Analysis of the use and cost of stress ulcer prophylaxis for surgical inpatients.

Background Stress ulcer is a superficial and asymptomatic lesion and causes bleeding. As many as 50% of death cases are reported as the result of stress ulcer bleeding. Stress ulcer prophylaxis (SUP) is a drug used to prevent gastrointestinal tract injuries due to stress ulcers. The inappropriate use of SUP drugs can cause adverse drug reactions, and thus SUP drugs are only given to patients in accordance with guidelines in order to avoid the overuse of SUP drugs. The aim of this present study is to analyse the suitability of SUP drug usage based on the criteria from the American Society of Health-System Pharmacists (ASHP) and the drug costs of SUP overuse. Methods An observational descriptive study was conducted from April 24, 2019, to May 17, 2019, in the inpatient surgical ward of Dr. Soetomo General Hospital. Data were obtained from patient medical health records. Results One hundred fifty-two patients used 1404 SUP drugs. Approximately 48% of usage did not suit the ASHP criteria and was considered as medication overuse. The cost of excessive SUP usage during the study period was more than US $65, which is 30.08% of the total drug cost of prescribed stress ulcer drugs. Conclusions The present study suggests that the relatively high excessive drug costs for SUP show a need for monitoring of the application of SUP therapy guidelines.

Consumption of medicines used for gastric acid-related disorders in Australia and South Korea: a cross-country comparison.

PURPOSE: The study's aim was to compare the use of proton pump inhibitors (PPIs), histamine 2-receptor antagonists (H2RAs) and mucoprotective medicines (MPs) used for gastric acid-related disorders (GARD) in Australia and South Korea (Korea) from 2004 to 2017. METHODS: Prescription data for PPIs, H2RAs and MPs for Australian outpatients were extracted from the Australian Statistics on Medicines annual reports, with dose-specific and expenditure data obtained from Medicare. Similar data were obtained from Korean National Health Insurance Service claims data. We analysed the volume and expenditure of medicines use annually using the defined daily dose per 1,000 population per day. We calculated which medicines accounted for 90% of use and estimated the proportions of use for low- and high-dose PPIs. RESULTS: While total utilisation for GARD medicines increased over time in both countries, patterns of use differed. Overall, use was somewhat higher in Australia but increased more rapidly in Korea. PPIs were used more extensively in Australia, while more MPs and H2RAs were used in Korea. Expenditure and use of low-dose PPIs is escalating in Korea. CONCLUSION: There were substantial differences in the use of GARD medicines in Australia and Korea over 14 years. Both countries face similar challenges to promote rational medicines use and contain medical care costs. The discrepant prescribing patterns can be attributed to differences in healthcare systems, pharmaceutical policies and demographics. This study provides a baseline to influence more rational use of these medicines. It provides insight into medicines policies for other countries that face similar challenges.

Cost-effectiveness of TLC-sucrose octasulfate versus control dressings in the treatment of diabetic foot ulcers.

OBJECTIVE: Diabetes is one of the most widespread diseases in Germany. Common complications are diabetic foot ulcers (DFU), which are associated with a cost-intensive treatment and serious adverse events, such as infections, amputations. This cost-effectiveness analysis compares two treatment options for patients with DFU: a TLC-NOSF dressing versus a neutral dressing, assessed through a European double-blind randomised controlled trial (RCT), Explorer. METHODS: The evaluation of the clinical outcomes was associated to direct costs (costs for dressings, nursing time, hospitalisation etc.) of both dressings, from the perspective of the statutory health insurance in Germany. Due to the long mean healing time of a DFU, the observation period was extended from 20 to 100 weeks in a Markov model. RESULTS: After 20 weeks, and with complete closure as a primary endpoint, the model revealed direct treatment costs for DFU of €2,864.21 when treated with a TLC-NOSF dressing compared with €2,958.69 with the neutral control dressing (cost-effectiveness: €6,017.25 versus €9,928.49). In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were €5,882.87 compared with €8,449.39 with the neutral dressing (cost-effectiveness: €6,277.58 versus €10,375.56). The robustness of results was underlined by several sensitivity analyses for varying assumptions. The frequency of weekly dressing changes had the most significant influence in terms of parameter uncertainty. CONCLUSION: Overall, the treatment of DFU with a TLC-NOSF dressing is supported from a health economic perspective, because both the treatment costs and the cost-effectiveness were superior compared with the neutral wound dressing.

