Daniel C Malone

Interests

Teaching

Health technology assessmentCost-effectiveness analysisBayesian network meta-analysisHealth informatics

Research

Drug-Drug Interactions and Health Care Knowledge SystemsCost-effectiveness AnalysisOutcomes Research

Courses

Scholarly Contributions

Journals/Publications

• Grizzle, A. J., Horn, J., Collins, C., Schneider, J., Malone, D. C., Stottlemyer, B., & Boyce, R. D. (2019). Identifying Common Methods Used by Drug Interaction Experts for Finding Evidence About Potential Drug-Drug Interactions: Web-Based Survey. Journal of medical Internet research, 21(1), e11182.
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  Preventing drug interactions is an important goal to maximize patient benefit from medications. Summarizing potential drug-drug interactions (PDDIs) for clinical decision support is challenging, and there is no single repository for PDDI evidence. Additionally, inconsistencies across compendia and other sources have been well documented. Standard search strategies for complete and current evidence about PDDIs have not heretofore been developed or validated.
• Panich, J., Gooden, A., Shirazi, F. M., & Malone, D. C. (2019). Warnings for drug-drug interactions in consumer medication information provided by community pharmacies. Journal of the American Pharmacists Association : JAPhA, 59(1), 35-42.
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  In 2006, the U.S. Food and Drug Administration (FDA) issued a draft guidance for pharmacies to provide consumer medication information (CMI) to patients receiving prescription medications. The objective of this study was to evaluate CMI leaflets provided by community pharmacies for accuracy and completeness regarding drug-drug interactions (DDIs).
• Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A. C., Devlin, N., Flechtner, H. H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J. F., King, M., , Kluetz, P. G., et al. (2018). Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials. Clinical trials (London, England), 15(6), 624-630.
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  There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs.
• Geskin, L., & Malone, D. C. (2018). An exploratory cost-effectiveness analysis of systemic treatments for cutaneous T-cell lymphoma. The Journal of dermatological treatment, 29(5), 522-530.
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  To conduct an exploratory cost-effectiveness analysis of systemic treatment options for more advanced cutaneous T-cell lymphoma (CTCL).
• Ip, Q., Malone, D. C., Chong, J. W., Harris, R. B., & Labiner, D. M. (2018). An update on the prevalence and incidence of epilepsy among older adults. Epilepsy Research, 139, 107-112.
• Ip, Q., Malone, D. C., Chong, J., Harris, R. B., & Labiner, D. M. (2018). Economic impact of epilepsy and the cost of nonadherence to antiepileptic drugs in older Medicare beneficiaries. Epilepsy & behavior : E&B, 80, 208-214.
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  Epilepsy is most prevalent among older individuals, and its economic impact is substantial. The development of economic burden estimates that account for known confounders, and using percent incremental costs may provide meaningful comparison across time and different health systems. The first objective of the current study was to estimate the percent incremental healthcare costs and the odds ratio (OR) for inpatient utilization for older Medicare beneficiaries with epilepsy and without epilepsy. The second objective was to estimate the percent incremental healthcare costs and the OR for inpatient utilization associated with antiepileptic drug (AED) nonadherence among Medicare beneficiaries with epilepsy. The OR of inpatient utilization for cases compared with controls (i.e., non-cases) were 2.4 (95% CI 2.3 to 2.6, p-value
• Ip, Q., Malone, D. C., Chong, J., Harris, R., & Labiner, D. (2018). Economic impact of epilepsy and the cost of nonadherence to antiepileptic drugs in older Medicare beneficiaries. Epilepsy & Behavior.
• Khalaf, K. M., Coyne, K. S., Globe, D. R., Armstrong, E. P., Malone, D. C., & Burks, J. (2018). Lower urinary tract symptom prevalence and management among patients with multiple sclerosis. International journal of MS care, 17(1), 14-25.
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  This study was conducted to assess self-reported prevalence and management of lower urinary tract symptoms (LUTS), along with drivers of treatment seeking, among patients with multiple sclerosis (MS).
• Malone, D. C. (2018). Are US Health Insurers Efficient or Not?. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 21(4), 398-399.
• Malone, D. C., Brown, M., Hurwitz, J. T., Peters, L., & Graff, J. S. (2018). Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 21(3), 326-333.
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  To examine how real-world evidence (RWE) is currently perceived and used in managed care environments, especially to inform pharmacy and therapeutic (P&T) committee decisions, to assess which study factors (e.g., data, design, and funding source) contribute to RWE utility in decisions, and to identify barriers to consideration of RWE studies in P&T decision making.
• Malone, D. C., Hurwitz, J. T., Brown, M., Peters, L., & Graff, J. (2018). Real-world evidence: useful in the real world of US payer decision making? How? When? And what studies?. Value in Health, 21(2).
• Pe, M., Dorme, L., Coens, C., Basch, E., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dirven, L., Dueck, A. C., Devlin, N., Flechtner, H. H., Gotay, C., Griebsch, I., Groenvold, M., King, M., Koller, M., Malone, D. C., , Martinelli, F., et al. (2018). Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review. The Lancet. Oncology, 19(9), e459-e469.
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  Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017. Eligible articles were those that reported PRO results from RCTs of adult patients with advanced breast cancer receiving anti-cancer treatments with reported sample sizes of at least 50 patients-66 RCTs met the selection criteria. Only eight (12%) RCTs reported a specific PRO research hypothesis. Heterogeneity in the statistical methods used to assess PRO data was observed, with a mixture of longitudinal and cross-sectional techniques. Not all articles addressed the problem of multiple testing. Fewer than half of RCTs (28 [42%]) reported the clinical significance of their findings. 48 (73%) did not report how missing data were handled. Our systematic review shows a need to improve standards in the analysis, interpretation, and reporting of PRO data in cancer RCTs. Lack of standardisation makes it difficult to draw robust conclusions and compare findings across trials. The Setting International Standards in the Analyzing Patient-Reported Outcomes and Quality of Life Data Consortium was set up to address this need and develop recommendations on the analysis of PRO data in RCTs.
• Siaw, M. Y., Malone, D. C., Ko, Y., & Lee, J. Y. (2018). Cost-effectiveness of multidisciplinary collaborative care versus usual care in the management of high-risk patients with diabetes in Singapore: Short-term results from a randomized controlled trial. Journal of clinical pharmacy and therapeutics, 43(6), 775-783.
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  Economic evidence of multidisciplinary collaborative care on glycaemic improvement in uncontrolled diabetic patients is limited. Therefore, the primary objective of this study was to assess the cost-effectiveness of multidisciplinary collaborative care versus usual care and the secondary objective was to assess the cost-effectiveness of these two care approaches in relation to varying glycaemic control of patients.
• Tate, W., Katragadda, C., Warholak, T. L., Hines, L., Verdell, A., Taylor, A., Brown, M., Hurwitz, J., & Malone, D. C. (2018). Quantitative Analysis of a Comparative Effectiveness Research (CER) Workshop on the Agency for Healthcare Research and Quality (AHRP) CER Website. ?, ?(?), ?.
• Trinkley, K. E., Anderson, H. D., Nair, K. V., Malone, D. C., & Saseen, J. J. (2018). Assessing the incidence of acidosis in patients receiving metformin with and without risk factors for lactic acidosis. Therapeutic advances in chronic disease, 9(9), 179-190.
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  Despite strong recommendations to use metformin as first-line therapy for type 2 diabetes (T2DM), its use has been suboptimal, likely due to concerns of lactic acidosis. This study compared the association of acidosis in patients with T2DM prescribed metformin with those prescribed other antihyperglycemic medications or no medications.
