HSCB PHARMACY AND MEDICINES MANAGEMENT TEAM
TITLE
Standard Operating Procedure (SOP) for reviewing patients
on full dose / maintenance dose PPIs
01 November
Dr Andrea Linton
Version Date:
2014
MissVeranne Lynch
Mrs Maura Corry
Mrs Karen Briers
Mrs Siobhan O’Hare
Smyth
Reviewed by Dr Brian
Johnston (BHSCT)
WRITTEN BY:
STATUS:
APPROVED BY:
Final
Emma Quinn
Date Approved :
REVIEW DATE:
01 November 2016
Version Number:
25 November
2014
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 form
NB: 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 longterm 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 2014
Reviewed 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
Scope
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.
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 plan
The 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 searches
a) 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
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
instance. Paper copies of the search must always be kept in the
practice and stored in a secure place when not in use.
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 patients
All 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
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
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 GP
Make 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 pharmacists
Ensure 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 steppingPPI 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

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
References
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
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 1
Proton Pump Inhibitor (PPI) Step-down Action Plan
Practice Name:
Date:
ACTION
The PPI of choice should be identified
and the maintenance dose identified e.g.
lansoprazole or omeprazole (see
Appendix 2)_______
Patient groups to be excluded in addition
to those listed under Step 3 of SOP
Practice Number:
AGREED
Yes / No( please delete)
Yes/No
Yes/No
(list additional groups if appropriate)
______________________________
______________________________
How will patients be contacted?
Telephone / letter
Record contact in Journal
Yes/No
Content of patient letter agreed:
See Appendix 5 for examples
Yes/No
Cancel repeat record of PPI until patient
Yes/No
has been reviewed
Name of GP who will authorise list of
patients suitable for review to consider
Name ________________
stepping-down or stepping-off
Name of person who will deal with patient
queries
Name ________________
Who will inform community pharmacists?
Name ________________
Record new PPI dose (or alternative e.g.
Acute / Repeat
alginate) as acute or repeat?
If repeat, number of repeats of generic
PPI to authorise if considered appropriate
following review:
Same as previous PPI
Yes/No
Synchronise with other repeats
Yes/No
Other
Yes/No
Quantity of generic maintenance dose
PPI to authorise if considered appropriate
following review:
Same as previous PPI
Yes/No
Synchronise with other repeats
Yes/No
Other
Yes/No
Repeat dispensing patients identified and
Yes/No
included in the change (if appropriate)
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 stepdown / 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:
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 2
Full and Maintenance doses of PPIs
Drug
Rabeprazole
Pantoprazole
Esomeprazole
Omeprazole
Lansoprazole
Full
(healing/higher)
dose
20mg
40mg
20-40mg
20-40mg
30mg
Maintenance/lower
dose
10-20mg
20mg
20mg
10-20mg
15-30mg
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 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
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

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 gastroprotection 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)
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
immunosuppressed
or terminally
ill
†Interacting
*Action
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: …………….....………….
PPI step-down SOP, produced by the Pharmacy and Medicines Management Team, HSCB. Updated October 2014
Reviewed by Dr Brian Johnston, Gastroenterologist, Belfast Health and Social Care Trust
Date: …………………
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.
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 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
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 6
Click 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
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