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A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry.

Targeted antibiotics could delay emergence of resistant Neisseria gonorrhoeae. The DNA gyrase subunit A assay predicts susceptibility to ciprofloxacin. A model found that adding a $50 gyrase subunit A test for asymptomatic patients screened for N. gonorrhoeae resulted in cost neutrality. When ciprofloxacin susceptibility was high, a $114 test resulted in savings.

Background: Klebsiella pneumoniae liver abscess is the most common etiology of liver abscess in Singapore and much of Asia, and its incidence is increasing. Current management includes prolonged intravenous antibiotic therapy, but there is limited evidence to guide oral conversion. The implicated K1/K2 capsule strain of Klebsiella pneumoniae is almost universally susceptible to ciprofloxacin, an antibiotic with high oral bioavailability. Our primary aim is to compare the efficacy of early (< one week) step-down to oral antibiotics, to continuing four weeks of intravenous antibiotics, in patients with Klebsiella liver abscess., Methods/design: The study is designed as a multi-center randomized open-label active comparator-controlled non-inferiority trial, with a non-inferiority margin of 12%. Eligible participants will be inpatients over the age of 21 with a CT or ultrasound scan suggestive of a liver abscess, and Klebsiella pneumoniae isolated from abscess fluid or blood. Randomization into intervention or active control arms will be performed with a 1:1 allocation ratio. Participants randomized to active control will receive IV ceftriaxone 2 grams daily to complete a total of four weeks of IV antibiotics. Participants randomized to intervention will be immediately converted to oral ciprofloxacin 750 mg twice daily. At Week four, all participants will undergo abdominal imaging and be assessed for clinical response (CRP < 20 mg/l, absence of fever, plus scan showing that the maximal diameter of the abscess has reduced). If criteria are met, antibiotics are stopped; if not, oral antibiotics are continued, with reassessment for clinical response fortnightly. If criteria for clinical response are met by Week 12, the primary endpoint of clinical cure is met. A cost analysis will be performed to assess the cost saving of early conversion to oral antibiotics, and a quality of life analysis will be performed to assess whether treatment with oral antibiotics is less burdensome than prolonged IV antibiotics., Discussion: Our results would help inform local and international practice guidelines regarding the optimal antibiotic management of Klebsiella liver abscess. A finding of non-inferiority may translate to the wider adoption of a more cost-effective strategy that reduces hospital length of stay and improves patient-centered outcomes and satisfaction., Trial Registration: Clinical trials gov NCT01723150.

Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.

The objectives of the present study were to determine the effects of multiple targeted interventions on the level of use of quinolones and the observed rates of resistance to quinolones in Escherichia coli isolates from hospitalized patients. A bundle consisting of four interventions to improve the use of quinolones was implemented. The outcome was measured from the monthly levels of use of intravenous (i.v.) and oral quinolones and the susceptibility patterns for E. coli isolates from hospitalized patients. Statistical analyses were performed using segmented regression analysis and segmented Poisson regression models. Before the bundle was implemented, the annual use of quinolones was 2.7 defined daily doses (DDDs)/100 patient days. After the interventions, in 2007, this was reduced to 1.7 DDDs/100 patient days. The first intervention, a switch from i.v. to oral medication, was associated with a stepwise reduction in i.v. quinolone use of 71 prescribed daily doses (PDDs) per month (95% confidence interval [CI] = 47 to 95 PDDs/month, P < 0.001). Intervention 2, introduction of a new antibiotic guideline and education program, was associated with a stepwise reduction in the overall use of quinolones (reduction, 107 PDDs/month [95% CI = 58 to 156 PDDs/month). Before the interventions the quinolone resistance rate was increasing, on average, by 4.6% (95% CI = 2.6 to 6.1%) per year. This increase leveled off, which was associated with intervention 2 and intervention 4, active monitoring of prescriptions and feedback. Trends in resistance to other antimicrobial agents did not change. This study showed that the hospital-wide use of quinolones can be significantly reduced by an active policy consisting of multiple interventions. There was also a stepwise reduction in the rate of quinolone resistance associated with the bundle of interventions.

