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This study aims to estimate the theoretical excess expenditure that would be incurred by the Irish state-payer, should drugs be reimbursed at their original asking (“list”) price rather than at a price at which the drug is considered cost-effective. In Ireland, all new drugs are evaluated by the National Centre for Pharmacoeconomics. For this study, drugs that were submitted by pharmaceutical companies from 2012 to 2017 and considered not cost-effective at list price were reviewed. A total of 43 such drugs met our inclusion criteria, and their pharmacoeconomic evaluations were further assessed. The price at which the drug could be considered cost-effective (cost-effective price) at the upper cost-effectiveness threshold used in Ireland (€ 45 000/quality adjusted life-year) was estimated for 18 drugs with an available cost-effectiveness model. Then, for each drug, the list price and cost-effective price (both per unit) were both individually applied to 1 year of national real-world drug utilization data. This allowed the estimation of the expected expenditures under the assumptions of list price paid and cost-effective price paid. The resulting theoretical excess expenditure, the expenditure at list price minus the expenditure at the cost-effective price, was estimated to be €108.2 million. This estimate is theoretical because of the confidentiality of actual drug prices. The estimation is calculated using the list price and likely overestimates the actual excess expenditure, which would reduce to zero if cost-effective prices are agreed. Nevertheless, this estimate illustrates the importance of a process to assess the value of new drugs so that potential excess drug expenditure is identified.

AIMS Recent increases in the number of patients with atrial fibrillation (AF) prescribed oral anticoagulants (OAC) are evident in Ireland and internationally, largely due to the availability of direct oral anticoagulants (DOACs). This study aimed to determine the rate of stroke in the context of increasing anticoagulation utilisation, with a focus on AF-related ischaemic stroke (IS). METHODS Dispensing data for OACs were identified for the period 2010-2018 as well as hospital discharges for IS (2005-2018). Irish National Stroke Register data were used to elucidate the characteristics of patients with acute ischaemic stroke. RESULTS The number of patients prescribed OACs increased by 94% from 2010-2018 with a significant change from 2013 (β = 2.57, P = .038), associated with a large increase in the number of patients on DOACs. There was 3.3-fold increase in expenditure on OACs nationally from 2013 to 2018, of which 94% was DOAC related. Using the 2013 timepoint, ischaemic stroke rates until 2018 did not show a significant deviation from the previous trend (β = 0.00, P = .898). The percentage of AF-related ischaemic stroke was stable from 2013 to 2017 with a 4.5% decrease in 2018. The percentage of ischaemic stroke patients with previously diagnosed AF decreased from 2013 to 2018; however, there was an increase in the percentage of ischaemic strokes while on OAC in this cohort. CONCLUSION Large increases in OAC utilisation have not resulted in changes in ischaemic stroke rates at a national level. The percentage of ischaemic strokes with a previous diagnosis of AF has decreased indicating a possible benefit from greater OAC utilisation. However, the percentage presenting with an ischaemic stroke while on OAC treatment is increasing. The increase in patients presenting with stroke while treated with OAC may largely reflect the national increase in patients prescribed DOACs but the findings raise concerns about treatment failures. The real-world effectiveness of DOACs requires further examination.

Previous research has suggested that prescribers’ knowledge of drug costs in Ireland is deficient. We aimed to update this finding by asking prescribers to estimate drug costs for low-and high-cost drugs, as well as examining their familiarity with a national prescribing initiative. We conducted a survey of five groups of prescribers and one group of medical students asking them to estimate the drug costs. Drugs recommended by the Preferred Drugs Initiative in Ireland were included, as were high-cost monoclonal antibody products and nutrition supplements. A 25% margin of error was allowed for a correct estimate. Comparisons were performed across participant groups and between drugs. A number of qualitative questions were included to provide context. The survey received 122 responses. General practitioners (GPs) had the most accurate estimates, with medical students having the least. The percentage with a correct estimate was lower for higher cost drugs across all participant groups. GPs were also most certain about the estimates and most familiar with the Preferred Drug Initiative, while the students rated worst for both these questions. The cost of most drugs was overestimated. Most prescribers were uncertain about their estimates, which was reflected by the large variation in estimates. Eighty-three percent of prescribers would consider a trade-off of drug efficacy for affordability at least sometimes. Prescribers’ knowledge of drug costs in Ireland remains poor and may negatively affect patient outcomes and national drug budgets. A national program provides recommendations to improve cost-effective prescribing; however, further alterations to national prescribing practices and policies are required to raise awareness of drug costs and these recommendations.

