Quality and Brands of Amoxicillin Formulations in Nairobi, Kenya.

Antibiotics are among the most counterfeited anti-infectious medicines in developing countries. Amoxicillin is one of the commonly prescribed, affordable, and easily accessible antibiotic in Kenya. It is a broad-spectrum antibiotic hence commonly used in chemotherapy. This study sought to determine the quality and identify the various brands of amoxicillin and its combination amoxicillin/clavulanic acid marketed in Nairobi County. Nairobi is the capital city of Kenya, gateway for imports and exports, and the headquarters to most of the pharmaceutical distributors. Ten wards in Nairobi County representing different socioeconomic settings were purposively sampled for the study. A detailed questionnaire was used to collect background data on brands of amoxicillin and amoxicillin/clavulanic acid in the market. A total of 106 different brands were found in the market: 85 were imports while 21 were locally manufactured. Fifty-three samples were analyzed with reference to the United States Pharmacopoeia. Amoxicillin and clavulanic acid contents for oral suspensions were determined immediately after reconstitution and 7 days thereafter to determine their stability during the prescription period. On day seven, 23.1% (3 out of 13) of amoxicillin and 66.7% (8 out of 12) amoxicillin/clavulanic acid oral suspensions presented levels below recommended limits. Uniformity of weight for amoxicillin capsules noted 13.6% (3 out of 22) failure rate, while amoxicillin/clavulanic acid tablets complied. Potency determination for all amoxicillin capsules analyzed were within required limits, but amoxicillin/clavulanic acid tablets showed 33.3% (2 out of 6) noncompliance. For amoxicillin capsule and amoxicillin/clavulanic acid tablet dissolution tests, there was 10.5% (2 out of 19) and 50% (2 out of 4) noncompliance, respectively. Overall, 37.7% of the drugs analyzed failed to comply with the Pharmacopoeia. These results highlight the presence of poor-quality amoxicillin formulations in Nairobi County, affirming the need for regular postmarket surveillance to inform on the situation of antibiotic quality in the Kenyan market.

Evaluation of different proton pump inhibitors combined with bismuth quadruple regimens in Helicobacter pylori eradication.

To evaluate the efficacy and economics of different proton pump inhibitors (PPIs) combined with bismuth quadruple regimens for Helicobacter pylori (Hp) eradication, a retrospective analysis method was used to collect Hp-positive patients who were treated with a bismuth-containing quadruple regimen (PPIs + amoxicillin + furazolidone + colloid pectin bismuth) from the outpatient department of gastroenterology in our hospital from January to June 2017. A total of 1410 patients were included in the study and divided into four groups according to different PPIs: group A (pantoprazole sodium enteric-coated capsules, 352 cases), group B (esomeprazole magnesium enteric-coated tablets, 462 cases), group C (pantoprazole sodium enteric-coated tablets, 392 cases) and group D (rabeprazole sodium enteric-coated tablets, 204 cases). The eradication rate of Hp and cost-saving in each group were then compared. There were no significant differences of gender (P = 0.526) and age (P = 0.366) between each Hp treatment regimen. The eradication rates of groups A, B, C and D were 91.48%, 89.83%, 86.73% and 90.69%, respectively. No statistical differences of Hp eradication rates were observed between each group yet (P > 0.05). However, the cost of group A was the lowest. In the present study, the Hp eradication rates between different PPIs regimens were similar in treating Hp infection. Nevertheless, the point in favor of pantoprazole capsules is the slightly higher Hp eradication rate and lower drug cost than other PPIs, which provides a significant evidence for the clinical medication decision in treating Hp infection.

Sequential Helicobacter pylori eradication therapy in Myanmar; a randomized clinical trial of efficacy and tolerability.

