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Prescription drug expenditures in the United States have been the fastest growing component of healthcare spending over the past several years. Although the actual rate of increase varies from year [...]

Background: The 2006 FDA’s Unapproved Drug Initiative (UDI) aimed to improve safety and public health by decreasing the availability of drug products that never obtained FDA approval (unapproved drug products) in the market and incentivizing manufacturers to emphasize that these products must obtain FDA approval. The objective of this study was to measure changes in the prices, sales, and quantities sold of drug products approved under the FDA-UDI. Methods: Drug products that obtained voluntary approval under FDA-UDI from 2006 to 2015 were identified and trends in prices, sales, and units sold were analyzed using the IQVIA National Sales Perspective database. Results: Eleven drug products were included in the final analysis. Relative to baseline levels 2 years before approval, a steep increase in price and sales was observed 2 years postapproval for all except 2 of the drug categories—with median percent change of 245% (range: −37% to 9618%) for price and 238% (range: −4% to 6707%) for sales. Substantial variance was observed in the changes in units sold. Conclusion: A marked increase was seen in postapproval prices and sales for the vast majority of drug products approved in the FDA-UDI with mixed results in changes in units sold. In addition to increased information on safety, the policy’s impact on postapproval drug prices and associated effects on units sold should be considered in assessing the policy, especially when substantial price increases and decreases in units sold may negatively impact health.

Background: The 2006 FDA’s Unapproved Drug Initiative (UDI) aimed to improve safety and public health by decreasing the availability of drug products that never obtained FDA approval (unapproved drug products) in the market and incentivizing manufacturers to emphasize that these products must obtain FDA approval. The objective of this study was to measure changes in the prices, sales, and quantities sold of drug products approved under the FDA-UDI.Methods: Drug products that obtained voluntary approval under FDA-UDI from 2006 to 2015 were identified and trends in prices, sales, and units sold were analyzed using the IQVIA National Sales Perspective database.Results: Eleven drug products were included in the final analysis. Relative to baseline levels 2 years before approval, a steep increase in price and sales was observed 2 years postapproval for all except 2 of the drug categories—with median percent change of 245% (range: –37% to 9618%) for price and 238% (range: –4% to 6707%) for sales. Substantial variance was observed in the changes in units sold.Conclusion: A marked increase was seen in postapproval prices and sales for the vast majority of drug products approved in the FDA-UDI with mixed results in changes in units sold. In addition to increased information on safety, the policy’s impact on postapproval drug prices and associated effects on units sold should be considered in assessing the policy, especially when substantial price increases and decreases in units sold may negatively impact health.

Evidence from comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) studies are increasingly available in the literature. However, there remain opportunities to better integrate that evidence into decision-making. An invitation-only conference held in January 2017, titled “Comparative Effectiveness and Patient-Centered Outcomes Research: Enhancing Uptake and Use by Patients, Clinicians and Payers”, sought to identify and discuss both gaps in the uptake and use of CER/PCOR, and approaches to enhance the uptake and use of CER/PCOR evidence by patients, clinicians and payers. In this article, we summarize the conference proceedings, and highlight the themes and recommendations that resulted from the sessions. This paper also introduces other articles in this issue of CER from that conference.

The term comparative effectiveness research (CER) took center stage with passage of the American Recovery and Reinvestment Act (2009). The companion US$1.1 billion in funding prompted the launch of initiatives to train the scientific workforce capable of conducting and using CER. Passage of the Patient Protection and Affordable Care Act (2010) focused these initiatives on patients, coining the term ‘patient-centered outcomes research’ (PCOR). Educational and training initiatives were soon launched. This report describes the initiative of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Foundation. Through provision of grant funding to six academic Centers of Excellence, to spearheading and sponsoring three national conferences, the PhRMA Foundation has made significant contributions to creation of the scientific workforce that conducts and uses CER/PCOR.