The lidocaine 5% medicated plaster, Versatis®, has one therapeutic indication listed on the Summary of Product Characteristics—symptomatic relief of post-herpetic neuralgia (PHN) in adults. Increased expenditure on Versatis® suggests that there is considerable off-label use. To support the appropriate use of Versatis®, the Health Service Executive’s Primary Care Reimbursement Service (PCRS) introduced a reimbursement application system for Versatis® from 1 September 2017. The aim of this study was to investigate the effect of introducing a reimbursement application system on Versatis® prescribing under the General Medical Services (GMS) scheme. This study was carried out using prescription dispensing data from the PCRS pharmacy claims database. We carried out segmented linear regression to assess changes in the Versatis® prescribing rate per 1000 GMS eligible population, before and after the introduction of the online reimbursement application system. The results of the segmented regression analysis show that there was a statistically significant level (− 4.91, p

Background and aims Statin associated muscle symptoms are common and affect adherence to statin treatment. The objective of this study was to assess whether patients with statin-associated myalgia can be successfully treated with Coenzyme Q10 (CoQ10) to improve symptoms and maintain them on statin therapy. Methods This systematic review was performed in line with the 2015 PRISMA statement. Relevant studies were identified via a search of MEDLINE, EMBASE and the Cochrane Library. Studies were screened to include randomised controlled trials of oral CoQ10 supplementation versus a placebo in adults with statin-associated myalgia. Continuation of statin therapy was a secondary outcome. Risk of bias was assessed using the Cochrane Risk of Bias tool. Pooled and sensitivity analyses were performed. Results 413 records were identified by the search strategy. Eight studies were selected for review, and 7 of them (with 321 patients) were included in the meta-analysis. Selected studies were published between 2007 and 2016 with the number of participants ranging from 37 to 76. Only two of these studies demonstrated a positive effect of CoQ10 therapy in relieving muscle pain. The meta-analysis did not demonstrate any benefit of CoQ10 supplementation in improving myalgia symptoms compared to placebo (weighted mean difference −0.42; 95% Confidence Interval [CI] −1.47 to 0.62). Similarly, CoQ10 did not improve the proportion of patients remaining on the statin treatment (RR 0.99; 95%CI, 0.81 to 1.20). Conclusions This systematic review and meta-analysis did not demonstrate that CoQ10 supplementation was beneficial for patients with statin-associated muscle pain or improved adherence to statin therapy.

Oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation is underutilised. One of the impediments to warfarin therapy is the frequent monitoring required, usually at a specialised warfarin clinic. The advent of direct oral anticoagulants (DOACs) facilitates OAC therapy without an onerous monitoring regimen. This benefit may result in the more significant adoption of DOACs in areas without a warfarin clinic. This study analysed national administrative data for reimbursed pharmacy claims to assess OAC prescribing from 2010 to 2017 and compared the use of DOACs in areas with warfarin clinics compared to those without. Over the study period, the number of patients on OAC increased by 84%, due to a rapid increase in DOAC prescribing. The findings demonstrate that DOACs have resulted in an increase in the overall uptake of OAC therapy in Ireland. However, the increased utilisation was not evidently related to populations underserved by warfarin clinics.

