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Date of preparation: April 2015 UK/G-NHS/1114/0058ac Your Toolkit Polypharmacy Medicines Optimisation Review (PMOR) The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd. 1

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Date of preparation: April 2015UK/G-NHS/1114/0058ac

Your ToolkitPolypharmacy Medicines Optimisation Review (PMOR)

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

1

Having downloaded Your Toolkit, the next step is to implement a PMOR in your CCG for PPI patients. We have therefore provided all you will need to carry this out simply and efficiently. This toolkit includes information for you, your colleagues and your patients.

A step-by-step guide to your PMOR1. Raise awareness among GPs of rebound acid hypersecretion and how it can be managed with the use of

licensed alginate preparations

2. Identify those responsible to champion, train, educate and engage healthcare professionals and patients1,2

• Establish that PPIs are, in some instances, being prescribed unnecessarily3-5

• Understand the role of polypharmacy patient reviews in reducing drug use1,2

• Recognise that symptoms of rebound acid hypersecretion6 resulting from long-term PPI use make it difficult for patients to reduce PPI intake, and that this defines the role of alginates as short-term rescue medication

• Address team members’ objections to PPI-indicated PMOR

Prepare protocols to:

• aid in the understanding of indications for PPI

• aid in the understanding of the choice of NSAID

• give advice on those instances where SSRIs may be discontinued

3. Create a baseline audit of patients taking PPIs for more than eight weeks, who, having been filtered by robust exclusion criteria, are selected for review.

4. Conduct patient reviews, by invitation to the clinic. At consultation, ensure any change in medication is agreed with the patient. Education and support is provided in the form of patient information leaflets with advice on PPIs, NSAIDs and SSRIs, and support for making healthy lifestyle changes.

Ensure community pharmacies in the area are informed of PMOR project activity, so that they are prepared to advise patients who may present with questions as to why their medication has been changed. Patient satisfaction surveys are completed at 4 months in order to assess effectiveness of this strategy on prescribing costs. These surveys assess any changes that may have been made and look at patients’ opinions of the review process, together with feedback from healthcare professionals involved. Such surveys are in line with Patient Reported Outcomes Measures (PROMs) guidelines, which assess the quality of care delivered to NHS patients from the patients’ perspective.

Introduction

2

1 McGinn D, Roberts C. Outcomes of a medication optimisation review in patients taking proton pump inhibitors. Guidelines in Practice. January 2015.

2 Dr. Spencer. Medicines optimisation reviews in patients taking PPIs. Reprinted from Prescriber 5 May 2013.

3 Forgacs I. BMJ 2008;336(7634):2-3.

4 Walker NM, McDonald J. Pharmacy World and Science 2001; 23(3):p116-117.

5 Gupta R et al. Overuse of Acid Suppression Therapy in Hospitalized Patients.

6 Reimer C et al. Proton-Pump Inhibitor Therapy Induces Acid-Related Symptoms in Healthy Volunteers After Withdrawal of Therapy. Gastroenterology 2009;137:80-78.

References

3

Contents

Here is an overview of the contents of this toolkit and how each item has been designed to help you:

Protocols5 PPI protocol

• A comprehensive 14-page booklet. It provides a protocol for prescribing PPIs - initiation, review and how discontinuation of PPIs is part of the medications review process

19 NSAID protocol• A comprehensive 10-page booklet. It provides a protocol for prescribing NSAIDs - initiation, review and

how discontinuation of NSAIDs is part of the medications review process

PMOR implementation materials29 Objection Handler

• This will help you overcome any objections and answer questions your colleagues may have in order for you to put together a local PMOR team

30 Medication Review Process for PPI patients• Provides details of those patients who are not suitable for a PPI review, or who may be considered for a

PPI dose step-down, to help you select the most appropriate patients for the PMOR

33 Dyspepsia Clinic Patient Invitation• An example of how you could invite patients for a review appointment

34 Pharmacy Letter• A 2-page leaflet to inform community pharmacists of the planned PMOR and assist with patients’ questions

36 Patient Satisfaction Questionnaire• A short, post-review questionnaire to gain patient feedback in line with PROM guidelines

37 Audit spreadsheet• An example of a patient overview spreadsheet showing types of information to be captured at a review.

It will also assist you in measuring project outcomes

38 Discontinuation of SSRIs in Adults• A 4-page guide to discontinuing SSRIs in adults

Patient Leaflets42 SSRI Patient Leaflet

• Information about SSRIs and discontinuing them safely

44 PPI Patient Leaflet • A leaflet providing reassurance to patients stepping-down or off PPIs, with advice on managing rebound

symptoms

46 NSAID Patient Leaflet• Information about taking NSAIDs and the need for reviews

48 Healthy Living Patient Leaflet• Lifestyle advice and support

4

Protocol For PrescribingProton Pump InhibitorsInitiation, Review & Discontinuation

Date of preparation: April 2015UK/G-NHS/1114/0058p

This material was authored by Diane McGinn, Medicines Management Consultant, Preston, Lancashire, UK

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

5

1 Indications for PPI

1.1 Treatment and Maintenance Therapy for GI Indication

• Lifestyle Advice

• Risks Associated with PPIs

• Licensed Indications, Doses, Length of Treatment

• Read Codes for GI Indications

• Patient Information and Review Timescales

1.2 Prophylaxis of GI Complications due to other Drugs

• Drugs Requiring use of Gastro-Protection

2 Medication Review Process2.1 Exclusion Criteria

2.2 Stepping down PPI dose

2.3 Stopping PPI and/or other meds

3 PPI Polypharmacy Medication Review Process3.1 Exclusion Criteria

3.2 Discontinuation of NSAIDs in Adults

Contents

6

1.1 Treatment and Maintenance Therapy for GI IndicationDiagnosis, referral and management should follow NICE CG184 2014 Management of dyspepsia in adults in primary care.

On first presentation with dyspepsia symptoms:

• Review medications for possible causes of dyspepsia, for example, calcium antagonists, nitrates, theophyllines, bisphosphonates, steroids and non-steroidal anti-inflammatory drugs (NSAIDs). Patients undergoing endoscopy should be free from medication with either a proton pump inhibitor (PPI) or an H2 receptor antagonist (H2RA) for a minimum of 2 weeks.

• If patient needs endoscopy stop NSAID and also where possible in uninvestigated dyspepsia patients.

• Consider trial of alginate or antacid if not already taking and review in one month if not needing referral.

Lifestyle Advice

• Offer simple lifestyle advice, including advice on healthy eating, weight reduction and smoking cessation.

• Advise patients to avoid known precipitants they associate with their dyspepsia where possible. These may include smoking, alcohol, coffee, chocolate, fatty foods and being overweight.

• Raising the head of the bed (using bricks or a plank of wood, not by using more pillows) and having a main meal well before going to bed may help some people.

Read codes for lifestyle advice should be recorded as follows:

• Lifestyle counselling 67H

• Smoking cessation advice 8CAL

• Patient advised re diet 8CA4

• Alcohol advice 8CAM

• Advice re exercise 8CA5

Provide patient information leaflets - www.patient.co.uk - for conditions as below plus local lifestyle and PPI step-down step-off leaflet.

• Dyspepsia (indigestion)

• Acid reflux and oesophagitis

Risks Associated with PPIs

PPIs may be associated with an increased risk of

• C. difficile

• Fractures of wrist, hip and spine

• Pneumonia

Consider if benefits of PPI outweigh risks for patients susceptible to these conditions e.g. elderly, care home residents, respiratory patients. Review continuing need for treatment regularly.

1 Indications for PPIs

7

Licensed Indications, Doses, Length of Treatment

PPIs may be used to treat uninvestigated dyspepsia, non-ulcer dyspepsia (NUD), gastro-oesophageal reflux disease (GORD) and peptic ulcer disease (PUD).

Generic omeprazole or lansoprazole capsules should be used first line. Dispersible formulations should be reserved for patients with dysphagia.

Refer to NICE algorithms for management pathway. Table 1 shows recommended dosages and treatment lengths from NICE.

Read Codes for GI Indications

Recording indication for PPI prescribing using Read code speeds up medication review and assists other HCPs who may see the patient.

Frequently used indications are as follows:

• Dyspepsia

• GORD

• Oesophagitis

• Hiatus hernia

• Reflux

• Gastritis

• Barrett’s oesophagus

• Non-ulcer dyspepsia

• Peptic ulcer disease

Patient Information and Review Timescales

• Ensure patients are aware of why they have been prescribed a PPI - supply patient leaflet from www.patient.co.uk

• Prescribe as acute for one month and ask patient to arrange a review appointment.

• Only put PPI on repeat if need for long-term therapy has been established.

• Explain to patients that over time their dose may be reduced and they may be asked to stop treatment once symptoms are well controlled - supply leaflet on step-down step-off.

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Dosage information on proton pump inhibitors (NICE CG184 2014)1

Table 1. PPI doses relating to evidence synthesis and recommendations in the original

CG17; 2004 guideline

Table 2. PPI doses for severe oesophagitis in the NICE CG184 2014 update

Table 3. PPI doses for H pylori eradication therapy in the NICE CG184 2014 update

Esomeprazole 20mg1 once a day Not available 40 mg3 once a day

Lansoprazole 30mg once a day 15mg once a day 30mg2 twice a day

Omeprazole 20mg once a day 10mg2 once a day 40mg once a day

Pantoprazole 40mg once a day 20mg once a day 40mg2 twice a day

Rabeprazole 20mg once a day 10mg once a day 20mg2 twice a day

Esomeprazole 40mg1 once a day 20mg1 once a day 40mg1 twice a day

Lansoprazole 30mg once a day 15mg once a day 30 mg2 twice a day

Omeprazole 40mg1 once a day 20mg1 once a day 40mg1 twice a day

Pantoprazole 40mg once a day 20mg once a day 40mg2 twice a day

Rabeprazole 20mg once a day 10mg once a day 20mg2 twice a day

Esomeprazole 20mg

Lansoprazole 30mg

Omeprazole 20–40mg

Pantoprazole 40mg

Rabeprazole 20mg

PPI Full/standard doseLow dose

(on-demand dose)Double dose

PPI Full/standard doseLow dose

(on-demand dose)High/double dose

PPI Dose

1 Lower than the licensed starting dose for esomeprazole in GORD, which is 40mg, but considered to be dose-equivalent to other PPIs. When undertaking meta-analysis of dose-related effects, NICE classed esomeprazole 20mg as a full-dose equivalent to omeprazole 20mg.

2 Off-label dose for GORD.3 40mg is recommended as a double dose of esomeprazole because the 20mg dose is considered equivalent to omeprazole 20mg.

1 Change from the 2004 dose, specifically for severe oesophagitis, agreed by the GDG during the update of CG17.2 Off-label dose for GORD.

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1.2 Prophylaxis of GI Complications due to other Drugs

Drugs Requiring use of Gastro-Protection

Certain patient groups may need gastro-protection with PPIs during treatment with the following drugs:

a. NSAIDs

Gastro-protection should be given to:

• Anyone with osteoarthritis or rheumatoid arthritis (NICE)

• Anyone 45 years of age and older with chronic low back pain (NICE)

• Patients aged 65 and over

• Past history of peptic ulcer disease (PUD) or serious GI complication

• Concomitant oral steroids or anticoagulants

• Presence of cardiovascular disease, diabetes, hypertension, renal or hepatic impairment

• Requirement for prolonged use of maximal doses of NSAIDs

Doses for NSAID Prophylaxis: Lansoprazole 15-30mg, Omeprazole 20mg

People younger than 45 years of age and at low risk of GI adverse events (e.g. no history of GI bleeding or Helicobacter pylori infection and not on aspirin, warfarin, or oral corticosteroids) may not need the concomitant use of a gastro-protective drug with an NSAID. Options for gastro-protective drugs to prescribe with standard NSAIDs also include misoprostol or a histamine2–receptor antagonist, but a PPI is the preferred choice (CKS Jan 2013).

b. Aspirin

Gastro-protect patients on low dose aspirin if also prescribed an NSAID, selective serotonin reuptake inhibitor (SSRI), a history of PUD or serious GI complication.

c. SSRI

Gastro-protect patients on SSRIs if co-prescribed an NSAID. Note CKS table below recommends alternative antidepressants for patients on NSAIDs.