BACKGROUND AND AIM: There is little published research to examine the best approach to the management of Helicobacter pylori in Myanmar. This study aimed to determine the relative efficacy and tolerability of sequential eradication therapy compared to Myanmar's current recommendation of a concomitant four drug regimen. METHODS: Patients were screened for H. pylori using monoclonal Stool Antigen Testing (SAT). Those testing positive were randomized 1:1 to receive receive Myanmar's first-line regimen of 14 days of concomitant rabeprazole, clarithromycin, amoxycillin and tinidazole (140 pills, cost US$23) or 10 days of sequential rabeprazole, clarithromycin, amoxycillin and tinidazole (60 pills, cost US$10). Adherence and adverse effects were recorded, and the efficacy of the regimens assessed with repeat SAT. RESULTS: Of the 1011 patients screened for H. pylori infection, 313 (31%) tested positive. There was no statistical difference in the cure rates of the two regimens in either intention-to-treat: 128/157 (82%; 95% confidence interval (CI): 75-87%) receiving sequential therapy versus 123/156 (79%; 95% CI: 72-85%) receiving concomitant therapy (P = 0.55) or per-protocol analysis: 125/131 (95%; 95% CI: 90-98) receiving sequential therapy versus 121/130 (93%; 95% CI: 87-96) receiving concomitant therapy (P = 0.42). Side effects of therapy were reported in 54/157 (47%) patients taking sequential therapy compared with 62/156 (53%) taking concomitant therapy, but this difference did not reach statistical significance (P = 0.33). CONCLUSIONS: In this high-burden, resource-poor setting, less expensive sequential therapy was as effective and as well tolerated as the currently recommended concomitant four drug regimen for eradication of H. pylori.

Helicobacter pylori eradication regimens in an antibiotic high-resistance European area: A cost-effectiveness analysis.

INTRODUCTION: Helicobacter pylori infection (H pylori-I) affects more than half of the global population and consists an important burden to public health and healthcare expenditures, by contributing to many diseases' pathogenesis. AIM: This study aimed to evaluate the current nonbismuth quadruple eradication regimens in a high antibiotic resistance area, such as Greece, concerning their cost-effectiveness, especially during financial crisis period. MATERIALS AND METHODS: Eight hundred and nine patients who received eradication treatment against H pylori-I were included to evaluate five different regimens, using amoxicillin, clarithromycin, and metronidazole as antibiotics and one proton-pump inhibitor, based on their current eradication rates. Regimes compared 10-day concomitant use of (a) pantoprazole or (b) esomeprazole; 10-day sequential use of (c) pantoprazole or (d) esomeprazole; and 14-day hybrid using esomeprazole. Cost-effectiveness analysis ratio (CEAR) and incremental cost-effectiveness ratios were calculated taking into account all direct costs and cases who needed second-line treatment. Additionally, sensitivity analysis was performed to predict all potential combinations. RESULTS: Ten-day concomitant regimen with esomeprazole was characterized by the lowest CEAR (179.17€) followed by the same regimen using pantoprazole (183.27€). Hybrid regimen, although equivalent in eradication rates, was found to have higher CEAR (187.42€), whereas sequential regimens were not cost-effective (CEAR: 204.12€ and 216.02€ respectively). DISCUSSION: This is the first study evaluating the cost-effectiveness of H pylori-I treatment regimens in a high clarithromycin-resistance (≈26.5%) European area, suggesting the 10-day concomitant regimen with generics using esomeprazole 40 mg as the most appropriate one. National and regional guidelines should include cost-effectiveness in their statements, and further studies are required to clarify the necessity of a wide "test and treat" policy for H pylori-I.

Investigating the exposure of Iranian households to catastrophic health expenditure due to the need to purchase medicines.

BACKGROUND: Catastrophic health expenditure (CHE) is an indicator used by the World Health Organization (WHO) to assess equity in households' payments to the health system. In this paper, we prospectively calculated the population at risk of facing catastrophic expenditure due to purchasing three selected medicines (metformin, atorvastatin and amoxicillin) in Iran. METHOD: This study draws on the data set of the Iranian National Household Survey of 38244 households in Iran. CHE was calculated based on "capacity to pay" using different thresholds. RESULTS: 20, 16 and 3 households had to spend more than 40% of their capacity to pay on amoxicillin, atorvastatin and metformin respectively. Lowest priced generic (LPG) medicines were found more affordable than the original brand (OB) medicines. Age, literacy and gender of head of household, economic status, settlement, size and number of breadwinners in the households share important association with CHE. CONCLUSION: Requirement of these specific medicines for long-term may subject the Iranian households to CHE. The study demonstrates important and specific insights for health policy makers in Iran to protect the households from healthcare catastrophes.

Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors.

Substandard and falsified medicines represent a serious threat for public health and patient safety. Especially in low and middle-income countries, the prevalence of substandard and falsified medicines is reportedly high. However, reliable information on the prevalence of poor-quality medicines is scarce. In this study, 12 essential medicines, including antibiotics, antidiabetics, cardiac drugs and antiasthmatic drugs, were collected from six informal vendors and six licensed pharmacies in the southern part of Togo (regions Maritime and Plateaux). A mystery shopper approach was used in both types of outlets. In total, 64 samples were collected from licensed pharmacies and 30 from informal vendors. Both availability of medicines and prices of medicines were higher in licensed pharmacies than in informal vendors. 92 medicine samples were analyzed by visual examination, followed by chemical analysis for the content and for the dissolution of the active pharmaceutical ingredients according to the respective monographs of the United States Pharmacopoeia. 7 samples (8%) did not comply with the pharmacopoeial specifications, and one sample (1%) showed even extreme deviations. None of the samples was obviously falsified. However, one sample of amoxicillin capsules contained only 47% of the declared content of the active pharmaceutical ingredient, indicating that it may represent amoxicillin capsules 250 mg, rather than 500mg as declared on the label. Medicines stated to originate from Asia (i.e. mainly from India and China) showed a significantly higher proportion (24%) of non-compliant samples than those from Africa and Europe (4%, p = 0.007). High failure rates were observed in medicines both from informal vendors (13%) and from licensed pharmacies (5%), but the difference between both groups was not statistically significant (p = 0.152). The observed high prevalence of substandard medicines requires action from regulatory authorities and health care providers. Testing of selected samples for related substances indicated that inappropriate transport and storage conditions may have been an important cause for substandard quality.

Non-prescribed sale of antibiotics for acute childhood diarrhea and upper respiratory tract infection in community pharmacies: a 2 phase mixed-methods study.

Background: Although prohibited by law and legal regulatory frameworks, non-prescribed sale of antibiotics in community medicine retail outlets (CMROs) remains a serious problem in Ethiopia. The aim of this study was to document the extent of and motivations behind non-prescribed sale of antibiotics among CMROs in Gondar town, Ethiopia. Methods: A 2 phase mixed-methods study (a simulated patient visit followed by an in-depth interview) was conducted among CMROs in Gondar town, Ethiopia. Two clinical case scenarios (acute childhood diarrhea and upper respiratory tract infection) were presented and the practice of non-prescribed sale were measured and results were reported as percentages. Pharmacy staff (pharmacists and pharmacy assistants) were interviewed to examine factors/motivations behind dispensing antibiotics without a valid prescription. Results: Out of 100 simulated visits (50 each scenarios) presented to drug retail outlets, 86 cases (86%) were provided with one or more medications. Of these, 18 (20.9%) asked about past medical and medication history and only 7 (8.1%) enquired about the patient's history of drug allergy. The most frequently dispensed medication for acute childhood diarrhoea simulation were oral rehydration fluid (ORS) with zinc (n = 16) and Metronidazole (n = 15). Among the dispensed antibiotics for upper respiratory infection simulation, the most common was Amoxicillin (n = 23) followed by Amoxicillin-clavulanic acid capsule (n = 19) and Azithromycin (n = 15). Perceived financial benefit, high expectation and/or demand of customers and competition among pharmacies were cited as the main drivers behind selling antibiotics without a prescription. Conclusions: A stringent law and policy enforcement regarding the sale of antibiotics without a valid prescription should be in place. This will ultimately help to shift the current pharmacy practices from commercial and business-based interests/practices to the provision of primary healthcare services to the community.

Guidelines for the treatment of severe acute malnutrition: a systematic review of the evidence for antimicrobial therapy.