Background Prescribing error represent a significant source of preventable harm to patients. Prescribing errors at discharge, including omission of pre-admission medications (PAM), are particularly harmful as they frequently propagate following discharge. This study assesses the impact of an educational intervention and introduction of an electronic patient record (EPR) in the same centre on omission of PAM at discharge using a pragmatic design. A survey of newly qualified doctors is used to contextualise findings. Methods Discharge prescriptions and discharge summaries were reviewed at discharge, and compared to admission medicine lists, using a paper-based chart system. Discrepancies were noted, using Health Information and Quality Authority guidelines for discharge prescribing. An educational intervention was conducted. Further review of discharge prescriptions and discharge summaries took place. Following introduction of an EPR, review of discharge summaries and discharge prescriptions was repeated. A survey was administered to recently qualified doctors (interns), and analysed using descriptive statistics and thematic analysis. Results Omission of PAM as prescribed or discontinued items at discharge occurs frequently. An educational intervention did not significantly change prescribing error rates (U = 1255.5, p = 0.206). EPR introduction did significantly reduce omission of PAM on discharge prescribing (U = 694, p p = 0.007). Survey results demonstrated that multiple sources are required to develop a discharge prescription. Time pressure, access to documentation and lack of admission medicine reconciliation are frequently cited causes of discharge prescribing error. Conclusion This study verified passive educational interventions alone do not improve discharge prescribing. Introduction of EPR improved discharge prescribing, but negatively impacted deliberate discontinuation of PAM at discharge. This is attributable to reduced access to key sources of information used in formulating discharge prescriptions, and separation of the discontinuation function from the prescribing function on the EPR discharge application.

Armolipid Plus® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus® on the basis of the available randomized, blinded, controlled clinical trials (RCTs). A systematic literature search in several databases was conducted in order to identify RCTs assessing the efficacy and safety of dietary supplementation with Armolipid Plus®. Two review authors independently identified 12 eligible studies (1050 included subjects overall) and extracted data on study characteristics, methods, and outcomes. Meta-analysis of the data suggested that dietary supplementation with Armolipid Plus® exerted a significant effect on body mass index (mean difference (MD) = −0.25 kg/m2, p = 0.008) and serum levels of total cholesterol (MD = −25.07 mg/dL, p &lt, 0.001), triglycerides (MD = −11.47 mg/dL, p &lt, 0.001), high-density lipoprotein cholesterol (MD = 1.84 mg/dL, p &lt, 0.001), low-density lipoprotein cholesterol (MD = −26.67 mg/dL, p &lt, 0.001), high sensitivity C reactive protein (hs-CRP, MD = −0.61 mg/L, p = 0.022), and fasting glucose (MD = −3.52 mg/dL, p &lt, 0.001). Armolipid Plus® was well tolerated. This meta-analysis demonstrates that dietary supplementation with Armolipid Plus® is associated with clinically meaningful improvements in serum lipids, glucose, and hs-CRP. These changes are consistent with improved cardiometabolic health.

The management of hypertension is suboptimal in Ireland and internationally. The role of a specialist hypertension clinic is not always defined but an analysis of the reasons for referral are likely informative. Also, a description of the clinical characteristics of patients with hypertension will inform requirements for comprehensive hypertension management in the community and secondary care. Patients were recruited at consecutive hypertension clinics at St James Hospital, Dublin from July to September 2019. Reasons for referral, clinical characteristics of patients, their investigations and treatment were analyzed. 236 patients were included in the study. The majority of patients, 83%, were obese or overweight. A family history of hypertension was a frequent finding with 70.8% of patients reporting same. 26.7% of patients were under the age of 40. 78% of referrals were from primary care and the most referrals were to investigate secondary causes of hypertension or because the patient was ≤40 years of age. Calcium channel blockers were the treatment most frequently prescribed (51.7%). Clinic blood pressure for the cohort was 137/81 mmHg and this was replicated by their ambulatory BP. This insight into the contemporary management of hypertension highlights the frequency of obesity and a positive family history in those with hypertension. Most referrals were consistent with international guidance though deviations were evident. Findings suggest a national program for hypertension with greater focus on public health interventions and better resourcing of primary care is required.

