Studies have consistently evidenced the positive clinical, economic, and humanistic benefits of pharmacist-directed patient care in a variety of settings. Given the vast differences in clinical outcomes associated with evaluated clinical pharmacy services (CPS), more detail as to the nature of the CPS is needed to better understand observed differences in economic outcomes. With the growing trend of outpatient pharmacy services, these economic evaluations serve as viable decision-making tools in choosing the most effective and cost-effective pharmacy programs. We previously conducted three systematic reviews to evaluate the economic impact of CPS from 1988 to 2005. In this systematic review, our objectives were to describe and evaluate the quality of economic evaluations of CPS published between 2006 and 2010, with the goal of informing administrators and practitioners as to their cost-effectiveness. We searched the scientific literature by using the Medline, International Pharmaceutical Abstracts, Embase, and Cumulative Index to Nursing and Allied Health Literature databases to identify studies describing CPS published from 2006 to 2010. Studies meeting our inclusion criteria (original research articles that evaluated CPS and described economic and clinical outcomes) were reviewed by two investigators. Methodology used, economic evaluation type, CPS setting and type, and clinical and economic outcome results were extracted. Results were informally compared with previous systematic reviews. Of 3587 potential studies identified, 25 met inclusion criteria. Common CPS settings were hospital (36%), community (32%), and clinic or hospital-based ambulatory practices (28%). CPS types were disease state management (48%), general pharmacotherapeutic monitoring (24%), target drug programs (8%), and patient education (4%). Two studies (8%) listed CPS as medication therapy management. Costs were evaluated in 24 studies (96%) and sufficiently described in 13 (52%). Clinical or humanistic outcomes were evaluated in 20 studies (80%) and were sufficiently described in 18 (72%). Control groups were included in 16 (70%) of 23 studies not involving modeling. Study assumptions and limitations were stated and justified in eight studies (32%). Conclusions and recommendations were considered justified and based on results in 24 studies (96%). Eighteen studies (72%) involved full economic evaluation. The mean ± SD study quality score for full economic evaluations (18 studies) was 60.4 ± 22.3 of a possible 100 points. Benefit-cost ratios from three studies ranged from 1.05:1 to 25.95:1, and incremental cost-effectiveness ratios of five studies were calculated and reported. Fewer studies documented the economic impact of CPS from 2006-2010 than from 2001-2005, although a higher proportion involved controlled designs and were full economic evaluations. Evaluations of ambulatory practices were increasingly common. CPS were generally considered cost-effective or provided a good benefit-cost ratio.
Publications
2014
Meta-analyses are increasingly influencing clinical practice, but significant methodological flaws have been reported. The purpose of this study was to evaluate the quality of search strategies utilized by anti-infective meta-analyses. The Embase database was searched for meta-analyses evaluating anti-infective drug therapy; 103 of 268 identified citations met inclusion criteria and were evaluated. A total of 80.6% of meta-analyses used search terms, and an average of 4.3 databases (Medline, 98.1%; Cochrane, 93.2%; Embase, 76.7%) were searched to identify relevant articles for inclusion. The majority of meta-analyses used a quality assessment tool (84.5%) and reported positive results (59.2%). The average impact factor of journals publishing meta-analyses was 5.7 ± 3.4. The number of resources searched was associated with the impact factor ( P = .0013). The majority of anti-infective meta-analyses used rigorous search strategies to identify all relevant studies for evaluation. This finding is inconsistent with reports in other therapeutic areas that have questioned the quality of meta-analyses, and it may increase confidence in anti-infective meta-analyses.
Antibiotic-resistant bacteria are an increasing threat to the effectiveness of antibiotics. The majority of antibiotics are prescribed in primary care settings for upper respiratory tract infections. The purpose of this study was to describe seasonal trends in outpatient antibiotic prescriptions (Rx) in the United States over a 5-year period. This study was a retrospective, cross-sectional observation of systemic antibiotic prescriptions in the outpatient setting from 2006 to 2010. Winter months were defined as the first and fourth quarters of the calendar year. Antibiotic prescribing rates were calculated (prescriptions/1,000 population) using annual U.S. Census Bureau population data. Over 1.34 billion antibiotic prescriptions were dispensed over the 5-year period. The antibiotic prescription (Rx) rate decreased from 892 Rx/1,000 population in 2006 to 867 Rx/1,000 population in 2010. Penicillins and macrolides were the primary antibiotic classes prescribed, but penicillin prescribing decreased while macrolide prescribing increased over the study period. Overall, antibiotic prescriptions were 24.5% higher in winter months than in the summer, with the largest difference (28.8%) in 2008 and the smallest (20.4%) in 2010. This seasonality was consistently drug class dependent, driven by 75% and 100% increases in penicillin and macrolide prescriptions, respectively, in the winter months. The mean outpatient antibiotic prescription rate decreased in the United States from 2006 to 2010. More antibiotic prescribing, predominately driven by the macrolide and penicillin classes, in the outpatient setting was observed in the winter months. Understanding annual variability in antibiotic use can assist with designing interventions to improve the judicious use of antibiotics.