• Hurwitz, J. T., Brown, M., Graff, J. S., Peters, L., & Malone, D. C. (2017). Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?. Journal of managed care & specialty pharmacy, 23(6), 613-620.
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  Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions.
• Ip, Q., Malone, D. C., Chong, J., Harris, R. B., & Labiner, D. M. (2017). An update on the prevalence and incidence of epilepsy among older adults. Epilepsy research, 139, 107-112.
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  To estimate the prevalence and incidence of epilepsy among beneficiaries of Arizona Medicare aged 65 and over.
• Malone, D., Gallo, T., Beck, J., & Clark, D. (2017). Feasibility of measuring QT intervals with a portable device. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 74(22), 1850-1851.
• Siaw, M., Ko, Y., Malone, D. C., Twou, K., Lew, Y., Foo, D., Tan, E., Chan, S., Chia, A., Sinaram, S., Coh, K., & Lee, J. (2017). Impact of pharmacist-involved collaborative care on the clinical, humanistic and cost outcomes of high-risk patients with Type 2 diabetes (IMPACT): a randomized controlled trial. Journal of Clinical Pharmacy and Therapeutics, 42, 475-482.
• Tang, W., Xie, J., Lu, Y., Liu, Q., Malone, D., & Ma, A. (2017). Effects on the medical revenue of comprehensive pricing reform in Chinese urban public hospitals after removing drug markups: case of Nanjing. Journal of medical economics, 1-14.
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  The State Council of China requires that all urban public hospitals must eliminate drug markups by September 2017, and that hospital drugs must be sold at the purchase price. Nanjing-one of the first provincial capital cities to implement the reform-is studied to evaluate the effects of the comprehensive reform on drug prices in public hospitals, and to explore differential compensation plans.
• Armstrong, E. P., Malone, D. C., Yeh, W. S., Dahl, G. J., Lee, R. L., & Sicignano, N. (2016). The economic burden of spinal muscular atrophy. Journal of medical economics, 19(8), 822-6.
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  To evaluate the economic burden of spinal muscular atrophy (SMA).
• Augustine, J., Warholak, T. L., Hines, L. E., Sun, D., Brown, M., Hurwitz, J., Taylor, A. M., Brixner, D., Cobaugh, D. J., Schlaifer, M., & Malone, D. C. (2016). Ability and Use of Comparative Effectiveness Research by P&T Committee Members and Support Staff: A 1-Year Follow-up. Journal of managed care & specialty pharmacy, 22(6), 618-25.
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  In recent years, comparative effectiveness tools and methods have evolved to assist health care decision makers in identifying optimal therapies. In-person training programs on comparative effectiveness research may be helpful in understanding and applying this information.
• Bottomly, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A., Devlin, N., Flechtner, H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J., King, M., , Kleutz, P., et al. (2016). for the Setting Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium. Lancet Oncology, Published Online October 18, 2016. doi:http://dx.doi.org/10.1016/S1470-2045(16)30510-1.
• Hincapie, A., Slack, M. K., Malone, D. C., MacKinnon, N., & Warholak, T. L. (2016). Relationship between Patients’ Perceptions of Care Quality and Patient Safety in 11 Countries: A Secondary Data Analysis. Quality and Management in Health Care, 25(1), 13-21.
• Malone, D. C. (2016). AMCP Partnership Forum: FDAMA Section 114-Improving the Exchange of Health Care Economic Data. Journal of managed care & specialty pharmacy, 22(7), 826-31.
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  The Food and Drug Administration Modernization Act (FDAMA) of 1997 included Section 114 as a regulatory safe harbor with the goal of increasing the dissemination of health care economic information (HCEI) to those responsible for formulary decision making. HCEI is typically not included within FDA-approved labeling. Although it has been nearly 20 years since passage and enactment of Section 114, proactive distribution of HCEI has been underutilized by biopharmaceutical companies partly because of (a) vague wording in the statute and (b) the absence of FDA-implementing regulations. Consequently, companies and health care decisions makers have had to speculate about the scope of the provisions. As a result, the biopharmaceutical industry has significant concerns about stepping over the line when using the safe harbor. Also, payers and other "payer-like" decision makers (e.g., self-funded corporate insurers) who are trying to make appropriate coverage and utilization decisions are demanding this information but are not receiving it because of the uncertainties in the statute. Considering this renewed interest by multiple stakeholders regarding the need for revisions and/or guidance pertaining to Section 114, the Academy of Managed Care Pharmacy held a partnership forum on March 1-2, 2016, with a diverse group of health care stakeholders to provide the FDA with considerations for disseminating a guidance document on current thinking for the sharing of HCEI with health care decision makers. Forum participants represented the managed care industry, biopharmaceutical industry, health care providers, pharmacoeconomic experts, policy experts, and patient advocacy groups with specific expertise in the development, use, and dissemination of HCEI. The multistakeholder group represented the key professionals and entities affected by the provisions of Section 114 and present the collective credibility necessary for Congress and the FDA to modernize and operationalize the safe harbor by using the consensus recommendations developed during the forum. Speakers, panelists, and attendees focused on 4 terms in Section 114 that remain open to interpretation by companies and enforcement bodies: (1) the scope of HCEI, (2) the scope of "formulary committee or similar entity," (3) the definition of "competent and reliable scientific evidence (CRSE)," and (4) the parameters of how information "directly relates to an approved indication." Based on the forum results, it was recommended that the safe harbor for companies' proactive dissemination of information under Section 114 should include health care decision makers beyond health plan formulary committees, including organizations, or individuals in their role in an organization, who make health care decisions for patient populations. Recommendations also suggested expansion to organizations that evaluate HCEI or develop value frameworks and compendia and individuals in such organizations. Forum participants also recommended that HCEI be truthful, and not misleading, and be based on the expertise of professionals in the relevant area. HCEI must also be developed and disclosed in a transparent, reproducible, and accurate manner. Forum participants also discussed and agreed on the types of information, format, and processes by which managed care pharmacy and other health care decision makers seek to receive HCEI from biopharmaceutical companies. Finally, participants encouraged the FDA, Congress, and other stakeholders to find ways to ensure that patients or their representative organizations have appropriate access to a full range of information about their medications and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner.
• Malone, D. C. (2016). The AMCP Format for Formulary Submissions: Welcome to Version 4.0. Journal of managed care & specialty pharmacy, 22(5), 444-6.
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  Managed care pharmacists are increasingly presented with complex considerations related to prescription drug formulary management. As prescription drug spending soars, and new effective, but expensive drugs rush to the market, pharmacists and other health care decision makers must evaluate a myriad of important clinical and economic considerations in determining the relative value and, subsequently, the appropriate placement of a product within a formulary. The AMCP Format for Formulary Submissions, Version 4.0, is the next iteration of the Format, which was first released in 2000. Version 4.0, developed by pharmacists from health plan, manufacturer, and academic perspectives, provides updated recommendations on acquiring and evaluating clinical and economic evidence to inform formulary and medical policy decisions. It also includes new guidance related to emerging special topic considerations such as biosimilars, specialty pharmacy products, and companion diagnostic tests. Version 4.0 has been modified to improve the usability of the Format, with clarifying guidance related to logistical considerations such as a recommended time frame for implementation of Version 4.0, as well as dossier updates and ongoing communication between manufacturers and health care decision makers. The Format should be used as a framework for ongoing evidence-based dialogue between manufacturers and payers. The evolving health care landscape will require new levels of collaboration and communication among key stakeholders to successfully navigate the challenges of this new environment. The Format provides a framework to support these critical interactions related to product value by facilitating an evidence-based, transparent approach.