[Influential factors in the quality of prescription in primary care and relation to pharmaceutical expenditure]. / Factores influyentes en la calidad de la prescripción en atención primaria y relación con el gasto farmacéutico.

OBJECTIVE: The high pharmaceutical consumption requires establishing improvement measures with the collaboration of all the agents involved. The objective of the study was to analyze the pharmaceutical expenditure generated by prescriptions made by physicians working in a primary care area and assess its relationship with the quality indicators of the prescription. METHODS: The prescriptions of 200 family physicians of the Basque Health Service Araba Countyand dispensed by the community pharmacies between 2009 and 2016 were studied. The variables evaluated retrospectively corresponded to the quality indicators of the pharmaceutical prescription included in the Contract-Program of the Basque Department Health of 2016. Prediction models were developed using linear regression and binary logistic regression analysis. RESULTS: The main factors which increased the pharmaceutical expenditure per person were: the use of novel drugs which do not offer therapeutic improvements, the proportion of pensioners, the use of statins and the use of antiulcer the proton pump inhibitors (PPI). On the contrary, the factors that reduced this expense were: the seniority in the medical position, the physician job stability and the prescription quality index. The profile of the doctor who generated the greatest expense of pharmaceutical prescription was mainly that of a professional who was responsible for a high percentage of pensioners, prescribed a high amount of inhibitors of the enzyme angiotensin converting enzyme inhibitors (ACEI), prescribed a high amount of first level non-steroidal anti-inflammatory drugs (NSAIDs) and also showed high use of antiulcer PPI. CONCLUSIONS: There is a statistically significant correlation between physicians who generate lower pharmaceutical expenditure and have a higher quality of prescription. The most influencing factors in the pharmaceutical expenditure are a high percentage of pensioners in the medical quota, the use of novel drugs that do not provide therapeutic improvements and the prescription of statins and anti-ulcer PPI drugs.

OBJETIVO: El elevado consumo farmacéutico requiere establecer medidas de mejora con la colaboración de todos los agentes implicados. El objetivo del estudio fue analizar el gasto farmacéutico generado por las recetas prescritas por los médicos que trabajan en un área de atención primaria y evaluar su relación con los indicadores de calidad de la prescripción. METODOS: Se estudiaron las prescripciones de 200 médicos de familia de la Comarca Araba de Osakidetza y dispensadas por las oficinas de farmacia entre los años 2009 y 2016. Las variables evaluadas retrospectivamente correspondieron a los indicadores de calidad de la prescripción farmacéutica recogidos en el Contrato-Programa del Departamento de Salud del 2016. Se elaboraron modelos de predicción mediante técnicas de regresión lineal y logística binaria. RESULTADOS: Los principales factores que aumentaron el gasto farmacéutico por persona fueron: el uso de medicamentos novedosos que no ofrecen mejoras terapéuticas, la proporción de pensionistas, el uso de estatinas y el uso de antiulcerosos inhibidores de la bomba de protones (IBP). Por el contrario, los factores que redujeron este gasto fueron: la antigüedad en la plaza médica, la estabilidad laboral e el índice de calidad de prescripción. El perfil del médico que generó mayor gasto de prescripción farmacéutica fue principalmente el de un profesional que tenía a su cargo un elevado porcentaje de pensionistas, recetaba una cantidad elevada de inhibidores del enzima convertidor de angiotensina (IECA), prescribía una elevada cantidad de antiinflamatorios no esteroideos (AINE) de primer nivel e igualmente tenía un elevado uso de antiulcerosos IBP. CONCLUSIONES: Existe una correlación estadísticamente significativa entre los médicos que generan un menor gasto farmacéutico y presentan mayor calidad de la prescripción. Los factores que más influyen en el gasto farmacéutico son un elevado porcentaje de pensionistas en el cupo médico, el uso de medicamentos novedosos que no aportan mejoras terapéuticas y la prescripción de estatinas y de antiulcerosos IBP.

