Community Pharmacy
Helicobacter Pylori
‘Test and Treat’
Enhanced Service
Specification
December 2005
Produced by: Medicines Management Team
North Sheffield Primary Care Trust
Firth Park Clinic
North Quadrant
Firth Park
Sheffield
S5 6NU
Tel: (0114) 2716338
Fax: (0114) 2716293
Contents
Page
1
2
3
4
5
6
7
8
Introduction
Service Description
Rationale
Aim and intended service outcomes
Service Outline
Duties of participating Surgeries
Duties of participating Community Pharmacists
Patient Pathway
4
4
4
5
5
6
6
8
9
9.1
9.2
9.3
9.4
9.5
9.6
9.7
Management of patients with dyspepsia as per NICE guideline
Who should be referred for endoscopy?
Who should be referred for H. pylori ‘test and treat’
How should uninvestigated dyspepsia be managed?
How should GORD be managed
How should Peptic Ulcer Disease be managed?
How should Non-Ulcer Dyspepsia be managed?
How should patients be reviewed?
9
9
9
10
10
11
11
11
10
10.1
10.2
10.3
The 13C-Urea breath test
Choice of test
Description of breath test
Supplies of test
12
12
12
12
11
12
13
14
15
16
Eradication therapy
Training
Untoward events and complaints
Documentation
Service funding and payment mechanism
Duration of service
12
13
13
13
13
13
Appendix 1
Referral Form for Breath Test for Diagnosis of H pylori (HP1)
14
Appendix 2
Patient Information Leaflet – Instructions pre - H pylori breath test
15
Appendix 3
Standard Operating Procedure for H pylori breath test
16
Appendix 4
Procedure Form for Diabact UBT (HP2)
17
Appendix 5
Pharmacy record summary form (HP3)
19
Appendix 6
Standard Operating Procedure for supply of H pylori eradication therapy
20
2
Appendix 7
Patient Information Leaflet: Your H pylori treatment
21
Appendix 8
Communication Form: H pylori result (HP4)
22
Appendix 9
H pylori test and treat patient record
23
Appendix 10
Declaration of prescription exemption
24
Contacts
25
3
1.
Introduction
1.1.
NICE guidelines on the management of dyspepsia were published in
August 2004 (NICE Clinical Guideline17). Two key priorities for
implementation include Helicobacter pylori (H. pylori) eradication in
appropriate patients and the appropriate use of endoscopy services.
2.
Service Description
2.1.
The pharmacy will carry out H. pylori breath tests on patients referred
to them via a written direction from a general practitioner.
2.2.
The pharmacist will subsequently treat H. pylori positive patients with
eradication therapy under a Patient Group Direction (PGD).
2.3.
The pharmacist will offer advice on the management of dyspepsia to
patients.
2.4.
The pharmacy will communicate the results in a routine and robust
manner to the general practice.
3.
Rationale
3.1.
40% of the population have dyspeptic symptoms. Of these the majority
will have non-ulcer or functional dyspepsia on endoscopy, i.e. normal
endoscopy.
3.2.
More is spent on treating dyspepsia than on any other drug group. It
accounts for 9-10% of the national drug budget.
3.3.
Gastroenterology services in Sheffield are under considerable strain at
present, especially the endoscopy waiting lists in relation to the
management of patients with dyspepsia. As part of trying to improve
gastroenterology services in Sheffield there is a desire to streamline
services for patients with dyspepsia.
3.4.
A significant number of patients currently have exploratory
gastroscopies to check for underlying pathology. This procedure is
unpleasant for patients and should be used efficiently and for
appropriate patient groups.
3.5.
The 13C-Urea Breath test is recognised as being the non-invasive test
of choice for identifying H.pylori status and has completely superseded
near-patient serology testing. Serology identifies antibodies to the
H.pylori bacteria, however this does not show if the infection is active or
not, merely that the person has had it in the past. Therefore serology
should not be used if re-testing for H.pylori.
4
3.6.
H.pylori is a bacteria strongly associated with peptic ulcer disease
(PUD) – 95% of duodenal ulcers and 70% of gastric ulcers. Eradicating
it from these patients reduces recurrence rates. Eradicating it from
patients with non-ulcer dyspepsia (NUD) reduces symptoms. NICE
recommends H.pylori testing and eradication in patients with PUD,
NUD and as an intervention for uninvestigated dyspepsia.
4.
Aim and intended service outcomes
4.1.
To improve the care of patients with dyspepsia symptoms through the
provision of a standardised effective & evidence based H. pylori test
and treat service.
4.2.
To ensure that all patients with dyspepsia requiring a H. pylori test as
per NICE guidelines have access to this test in primary care and are
given eradication therapy if positive.
4.3.
To ensure that all requests for endoscopy are appropriate and only
those patients with ALARM symptoms are referred to secondary care.
An individualised approach to endoscopy has to be adopted.
4.4.