BACKGROUND: Osteoporosis is a major contributor to the propensity to fracture among older adults, and various pharmaceuticals are available to treat it.
PURPOSE: To update a review about the benefits and harms of pharmacologic treatments used to prevent fractures in adults at risk.
DATA SOURCES: Multiple computerized databases were searched between 2 January 2005 and 4 March 2014 for English-language studies.
STUDY SELECTION: Trials, observational studies, and systematic reviews.
DATA EXTRACTION: Duplicate extraction and assessment of data about study characteristics, outcomes, and quality.
DATA SYNTHESIS: From more than 52 000 titles screened, 315 articles were included in this update. There is high-strength evidence that bisphosphonates, denosumab, and teriparatide reduce fractures compared with placebo, with relative risk reductions from 0.40 to 0.60 for vertebral fractures and 0.60 to 0.80 for nonvertebral fractures. Raloxifene has been shown in placebo-controlled trials to reduce only vertebral fractures. Since 2007, there is a newly recognized adverse event of bisphosphonate use: atypical subtrochanteric femur fracture. Gastrointestinal side effects, hot flashes, thromboembolic events, and infections vary among drugs.
LIMITATIONS: Few studies have directly compared drugs used to treat osteoporosis. Data in men are very sparse. Costs were not assessed.
CONCLUSION: Good-quality evidence supports that several medications for bone density in osteoporotic range and/or preexisting hip or vertebral fracture reduce fracture risk. Side effects vary among drugs, and the comparative effectiveness of the drugs is unclear.
PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and RAND Corporation.
OBJECTIVES: A "chiral switch" occurs in the pharmaceutical market when a drug made up of 2 enantiomer forms is replaced with a purified single-enantiomer version, often in the context of a patent expiration. We studied the prevalence of chiral switching in the United States over the past decade, including trends in use of, and expenditures on, these products in Medicaid.
STUDY DESIGN: Retrospective analysis.
METHODS: We used US Adopted Names prefixes (lev/levo/ar/es/dex/dextro) to identify all single-enantiomer drugs approved from 2001 to 2011. From publicly available US Food and Drug Administration (FDA) approval documents, we extracted the characteristics of the pivotal premarket trials for the single enantiomers. Specifically, we evaluated whether the single enantiomer was directly compared with the precursor racemic drug and whether there was evidence of superior efficacy. We used quarterly drug expenditure data from each state Medicaid program to chart trends in use of, and spending on, the single-enantiomer products and their racemic precursors during the study period.
RESULTS: From 2001 to 2011, the FDA approved 9 single-enantiomer products: dexlansoprazole, levoleucovorin, levocetirizine, armodafinil, arformoterol, eszopiclone, escitalopram, dexmethylphenidate, and esomeprazole. Of those 9 drugs, 3 had at least 1 pre-approval randomized trial that included the racemic precursor as a direct comparator, but there was no evidence of superiority of the single enantiomer over the racemic at comparable doses. Between 2001 and 2011, US Medicaid programs spent approximately $6.3 billion on these 9 single-enantiomer drugs.
CONCLUSIONS: Recently approved single-enantiomer drugs showed no evidence of superior efficacy over the older racemic precursors in the pivotal trials leading to their approval, and in a majority of cases, they were not directly compared.
BACKGROUND: Clinical trials often compare hypoglycemic medications on the basis of glycemic control but do not examine long-term outcomes (e.g., mortality). This study demonstrates an alternative approach to lengthening clinical trials to assess these long-term outcomes.
OBJECTIVE: To use observational quasi-experimental methods using instrumental variables (IVs) to compare the effect of two hypoglycemic medications, sulfonylureas (SUs) and thiazolidinediones (TZDs), on long-term outcomes.
METHODS: This study used administrative data from the Veterans Health Administration and Medicare from 2000 to 2010. The study population included US veterans dually enrolled in Medicare who received a prescription for metformin and then initiated SUs or TZDs. Patients could either continue on or discontinue metformin after the initiation of the second agent. Treatment was defined as starting either a SU or a TZD. Local variations in SU prescribing rates were used as instruments in IV models to control for selection bias. Survival models predicted all-cause mortality, ambulatory care sensitive condition hospitalizations, and stroke or heart attack (acute myocardial infarction).
RESULTS: Starting on SUs compared to TZDs significantly increased the likelihood of experiencing mortality and ACSC hospitalization. The estimated hazard ratio for the effect of starting on SUs compared to TZDs was 1.50 (95% confidence interval [CI] 1.09-2.09) for all-cause mortality, 1.68 (95% CI 1.31-2.15) for ambulatory care sensitive condition hospitalization, and 1.15 (95% CI 0.80-1.66) for acute myocardial infarction or stroke.
CONCLUSIONS: Our findings suggest increased risk of major adverse events associated with SUs as a second-line agent. Quasi-experimental IV methods may be an important alternative to lengthening clinical trials to assess long-term outcomes.