Factores influyentes en la calidad de la prescripción en atención primaria y relación con el gasto farmacéutico / Influential factors in the quality of prescription in primary care and relation to pharmaceutical expenditure

OBJETIVO: El elevado consumo farmacéutico requiere establecer medidas de mejora con la colaboración de todos los agentes implicados. El objetivo del estudio fue analizar el gasto farmacéutico generado por las recetas prescritas por los médicos que trabajan en un área de atención primaria y evaluar su relación con los indicadores de calidad de la prescripción. MÉTODOS: Se estudiaron las prescripciones de 200 médicos de familia de la Comarca Araba de Osakidetza y dispensadas por las oficinas de farmacia entre los años 2009 y 2016. Las variables evaluadas retrospectivamente correspondieron a los indicadores de calidad de la prescripción farmacéutica recogidos en el Contrato-Programa del Departamento de Salud del 2016. Se elaboraron modelos de predicción mediante técnicas de regresión lineal y logística binaria. RESULTADOS: Los principales factores que aumentaron el gasto farmacéutico por persona fueron: el uso de medicamentos novedosos que no ofrecen mejoras terapéuticas, la proporción de pensionistas, el uso de estatinas y el uso de antiulcerosos inhibidores de la bomba de protones (IBP). Por el contrario, los factores que redujeron este gasto fueron: la antigüedad en la plaza médica, la estabilidad laboral e el índice de calidad de prescripción. El perfil del médico que generó mayor gasto de prescripción farmacéutica fue principalmente el de un profesional que tenía a su cargo un elevado porcentaje de pensionistas, recetaba una cantidad elevada de inhibidores del enzima convertidor de angiotensina (IECA), prescribía una elevada cantidad de antiinflamatorios no esteroideos (AINE) de primer nivel e igualmente tenía un elevado uso de antiulcerosos IBP. CONCLUSIONES: Existe una correlación estadísticamente significativa entre los médicos que generan un menor gasto farmacéutico y presentan mayor calidad de la prescripción. Los factores que más influyen en el gasto farmacéutico son un elevado porcentaje de pensionistas en el cupo médico, el uso de medicamentos novedosos que no aportan mejoras terapéuticas y la prescripción de estatinas y de antiulcerosos IBP

OBJECTIVE: The high pharmaceutical consumption requires establishing improvement measures with the collaboration of all the agents involved. The objective of the study was to analyze the pharmaceutical expenditure generated by prescriptions made by physicians working in a primary care area and assess its relationship with the quality indicators of the prescription. METHODS: The prescriptions of 200 family physicians of the Basque Health Service Araba Countyand dispensed by the community pharmacies between 2009 and 2016 were studied. The variables evaluated retrospectively corresponded to the quality indicators of the pharmaceutical prescription included in the Contract-Program of the Basque Department Health of 2016. Prediction models were developed using linear regression and binary logistic regression analysis. RESULTS: The main factors which increased the pharmaceutical expenditure per person were: the use of novel drugs which do not offer therapeutic improvements, the proportion of pensioners, the use of statins and the use of antiulcer the proton pump inhibitors (PPI). On the contrary, the factors that reduced this expense were: the seniority in the medical position, the physician job stability and the prescription quality index. The profile of the doctor who generated the greatest expense of pharmaceutical prescription was mainly that of a professional who was responsible for a high percentage of pensioners, prescribed a high amount of inhibitors of the enzyme angiotensin converting enzyme inhibitors (ACEI), prescribed a high amount of first level non-steroidal anti-inflammatory drugs (NSAIDs) and also showed high use of antiulcer PPI. CONCLUSIONS: There is a statistically significant correlation between physicians who generate lower pharmaceutical expenditure and have a higher quality of prescription. The most influencing factors in the pharmaceutical expenditure are a high percentage of pensioners in the medical quota, the use of novel drugs that do not provide therapeutic improvements and the prescription of statins and anti-ulcer PPI drugs

Rethinking the laryngopharyngeal reflux treatment algorithm: Evaluating an alternate empiric dosing regimen and considering up-front, pH-impedance, and manometry testing to minimize cost in treating suspect laryngopharyngeal reflux disease.