Non-steroidal anti-inflammatory drugs (NSAIDs)

Do not normally offer an SSRI or an SNRI — but if no suitable alternative can be found, offer gastro-protection in addition to an SSRI or SNRI. Consider any alternative

(for example mirtazapine, moclobemide, reboxetine, or trazodone).

WarfarinDo not normally offer mirtazapine, TCAs, SSRIs, or SNRIs.

Consider reboxetine, trazodone, or mianserin.

HeparinDo not normally offer an SSRI or an SNRI.

Consider any alternative (for example mirtazapine, trazodone, reboxetine, or a TCA).

AspirinUse SSRIs and SNRIs with caution — if no suitable alternative can be found, offer gastro-protection in addition to an SSRI. When aspirin is used alone,

consider trazodone or reboxetine. Consider mirtazapine.

Medication being taken for a chronic physical health problem

Recommended antidepressant(s)

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Major Drug Interactions & Cautions

PPIs undergo extensive hepatic metabolism. Recommended doses in hepatic impairment are as follows:

• In people with liver disease do not exceed 20mg daily for omeprazole, pantoprazole,and esomeprazole, and 30mg daily for lansoprazole. There are no data on the use of rabeprazole in people with severe hepatic impairment, and the manufacturer advises caution.

• Esomeprazole - 20mg in severe impairment; lansoprazole - half normal dose in moderate to severe impairment; omeprazole - 20mg in hepatic impairment; pantoprazole - max. 20mg daily in severe impairment and cirrhosis - monitor liver function (discontinue if deterioration); pantoprazole - caution in severe hepatic dysfunction.

• Occasional and unpredictable bleeding has been reported with warfarin and certain PPIs (esomeprazole, omeprazole, and lansoprazole). The interaction is not thought to occur with rabeprazole or pantoprazole. Advise INR clinic when starting or stopping PPIs with interaction potential.

• There are case reports of esomeprazole interacting with phenytoin (causing an increase in phenytoin level). No special precautions would normally seem necessary if lansoprazole or omeprazole is given with phenytoin, but prescribers should be aware of this possible interaction.

• Because of decreased intragastric acidity, the absorption of itraconazole may be reduced during PPI treatment as is that of voriconazole with esomeprazole and omeprazole.

• Esomeprazole and omeprazole can significantly reduce the efficacy of clopidogrel. Lansoprazole should be PPI of choice in patients prescribed clopidogrel.

• Omeprazole increases plasma concentration of cilostazol increasing risk of toxicity. Avoid concomitant use.

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2.1 Exclusion criteria

The following patients are not suitable for PPI review:

• Patients under 18 (except for GP review)

• Patients on healing doses of PPIs <one month for uninvestigated dyspepsia

• Patients on maintenance dose PPIs <one month for non-ulcer dyspepsia

• Patients on healing doses of PPIs <two months for gastro-oesophageal reflux disease / peptic ulcer disease

• Patients currently on H. Pylori eradication therapy

• Patients under review at GI clinic or awaiting referral

• Patients awaiting gastroscopy or review

• Zollinger-Ellison Syndrome

• Patients in end stage GSF

• Patients with grade 3 or 4 oesophagitis

• Patients on high dose steroids with life threatening or chronic illness, e.g. patients awaiting transplant, post transplant patients

• Patients receiving immuno-suppression therapy

• Patients undergoing chemotherapy or radiotherapy

• Patients with oesophageal strictures or oesophageal dilation

• Patients with a history of oesophageal varices

• Alarm signs - refer to GP - If any of the following alarm features are present, the patient should be referred to the GP for immediate consultation

• Anaemia

• Vomiting

• Weight loss

• Dysphagia

• Epigastric mass

• Haematemesis

• Jaundice

• Progressively worsening symptoms

2 Medication Review Process

12

The following patients may be considered for step-down to the lowest maintenance dose of PPI (and change to generic, cost-effective PPI where applicable as per NICE), but should not proceed to self-management plans:

• Patients with a history of peptic ulceration associated with clo negative status.

• Patients diagnosed with Barrett’s oesophagus (20mg maintenance dose omeprazole).

• Patients who must unavoidably continue with NSAID therapy apart from those considered at high risk i.e. those with previous ulceration; those on other medication harmful to the gastric and duodenal lining; the elderly and those on long term high NSAID use. (20mg Omeprazole is defined as maintenance dose for NSAID coverage).

• Patients using aspirin or clopidogrel to prevent cardiovascular disease can be stepped-off concomitant PPI treatment, apart from those considered to be at high risk e.g. those with previous ulceration; those on other medication harmful to the gastric or duodenal lining and the elderly.

Review Process

If patient attends Long Term Condition (LTC) clinic - practice nurse to review at next clinic appointment.

If patients does not attend LTC clinic - practice pharmacist or GP to review.

1 Confirm drug indication - patient notes or by asking patient why they are taking the PPI.

2 Confirm if they are in the exclusion group or for step-down only as above.

3 Is the prescribing for treatment or prophylaxis? If for prophylaxis, is the other drug still being prescribed or still needed?

4 Check length of treatment and dosage - can healing dose be stepped down, maintenance dose stepped off? Check symptom control.

5 Discuss risk factors associated with long term use of PPIs i.e. increased risk of fractures, pneumonia and C. difficile.

6 Discuss lifestyle issues (see 1.1) and Read code for advice given.

7 Discuss rebound and rescue treatment.

8 Follow up after 2-3 months.

Refer to pharmacist if concerned about drug interactions, contra-indications or if concerned about stopping any other medications.

Patient Counselling/Lifestyle Advice

All patients will be counselled about effective non-pharmacological treatments to reduce the occurrence of heartburn.

Counselling will include advice on weight loss, head elevation in bed, avoidance of bending over, dietary advice (fatty foods), alcohol intake reduction etc.

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2.2 Stepping Down PPI DosePatients who have been prescribed a PPI healing dose for more than four to eight weeks and are not excluded by the specified exclusion criteria in stage one of the protocol will be identified and counselled by the nurse/pharmacist. If appropriate, these patients should then be stepped down to a low dose treatment as required with an agreed limit on the number of repeat prescriptions.

To improve symptom control and the success of this dosage reduction, a suitable alginate/antacid symptomatic treatment may be recommended at a nurse/pharmacist clinic consultation, to prevent, and/or treat occasional breakthrough symptoms, due to rebound acid hypersecretion/acid breakthrough.

Patients stepped down from a PPI healing dose to a PPI maintenance dose, and who are not excluded by the step down only caution criteria, will be reviewed for step off (usually 2-3 months post step-down).

2.3 Stopping PPI & Other DrugsPatients who have been prescribed a PPI maintenance dose for more than eight weeks and are not excluded by the specified exclusion criteria in stage one of the protocol will be counselled and recommended by the nurse or pharmacist to be stepped off PPI treatment to a suitable alginate/antacid symptomatic treatment.

Consider stopping other medication that could be contributing to symptoms as follows:

a NSAIDs - See 1.2 for need for PPI. Follow NSAID discontinuation flow chart at end of this document. Give NSAID leaflet and try alternative analgesia. Review after one month. If successfully stopped NSAID, step off PPI.

b SSRIs - If patient has been taking for >2 years and not under regular review discuss possibility of withdrawal. Follow SSRI protocol for discontinuation. Once stopped discontinue PPI if appropriate. Follow SSRI discontinuation flowchart protocol.

c Aspirin/clopidogrel - No longer recommended for primary prevention patients. Stop and step off PPI if no other ongoing need.

d Nitrates and nicorandil - Was PPI started for chest pain prior to diagnosis of angina? If so try stepping off and monitor symptoms Is angina well controlled? Consider reducing dose of nitrate and/or nicorandil - refer to GP to confirm.

e Steroids - Only need PPI if also on NSAID or aspirin. If long term check prescribed bisphophonate for osteoporosis prophylaxis - if not refer to GP.

f Theophyllines - Are respiratory symptoms well controlled on maximum tolerated doses of inhaled meds? Try reducing theophylline dose and review symptom control.

Record step-down, step-off or any other amendments to medication. Where all medication has been reviewed, code as ‘medication review done’ and move diary date of next review on.

Review Period

Step-down patients - Review 2 - 3 months post step-down. If symptoms controlled, consider step-off where not covered in step-down only criteria.

Step-off patients - Follow up not necessary but encourage patients to report any further symptoms or issues.

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3.1 Exclusion CriteriaExclusion Criteria as Follows:

• Patients under 18 (except for GP review)

• Patients on healing doses of PPIs <one month for uninvestigated dyspepsia

• Patients on maintenance dose PPIs <one month for Non-Ulcer dyspepsia

• Patients on healing doses of PPIs <two months for Gastro-oesophageal reflux disease / Peptic Ulcer disease

• Patients currently on H. pylori eradication therapy

• Patients under review at GI clinic or awaiting referral

• Patients awaiting gastroscopy or review

• Zollinger-Ellison Syndrome

• Patients in end stage GSF

• Patients with grade 3 or 4 oesophagitis

• Patients on high dose steroids with life threatening or chronic illness, e.g. patients awaiting transplant, post transplant patients

• Patients receiving immuno-suppression therapy

• Patients undergoing chemotherapy or radiotherapy

• Patients with oesophageal strictures or oesophageal dilation

• Patients with a history of oesophageal varices

• Alarm signs - refer to GP - If any of the following alarm features are present, the patient should be referred to the GP for immediate consultation.

• Anaemia

• Vomiting

• Weight loss

• Dysphagia

• Epigastric mass

• Haematemesis

• Jaundice

• Progressively worsening symptoms

3 PPI Polypharmacy Medication Review Process

15

Patient on PPI for gastroindication or not coded.

Discuss risks with PPIs, lifestyle,step-down process.

Give PIL on lifestyle and step down.

Review after 2-3 months.Send out clinic/telephone

review invitation plus processquestionnaire.

Suitable for step-down only:Patients with a history of

peptic ulceration associatedwith clo negative status;Patients diagnosed with

Barrett’s oesophagus (20mg maintenance dose omeprazole);Patients who must unavoidablycontinue with NSAID therapy

apart from those considered athigh risk (see prophylaxis arm).

Prescribe lower dose generic PPIwith alginate cover and explain

rebound effect.Advise to contact surgery if any

alarm symptoms as per PIL. Read code for step-down and

lifestyle advice given.

Patient on PPI for prophylaxis of GI complication due

to other meds.

If on high dose PPIprescribe lowerdose of genericPPI with alginatecover and explainrebound effect.

Advise to contactsurgery if any alarm

symptoms as perPIL. Read code

for step-down andlifestyle advice given.

Review after2-3 months to

consider step-off.

Review after 2-3months to assesssymptom control.

Send out clinic/telephonereview invitation

plus processquestionnaire.

If on low dosePPI, stop PPI

and prescribe alginate cover.

Explain reboundeffect. Advise tocontact surgery

if any alarmsymptoms as perPIL. Read code for

step-off and lifestyleadvice given.

Is co-prescribed drug still on repeat?

If drug requiring gastro-protection stopped, follow step-

down and/or step-off arm.

Could co-prescribed drugbe stopped?

Follow flow chart for NSAID or SSRIs.

If stopped review patient after1 month and follow step-down

and/or step-off arm for PPI.

If co-prescribed drug still needed, check dose of PPI and

choice of drug - change to lowest effective dose of generic

PPI for gastro-protection.

Patients who must unavoidablycontinue with NSAID therapyand considered at high risk

should continue without step-down i.e. those with previous

ulceration; those on othermedication harmful to the

gastric and duodenal lining; the elderly and those on long term high NSAID use. (20mg

omeprazole is defined as maintenance dose for

NSAID coverage).

If on NSAID or SSRI see flowchart for discontinuation.

Suitable for step-down and/or step-off i.e. notcovered in other two arms.

Discuss risks with PPIs, lifestyle, step-down process.Give PIL on lifestyle and step-down/step-off.

