Background
Proton pump inhibitors (PPI) are indicated in the treatment of acid related dyspepsia and peptic ulcers and are one of the most frequently prescribed classes of drugs in the world [
1]. PPIs ranked as the sixth most frequently dispensed therapeutic class in the US and third in Ireland in 2009 [
2,
3]. The high volume of PPI prescribing may reflect the superior efficacy of PPIs and the relative lack of adverse drug effects and interactions compared to other acid inhibiting agents. However PPIs cost more than other acid inhibiting agents and the volume of prescribing has had a substantial impact on prescribing budgets worldwide [
4,
5]. Expenditure on PPIs was €595 million in England in 2006 and €4.5 billion on one PPI (Esomeprazole-Nexium®) in the US in 2009 [
6,
7]. In Ireland total expenditure on PPIs has increased from approximately €7 million in 1995 to €95 million in 2009. PPIs are one of the most expensive drug groups reimbursed in Ireland accounting for approximately 10% of overall drug expenditure [
3].
Prescribing guidelines have been developed in several countries to reduce PPI expenditure and ensure appropriate use. The National Institute of Clinical Excellence (NICE) guidelines on the appropriate use of PPIs in the treatment of dyspepsia recommends regular review of patients to assess the continuing need for PPIs and stepping down to a lower maintenance dose or alternative medication to control symptoms. The guidelines also recommend prescribing the least expensive PPI [
8,
9]. Studies to date have indicated that guidelines are not being followed with evidence of overprescribing of PPIs in both primary and secondary care. A UK study, found that 24% of patients admitted to hospital were prescribed a PPI in the community and of these only 54% had an appropriate indication for PPI treatment [
10]. Studies in secondary care in the US, Australia, New Zealand, Italy, UK and Ireland found 65%, 63%, 40%, 68%, 51% and 33% of hospital inpatients did not have appropriate indication for PPI therapy, respectively [
11‐
16]. In Ireland and Italy, 71% and 66% of PPI prescribing was initiated in hospital [
14,
16]. In the UK, 54% of PPI prescribing was initiated in hospital and 51% of initiated prescribing was without an appropriate indication [
15].
The superior efficacy and safety of PPIs are often used as justification for their use over other acid-suppressing agents but side-effects, though rare, need to be considered. Long term PPI use has been associated with an increase in community and hospital acquired pneumonia, clostridium difficile colitis and fractures [
17‐
21]. Given these associations, limiting PPI use to short term treatment and taking the minimum amount required may be considered prudent in view of clinical uncertainty over long term acid suppression.
Economic modelling has assessed whether the additional cost of PPI therapy compared to other acid inhibiting agents is acceptable given PPIs superior efficacy in healing and relieving symptoms. A cost-effectiveness analysis of long term strategies for managing gastrointestinal symptoms in primary care reported initial treatment with a PPI followed by maintenance therapy with a H2 antagonist to prevent symptomatic recurrence as the optimal strategy [
22]. Treatment with H2 antagonists was also the optimal strategy for the prevention of non-steroidal anti-inflammatory drug induced gastro-intestional toxicity [
23].
Research to date has focused on the clinical evidence of whether or not the guidelines are being followed and on specific groups of patients in different clinical settings (e.g. hospitals). Economic data is needed to inform health policy makers and practitioners at a national level to guide policy development. Expenditure on PPIs decreased in Northern European countries (England, Scotland and Sweden) between 2001 and 2007, despite an increase in PPI utilisation, through multiple demand side reforms encouraging the prescribing of low cost generic PPIs, such as omeprazole. The exception was Ireland, were both utilisation and expenditure on PPIs increased due to increased prescribing of esomeprazole and decreased prescribing of generic omeprazole [
24,
25]. If PPI prescriptions were restricted generally to the recommended guidelines, what would the impact be on government drug expenditure? The aims of this study were to: (i) investigate trends in the duration and dose of PPI prescribing in a national community drug scheme in Ireland in a one year period 2007–2008; (ii) determine potential cost savings in a one year period (2007–2008) by examining different scenarios in prescribing patterns of PPIs according to clinical and cost-effectiveness guidelines and (iii) compare potential cost savings stratified by different age groups.
Conclusion
PPIs are highly effective for a wide range of acid-peptic conditions but the evidence suggests they are being over prescribed in Ireland for longer durations and at higher doses than current guidelines advise. At a time of growing concern over rising drug costs and limited health care resources potentially inappropriate or unnecessary use of expensive drugs like PPIs should be limited where possible [
34]. Many patients with gastro-intestional disorders have legitimate needs for PPI to enhance their quality of life; however, this analysis highlights the potential cost savings that could be obtained with limited impact on clinical outcomes.
As PPIs lose patent protection and cheaper generic equivalents become available on the market, cost savings will increase. However, unless an incentive is introduced to promote increased generic drug utilisation and physicians are motivated and supported in changing their prescribing practices it is unlikely that the trends in PPI prescribing reported in this study will change and potential cost savings will be realised.
CC: HRB PhD Scholar in Health Service Research. TF: Professor of General Practice, Royal College of Surgeons in Ireland. LT: Chief Pharmacist at the National Centre for Pharmacoeconomics. CT: Statistician at the Health Information and Quality Authority. KB: Senior Lecturer in Pharmacoepidemiology, Trinity College Dublin.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
CC and KB and CT planned and designed the study. CC, KB, CT, LT and TF interpreted the guidelines and their application to the prescribing database. CC drafted the manuscript. KB, TF, CT and LT critically reviewed and approved the final manuscript. KB is guarantor. All authors read and approved the final manuscript.