Hscb Pharmacy and Medicines Management Team

HSCB PHARMACY AND MEDICINES MANAGEMENT TEAM

Revision History

Please refer to guidance notes below when completing this form

NB: Information under each of the headings should be concise

1. Ensuring that patients receive the lowest effective dose appropriate for the management of their symptoms, in line with NICE guidelines.
2. Encouraging and supporting the practice to use omeprazole or lansoprazole as first line PPI.

• Esomeprazole (Nexium®) ≥40mg
• Rabeprazole (Pariet®) ≥20mg
• Omeprazole (Losec®) ≥20-40mg
• Lansoprazole (Zoton®) ≥30mg
• Pantoprazole(Protium®) ≥40mg

• Esomeprazole (Nexium®) 20mg
• Rabeprazole (Pariet®) 10mg
• Omeprazole (Losec®) 10mg
• Lansoprazole (Zoton®) 15mg
• Pantoprazole(Protium®) 20mg

• Taking healing dose for less than 3 months.
• Awaiting a referral or endoscopy
• Under ongoing care of gastroenterologist/ ENT consultants in secondary/tertiary care.
• Taking an interacting medicine – e.g. warfarin, acenocoumarol (Sinthrome®), phenytoin (Flynn®), atazanavir (Reyataz®), nelfinavir (Viracept®), raltegravir (Isentress®), tipranavir (Aptivus®), cilostazol (Pletal®). Furthermore, certain PPIs have specific interactions, for instance omeprazole with methotrexate. See current BNF and SPCs for full details. Highlight interacting medicines on review list (Appendix 4) for GP consideration.
• Takingclopidogrel – GPs should be informed of need to review patients on clopidogrel and either omeprazole or esomeprazole due to potential for interaction. A note to this effect should be added to the patient’s clinical record.
• Patients with conditions such as Barrett’s oesophagus, Zollinger Ellison, patients with oesophageal strictures or oesophageal dilation or history of oesophageal varices.
• Immunosuppressed patients or patients receiving immunosuppression therapy
• Terminally ill patients
• Please note, although not a cause for exclusion patients on concomitant medicines that are known to cause peptic ulcer disease will require long-term gastro-protection and, therefore, will not be suitable for step-off but can be considered for step-down e.g. NSAIDs, high dose steroids, aspirin or SSRIs (please refer to the SPCs for individual products for further details).
• If the patient has a history of NSAID-associated ulcer and needs to continue on NSAID treatment after ulcer healed then the recommendation is that the dose of PPI should not normally be reduced because asymptomatic ulcer deterioration may occur (please refer to the BNF for appropriate gastroprotection doses).

Step 5: GP authorisation and informing practice staff

• Lead GP to review the list of patients in Appendix 4 to ensure that he/she is happy for suitable patients to be written to or contacted by phone (as per practice action plan) to request them to make an appointment.

• Inform all reception staff about the review process. Ensure staff are aware of who the patient should be referred to if they phone the practice with any queries, e.g. practice pharmacist, nurse or GP leading on the project.

Step 6: Inform local community pharmacists

Step 7: Prepare for review

• Send a letter to each patient requesting them to make an appointment or arrange a telephone slot to have their PPI reviewed with a prescriber (sample letters are included in appendix 5, but each practice will need to agree the content of letter). You may wish to include a patient information leaflet (Appendix 6).

• Add a note to the journal or consultation record that the patient has been sent a letter requesting them to make an appointment or to contact prescriber by phone (as agreed in Action Plan Appendix 1).
• If agreed as part of the action plan cancel PPI from the active repeat list so that patient will be unable to reorder further repeats until review has taken place. Ensure reason for cancellation is documented. Please note that there may be Repeat Dispensing (RD) patients suitable for stepping-down or stepping-off. [For RD patients, the practice may want to consider flagging these patients to have the review performed when their current RD cycle finishes at time of medication review].
• Ensure adequate mechanisms are in place to facilitate ongoing review e.g.by utilising medication review of repeat medicines, “due diary” dates or recall flags:
• Review long-term patient care at least annually to discuss medication and symptoms.
• Inform patients to report changes in symptoms

1. NICE CG 17. Dyspepsia: Managing dyspepsia in primary care.National Institute for Health and Clinical Excellence, April 2014.
2. MHRA Drug Safety Update April 2012
3. NI Medicines Management Formulary (Adult) BNF Chapter 1 – Gastrointestinal System (August 2013)
4. Northern Ireland Medicines Management Newsletter Supplement October 2013 – Antisecretory drugs for Children

Appendix 1

Proton Pump Inhibitor (PPI) Step-down Action Plan

Practice Name: Practice Number:

Date:

I agree to the above action plan being undertaken by (insert name i.e. GP, pharmacist or practice nurse) to identify suitable patients for consideration of step-down / step-off at follow-up appointment with a GP in accordance with the SOP for reviewing patients on full dose / maintenance dose PPIs.