Exclusion Criteria

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3.2 Discontinuation of NSAIDs in AdultsExclude patients with long term indication for NSAIDs as follows:

• Rheumatoid arthritis

• Ankylosing spondylitis

• Acute gout

• Dysmenorrhoea

• Patients awaiting referral for musculoskeletal symptoms/conditions

• Patients in end stage GSF

Determine indication for NSAIDand how often being taken.

Provide PIL re condition for advicere non-pharmacological measures

e.g. for OA www.patient.co.uk

Review after 1-2 months or soonerif any problems.

Is patient in high risk group forharm from NSAIDs:

• Renal failure or impairment

• Heart failure

• History of PUD or GI bleed

• Over 65

• Cardiovascular disease including hypertension

• More than one NSAID NOYESProvide PIL re NSAIDs and

discuss safety issues - aim to stop NSAID in high risk patients.

Prescribe alternative paracetamol based

analgesia if not already taking.Ensure regular dosing not PRN.

Provide PIL re NSAIDs and advise lowest dose, shortest

length of treatment.

Prescribe alternative paracetamol based

analgesia if not already taking.Advise regular dosing and reserve NSAID for PRN only

flare-ups.

17

• Dyspepsia: Managing dyspepsia in adults in primary care. NICE CG184 Sept 2014 www.nice.org.uk Date last accessed 02/4/2015

• NICE Key Therapeutic Topics- Medicines management options for local implementation: Non-steroidal anti-inflammatory drugs (NSAIDs) http://www.nice.org.uk/mpc/keytherapeutictopics/KTT13.jsp Date last accessed 02/4/2015

• MeReC Bulletin Vol 22 No3: Implementing key therapeutic topics:1 NSAIDs, antibiotics and inhaled corticosteroids in asthma. Jan 2012 http://www.npc.nhs.uk/merec/therap/other/merec_bulletin_vol22_no3.php Date last accessed 02/4/2015

• Clinical Knowledge Summaries (CKS) Dyspepsia- Unidentified cause Proton Pump Inhibitors http://cks.nice.org.uk/dyspepsia-unidentified-cause#!prescribinginfosub:4 Date last accessed 02/4/2015

• British National Formulary http://www.evidence.nhs.uk/formulary/bnf/current/search?q=PPIs Date last accessed 02/4/2015

References

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

ARM and the Medicines Optimisation Academy are non-promotional education programmes designed by RB UK to improve patient care and support healthcare professional.

18

Protocol for Prescribing NSAIDs:Initiation, Review & Discontinuation

This material was authored by Diane McGinn, Medicines Management Consultant, Preston, Lancashire, UK

Date of preparation: April 2015UK/G-NHS/1114/0058q

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

19

1 Choice of NSAID

1.1 Relative Efficacy and Side-Effects• Lifestyle Interventions

• Devices

• Walking Aids

• Alternatives to NSAIDs

• Cautions and Contra-Indications

1.2 Specific Safety Concerns• Cardiovascular events

• Gastro-intestinal toxicity and gastro-protection

• Major Drug Interactions

2 Discontinuation of NSAIDs in Adults

Contents

20

Non-steroidal anti-inflammatory drug (NSAIDs) are prescribed for their analgesic and anti-inflammatory effects.

All NSAIDs are associated with gastrointestinal, cardiovascular and renal side effects. If NSAIDs are required, they should be prescribed at the lowest effective dose for the shortest period of time necessary to control symptoms.

Wherever possible, and particularly for patients most at risk of side-effects, if NSAIDs are being considered for pain relief, alternative analgesia should be tried first line especially in conditions with minimal inflammation e.g. osteoarthritis.

Paracetamol (and/or topical NSAIDs) is recommended ahead of oral NSAIDs in the NICE osteoarthritis guideline.

1.1 Relative Efficacy & Side-EffectsDifferences in anti-inflammatory activity between NSAIDs are small but patients vary considerably in their response and ability to tolerate different drugs. 60% of patients will respond to any one NSAID - those who don’t respond to one may well respond to another.

Pain relief starts soon after first dose and full analgesic effect should normally be attained after one week.

Anti-inflammatory effect, if able to be assessed, may not be achieved for up to three weeks.

If effects are not seen after this time then another NSAID should be tried.

1 Choice of NSAID

21

Ibuprofen Weak anti-inflammatory Fewer side-effects than other NSAIDs

Naproxen Good anti-inflammatory Greater than ibuprofen but still low

Fenbufen Less GI bleeds, high risk of rash

Fenoprofen As effective as naproxen Slightly more GI side-effects than ibuprofen

Flurbiprofen Slightly more effective than naproxen Slightly more GI side-effects than ibuprofen

Ketoprofen Similar to ibuprofen Greater than ibuprofen

Tiaprofenic acid As effective as naproxenMore than ibuprofen including severe

cystitis

Diclofenac & aceclofenac Similar to naproxen Similar to naproxen

Etodolac Similar to naproxen

Indometacin Equal or better than naproxenHigh incidence of side-effects e.g.

headache, dizziness and GI disturbances

Mefenamic acid Minor anti-inflammatory propertiesDiarrhoea & haemolytic anaemia may

require stopping treatment

MeloxicamLicensed for short term pain relief in OA and long

term for RA & Ankylosing spondylitis

Nabumetone Comparable to naproxen

Piroxicam As effective as naproxen - long durationMore GI side-effects than most other

NSAIDs & frequent serious skin reactions

Sulindac Similar to naproxen

Tenoxicam Similar to naproxen. Long duration of action Similar to naproxen

Celecoxib and Etoricoxib As effective as naproxenGI events lower than non-selective (unless

on aspirin) but higher CV risk

Drug Frequently Prescribed NSAIDs

Relative Anti-Inflammatory Efficacy

Relative Side-Effects Compared

Lifestyle Interventions

For patients with osteoarthritis general lifestyle measures may help reduce the need for regular NSAIDs:

• Exercise - Regular exercise helps to strengthen the muscles around affected joints and maintain a good range of joint movement. Swimming is ideal for most joints, but any exercise is better than none. Many people can manage a regular walk.

• Weight Control - If overweight, even a modest weight loss can make quite a difference.

22

Devices

Some trials have shown that the following may help to ease symptoms from OA of the knee in some cases:

• Wearing a knee brace.

• Using shoe insoles.

• The use of tape to pull the kneecap inwards.

These measures slightly alter the distribution of weight and pressure on the knee joint. A podiatrist or physiotherapist can advise on use. Braces or supports may also be helpful for other joints affected by OA e.g. thumb.

Walking Aids

Use of a walking stick may help with OA of the hip or knee. It should be held in the hand on the opposite side of the body to the affected joint.

Alternatives to NSAIDs

For analgesia in conditions where an anti-inflammatory effect is not generally required the WHO pain ladder should be followed.

First line treatment should be paracetamol taken regularly i.e. 1g QDS. Patients should be reassured that this is safe to take on a regular basis with NSAIDs being reserved for PRN use rather than the other way round.

For patients at high risk of NSAID associated side-effects, addition of codeine to paracetamol is preferable to addition of an NSAID. Note that adjuvants such as TCAs for neuropathic pain can be added at any time.

e.g. morphine, oxycodone fentanyl

e.g. codeine

e.g. aspirin, paracetamol or a NSAID

23

Cautions & Contra-Indications

NSAIDs are contra-indicated in the following:

• Severe heart failure (although not contra-indicated it would be advisable to avoid use in any degree of heart failure due to risk of fluid retention).

• Non-selective (i.e. non-COX-II) NSAIDs C/I in previous or active peptic ulceration. If required in rheumatic disease in these patients COX-II inhibitors should be used with gastro-protection (see below).

• Celecoxib and etoricoxib are C/I in: - IHD - Cerebrovascular disease - Peripheral arterial disease - Moderate or severe heart failure

NSAIDs should be used with caution in:

• The elderly

• Allergic disorder including asthma

• Cardiac impairment due to risk of renal impairment

• Celecoxib and etoricoxib should be used with caution in: - Cardiac failure - Left ventricular dysfunction - Hypertension - Oedema for any reason - Patients with risk factor for heart disease

• Hepatic impairment - increased risk of GI bleeds and fluid retention. Avoid in severe liver disease.

• Renal impairment - avoid if possible

1.2 Specific Safety Concerns Cardiovascular Events

How can the CV risks of NSAIDs be reduced?

• If an NSAID is required, low-dose ibuprofen (1200mg/day or less) or naproxen 1000mg/day or less would appear more appropriate than other NSAIDs for patients in whom CV risk is a significant consideration in decision making.

• Coxibs (celecoxib and etoricoxib) are associated with an increased thrombotic risk.

• Diclofenac 150mg/day has a similar excess thrombotic risk to etoricoxib and possibly other coxibs.

• A meta-analysis of observational studies has confirmed an increased risk of CV events with diclofenac (even at comparatively low doses of 100mg/day or less).

• A high CV risk was also seen with etoricoxib and etodolac.

• With regard to ibuprofen, the meta-analysis underlined the need to use lower doses (1200mg/day or less) to avoid increasing the risk of CV events.

• The risk of CV events with naproxen was low or absent at higher as well as lower doses.

24

Gastro-Intestinal Toxicity & Gastro-Protection

How can the GI risks of NSAIDs be reduced?

NICE guidance states that a PPI should routinely be co-prescribed with an NSAID (including coxibs) for anyone with osteoarthritis or rheumatoid arthritis, and anyone 45 years of age and older with chronic low back pain, choosing the PPI with the lowest acquisition cost.

Gastro-protection should also be given to:

• Patients aged 65 and over

• Past history of peptic ulcer disease (PUD) or serious GI complication

• Concomitant oral steroids or anticoagulants

• Presence of cardiovascular disease, diabetes, hypertension, renal or hepatic impairment

• Requirement for prolonged use of maximal doses of NSAIDs

Doses for NSAID prophylaxis:

• Lansoprazole 15-30mg, Omeprazole 20mg

People younger than 45 years of age and at low risk of GI adverse events (e.g. no history of GI bleeding or Helicobacter pylori infection and not on aspirin, warfarin, or oral corticosteroids) may not need the concomitant use of a gastro-protective drug with an NSAID.

Options for gastro-protective drugs to prescribe with standard NSAIDs also include misoprostol or a histamine2–receptor antagonist, but a PPI is the preferred choice. (CKS Feb 2012)

Gastro-protect patients on low dose aspirin if also prescribed an NSAID, SSRI, a history of PUD or serious GI complication.

Gastro-protect patients on SSRIs if co-prescribed an NSAID. Note CKS table below recommends alternative antidepressants for patients on NSAIDs:

Non-steroidal anti-inflammatory drugs (NSAIDs)

Do not normally offer an SSRI or an SNRI - but if no suitable alternative can be found, offer gastro-protection in addition to an SSRI or SNRI. Consider any alternative

(for example mirtazapine, moclobemide, reboxetine, or trazodone

Warfarin Do not normally offer mirtazapine, TCAs, SSRIs, or SNRIs.

HeparinDo not normally offer an SSRI or an SNRI. Consider any alternative

(for example mirtazapine, trazodone, reboxetine, or a TCA)

AspirinUse SSRIs and SNRIs with caution - if no suitable alternative can be found, offer gastro-

protection in addition to an SSRI. When aspirin is used alone, consider trazodone or reboxetine. Consider mirtazapine.

Medication Being Taken For A Chronic Physical Health Problem

Recommended Antidepressant(S)

25

Major Drug Interactions - Refer To BNF For Full List

Wherever possible, combinations of drugs with additive side-effects should be avoided. Consider reviewing patients on NSAIDs and drugs which may increase the risk of bleeding, cardiovascular events and renal toxicity.

• Antiplatelets - increased risk of bleeding with aspirin, clopidogrel and prasugrel

• Quinolones - possible increased risk of convulsions when given with NSAIDs

• Anticoagulants - increased bleeding risk. Advise patients against purchasing oral and topical NSAIDs OTC.