Background:The recent approval of several fixed-dose combination long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) products has increased the use of dual bronchodilators in the treatment of chronic obstructive pulmonary disease (COPD). Understanding the comparative safety of this combination is important for informing treatment decisions. Objective:To compare the risk of cardiovascular and cerebrovascular (CCV) events associated with LABA/LAMA compared with a combination of LABA and inhaled corticosteroid (ICS). Methods:This was a retrospective, observational cohort study using health insurance claims data to identify COPD patients initiating LABA/LAMA or LABA/ICS. CCV outcomes included hospitalizations with a primary diagnosis for acute coronary syndrome, heart failure, cardiac dysrhythmia, stroke, or transient ischemic attack. Patients were followed until they experienced an event, discontinued treatment, initiated medication from the opposite cohort, or lost enrollment. Patients were matched 1:4 on propensity scores, and time to event was compared using Cox proportional hazards models. Results:After matching, there were 3842 patients in the LABA/LAMA cohort and 15 225 in the LABA/ICS cohort. Cardiovascular events in the LABA/LAMA cohort were lower than in the LABA/ICS: hazard ratio (HR) = 0.794; 95% CI = 0.623-0.997. No significant difference in the risk of cerebrovascular events (HR = 1.166; 95% CI = 0.653-1.959) was observed. Conclusions:Despite concerns about the CCV effects of LAMA and LABA monotherapy, the LABA/LAMA combination had similar or lower risk of these events in comparison to LABA/ICS. Further studies are recommended to confirm these findings.

The validity of algorithms used to identify health outcomes in claims-based and administrative data is critical to the reliability of findings from observational studies. The traditional approach to algorithm validation, using medical charts, is expensive and time-consuming. An alternative method is to link the claims data to an external, electronic data source that contains information allowing confirmation of the event of interest. In this paper, we describe this external linkage validation method and delineate important considerations to assess the feasibility and appropriateness of validating health outcomes using this approach. This framework can help investigators decide whether to pursue an external linkage validation method for identifying health outcomes in administrative/claims data.

AbstractObjective:The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D, and of phosphate binders, in patients in the IMPACT SHPT study; and to extrapolate those to estimate expected annual maintenance costs.Methods:IMPACT SHPT was a 28-week, randomized, open-label trial. Subjects from 12 countries received intravenous (IV) or oral paricalcitol, or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol. The primary end-point was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) value of 150–300 pg/mL during weeks 21–28 (evaluation period). This study compares the costs of study drugs and phosphate binders among participants during the study and annualized. This analysis includes only those subjects that reached the evaluation period (134 in each group).Results:The mean total drug costs over the study period were €2606 (SD  €2000) in the paricalcitol group and €3034 (SD  €3006) in the cinacalcet group (difference €428, p  0.1712). The estimated annualized costs were €5387 (SD  €4139) in the paricalcitol group and €6870 (SD  €6256) in the cinacalcet group (difference €1492, p  0.0395). In addition, a significantly greater proportion (p  0.010) of subjects in the paricalcitol arm (56.0) achieved an iPTH of 150–300 pg/mL during the evaluation period compared to the cinacalcet arm (38.2).Limitations:This was a secondary analysis of the IMPACT SHPT study which was not designed or powered for costs as an outcome. The dosing of study drugs and phosphate binders in the IMPACT study may not reflect actual practice, and patients were followed for 28 weeks, while the treatment of SHPT is long-term.Conclusion:Patients with SHPT requiring hemodialysis who were treated with a paricalcitol-based regimen for iPTH control had lower estimated annual drug costs compared to those treated with cinacalcet plus low-dose vitamin D.

Acute exacerbations of COPD (AE-COPD) are a leading cause of hospitalizations in the United States. To estimate the burden of disease (eg, prevalence and cost), identify opportunities to improve care quality (eg, performance measures), and conduct observational comparative effectiveness research studies, various algorithms based on the International Classification of Diseases, Ninth Revision, Clinical Modification(ICD-9-CM) codes have been used to identify patients with COPD. However, the validity of these algorithms remains unclear.

The purpose of this study was to examine the association between leukotriene-modifying agents (LTMAs) and completed suicide. Data from the Food and Drug Administration (FDA) Adverse Event Reporting System from 1999 to 2009 were used to identify the number of completed suicides for each LTMA. Data from IMS Health were used to determine the number of prescriptions dispensed by drug in the same time period. The authors calculated the rate of completed suicides per million prescriptions and, using a mixed-effects Poisson regression analysis, determined the empirical Bayes (EB) rate multipliers and 95% confidence intervals for each drug. Selective serotonin-reuptake inhibitors (SSRIs) and short-acting beta-agonist (SABAs) were analyzed for comparison purposes. There were 105 completed suicides reported where a LTMA was implicated. Most (n ¼ 101) involved montelukast, and all but 9 occurred in 2008 to 2009, following an FDA warning. Aggregated suicide rates over the 1999-2009 period were 0.51, 0.24, and 4.09 per million prescriptions for montelukast, zafirlukast, and zileuton. The suicide rate as a class was 0.06 per million prescriptions in the prewarning period and 1.82 per million prescriptions in the postwarning period. Montelukast was associated with a significantly lower rate of suicide when compared to SSRIs and a significantly higher rate when compared to SABAs.

AbstractBackground/Aims:Parathyroidectomies are performed when medical therapy fails to control secondary hyperparathyroidism in hemodialysis patients. The objective of this study was to compare parathyroidectomy rates in secondary hyperparathyroidism patients treated with paricalcitol or cinacalcet. Methods:Retrospective cohort study using health insurance claims from January 2001 through June 2007 for adult hemodialysis patients who were new users of paricalcitol or cinacalcet. Subjects had a minimum of 12 months’ enrollment prior to initiation of treatment and at least 30-day follow-up. Results:We identified 1,387 paricalcitol- and 1,317 cinacalcet-treated patients. The parathyroidectomy incident rate was 74 lower in the paricalcitol (0.58 per 100 patient-years) compared to the cinacalcet (2.24 per 100 patient-years) cohort, with an unadjusted rate ratio of 0.26 (95 CI 0.12–0.52). The time to parathyroidectomy from medication initiation was longer for paricalcitol than cinacalcet; however, it was not statistically significant (535 vs. 443 days, p = 0.377). A Cox proportional hazard model that adjusted for age, gender, obesity, significantly different comorbidities, and duration of hemodialysis resulted in an adjusted risk reduction for parathyroidectomy of 79 (HR = 0.21, 95 CI 0.10–0.46) for paricalcitol compared to cinacalcet. Conclusion:These data suggest that long-term treatment with paricalcitol is associated with fewer parathyroidectomies when compared to cinacalcet. Further comparative studies are needed to validate these results.Copyright © 2010 S. Karger AG, Basel

AbstractBackground/Aims:The objective of this study was to examine health care costs and utilization and the risks of dialysis or mortality among diabetic predialysis chronic kidney disease (CKD) patients with and without secondary hyperparathyroidism (SHPT). Methods:This retrospective, matched cohort study examined insurance claims from 703 adult diabetic predialysis CKD patients with and without SHPT during a 72-month follow-up period. Annualized estimates of health care service utilization, costs and disease progression to dialysis or death following index CKD diagnosis were compared. Results:Preindex (baseline) characteristics were similar between the cohorts. Postindex numbers of prescription utilization, outpatient service utilization and hospitalizations were all higher (p < 0.0001) in diabetic CKD patients with SHPT compared to those without SPHT in both unadjusted and adjusted analyses even after multivariate adjustment for known confounders. The rate of progression to dialysis or death was higher for diabetic CKD patients with SHPT compared to those without SPHT. Those with SHPT were at higher risk of requiring dialysis treatment [hazard ratio (HR) = 6.7; 95 confidence interval (CI) = 4.3–10.6] and death (HR = 2.3; 95 CI = 1.1–4.9) compared to those without SHPT. Conclusion:In diabetic predialysis CKD patients, the presence of SHPT is associated with significantly greater health care resource utilization and costs, and a faster rate of disease progression.Copyright © 2009 S. Karger AG, Basel