Aims Entresto (sacubitril/valsartan) is used to treat symptomatic chronic heart failure with reduced ejection fraction. Given its high potential budget impact, the Health Services Executive introduced a reimbursement application system (RAS) to ensure its appropriate use. The aim of this study was to evaluate the utilisation of Entresto in Ireland and compare patient characteristics to those of the pivotal PARADIGM-HF trial. Methods We used dispensed claims data from the Primary Care Reimbursement Services, clinical data obtained from the RAS, and data from published studies of Entresto utilisation. Differences in the baseline characteristics in the study populations vs the Entresto arm of the PARADIGM-HF trial were analysed. We also investigated cardiovascular medication use in the 6 months pre- and post-Entresto initiation. Results In 2018, there were 1043 individuals receiving Entresto, corresponding to an expenditure of €1.2 million. Patients prescribed Entresto in Ireland were older, had lower left ventricular ejection fraction and were more symptomatic than those in the PARADIGM-HF trial. Irish patient characteristics were reflective of Entresto-treated populations in other real-world studies. More than 63% of patients were commenced on the lowest Entresto dose. Entresto initiation was associated with a reduction in the use of other medications for heart failure. Conclusion The utilisation of Entresto has been steadily increasing in Ireland since its reimbursement approval. The expenditure in the first year was substantially lower than predicted, and the RAS is an example of how health technology management can facilitate appropriate and cost-effective use of medicines.

Alpha-lipoic acid (ALA) is a natural short-chain fatty acid that has attracted great attention in recent years as an antioxidant molecule. However, some concerns have been recently raised regarding its safety profile. To address the issue, we aimed to assess ALA safety profile through a systematic review of the literature and a meta-analysis of the available randomized placebo-controlled clinical studies. The literature search included EMBASE, PubMed Medline, SCOPUS, Google Scholar, and ISI Web of Science by Clarivate databases up to 15th August 2020. Data were pooled from 71 clinical studies, comprising 155 treatment arms, which included 4749 subjects with 2558 subjects treated with ALA and 2294 assigned to placebo. A meta-analysis of extracted data suggested that supplementation with ALA was not associated with an increased risk of any treatment-emergent adverse event (all p &gt, 0.05). ALA supplementation was safe, even in subsets of studies categorized according to smoking habit, cardiovascular disease, presence of diabetes, pregnancy status, neurological disorders, rheumatic affections, severe renal impairment, and status of children/adolescents at baseline.

PURPOSE: The aims of this study were to examine a national database to assess codeine poisonings before and after the new guidance for pharmacists while also evaluating rates of codeine prescriptions following the introduction of restrictions on supply. METHODS: Anonymised enquiry data of reported poisoning cases were reviewed for a period from 2005 to 2016 inclusive. The rate of pharmacy claims for codeine containing products was also examined using the national pharmacy claims database. Segmented regression analysis was used to detect changes in poisonings and claims before and after the new guidance. RESULTS: There were 1851 codeine-related poisonings reported over the study period. An annual decline was evident with a significant 33% reduction from 2010 to 2011 (β2 coefficient for level change, 42.1; 95% CI, -68.1 to -16.0; P = 0.006). Following 2011, the declining rate of codeine poisonings plateaued. Analysis of the national pharmacy claims data revealed no change in the reimbursement rate for co-codamol products restricted by the guidance in 2010 (Incidence rate ratio 1.04, 95% CI, 0.997-1.08; P = 0.07). There was no corresponding increase in the reimbursement of alternative opioid medications. CONCLUSIONS: New guidance on codeine supply coincided with an initial reduction in reported codeine poisoning cases. This reduction was in keeping with the previous trend. However, this was without an increase in the prevailing rate of prescription claims for these products or potential substitutes. Policymakers may consider further restriction of codeine products to improve public health outcomes.