• SSRIs and venlafaxine - increased bleeding risk. Gastro-protection may be advisable

• Sulphonylureas - NSAIDs possibly enhance effects - risk of hypos

• Phenytoin - NSAIDs possibly enhance effects

• Ciclosporin - increased risk of nephrotoxicity

• Methotrexate - increased risk of toxicity from methotrexate due to NSAIDs reducing excretion. Combination may be required in inflammatory disease but advise patients against self-medicating with OTC preparations

• Diuretics - increased risk of renal toxicity

• Lithium - NSAIDs reduce excretion - increased risk of toxicity. Avoid use of NSAIDs where possible

• Pentoxifylline - possible increased bleeding risk

• Tacrolimus - possible increased risk of toxicity

26

Exclude Patients With Long Term Indication for NSAIDs as Follows:

• Rheumatoid arthritis

• Ankylosing spondylitis

• Acute gout

• Dysmenorrhoea

• Patients awaiting referral for musculoskeletal symptoms/conditions

• Patients in end stage GSF

2 Discontinuation of NSAIDs in Adults

Determine indication for NSAIDand how often being taken.

Provide PIL re condition for advicere non-pharmacological measures

e.g. for OA www.patient.co.uk

Review after 1-2 months or soonerif any problems.

Is patient in high risk group forharm from NSAIDs:

• Renal failure or impairment

• Heart failure

• History of PUD or GI bleed

• Over 65

• Cardiovascular disease including hypertension

• More than one NSAID NOYESProvide PIL re NSAIDs and

discuss safety issues - aim to stop NSAID in high risk patients.

Prescribe alternative paracetamol based

analgesia if not already taking.Ensure regular dosing not PRN.

Provide PIL re NSAIDs and advise lowest dose, shortest

length of treatment.

Prescribe alternative paracetamol based

analgesia if not already taking.Advise regular dosing and reserve NSAID for PRN only

flare-ups.

27

1 British National Formulary http://www.evidence.nhs.uk/formulary/bnf/current/a1-interactions/list-of-drug-interactions/analgesics/nsaids Date last accessed 27/3/2015

2 NICE Key Therapeutic Topics- Medicines management options for local implementation: Non-steroidal anti-inflammatory drugs (NSAIDs) http://www.nice.org.uk/mpc/keytherapeutictopics/KTT13.jsp Date last accessed 27/3/2015

3 MeReC Bulletin Vol 22 No3: Implementing key therapeutic topics:1 NSAIDs, antibiotics and inhaled corticosteroids in asthma. Jan 2012 http://www.npc.nhs.uk/merec/therap/other/merec_bulletin_vol22_no3.php Date last accessed 27/3/2015

4 Clinical Knowledge Summaries (CKS) NSAIDs- Prescribing issues http://cks.nice.org.uk/nsaids-prescribing-issues#!scenarioclarification Date last accessed 27/3/2015

5 Osteoarthritis. Patient.co.uk http://www.patient.co.uk/health/Osteoarthritis.htm Date last accessed 27/3/2015

6 Dyspepsia: Managing dyspepsia in adults in primary care. NICE CG17 Aug 2004 www.nice.org.uk Date last accessed 27/3/2015

References

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

ARM and the Medicines Optimisation Academy are non-promotional education programmes designed by RB UK to improve patient care and support healthcare professional.

28

Identification of Local Team to Run Pilot Project

I don’t overprescribe, my patients taking PPIs all need them

Data show that PPIs are widely overused – a UK pilot shows that approx. 38%1 of patients taking PPIs were eligible for review. Conducting a baseline audit will confirm whether this is the case before committing to any patient reviews

Acceptance that there may be a cohort of patients found in the audit

I am worried about stopping PPIs, what if a patient were to suffer a bleed?

It is very important that only patients who no longer need their PPI are reviewed. Robust exclusion criteria will be agreed before the project is started

PPI reviews can be carried out with minimal risk to patient safety

I’ve tried stopping PPIs, patients come back and I have to return them to PPIs

The reason patients are coming back is likely to be due to symptoms caused by rebound acid hypersecretion, which is a short term issue (2-4 weeks, can be longer) . Patients can use alginates to help with symptom relief during this period as they do not suppress acid production so will not cause rebound when stopped.

Acceptance that stopping PPIs may be successful in some patients

This might work for a few weeks but patients will all be back on PPIs within a year

Data from the UK have shown that at 12m post review a proportion of patients are able to maintain the lower dose or remain off PPIs. The recent UK study that of patients who stepped down/off PPIs at the initial review, 66% who stepped down and 56% who stepped off, maintained their change at the follow-up audit, 12 months after the end of the PMOR.1

Patients can sustainably reduce PPI use

Why would I stop a PPI to swap it for an alginate, they are more expensive and less effective?

This is not a medication switch – the alginate is used in the short term to manage rebound, it does not need to be continued once the symptoms subside. A recent UK study showed patients used an average of only 2.9 bottles in 12m.1 Overall spend on medication was reduced

The project is cost effective despite the low cost of PPIs relative to alginate

It’s not worth the effort for the amount of money saved

Quality of care and patient safety are the main benefits for running these projects but they can offer cost savings as long term drug spend and referrals for endoscopy have shown to be reduced1

There are sufficient benefits and savings to justify this project

I don’t think there’s anything wrong with using PPIs long term

PPIs are generally safe and effective but all medicines carry some risk and should not be used unnecessarily. There is also evidence that PPIs may be associated with safety issues when used long term2,3

It is important to limit long term PPI use to those patients who really need them

I’m not that interested in PPI reduction, I have more important issues to tackle

PPI use may not be top of the agenda but patients taking PPIs are likely to be taking a number of other medications and may be a useful group to address polypharmacy.4 The average number of medicines taken by patients prescribed PPIs in the pilot study was shown to be 7.1 Note there may be local initiatives to review/reduce NSAID use that can be addressed as part of a PPI review, as these patients should be taking PPI for gastro-protection

PPIs can be a useful way to access patients taking multiple other medicines and this is a patient group of interest

My patients won’t be happy about having their medication changed – I don’t want to upset them

A study in the UK has recorded patient satisfaction, using questionnaires. Patients were happy with the medication change and have welcomed the opportunity to discuss their treatments1

Patients rated the PMOR highly and welcomed the opportunity to discuss their treatment.1 The mean score for their satisfaction with the review was 4.8 out of 5.1

Perception Response Outcome

References1. McGinn D, Roberts C. Outcomes of a medication optimisation

review in patients taking proton pump inhibitors. Guidelines in Practice. January 2015.

2. Dr Spencer, GP. Medicines optimisation reviews in patients taking PPIs. Reprinted from Prescriber 5 May 2013.

3. BNF. March 2015.

4. McGinn D, Roberts C. Outcomes of an Audit of PPI Prescribing in Primary Care. Gastroenterology.

There are a number of hurdles to overcome when first introducing the concept to HCPs. The objection handler below has been compiled based on experience from the UK projects.

Date of preparation: March 2015 UK/G-NHS/1114/0058w

ARM and the Medicines Optimisation Academy are non-promotional education programmes designed by RB UK to improve patient care and support healthcare professional

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

29

1. Exclude patients for review based on following criteria:• Patients under 18 (except for GP review)

• Patients on healing doses of PPIs <one month for uninvestigated dyspepsia.

• Patients on maintenance dose PPIs <one month for Non-Ulcer dyspepsia.

• Patients on healing doses of PPIs <two months for Gastro-oesophageal reflux disease/ Peptic Ulcer disease

• Patients currently on H. pylori eradication therapy

• Patients under review at GI clinic or awaiting referral

• Patients awaiting gastroscopy or review

• Zollinger-Ellison Syndrome

• Patients in end stage GSF

• Patients with grade 3 or 4 oesophagitis

• Patients on high dose steroids with life threatening or chronic illness, e.g. patients awaiting transplant, post-transplant patients

• Patients receiving immuno-suppression therapy

• Patients undergoing chemotherapy or radiotherapy

• Patients with oesophageal strictures or oesophageal dilation

• Patients with a history of oesophageal varices

• Patients >90 years old

• Patients with a terminal illness

Alarm signals: People under review for alcohol related illness or under mental health review will not be

seen in clinic.

The following patients may be considered for step-down to the lowest maintenance dose of PPI (and change to generic, cost-effective PPI where applicable as per NICE), but should not proceed to self-management plans:

• Patients with a history of peptic ulceration associated with clo negative status.

• Patients diagnosed with Barrett’s Oesophagus (20mg maintenance dose omeprazole)

• Patients who must unavoidably continue with NSAID therapy apart from those considered at high risk i.e. those with previous ulceration; those on other medication harmful to the gastric and duodenal lining; the elderly and those on long term high NSAID use. (20mg Omeprazole is defined as maintenance dose for NSAID coverage).

• Patients using aspirin or clopidogrel to prevent cardiovascular disease can be stepped-off concomitant PPI treatment, apart from those considered to be at high risk e.g. those with previous ulceration; those on other medication harmful to the gastric or duodenal lining and the elderly.

• Patients under 18 years will be referred to the GP for management.

2. If patients are due to attend a chronic disease management clinic:Flag these patients for review of their PPI use with the practice nurse. For other patients invite in for review (by letter or telephone)

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

Medication review process for patientsprescribed PPIs

Date of preparation: March 2015 UK/G-NHS/1114/0058ad

30

3. At nurse review:Flag these patients for review of their PPI use with the practice nurse. For other patients invite in for review (by letter or telephone)

a Confirm drug indication - patient notes or by asking patient why they are taking the PPI

b Confirm if they are in the exclusion group or for step-down only as above. If any of the following alarm features are present, the patient should be referred to the GP for immediate consultation:

• Anaemia

• Vomiting

• Weight loss

• Dysphagia

• Epigastric mass

• Haematemesis

• Jaundice

• Progressively worsening symptoms

c Is the prescribing for treatment or prophylaxis? If for prophylaxis, is the other drug still being prescribed or still needed?

d Check length of treatment and dosage - can healing dose be stepped-down, maintenance dose stepped-off? Check symptom control.

e Discuss risk factors associated with long term use of PPIs i.e. increased risk of fractures, pneumonia and C. difficile.

f Discuss lifestyle issues and Read code for advice given. Provide patient information leaflets on PPIs and lifestyle advice.

g All patients will be counselled about effective non-pharmacological treatments for heartburn. Counselling will include advice on weight loss, head elevation in bed, avoidance of bending over, dietary advice (fatty foods), alcohol intake reduction etc.

h Discuss rebound and rescue treatment. If stepping-down/off arrange for prescription to be issued for alginate cover and lower dose PPI if applicable.

i Follow up after 2-3 months

Refer to pharmacist/GP if concerned about drug interactions, contra-indications or if concerned about stopping any other medications.

4. At pharmacist review:As above but conduct review of ALL medication prescribed in line with national and local guidance. Consider stopping medication no longer of benefit, or where risk outweighs benefit, after discussion with patient e.g. NSAIDs, aspirin for primary prevention of CHD.

Use patient information leaflets to discuss alternatives to NSAIDs and stepping-down/off SSRIs.

Rationalise any dosages where more cost-effective formulations exist.

Assess adherence to treatment for all medication and refer to GP where patient is experiencing new symptoms, poor control or side-effects from medication.

Date of preparation: March 2015 UK/G-NHS/1114/0058ad

31

5. Stepping-down PPI dose:Patients who have been prescribed a PPI healing dose for more than four to eight weeks and are not excluded by the specified exclusion criteria in stage one of the protocol, will be identified and counselled by the nurse/pharmacist. If appropriate these patients should then be stepped-down to a low dose treatment as required with an agreed limit on the number of repeat prescriptions.

To improve symptom control and the success of this dosage reduction, a suitable alginate/antacid symptomatic treatment may be recommended to prevent and/or treat occasional breakthrough symptoms due to rebound acid hypersecretion/acid breakthrough.

Patients stepped-down from a PPI healing dose to a PPI maintenance dose, and who are not excluded by the step-down only caution criteria, will be reviewed for step-off (usually 2-3 months post step-down).

6. Stopping PPI and other drugs:Patients who have been prescribed a PPI maintenance dose for more than eight weeks and are not excluded by the specified exclusion criteria in stage one of the protocol, will be counselled and recommended by the nurse or pharmacist to be stepped-off PPI treatment to a suitable alginate / antacid symptomatic treatment.