Lead GP signature:…………………..Name:

Appendix 2

Full and Maintenance doses of PPIs

Appendix 3

Review of patient – things to consider:

Long-term safety risks

Long term PPI use (>1 year) has been linked to:

• Increased risk of fractures (hip, wrist or spine)
• Hypomagnesaemia (can present as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmias)
• Increased risk of Clostridium difficile associated diarrhoea
• Increased risk of pneumonia
• Vitamin B12 deficiency
• Rebound hypersecretion
• Acute interstitial nephritis

Further information

• Is the patient taking any OTC medicines in addition to prescribed medicines for the management of symptoms?
• Is the patient taking any OTC or prescribed medicines that can cause symptoms of dyspepsia? E.g. bisphosphonates, calcium antagonists, corticosteroids, NSAIDs, Nitrates, theophyllines, SSRIs. Patients may still be suitable for step-down (refer to Process Step 4 for further details).

Options for step down

• Low-dose maintenance therapy with PPIs

E.g. In patients with gastro-oesophageal reflux disease evidence suggests that a low-dose PPI prevents relapse in 70-80% of people with healed oesophagitis over 12 months.

• Intermittent, symptom–dependent use of PPIs

Most people with endoscopy-negative GORD can satisfactorily control symptoms using this option.

• Trial cessation

The decision to cease therapy should be guided by symptom control and each patient’s ability to report return of symptoms

• Rebound Acid Hypersecretion (RAHS) can occur when a PPI is withdrawn, which in some cases can be managed with short-term alginate or H2 antagonist cover

Patient information / advice

• Lifestyle interventions are important in controlling symptoms and reducing the need for ongoing PPI therapy
• For best results, PPI should be taken 30-60 minutes before breakfast
• Once symptoms are controlled the patient may be able to take a lower dose or just take when needed
• Expect the same benefits from lower dose PPI therapy
• By taking less medicines you reduce the risk of unwanted effects
• Report any abdominal symptoms lasting more than 2-3 days
• Patient leaflets (e.g.see Appendix 6)

Ongoing review

• Review long-term patient care at least annually to discuss medication and symptoms.
• Patients to report changes in symptoms
• Add stop date to directions if appropriate e.g.” omeprazole 20mg daily until 15th July 2014” for patients that do not need long-term gastro-protection or acid suppression (see earlier exclusion criteria).

PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. October 2014

Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust

Appendix 4: Assessment of patients’ suitability for PPI switch (GP to authorise list before letters sent to patients)

†Interacting medicines include warfarin, clopidogrel (interacts with omeprazole and esomeprazole), acenocoumarol (Sinthrome®), phenytoin (Epanutin®), atazanavir (Reyataz®), nelfinavir (Viracept®), raltegravir (Isentress®), tipranavir (Aptivus®), cilostazol (Pletal®). Please highlight for GP consideration.

*Action should be one of the following:

1. Patient not suitable for step-down or step-off – please note if this is due to potential interaction of either omeprazole or esomeprazole with clopidogrel then action should detail need for GP to review ongoing treatment with these medicines.
2. Patient suitable for an appointment to discuss stepping down or stepping off (refer to Appendix for possible strategies)

Authorised by:

GP name: …………………………… GP signature:…………….....…………. Date:…………………

PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. October 2014

Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust

Appendix 5Patient information letter – sample 1

Practice header

Dear

MEDICATION REVIEW

In the interest of ensuring that all our patients receive the medicines that are best for their medical conditions, we are constantly reviewing our prescribing. This means that from time to time, your medicine, or the dose prescribed may change.

We are currently carrying out a review of our patients taking ………………………..and our records show that you are being prescribed this medicine.

………………………………… belongs to a group of drugs known as proton pump inhibitors (PPIs). PPIs work by reducing the amount of acid in your stomach. You are currently taking the full dose of this medicine and it is recommended that in most patients the dose should be stepped down to a lower maintenance dose after a period of time.

As a result we would like you to make an appointment to discuss and review this treatment. This appointment should be made before your next prescription for this medicine is due.

It is hoped that you will support the practice as we endeavour to follow guidance as set out in the Northern Ireland Medicines Management Formulary to provide the best level of care to our patients. We look forward to seeing you at your appointment. However if you have any questions in the meantime please contact the practice.

Appendix 5

Patient information letter – sample 2

Dear

In the interest of ensuring that all our patients receive the medicines that arebest for their medical conditions, we are constantly reviewing our prescribing.

This means that from time to time, your medicine, or the dose prescribed maychange.

We are currently carrying out a review of our patients taking ……………………..and our records show that you are being prescribed thismedicine.

………………………………… belongs to a group of drugs known as protonpump inhibitors (PPIs). PPIs work by reducing the amount of acid in yourstomach.

As time has gone on, doctors have learned more about these drugs and it is now recognised that some patients may experience side-effects with long-term use. For this reason, we want to review our patients that have been taking these drugs for longer than 3 months to make sure this is still the best treatment for you and that the medicine is at the right dose for your condition.

As a result we would like you to either make an appointment or contact a GP / Nurse Practitioner by phone to discuss and review this treatment before your next prescription for this medicine is due.

It is hoped that you will support the practice as we endeavour to follow best practice guidance to provide the best level of care to our patients.

We look forward to hearing from you.

Yours sincerely

PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. October 2014

Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust

Appendix 6Click here for printable version of Patient Information Leaflet‘Review of medication used for heartburn and indigestion’

PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. October 2014

Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust