Proton pump inhibitors (PPIs) are indicated for the prevention and treatment of symptoms related to gastric acid secretion.
There are currently three fully subsidised PPIs available in New Zealand: omeprazole, pantoprazole and lansoprazole. PPIs
are highly effective and well tolerated, contributing to their widespread use; in 2018, omeprazole was the third most
commonly dispensed medicine in the community in New Zealand. However, PPI treatment is associated with a small increase
in the risk of adverse outcomes including acute interstitial nephritis, bone fractures, gastrointestinal and respiratory
infections and nutrient deficiencies. PPIs may also interact with other medicines by altering their absorption or hepatic
metabolism and clearance. To prevent unnecessary exposure to these risks, PPIs should only be prescribed to people with
a specific clinical indication for treatment, and at the lowest effective dose for the shortest period of time.
Gastro-oesophageal reflux disease (GORD) is one of the most common indications for the use of PPIs with 15–20% of all
adults experiencing heartburn, the cardinal symptom of GORD, at least once a week. Patients with uncomplicated GORD can
generally be managed in a primary care setting by treating with a PPI for four to eight weeks, e.g. omeprazole 20 mg,
once daily. PPIs are also frequently prescribed prophylactically to prevent gastrointestinal (GI) adverse events, e.g.
ulceration and bleeding, associated with the long-term use of non-steroidal anti-inflammatory drugs (NSAIDs).
Because PPI use is very prevalent, each practice is likely to have a number of patients who are being treated with a
higher dose than is necessary or for longer than is recommended. These patients may benefit from reducing their PPI dose,
using “as needed” or stopping the medicine completely. Abrupt withdrawal of a PPI can cause rebound gastric acid secretion,
leading to symptoms which may be confused for the re-emergence of GORD and consequently the re-initiation of the PPI.
This rebound acid secretion can be managed by stepping down the dose over two to four weeks, e.g. halving the daily dose,
then taking the medicine on alternate days before discontinuing the PPI completely. Some patients may require another
medicine to manage their rebound symptoms, e.g. a histamine H2-receptor antagonist, antacid or antacid in combination
with an alginate.
Patients who are trialling stepping down to a lower dose or stopping PPI treatment should be reminded about lifestyle
strategies to help manage the symptoms of GORD. For example, weight loss, smoking cessation, eating smaller meals, avoiding
alcohol, coffee and spicy or acidic foods may help to reduce symptoms such as heartburn, indigestion and regurgitation.
Recommend that patients avoid eating three to four hours before lying down and to slightly elevate the head of the bed
if necessary.
There will be some patients taking PPIs long-term for whom withdrawal of the PPI is inappropriate, e.g. patients with
Barrett’s oesophagus. In other patients, e.g. with a history of severe erosive oesophagitis, withdrawal of PPIs should
only be considered after discussion with an appropriate specialist. Clinicians should ensure that a PPI prescribed prophylactically
is discontinued once NSAID treatment is stopped.
For further information on GORD, see: www.bpac.org.nz/bpj/2014/june/gord.aspx
For further information on stopping PPIs, see: “Stopping proton pump inhibitors in older people”, see:
www.bpac.org.nz/2019/ppi.aspx
Summary
This audit identifies patients who are currently taking omeprazole to assess whether their indication for treatment remains and if they are taking the lowest
effective dose. If “stepping down” is appropriate and has not yet been trialled, this can be flagged in the patient’s clinical record for discussion at their next appointment.
N.B. This audit focuses on omeprazole as it is the most commonly prescribed PPI, but could be applied to pantoprazole or lansoprazole.
Recommended audit standards
Ideally, all patients who have been taking a PPI for longer than three months* should have documented evidence in their patient record of an indication
for ongoing treatment or evidence of a discussion about stepping down to a lower dose or stopping completely. Any patients that do not have the
recommended information in their clinical notes should be flagged for review.
* Four to eight weeks is the recommended duration of PPI treatment for GORD, however, three months has
been selected pragmatically for this audit to allow sufficient time for patients that are continuing PPI treatment for longer than eight weeks to have had a review.
Identifying eligible patients
All patients within the practice who have been taking omeprazole for longer than three months are eligible for this audit.