Background: No data exist that demonstrate the impact of comprehensive acute decompensated heart failure (ADHF) treatment guidelines on clinical and economic outcomes in hospitalized patients with this condition.Objectives: To compare clinical and economic outcomes before and after implementation of treatment guidelines for ADHF.Methods: A single-center, retrospective, chart review study was conducted in a university hospital. ADHF treatment guidelines were developed and implemented on January 1, 2004. Patients hospitalized for ADHF between January 2003 and November 2004 were identified using the Acute Decompensated Heart Failure Registry. Study periods were 12 months prior to and the 11 months following guideline implementation.Results: This cohort was comprised of 683 ADHF hospitalizations (357 preguideline, 326 postguideline); several patients were admitted more than once. There was a trend toward increased use of intravenous vasoactive drugs (VADs) following guideline implementation (19.9% vs 24.2%; p = 0.05). The duration of intravenous VAD use decreased by more than 40% following guideline implementation, but this was not statistically significant after risk adjustment (p = 0.22). The need for intensive care unit monitoring decreased from 45.1% before guideline implementation to 25.3% following guideline implementation (p < 0.02) in patients treated with intravenous VADs. The need for mechanical ventilation was reduced by nearly 80% (p = 0.04) following guideline implementation. Significantly more patients of the postguideline cohort were prescribed β-blockers at discharge (54.9% vs 75.2%; p = 0.0001). Costs were not significantly different between the groups.Conclusions: Implementation of ADHF treatment guidelines was associated with reduced need for mechanical ventilation, improved utilization of β-blockers at discharge, and trends toward increased use of intravenous VADs, while not significantly changing total costs. More rigorous studies need to be conducted to estimate the true effect of treatment guidelines on ADHF care and outcomes.

To examine long-term changes in the U.S. pharmacist labor market across states.

Background: It is unclear to what extent hospitals use guidelines or protocols in treating acute decompensated heart failure (ADHF) and whether nesiritide is included in these guidelines or protocols.Objective: To assess the formulary status of currently used drugs, therapeutic guidelines, and perceptions about the appropriateness of treatment of ADHF in community hospitals.Methods: A Web-based survey of pharmacy directors at community hospitals that were part of a national group purchasing organization was conducted.Results: One hundred seven hospitals participated in the survey (response rate 47.1%). Diuretics such as furosemide and bumetanide were more commonly included (100% and 94.4%, respectively) on hospital formularies than was torsemide (69.2%). Dopamine and dobutamine were more common (94.4% each) on the formulary than was milrinone (68.2%), Nitroprusside and nitroglycerin were listed on the formularies of more than 90% of participating institutions, while nesiritide was listed on the formularies in only 48.6% of hospitals and was placed on restricted status in 36.4% of hospitals. Guidelines for care of patients with ADHF were used in the emergency department (ED), inpatient care units, and outpatient clinics in 18.6%, 43.0%, and 8.5% of hospitals, respectively. Overall, ADHF care, including general treatment as well as specific use of nesiritide, was deemed appropriate in the majority of patients, but nearly twice as many respondents perceived the management of ADHF and specific use of nesiritide as inappropriate in the ED compared with inpatient treatment. Only 41.1% of the respondents reported following Braunwald recommendations for the use of nesiritide.Conclusions: A sizable percentage of responding community hospitals do not have guidelines for treatment of ADHF despite the existence of such guidelines in the literature. There are opportunities for improvement in the general treatment of ADHF as well as for the use of nesiritide in ADHF, especially in the ED or observation unit versus inpatient units.

BACKGROUND Anticoagulants are widely used and represent a class of drugs that are problem-prone and have a high potential for adverse patient outcomes. As such, these drugs may be amenable to the use of prescribing guidelines. However, relatively little has been published on the effect of such guidelines on clinical outcomes or costs of care.OBJECTIVE To assess whether guidelines improve the appropriateness of prescribing, clinical outcomes, and costs associated with use of anticoagulants in a sample of community hospitals in the US.METHODS A retrospective analysis was performed of data voluntarily collected by 15 hospitals before (July—September 2001) and after (March—May 2002) implementation of anticoagulant prescribing guidelines. Statistical analyses of both patient- and hospital-level variables were conducted.RESULTS Implementation of the guidelines resulted in a significant increase in the proportion of anticoagulants that were prescribed appropriately (59.8% vs 86.9%; p < 0.001). The guidelines also resulted in a shift in the type of anticoagulants prescribed (decreased use of unfractionated heparin and increased use of low-molecular-weight heparins). There was suggestive evidence, although not statistically significant, that the guidelines resulted in fewer anticoagulant-associated adverse events (total bleeding RR 0.71) and lower costs (savings of $56.15 per patient per day).CONCLUSIONS While limitations existed with the study design, sufficient benefits were identified to warrant hospitals to consider use of these or similar guidelines on a routine basis. Clearly, additional study in this area would be useful.