To provide a means by which H. pylori 13C-Urea breath testing can be
performed in primary care.
4.5.
To improve access and choice for patients.
4.6.
To improve primary care capacity by reducing medical practice
workload related to the management of dyspepsia symptoms.
5.
Service Outline
5.1.
The pharmacy must have a consultation area, which provides a
sufficient level of privacy and safety.
5.2.
The pharmacy must have continuity of pharmacist providing the
service.
5.3.
The pharmacy contractor has a duty to ensure that pharmacists and
staff involved in the provision of the service have relevant knowledge
and are appropriately trained in the administration of the H. pylori
breath test and all other aspects of the service.
5.4.
The pharmacy contractor has a duty to ensure that pharmacists and
staff involved in the provision of the service are aware of and operate
within the protocols and guidance detailed in the service specification.
5.5.
The pharmacy will maintain records of the consultations performed and
any medicines supplied (using the HP forms provided), to ensure
effective ongoing service, delivery and audit.
5
5.6.
The agreed PGDs will be used and only pharmacists who have gained
accreditation in providing eradication treatment under a PGD issue to
treatment and advice to H. pylori positive patients.
5.7.
The pharmacy will:
 Provide advice to patients on the management of
dyspeptic symptoms.
 Refer to general practitioner where appropriate.
5.8.
The PCT will provide training on the administration of the H. pylori
breath test to pharmacists and pharmacy staff.
5.9.
The PCT will provide accredited training on the PGD for eradication
therapy for pharmacists
6.
Duties of participating Surgeries
6.1.
GPs should refer patients who meet the criteria identified in this service
specification for a H. pylori breath test to a participating pharmacy.
6.2.
Surgeries should record the test results and all other relevant
information in the patients’ medical notes.
6.3.
Surgeries should co-operate and liase with community pharmacists
operating the service.
7.
Duties of participating Community Pharmacists
7.1.
Patients should only be accepted into the service on presentation with
a referral card (form HP1; appendix 1) signed by a GP of a participating
surgery.
7.2.
A member of the pharmacy team who has been trained in undertaking
the H. pylori breath test will perform the test as per the protocols
detailed in the service specification and complete procedure form (form
HP2; appendix 4).
7.3.
A pharmacist will deal with results.
7.4.
Patients with positive H. pylori results will be contacted and managed
by a pharmacist accredited to issue eradication therapy under a PGD
to arrange an appropriate consultation time for the patient to present for
treatment.
7.5.
Patients requiring eradication therapy will be charged prescription
charges as appropriate. Pharmacists should ensure that patients
exempt from prescription charges have completed and signed the
declaration of exemption of prescription charges (see example form in
appendix 10).
6
7.6.
The pharmacy will complete the appropriate communication forms
(form HP4; appendix 8) and send to GP.
7.7.
The pharmacists will submit claim/activity forms monthly (form HP3;
appendix 5).
7.8.
The pharmacy will audit the service annually.
7.9.
The pharmacy will keep records of all consultations. A summary record
form may be used to assist with this – see appendix 9.
7
8.
Patient Pathway
Patient presents to the GP with dyspepsia.
No Alarm symptoms and symptoms not suggestive of GORD.
GP completes referral form (appendix 1) and refers patient to community
pharmacy for a H. pylori breath test.
GP also gives patient information leaflet ‘Your Helicobacter Pylori Breath
Test’ with pre-test instructions (appendix 2).
Patient presents at pharmacy with referral form
Member of the pharmacy team undertakes H. pylori breath test as per
standard operating procedure (SOP) (appendix 3) and completes
procedure form (appendix 4).
Member of the pharmacy team completes summary form (appendix 5).
On receipt of a H. pylori breath test result, pharmacist to contact patient by
telephone and inform of the results.
If result positive
Pharmacist to invite patient
back to pharmacy for
eradication therapy as per
Patient Group Direction.
Refer to SOP for eradication
therapy (appendix 6).
Provide patient with ‘Your
Helicobacter Pylori
Treatment’ information
leaflet (appendix 7).
If result negative
Pharmacist to offer
patient diet and
lifestyle advice and
OTC therapy if
appropriate.
Advise patient to
see GP if
symptoms persist.
Pharmacist to complete communication form and send to GP (appendix 8).
Member of the pharmacy team to complete and submit summary form
monthly. – (see appendix 5).
8
9.
Management of patients with dyspepsia as per NICE guideline
9.1.
Who should be referred for endoscopy?

Urgent referral for endoscopy is indicated for patients of any age
with dyspepsia presenting with ALARM symptoms.
o Alarm symptoms:
 Chronic gastrointestinal bleeding
 Progressive unintentional weight loss
 Progressive difficulty swallowing
 Persistent vomiting
 Iron deficiency anaemia
 Epigastric mass
 Suspicious barium meal

Patients over 55 with unexplained* and persistent** recent onset
dyspepsia.
*’Unexplained’ is defined as a symptoms and or sign that has not led to a
diagnosis being made by the primary care professional after initial
assessment of the history, examination and primary care investigations (if
any).
** ‘Persistent’ refers to the continuation of specified symptoms and/or signs
beyond a period that would normally be associated with self-limiting problems.
The precise period will vary depending on the severity of symptoms and
associated features, as assessed by the healthcare professional. In many
cases, the upper limit the professional will permit symptoms and/or signs to
persist before initiating referral will be 4-6 weeks. (Extracted from NICE
Clinical Guidelines 17)

9.2.
Routine endoscopic investigation of patients of any age,
presenting with dyspepsia and without alarm signs is not
necessary.
Who should be referred for H.pylori ‘test and treat’?
9.2.1. Patients who should be tested

Patients (aged 18+) with dyspepsia (no ALARM symptoms) and
without typical reflux symptoms.

Patients (aged 18+) with dyspepsia (no ALARM symptoms) without
typical reflux symptoms whose symptoms have not improved with
lifestyle advice or antacid/H2RA / PPI trial.

Patients who have received antibiotics for H pylori (detected at
endoscopy or by previous breath test) but have continuing
symptoms. To confirm eradication the test must be carried out at
least 4 weeks after completing the course of treatment.
9

Patients with previously documented evidence of gastric ulcer (but
not had H. pylori eradication) and no recent change in symptoms.
9.2.2.Patients who should not be tested
9.3.
9.4.

Patients with ALARM features; these patients should be referred.

Patients aged under 18 (not licensed)

Patients with previous diagnosis of duodenal ulcer: eradication
therapy without prior testing is now recommended for those patients
that have not had eradication therapy before.

Patients with symptoms typical of gastro-oesophageal reflux.
There is insufficient evidence of benefit (and some evidence of
harm) in eradicating H. pylori from patients with GORD.

Patients who have received antibiotic therapy for any reason within
the previous 4 weeks - this may suppress H pylori and thus give a
falsely negative result. These patients may be tested 4 weeks after
completion of their course of antibiotics.

Patients who have received treatment with proton pump inhibitors
(PPIs) within the previous 2 weeks - they may suppress H
pylori
and thus give a falsely negative result. These patients may be
tested 2 weeks after stopping PPIs.
How should uninvestigated dyspepsia be managed?

Patients with dyspepsia without alarm signs and symptoms not
suggestive of GORD should be tested and treated for H.pylori.

Patients who have had eradication but whose symptoms recur
should be managed with a PPI and stepped down to the lowest
dose required to control symptoms.

Patients who test negative for H.pylori should be offered a PPI for
one month and then reviewed.
How should GORD be managed?

Patients with GORD should be given a full-dose proton pump
inhibitor (PPI) for 1 or 2 months and then reviewed.

If symptoms recur after initial treatment a maintenance dose PPI
should be used to control symptoms, with a limited number of
repeat prescriptions.
10
9.5.
9.6.
How should PUD be managed?

Patients with PUD should stop their NSAIDs if used.

Patients with PUD should be tested for H.pylori infection and offered
eradication if positive.

An endoscopy to confirm healing post eradication therapy is only
needed in patients with gastric ulcer.

If symptoms persist and patients are H.pylori negative then a
maintenance dose PPI should be used as required.
How should NUD be managed?

9.7.
Patients with endoscopically determined NUD should be tested for
H.pylori and treated if positive, followed by symptomatic
management and periodic monitoring.
How should patients be reviewed?

Patients requiring long-term management of symptoms for
dyspepsia should be offered an annual review of their condition,
encouraging them to try stepping down or stopping treatment.

A return to self-treatment with antacid or alginate therapy
(prescribed or over the counter) may be appropriate.

Patients should be offered lifestyle advice, including advice about
healthy eating, weight reduction and smoking cessation.
11
The 13C-Urea breath test
10.
10.1. Choice of test

The 13C-Urea Breath test is recognised as being the non-invasive
test of choice for identifying H.Pylori status and has completely
superseded near-patient serology testing.

In a systematic review of 30 published studies, 13C-urea breath
tests were more accurate than serological tests.

The 13C-Urea breath test can also be used post eradication to
confirm that treatment has been successful. Serological tests are of
no value in confirming successful eradication as the antibody
remains in the blood stream long after successful eradication.
10.2. Description of 13C-Urea breath test
10.3.


On the basis of convenience and cost, DIABACT UBT is the
Urea breath testing kit of choice.

The test involves the collection of breath samples before and after
the ingestion of a 13C-Urea tablet. If H. pylori is present in the
stomach it produces the enzyme urease, which breaks down the
ingested 13C-Urea to ammonia and 13CO2. The samples are sent
away for laboratory analysis and a result is provided within 48
hours. The post dose breath sample will contain this 13CO2 if H.
pylori is present. Analysis and test tubes for breath samples are
included in the kit provided.