Background Severe acute malnutrition (SAM) affects nearly 20 million children worldwide and is responsible for up to 1 million deaths per year in children under the age of 5 years. Current WHO guidelines recommend oral amoxicillin for children with uncomplicated malnutrition and parenteral benzylpenicillin and gentamicin for those with complicated malnutrition. Because of cost pressures and increasing antimicrobial resistance, the administration of empirical antibiotics for children with SAM has recently been debated. Methods A systematic review of the current published literature was undertaken to assess the efficacy, safety, cost-effectiveness and pharmacokinetics of antimicrobial treatment of children with SAM in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Results The initial search found 712 papers, eight of which met the inclusion criteria. Quality assessment of the studies was performed as per the Grading of Recommendations Assessment, Development and Evaluation guidelines. International guidelines and clinical data registries were also reviewed which identified inconsistencies in current first- and second-line therapies and dosing regimens. Conclusion Current evidence supports the continued use of broad-spectrum oral amoxicillin for treating children with uncomplicated SAM as outpatients. There is no strong evidence to justify changing the current parenteral therapy guidelines for children admitted with complicated SAM, although they should be clarified to harmonise the dosage regimen of amoxicillin for the treatment of SAM to 40 mg/kg twice daily, and to continue parenteral antimicrobials beyond 2 days if indicated by the clinical condition.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

Analysis of the cost-effectiveness of using vonoprazan-amoxicillin-clarithromycin triple therapy for first-line Helicobacter pylori eradication.

BACKGROUND: Vonoprazan (VPZ)-based triple therapy has been reported to have greater efficacy than a proton pump inhibitor (PPI)-based triple therapy for Helicobacter pylori (H. pylori) eradication. However, because VPZ is more expensive than PPIs such as rabeprazole (RPZ), economic evaluation is essential. METHODS: We performed a retrospective study on 209 patients who underwent first-line eradication of H. pylori infection in Fuyoukai Murakami Hospital from 1 March 2015 to 31 March 2016. Patients who received VPZ, amoxicillin (AMPC) and clarithromycin (CAM) were assigned to the VPZ/AC group (n = 111) and patients who received RPZ, AMPC and CAM to the RPZ/AC group (n = 98). We compared the patients' backgrounds, including age, gender, use of high-dose CAM, past history of peptic ulcer, smoking and drug-related adverse events between the two groups. We defined cost as direct medical costs per patient and effectiveness as the first-line eradication rate in the intention-to-treat (ITT) analysis and analyzed the cost-effectiveness using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER). RESULTS: There was no significant difference in the patients' backgrounds. The ITT analysis revealed an eradication rate of 94.6% for VPZ/AC and 86.7% for RPZ/AC. VPZ/AC cost 1155.4 Japanese yen (JPY) higher than RPZ/AC (34063.4 vs. 32908.0, JPY). CER of VPZ/AC was less than that of RPZ/AC (360.1 vs. 379.4, JPY per percent) and ICER of VPZ/AC was 147.0 JPY (1.28 Euro (EUR), 1 EUR =115 JPY) per percent. CONCLUSIONS: VPZ/AC was more cost-effective than RPZ/AC as first-line therapy for H. pylori eradication.

Cost effectiveness of amoxicillin for lower respiratory tract infections in primary care: an economic evaluation accounting for the cost of antimicrobial resistance.

BACKGROUND: Lower respiratory tract infections (LRTIs) are a major disease burden and are often treated with antibiotics. Typically, studies evaluating the use of antibiotics focus on immediate costs of care, and do not account for the wider implications of antimicrobial resistance. AIM: This study sought to establish whether antibiotics (principally amoxicillin) are cost effective in patients with LRTIs, and to explore the implications of taking into account costs associated with resistance. DESIGN AND SETTING: Multinational randomised double-blinded trial in 2060 patients with acute cough/LRTIs recruited in 12 European countries. METHOD: A cost-utility analysis from a health system perspective with a time horizon of 28 days was conducted. The primary outcome measure was the quality-adjusted life year (QALY). Hierarchical modelling was used to estimate incremental cost-effectiveness ratios (ICERs). RESULTS: Amoxicillin was associated with an ICER of €8216 (£6540) per QALY gained when the cost of resistance was excluded. If the cost of resistance is greater than €11 (£9) per patient, then amoxicillin treatment is no longer cost effective. Including possible estimates of the cost of resistance resulted in ICERs ranging from €14 730 (£11 949) per QALY gained - when only multidrug resistance costs and health care costs are included - to €727 135 (£589 856) per QALY gained when broader societal costs are also included. CONCLUSION: Economic evaluation of antibiotic prescribing strategies that do not include the cost of resistance may provide misleading results that could be of questionable use to policymakers. However, further work is required to estimate robust costs of resistance.