7. Consider stopping other medication which could be contributing to

symptoms as followsPatients who have been prescribed a PPI maintenance dose for more than eight weeks and are not excluded by the specified exclusion criteria in stage one of the protocol will be counselled and recommended by the nurse or pharmacist to be stepped-off PPI treatment to a suitable alginate/antacid symptomatic treatment.

a NSAIDs - Follow NSAID discontinuation flow chart. Give NSAID leaflet and try alternative analgesia. Review after one month. If successfully stopped NSAID, step-off PPI.

b SSRIs - If patient has been taking for >2 years and not under regular review discuss possibility of withdrawal. Follow SSRI protocol for discontinuation. Once stopped, discontinue PPI if appropriate.

c Aspirin/clopidogrel - No longer recommended for primary prevention patients. Stop and step-off PPI if no other on-going need.

d Nitrates and nicorandil - Was PPI started for chest pain prior to diagnosis of angina? If so try stepping-off and monitor symptoms. Is angina well controlled? Consider reducing dose of nitrate and/or nicorandil - refer to GP to confirm.

e Steroids - only need PPI if also on NSAID or aspirin. If long-term check prescribed bisphosphonate for osteoporosis prophylaxis - if not refer to GP.

f Theophyllines - Are respiratory symptoms well controlled on maximal tolerated doses of inhaled meds? Try reducing theophylline dose and review symptom control.

Record step-down or step-off or any other amendments to medication. Where all medication has been reviewed, code as ‘medication review done’ and move diary date of next review on.

The information above is advice only. When reviewing patients’ medicines always consider the current clinical guidance for the applicable therapy area.

Review Period• Step-down patients - Review 2 - 3 months post step-down. If symptoms controlled consider step

off where not covered in step down only criteria.

• Step-off patients - Follow up not necessary but encourage patients to report any further symptoms or issues.

Date of preparation: March 2015 UK/G-NHS/1114/0058ad

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

ARM and the Medicines Optimisation Academy are non-promotional education programmes designed by RB UK to improve patient care and support healthcare professional.

32

Dear

Dyspepsia Clinic AppointmentWe are continually working to improve the healthcare offered to our patients, and to ensure that you receive the most appropriate medication for your condition. We are currently reviewing patients receiving repeat prescriptions for their acid-related disorders (heartburn, hiatus hernia etc.) and patients on medication after ulcer healing. Accordingly, I would like to invite you to attend the dyspepsia clinic where the nurse will review your condition and ensure that you continue to receive the most appropriate treatment.

This is a temporary clinic being run by the nurse specialist to ensure we are helping to achieve the curr nt guidelines and your records are kept up to date. Your individual appointment is for 15 mins during which you will be asked to help complete a simple questionnaire. It is also an ideal opportunity to ask any questions you may have.

We would be grateful if you could attend the surgery for your dyspepsia clinic appointment:

at:

on:

PLEASE INFORM THE SURGERY IF YOU ARE UNABLE TO ATTEND AS ANOTHER APPOINTMENT CAN BE ARRANGED.

It is to your benefit and therefore important that you attend. Thank you for your co-operation,

Yours faithfully,

Nurse Advisor (RGN)

On behalf of Medical Practice

Dyspepsia Clinic: Patient Invite

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

Date of preparation: March 2015 UK/G-NHS/1114/0058t

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

33

Dear Colleague,

A polypharmacy medicine review is being conducted in patients registered at the following practices: Mountview, Bellevue and Broadway. This leaflet will explain the purpose and scope of the project so that you are kept informed and prepared for questions your patients might have about their medication, as their prescription may change following clinical review.

BackgroundAs part of our work to achieve medicines optimisation we have conducted an audit of the prescribing of proton proton pump inhibitors (PPI) and found this patient group to be well suited to polypharmacy medicines review. On average, a patient taking a PPI was found to be taking six other medications.1

Polypharmacy Review: Project ScopeConsequently, we plan to review the prescribing of PPIs, NSAIDs and SSRIs, to reduce any inappropriate or obsolete use. Where possible this will take place at routine long term condition clinic appointments. Patients not attending these clinics will be invited to an appointment specifically for medicines review.

Information leaflets will be provided when medication is changed but some patients may require further help and advice from you as they change, reduce or stop medication they have been taking for some time.

Reviewing PPI PrescribingWhile PPIs are generally well tolerated we now know that long term PPI therapy may not be without its problems as seen in recent literature potentially linking long term PPI use with C. difficile infections and increased risk of infection.2 NICE guidance for dyspepsia recommends patients taking PPIs have their medication reviewed at least annually with a view to returning to self care using antacids or alginates.3 In practice this can be difficult as PPIs are now recognised to cause rebound acid hypersecretion symptoms on cessation, causing the symptoms they are often initiated to treat,4 as noted recently in the British National Formulary (BNF).2

Despite the short-lived nature of this rebound phenomenon, patients may still need help with symptom relief when reducing or stopping treatment and reassurance that this is to be expected and can be managed. It is advisable to check drug interactions when recommending a product for rebound as the patient may still be taking low dose PPIs and is likely to be on other medications.

Reviewing SSRI PrescribingPatients who take SSRIs along with NSAIDs have a higher risk of GI bleeds, hence why PPIs are often prescribed for gastro-protection.5

If patients have been taking a SSRI for longer than 2 years and are free from relapse in the last 6 months they will be considered for review.6,7 With patient agreement the SSRI will be stopped or reduced over a period of 4 weeks (depending on the individual SSRI). Patients will be made aware of the potential withdrawal effects including:

Please be aware patients may present in community pharmacy with these symptoms. If the symptoms are mild please reassure the patient that they will subside in a few days. However if the symptoms are more severe please refer back to the surgery where we can consider either reinstating the SSRI or consider a slower withdrawal.

• Anxiety

• Sleep Disturbances

• Dizziness & Vertigo

• Nausea, Vomiting & Diarrhoea

• Flu-like symptoms

• Headache

• Tremor

• Sweating

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

Information for Community Pharmacy:Polypharmacy Medicines Review

Date of preparation: April 2015 UK/G-NHS/1114/0058u

34

Reviewing NSAID PrescribingMany patients on NSAIDs may be prescribed PPIs for gastro-protection.5 If the NSAID is stopped then the PPI may no longer be indicated and should be withdrawn also.

Some lower risk patients may be prescribed PPIs for gastro-protection when it is not indicated.

Gastro-protection should be given to:

• Patients aged 65 and over

• Past history of peptic ulcer disease (PUD) or serious GI complication

• Concomitant oral steroids or anticoagulants

• Presence of cardiovascular disease, diabetes, hypertension, renal or hepatic impairment

• Requirement for prolonged use of maximal doses of NSAIDs

Doses for NSAID prophylaxis:

• Lansoprazole 15-30mg, Omeprazole 20mg

People younger than 45 years of age and at low risk of GI adverse events (e.g. no history of GI bleeding or Helicobacter pylori infection and not on aspirin, warfarin, or oral corticosteroids) may not need the concomitant use of a gastro-protective drug with an NSAID.5,8

Options for gastro-protective drugs to prescribe with standard NSAIDs also include misoprostol or a H2–receptor antagonist, but a PPI is the preferred choice.2

Long term NSAID use particularly in high risk groups may increase risk of:

• Gastrointestinal ulcers and bleeds

• Renal toxicity especially if co-prescribed with ACEI or ARBs

• Cardiovascular events

• Heart failure

Where NSAIDs are indicated, use of those with the best cardiovascular safety should be used i.e. ibuprofen 1200mg daily (or less) or naproxen 1000mg daily (or less). Use of diclofenac should be discouraged.2,8

Patient at high risk for harm from NSAIDs include those in the following groups:2

• Renal failure or impairment

• Heart failure

• History of PUD or GI bleed

• Over 65

• Cardiovascular disease including hypertension

References

Date of preparation: April 2015 UK/G-NHS/1114/0058u

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

1. McGinn D, Roberts C. Outcomes of a medication optimisation review in patients taking proton pump inhibitors. Guidelines in Practice. January 2015.

2. BNF Volume 68 March 2015.

3. http://www.nice.org.uk/guidance/cg184/resources/guidance-dyspepsia-and-gastrooesophageal-reflux-disease-pdf

4. Reimer C et al. Gastroenterology 2009;137:80-87

5. Clinical Knowledge Summaries (CKS) NSAIDs- Prescribing issues http://cks.nice.org.uk/nsaids-prescribing-issues#!scenarioclarification Date last accessed 15/5/2014

6. NICE (2009a) Depression. The treatment and management of depression in adults (NICE guideline) Clinical guideline 90. National Institute for Health and Care Excellence. www.nice.org.uk Date last accessed 15/5/2014

7. http://www.prescriber.co.uk/SpringboardWebApp/userfiles/espres/file/cpd/Depression.pdf

8. Barnes J, Sorley R & Arolker M. Yorkshire Palliative Medicine Guidelines Group. Guidelines on the use of non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclo-oxygenase-2 (COX-2) inhibitors in palliative care. April 2010.

35

We recognise the importance of receiving feedback from our Service Users in order to help improve the quality of care and services we provide.

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

Patient Satisfaction Questionnaire

Name (Optional)

Date

Please tell us what you appreciate most about our service

Please tell us how we can make our service better for you

1 = Lowest score, 5 = Highest score 1 2 3 4 5

1Did you feel that the review of your medicine was properly explained to you?

2 If your medication was changed, how happy were you about this?

3Did you feel that the nurse/pharmacist/doctor listened to what you had to say and took your concerns seriously?

4Did you feel that your questions were well answered and that you were given appropriate advice?

5What is your opinion of the patient information leaflets that you received for your service?

6Overall, how would you rate your satisfaction with the medicines review you received?

7 Was your privacy and dignity respected?

Date of preparation: March 2015 UK/G-NHS/1114/0058s

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

36

Pt no Age Sex PPI DoseStart date

Indication GI medsTotal no of meds

Aspirin NSAIDs SSRI Steroids BisphosChronic disease clinic

4 week review?

Dose & time as per NICE?

Gastro-protection

as per NICE?

Example from PMOR pilot project not to be used without local clinical review and approval

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

Date of preparation: March 2015 UK/G-NHS/1114/0058r 37

Discontinuation of SSRIs in Adults

Date of preparation: April 2015UK/G-NHS/1114/0058o

The polypharmacy medicines review project, The Medicines Optimisation Academy and production of the supporting materials, including this leaflet, have been wholly supported with funding from RB Healthcare UK Ltd.

This material was authored by Diane McGinn, Medicines Management Consultant, Preston, Lancashire, UK

38

39

Exclude Patients in Any of The Following Groups: • Currently under secondary or tertiary care

• On more than one CNS drug (BNF category 4)

• With a previous history of relapse on discontinuation of SSRI

• At significant risk of relapse on discontinuation of SSRI

• Have had symptoms of anxiety or depression within the last 6 months

• On either venlafaxine or duloxetine

Include Patients if They Have Been Taking an SSRI For >2 yearsIn general, reduce the dose or frequency of the antidepressant gradually over a 4-week period to minimise discontinuation symptoms.

• Discontinuation symptoms include dizziness, nausea, paraesthesiae, anxiety, diarrhoea, flu-like symptoms, and headache (for complete list see Fig 1). They may occur when stopping or reducing the dose of any antidepressant.

• Onset is usually within 5 days of stopping treatment. Occasionally, symptoms occur during tapering or after missed doses.

• These symptoms are usually mild and self-limiting, rarely lasting for more than 1–2 weeks. However, occasionally they can be severe, particularly if the drug is stopped abruptly.

• Discontinuation symptoms are more common with longer treatment courses, and rarely occur with treatments lasting less than 8 weeks.

• Discontinuation symptoms are more likely with antidepressants with a short half-life (see below) and in people who developed anxiety symptoms at the start of treatment.

• For people taking fluoxetine — treatment can be stopped abruptly because fluoxetine has a long half-life and active metabolites. However, people taking higher doses (40mg to 60mg daily) may require gradual withdrawal.

