Problem: Overprescribing of Proton Pump Inhibitors (PPI) for the treatment of gastro-oesophageal reflux disease (GORD)
GORD is a term used to describe the pain and discomfort caused by contents of the stomach, leaking up into the oesophagus. A dysfunctional lower oesophageal sphincter is the physiological cause of the condition (Moayyedi & Talley, 2006). It is more likely to occur in people who are obese, smoke, drink alcohol or coffee regularly, and take certain medications (Moayyedi et al., 2006). GORD can lead to the development of extra-oesophageal symptoms and related conditions. These include oesophageal ulcers and strictures, non-cardiac chest pain and oral diseases (Moayyedi et al., 2006). If symptoms of GORD are experienced two or more times per week, then patients are deemed to have severe GORD, which can impact quality of life (Dibley, Norton, & Jones, 2010. The problem then requires pharmacological management (Moayyedi et al., 2006).
According to a systematic review produced by Ksiadzyna, Szelag, & Paradowski, (2015), first line treatment of the GORD involves the use of PPI’s for symptomatic control, in conjunction with dietary and lifestyle modification (Moayyedi et al., 2006). PPI’s hold a clear advantage over H2-receptor antagonists, in that they suppress parietal cell hydrogen pumps in the stomach directly, resulting in longer lasting acid suppression according to Savarino, Dulbecco, de Bortoli, Ottonello, & Savarino (2017). This leads to increased gastric pH levels from pH 1 to 4 (Scarpignato, Gatta, Zullo, & Blandizzi, 2016), an overall reduction in gastric acid production (Moayyedi et al., 2006), and a greater effect in healing oesophageal erosions according to Savarino et al., (2017) and Scarpignato et al., (2016). PPI’s however, are only indicated for long-term maintenance in select conditions. Despite this, many patients use PPI’s inappropriately, often without an evidence-based indication.
Medication usage to treat health conditions is increasing annually. The use of medications should follow evidence-based indications and be in line with therapeutic guidelines. Despite this, GP’s have been known to use medications to treat conditions outside of the recommended indications, and treat patients with doses higher than guidelines suggest. This concept is known as overprescribing. One such potential trend of overprescribing that has appeared in recent years is the inappropriate use of PPI’s to treat adults with GORD. This literature review will focus on the themes of overprescribing, and their long-term implications. This shall be explored through documenting the reasons for potential over-prescribing, the incidence of overprescribing and the potential long-term side effects of PPI’s.
Inappropriate use of PPI’s to treat GORD is an overprescribing issue that is currently appearing within health literature today. The results of a study conducted in a hospital by Akram, Huang, Lim, Huggan, & Merchant (2014), left the authors to contend that PPI overuse could be attributed to the fact that it is commonly regarded as a ‘safe’ medication. A systematic review by Scarpignato et al., (2016) found that healthcare providers were prescribing PPI’s for prolonged periods; in some cases lifelong. A different systematic review produced by Ksiadzyna et al., (2015) meanwhile, attributed a higher prevalence of GORD as a potential reason for increased PPI prescribing rates. Shifting the focus away from GP’s, in the aforementioned hospital study conducted by Akram et al., (2014), it was found that 81% of patients were using PPI’s without a documented indication. The most common reasons were the use of low dose Aspirin in low risk patients, and patients having no history of GI problems. Others included taking antiplatelet, anticoagulant, or corticosteroids alone, without concomitant use of NSAID’s, or the presence of a current or prior peptic ulcer. These results are supported by the work of Savarino et al., (2017) and Scarpignato et al., (2016) who also found the above to be the common causes of over-prescribing. Adding to this, Ksiadzyna et al., (2015) also found that the efficacy of PPI’s in relieving extra-oesophageal symptoms is uncertain. Evidently, the literature suggests there are a number of reasons for potential PPI overprescribing; however further research is required to quantify the incidence of the problem.
