Pharmacists play an important role in reviewing the symptoms of gastro-oesophageal reflux disease, assisting in managing the condition and identifying patients who may benefit from stepping down their PPI therapy, writes Leanne Philpott
Gastro-oesophageal reflux disease (GORD) is a common gastrointestinal condition. It’s believed that 15-20% of adults experience the symptoms of GORD at least once a week.
Typical symptoms of GORD include heartburn and regurgitation but atypical symptoms can also present. According to the Gastroenterological Society of Australia (GESA), atypical symptoms include ‘angina-like chest pain, throat or voice changes, cough, asthma, excessive belching, dyspepsia and nausea.
Red flags (alarm) symptoms that might indicate further investigation and referral include:
- Weight loss
- Recurrent vomitting
- Dysphagia or odynophagia
- Abdominal pain
- Evidence of gastrointestinal blood loss. For example, haematemesis, iron deficiency or anaemia
- Epigastric mass
- Aged over 50 years
Risk factors for GORD include:
- Excessive alcohol consumption
- Family history of heartburn
- Medical conditions such as scleroderma, asthma, cystic fibrosis
“The role of the pharmacist is obviously to firstly always be involved in any query relating to gastrointestinal symptom request. We have the appropriate skills to cross check a patient’s self-diagnosis and to identify the need for referral,” says pharmacy educator and mentor Rachel Dienaar (BPharm, MPS).
Where patients are identified as having intermittent reflux symptoms, lifestyle and dietary changes can be discussed along with the use of antacids, alginates or low-dose histamine-2 receptor antagonists.
“Antacids, often combined with alginates, neutralise gastric acid by increasing gastric pH. They have a rapid onset and short duration of action and are suitable for mild intermittent or occasional breakthrough symptoms,” says Dienaar.
“H2-receptor-antagonists on the other hand work by reducing the amount of acid produced by the stomach. While both H2-receptor-antagonists and antacids provide rapid relief of symptoms in patients with acid reflux, antacids are ineffective in managing symptoms in the long term.”
She adds that when identifying GORD, symptom regularity is a key factor. Patients who experience frequent symptoms of heartburn (two or more episodes per week) or symptoms severe enough to impair quality of life are considered to have gastro-oesophageal reflux disease.
“If GORD is suspected a trial of Proton Pump Inhibitors (PPIs) for two weeks may be considered as the mainstay of treatment, to suppress gastric acid production—unless referral is indicated.
“Existing medical conditions and current medication interactions should of course be considered, as these may predispose the patient to reflux events or aggravate existing GORD symptoms,” says Dienaar.
Medicines that relax the lower oesophageal sphincter include:
- Anticholinergics (e.g. tricyclic antidepressants, antipsychotics, oxybutynin, sedating antihistamines)
- Calcium channel blockers
- Phosphodiesterase inhibitors
- Beta blockers
- Alpha blockers
Medicines that increase gastrointestinal transit time include:
- Oral corticosteroids
Medicines that may cause or exacerbate oesophagitis include:
- NSAIDs (including aspirin)
Proton pump inhibitors (PPIs) are highly effective and have been the mainstay of GORD treatment for years, so why the push to get people off PPIs?
Evidence indicates that the benefits and perceived safety of PPIs in the management of GORD means they are often used for long periods of time without ongoing review and therefore may lack clear indication for their continuation.
According to The Third Australian Atlas of Healthcare Variation, it is estimated that 22% to 63% of PPIs are inappropriately prescribed in Australia. Additionally, in 2015–16, an estimated 12% of the Australian population were taking a PPI medicine or had in the past year.
While PPIs are in the main well tolerated, concern centres on a number of potential risks associated with their long-term use. Identified risks include Clostridium difficile infection, vitamin B12 and magnesium deficiencies, community-acquired pneumonia (CAP), bone fractures and kidney disease.
However, most studies into the risks of long-term PPI use appear to be observational and not large enough to be clinically relevant.
Peter Haastrup et al, in the paper ‘Side Effects of Long‐Term Proton Pump Inhibitor Use: A Review’, state, “For most of the suggested side effects, the concern has been raised based on associations between the suspected side effect and long‐term use of PPIs demonstrated in observational studies. Observational studies of side effects related to drug use have the advantage that they are based on ‘real world’ observations. This means that the effects (and side effects) of a drug can be studied in the population that actually is the target of the drug and not in a selected group of test subjects.
“One of the major challenges when studying side effects in observational studies is that they cannot prove causality between drug use and suspected side effect, merely association.”
Professor Peter Bytzer, gastroenterologist and head of the Department of Clinical Medicine at the University of Copenhagen in Denmark, has written many articles on this subject.
He says, “As long as PPIs have been around (for the last 25 years) the number of people using them and the amount of drug has increased year on year.
“In most European countries approximately 10% of the adult population use a PPI within a given year. We are still wondering why prescribing has increased, as during those years the number of peptic ulcers has decreased dramatically but at the same time the number of patients with GORD has increased.
“Apparently, the increase in use is mainly described by patients who are chronic PPI users. This may be because many doctors view PPIs as very safe drugs, so they prescribe them for many indications. They also want to protect people, particularly the elderly, from developing peptic ulcer disease.
“However, it is fair to say that PPIs are pretty safe but we should always consider if a drug is necessary. In patients who are chronic PPI users and are symptom free it’s reasonable to consider, in discussion with the patient, whether the drug should be continued or not. After all, why put chemicals in your mouth if it’s not necessary?”