• Malone, D. C., Berg, N. S., Claxton, K., Garrison, L. P., IJzerman, M., Marsh, K., Neumann, P. J., Sculpher, M., Towse, A., Uyl-de Groot, C., & Weinstein, M. C. (2016). International Society for Pharmacoeconomics and Outcomes Research Comments on the American Society of Clinical Oncology Value Framework. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 34(24), 2936-7.
• McGarry, L. J., Chen, Y. J., Divino, V., Pokras, S., Taylor, C. R., Munakata, J., Nieset, C. C., Huang, H., Jabbour, E., & Malone, D. C. (2016). Increasing economic burden of tyrosine kinase inhibitor treatment failure by line of therapy in chronic myeloid leukemia. Current medical research and opinion, 32(2), 289-99.
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  To assess the economic burden of tyrosine kinase inhibitor (TKI) treatment failure in chronic myeloid leukemia (CML), by assessing all-cause health care resource use (HCRU) and costs in the year after treatment failure by line of therapy (LOT; 1L/2L/3L) using real-world data.
• Samwald, M., Blagec, K., Empey, P., Malone, D. C., Ahmed, S., Ryan, P., Hofer, S., & Boyce, R. (2016). Incidence of exposure of patients in the United States to multiple drugs for which pharmacogenomics guidelines are available. PLOS One. doi:DOI:10.1371/journal.pone.0164972
• Sarker, A., O'Connor, K., Ginn, R., Scotch, M., Smith, K., Malone, D., & Gonzalez, G. (2016). Social Media Mining for Toxicovigilance: Automatic Monitoring of Prescription Medication Abuse from Twitter. Drug safety.
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  Prescription medication overdose is the fastest growing drug-related problem in the USA. The growing nature of this problem necessitates the implementation of improved monitoring strategies for investigating the prevalence and patterns of abuse of specific medications.
• Schultz, N. M., Wong, W. B., Coleman, A. L., & Malone, D. C. (2016). Predictors, Resource Utilization, and Short-term Costs of Laser Trabeculoplasty Versus Medication Management in Open-Angle Glaucoma. American journal of ophthalmology, 168, 78-85.
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  Adjunctive laser trabeculoplasty (LT) is an alternative to topical medications for open-angle glaucoma (OAG). The purpose was to: (1) identify predictors of LT vs glaucoma medication treatment; and (2) estimate the resource utilization and short-term costs associated with LT vs medication management.
• Tilson, H., Hines, L. E., McEvoy, G., Weinstein, D. M., Hansten, P. D., Matuszewski, K., le Comte, M., Higby-Baker, S., Hanlon, J. T., Pezzullo, L., Vieson, K., Helwig, A. L., Huang, S. M., Perre, A., Bates, D. W., Poikonen, J., Wittie, M. A., Grizzle, A. J., Brown, M., & Malone, D. C. (2016). Recommendations for selecting drug-drug interactions for clinical decision support. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 73(8), 576-85.
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  Recommendations for including drug-drug interactions (DDIs) in clinical decision support (CDS) are presented.
• Trinkley, K. E., Malone, D. C., Nelson, J. A., & Saseen, J. J. (2016). Prescribing attitudes, behaviors and opinions regarding metformin for patients with diabetes: a focus group study. Therapeutic advances in chronic disease, 7(5), 220-8.
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  The purpose of this study was to identify the reasons why metformin prescribing is suboptimal.
• Yehoshua, A., Chancellor, M., Vasavada, S., Malone, D. C., Armstrong, E. P., Joshi, M., Campbell, K., & Pulicharam, R. (2016). Health Resource Utilization and Cost for Patients with Incontinent Overactive Bladder Treated with Anticholinergics. Journal of managed care & specialty pharmacy, 22(4), 406-13.
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  Overactive bladder (OAB) is a common medical condition with significant economic and humanistic burden. Inadequately managed OAB may exacerbate or result in comorbidities such as depression, falls, and urinary tract infections, which can further increase the burden to the health care system. Anticholinergics are often prescribed for management of OAB with urinary incontinence ("wet" OAB). However, research has shown that patient adherence and persistence to anticholinergic therapy is poor, with approximately 80% of patients ultimately failing their first prescribed anticholinergic medication within the first year. While there has been a fair amount of research on the economic burden of OAB, the real-world impact of initiating anticholinergic therapy in patients with wet OAB has not been well studied.
• Derek, T., Malone, D. C., Warholak, T. L., Chong, J., Armstrong, E. P., Slack, M. K., Hsu, C., & Labiner, D. (2015). Healthcare Resource Burden of Newly Diagnosed Epilepsy Among the US Low-Income Elderly. European Geriatric Medicine, 6(3), 252-256. doi:10.1016
• Khalaf, K. M., Coyne, K. S., Globe, D. R., Malone, D. C., Armstrong, E. P., Patel, V., & Burks, J. (2015). The impact of lower urinary tract symptoms on health-related quality of life among patients with multiple sclerosis. Neurourology and urodynamics, 35(1), 48-54.
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  Lower urinary tract symptoms are commonly experienced among patients with multiple sclerosis (MS), however, their impact on health-related quality of life (HRQOL) has not been well characterized. Herein the incremental impact of lower urinary tract symptoms on HRQOL among patients with MS has been evaluated.
• Lao, W., Malone, D. C., Armstrong, E. P., Voellinger, D., Somers, S., Jin, J., Dreyer, N., & Globe, D. (2015). Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2 year analysis. Current medical research and opinion, 31(8), 1451-60.
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  This report from the Helping Evaluate Reduction in Obesity (HERO) Study investigated weight loss, health-related quality of life (HRQOL), and factors predictive of HRQOL improvement during a 2 year period following Lap-Band AP implantation (post-LBAP).
• Malone, D. C., & Hines, L. (2015). A population-based approach to improving patient safety related to drug-drug interactions. The American Journal of Pharmacy Benefits, 7(5), 212-214..
• Malone, D. C., Khalaf, K. M., Coyne, K., Globe, D., Armstrong, E., & Burks, J. (2015). Lower urinary symptom treatment patterns among patients with multiple sclerosis. International Journal of Multiple Sclerosis Care, 17(1), 14-25.
• Nelson, S. D., Malone, D., & Lafleur, J. (2015). Calculating the Baseline Incidence in Patients Without Risk Factors: A Strategy for Economic Evaluation. PharmacoEconomics, 33(9), 887-92.
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  Economic and epidemiological models need various inputs to estimate the occurrence of events in different subsets of the population, such as the incidence of events for patients with risk factors compared with those without. However, the baseline event incidence for patients without risk factors (incidence_no_risk) may not be reported in the literature, therefore the event incidence in the population (incidence_pop) is commonly used in its place as the baseline. However, this is problematic because incidence_pop is a weighted average of a heterogeneous population. We therefore developed a method for deriving the incidence for persons without risk factors (incidence_no_risk) by adjustment of incidence_pop. We calculated incidence_no_risk using the relative risk for events due to risk factors (RR_risk), incidence_pop, and the prevalence of the risk factor (pRF), which are typically available in the literature. Since the incidence for patient with risk factors (incidence_risk) can be expressed as incidence_risk = incidence_no_risk × RR_risk, we found that incidence_no_risk = incidence_pop/((RR_risk × pRF) + (1 - pRF)). We validated the equation by modeling the fracture incidence in high-risk patients in an osteoporosis transition-state model. With incidence_pop used as the baseline fracture incidence, the model overestimated hip fractures in the study population (10.72 fractures/1000 patient-years). After adjustment of incidence_pop using incidence_no_risk as the baseline incidence, the model accurately predicted hip fractures (2.27/1000 patient-years). Therefore, incidence_no_risk can be calculated using this method based on the event incidence for the study population, the relative risk increase associated with the risk factor, and the prevalence of the risk factor.
• Nerapusse, O., Chinthammit, C., Romyen, C., Pangjunhom, M., Malone, D. C., & Sakulbumrungsil., . (2015). Long-acting injectable antipsychotics in patients with schizophrenia: systematic review and mixed treatment comparison. Asian Biomedicine, 9(6), 741-750.
• Park, H., Rascati, K. L., Lawson, K. A., Barner, J. C., Richards, K. M., & Malone, D. C. (2015). Health Costs and Outcomes Associated with Medicare Part D Prescription Drug Cost-Sharing in Beneficiaries on Dialysis. Journal of managed care & specialty pharmacy, 21(10), 956-64.
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  High out-of-pocket costs for prescription medications have been associated with poor patient outcomes. A previous study found that the Part D coverage gap was significantly associated with decreases in adherence and persistence for medications frequently used in patients undergoing dialysis. It is not known what effect the decreased use of prescription drugs associated with the coverage gap had on utilization and spending for other medical care. 
• Payne, T. H., Hines, L. E., Chan, R. C., Hartman, S., Kapusnik-Uner, J., Russ, A. L., Chaffee, B. W., Hartman, C., Tamis, V., Galbreth, B., Glassman, P. A., Phansalkar, S., van der Sijs, H., Gephart, S. M., Mann, G., Strasberg, H. R., Grizzle, A. J., Brown, M., Kuperman, G. J., , Steiner, C., et al. (2015). Recommendations to improve the usability of drug-drug interaction clinical decision support alerts. Journal of the American Medical Informatics Association : JAMIA, 22(6), 1243-50.
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  To establish preferred strategies for presenting drug-drug interaction (DDI) clinical decision support alerts.
• Scheife, R. T., Hines, L. E., Boyce, R. D., Chung, S. P., Momper, J. D., Sommer, C. D., Abernethy, D. R., Horn, J. R., Sklar, S. J., Wong, S. K., Jones, G., Brown, M. L., Grizzle, A. J., Comes, S., Wilkins, T. L., Borst, C., Wittie, M. A., & Malone, D. C. (2015). Consensus Recommendations for Systematic Evaluation of Drug-Drug Interaction Evidence for Clinical Decision Support. Drug safety.
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  Healthcare organizations, compendia, and drug knowledgebase vendors use varying methods to evaluate and synthesize evidence on drug-drug interactions (DDIs). This situation has a negative effect on electronic prescribing and medication information systems that warn clinicians of potentially harmful medication combinations.
• Tang, D. H., Malone, D. C., Warholak, T. L., Chong, J., Armstrong, E. P., Slack, M. K., Hsu, C. H., & Labiner, D. M. (2015). Prevalence and Incidence of Epilepsy in an Elderly and Low-Income Population in the United States. Journal of clinical neurology (Seoul, Korea), 11(3), 252-61.
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  The purpose of this study was to estimate the incidence and prevalence of epilepsy among an elderly and poor population in the United States.
• Tang, D. H., Malone, D. C., Warholak, T. L., Chong, J., Armstrong, E. P., Slack, M. K., Hsu, C., & Labiner, D. (2015). Prevalence and incidence of epilepsy in the United States elderly and low income population. Journal of Clinical Neurology, 11(3), e pub ahead of print 252-61.
• Villa-Zapata, L., Warholak, T., Slack, M., Malone, D., Murcko, A., Runger, G., & Levengood, M. (2016). Predictive modeling using a nationally representative database to identify patients at risk of developing microalbuminuria. International urology and nephrology, 48(2), 249-56.
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  Predictive models allow clinicians to identify higher- and lower-risk patients and make targeted treatment decisions. Microalbuminuria (MA) is a condition whose presence is understood to be an early marker for cardiovascular disease. The aims of this study were to develop a patient data-driven predictive model and a risk-score assessment to improve the identification of MA.
• Wang, M., Chu, C., Yeh, C., Chang, L., Malone, D. C., & Liou, J. (2015). Antidepressant use and risk of recurrent stroke: a population-based nested case-control study. The Journal of clinical psychiatry, 76(7), e877-85.
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  Antidepressants may carry an increased risk for incident stroke, but there is little safety evidence regarding poststroke antidepressant use. This study aimed to examine whether antidepressants are associated with an increased risk of stroke recurrence.
• Armstrong, E. P., Malone, D. C., Krishnan, S., & Wessler, M. J. (2014). Adherence to clotting factors among persons with hemophilia A or B. Hematology (Amsterdam, Netherlands).
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  Objective Evaluate adherence to clotting factor treatment and associated outcomes for patients with hemophilia using an integrated delivery database. Methods This was a retrospective, observational study tracking patients between 2006 and 2011. Patients with diagnosis codes for hemophilia were identified. Bleeding and complication rates were annualized over the study period. Medication adherence was assessed using prescription claims for clotting factors by examining sequential time periods of 180 days for each patient's continuous enrollment. Adherence within the time period was calculated using the 'days supply' field divided by 180 days. Under the assumption that severe patients should be treated prophylactically, patients were considered adherent within the time period if the ratio of 'days supply' to observed days was 60% or greater. Results A total of 207 patients (74.9 and 25.1% hemophilia A and B, respectively) met the inclusion/exclusion criteria. There were 101 (48.8%) mild, 32 (15.5%) moderate, and 74 (35.7%) severe patients with hemophilia. The percentage of time periods where adherence to clotting factors was 60% or greater was 14% (SD = 28%) for mild disease, 21% (SD = 32%) for moderate disease, and 51% (SD = 36%) for severe disease. Among patients with severe disease, 27 (36.5%) were adherent ≤30% of time periods, 22 (29.7%) adherent 31-70% of the time periods, and 25 (33.8%) were adherent ≥71% of time periods. Joint bleeding episodes and hospitalizations were uncommon events among the three groups. Conclusions Among patients with severe disease, the majority (66.2%) were adherent
• Armstrong, E. P., Malone, D. C., Krishnan, S., & Wessler, M. J. (2014). Costs and utilization of hemophilia A and B patients with and without inhibitors. Journal of medical economics, 17(11), 798-802.
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  To evaluate the health system costs among patients with hemophilia A and B with and without inhibitors over 5 years.
• Armstrong, E. P., Wang, S. M., Hines, L. E., Patel, B. V., Leslie, R. S., & Malone, D. C. (2014). Prescriber perceptions of a near real-time fax alert program for potential drug-drug interactions. Journal of managed care & specialty pharmacy, 20(5), 494-500a.
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  Health systems have developed interventions to reduce harm associated with drug-drug interactions. Pharmacy benefit managers are in an important position to identify the coprescribing of medications known to interact, since they process data on a large portion of prescription claims in the United States. Electronic health records and electronic prescribing also include alerts through their systems' clinical decision support. However, limited data are available that assess prescribers' perceptions of processes that screen for potential drug-drug interactions (PDDIs).
• Gharaibeh, M., & Malone, D. C. (2014). Economic Evaluation of Paclitaxel Albumin, Paclitaxel, and Docetaxel as a Second Line Treatment for Metastatic Breast Cancer. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 17(7), A640.
• Malone, D. C., Hines, L. E., & Graff, J. S. (2014). The good, the bad, and the different: a primer on aspects of heterogeneity of treatment effects. Journal of managed care & specialty pharmacy, 20(6), 555-63.