Amoxicillin for acute lower respiratory tract infection in primary care: subgroup analysis of potential high-risk groups.

BACKGROUND: Antibiotics are of limited overall clinical benefit for uncomplicated lower respiratory tract infection (LRTI) but there is uncertainty about their effectiveness for patients with features associated with higher levels of antibiotic prescribing. AIM: To estimate the benefits and harms of antibiotics for acute LRTI among those producing coloured sputum, smokers, those with fever or prior comorbidities, and longer duration of prior illness. DESIGN AND SETTING: Secondary analysis of a randomised controlled trial of antibiotic placebo for acute LRTI in primary care. METHOD: Two thousand and sixty-one adults with acute LRTI, where pneumonia was not suspected clinically, were given amoxicillin or matching placebo. The duration of symptoms, rated moderately bad or worse (primary outcome), symptom severity on days 2-4 (0-6 scale), and the development of new or worsening symptoms were analysed in pre-specified subgroups of interest. Evidence of differential treatment effectiveness was assessed in prespecified subgroups by interaction terms. RESULTS: No subgroups were identified that were significantly more likely to benefit from antibiotics in terms of symptom duration or the development of new or worsening symptoms. Those with a history of significant comorbidities experienced a significantly greater reduction in symptom severity between days 2 and 4 (interaction term -0.28, P = 0.003; estimated effect of antibiotics among those with a past history -0.28 [95% confidence interval = -0.44 to -0.11], P = 0.001), equivalent to three people in 10 rating symptoms as a slight rather than a moderately bad problem. For subgroups not specified in advance antibiotics provided a modest reduction in symptom severity for non-smokers and for those with short prior illness duration (<7 days), and a modest reduction in symptom duration for those with short prior illness duration. CONCLUSION: There is no clear evidence of clinically meaningful benefit from antibiotics in the studied high-risk groups of patients presenting in general practice with uncomplicated LRTIs where prescribing is highest. Any possible benefit must be balanced against the side-effects and longer-term effects on antibiotic resistance.

Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a systematic review of recent evidence.

BACKGROUND: Several alternative treatment regimens for Helicobacter pylori eradication have been proposed since the efficacy of standard triple therapy has declined over time, and sequential therapy is one of them. The purpose of this systematic review is to analyze and compare the efficacy, adverse effects and cost of sequential therapy with that of standard triple therapy for H. pylori infection. METHODS: MEDLINE, EMBASE, Google Scholar and Cochrane databases were used to retrieve all relevant articles published in the English language over the last 5 years (January 2008-October 2012). Eligibility criteria were randomized controlled trials (RCTs) comparing sequential and standard triple therapies in patients with documented H. pylori infection. Eligibility and quality of the trials were assessed independently by two reviewers, and the data regarding eradication rate, adverse effects and the cost of therapy were extracted. RESULTS: Of the 17 RCTs included in the analysis (Asia 13, Europe 3, Latin America, 1), 12 reported better eradication rates with the sequential therapy, four did not find a significant difference between the two treatment regimens, and one reported a better eradication rate with standard triple therapy. All except one RCT reported no significant difference in the incidence of adverse effects between standard triple therapy and sequential therapy. Sequential therapy was cheaper than standard triple therapy in all three RCTs where a cost analysis was performed. The limitations of the RCTs included in the systematic review were that the sequential therapy regimen and the duration of standard triple therapy were not uniform. Antibiotic susceptibility tests were performed in only three RCTs. CONCLUSIONS: While the majority of the RCTs have shown superior eradication rates with sequential therapy, the largest RCT from Latin America did not find a significant difference between the two treatment regimens. Sequential therapy has good efficacy; however, further trials other than those from Asia and Italy are required to assess its superiority over existing regimens before recommending sequential therapy as the first line of treatment for H. pylori infection.

