Locally commissioned Enhanced Service – Helicobacter pylori testing provided by accredited community pharmacists

  1. Background
  • NICE’s clinical guidelines on managing dyspepsia in adults in primary care recommend when to test for Helicobacter pylori (H. pylori)1.
  • Three types of non-invasive test for H. pylori are available in the UK. 13C-urea breath tests and stool antigen tests are generally more accurate than serological tests and they can be used both pre- and post-treatment2. 13C-urea breath tests may be more acceptable to the patient than stool antigen tests.
  • Drug and Therapeutics Bulletin concluded that on the basis of convenience and cost, diabact UBT appeared to be the 13C-urea breath testing kit of choice2.
  • The diabact UBT test is fairly simple to use but the manufacturer recommends that it should be performed in the presence of a qualified person.
  • Community pharmacists will be trained to use diabact UBT before being accredited to provide this service in Hammersmith and Fulham.

2. Aims

  • To provide a high quality H. pylori testing service that is convenient for patients and GPs and provides good value for money.
  • To avoid unnecessary hospital appointments.

3. Process

  • Only diabact UBT will be used. Other marketed 13C-urea breath tests take longer to perform.
  • Community pharmacists who would like to provide the service will be trained to use diabact UBT, probably by trainers who have been trained by the kits’ manufacturer.
  • GPs will be encouraged to order H. pylori testing only in line with NICE’s guideline.
  • If the GP decides that a 13C-urea breath test is indicated and that there is no reason not to test (e.g. ulcer treatments should not be used in the previous 2 weeks and the patient is over 18 years) they should explain the test to the patient and give him or her a prescription for diabact UBT, an instruction leaflet and a list of pharmacies providing the service.
  • The patient will be asked to contact one of the listed pharmacies to arrange an appointment for the test. The pharmacist will check the following before an appointment is offered:

-that the patient has not taken an antibiotic in the previous 4 weeks or a peptic ulcer treatment in the previous 2 weeks.

-the patient has a prescription for diabact UBT

-The pharmacist has a diabact UBT kit or can obtain one in time (Pharmacists should endeavour to keep one diabact UBT in stock at all time).

  • The appointment must be within 2 working days of the patient requesting an appointment, unless he or she requests a later appointment.
  • When an appointment is offered the patient must be told to fast (no food or drinks apart from water, tea or coffee) for at least 6 hours before the test.
  • When the patient attends he or she will be asked to sign the consent form, diabact UBT will be dispensed and the test will be performed under the supervision of the accredited pharmacist.
  • The Breath Test Report Form will be completed by the pharmacist (specifying that the test result must be sent direct to the prescriber), packed with the sample tubes and posted to the laboratory.
  • The pharmacist will record the test on the PCT’s H. pylori test payment form and send this to the PCT monthly. He or she will retain the consent form for 3 years.
  • The test result will be sent directly to the GP, generally arriving 3-4 days after the test.
  • One page notes on how to use the service will be available for GPs and patients, and a one page aide memoire for participating pharmacists.

4. Audit reporting

  • The test is qualitative not quantitative. If a test fails because there is insufficient expired breath in the sample tubes this will be reported to the GP who will be asked to communicate this to the administrator of the scheme at the PCT. >3 failed tests from a single pharmacy will indicate the need for investigation and corrective action.
  • Feedback on the service will be sought from patients who use it.
  • The number of payments claimed by each participating pharmacy will be monitored. If fraudulent payment claims are suspected appropriate investigations will be instigated.

5. Payment structure

  • diabact UBT prescriptions will be sent by the community pharmacist to the Prescription Pricing Authority for reimbursement.
  • £15 will be paid by the PCT to the pharmacy for each test supervised by the accredited pharmacist. Forms will be submitted by the 5th of each month and payment will be processed by the PCT’s Primary Care Administrators.

6. Monitoring

  • The accredited pharmacist must sign and return the agreement to provide the service.
  • The pharmacist must ensure that patient consent forms are retained for 3 years. These forms, together with records of prescriptions, will enable the PCT to verify that the service provided reconciles with payment claims made should the need arise.

7. Contact point

Someone from the PCT Pharmacy Team – currently Helen Scholes (tel: 020 8846 6587 & email:

  1. References
  1. National Institute for Clinical Excellence. Dyspepsia – management of dyspepsia in adults in primary care. Clinical Guideline 17. August 2004.
  2. Anon. Which test for Helicobacter pylori in primary care? Drug and Therapeutics Bulletin 2004 (September); 42: 71-2.

Chris Corfield

10.2.05

Hammersmith and Fulham PCT

Application to provide a Helicobacter pylori testing service from a community pharmacy

Pharmacy…………………………………………………………………………

This pharmacy has a consultation area where the diabact UBT test can be performed and the patient and pharmacist can talk at normal speaking volumes without being overheard by staff or customers.

Yes / No

I wish to provide this service. I will:

  • Attend a training session on diabact UBT and the service.
  • Provide the service by appointment.
  • Use only diabact UBT when providing the service.
  • Make the necessary checks before offering a patient an appointment for the test.
  • Perform the test within 2 working day of the patient asking for an appointment, unless the patient requests a later appointment.
  • Post the sample tubes and Breath Test Report form to the laboratory within 24 hours of the test, specifying the GP’s name and address in the customer details section of the diabact UBT Patient Details form to ensure that the result is sent directly to the GP who prescribed the test.
  • Record each test on the PCT’s H. pylori test payment form and return this to the PCT by 5th of each month.
  • Retain patients’ consent forms for 3 years.
  • Participate in audits of the service if requested to do so.

Pharmacist’s signature…………………………………………………………………

Name (BLOCK CAPITALS)…………………………………………………….

Date……………………………………………………………………………….

Pharmacy stamp

Please return to: Helen Scholes

Hammersmith and Fulham PCT, 5-7 Parsons Green, London SW6 4UL

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