OBJECTIVES/HYPOTHESIS: Empiric proton pump inhibitor (PPI) trials for laryngopharyngeal reflux (LPR) are common. A majority of the patients respond to acid suppression. This work intends to evaluate once-daily, 40 mg omeprazole and once-nightly, 300 mg ranitidine (QD/QHS) dosing as an alternative regimen, and use this study's cohort to evaluate empiric regimens prescribed for LPR as compared to up-front testing with pH impedance multichannel intraluminal impedance (MII) with dual pH probes and high-resolution manometry (HRM) for potential cost minimization. STUDY DESIGN: Retrospective cohort review and cost minimization study. METHODS: A chart review identified patients diagnosed with LPR. All subjects were treated sequentially and outcomes recorded. Initial QD/QHS dosing increased after 3 months to BID if no improvement and ultimately prescribed MII and HRM if they failed BID dosing. Decision tree diagrams were constructed to determine costs of two empiric regimens and up-front MII and HRM. RESULTS: Ninety-seven subjects met the criteria. Responders and nonresponders to empiric therapy were identified. Seventy-two subjects (74%) responded. Forty-eight (67% of responders and 49% of all) improved with QD/QHS dosing. Forty-nine (51%) subjects escalated to BID dosing. Twenty-four subjects (33% of responders and 25% of all) improved on BID therapy. Twenty-five subjects (26%) did not respond to acid suppression. Average weighted cost was $1,897.00 per patient for up-front testing, $3,033.00 for initial BID, and $3,366.00 for initial QD/QHS. CONCLUSIONS: An alternate QD/QHS regimen improved the majority who presented with presumed LPR. Cost estimates demonstrate that the QD/QHS regimen was more expensive than the initial BID high-dose PPI for 6 months. Overall per-patient cost appears less with up-front MII and HRM. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:S1-S13, 2017.

Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial.

BACKGROUND: Critically ill patients in the intensive care unit (ICU) are at risk of clinically important gastrointestinal bleeding, and acid suppressants are frequently used prophylactically. However, stress ulcer prophylaxis may increase the risk of serious adverse events and, additionally, the quantity and quality of evidence supporting the use of stress ulcer prophylaxis is low. The aim of the SUP-ICU trial is to assess the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in adult patients in the ICU. We hypothesise that stress ulcer prophylaxis reduces the rate of gastrointestinal bleeding, but increases rates of nosocomial infections and myocardial ischaemia. The overall effect on mortality is unpredictable. METHODS/DESIGN: The SUP-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomised, blinded, parallel-group trial of stress ulcer prophylaxis with a proton pump inhibitor versus placebo (saline) in 3350 acutely ill ICU patients at risk of gastrointestinal bleeding. The primary outcome measure is 90-day mortality. Secondary outcomes include the proportion of patients with clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection or myocardial ischaemia, days alive without life support in the 90-day period, serious adverse reactions, 1-year mortality, and health economic analyses. The sample size will enable us to detect a 20 % relative risk difference (5 % absolute risk difference) in 90-day mortality assuming a 25 % event rate with a risk of type I error of 5 % and power of 90 %. The trial will be externally monitored according to Good Clinical Practice standards. Interim analyses will be performed after 1650 and 2500 patients. CONCLUSION: The SUP-ICU trial will provide high-quality data on the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in critically ill adult patients admitted in the ICU. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02467621 .

Impact of a clinical pharmacist stress ulcer prophylaxis management program on inappropriate use in hospitalized patients.

PURPOSE: Appropriate utilization of stress ulcer prophylaxis should be limited to high-risk, intensive care unit (ICU) patients. However, inappropriate stress ulcer prophylaxis use among all hospitalized patients remains a concern. The purpose of this study was to evaluate the clinical and economic impact of a novel pharmacist-managed stress ulcer prophylaxis program in ICU and general ward patients. METHODS: This retrospective, pre- and poststudy design was conducted in adult ICU and general ward patients at a large academic medical center between January 1, 2011 and January 31, 2012 to compare the rates of inappropriate stress ulcer prophylaxis before and after the implementation of a pharmacist-led stress ulcer prophylaxis management program. RESULTS: A total of 1134 unique patients consisting of 16,415 patient days were evaluated. The relative reduction in the rate of inappropriate stress ulcer prophylaxis days after program implementation in ICU and general ward patients was 58.3% and 83.5%, respectively (P < .001). The rates of ICU patients inappropriately continued on stress ulcer prophylaxis upon hospital discharge in the pre- and postimplementation groups were 29.9% and 3.6%, respectively (P < .001), whereas general ward patients significantly decreased from 36.2% to 5.4% in the pre- and postimplementation groups, respectively (P < .001). Total inpatient costs associated with all stress ulcer prophylaxis administered was $20,052.70 in the pre- and $3280.49 in the postimplementation group (P < .001), resulting in an estimated cost savings of > $200,000 annually. No differences in clinical outcomes were observed. CONCLUSIONS: The implementation of a pharmacist-managed stress ulcer prophylaxis program was associated with a decrease in inappropriate acid suppression rates during hospitalization and upon discharge, as well as significant cost savings.

[Pharmacoeconomic evaluation of treatment in patients with Helicobacter pylori-associated diseases].

AIM: To estimate the pharmacoeconomic parameters of treatment in patients with Helicobacter pylori-associated diseases when using 6 eradication therapy (ET) regimens. SUBJECTS AND METHODS: The investigation enrolled a total of 231 patients who received anti-Helicobacter pylori therapy according to the intention-to-treat (ITT) principle, including 229 patients who met the protocol requirements, i.e. who completed the prescribed per-protocol (PP) treatment: 106 patients with duodenal bulb ulcer disease, 2 with gastric ulcer, 90 with erosive gastritis, and 31 patients with non-atrophic gastritis. In an outpatient setting, the patients received one of the 6 ET regimens: OAC, RBMA, RBCA, EBCA, sequential OACM therapy, and modified sequential OACMB therapy (O--omeprazole; A--amoxicillin; C--clarithromycin; B--bismuth tripotassium dicitrate, R--rabeprazole; M--metronidazole; E--esomeprazole). Treatment costs were calculated only from direct drug expenditures. The effective cost coefficient (K(eff)) was determined from the cost/ treatment efficiency ratio: K(eff) = cos/eff, where the cost was the average total costs; the eff was efficiency (%). RESULTS: The modified sequential OACMB therapy has proven to be more cost-efficient than the other regimens as it has a lower K(eff), (14). The RBMA regimens can overcome an 80% ET barrier (82.4%); however, in this case the K(eff) is 21.5. the sequential OACM therapy can also overcome an 80% ET barrier (84.8%); the K(eff) being 10.8. Incorporation of the bismuth preparation can achieve a more noticeable therapeutic effect up to 95.4%. The EBCA regimen has turned out to be most expensive with the highest K(eff) of 36.9. The RBCA regimen is most effective with the least K(eff) of 29; the therapeutic effect is 96.7%. CONCLUSION: The clinical cost-efficiency of ET is enhanced by the incorporation of the bismuth preparation for the treatment of patients with H. pylori-associated diseases. The modified sequential OACMB therapy can overcome resistance to clarithromycin and metronidazole with a good cost-efficiency.

An economic analysis of inadequate prescription of antiulcer medications for in-hospital patients at a third level institution in Colombia.