Household costs for treatment of severe pneumonia in Pakistan.

Current World Health Organization (WHO) guidelines for severe pneumonia treatment of under-5 children recommend hospital referral. However, high treatment cost is a major barrier for communities. We compared household costs for referred cases with management by lady health workers (LHWs) using oral antibiotics. This study was nested within a cluster randomized trial in Haripur, Pakistan. Data on direct and indirect costs were collected through interviews and record reviews in the 14 intervention and 14 control clusters. The average household cost/case for a LHW managed case was $1.46 compared with $7.60 for referred cases. When the cost of antibiotics provided by the LHW program was excluded from the estimates, the cost/case came to $0.25 and $7.51 for the community managed and referred cases, respectively, a 30-fold difference. Expanding severe pneumonia treatment with oral amoxicillin to community level could significantly reduce household costs and improve access to the underprivileged population, preventing many child deaths.

Sequential therapy versus standard triple drug therapy for eradication of Helicobacter pylori in patients with perforated duodenal ulcer following simple closure.

BACKGROUND: Resistance to clarithromycin, a component of standard triple therapy, leads to inconsistent eradication rates of Helicobacter pylori infection. Some studies have shown higher eradication rates for H. pylori using sequential regimen. This study was done to compare the eradication rates for H. pylori infection between the standard triple drug therapy and the sequential therapy. METHODS: Seventy-three patients with perforated duodenal ulcer following simple closure with H. pylori infection were randomized to receive either standard triple drug therapy or the sequential therapy. Standard triple drug therapy comprised of omeprazole, clarithromycin, and amoxicillin for 10 days. Sequential therapy comprised of omeprazole and amoxicillin or the first 5 days followed by omeprazole, clarithromycin, and amoxicillin for the next 5 days. Follow-up endoscopy was done at 2 months to assess the eradication rates, compliance, and side effects with each regimen. RESULTS: Eradication rates for standard triple therapy and sequential regimen were 81.25% and 87.09%, respectively (p = 0.732). The cost of sequential therapy was cheaper and incidence of side effects and compliance were similar in each group. CONCLUSION: Standard triple therapy and sequential therapy have similar efficacy for eradication of H. pylori and sequential therapy is an economical alternative to standard triple therapy.

Estimation of the clinical and economic consequences of non-compliance with antimicrobial treatment of canine skin infections.

The goal of this study was to estimate the health and economic consequences of non-compliance with oral antimicrobial treatment in dogs with superficial pyoderma, wounds or abscesses in the US. A mathematical model (Markov model) which simulated treatment with long-term injectable cefovecin versus oral amoxicillin/clavulanic acid was developed and accounted for the effect of non-compliance on clinical outcomes and mean total treatment costs per patient. Efficacy parameters considered in the model were derived from clinical studies. Treatment failure due to oral antimicrobial treatment non-compliance was approximated from published data at 13.6%. US cost data for 2009 were derived from public sources. When non-compliance was considered as a cause of treatment failure with oral medication, the long-term injectable antibiotic was more effective than oral comparator (162 versus 158 days without clinical signs). Mean total treatment costs were lower with cefovecin (USD 376.74) versus amoxicillin/clavulanic acid (USD 382.34) in dogs of 25 kg; and cefovecin remained cost-saving up to a body weight of 31 kg. In large dogs, cefovecin was more costly; however, total therapy costs were less than 6% greater than with amoxicillin/clavulanic acid. Accordingly the higher drug and administration costs of the long-term injectable antibiotic were totally or substantially offset when non-compliance was considered as reason for treatment failure with oral medication. The model also allowed for the estimation of the impact of various non-compliance scenarios.

Oral versus i.v. antibiotics for community-acquired pneumonia in children: a cost-minimisation analysis.