13C-Urea
13C-
is a stable isotope and therefore has no associated
radioactivity.
Supplies of test
Breath tests will be obtained under contract by the PCT and supplied to
providers
For practices participating in this service breath tests should NOT
be prescribed on FP10 unless a patient is unable to swallow the
Diabact tablet. An alternative breath test could then be prescribed
by FP10.
11.
Eradication therapy
11.1. For patients who test positive, a 7-day, twice-daily course of treatment
consisting of lansoprazole 30mg, amoxicillin 1 g and clarithromycin
500 mg (HeliclearTM) should be given under a PGD. For patients
12
allergic to penicillin the PGD for lansoprazole, clarithromycin and
metronidazole should be used.
11.2. Eradication is effective in 80–85% of patients.
11.3. Pharmacists will be reimbursed the cost of the Heliclear™ (or individual
components where used) plus VAT. Requirements for patients who
normally pay for NHS prescription charges also applies under a PGD.
12.
Training
12.1. The PCT will provide training to the community pharmacists
participating in the scheme.
12.2. Each community pharmacy manager must ensure that all staff involved
in providing any aspect of care under the scheme have the necessary
training and skills to do so.
13.
Untoward events and complaints
13.1. It is a condition of participation in the pilot service that pharmacists and
GPs give notification to the PCT clinical governance manager of any
clinical governance issues or untoward events in relation to the pilot.
13.2. All complaints in relation to the service should be submitted to the
complaints manager at North Sheffield PCT.
14.
Documentation
14.1. Pharmacies are to complete summary form and submit to the PCT
monthly.
14.2. Practices are to document procedure in the patients’ notes on receipt of
the communication form from the pharmacy.
15.
Service Funding and Payment mechanism
15.1. The PCT agrees to pay £15 per breath test and to reimburse the
pharmacy for the cost of the Heliclear™ (or individual components
used) plus VAT, minus prescription charges where applicable.
15.2. The payments will be made monthly as per the Service Level
Agreement.
16.
Duration of Service
16.1. The service will run to the date specified in the service level agreement.
13
Appendix 1. (Form HP1)
Referral Form for Breath Test for Diagnosis of Helicobacter Pylori
infection.
Patients Name:
Patients Address:
NHS number:
Date of Birth:
Telephone no:
I confirm that the patient has dyspepsia but none of the following:



ALARM symptoms
GORD symptoms
Over 55 with unexplained and persistent recent onset dyspepsia.
I authorise that the above person be tested for Helicobacter Pylori
infection by using Diabact UBT 13C-urea breath test. (Read Code: 3167)
I understand that if the H.pylori test is positive the patient will be offered
H pylori eradication therapy under a PGD. Does the patient have:
An allergy to penicillins?
Y/N
An allergy to metronidazole, clarithromycin or lansoprazole? Y/N
Severe renal or hepatic impairment?
Y/N
If this service were unavailable would this patient have been referred for a
gastroscopy?
Y/N
GP Name: ____________________________________
Signed: ______________________________________
Date: _______________________________________
GP stamp:
14
A list of participating pharmacies will be printed on the reverse of the referral
form.
Appendix 2: Instructions pre – Helicobacter pylori breath test.
What do I have to do
before the test?
W hat will happen next?
So that the test works
properly it is important that
you make sure that:
send away your
The pharmacy will
test and a
r range
to contact you
 you have not eat
en for
6 hours before taking
the test — It is a good
idea if possible to arrange
to have your test in the
morning and delay your
breakfast until after the
test.
a f ter about a
 you have not taken any
What if I still have any
questions
?
of your stomach
medicines (e.g. Omeprazole
or Lansoprazole) for two
weeks.
week and give
you your r
e sults.
At this point the pharmacist
will discuss with you if you
will need treatment or not.
If you have any further
questions about H pylori,
your test or your result ask
 y ou have not taken any
your community pharmacy
antacids such as Peptac
or Gaviscon in the last
24 hours
staff, GP or practi
If you are in any doubt about
which medicines ma
y
interfere with the test then
ask your pharmacist
Helicobacte r
Yo u r d o c t o r w i l l h a ve
d i s c u s s e d w i t h yo u w h y t h e y
h a ve r e f e r r e d yo u t o b e
t e s t e d f o r H P yl o r i . T h e m o s t
comm on reasons ar e:
 I f yo u h a ve a s t o m a c h
ulcer
 I f yo u h a ve s ym p t o m s o f
indigestion that won’t go
a w a y d e s p i t e h a vi n g u s e d
m edication
I t i s t h o u g h t t h a t H P yl o r i
alters the linin g of the
stom ach and can be t he
cause of st om ach ulcers a nd
indigestion.
breath test.
H elicobacter pylori is,
explain about the test and
tell you what you need to do
before you have the test
What is a b reath test?
T h e H P yl o r i b r e a t h t e s t i s
w h e r e a s a m p l e o f yo u r b r e a t h
i s t e s t e d t o s e e i f yo u a r e
i n f e c t e d w i t h H P yl o r i .
How do I arrang e m y
test?
Go to on e of the c om m uni ty
pharm acies listed o n th e back
o f yo u r r e f e r r a l c a r d . T h e y w i l l
d i s c u s s w i t h yo u w h e n y o u c a n
h a ve t h e t e s t .
 Before doin g an y othe r
tests fo r indig estion
Why is it a prob lem?
Your doctor has referred you
for a Helicobacter pylori
This leaflet will tell you what
Medicines Management Team
North Sheffield PCT
Firth Park Clinic
North Quadrant
Sheffield
S5 6NU
Telephone 0114 2716338
Review Date: Dec 2007
Who ne eds to be test ed
for H Py lori?
It is one of the m ost com m on
infections in the UK alt hough
m o s t p e o p l e d o n o t e ve n
k n o w t h a t t h e y h a ve i t .
Patient Information
ce nurse.
What is Hel icoba cte r
Pylo ri?
p yl o r i ( o r H P yl o r i a s i t i s
m ore com m only called)
refe rs t o a b ac te rial infec tion
that can be foun d in t he
stom ach or sm all
intestine.
Your
Helicobact
er Pylor
Breath
i
Test
Yo u r d o c t o r w i l l d e c i d e i f
yo u n e e d a n y f u r t h e r t e s t s
afte r this one
How can I b e tested fo r
H Pylori?
B y yo u r d o c t o r r e f e r r i n g yo u
to the com m uni ty pha rm acy
yo u c a n h a ve a s i m p l e b r e a t h
t e s t t o s e e i f yo u a r e i n f e c t e d
w i t h H p yl o r i o r n o t .
What w ill I hav e to do?
F i r s t yo u w i l l b e a s k e d t o b l o w
into a tube.
After this is do ne
yo u w i l l b e a s k e d t o
swallow a whole
tablet w ith a d rink of
w ater.
After waiting fo r 10 m inutes
yo u w i l l b e a s k e d t o b l o w i n t o
anothe r tube.
It’s a sim ple as tha t
\\Pctnorth\data\Library\Shared\Prescribing Folder\Pharmacy\H pylori
Pilot\Forms,PILs,Quest\Amended docs\Pre PIL final.pub