BACKGROUND Strategies to control the quality and cost of medication use are largely dependent on the ability to alter selection of medications. Previous models of prescribing behavior have focused on physicians. In the hospital setting, clinical pharmacists and formulary committee members are also key players in drug therapy decision-making. Differences between physicians, formulary committee members, and clinical pharmacists have not been compared. Knowledge of these differences could have importance in predicting the effectiveness of strategies designed to influence drug use in this setting.OBJECTIVE To describe and compare the opinions of physicians, clinical pharmacists, and formulary committee members with respect to key factors that influence medication prescribing in community hospitals.METHODS Physicians, clinical pharmacists, and formulary committee members were solicited to participate. A trained interviewer administered a standardized questionnaire designed to elicit opinions of participants regarding the importance of factors thought to influence drug prescribing. Responses were described using descriptive statistics, and differences between the groups were determined by post hoc analysis.RESULTS A total of 150 individuals participated in the study. Safety, effectiveness, formulary status, and restrictions on prescribing were considered highly influential by all participants. Physicians rated the availability of drug samples and personal experience higher (more influential on prescribing) than clinical pharmacists and formulary committee members. Clinical pharmacists and formulary committee members rated the influence of recommendations by clinical pharmacists, prescribing guidelines, and cost or cost comparisons higher than physicians. Factors that were drug-related or that involved policy-related programs tended to be more influential than indirect factors.CONCLUSIONS Those who seek to implement programs to alter medication use should recognize and employ factors that are most influential in the decision-making process. Further, it may be important to consider differences that exist between key participants in the medication use process.

OBJECTIVE To describe the development of guidelines for the treatment of acute decompensated heart failure (ADHF) in the emergency department/observation unit (ED-OU) setting for hospitals that are part of a group purchasing organization (GPO).DATA SOURCES A MEDLINE search (1966-March 2003) using the following search terms: cardiotonic agents; diuretic; dobutamine; heart failure, congestive; milrinone; natriuretic peptide, brain; nesiritide; nitroglycerin; vasodilator agents, was conducted.STUDY SELECTION AND DATA EXTRACTION Relevant articles in the English language were identified. All randomized studies and meta-analyses for each category of drugs were included.DATA SYNTHESIS A group consensus method was used to develop guidelines. An expert panel reviewed and revised the guidelines. The final guidelines were approved June 1, 2003, and are described here. They are organized based upon a patient's symptomatology at the time the diagnosis of ADHF is made. Patients with evidence of volume overload require intravenous diuretics and/or intravenous vasodilators to alleviate the symptoms of ADHF. Patients with signs and symptoms of low cardiac output require inotropic support to manage their ADHF. A timeline for diagnosis, treatment, reassessment, and disposition is provided and encourages an early, aggressive approach to treating patients with ADHF.CONCLUSIONS Hospitalization for ADHF is common and costly. Consensus guidelines for the treatment of ADHF did not previously exist, resulting in inconsistent and inefficient treatment. Consequently, hospitals struggling with the treatment of ADHF may find these guidelines and the process by which they were developed useful. THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT ACPE UNIVERSAL PROGRAM NUMBER:407-000-04-015-H01