INTRODUCTION: The prescription and costs of antiulcer medications for in-hospital use have increased during recent years with reported inadequate use and underused. AIM: To determine the patterns of prescription-indication and also perform an economic analysis of the overcost caused by the non-justified use of antiulcer medications in a third level hospital in Colombia. MATERIALS AND METHODS: Cross-sectional study of prescription-indication of antiulcer medications for patients hospitalized in "Hospital Universitario San Jorge" of Pereira during July of 2012. Adequate or inadequate prescription of the first antiulcer medication prescribed was determined as well as for others prescribed during the hospital stay, supported by clinical practice guidelines from the Zaragoza I sector workgroup, clinical guidelines from the Australian Health Department, and finally the American College of Gastroenterology Criteria for stress ulcer prophylaxis. Daily defined dose per bed/day was used, as well as the cost for 100 beds/day and the cost of each bed/drug. A multivariate analysis was carried out using SPSS 21.0. RESULTS: 778 patients were analyzed, 435 men (55.9 %) and 343 women, mean age 56.6 +/- 20.1 years. The number of patients without justification for the prescription of the first antiulcer medication was 377 (48.5 %), and during the whole in-hospital time it was 336 (43.2 %). Ranitidine was the most used medication, in 438 patients (56.3 %). The cost/month for poorly justified antiulcer medications was € 3,335.6. The annual estimated cost for inadequate prescriptions of antiulcer medications was € 16,770.0 per 100 beds. CONCLUSION: A lower inadequate prescription rate of antiulcer medications was identified compared with other studies; however it was still high and is troubling because of the major costs that these inadequate prescriptions generates for the institution.

Gastroprotective strategies in chronic NSAID users: a cost-effectiveness analysis comparing single-tablet formulations with individual components.

OBJECTIVES: To evaluate the cost-effectiveness of competing gastroprotective strategies, including single-tablet formulations, in the prevention of gastrointestinal (GI) complications in patients with chronic arthritis taking nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: We performed a cost-utility analysis to compare eight gastroprotective strategies including NSAIDs, cyclooxygenase-2 inhibitors, proton pump inhibitors (PPIs), histamine-2 receptor antagonists, misoprostol, and single-tablet formulations. We derived estimates for outcomes and costs from medical literature. The primary outcome was incremental cost per quality-adjusted life-year gained. We performed sensitivity analyses to assess the effect of GI complications, compliance rates, and drug costs. RESULTS: For average-risk patients, NSAID + PPI cotherapy was most cost-effective. The NSAID/PPI single-tablet formulation became cost-effective only when its price decreased from €0.78 to €0.56 per tablet, or when PPI compliance fell below 51% in the NSAID + PPI strategy. All other strategies were more costly and less effective. The model was highly sensitive to the GI complication risk, costs of PPI and NSAID/PPI single-tablet formulation, and compliance to PPI. In patients with a threefold higher risk of GI complications, both NSAID + PPI cotherapy and single-tablet formulation were cost-effective. CONCLUSIONS: NSAID + PPI cotherapy is the most cost-effective strategy in all patients with chronic arthritis irrespective of their risk for GI complications. For patients with increased GI risk, the NSAID/PPI single-tablet formulation is also cost-effective.

The efficacy, safety and cost-effectiveness of hydrotalcite versus esomeprazole in on-demand therapy of NERD: A multicenter, randomized, open-label study in China.

OBJECTIVE: The aim of the study was to investigate whether hydrotalcite was comparable to esomeprazole, a proton pump inhibitor, in on-demand therapy for non-erosive reflux disease (NERD). METHODS: This was a multicenter, randomized, open-label clinical trial with initial and on-demand therapy. Patients who had complete symptom relief in the initial therapy were randomized to either hydrotalcite or esomeprazole in the on-demand therapy. The percentage of patients who quit on-demand therapy in the two groups and the cost-effectiveness of the treatment were evaluated as primary end points. The rate of symptom relief and the improvement of symptom score for initial therapy and the weekly average symptom score and weekly average number of days on treatment for on-demand therapy were evaluated as secondary end points. RESULTS: In total, 398 patients were recruited in the initial therapy group, among whom 253 were included in on-demand therapy, with 127 patients in the hydrotalcite group and the remaining 126 in the esomeprazole group. 14 (11.0%) patients in the hydrotalcite group and six (4.8%) in the esomeprazole group quit the on-demand therapy due to unsatisfactory symptom control (P = 0.065). Cost-effectiveness calculated as the ratio of the cost of hydrotalcite to that of esomeprazole (per person/day) was 35.3% in the on-demand therapy. Similar number of patients achieved symptom relief in both groups. CONCLUSION: Hydrotalcite is a good option of on-demand therapy for NERD patients due to its cost-effectiveness and speed of action.