Following on, although figures differed study-to-study (Molloy, Molloy, O’Loughlin, Falconer, & Hennessy, 2010) (Ksiadzyna et al., 2015) (Akram et al., 2014) (Batuwitage, Kingham, Morgan, & Bartlett, 2007) (Ahrens, Chenot, Behrens, Grimmsmann, & Kochen, 2010), it was found that PPIs were inappropriately prescribed and used without an evidence based indication in 50-80% of patients. A number of hospital and primary care, cross-sectional retrospective and observational studies have been conducted to investigate the appropriateness of PPI prescribing. These studies (Hamzat, Sun, Ford, MacLeod, Soiza, Mangoni, 2012) (Ahrens et al., 2010) (Ahrens, Behrens, Himmel, Kochen, & Chenot, 2012) all involved reviewing discharge medications and discharge letters. Their results similarly found that around 50% of patients were prescribed PPI’s without an evidence-based indication. This most commonly occurred in patients who had no symptoms of GORD, no history of upper GI symptoms, and for peptic ulcer (PU) prophylaxis in low risk patients taking low dose Aspirin. Work by McDonald, Jones, Green, Jayaraman, & Lee, (2015), aimed to reduce inappropriate discharge prescriptions for PPI’s. Researchers educated prescribers on the benefits and harms of PPI’s, and encouraged them to review admission and discharge prescriptions. Whilst again around 50% of patients were found to be using PPI’s inappropriately, there was a jump post intervention, 7.7% to 18.5%, in the percentage of patients whose inappropriate pre-admission prescriptions were ceased. Ahrens et al., (2012) meanwhile found that the majority of these prescribing errors occurred within hospital and they were continued by GP’s post discharge. It is the continuation of unnecessary medications, due to overprescribing, that leaves the patient at risk of needless adverse effects, which wouldn’t otherwise occur.
Any medication has the potential to cause long-term adverse effects. Whilst it has been noted that PPI’s have an excellent safety profile in the short term and are well tolerated (Ksiadzyna et al., 2015) (Scarpignato et al., 2016), recent research has been focused on detailing their relatively unknown long-term safety profile. A systematic review focusing on the overutilization of PPI’s (Heidelbaugh, Kim, Chang, & Walker, 2012), found significant evidence to support links between PPI’s and C. difficule infection. Small increases in the risk of community-acquired pneumonia (CAP) were also documented, as well as a potential increased risk of bone fracture; evidence that was supported by Savarino et al. (2017). Interactions with PPI’s and Clopidogrel, leading to a reduction in its anti-thrombotic effects were noted. Nutritional deficiencies for Vit B12 is an issue that occurred in malnourished elderly patients taking PPI’s only. Evidence for interactions with Clopidogrel, and the risks of C. difficule infection was reinforced by the work of Scarpignato et al., (2016), (Ksiadzyna et al., 2015) and (Molloy et al., 2010). Scarpignato et al., (2016) however were of the position that further higher quality research was required to strengthen the link between PPI’s and CAP. PPI’s also weren’t believed to accelerate BMD loss and promote osteoporosis in the long term. Scarpignato et al., (2016) and Heidelbaugh et al., (2012) also introduced concerns relating to rebound acid hypersecretion upon cessation of PPI’s, which correlated with the treatment length. An increased risk of stomach carcinoma was found in animal studies caused by PPI related hypergastrinemia. However, Scarpignato et al., (2016) identified a lack of current evidence in human populations to support this. Despite these potential long-term effects, the benefits of treatment with PPI’s outweigh the potential risks.
Upon reviewing the literature, it becomes clear that there is an increased need for intervention by health physicians in reviewing patient’s medications. As documented in the literature, a large proportion of PPI’s are often overprescribed. This consequently adds unnecessarily to a patient’s medication regimen. Such unnecessary addition can compound or create issues surrounding polypharmacy, as well as increasing the risk of adverse events, adding to the cost of public health. Many papers allude to the need for PPI’s to be prescribed according to evidence-based indications. They also highlight the need for re-evaluation of the appropriateness of all PPI’s. Pharmacists are prime candidates to fulfil these recommendations, as they are medication experts who have the potential to make valuable interventions. The potential inclusion of pharmacists into the discharge process in hospitals can help correct over-prescribing through medication review. The effects of their inclusion can be evaluated by further research.
The aim of the study will be to determine if integrating a pharmacist into the discharge process will reduce the over-prescribing of inappropriate PPI’s to treat adults with GORD in a general medicine ward.
In order to achieve this I will:
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