You will need to have a system in place that allows you to identify eligible patients. Many practices will be able to identify patients by running a ‘query’
through their PMS. Identify all patients who have received a prescription for omeprazole in the last 12 months and then select those who have been taking it
for longer than three months.
Sample size
The number of eligible patients will vary according to your practice demographic. A sample size of 30 patients is sufficient for this audit.
Criteria for a positive outcome
For a positive result for the audit, the patient’s clinical notes should contain one of the following:
- A record of a current indication for ongoing PPI treatment, e.g. symptoms of GORD have not resolved, erosive oesophagitis,
Barrett’s oesophagus, continued use of an NSAID
- A record of a discussion with the patient about “stepping down” to a lower dose or stopping the PPI completely
and evidence that this process is in place, e.g. a plan for the patient to reduce their dose over a two-week period
and then to stop or use as needed for symptom control
Data analysis
Use the data sheet provided to record your data. A positive result is any patient who has evidence in their notes of a current indication for continued PPI
use or evidence that reducing or stopping the PPI has been discussed. The percentage achievement can be calculated by dividing the number of patients with a
positive result by the total number of patients audited.
The first step to improving medical practice is to identify the criteria where gaps exist between
expected and actual performance and then to decide how to change practice.
Once a set of priorities for change have been decided on, an action plan should be developed to implement any changes.
Taking action
It may be useful to consider the following points when developing a plan for action (RNZCGP 2002).
Problem solving process
- What is the problem or underlying problem(s)?
- Change it to an aim
- What are the solutions or options?
- What are the barriers?
- How can you overcome them?
Overcoming barriers to promote change
- Identifying barriers can provide a basis for change
- What is achievable – find out what the external pressures on the practice are and discuss ways of dealing with
them in the practice setting
- Identify the barriers
- Develop a priority list
- Choose one or two achievable goals
Effective interventions
- No single strategy or intervention is more effective than another, and sometimes a variety of methods are needed
to bring about lasting change
- Interventions should be directed at existing barriers or problems, knowledge, skills and attitudes, as well as
performance and behaviour
Monitoring change and progress
It is important to review the action plan developed previously at regular intervals. It may be
helpful to review the following questions:
- Is the process working?
- Are the goals for improvement being achieved?
- Are the goals still appropriate?
- Do you need to develop new tools to achieve the goals you have set?
Following the completion of the first cycle, it is recommended that the doctor completes the first part of the
Audit
of Medical Practice summary sheet (Appendix 1).
Undertaking a second cycle
In addition to regular reviews of progress with the practice team, a second audit cycle should be completed in order
to quantify progress on closing the gaps in performance.
It is recommended that the second cycle be completed within 12 months of completing the first cycle. The second cycle
should begin at the data collection stage. Following the completion of the second cycle it is recommended that practices
complete the remainder of the Audit
of Medical Practice summary sheet.
Claiming credits for Te Whanake CPD programme requirements
Practice or clinical audits are useful tools for improving clinical practice and credits can be claimed towards the Patient Outcomes (Improving Patient Care and Health Outcomes) learning category of the Te Whanake CPD programme, on a credit per learning hour basis. A minimum of 12 credits is required in the Patient Outcomes category over a triennium (three years).
Any data driven activity that assesses the outcomes and quality of general practice work can be used to gain credits in the Patient Outcomes learning category. Under the refreshed Te Whanake CPD programme, audits are not compulsory and the RNZCGP also no longer requires that clinical audits are approved prior to use. The college recommends the PDSA format for developing and checking the relevance of a clinical audit.
To claim points go to the RNZCGP website: www.rnzcgp.org.nz
If a clinical audit is completed as part of Te Whanake requirements, the RNZCGP continues to encourage that evidence of participation in the audit be attached to your recorded activity. Evidence can include:
- A summary of the data collected
- An Audit of Medical Practice (CQI) Activity summary sheet (Appendix 1 in this audit or available on the
RNZCGP website).
N.B. Audits can also be completed by other health professionals working in primary care (particularly prescribers), if relevant. Check with your accrediting authority as to documentation requirements.
