartburn and reflux Your doctor has prescribed you one of a group of medicines called proton pump inhibitors. Proton pump inhibitors are medicines which reduce the amount of acid that the stomach makes. This can allow inflammation of the oesophagus (food pipe) to heal and help relieve the symptoms of heartburn and reflux. They can also treat and help heal gastric ulcers (ulcers in the stomach) or duodenal ulcers (ulcers in the duodenum - the tube leading out of the stomach). Proton pump inhibitors do not stop you digesting food in the normal way. You are taking one of the medicines listed below. Active ingredient esomeprazole lansoprazole omeprazole
Brand names Nexium Zoton Acimax, Losec, Meprazol, Omepral, Probitor
pantoprazole rabeprazole
Somac Pariet
Proton pump inhibitors are very effective medicines, however it can take several days for their full effect to be felt. Some people find that using an antacid for a day or two helps relieve heartburn and reflux symptoms when they first start taking a proton pump inhibitor.
How long will I need to take this medicine for? How long you need to take a proton pump inhibitor for will depend on why your doctor has prescribed it. They can be used for a number of different medical conditions. Continue to take your medicine for as long as your doctor tells you to. Starting your medicine To start with, you may be given a prescription for 4–8 weeks. This should help to relieve your symptoms and allow healing to take place. If your symptoms are better after this time, you may be able to have your treatment ‘stepped down’. You may be able to: • stop taking the proton pump inhibitor • use a lower dose • manage your symptoms by using the medicine only on the days that you have symptoms. These options are not suitable for everybody. If your symptoms are well controlled and you think you may be able to have your treatment ‘stepped down’, talk to your doctor. It is very important to speak to your doctor before making any changes to the way you take your medicine.
If symptoms continue you should see your doctor.
Some patients will need to use this medicine long term
If your doctor has prescribed lansoprazole (Zoton), it is recommended that you wait at least one hour after taking lansoprazole (Zoton) before you use an antacid.
People with certain conditions such as severe oesophagitis, strictures, scleroderma, Barrett’s oesophagus or Zollinger–Ellison syndrome need long-term treatment with a proton pump inhibitor. People using a medicine that can cause gastric or duodenal ulcers may take a proton pump inhibitor to help prevent an ulcer developing. In this case, the proton pump inhibitor is used for the same period of time as the medicine that can cause the ulcer.
Please turn over
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Medicines for heartburn and reflux continued... Do these medicines have any side effects? Proton pump inhibitors are well tolerated by most people. Headache, nausea, vomiting, diarrhoea, abdominal pain, constipation and flatulence are the most common side effects. More serious side effects, such as kidney problems are rare. Ask your pharmacist or doctor for a copy of the consumer medicine information (CMI) leaflet for more information about possible side effects for your medicine.
Record your symptoms until your next doctor’s appointment.
What should I do if I develop problems?
What about other medicines? Other medicines including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop may be affected by a proton pump inhibitor or may affect how it works. Medicines used to prevent blood clots (warfarin) may be affected. Medicines that depend on the amount of acid in the stomach to work may not work as well. Check with your doctor or pharmacist before starting any new medicines.
Can I do anything to improve my reflux or heartburn symptoms? • Avoid food and drinks that make your symptoms worse (for example, spicy foods, fatty foods, chocolate, coffee, cola drinks and orange juice may make your heartburn symptoms worse).
See your doctor if your symptoms do not get better, or get worse or if you develop any of the following problems: • vomiting, especially if you vomit blood or material that looks like coffee grounds • dark, sticky bowel motions • difficult or painful swallowing • unexplained weight loss. • chest pain, chest pain that gets worse with or after exercise or chest pain that goes into your chin or left shoulder. These may be signs of a heart problem.
For more information on your medicine
• Avoid large or late meals and avoid lying down immediately after meals.
Ask your pharmacist or doctor for a copy of the Consumer Medicine Information (CMI) leaflet for your medicine or search online at www.nps.org.au/consumers.
• If you experience heartburn symptoms that are worse at night and disrupt your sleep, try raising the head of your bed.
Call Medicines Line 1300 888 763 (Monday to Friday 9am – 6pm EST) for independent information on your medicines.
• If you drink more than two standard drinks of alcohol a day, reduce the amount you drink.
Other resources
• If you are overweight, try losing some weight.
Download or order free resources from National Prescribing Service Limited at nps.org.au/order_free_information or order on 02 8217 8700.