Advise the person to seek advice if they experience significant discontinuation symptoms.

If discontinuation symptoms are mild, reassure the person that they will pass in a few days — this is often all that is required.

If discontinuation symptoms are severe, consider reintroducing the original antidepressant at a dose not associated with discontinuation symptoms (or another antidepressant with a longer half-life from the same class) and then taper more slowly while monitoring symptoms.

Discontinuation of SSRIs in Adults

Paroxetine 21 hoursSertraline 26 hours

Citalopram 35 hoursEscitalopram 30 hours

Short Half-Life SSRIs

Fluoxetine 96 hours

Long Half-Life SSRIs

40

Citalopram 40mg 30mg 20mg 10mg 10mg alt days

20mg 20mg/10mg alt days 10mg 10mg alt days 5mg alt days

10mg 10mg/5mg alt days 5mg 5mg alt days 5mg alt days

Escitalopram 20mg 20mg/10mg alt days 10mg 10mg alt days 5mg alt days

10mg 10mg/5mg alt days 5mg 5mg alt days 5mg alt days

Fluoxetine 20mg STOP

40mg 40mg/30mg alt days 30mg 30mg/20mg alt days 20mg

60mg* 60mg/40mg alt days 40mg As for 40mg above

Fluvoxamine** 150mg BD 150mg + 100mg 100mg + 50mg 50mg BD 50mg

100mg BD 100mg + 50mg 50mg BD 50mg 50mg alt days

100mg 50mg BD50mg BD + 50mg daily

alt days50mg 50mg alt days

50mg Miss every 3rd day’s dose 50mg alt days 50mg alt days 50mg every 4th day

Paroxetine 30mg 30mg/20mg alt days 20mg 20mg/10mg alt days 10mg

20mg 20mg/10mg alt days 10mg 10mg alt days 10mg alt days

Sertraline 200mg 200mg/150mg alt days 150mg 100mg 50mg

150mg 150mg/100mg alt days 100mg 100mg/50mg alt days 50mg

100mg 100mg/50mg alt days 50mg 50mg alt days 50mg half a tab alt days

50mg Miss every 3rd day’s dose 50mg alt days25mg

(half a tablet)25mg alt days

DrugStarting

Daily DoseWeek 1 Week 2 Week 3

Week 4 Then Stop

If patients experience withdrawal symptoms at any stage, move back to previous week’s dosage and reduce more slowly. For lowest doses patients may need to switch to liquid preparations where available — may also assist if need slower withdrawal.

Fluoxetine at doses of less than 40mg daily may be stopped without gradual reduction. For higher doses consider dosage reduction of 25% per week as for other drugs below.

* Check indication for fluoxetine 60mg not for eating disorders

** Where dose is split, choice of whether to reduce AM or PM dose first depends on patient preference

41

ParaesthesiaNumbness

Electric-shock-like sensationsRushing noise ‘in head’Palinopsia (visual trails)

General Symptoms

IrritabilityAnxiety/agitation

Low moodTearfulness

Affective Symptoms

Light-headednessDizzinessVertigo

Disequilibrium

NauseaVomitingDiarrhoea

Gastrointestinal Symptoms

LethargyHeadache

TremorSweatingAnorexia

General Somatis Symptoms

InsomniaNightmares

Excessive dreaming

Sleep Disturbance

Primary SSRIDiscontinuation

Syndrome

Fig 1: Key symptom groups of primary SSRI discontinuation syndrome. Common or characteristic symptoms are listed, but many others are reported. Patients vary in the number and combination of symptoms they manifest.

ARM and the Medicines Optimisation Academy are non-promotional education programmes designed by RB UK to improve patient care and support healthcare professional.

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

42

Ad

vice

fo

r Pa

tien

ts t

akin

g

Sele

ctiv

e Se

roto

nin

Re-

up

take

In

hib

ito

rs (

SSR

Is)

A m

edic

ine

use

d t

o h

elp

wit

hd

epre

ssio

n a

nd

oth

er m

enta

lh

ealt

h d

iso

rder

s

This

mat

eria

l was

dev

elo

ped

by

Dia

ne

McG

inn

MPh

arm

Pro

du

ctio

n o

f th

is le

afl e

t h

as b

een

su

pp

ort

ed w

ith

fu

nd

ing

fro

m R

B H

ealt

hca

re U

K L

td.

UK

/G-N

SH/1

14/0

058x

Dat

e of

pre

para

tion:

Mar

ch 2

015.

Prac

tice

stam

p to

go

here

Ho

w D

o I

Sto

p S

afel

y?If

you

have

bee

n on

ant

idep

ress

ants

co

ntin

ually

for

6 w

eeks

or

mor

e yo

u sh

ould

no

t st

op t

reat

men

t ab

rupt

ly u

nles

s th

ere

are

spec

ial c

ircum

stan

ces.

The

exce

ptio

n to

thi

s is

fl uo

xetin

e at

a d

ose

of 2

0mg

a da

y. B

ecau

se it

rem

ains

in t

he

bloo

dstr

eam

for

suc

h a

long

tim

e an

yway

, it

can

be s

topp

ed s

trai

ght

away

with

out

redu

cing

th

e do

se s

low

ly. I

f yo

u pr

efer

, you

can

gra

dual

ly

spac

e ou

t th

e do

ses

from

onc

e da

ily t

o on

ce

ever

y tw

o da

ys a

nd s

o on

.

With

oth

er a

ntid

epre

ssan

ts t

hat

last

a s

hort

er

time

in y

our

bloo

dstr

eam

, the

bes

t th

ing

to d

o is

red

uce

the

daily

dos

e ev

ery

one

to t

wo

wee

ks.

Your

pra

ctic

e w

ill b

e ab

le t

o ad

vise

you

abo

ut

how

bes

t to

red

uce

your

dos

e.

With

draw

al s

ympt

oms

are

unlik

ely

to o

ccur

if

you

redu

ce t

he d

ose

grad

ually

. If

with

draw

al

sym

ptom

s do

occ

ur, t

hey

will

usu

ally

last

less

th

an t

wo

wee

ks. A

n op

tion

if th

ey d

o oc

cur

is

to r

esta

rt t

he d

rug

and

redu

ce t

he d

ose

even

m

ore

slow

ly.

Alw

ays

take

you

r m

edic

atio

n as

adv

ised

by

a he

alth

care

pro

fess

iona

l and

tal

k to

you

r do

ctor

be

fore

sto

ppin

g an

y tr

eatm

ents

you

rsel

f.

Rep

ort

ing

of

sid

e-ef

fect

s If

you

get

any

side

eff

ects

, tal

k to

you

r do

ctor

, ph

arm

acis

t or

nur

se. T

his

incl

udes

any

pos

sibl

e si

de-e

ffec

ts n

ot li

sted

in t

he p

acka

ge le

afl e

t. Y

ou

can

also

rep

ort

side

eff

ects

dire

ctly

via

the

Yel

low

C

ard

Sche

me

at w

ww

.mhr

a.go

v.uk

/yel

low

card

.

By r

epor

ting

side

eff

ects

you

can

hel

p pr

ovid

e m

ore

info

rmat

ion

on t

he s

afet

y of

thi

s m

edic

ine.

Follo

w U

pM

ost

peop

le c

ome

off

antid

epre

ssan

ts w

ith li

ttle

or

no

prob

lem

s an

d fo

llow

ing

the

advi

ce in

thi

s le

afl e

t sh

ould

hel

p yo

u do

tha

t. H

owev

er if

you

do

get

any

pro

blem

s th

en p

leas

e as

k fo

r he

lp.

You

can

cont

act

one

of t

he M

enta

l Hea

lth T

eam

or

dis

cuss

you

r w

orrie

s w

ith y

our

GP.

Hel

plin

esM

ind

Tel:

0300

123

339

3w

ww

.min

d.or

g.uk

NH

S ad

vice

Tel:

111

ww

w.n

hsdi

rect

.nhs

.uk

Dep

ress

ion

Alli

ance

ww

w.d

epre

ssio

nalli

ance

.org

Dep

ress

ion

UK

Tel:

0115

960

8855

ww

w.d

epre

ssio

n.uk

.org

Ret

hin

k M

enta

l Illn

ess

Tel:

0300

500

0927

(Mon

-Fri

10am

-2pm

)w

ww

.ret

hink

.org

San

elin

eTe

l: 08

45 6

7800

0 (6

pm-1

1pm

)

43

Wh

at A

re S

SRIs

?Se

lect

ive

sero

toni

n re

-upt

ake

inhi

bito

rs, k

now

n as

SSR

Is, a

re a

gro

up o

f m

edic

ines

pre

scrib

ed

to h

elp

with

the

sym

ptom

s of

dep

ress

ion

and

othe

r co

nditi

ons

such

as

pani

c di

sord

er,

obse

ssiv

e co

mpu

lsiv

e di

sord

er a

nd g

ener

alis

ed

anxi

ety

diso

rder

.

Ther

e ar

e a

num

ber

of S

SRIs

with

diff

eren

t na

mes

yo

u m

ay b

e ta

king

. The

se in

clud

e:

• C

italo

pram

• Es

citlo

pram

• Fl

uoxe

tine

• Fl

uvox

amin

e

• Pa

roxe

tine

• Se

rtra

line

Ho

w E

ffec

tive

Are

SSR

Is?

Abo

ut 5

-7 in

10

peop

le w

ith m

oder

ate

or s

ever

e de

pres

sion

hav

e an

impr

ovem

ent

in s

ympt

oms

with

in a

few

wee

ks o

f st

artin

g tr

eatm

ent

with

an

antid

epre

ssan

t.

It is

bes

t to

wai

t fo

r 3-

4 w

eeks

bef

ore

deci

ding

if

trea

tmen

t w

ith a

n SS

RI is

hel

ping

or

not.

Ho

w D

o S

SRIs

Wo

rk?

Ant

idep

ress

ants

alte

r th

e ba

lanc

e of

som

e of

the

ch

emic

als

in t

he b

rain

(neu

rotr

ansm

itter

s). S

SRI

antid

epre

ssan

ts m

ainl

y af

fect

a n

euro

tran

smitt

er

calle

d se

roto

nin.

An

alte

red

bala

nce

of s

erot

onin

an

d ot

her

neur

otra

nsm

itter

s is

tho

ught

to

play

a

part

in c

ausi

ng d

epre

ssio

n an

d ot

her

cond

ition

s.

Wh

en D

o I

Sto

p?

If yo

u st

op a

ntid

epre

ssan

ts b

efor

e 8

or 9

m

onth

s is

up,

the

sym

ptom

s of

dep

ress

ion

are

mor

e lik

ely

to c

ome

back

.

The

curr

ent

reco

mm

enda

tions

are

tha

t it

is b

est

for

mos

t pe

ople

to

cont

inue

tak

ing

antid

epre

ssan

ts f

or s

ix m

onth

s af

ter

thei

r sy

mpt

oms

have

red

uced

.

Will

I H

ave

An

y W

ith

dra

wal

Sym

pto

ms?

Stud

ies

have

sho

wn

that

up

to a

thi

rd o

f pe

ople

ha

ve d

isco

ntin

uatio

n sy

mpt

oms

for

a s

hort

tim

e w

hen

they

sto

p an

tidep

ress

ants

. You

may

get

sy

mpt

oms

if yo

u st

op to

o qu

ickl

y an

d th

is s

eem

s to

ha

ppen

mor

e of

ten

with

long

er tr

eatm

ent c

ours

es.

Sym

ptom

s in

clud

e:

• St

omac

h up

sets

• Fl

u-lik

e sy

mpt

oms

• A

nxie

ty

• D

izzi

ness

• V

ivid

dre

ams

at n

ight

• Se

nsat

ions

in t

he b

ody

like

little

sho

cks

They

are

mos

t lik

ely

to b

e ex

perie

nced

whe

n re

duci

ng f

rom

an

SSRI

ant

idep

ress

ant

calle

d Pa

roxe

tine

(Ser

oxat

)

(Ver

y ra

rely

som

e pe

ople

rep

orte

d su

icid

al

thou

ghts

eve

n in

tho

se w

ho h

ave

neve

r ex

perie

nced

thi

s be

fore

. If

this

occ

urs

plea

se

mak

e an

urg

ent

appo

intm

ent

to s

ee y

our

GP

and

rem

embe

r th

at t

hese

tho

ught

s do

not

re

mov

e yo

ur a

bilit

y to

con

trol

you

r ac

tions

.)