OBJECTIVE: To describe the development of guidelines for initial use of low-molecular-weight heparins (LMWHs) and other anticoagulants in acute-care hospitals that are part of a national group purchasing organization (GPO).DATA SOURCES: A systematic literature search (1970–December 2001) was conducted to identify evidence on the efficacy of various anticoagulants for initial therapy in deep-vein thrombosis and pulmonary embolism, and in treatment of acute coronary syndrome. A group consensus method was then used to develop guidelines. Guidelines were reviewed and revised by an internal expert panel as well as an external expert panel. Final guidelines were disseminated to GPO members and assistance was provided with implementation at the local level.RESULTS: The final set of guidelines is described. The guidelines are organized based on recommended therapeutic options for each indication. For each option, consensus opinion is provided on the level of evidence that exists in the literature, comparisons of cost and convenience, and additional dosing information. The guidelines were disseminated along with supporting material to interested GPO member hospitals, and teleconferences were held to facilitate implementation at the local level. The guidelines were initially implemented at 18 hospitals across the country.CONCLUSIONS: The process by which these guidelines were developed, plus the final set of guidelines, may be useful to hospitals and healthcare systems contemplating or engaged in a similar effort with this class of drugs.

Studies that demonstrate the clinical and economic burden of drug misadventures have been published. The economic burden of drug misadventures likely exceeds $100 billion annually in the United States alone. Clinical pharmacy services (CPS) have been shown to reduce negative clinical outcomes and costs of drug therapy. Pharmacy practitioners and pharmacy managers need to demonstrate the impact of CPS at the local level and present the value to financial decision‐makers to gain support for implementation, continuation, and/or expansion of those services. The basic model of an economic evaluation includes measurement of both costs and consequences of a service and of an alternative for comparison. Strategies for economic assessments include the generalization from previously published literature, use of modeling techniques, and measurement of actual costs and consequences of an existing service. Guidelines for conducting an economic assessment are widely available. Pharmacy practitioners and managers should use these methods of assessing economic outcomes of CPS and, at the same time, develop relationships and skills to effectively communicate the value of those services so as to ensure long‐term success.

We conducted a retrospective analysis to identify characteristics of preventable adverse drug reactions (ADRs). We reviewed reports on 612 ADRs occurring in hospitalized patients over 4 years, identified by the hospital's spontaneous ADR reporting program, and classified the events as potentially preventable or not preventable. Characteristics related to ADR preventability in the univariate analysis were the patient's clinical service, organ system involved in the ADR, class of drug causing the ADR, relationship to dosage, type of ADR, and probability that the reaction was due to the drug. Among these, relationship to dosage (p<0.001) and type of ADR (p<0.001) appeared to be most strongly related to preventability. In a multivariate analysis, preventable ADRs were associated with dosing (OR 3.82, 95% CI 2.42‐6.03) and previous allergy to the drug (OR 3.46, 95%CI 1.01–11.88). An ADR that was classified as an allergic (OR 0.50, 95% CI 0.27‐0.94) or idiosyncratic reaction (OR 0.44, 95% CI 0.28‐0.71) was unlikely to be considered preventable. Preventable ADRs in hospitalized patients are likely to be dosage related or to occur among patients allergic to the specific agent.

Alzheimer's disease (AD) is the third most expensive disease in the United States, costing society approximately $100 billion each year. It is one of the most prevalent illnesses in the elderly population, and with the aging of society, will become even more significant. Costs associated with AD include direct medical costs such as nursing home care, direct nonmedical costs such as in‐home day care, and indirect costs such as lost patient and caregiver productivity. Medical treatment may have economic benefits by slowing the rate of cognitive decline, delaying institutionalization, reducing caregiver hours, and improving quality of life. Pharmacoeconomic evaluations have shown positive results regarding the effect of drug therapy on nursing home placement, cognition, and caregiver time.