• Stop smoking. Discuss with your doctor or pharmacist ways to quit, or call the Quitline 13 QUIT (13 7848). Plan your quit date.
Medicines List – a sheet for you to record your medicines
• Ask your pharmacist or doctor to review your medicines to make sure that none of your other medicines could be making your symptoms worse.
Fact sheets – including, What is a medicine? Generic medicines, Remembering your medicines Medimate – helps you find, understand and use information about medicines (in 5 languages)
This leaflet has been provided to you by your pharmacist to help discuss the use of your medicines, and has been designed to be used with the consumer medicine information leaflet for your medicine. April 2009
NPS is an independent, non-profit organisation for Quality Use of Medicines, funded by the Australian Government Department of Health and Ageing. ABN 61 082 034 393 l Level 7/418A Elizabeth Street Surry Hills NSW 2010 l PO Box 1147 Strawberry Hills NSW 2012 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email:
[email protected] l web: www.nps.org.au
NPSA0879
Counselling checklist and action plan Pharmacy practice review: Quality use of prescription PPIs: Complete the details of the counselling provided at this episode of care and any planned actions for each patient. Keep this form to identify counselling areas to be discussed with the patient during future episodes of care and to review the outcomes for each planned action. Planned actions Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Patient name: Counselling provided purpose of PPI therapy how to take PPI medicine response to therapy anticipated duration of treatment possible adverse effects of PPIs
potential benefits of lifestyle changes possible suitability for a step-down strategy use of concomitant medicines that may cause GI symptoms potential for interactions with other medicines
Outcomes
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Review your practice Pharmacy practice review: Quality use of prescription PPIs
Completing this Pharmacy practice review: After completing the 10 forms, review your current practice and identify your training/development needs. Complete the details below and keep for future reference. Review your current pharmacy practice Yes
Usually
No
Complete your own training/development plan My training/development plan
How I will implement this plan
Due date
If you tick (✓) a shaded box below complete your plan Is my knowledge of PPIs evidence based and up to date? (Competency units 1.3, 3.1, 4.2; standards 7.7, 5.4)1,2 Do I individualise counselling by exploring patient’s knowledge and understanding of their indication for PPI therapy and disease state management? (Competency units 1.2, 2.1, 3.1, 3.2, 4.2, 4.3, 6.1, 6.2, 6.3, 7.3; standards 1.6, 7.2)1,2 Do I routinely discuss the potential benefits of lifestyle modifications and tailor the provision of lifestyle advice based on symptom presentation? (Competency units 3.1, 6.1, 6.2, 6.3, 7.3; standard 7.2)1,2 Do I refer confidently to other healthcare professionals when appropriate? (Competency units 1.2, 2.1, 2.3, 3.2, 4.2, 6.1, 8.4; standard 1.9)1,2 Do I provide written information to supplement oral counselling in a timely manner when appropriate for patients using PPIs? (Competency units 1.2, 2.1, 3.1, 4.3, 7.3, 8.1; standards 2.8, 7.4, 15.4)1,2 Other issues identified
1. Pharmaceutical Society of Australia. Competency standards for pharmacists in Australia. Canberra: Pharmaceutical Society of Australia, 2003. 2. Pharmaceutical Society of Australia. Professional practice standards, version 3. Canberra: Pharmaceutical Society of Australia, 2006. NPSA0879
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Ensuring the best possible advice This pharmacy is currently participating in a quality improvement activity provided by the National Prescribing Service (NPS). This activity focuses on the use of proton pump inhibitor medicines. These medicines reduce the amount of acid made by your stomach. What does this mean for me? Your pharmacist may ask you about your medical condition(s) and your medicine(s). The pharmacist may assess the way they help you. How will the pharmacist help me? Your medicines will be reviewed. You will be provided with up-to-date information on proton pump inhibitor medicines, advice on how to control your symptoms and advice to see your doctor if needed. What about my privacy? Information the pharmacist records for this activity can not identify you and remains anonymous to comply with the National Privacy Principles contained in the Privacy Act 1988 (Cwth). If you do not wish your anonymous information to be included in this quality assurance activity, please tell your pharmacist. Want to know more? Please ask the pharmacist.
NPS is an independent, non-profit organisation for Quality Use of Medicines, funded by the Australian Government Department of Health and Ageing. National Prescribing Service Limited ABN 61 082 034 393 l Level 7/418A Elizabeth Street Surry Hills NSW 2010 l PO Box 1147 Strawberry Hills NSW 2012 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email:
[email protected] l web: www.nps.org.au NPSA0879