[The communication with patients about analogue substitution is complex]. / Kommunikation med patienter om analog medicinsubstitution er kompleks.

Information about "effect" was considered more important than "price" on analogue substitution by a group of patients using the original medicine, esomeprazol, and having mixed experiences with generics. The word "cheap" implied negative associations to the expected effect and was associated with perception of more side effects. Patients adapted individually to substitution, e.g. by self-payment and -dosing.Furthermore they expressed themselves in methaphors, which was a figure lacking in written information to them. This qualitative study supports the need for, as well as more knowledge on, patient-oriented information and -dialogue on analogue substitution of medicines.

Budget impact modeling for a single-tablet formulation of ibuprofen and famotidine for prevention of upper gastrointestinal ulcers in patients with osteoarthritis and/or rheumatoid arthritis.

BACKGROUND: Single-tablet ibuprofen/famotidine is approved by the US Food and Drug Administration for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcers in patients taking ibuprofen for those indications. Currently, little is known about the cost impact of gastroprotective therapies, and an estimate of the financial consequences of adopting these therapies will be helpful to decision makers. OBJECTIVES: The goal of this study was to review a model that evaluates the expected financial impact to US health care plans from the introduction of single-tablet ibuprofen/famotidine into the chronic NSAID user population. METHODS: A budget impact model, considering a typical health plan of 1 million enrollees, was used to compare patients receiving: (1) single-tablet ibuprofen/famotidine; (2) chronic NSAID treatment plus any GI-protective agent; and (3) chronic NSAID treatment without a GI-protective agent. RESULTS: The expected medication cost for single-tablet ibuprofen/famotidine was $734,192 ($81,577 in year 1, $244,731 in year 2, and $407,884 in year 3), corresponding to a total per-member per-month cost of $0.020 ($0.007 in year 1, $0.020 in year 2, and $0.034 in year 3). Considering anticipated decreases in the use of other NSAIDs, the use of GI-protective agents, and GI complications, the total expected 3-year drug cost for single-tablet ibuprofen/famotidine was offset by 50%, representing an estimated total budget impact of $364,396 or $0.010 per member per month. Sensitivity analyses of cost and market share variables and clinical and drug characteristics identified the most influential variables to be the cost of the drug and persistence to the ibuprofen/famotidine formulation, respectively. CONCLUSIONS: The expected decrease in treatment costs for less serious GI-related complications illustrates the benefits of single-tablet ibuprofen/famotidine as a gastroprotective therapy in patients receiving chronic NSAID treatment, with a modest financial impact on total health care costs.

Cost-effectiveness analysis: stress ulcer bleeding prophylaxis with proton pump inhibitors, H2 receptor antagonists.

OBJECTIVES: Proton pump inhibitors (PPIs) and H2-receptor antagonists (H2RAs) present varying pharmacological efficacy in preventing stress ulcer bleeding (SUB) in intensive care units. The literature also reports disparate rates of ventilator-assisted pneumonia (VAP) as side effects of these treatments. We compared the cost-effectiveness of these two prophylactic pharmacological options. METHODS: We constructed a decision tree with a 60-day time horizon for patients at high risk for developing SUB, receiving either PPIs or H2RAs. For each treatment strategy, patients could be in one of three states of health: SUB, VAP, or no complication. Contemporary, clinically relevant probabilities were obtained from a broad literature search. Costs were estimated by using a representative US countrywide database. A third-party payer perspective was adopted. Cost-effectiveness and univariate and multivariate sensitivity analyses were performed. RESULTS: Probabilities of SUB and VAP were 1.3% and 10.3% for PPIs versus 6.6% and 10.3% for H2RAs, respectively. Lengths of stay and per diem costs were 24 days and US $2764 for SUB, 42 days and US $3310 for VAP, and 14 days and US $2993 for patients without complications. Average costs per no complication were US $58,700 for PPIs and US $63,920 for H2RAs. The H2RA strategy was dominated by PPIs. Sensitivity analysis showed that these findings were sensitive to VAP rates but PPIs remain cost-effective. The acceptability curve shows the stability of the probabilistic results according to varying willingness-to-pay values. CONCLUSION: PPI prophylaxis is the most efficient prophylactic strategy in patients at high risk of developing SUB when compared with using H2RAs.