OBJECTIVE: To determine the role of inhaled corticosteroids in the treatment of mild chronic asthma.SOURCE OF STUDIES: Searches of MEDLINE and Index Medicusfor English language literature dealing with asthma and inhaled corticosteroids.DESIGN: All retrieved articles were subjected to predetermined criteria for inclusion in the meta-analysis. Inclusion criteria centered around randomized, double-blind studies reporting objective clinical endpoint(s) for subjects with mild chronic asthma who were treated for more than seven days. Studies that were included were not allowed to have any predetermined exclusion criteria.RESULTS: The literature search identified 129 articles, of which 41 satisfied some but not all of the criteria for inclusion. Five articles met all the criteria and were subjected to meta-analysis. The total number of subjects was 141. Peak expiratory flow rate (PEFR) was used as the objective endpoint for effect size calculation. Subjecting these five studies to quality review revealed a range of 0.607–0.741, with 1 as the highest attainable quality and 0 the lowest. Reported results for the different studies were found to be homogenous, thus allowing for the calculation of overall effect size. Inclusion of children in some of the studies added variance to the reported studies, but not to the point at which studies would be considered heterogenous. Effect sizes ranged between 0.41 and 0.89, and the overall weighted average effect size for PEFR was 0.59, with the calculated 95 percent confidence interval at 0.32 to 0.84. A tabulated display of binomial effect size for included trials provided ranges of success rates for treatment versus control values. Results of the studies were judged robust, as 92 studies reporting no significant effects are needed to turn the finding of the meta-analysis insignificant.CONCLUSIONS: Based on the results of the meta-analysis, the existing literature suggests a role for inhaled corticosteroids in the treatment of mild chronic asthma.

No relevant conflicts of interest to declare.

No relevant conflicts of interest to declare.

The article reports on the concern of community pharmacists on the issue of prescription drug importation in the U.S. A telephone interview was conducted to community pharmacists. They agreed on their experiences with consumer demand for international imported pharmaceuticals. They also believe that unsupervised importation may increase the risk of counterfeiting and reduce patient safety.

While studies have reported clinical and adverse outcomes of individual anticoagulation clinics (ACC), collective data from ACC has not been reported. The objective of the study was to assess efficacy, safety, monitoring, and resource utilization outcomes associated with warfarin therapy in US ACC. We conducted a postal survey among the members of the Anticoagulation Forum (AF) in January 2006. The response rate was 27.9% (146 of 524 clinics); respondents were spread across 36 states in the US and together were representative of a base of 94,177 patients (pts). The majority of respondents were pharmacists (61%, 89 of 146) affiliated with hospitals (62.3%, 91 of 146). Atrial fibrillation and venous thromboembolisms were the 2 most common indications for anticoagulation therapy. The median time devoted to a new and follow-up visit was 30 and 15 minutes respectively. The median number of visits required for dose adjustment for warfarin nai¨ve and established pts were 4 and 1.5 respectively per patient per month. The median % of pts having difficulty in attaining therapeutic international normalized ratio (INR) in the first 4–6 weeks of therapy was 10, as was the % of pts whose INR was poorly controlled (in range <50% of time). The median % of pts with INR controlled within therapeutic and expanded therapeutic (+/- 0.2) range was 65% and 77.5% respectively, and it took a median of 10 days to reach therapeutic INR in both groups of pts. The median % of pts who visited the emergency room (ER) and those who were hospitalized due to warfarin related adverse drug event was 2% and 1.5% respectively. Warfarin associated adverse drug event fatality rate was 0.2±0.8%. The median % of pts who develop a thromboembolic event (TE), major and minor bleeding at least once during therapy with warfarin was reported to be 1, 1 and 10% respectively. Drug interactions of warfarin and poor patient compliance were reported to be the two most important barriers for maintaining desired anticoagulation levels. We also performed an item-to-item comparison of the actual efficacy and safety data of warfarin from the present survey with a previous perception-based, in-person survey, conducted in May 2005. The response rate of the in-person survey was 56% (329 of 586). Respondent’s demographics were comparable in both surveys. Comparison of the perceived and the actual rates for warfarin related ER visits, hospitalization, TE events, and mortality rate is illustrated in (Figure1). In the perception based survey, respondents underrated the efficacy of warfarin and overrated the adverse outcomes of warfarin. It is possible that this perception contributes to the underutilization of warfarin. This is the first study to report aggregate data on efficacy, safety, monitoring, and resource utilization outcomes associated with warfarin therapy in US ACC. This data can be used as a benchmark by individual ACC to rate their performance, identify opportunities for improvement and as a source of secondary data for pharmacoeconomic and outcomes research studies. Figure 1. Comparison of perception vs the actual adverse outcomes of warfarin therapy Figure 1. Comparison of perception vs the actual adverse outcomes of warfarin therapy