Introduction: Rhinosinusitis is one of the more common diseases encountered in outpatient visits to health care. The objective of this study was to determine the most cost-effective antibiotic treatment for patients with acute (RSA) and chronic rhinosinusitis (RSC) that is available at the Mexican Institute of Social Security (IMSS)., Methods: Cost-effectiveness analysis of RSA and RSC treatment from an institutional perspective. Effectiveness outcome was defined as the percentage of cure. A decision tree with a Bayesian approach included the following therapeutic alternatives: ciprofloxacin, gatifloxacin, trimetoprim/sulfametoxazol (TMP/SMX), amoxicilin/clavulanic acid (AAC) and clindamicin., Results: Treatment for RSA with AAC showed a mean cost per cured patient of $ 878 pesos. The remaining antibiotics had a higher cost per unit of success, and therefore the results showed that AAC was the best alternative considering this criterion. The therapy that showed a larger percentage of cured patients in RSC was clindamicin; however, the therapeutic alternative with the lowest cost per successful unit was the one based on ciprofloxacin, which dominates gatifloxacin and AAC., Conclusions: The most cost-effective alternative in the antibiotic treatment of patients with RSA was ACC while for RSC it was ciprofloxacin; sensitivity analysis showed the strength of the base study results.

Objective: The goal of this research was to determine the cost-effectiveness of ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension versus ofloxacin 0.3% otic solution (OFX) for treatment of acute otitis media in tympanostomy tube patients., Methods: A decision-analytic model was used to emulate the ototopical treatment of acute otitis media in patients with tympanostomy tubes. The economic outcome was the cost per otorrhea-free day (OFD) achieved per episode of care. Three tiers of antimicrobial therapy were modeled, with each successive tier representing the retreatment of clinical failures from the preceding tier. First-tier therapy compared CD and OFX using outcome measures obtained from a randomized clinical trial (n = 599). Second-tier therapy modeled the use of amoxicillin/clavulanate (ACA) using outcome measures obtained from a physician survey and medical literature. Third-tier therapy was modeled as pathogen-specific and curative. It could follow one of three pathways: 1) intramuscular ceftriaxone; 2) oral fluconazole; or 3) hospitalization for intravenous antibiotics. Third-tier outcomes were based on a physician survey. Cost data were obtained from standard references and presented from a payer perspective., Results: The expected therapeutic costs were 249.40 dollars for the CD pathway and 265.44 dollars for the OFX pathway. The estimated number of OFDs per episode of care was 25.88 for the CD pathway and 23.86 for the OFX pathway. The cost-effectiveness ratios for CD and OFX therapies were 9.64 dollars and 11.13 dollars per OFD, respectively., Conclusion: CD is both more effective and less costly than OFX for the treatment of acute otitis media in patients with tympanostomy tubes.

Background: The optimal treatment regimen and duration of the therapy is still controversial in spinal brucellosis. The aim of this study is to compare the efficacy, adverse drug reactions, complications and cost of ciprofloxacin plus rifampicin versus doxycycline plus streptomycin in the treatment of spinal brucellosis., Methods: The patients diagnosed as spinal brucellosis between January 2002 to December 2004 were enrolled into the study. Patients were enrolled into the two antimicrobial therapy groups (doxycycline plus streptomycin vs. ciprofloxacin plus rifampicin) consecutively. For the cost analysis of the two regimens, only the cost of antibiotic therapy was analysed for each patient., Results: During the study period, 31 patients with spinal brucellosis were enrolled into the two antimicrobial therapy groups. Fifteen patients were included in doxycycline plus streptomycin group and 16 patients were included in ciprofloxacin plus rifampicin group. Forty-two levels of spinal column were involved in 31 patients. The most common affected site was lumbar spine (n = 32, 76%) and involvement level was not different in two groups. Despite the disadvantages (older age, more prevalent operation and abscess formation before the therapy) of the patients in the ciprofloxacin plus rifampicin group, the duration of the therapy (median 12 weeks in both groups) and clinical response were not different from the doxycycline plus streptomycin. The cost of ciprofloxacin plus rifampicin therapy was 1.2 fold higher than the cost of doxycycline plus streptomycin therapy., Conclusion: Classical regimen (doxycycline plus streptomycin), with the appropriate duration (at least 12 weeks), is still the first line antibiotics and alternative therapies should be considered when adverse drug reactions were observed.

The increasing prevalence of ciprofloxacin-resistant Neisseria gonorrhoeae has required replacing inexpensive oral ciprofloxacin treatment with more expensive injectable ceftriaxone. Further, monitoring antimicrobial resistance requires culture testing, but nonculture gonorrhea tests are rapidly replacing culture. Since the strategies were similar in effectiveness (> 99%), we evaluated, from the healthcare system perspective, cost-minimizing strategies for both diagnosis (culture followed by antimicrobial susceptibility tests versus nonculture-based tests) and treatment (ciprofloxacin versus ceftriaxone) of gonorrhea in women. Our results indicate that switching from ciprofloxacin to ceftriaxone is cost-minimizing (i.e., optimal) when the prevalence of gonorrhea is > 3% and prevalence of ciprofloxacin resistance is > 5%. Similarly, culture-based testing and susceptibility surveillance are optimal when the prevalence of gonorrhea is < 13%; nonculture-based testing is optimal (cost-minimizing) when gonorrhea prevalence is > or = 13%.