PPIs and the role of the pharmacist
In the article ‘The role of the pharmacist in the selection and use of over-the-counter proton-pump inhibitors’ (published in the International Journal of Clinical Pharmacy, 2015), authors Broadman and Heeley say, “The safety and tolerability of proton-pump inhibitors have been well established in clinical trial and post-marketing settings, and use of a short regimen is associated with a very low likelihood of missing a more serious condition.
“Pharmacists can assist patients with accurate self-diagnosis by asking short, simple questions to characterize the nature, severity, and frequency of symptoms. Additionally, pharmacists can inquire about alarm symptoms that should prompt referral to a physician.”
Patient counselling will help ensure PPIs are used for appropriate indications and at the lowest effective dose for the shortest duration, in accordance with the guidelines.
Key information pharmacists can educate patients on include:
- PPIs are indicated for short-term use (14-28 days)
- PPIs are administered once daily
- They should be taken 30-60 minutes before food (ideally breakfast) for optimal effect
- Ideally they should be taken at the same time each day
- Unlike antacids, PPIs are not to be taken symptomatically
- Lifestyle modifications, particularly weight loss and avoiding known triggers, can help reduce symptoms of GORD
- Long-term use of PPIs can contribute to polypharmacy, adverse reactions and drug interactions
- Once symptoms are controlled, PPI therapy should be creased or reduced to the lowest dose possible
- Following initial PPI treatment, if symptoms remain referral is required
Dienaar advises, “To help identify whether the ongoing use of PPIs is necessary pharmacists can ask the patient if they are taking the medication daily. If the answer is no, then we can suggest they step down to the lowest strength or even a H2 antagonist might be appropriate.
“If the answer is ‘yes’, we should ask if the patient has tried to stop taking PPIs before. If the response is yes and they have experienced a flare up then appropriate counselling around alternative therapy, such as a H2 antagonist or antacid when trialling cessation should be discussed. The mechanism for this flare should also be clearly explained.
“If the response is ‘no’, then we can explain potential issues, recent guidelines and suggest discussion with their doctor (if they prescribed the PPIs) around stepping down or trialling cessation. Ceasing PPIs should of course take into consideration the diagnosis and need for ongoing treatment.”
According to NPS Medicinewise, patients can step down PPI medicines by:
- taking the standard dose less often (for example, alternate-day dosing)
- reducing their PPI dose to a low dose
- or only taking PPIs ‘on demand’ when they experience symptoms.
Dienaar explains that one of the barriers that might prevent a patient from wanting to step down their PPI therapy is flare-up of symptoms. “A flare-up of symptoms can occur in the first 2-3 days of cessation and can be interpreted by the patient as a need for ongoing use of the PPI, when this may not be the case.”
Another barrier to stopping PPI therapy is patient preference. Given the effectiveness of PPIs, many people are not optimistic about ceasing therapy. In this case pharmacists are well positioned to discuss changes in lifestyle that may help reduce GORD symptoms.
Dienaar says, “At every dispensing of medication pharmacists should be involved in discussion around the efficacy of medications, adverse effects and supporting lifestyle information to prevent symptoms and assist in the control of GORD.
“Medication should never be a replacement for lifestyle modification and intervention. Lifestyle and preventative advice should always be offered. Pharmacists involvement in the primary health care consultation is the most important aspect of the job, otherwise a pharmacist’s knowledge and skills to assist the consumer are wasted and will not result in improved health outcomes.”
Self-care advice that may help to reduce or prevent GORD includes:
- Maintaining a healthy weight and losing weight if overweight
- Quitting smoking
- Avoiding foods that aggravate reflux symptoms (e.g. citrus, chocolate, tomato based products, spicy foods, high fat content foods) without overly restricting diet
- Limiting intake of alcohol and other beverages with a low pH (e.g. carbonated drinks)
- Eating smaller meals more frequently, rather than large meals less often
- Avoiding large meals, especially close to bedtime
- Avoiding lying down or vigorously exercising shortly after meals
- Raising the bed‑head or using a wedge pillow if nocturnal or laryngeal symptoms are troublesome
- Exercising regularly
Of the non-pharmacological approaches to the management of GORD, weight loss has been identified as having the strongest evidence for efficacy.
A reduction in the body mass index of 3.5 kg/m2 can result in nearly a 40% reduction in the risk of having frequent symptoms.
Dienaar says, “There are many professional services that pharmacy can offer to support the prevention and treatment of GORD. For example, weight loss, MedsCheck, smoking cessation and healthy eating programs.
“To help prevent the over-reliance on PPIs, pharmacies can initiate a range of health promotion activities within the pharmacy to raise awareness of how consumers can help prevent and treat GORD through lifestyle change.
“While through effective collaboration and communication with GPs, pharmacists can support the uptake of referrals and facilitate review of treatment recommendations.”
Keung, C and Hebbard, G, the management of gastro-oesophageal reflux disease. Australian Prescriber, 2016
Australian Atlas of Healthcare Variation Series, Atlas, 2018, Section 2.3: Proton pump inhibitor medicines dispensing, 18 years and over.
Haastrup, P et al, Side Effects of Long-term Proton Pump Inhibitor Use: A Review. Basic & Clinical Pharmacology & Toxicology, April 2018.
Broadman, H and Heeley, G, The role of the pharmacist in the selection and use of over-the-counter proton-pump inhibitors. International Journal of Clinical Pharmacy, 2015.
NPS Medicinewise: Stepping the appropriate path with GORD medicines, June 2018.