Wh

at A

re T

he

Poss

ible

Sid

e Ef

fect

s an

d R

isks

?M

ost

peop

le h

ave

eith

er li

ttle

, or

no s

ide-

effe

cts

and

thes

e m

ay v

ary

betw

een

diff

eren

t pr

epar

atio

ns. T

he le

afl e

t th

at c

omes

in t

he

med

icin

e pa

cket

giv

es a

ful

l lis

t of

pos

sibl

e si

de-e

ffec

ts.

The

mos

t co

mm

on s

ide-

effe

cts

incl

ude:

• D

iarr

hoea

, fee

ling

sick

, vom

iting

• H

eada

ches

• D

row

sine

ss

SSRI

s ar

e as

soci

ated

with

a s

mal

l inc

reas

ed r

isk

of b

leed

ing

into

the

gut

. Thi

s is

esp

ecia

lly in

ol

der

peop

le a

nd in

peo

ple

taki

ng o

ther

m

edic

ines

. The

refo

re, i

deal

ly, S

SRIs

sho

uld

be a

void

ed if

you

tak

e as

pirin

, war

farin

or

nons

tero

idal

ant

i-infl

am

mat

ory

drug

s (N

SAID

s)

such

as

ibup

rofe

n, n

apro

xen

or d

iclo

fena

c. If

no

sui

tabl

e al

tern

ativ

e to

an

SSRI

can

be

foun

d an

d yo

u ha

ve a

n in

crea

sed

risk

of b

leed

ing,

the

n yo

ur d

octo

r m

ay a

dvis

e th

at y

ou t

ake

anot

her

m

edic

ine

to p

rote

ct t

he li

ning

of

the

gut.

Ad

vice

fo

r Pa

tien

ts t

akin

g

Pro

ton

Pu

mp

Inh

ibit

ors

(PP

Is)

A m

edic

ine

use

d f

or

Hea

rtb

urn

an

d In

dig

esti

on

(als

o c

alle

d r

efl u

x)

Pro

du

ctio

n o

f th

is le

afl e

t h

as b

een

su

pp

ort

ed w

ith

fu

nd

ing

fro

m R

B H

ealt

hca

re U

K L

td.

UK

/G-N

HS/

1114

/005

8y D

ate

of p

repa

ratio

n: M

arch

201

5.

Prac

tice

stam

p to

go

here

Hel

p T

o M

anag

e R

ebo

un

d S

ymp

tom

sYo

ur h

ealth

care

pro

fess

iona

l will

adv

ise

on w

ays

to h

elp

with

hea

rtbu

rn a

nd in

dige

stio

n th

at

can

happ

en w

hen

you

try

to s

top

a PP

I. Th

ey

may

pre

scrib

e or

rec

omm

end

a di

ffer

ent

type

of

med

icin

e ca

lled

an a

lgin

ate.

Alg

inat

es w

ork

by f

orm

ing

a ph

ysic

al b

arrie

r at

the

top

of

the

stom

ach

that

can

sto

p th

e ac

id g

ettin

g ba

ck o

ut

into

the

oes

opha

gus

whe

re it

cau

ses

pain

.

Will

I N

eed

To

Tak

e a

PPI I

n T

he

Futu

re?

Hea

rtbu

rn a

nd in

dige

stio

n ar

e qu

ite c

omm

on

and

can

com

e an

d go

ove

r tim

e. Y

ou m

ight

fi nd

a

few

cha

nges

to

your

life

styl

e or

the

way

you

ea

t an

d dr

ink

will

hel

p ke

ep y

our

sym

ptom

s un

der

cont

rol.

If no

t, y

our

phar

mac

ist

can

advi

se o

n re

med

ies

you

can

buy

to h

elp.

If y

our

sym

ptom

s be

com

e co

mm

on o

r tr

oubl

esom

e ag

ain

you

shou

ld s

peak

to

your

doc

tor

who

may

th

ink

it ne

cess

ary

to p

resc

ribe

a PP

I aga

in.

Alw

ays

go s

trai

ght

to y

our

doct

or if

you

ex

perie

nce

any

of t

he f

ollo

win

g:

• W

eigh

t lo

ss t

hat

isn’

t in

tent

iona

l.

• D

iffi c

ulty

sw

allo

win

g.

• Vo

miti

ng r

outin

ely

or o

ften

.

• Si

gns

of b

lood

if y

ou v

omit

or w

hen

you

go

to t

he t

oile

t.

Way

s To

Try

& A

void

H

eart

bu

rn &

Ind

iges

tio

nLo

ts o

f pe

ople

get

hea

rtbu

rn a

nd in

dige

stio

n fr

om t

ime

and

time.

Get

ting

to k

now

whe

n yo

uge

t he

artb

urn

and

indi

gest

ion

can

allo

w y

ou t

o sp

ot t

he t

rigge

rs. I

f yo

u’re

not

sur

e w

hat

sets

off

yo

ur h

eart

burn

try

kee

ping

a f

ood

and

sym

ptom

di

ary

and

see

if yo

u ca

n sp

ot a

ny p

atte

rns.

So

met

imes

it’s

not

a pa

rtic

ular

foo

d bu

t a

time

of d

ay o

r ty

pe o

f ex

erci

se.

• Ea

t yo

ur m

eals

at

regu

lar

times

and

try

not

to

eat

too

qui

ckly.

Bet

ter

to e

at s

mal

ler

mea

ls

mor

e of

ten,

so yo

u do

n’t o

verfi

ll yo

ur st

omac

h.

• Tr

y no

t to

eat

too

clo

se t

o be

dtim

e if

you

tend

to

suff

er a

t ni

ght.

Lea

ving

3 h

ours

be

twee

n ea

ting

and

goin

g to

bed

can

hel

p.

• If

you’

re a

nig

ht t

ime

suff

erer

, lift

the

hea

d of

the

bed

. A g

ood

idea

is t

o pu

t br

icks

or

book

s un

der

the

bed.

• Tr

y no

t to

drin

k to

o m

any

fi zzy

drin

ks, e

ven

if it’

s sp

arkl

ing

wat

er. T

he g

as c

an c

ause

pr

essu

re in

you

r st

omac

h.

• If

you

drin

k al

coho

l, it

help

s to

cut

dow

n bu

t it

can

be t

he t

ype

of d

rink

that

’s a

prob

lem

as

wel

l, fo

r ex

ampl

e w

hite

win

e is

a

mor

e co

mm

on t

rigge

r th

an r

ed w

ine.

• If

you

smok

e tr

y to

cut

dow

n or

sto

p.

• A

void

foo

ds y

ou a

ssoc

iate

with

sym

ptom

s.

• M

any

peop

le k

now

the

ir tr

igge

rs -

tom

atoe

s ar

e a

com

mon

one

.

Alg

inat

eb

arrie

r

ACID

BILE

PEPSIN

44

Wh

at A

re P

roto

n P

um

p In

hib

ito

rs?

Prot

on p

ump

inhi

bito

rs, o

ften

cal

led

PPIs

are

a

type

of

med

icin

e, u

sual

ly p

resc

ribed

by

your

do

ctor

.

Ther

e ar

e a

num

ber

of P

PIs

with

diff

eren

t na

mes

, yo

u m

ay b

e ta

king

:

• O

mep

razo

le

• La

nsop

razo

le

• Pa

ntop

razo

le

• Ra

bepr

azol

e

• Es

omep

razo

le

Wh

y D

o P

eop

le T

ake

PPIs

?Yo

ur s

tom

ach

mak

es a

cid

to h

elp

dige

st f

ood

but

in s

ome

peop

le t

he a

cid

can

irrita

te t

he s

tom

ach

caus

ing

disc

omfo

rt. I

t ca

n al

so g

et b

ack

up in

to

the

oeso

phag

us (f

oodp

ipe

that

goe

s fr

om y

our

mou

th t

o yo

ur s

tom

ach)

and

cau

ses

pain

, kno

wn

as h

eart

burn

. Thi

s is

cal

led

refl u

x.

PPIs

are

use

d to

rel

ieve

sym

ptom

s of

hea

rtbu

rn

and

indi

gest

ion

and

rela

ted

stom

ach

prob

lem

s.

Som

e ot

her

med

icin

es c

an ir

ritat

e th

e st

omac

h so

som

etim

es p

eopl

e w

ho d

on’t

ha

ve t

hese

con

ditio

ns t

ake

PPIs

to

help

pr

even

t th

is h

appe

ning

.

Ho

w D

o P

PIs

Wo

rk?

PPIs

wor

k by

red

ucin

g th

e am

ount

of

acid

tha

t yo

ur s

tom

ach

mak

es. T

his

in t

urn

redu

ces

the

disc

omfo

rt o

r pa

in t

hat

you

feel

in y

our

stom

ach

or c

hest

whe

n th

e ac

id c

ause

s irr

itatio

n.

Wh

at H

app

ens

Wh

en Y

ou

Sto

pTa

kin

g P

PIs?

If yo

u ta

ke a

PPI

for

mor

e th

an a

few

wee

ks,

your

sto

mac

h ca

n in

crea

se it

s ab

ility

to

mak

e ac

id. T

his

mea

ns t

hat

whe

n th

e PP

I is

stop

ped,

ac

id le

vels

can

be

high

er t

han

befo

re y

ou s

tart

ed

taki

ng t

hem

.

For

this

rea

son

som

e pe

ople

fi nd

tha

t th

eir

hear

tbur

n or

indi

gest

ion

wor

sens

whe

n th

ey t

ry

to s

top

taki

ng a

PPI

. The

se a

re c

alle

d re

boun

d sy

mpt

oms

and

they

can

last

abo

ut 2

wee

ks.

Step

pin

g D

ow

n O

r O

ff P

PIs

Beca

use

of th

e re

boun

d sy

mpt

oms

it is

adv

isab

le

to s

top

taki

ng P

PIs

grad

ually

and

follo

w th

e ad

vice

of

you

r doc

tor o

r hea

lthca

re p

rofe

ssio

nal t

o he

lp

man

age

your

sym

ptom

s in

the

fi rst

few

wee

ks.

You

r H

ealt

hca

re P

rofe

ssio

nal

may

ad

vise

:

• Ju

st r

educ

ing

the

dose

of

the

PPI.

• St

oppi

ng t

he P

PI.

• Re

duci

ng t

he d

ose

for

a fe

w w

eeks

th

en s

topp

ing

alto

geth

er.

• C

hang

ing

the

way

you

tak

e th

e PP

I so

you

just

tak

e it

occa

sion

ally

whe

n yo

u fe

el s

ympt

oms.

• U

se o

f an

othe

r m

edic

ine

(cal

led

an

algi

nate

) for

a f

ew w

eeks

to

help

with

th

e re

boun

d sy

mpt

oms.

• Li

fest

yle

chan

ges

that

cou

ld h

elp

stop

sy

mpt

oms

com

ing

back

in t

he f

utur

e.

Ho

w L

on

g S

ho

uld

Yo

u T

ake

PPIs

Fo

r?A

lthou

gh P

PIs

are

wel

l tol

erat

ed in

mos

t pa

tient

s, n

o m

edic

ines

are

com

plet

ely

safe

or

with

out

side

eff

ects

. So

, as

with

all

med

icin

es, y

ou s

houl

d on

ly t

ake

a PP

I fo

r as

long

as

you

need

it.

Peop

le t

ake

PPIs

for

diff

eren

t le

ngth

s of

tim

e, y

our

doct

or w

ill a

dvis

e w

hat

is r

ight

for

you

.

On

aver

age,

if y

ou’r

e ta

king

PPI

s fo

r he

artb

urn

or

indi

gest

ion

you’

ll ta

ke t

hem

for

4-8

wee

ks t

o al

low

yo

ur b

ody

to h

eal a

ny in

fl am

mat

ion.