15
Appendix 3: Standard Operating Procedure
Summary of Helicobacter pylori breath test Procedure
Pre-dose breath samples taken in duplicate
Patient takes the 13C-urea tablet and waits 10 minutes
Post dose breath samples taken in duplicate
1. Check that the patient is over 18 years of age.
2. Check that the patient can swallow tablets. If not refer the patient back
to the GP who can prescribe an alternative test.
3. Certain medicines taken before the test may lead to false negative
results. For example, the test should not be performed within 28 days
of an antibacterial drug, within 14 days of a PPI (omeprazole,
lansoprazole, rabeprazole, pantoprazole) or within 24 hours of an
antacid or H2 antagonist (ranitidine, cimetidine). Patients should be
counselled to avoid taking their PPI for two weeks prior to the test.
4. Ideally the patient should have fasted overnight i.e. no breakfast on the
day of the test and advised to attend for the test first thing in the
morning. The patient should not have eaten for at least 6 hours before
the test is performed.
5. The timing of post dose breath samples needs to be accurate- the
manufacturers of Diabact UBT advise that they are collected 10
minutes after ingestion of the 13C-Urea tablet.
6. The two pre-dose and two post-dose samples are returned to the
laboratory for analysis as per the method detailed in the Diabact UBT
kit.
7. Complete procedure form.
16
Appendix 4
Procedure Form for Diabact UBT (Form HP2)
Patient Details
Patient name:…………………..
NHS number: ….…………
Patient Address:…………………………………..
………………………………………………………
………………………………………………………
Postcode………………………
Tel no (home):…………………………
Tel No (mobile):……………
GP name…………………………………………………………
GP Tel No:……………………………………………………….
Diabact UBT
Batch number:
Expiry Date:
Questions pre test:
Y
N
Questions to ask patient before the test is commenced
1. Have you had anything to eat in the last 6 hours?
2. Have you had antibiotics in the last 4 weeks?
3. Have you had a PPI in the last 14 days?
4. Have you had an antacid e.g. Gaviscon in the last
24 hours?
If any of the above has been answered yes then do not proceed with the test.
17
Test Procedure
1. Begin the procedure by blowing into the two empty “00 minutes” tubes
(BLUE LID)
a) Unscrew the stopper
b) Unwrap the straw and place it in the bottom of the tube
c) Blow into the tube until the inside of the sample tube steams up
d) Continue to breath through the straw while removing it from the
tube and immediately seal the tube with the stopper.
e) Repeat for 2nd tube
Blue tube 1
Blue tube 2
2. Swallow the tablet together with a glass of water and wait 10 minutes
Start time
End time
3. Blow into the two empty “10 minutes” tubes (RED LID)
a) Unscrew the stopper
b) Unwrap the straw and place it in the bottom of the tube
c) Blow into the tube until the inside of the sample tube steams up
d) Continue to breath through the straw while removing it from the
tube and immediately seal the tube with the stopper
e) Repeat for 2nd tube
Red tube 1
Red tube 2
4. Place the four tubes into the box.
5. Fill in the leaflet entitled “Patient details for breath analysis at Glasgow
Royal Infirmary”
6. Stick the barcode label onto the leaflet
7. Close the white box with the leaflet inside and attach security sticker.
8. Place inside blue box. Attach address label and pharmacy stamp.
Test carried out by:…………………………… Date……………..
Checked by…………………………………….
18
Appendix 5: Pharmacy Record Summary Form (Form HP3)
Patient
Gastroscopy Diabact Date
Identifier Avoided?
UBT
test
Y/N
test
done
done
Y/N
Date
test
result
received
H.
pylori
result
+/-
Eradication
therapy
given
Y/N/n/a
Prescription Advice Comments Fee
Eradication
charge
given
claimed fee
levied
Y/N
for H.
claimed
Y/N/n/a
pylori
Y/N/n/a
test
Y/N
Totals:
If the patient normally pays prescription charges, the same applies under the PGD – total claimed is the eradication fee minus the
prescription charge.
I confirm that I have carried out the above service and claim the following fee: £
Name:
Date:
Signature:
Please make cheque payable to:
Approved by PCT:……………………………………Date:…………………………….
Please keep a copy for your records
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Appendix 6.
Standard Operating Procedure
Summary of eradication therapy supply to patient under PGD
Upon receipt of a positive result from Glasgow Royal Infirmary