Community-acquired pneumonia represents a high financial burden to healthcare providers. This manuscript seeks to estimate and compare the costs of treating children hospitalised with community-acquired pneumonia, with oral and intravenous antibiotics, thus determining which treatment is cost minimising. A cost-minimisation analysis was undertaken alongside a randomised controlled non-blinded equivalence trial. 232 children (from eight paediatric centres in England) diagnosed with pneumonia, who required admission to hospital, were randomised to receive oral amoxicillin or i.v. benzyl penicillin. The analysis considered the cost to the health service, patients and society, from pre-admission until the child was fully recovered. Oral amoxicillin and i.v. benzyl penicillin have equivalent efficacy. Children treated with i.v. antibiotics were found to have significantly longer in-patient stays (3.12 versus 1.93 days; p<0.001). i.v. treatment was found to be more expensive than oral treatment ( pound1,256 versus pound769; difference pound488; 95% CI: pound233- pound750), such that treatment of community-acquired pneumonia with oral amoxicillin would result in savings of between pound473 and pound518 per child (euro545 and euro596 per child) admitted. The findings demonstrate that oral amoxicillin is a cost-effective treatment for the majority of children admitted to hospital with pneumonia.

Has UK guidance affected general practitioner antibiotic prescribing for otitis media in children?

BACKGROUND: Since 1997, UK guidance has advocated limiting antibiotic prescribing for otitis media. It is not known whether this has influenced general practitioner prescribing practice. Aims and objectives To investigate the trends in diagnoses and antibiotic prescribing for otitis media in children in relation to guidance. METHODS: We used the General Practice Research Database to conduct time-trend analyses of diagnoses and antibiotic prescribing for otitis media in 3 months to 15 years old, between 1990 and 2006. RESULTS: A total of 1 210 237 otitis media episodes were identified in 464 845 children; two-thirds (68%; 818 006) received antibiotics. Twenty-two percent (267 335) were classified as acute, 85% (227 335) of which received antibiotics. Overall, antibiotic prescribing for otitis media declined by 51% between 1995 and 2000. Much of this reduction predated guidance. During this period, prescribing for otitis media coded as acute increased by 22%. Children diagnosed with acute otitis media were more likely to receive antibiotics than otitis media not coded as acute (P < 0.05). From 2000 prescribing plateaued, despite publication of further guidance. Otitis media diagnoses consistently paralleled prescribing. CONCLUSIONS: The reduction in antibiotic prescribing for otitis media predated guidance. The simultaneous decrease in prescribing for non-acute otitis media and increase for acute otitis media suggest diagnostic transfer, possibly to justify the decision to treat.

Helicobacter pylori eradication in long-term proton pump inhibitor users is highly cost-effective: economic analysis of the HELPUP trial.

BACKGROUND: Proton pump inhibitor (PPI) use is costly and about two-thirds of prescribing is long-term. Although 20-50% of patients may be infected with Helicobacter pylori, eradication is not normal clinical practice. AIM: To establish if H. pylori eradication in long-term PPI users is cost-effective. METHODS: Long-term PPI-using patients (n = 183) testing positive for H. pylori were randomly assigned to true or placebo eradication therapy. Patients provided 2-year resource data, and 1-year symptom severity scores. A within-trial cost effectiveness analysis was conducted from a British health service perspective. RESULTS: Significant reductions in resource use occurred comparing eradication with placebo. After 2 years, PPI prescriptions (full-dose equivalents) fell by 3.9 (P < 0.0001); clinician (GP) consultations by 2.4 (P = 0.0001); upper gastrointestinal (GI) endoscopies by 14.8% (P = 0.008); clinician GI-related home visits by 19.9% (P = 0.005) and abdominal ultrasound scans fell by 20.3% (P = 0.005). Average net savings/patient were pound93 (95% CI: 33-153) after costs of detection and eradication had been deducted. At 1 year, Leeds Dyspepsia Questionnaire symptoms fell by 3.1 (P = 0.005) and quality-of-life measures improved (EuroQol-5D: 0.089, P = 0.08; visual analogue scale: 5.6, P = 0.002) favouring eradication. CONCLUSION: Helicobacter pylori eradication in infected, long-term PPI users is an economically dominant strategy, significantly reducing overall healthcare costs and symptom severity.