Background: Despite cost containment efforts, parenteral (IV) ciprofloxacin appears to be overutilized at Vancouver General Hospital. In November 2003, the Pharmacist-managed intravenous to oral (IV-PO) Dosage Form Conversion Service was implemented, enabling autonomous pharmacist-initiated dosage form conversion for ciprofloxacin. This study evaluates characteristics of ciprofloxacin use prior to and following implementation of this conversion service., Methods: This was a single-centre, two-phase (pre/post), unblinded study. Phase I occurred between November 12, 2002 and November 11, 2003 (365 days), and Phase II between November 12, 2003 and March 11, 2004 (120 days). All patients receiving ciprofloxacin IV during these periods were reviewed. The primary endpoint was IV:PO ciprofloxacin use ratio. Secondary endpoints were total number of ciprofloxacin doses, proportion of inappropriate IV ciprofloxacin doses, cost of therapy between phases, and estimated cost avoidance with the intervention., Results: Two hundred ciprofloxacin IV treatment courses were evaluated (100 per phase). The IV:PO ciprofloxacin use ratio was 3.03 (Phase I) vs. 3.48 (Phase II). Total number of doses and ratio of IV to total doses across phases were similar (p = 0.2830). IV-PO ciprofloxacin conversion occurred in 27/100 (27%) of IV courses in Phase I and 23/100 (23%) in Phase II. Proportion of inappropriate ciprofloxacin IV doses decreased between Phases I and II (244/521 (47%) vs. 201/554 (36%) (p = 0.0005), respectively). Furthermore, the proportion of pharmacist-preventable inappropriate ciprofloxacin IV doses was reduced between Phases I and II (114/244 (47%) vs. 65/201 (32%) (p = 0.0026). Proportional cost avoidance associated with total inappropriate IV use was 7,172 Can dollars/16,517 Can dollars (43%) (in Canadian dollars) in Phase I vs. 6,012 Can dollars/17,919 Can dollars (34%) in Phase II (p = 0.001). Similarly, proportional cost avoidance associated with pharmacist-preventable inappropriate IV doses was reduced from 3,367 Can dollars/16,517 Can dollars (20%) in Phase I to 1,975 Can dollars/17,919 Can dollars (11%) in Phase II (p = 0.001)., Conclusion: While overall utilization of ciprofloxacin remained unchanged and the proportion of IV to total doses was stable during the study period, the proportion of inappropriate IV doses and its associated costs appear to have declined subsequent to implementation of a Pharmacist-managed IV-PO Dosage Form Conversion Service. Such a program may be a beneficial adjunct in facilitating appropriate and cost-effective usage of ciprofloxacin.

Background: Problems of initial empirical antibiotic therapy in febrile neutropenia are further complicated by other factors such as cost and the pattern of infective organisms in a particular institution. We, therefore, conducted a randomized study comparing the efficacy of two sets of antibiotics which differed in their spectrum of action, availability and price., Methods: Sixty episodes of febrile neutropenia in 40 patients who were not on any prophylactic antibiotics were randomized into one of two arms--cefotaxime and gentamicin or ciprofloxacin and gentamicin. Depending upon the response by 72 hours, they were crossed over to the other arm or continued with the same combination. Empirical antifungal therapy was added in those who did not become afebrile., Results: Infection was documented either clinically, bacteriologically or radiologically in 42% of the febrile episodes. The commonest organism isolated was Klebsiella and the commonest organism producing bacteraemia was the Staphylococcus. The temperature was reduced to normal without cross-over in 53% of the febrile episodes with cefotaxime and gentamicin and in 60% with ciprofloxacin and gentamicin (p > 0.05). After cross-over the temperature came down in 30% of the episodes with cefotaxime and gentamicin (initial combination) and 40% with ciprofloxacin and gentamicin (initial combination; p > 0.05). The overall response rate without empirical antifungal therapy was 83% in the patients on cefotaxime and gentamicin (initial combination; p > 0.05). While both the arms of the study had a 100% response rate, there was no significant difference between the efficacy of the antibiotic combinations. The ciprofloxacin-gentamicin combination is one-third as expensive as cefotaxime-gentamicin and is more readily available., Conclusion: We recommend the use of ciprofloxacin and gentamicin as the initial drug combination and cefotaxime and gentamicin only when the former is not effective.