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  The concept of heterogeneity is concerned with understanding differences within and across patients and studies. Heterogeneity of treatment effects is nonrandom variability in response to treatment and includes both benefits and harms. Because not all patients respond the same way, treatment decisions applied in a "one size fits all" fashion based on the average response observed in clinical trials may lead to suboptimal outcomes for some patients. Variation in outcomes among patients may be caused by observable and nonobservable factors. Changes in patients' health status over time can contribute to variability among patients. Assuming that the results from clinical trials are homogeneous across patients may fail to take into account clinically significant variability where some patients may receive benefit and others harm. Subgroup analyses and prediction models are 2 tools to explain variability observed within a study. Evidence synthesis with meta-analysis can provide useful information on the overall effectiveness and response among groups of patients undersampled in individual studies. Yet caution is warranted if the meta-analysis is missing studies or the individual studies comprising the meta-analysis are inherently different.For those making clinical, coverage, and reimbursement decisions at a population level, such as clinicians and pharmacy and therapeutics committee members, understanding the variation among patients, among subpopulations or populations of patients, among clinical studies, or within a meta-analysis is important to ensuring optimal patient outcomes. This article presents a variety of tools and resources to aid decision makers as they evaluate the literature to determine when clinically relevant differences exist.
• Park, H., Rascati, K. L., Lawson, K. A., Barner, J. C., Richards, K. M., & Malone, D. C. (2014). Adherence and persistence to prescribed medication therapy among Medicare part D beneficiaries on dialysis: comparisons of benefit type and benefit phase. Journal of managed care & specialty pharmacy, 20(8), 862-76.
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  The implementation of Medicare Part D provided insurance coverage for outpatient medications, but when persons reach the "gap," they have very limited or no medication insurance coverage until they reach a second threshold for catastrophic coverage. In addition, some patients have a low-income subsidy (LIS), and their out-of-pocket costs do not reach the threshold for the gap. Little is known about how these Part D types (LIS versus non-LIS) and benefit phases (before the gap, during the gap, after the gap) affect medication adherence and persistence of dialysis patients. 
• Tang, D. H., Warholak, T. L., Hines, L. E., Hurwitz, J., Brown, M., Taylor, A. M., Brixner, D., & Malone, D. C. (2014). Evaluation of Pharmacy and Therapeutic (P&T) Committee member knowledge, attitudes and ability regarding the use of comparative effectiveness research (CER) in health care decision-making. Research in social & administrative pharmacy : RSAP, 10(5), 768-80.
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  Comparative effectiveness research (CER) is a constellation of research methods designed to improve health care decision making. Educational programs that improve health care decision makers' CER knowledge and awareness may ultimately lead to more cost-effective use of health care resources.
• Warholak, T. L., Hilgaertner, J. W., Dean, J. L., Taylor, A. M., Hines, L. E., Hurwitz, J., Brown, M., & Malone, D. C. (2014). Evaluation of an educational program on deciphering heterogeneity for medical coverage decisions. Journal of managed care & specialty pharmacy.
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  It is increasingly important for decision makers, such as medical and pharmacy managers (or pharmacy therapeutics committee members and staff), to understand the variation and diversity in treatment response as decisions shift from an individual patient perspective to optimizing care for populations of patients.
• Gilligan, A. M., Malone, D. C., Warholak, T. L., & Armstrong, E. P. (2013). Health disparities in cost of care in patients with Alzheimer's disease: an analysis across 4 state Medicaid populations. American journal of Alzheimer's disease and other dementias, 28(1), 84-92.
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  To investigate health disparities with respect to cost of care across 4 state Medicaid populations.
• Kuan, R., Holt, R. J., Johnson, K. E., Kent, J. D., Peura, D. A., & Malone, D. (2013). Budget Impact Modeling for a Single-Tablet Formulation of Ibuprofen and Famotidine for Prevention of Upper Gastrointestinal Ulcers in Patients With Osteoarthritis and/or Rheumatoid Arthritis. Clinical Therapeutics, 35(3), 321-332.
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  PMID: 23497762;Abstract: Background: Single-tablet ibuprofen/famotidine is approved by the US Food and Drug Administration for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcers in patients taking ibuprofen for those indications. Currently, little is known about the cost impact of gastroprotective therapies, and an estimate of the financial consequences of adopting these therapies will be helpful to decision makers. Objectives: The goal of this study was to review a model that evaluates the expected financial impact to US health care plans from the introduction of single-tablet ibuprofen/famotidine into the chronic NSAID user population. Methods: A budget impact model, considering a typical health plan of 1 million enrollees, was used to compare patients receiving: (1) single-tablet ibuprofen/famotidine; (2) chronic NSAID treatment plus any GI-protective agent; and (3) chronic NSAID treatment without a GI-protective agent. Results: The expected medication cost for single-tablet ibuprofen/famotidine was $734,192 ($81,577 in year 1, $244,731 in year 2, and $407,884 in year 3), corresponding to a total per-member per-month cost of $0.020 ($0.007 in year 1, $0.020 in year 2, and $0.034 in year 3). Considering anticipated decreases in the use of other NSAIDs, the use of GI-protective agents, and GI complications, the total expected 3-year drug cost for single-tablet ibuprofen/famotidine was offset by 50%, representing an estimated total budget impact of $364,396 or $0.010 per member per month. Sensitivity analyses of cost and market share variables and clinical and drug characteristics identified the most influential variables to be the cost of the drug and persistence to the ibuprofen/famotidine formulation, respectively. Conclusions: The expected decrease in treatment costs for less serious GI-related complications illustrates the benefits of single-tablet ibuprofen/famotidine as a gastroprotective therapy in patients receiving chronic NSAID treatment, with a modest financial impact on total health care costs. © 2013 Elsevier HS Journals, Inc.
• Malone, D. C., Gilligan, A. M., Warholak, T. L., & Armstrong, E. P. (2013). Predictors of hospitalization and institutionalization in Medicaid patient populations with Alzheimer's disease. Advances in Alzheimer's Disease, 20(3), 74-82.
• Malone, D. C., Liberman, J. N., & Sun, D. (2013). Effect of an educational outreach program on prescribing potential drug-drug interactions. Journal of managed care pharmacy : JMCP, 19(7), 549-57.
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  The topic of improving prescribing practices is a major focus of many national initiatives, not only to enhance the quality of health care but also to reduce medical care costs. Educational outreach (also known as academic detailing) is a type of postgraduate education where trained clinical consultants meet face-to-face with prescribers to provide one-on-one information. Ideally, such visits promote evidence-based knowledge, create trusting relationships, and induce practice change, particularly with regard to prescribing potentially interacting medications.
• Malone, D., Armstrong, E. P., Wang, S. M., Hines, L. E., Gao, S., Patel, B. V., & Malone, D. C. (2013). Evaluation of a drug-drug interaction: fax alert intervention program. BMC medical informatics and decision making, 13.
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  Clinicians often encounter information about drug-drug interactions (DDIs) during clinical practice. This information is found within product information (hardcopy and electronic) and various electronic systems. Prescribers may receive medication-related communications in practice that are distributed by facsimile (fax), mail, or telephone from pharmacies and pharmacy benefit managers (PBMs). The purpose of this study was to determine if near-real time fax alerts for potential drug-drug interactions (PDDIs) would influence prescribing.
• Malone, D., Harrington, A. R., Armstrong, E. P., Nolan, P. E., & Malone, D. C. (2013). Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation. Stroke; a journal of cerebral circulation, 44(6).
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  To estimate the cost-effectiveness of stroke prevention in patients with nonvalvular atrial fibrillation by using novel oral anticoagulants apixaban 5 mg, dabigatran 150 mg, and rivaroxaban 20 mg compared with warfarin.
• Mutebi, A., Warholak, T. L., Hines, L. E., Plummer, R., & Malone, D. C. (2013). Assessing patients' information needs regarding drug-drug interactions. Journal of the American Pharmacists Association, 53(1), 39-45.