Prevention of gastrointestinal bleeding due to stress ulceration: a review of current literature.

Our objective was to audit our current stress ulcer prophylaxis protocol (routine prescription of ranitidine and early enteral feeding) by identifying whether routine prescription of histamine-2 receptor antagonists or proton pump inhibitors as prophylaxis against stress-related mucosal disease and subsequent upper gastrointestinal bleeding is supported in the literature. We also aimed to ascertain what literature evidence supports the role of early enteral feeding as an adjunctive prophylactic therapy, as well as to search for burn-patient specific evidence, since burn patients are at high risk for developing this condition, with the aim of changing our practice. PubMed and Cochrane databases were searched for relevant articles, yielding seven randomised controlled trials comparing histamine-2 receptor antagonists and proton pump inhibitors in the prevention of upper gastrointestinal bleeding associated with stress-related mucosal disease and three separate meta-analyses. Despite level 1 clinical evidence, no significant difference in efficacy between histamine-2 receptor antagonists and proton pump inhibitor treatment groups was demonstrated. No significant difference was demonstrated in the incidence of nosocomial pneumonia between the two drugs given in this indication. However, enteral feeding was found to be safe and effective in preventing clinically significant upper gastrointestinal bleeding. Patients able to tolerate feeds demonstrated no additional benefit with concomitant pharmacological prophylactic therapy. Since all burn patients at the Royal Adelaide Hospital are fed from very early in their admission, the literature suggests that we, like our intensive care unit colleagues, should abolish our reliance on pharmacological prophylaxis, the routine prescription of which is not supported by the evidence.

Variables associated with stress ulcer prophylaxis misuse: a retrospective analysis.

BACKGROUND: Stress ulcer prophylaxis (SUP) is commonly used in hospitals. Although its indications are better delineated for intensive care unit (ICU) patients, its use in non-ICU settings is somewhat arbitrary and based on judgment. OBJECTIVE: We attempted to assess the extent of SUP overuse in our hospital. We also carefully collected and analyzed several variables to detect associations governing this flawed behavior and its financial burden on the hospital's budget. MATERIALS AND METHODS: We retrospectively analyzed charts of patients admitted to the medical floor of a tertiary referral university hospital over a 1 year period. All adult patients admitted to the medical ward who received at least one dose of SUP were included and reviewed for a multitude of variables in addition to the appropriateness of acid suppression therapy (AST). RESULTS: We included 320 charts and found that 92% of patients admitted during that period were not eligible for SUP. The total inappropriateness of SUP was noted to be 58% (p = 0.015). Increasing age and male gender were found to be significant variables in AST misuse (p = 0.045 and p = 0.010), much like duration of hospital stay (p = 0.008). Comorbidities was also found to be a defining variable for AST overuse (odds ratio [OR] = 3.27). Patients with two or more minor risk factors were also subjected more to SUP inappropriately (OR = 3.53), in addition to patients of certain specialties (Neurology, Infectious Diseases, etc.). Our calculated financial burden was more than $23,000 per year for the medical floor. CONCLUSION: This retrospective study confirmed the growing suspicion that SUP misuse is evident on the medical floors. We also delineated several factors and variables associated with and affecting SUP overuse.

Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study.

BACKGROUND: Patients with dyspepsia often experience troublesome symptoms. AIM: To assess the burden of uninvestigated dyspepsia (symptoms, health-related quality of life [HRQL] and work productivity) before and after 8 weeks' esomeprazole treatment. METHODS: Patients (n=1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤ 2 endoscopies within 10 years) underwent a 1-week esomeprazole acid-suppression test before randomisation to 7 weeks' esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1-week off-treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid-suppression test. RESULTS: The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub-population of acid-suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo. CONCLUSIONS: Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1-week acid-suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.