Step 5: GP authorisation and informing practice...

HSCB PHARMACY AND MEDICINES MANAGEMENT TEAM

TITLE Standard Operating Procedure (SOP) for reviewing patients on full dose / maintenance dose PPIs

WRITTEN BY: Dr Andrea LintonMissVeranne LynchMrs Maura CorryMrs Karen BriersMrs Siobhan O’Hare SmythReviewed by Dr Brian Johnston (BHSCT)

Version Date: 01 November 2014

STATUS: FinalAPPROVED BY: Emma Quinn Date Approved : 25 November

2014REVIEW DATE: 01 November 2016 Version Number: 1.0

This SOP has been developed for use by HSCB staff to support improvements in prescribing. HSCB staff operating under this SOP should seek approval from the lead GP for each step of the process outlined. The HSCB will not be responsible for the use of this SOP by non-HSCB staff.

Revision History

VERSION NUMBER

REVISION DATE SUMMARY OF CHANGES

Please refer to guidance notes below when completing this formNB: Information under each of the headings should be concise

Introduction NICE guidance1 encourages people who need long-term management of dyspepsia symptoms to reduce their use of prescribed medications stepwise: by using the lowest effective dose, by trying “as needed” use when appropriate, and by returning to self-treatment with antacid and/or alginate therapy (unless there is an underlying condition or concurrent medication that needs continuing treatment. If the need for ongoing therapy is not reviewed, patients may continue to take unnecessarily high doses of PPIs or continue treatment beyond therapeutic need and may, therefore, be at risk of adverse effects associated with long-term use as highlighted by the MHRA in April 20122. Generic omeprazole and lansoprazole capsules are the preferred options

PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. Updated October 2014Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust

in the Northern Ireland formulary 3 currently as they are available at lower cost to the NHS than other PPIs.

Purpose This standard operating procedure (SOP) is offered to practices to identify patients on full dose PPIs that may be suitable for stepping down to maintenance dose of PPI, preferably to either omeprazole or lansoprazole capsules, and patients on maintenance dose PPIs that may be suitable for stepping off PPI thereby improving patient safety and generating efficiencies.

Scope Patients identified by the SOP should be invited to attend the surgery for a review appointment or be allocated a telephone slot to discuss ongoing treatment needs with a prescriber with a view to:

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.

Process This process should be carried out by a practice or HSCB employed healthcare professional only i.e. GP, nurse or pharmacist. Clinical knowledge is required to exclude unsuitable patients from the switch, and therefore, it is advised that this process is not a suitable task for a non-health care professional e.g. practice manager or administration staff.

Step 1: Agree action planThe practice should agree the changes to be made and how they will be carried out in the form of an Action Plan (Appendix 1).

Step 2: Perform searchesa) Identify all adult patients (> 18 years) currently receiving

higher/full/healing dose PPIs > 3 months – (search by generic and brand name) i.e:

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

Children prescribed PPIs should be reviewed on a case by case basis by the prescriber – refer to NI Medicines Management Newsletter (Anti-secretory drugs for children (Oct 2013) for further details4.

Practices are encouraged to prioritise workload by identifying and targeting patients on esomeprazole (Nexium®) in the first instance. Paper copies of the search must always be kept in the practice and stored in a secure place when not in use.

PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. October 2014Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust

b) Identify all adult patients (> 18 years) currently receiving lower/maintenance dose PPIs for > 3 months – (search by generic and brand name) i.e:

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

Step 3: Exclude unsuitable patientsAll patients should be reviewed and individually assessed: however, it may not be appropriate to consider changes to PPI treatment in certain cases. Consideration should be given to whether a previous PPI switch has been attempted, and to other circumstances, listed below:

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.

Taking clopidogrel – 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 4: Compile list of patients suitable for review by GPMake recommendations for the change using the dose guides in Appendix 2 and review recommendations in Appendix 3 remembering that omeprazole and lansoprazole are the preferred PPI options.

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 pharmacistsEnsure that all local community pharmacists have been informed about the review in advance. This will allow them to reinforce the advantages of stepping down to maintenance dose to patients and offer advice to patients that have their PPI stopped e.g.: what to do if they experience rebound acid hypersecretion and to adjust their stock levels.

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:

o Review long-term patient care at least annually to discuss medication and symptoms.

o Inform patients to report changes in symptoms

Review 01 November 2014

Other Useful Information

References1. 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


http://niformulary.hscni.net/PrescribingNewsletters/MedicinesManagement/Vol4/MMNewsVol4Special2/Pages/default.aspx

http://niformulary.hscni.net/PrescribingNewsletters/MedicinesManagement/Vol4/MMNewsVol4Special2/Pages/default.aspx

http://niformulary.hscni.net/

http://www.mhra.gov.uk/home/groups/dsu/documents/publication/con149785.pdf

https://www.nice.org.uk/guidance/cg17

Appendix 1Proton Pump Inhibitor (PPI) Step-down Action Plan Practice Name: Practice Number: Date: ACTION AGREED

Yes / No( please delete)The PPI of choice should be identified and the maintenance dose identified e.g. lansoprazole or omeprazole (see Appendix 2)_______

Yes/No

Patient groups to be excluded in addition to those listed under Step 3 of SOP

Yes/No(list additional groups if appropriate)

______________________________

______________________________

How will patients be contacted? Telephone / letterRecord contact in Journal Yes/NoContent of patient letter agreed: See Appendix 5 for examples Yes/NoCancel repeat record of PPI until patient has been reviewed

Yes/No

Name of GP who will authorise list of patients suitable for review to consider stepping-down or stepping-off

Name ________________

Name of person who will deal with patient queries Name ________________Who will inform community pharmacists? Name ________________Record new PPI dose (or alternative e.g. alginate) as acute or repeat?

Acute / Repeat

If repeat, number of repeats of generic PPI to authorise if considered appropriate following review: Same as previous PPI Synchronise with other repeats Other

Yes/NoYes/NoYes/No

Quantity of generic maintenance dose PPI to authorise if considered appropriate following review: Same as previous PPI Synchronise with other repeats Other

Yes/NoYes/NoYes/No

Repeat dispensing patients identified and included in the change (if appropriate)

Yes/No

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

Drug Full (healing/higher) dose

Maintenance/lower dose

Rabeprazole 20mg 10-20mgPantoprazole 40mg 20mgEsomeprazole 20-40mg 20mgOmeprazole 20-40mg 10-20mgLansoprazole 30mg 15-30mg


Appendix 3

Review of patient – things to consider:

Long-term safety risksLong 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 PPIsMost people with endoscopy-negative GORD can satisfactorily control symptoms using this option.

Trial cessationThe 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).


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

Patient Name Current PPI and dose

Current PPI dose

duration

Taking an interacting medicine†

Patient has Barrett’s, ZE, oesophageal strictures or

Hx of oesophageal

varices

Under ongoing care of

2o/3o

GI/ENT consultant

Awaiting referral to

gastro/ ENT or

endoscopy

Taking concurrent drug which requires L/T

gastroprotect-ion

Patient is immuno-

suppressed or terminally

ill

*Action

†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. Updated October 2014Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust

Appendix 5 Patient 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 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.

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


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


http://primarycare.hscni.net/pdf/PPIPatientLeafletWeb.docx

Step 5: GP authorisation and informing practice...

Documents

Transcript of Step 5: GP authorisation and informing practice...