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  PMID: 23636154;Abstract: Objective: To assess patients' information needs regarding drug-drug interactions (DDIs) to inform patient DDI education resources. Design: Cross-sectional study. Setting: Online (United States in May 2011). Participants: Registered users of an online medication monitoring service (MediGuard). Intervention: Online questionnaire. Main outcome measure: Participants' information needs regarding DDIs and perceived importance of questions related to detecting and preventing harm from DDIs. Results: Characteristics of the 100 surveyed participants were as follows: 57% women, 88% white, 96% non-Hispanic, 71% retired, mean (±SD) age 65.2 ± 9.7 years (range 35-86). The number of prescription medications ranged from 2 to 22 (median 7) and the number of over-the-counter (OTC) medications from 1 to 10 (4). The most common concerns cited by participants were identification of interacting medications, seriousness of DDIs, interactions with OTC medications, interactions with foods, exacerbating comorbidities, short- and long-term adverse effects, signs and frequency of DDIs, and how to minimize adverse effects. Statistically significant differences based on gender, number of prescriptions, and number of OTC medications were observed in rankings of the importance of some DDI questions (P < 0.05). Conclusion: Patient-centered DDI education programs should consider addressing the seriousness of DDIs, the effect of DDIs on comorbidities, and interactions with OTC medications and foods and determining methods for identifying, minimizing, and managing DDIs.
• Villa, L. A., Malone, D. C., & Ross, D. (2013). Evaluating the efficacy and safety of apixaban, a new oral anticoagulant, using Bayesian meta-analysis. International journal of hematology, 98(4), 390-7.
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  Apixaban is a direct inhibitor of factor Xa, and is a potential alternative for the treatment of acute venous thromboembolism. This study sought to evaluate the efficacy and safety of apixaban versus enoxaparin. A systematic search of the literature for randomized controlled trials of apixaban thromboprophylaxis versus enoxaparin was conducted using three databases: PubMed, EMBASE, and the Cochrane library. Five studies that included a total of 12,938 patients were analyzed using Bayesian random-effects meta-analysis. To evaluate efficacy, a composite of venous thromboembolism and death during follow-up was measured. To evaluate safety, major and total bleeding events were considered. The odds ratio (OR) for the composite outcome of efficacy was 0.66 (95 % CI 0.33-1.29) for apixaban compared to enoxaparin, while there was a similar risk of major bleeding (OR 1.03, 95 % CI 0.36-3.73) and total bleeding (OR 0.92, 95 % CI 0.64-1.20). These results suggest a lack of clear superiority of apixaban relative to enoxaparin. Apixaban is an oral alternative with similar efficacy and safety to existing anticoagulant therapies.
• Villa, L., Warholak, T. L., Hines, L. E., Taylor, A. M., Brown, M., Hurwitz, J., Brixner, D., & Malone, D. C. (2013). Health care decision makers' use of comparative effectiveness research: Report from a series of focus groups. Journal of Managed Care Pharmacy, 19(9), 745-754.
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  Abstract: BACKGROUND: Comparative effectiveness research (CER) is a helpful approach to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision makers about the most effective interventions. OBJECTIVES: To (a) identify the factors necessary to increase the use of the Agency for Healthcare Research and Quality's (AHRQ) CER reviews in hospitals and managed care organizations; (b) assess current awareness and implementation of CER materials in these facilities and organizations; and (c) inform development of content for a workshop on CER. METHODS: Pharmacy and therapeutics (P&T) committee members and supportive personnel were recruited to participate in focus groups conducted at national health professional meetings. Prior to the sessions, each participant completed a prefocus group questionnaire evaluating the organization and process of the respondent's P&T committee, as well as the respondent's role in the P&T committee and awareness of AHRQ CER reports. Each session consisted of a focused discussion about CER and sources of evidence for P&T monographs, and each participant completed a ballot to rank topics of importance for inclusion in a CER workshop for health care professionals involved in the P&T process. Overarching themes were later identified using qualitative analysis of the transcripts of the focus group sessions. RESULTS: Thirty-nine (68%) pharmacists and 18 (32%) physicians involved in the P&T process participated in 1 of 7 focus groups. Almost half of the participants had 6-15 years experience with the P&T process. Participants represented health plans, hospitals, and health care systems. Two-thirds indicated they were aware of AHRQ's Effective Health Care Program's CER reviews, yet only 26% reported using the reviews in their organizations. The overarching themes reflected the need for timely and conclusive CER information; the role of the pharmacist as central to evidence synthesis for the P&T process; and the need for educational programs in online formats that are designed primarily for pharmacists. CONCLUSION: Health care decision makers identified timeliness as a key factor for facilitating the use of AHRQ CER reviews and guides in hospitals and managed care organizations. To facilitate integration of CER into the decision-making process, it is imperative that key stakeholders have access to comprehensive and timely information. While the majority of participants indicated that they were aware of AHRQ CER reviews, few had used them in the P&T process. © 2013, Academy of Managed Care Pharmacy.
• Wang, M., Lo, Y., Tsai, C., Chang, L., Malone, D. C., Chu, C., & Liou, J. (2013). Statin use and risk of COPD exacerbation requiring hospitalization. American Journal of Medicine, 126(7), 598-606.
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  PMID: 23684060;Abstract: Background: Despite recent studies that suggested statins' beneficial effects on chronic obstructive pulmonary disease (COPD) outcomes, the impact, if any, of statins on COPD exacerbations remains unclear. This study aimed to examine the association between statin use and risk of hospitalized COPD exacerbation, and to assess whether the association varied by statin initiation, dose, or duration of use. Methods: A retrospective nested case-control study among patients with COPD was conducted analyzing a nationwide health insurance claims database in Taiwan. Cases were subjects hospitalized for COPD exacerbations; each case was matched to 4 randomly selected controls on age, sex, cohort entry, and number of COPD-related outpatient visits by an incident-density sampling approach. Conditional logistic regressions were employed to quantify the COPD exacerbation risk associated with statin use. Results: The study cohort comprised 14,316 COPD patients, from which 1584 cases with COPD exacerbations and 5950 matched controls were identified. Any use of statins was associated with a 30% decreased risk of COPD exacerbation (95% confidence interval [CI], 0.56-0.88), and current use of statins was related to a greater reduced risk (adjusted odds ratio [OR] 0.60; 95% CI, 0.44-0.81). A dose-dependent reduced risk of COPD exacerbation by statins was observed (medium average daily dose: adjusted OR 0.60; 95% CI, 0.41-0.89; high daily dose: adjusted OR 0.33; 95% CI, 0.14-0.73). The reduced risk remained significant for either short or long duration of statin use. Conclusions: Statin use was associated with a reduced risk of COPD exacerbation, with a further risk reduction for statins prescribed more recently or at high doses.
• Armstrong, E. P., Malone, D. C., & Bui, C. N. (2012). Cost-effectiveness analysis of anti-muscarinic agents for the treatment of overactive bladder. Journal of medical economics, 15 Suppl 1, 35-44.
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  To determine the cost-effectiveness of pharmacologic treatments for overactive bladder (OAB) in the US.
• Brown, M. R., Leib, M. L., Brown, S. R., Warholak, T., & Malone, D. C. (2012). The appropriateness of use of 3 classes of psychotropic medications in children and adolescents. American Journal of Pharmacy Benefits, 4(2), 49-56.