If yo

u’re

tak

ing

PPIs

bec

ause

you

’re

also

usi

ng

anot

her

med

icin

e th

at c

an ir

ritat

e th

e st

omac

h, y

ou

mig

ht n

eed

to t

ake

them

for

long

er.

Alw

ays

take

you

r m

edic

atio

n as

adv

ised

by

a he

alth

care

pr

ofes

sion

al a

nd t

alk

to y

our

doct

or b

efor

e st

oppi

ng

any

trea

tmen

ts y

ours

elf.

If y

ou g

et a

ny s

ide

effe

cts,

ta

lk t

o yo

ur d

octo

r, ph

arm

acis

t or

nur

se. T

his

incl

udes

an

y po

ssib

le s

ide

effe

cts

not

liste

d in

the

pac

kage

le

afl e

t. Y

ou c

an a

lso

repo

rt s

ide

effe

cts

dire

ctly

via

the

Ye

llow

Car

d Sc

hem

e at

ww

w.m

hra.

gov.

uk/y

ello

wca

rd.

By re

port

ing

side

eff

ects

you

can

hel

p pr

ovid

e m

ore

info

rmat

ion

on t

he s

afet

y of

you

r m

edic

ines

.

Aci

dre

�ux

Sto

mac

h

Low

er

oeso

pha

geal

sp

hinc

ter

45

Pra

ctic

e st

amp

to

go h

ere

Ad

vice

fo

r Pa

tien

ts t

akin

g

No

n-s

tero

idal

An

ti-i

nfl

amm

ato

ryD

rug

s (N

SAID

s)

A t

ype

of

med

icin

e u

sed

to

hel

p w

ith

pai

n a

nd

sw

ellin

gin

mu

scle

s an

d jo

ints

Pro

du

ctio

n o

f th

is le

afl e

t h

as b

een

su

pp

ort

ed w

ith

fu

nd

ing

fro

m R

B H

ealt

hca

re U

K L

td.

UK

/G-N

HS/

1114

/005

8z D

ate

of p

repa

ratio

n: M

arch

201

5.

Prac

tice

stam

p to

go

here

You

r Si

de-

effe

cts

Som

e pa

tient

s m

ay g

et s

ide-

effe

cts

with

NSA

IDs

whi

ch c

an in

clud

e th

e fo

llow

ing

- th

ese

shou

ld

stop

if y

ou s

top

taki

ng t

he N

SAID

:

Nau

sea

(fee

ling

sick

), di

arrh

oea,

ras

hes,

head

ache

, diz

zine

ss, n

ervo

usne

ss, d

epr e

ssio

n,

drow

sine

ss, i

nsom

nia

(poo

r sl

eep)

, ver

tigo

(diz

zine

ss),

and

tinni

tus

(noi

ses

in t

he e

ar).

Alw

ays

take

you

r m

edic

atio

n as

adv

ised

by

a he

alth

car e

pro

fess

iona

l and

tal

k to

you

r do

ctor

be

fore

sto

ppin

g an

y tr

eatm

ents

you

rsel

f.

If yo

u ge

t an

y si

de e

ffec

ts, t

alk

to y

our

doct

or,

phar

mac

ist

or n

urse

. Thi

s in

clud

es a

ny p

ossi

ble

side

eff

ects

not

list

ed in

the

pac

kage

leafl

et.

Yo

u ca

n al

so r

epor

t si

de e

ffec

ts d

irect

ly v

ia t

he

Yello

w C

ard

Sche

me

at w

ww

.mhr

a.go

v.uk

/ye

llow

card

. By

repo

rtin

g si

de e

ffec

ts y

ou c

an

help

pro

vide

mor

e in

form

atio

n on

the

saf

ety

of

your

med

icin

es

Oth

er M

edic

atio

nU

sing

mor

e th

an o

ne N

SAID

at

a tim

e ca

n in

crea

se t

he r

isk

of h

arm

. Alw

ays

tell

the

phar

mac

ist

wha

t m

edic

atio

n yo

u ar

e ta

king

w

hen

buyi

ng m

edic

ines

.

NSA

IDs

are

also

an

ingr

edie

nt in

man

y ru

bs

and

gels

tha

t ar

e us

ed f

or m

uscl

e an

d jo

int

pain

. Th

ese

shou

ld n

ot b

e us

ed if

you

are

als

o ta

king

N

SAID

tab

lets

or

caps

ules

.

Med

icat

ion

Rev

iew

If yo

u ha

ve b

een

taki

ng a

n N

SAID

reg

ular

ly a

s pa

rt o

f yo

ur r

epea

t m

edic

atio

n, y

our

GP,

pra

ctic

e nu

rse

or p

harm

acis

t m

ay n

eed

to r

evie

w t

his

from

tim

e to

tim

e to

ass

ess

if it

is s

afe

for

you

to c

ontin

ue o

r if

it w

ould

be

bett

er t

o pr

escr

ibe

an a

ltern

ativ

e m

edic

atio

n to

hel

p w

ith y

our

sym

ptom

s.

46

Wh

at A

re N

on

-ste

roid

al

An

ti-i

nfl

amm

ato

ry D

rug

s?N

on-s

tero

idal

ant

i-infl

am

mat

ory

drug

s, o

ften

ca

lled

NSA

IDs,

are

a t

ype

of m

edic

ine

that

is

pres

crib

ed b

y yo

ur G

P fo

r pa

in o

r in

fl am

mat

ion.

Th

ere

are

a nu

mbe

r of

NSA

IDs

with

diff

eren

t na

mes

tha

t yo

u m

ay b

e ta

king

. The

se in

clud

e:

Wh

y D

o p

eop

le T

ake

NSA

IDs?

NSA

IDs

are

used

for

tw

o m

ain

reas

ons:

• To

eff

ectiv

ely

help

with

pai

n -

NSA

IDs

are

used

in v

ario

us c

ondi

tions

suc

h as

os

teoa

rthr

itis,

mus

cula

r sp

rain

s an

d st

rain

s an

d he

adac

hes.

• To

red

uce

infl a

mm

atio

n -

NSA

IDs

take

n in

rep

eate

d do

ses

can

help

with

pai

n an

d st

iffne

ss in

con

ditio

ns s

uch

as

rheu

mat

oid

arth

ritis

.

Ho

w D

o N

SAID

s W

ork

?Th

ey w

ork

by s

topp

ing

the

body

mak

ing

chem

ical

s ca

lled

pros

tagl

andi

ns w

hich

cau

se

pain

and

infl a

mm

atio

n.

• C

elec

oxib

• D

iclo

fena

c

• Et

oric

oxib

• Ib

upro

fen

• In

dom

etac

in

• K

etop

rofe

n

• M

elox

icam

• N

apro

xen

• Pi

roxi

cam

Patie

nts

mos

t at

ris

k of

sto

mac

h bl

eeds

incl

ude:

• Th

ose

taki

ng a

n an

ti-in

fl am

mat

ory

plus

w

arfa

rin, s

tero

ids,

or

low

-dos

e as

pirin

. Th

ese

com

bina

tions

of

med

icin

es s

houl

d on

ly b

e us

ed if

abs

olut

ely

nece

ssar

y.

• Pe

ople

age

d ov

er 6

5

• Pe

ople

with

a p

ast

hist

ory

of a

sto

mac

h or

duo

dena

l ulc

er

Thes

e pa

tient

s m

ay n

eed

to t

ake

a m

edic

ine

to

prot

ect

thei

r st

omac

h fr

om t

he e

ffec

ts o

f th

e N

SAID

. You

r do

ctor

will

adv

ise

if th

is is

the

ca

se f

or y

ou.

Ad

vice

Ab

ou

t Ta

kin

g N

SAID

sN

SAID

s do

not

alte

r th

e co

urse

of

pain

ful

cond

ition

s su

ch a

s ar

thrit

is. T

hey

just

eas

e sy

mpt

oms

of p

ain

and

stiff

ness

.

If yo

u ta

ke a

n an

ti-in

fl am

mat

ory

pain

kille

r, as

a r

ule

you

shou

ld t

ake

the

low

est

dose

tha

t is

eff

ectiv

e, f

or t

he s

hort

est

leng

th o

f tim

e th

at is

pos

sibl

e to

red

uce

the

risk

of

deve

lopi

ng s

ide-

effe

cts.

Wh

at A

re T

he

Poss

ible

Ris

ks

of

Taki

ng

NSA

IDs?

The

chem

ical

s (p

rost

agla

ndin

s) t

hat

are

redu

ced

by a

nti-i

nfl a

mm

ator

ies

are

also

invo

lved

in h

elpi

ng

to p

rote

ct t

he li

ning

of

the

stom

ach

from

the

ef

fect

s of

the

aci

d w

ithin

the

sto

mac

h. U

sual

ly

NSA

IDs

are

effe

ctiv

e m

edic

ines

tha

t ar

e w

ell

tole

rate

d bu

t oc

casi

onal

ly a

sto

mac

h ul

cer

can

deve

lop.

Blee

ding

in t

he s

tom

ach

is a

pro

blem

tha

t ne

eds

urge

nt m

edic

al a

tten

tion.

Eld

erly

peo

ple

are

mor

e pr

one

to t

his

prob

lem

, but

it c

an o

ccur

in

any

body

.

Ther

efor

e, if

you

are

tak

ing

an a

nti-i

nfl a

mm

ator

y an

d yo

u de

velo

p up

per

abdo

min

al p

ains

, pas

s bl

ood

or b

lack

sto

ols,

or

vom

it bl

ood,

the

n st

op

taki

ng t

he t

able

ts a

nd s

ee a

doc

tor

urge

ntly

, or

go t

o a

casu

alty

dep

artm

ent.

47

Life

styl

eSe

rvic

es In

form

atio

n

Loca

l hel

p a

nd

su

pp

ort

fo

rw

hen

yo

u w

ant

to m

ake

po

siti

ve li

fest

yle

chan

ges

Pro

du

ctio

n o

f th

is le

afl e

t h

as b

een

su

pp

ort

ed w

ith

fu

nd

ing

fro

m R

B H

ealt

hca

re U

K L

td.

UK

/G-N

HS/

1114

/005

8aa

Dat

e of

pre

para

tion:

Mar

ch 2

015.

Prac

tice

stam

p to

go

here

Smo

kin

gIf

you

wan

t to

sto

p sm

okin

g an

d th

ink

you’

re

read

y to

giv

e it

a tr

y yo

u m

ight

sta

nd a

bet

ter

chan

ce o

f su

ccee

ding

if y

ou g

et s

ome

help

an

d su

ppor

t.

Your

loca

l pha

rmac

ist

can

advi

se o

r fo

r he

lp

incl

udin

g ni

cotin

e re

plac

emen

t an

d ot

her

prod

ucts

on

pres

crip

tion

you

can

cont

act

your

lo

cal S

top

Smok

ing

serv

ice.

Alc

oh

ol &

Ille

gal

Dru

g U

seTh

e re

com

men

ded

safe

leve

l of

alco

hol i

s no

m

ore

than

3-4

uni

ts (1

uni

t =

hal

f a

pint

of

lage

r or

a s

mal

l gla

ss o

f w

ine)

for

adu

lt m

ales

per

day

an

d no

mor

e th

an 2

-3 u

nits

for

adu

lt fe

mal

es p

er

day.

The

re a

re n

o sa

fe li

mits

for

you

ng p

eopl

e.

Exce

ssiv

e al

coho

l use

is li

nked

to

viol

ent

crim

es

and

dom

estic

vio

lenc

e, c

ar r

elat

ed d

eath

s an

d ta

king

ris

ks s

uch

as h

avin

g un

prot

ecte

d se

x.

You

can

fi nd

info

rmat

ion

abou

t se

xual

hea

lth,

cont

race

ptio

n an

d lo

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49

50

Notes

51

Notes

52

Notes

Date of preparation: April 2015 UK/G-NHS/1114/0058ac

This material is not approved for use for projects with RB (ie. MEGS/Joint working)

ARM and the Medicines Optimisation Academy are non-promotional education programmes designed by RB UK to improve patient care and support healthcare professional.

53