Recall patient to see pharmacist who is authorised to supply as per the
HeliclearTM or the H. pylori eradication therapy PGD.

Go through the exclusion criteria. If the patient is not allergic to
penicillin use the HeliclearTM PGD. If HeliclearTM is out of stock use the
H. pylori eradication therapy PGD and supply the individual drug
components i.e. amoxicillin, lansoprazole, and clarithromycin. If the
patient is allergic to penicillin supply metronidazole, lansoprazole,
clarithromycin.

Check cautions

Check contra-indications

If after checking interactions, cautions and exclusions the pharmacist
has any concerns as to the suitability of eradication therapy, the GP
should be consulted and informed of any potential consequences. If
necessary then therapy should be withheld until such a time, as the
pharmacist is satisfied as to the safety of supplying the drugs.

Label the drugs to be supplied.

Check if the patient normally pays NHS prescription charges, complete
exemption form if patient exempt from charges.

Supply to the patient, giving a Patient Information Leaflet and any
relevant counselling and advice.

The summary form should be completed.
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Appendix 7: Patient Information Leaflet for eradication therapy
Your Helicobacter Pylori Treatment
Patient Information
What treatment will I need for H Pylori?
For effective treatment you will need to take a combination of medicines, two
antibiotics and a medicine to reduce the acid in your stomach, all at the same time.
How long will I have to take this combination?
You will need to take this combination of medicines for one week.
What should I expect after I have finished my course of treatment?
After taking your course of medicines you may suffer from further symptoms similar
to those you had before treatment.
How long will this last?
Usually these symptoms will settle on their own within a few weeks.
What if I don’t get any better?
If the symptoms have not settled down after a month then please return to your GP.
Please consult you pharmacist or GP if you have any concerns about this.
Medicines Management Team
North Sheffield PCT
Firth Park Clinic
Tel: 0114 2716338
Review date: Dec 2007
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Appendix 8. Form HP4
Communication Form: Helicobacter pylori result
Patient name:………………………………………….
Patient Address:……………………………………….
…………………………………………
…………………………………………
NHS number……………………………………………
Referring GP:…………………………………………..
GP address:…………………………………………….
………………………………………………
………………………………………………
Date of test:………………………………..
I confirm that the above patient presented for a helicobacter pylori
breath test and the result was:
Positive
Negative
Therefore the patient was given:
Eradication therapy under a PGD
Advice*
* Patient (Hp negative only) given diet and lifestyle advice plus over the
counter medication where appropriate. Advised to see GP if dyspepsia
symptoms persist. Patient should be managed as per NICE guidelines.
Any other comments:
……………………………………………………………………………………
……………………………………………………………………………………
Please add to the patient’s medical records and read code accordingly:
4JM1 Helicobacter pylori GI tract infection.
8BAC Helicobacter eradication therapy.
4JM0 Helicobacter pylori negative
Name of Pharmacist:
Date:
Signature of Pharmacist:
Pharmacy Stamp:
22
Appendix 9: H Pylori ‘Test and Treat’ Patient Record
23
Patients Name:
Contact Number:
GP/ Surgery:
Yes No
Comments
GP referral form (HP1) complete
Patient given pre-test PIL (Appendix 2)
Appointment made
Date:
Test undertaken (Appendix 3)
Date:
Test procedure form (HP2) completed
Record test identification code:
Commence summary form (HP3)
Counselling given (test,result.implications)
Test kit completed (Form, box sealed &
addressed)
Test kit posted
Date:
Result received
Date:
Test result
+ve -ve
Patient informed of result
Date:
Positive result: Appointment made
Date
Treatment prescribed
Counselling given
Treatment PIL given (A7)
Negative result: Counselling given
Summary form ( HP3) completed
GP Informed (HP4)
Notes:
24
Test Reference Number……….
Adapted from J Stephen Hawkins Ltd
25
Appendix 10: Declaration of Prescription Exemption
To be completed by the patient
The patient doesn’t have to pay because he/she:
A
B
C
D
E
F
G
L
H
K
M
×
×
×
×
×
×
×
×
×
×
×
N
×
is under 16 years of age
is 16, 17 or 18 and in full-time education
is 60 years of age or over
has a maternity exemption certificate
has a medical exemption certificate
has a prescription prepayment certificate
has a war pension exemption certificate
is named on a current HC2 charges certificate
gets income support
gets income-based jobseekers allowance
is named on a working families Tax Credit NHS exemption
certificate
is named on a disabled persons Tax Credit NHS exemption
certificate
I am the patient 
I am the patient’s representative 
To the Patient - Please complete the declaration below:1. I am exempt from charges for the reason specified above. I understand that this is an NHS service
and that the NHS will retain data relating to my use of the service and may contact me for my views.
Signed (Patient)…………………………………….Date……………………………………………….
Evidence of Exemption Seen:
YES

NO

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Contacts:
For further forms and general enquiries contact:
Susan Rutherford in the Medicines Management team: (0114) 2716338
(Please note: Forms HP1, 2,3,4 and patient information leaflets will be
supplied by the PCT)
For clinical governance issues contact:
Michelle Black or Paul Schatzberger
(0114) 2716275
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