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  Abstract: Objectives: Concerns have been raised about the increasing use and potential adverse effects of psychotropic medications in children and adolescents. The objective of this study was to estimate the degree of appropriate use, and rates of use, of 3 groups of psychotropic medications (Attention Deficit Hyperactivity Disorder [ADHD)], atypical antipsychotic, selective serotonin receptor inhibitor [SSRI] antidepressant) among children in a Medicaid population. Methods: The study population consisted of members of one state's Medicaid program and State Children's Health Insurance Program who were 17 years or younger and continuously enrolled during calendar year 2006. A retrospective analysis was conducted using pharmacy and medical claims databases. Age-specific appropriateness of care criteria were developed based on US Food and Drug Administration-approved package inserts, national guidelines, and the professional literature. Diagnoses were obtained from medical claims, using 3-digit International Classification of Diseases, Ninth Revision, Clinical Modification codes. Results: Data were available for 274,569 children. Seventy-five percent of their use of any study medication was consistent with study criteria. Eighty-two percent of children had ADHD medication use, 67% had antipsychotic medication use, and 63% had antidepressant medication use that was consistent with criteria. The prevalence of having at least 1 prescription for any psychotropic medication was 52.7 per 1000, with rates of ADHD medication use of 39.2 per 1000, antipsychotic medication of 21.2 per 1000, and an antidepressant of 13.3 per 1000. The prevalence of use of any medication for whites was 1.5 times higher than for blacks, 4.1 times higher than for Hispanics, and 7.3 times higher than for Native Americans. Conclusions: The majority of use of these medications was appropriate as determined by our evidence-based methodology. The prevalence of use was modest and consistent with previous literature. There was evidence of racial disparity in access to these medications.
• Dworkin, R. H., Panarites, C. J., Armstrong, E. P., Malone, D. C., & Pham, S. V. (2012). Is treatment of postherpetic neuralgia in the community consistent with evidence-based recommendations?. Pain, 153(4), 869-75.
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  Few studies have examined the extent to which treatment of patients with neuropathic pain in the community is consistent with evidence-based treatment recommendations. U.S. health care claims were used to identify patients who received a diagnosis of postherpetic neuralgia (PHN). The initial pharmacologic treatments and changes to these treatment regimens were categorized according to the International Association for the Study of Pain Neuropathic Pain Special Interest Group recommendations for first-, second-, and third-line treatment of neuropathic pain. The results indicated that the treatment of PHN was only partially consistent with these treatment recommendations. Of the patients diagnosed with PHN who were not already on a specified treatment, 70% began treatment with either a first-, second-, or third-line treatment or a not-recommended treatment, and 30% did not begin treatment with any of these medications. Only one-quarter of patients began treatment with a first-line medication, the same percentage that began treatment with either a third-line medication or a not-recommended treatment. There was a wide range of initial treatment durations, but the means and medians suggest that patients and clinicians often decide to change the initial treatment within 2 months, either by discontinuing it, replacing it with a new medication, or adding a new medication. Although there were generally shorter treatment durations with opioid analgesics and tramadol, these medications were more frequently used in beginning treatment than the other treatments. The results suggest that a considerable number of patients with PHN in the community are not receiving evidence-based treatment.
• Faulkner, E., Annemans, L., Garrison, L., Helfand, M., Holtorf, A., Hornberger, J., Hughes, D., Tracy, L. i., Malone, D., Payne, K., Siebert, U., Towse, A., Veenstra, D., & Watkins, J. (2012). Challenges in the development and reimbursement of personalized medicine-payer and manufacturer perspectives and implications for health economics and outcomes research: A report of the ISPOR personalized medicine special interest group. Value in Health, 15(8), 1162-1171.
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  PMID: 23244820;Abstract: Background: Personalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes. Objectives: In this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives. Methods: Five key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified. Results: These areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine. Conclusions: Key gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine. © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
• Gilligan, A. M., Malone, D. C., Warholak, T. L., & Armstrong, E. P. (2012). Racial and ethnic disparities in Alzheimer's disease pharmacotherapy exposure: an analysis across four state Medicaid populations. The American journal of geriatric pharmacotherapy, 10(5), 303-12.
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  Treatment disparities in Alzheimer's disease (AD) have received little attention. Determining whether disparities exist in this subpopulation is an important health policy issue.
• Hincapie, A. L., Warholak, T. L., Hines, L. E., Taylor, A. M., & Malone, D. C. (2012). Impact of a drug-drug interaction intervention on pharmacy and medical students' knowledge and attitudes: A 1-year follow-up. Research in Social and Administrative Pharmacy, 8(5), 472-477.
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  PMID: 22222339;Abstract: Background: There have been many interventions aimed at improving retention of drug-drug interaction (DDI) knowledge of health care professionals. Much less is known about their retention of such knowledge for extended periods of time after an educational intervention. Objectives: To evaluate pharmacy and medical students' knowledge retention and attitudes 1 year after participating in an educational session on DDIs. Methods: This study used a pre-post design with an assessment of DDI knowledge and attitude by pharmacy and medical students before and after the final didactic year of their professional education. The intervention was a 1-hour program. Results: A total of 74 of 193 students (38%) completed the pre, post, and final questionnaire. The median numbers of correctly identified DDIs before the program were 8 and 7 for pharmacy and medical students, respectively, out of a possible score of 15. One year after, the median identification knowledge scores were 12 and 8, respectively, for pharmacy and medical students. The median difference scores of correctly managed DDIs on this evaluation 1 year after the program were -4 and -8 for pharmacy and medical students, respectively (P< 05). Conclusion: This study found that the ability to identify important DDIs is poor among both pharmacy and medical students 1 year after being exposed to the educational session. © 2012 Elsevier Inc.
• Hines, L. E., Malone, D. C., & Murphy, J. E. (2012). Recommendations for generating, evaluating, and implementing drug-drug interaction evidence. Pharmacotherapy, 32(4), 304-13.
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  In October 2009, a 2-day, multistakeholder, national conference was held in Rockville, Maryland, to discuss and propose methods to improve the drug-drug interaction (DDI) evidence base and its evaluation and integration into clinical decision support (CDS) systems. The conference featured participants representing consumers, health care providers, those responsible for relevant policies and guidelines, and developers and vendors of DDI compendia, databases, and CDS systems. One desired outcome of the conference was to prepare recommendations on critical issues surrounding DDI evidence. A set of recommendations was developed to improve the generation, evaluation, and translation of DDI evidence into CDS systems based on presentations by experts and the supporting literature. These recommendations were reviewed initially by conference moderators, speakers, and Scientific Steering and Planning Committee members, and subsequently by all attendees. The following recommendations were developed to increase patient safety by improving the relevance and assessment of DDI evidence: conduct well-designed studies to determine the incidence, outcomes, and patient-level risk factors for DDIs; use a systematic and transparent process for evaluating the DDI evidence in order to estimate the severity and risks of DDIs; and improve the integration of DDI evidence into electronic CDS. Opportunities exist to improve the DDI evidence base, develop and promote a systematic approach for evaluating the evidence, and integrate this evidence into meaningful CDS.
• Malone, D. C., & Saverno, K. R. (2012). Evaluation of a wireless handheld medication management device in the prevention of drug-drug interactions in a medicaid population. Journal of Managed Care Pharmacy, 18(1), 33-45.
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  PMID: 22235953;Abstract: Background: With the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, widespread adoption of certain health information technologies, such as electronic health records (EHRs) and electronic prescribing (e-prescribing), is imminent. Drug-drug interaction (DDI) screening and medication history information are commonly incorporated into health information exchange systems to improve medical decision making, safety, and quality of care, but the value of these features is unclear. Objective: To evaluate the effect of providing access to an early generation electronic medication management program with medication history accessible to prescribers via a wireless handheld personal digital assistant (PDA) device on the incidence of potential DDIs (i.e., DDIs that may or may not cause patient harm). Methods: This study employed a retrospective pre-intervention/postintervention study design with a comparison group to evaluate the effectiveness of a wireless handheld medication management program in preventing serious potential DDIs. Licensed prescribers in a state Medicaid program who wrote prescriptions during the period from August 2003 through June 2006 were included in this study. The intervention (PDA) group consisted of clinicians who requested and were granted access to the wireless handheld device containing prescription drug history between August 1, 2004, and June 30, 2005. Initially the device contained 100-day patient-specific medication history, but other functionalities were added during the study period including the ability to check for drug-drug interactions and e-prescribing. The comparison group consisted of prescribers who sent a request to obtain, but did not receive, the wireless handheld device during the same time period. Baseline prescribing patterns of 25 previously identified clinically important potential DDIs were assessed over two 12-month periods, one period prior to (baseline) and one period after (follow-up) an index date (date of device deployment for PDA group; date of request for comparison group). A random-effects negative binomial model was used to analyze the primary outcome, the number of potential DDIs per prescriber per 12-month time period. A secondary outcome of interest, the likelihood that a prescriber would prescribe at least 1 potentially interacting medication pair during the baseline and follow-up periods, was analyzed using a random-effects logistic model. Results: A total of 1,615 prescribers constituted the PDA group, and 600 prescribers made up the comparison group. Prescribers in the 2 groups were significantly different in their specialty practice areas (P < 0.001), number of pharmacy claims at baseline (P < 0.001), and the likelihood of prescribing at least 1 potential DDI combination during the 1-year baseline period (P = 0.003). However, the prescriber groups were similar in their average age (P = 0.241) and geographic location (P = 0.181). The most widely prescribed potential DDIs included those involving warfarin with nonsteroidal anti-inflammatory drugs (NSAIDs) and thyroid hormones. The median number of patient medication history updates requested per PDA group prescriber during follow-up was 24 (range 0 to 1,073). At baseline, 1,104 (68.4%) of the PDA group and 449 (74.8%) of the comparison group had no potential DDIs. During the next year, 1,131 (70.0%) and 462 (77.0%) of the PDA group and comparison group, respectively, had no DDIs. The incidence rate ratio was 1.01 (95% CI = 0.87-1.17) for the PDA group relative to the comparison group for change in number of potential DDIs. In the logistic regression model, the odds of prescribing at least 1 potential DDI did not significantly differ by group (odds ratio = 1.26, 95% CI = 0.96-1.66). These results indicate that there was no significant difference between the intervention and comparison group with regard to the change in the rate of potential DDIs between the baseline and follow-up periods. Conclusion: A stand-alone medication management program in a wireless PDA device was not frequently used by most prescribers to update patient medication histories and was not associated with a reduction in the rate of prescribing potentially clinically important DDIs. © 2012, Academy of Managed Care Pharmacy.
• Malone, D., Tang, D. H., & Malone, D. C. (2012). A network meta-analysis on the efficacy of serotonin type 3 receptor antagonists used in adults during the first 24 hours for postoperative nausea and vomiting prophylaxis. Clinical therapeutics, 34(2).
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  The serotonin type 3 receptor antagonists (5-HT(3) antagonists) ondansetron, granisetron, tropisetron, and dolasetron are potential prophylactic agents for patients with mild to moderate risk of postoperative nausea and vomiting (PONV). A few trials have been conducted to compare the efficacy among 2 to 3 of these 4 agents. However, the comparative efficacy of all four 5-HT(3) antagonists has not yet been quantitatively investigated.
• Tang, D. H., & Malone, D. C. (2012). The authors respond. Clinical Therapeutics, 34(5), 1206-1208.
• Armstrong, E. P., Malone, D. C., McCarberg, B., Panarites, C. J., & Pham, S. V. (2011). Cost-effectiveness analysis of a new 8% capsaicin patch compared to existing therapies for postherpetic neuralgia. Current medical research and opinion, 27(5), 939-50.
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  The purpose of this study was to compare the cost effectiveness of a new 8% capsaicin patch, compared to the current treatments for postherpetic neuralgia (PHN), including tricyclic antidepressants (TCAs), topical lidocaine patches, duloxetine, gabapentin, and pregabalin.
• Dworkin, R. H., Panarites, C. J., Armstrong, E. P., Malone, D. C., & Pham, S. V. (2011). Healthcare utilization in people with postherpetic neuralgia and painful diabetic peripheral neuropathy. Journal of the American Geriatrics Society, 59(5), 827-36.
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  To determine and compare healthcare utilization and costs for younger and older adults with postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (DPN).
• Harrington, A. R., Warholak, T. L., Hines, L. E., Taylor, A. M., Sherrill, D., & Malone, D. C. (2011). Healthcare professional students' knowledge of drug-drug interactions. American journal of pharmaceutical education, 75(10), 199.
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  To evaluate changes in medical, pharmacy, and nurse practitioner students' drug-drug interaction (DDI) knowledge after attending an educational program.
• Higgins, L., Brown, M., Murphy, J. E., Malone, D. C., Armstrong, E. P., & Woosley, R. L. (2011). Community pharmacy and pharmacist staff call center: assessment of medication safety and effectiveness. Journal of the American Pharmacists Association : JAPhA, 51(1), 82-9.
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  To determine proof of concept for use of a network of pharmacists to evaluate the safety of medications.
• Hincapie, A. L., Warholak, T. L., Murcko, A. C., Slack, M., & Malone, D. C. (2011). Physicians' opinions of a health information exchange. Journal of the American Medical Informatics Association, 18(1), 60-65.
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  PMID: 21106994;PMCID: PMC3005874;Abstract: Background: Arizona Medicaid developed a Health Information Exchange (HIE) system called the Arizona Medical Information Exchange (AMIE). Objective: To evaluate physicians' perceptions regarding AMIE's impact on health outcomes and healthcare costs. Measurements: A focus-group guide was developed and included five domains: perceived impact of AMIE on (1) quality of care; (2) workflow and efficiency; (3) healthcare costs; (4) system usability; and (5) AMIE data content. Qualitative data were analyzed using analytical coding. Results: A total of 29 clinicians participated in the study. The attendance rate was 66% (N=19) for the first and last month of focus-group meetings and 52% (N=15) for the focus group meetings conducted during the second month. The benefits most frequently mentioned during the focus groups included: (1) identification of "doctor shopping"; (2) averting duplicative testing; and (3) increased efficiency of clinical information gathering. The most frequent disadvantage mentioned was the limited availability of data in the AMIE system. Conclusion: Respondents reported that AMIE had the potential to improve care, but they felt that AMIE impact was limited due to the data available. © 2010 by the American Medical Informatics Association.
• Hines, L. E., Warholak, T. L., Saverno, K. R., Boesen, M. D., Sisk, M. A., & Malone, D. C. (2011). Drug-drug interaction software quality assurance: Lessons learned. Journal of the American Pharmacists Association : JAPhA, 51(5), 570-2.
• Malone, D., Gilligan, A. M., Warholak, T. L., Murphy, J. E., Hines, L. E., & Malone, D. C. (2011). Pharmacy students' retention of knowledge of drug-drug interactions. American journal of pharmaceutical education, 75(6).
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  To evaluate pharmacy students' drug-drug interaction (DDI) knowledge retention over 1 year and to determine whether presenting DDI vignettes increased knowledge retention.
• Malone, D., Hines, L. E., Ceron-Cabrera, D., Romero, K., Anthony, M., Woosley, R. L., Armstrong, E. P., & Malone, D. C. (2011). Evaluation of warfarin drug interaction listings in US product information for warfarin and interacting drugs. Clinical therapeutics, 33(1).
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  Because interactions with warfarin represent a serious risk to patients, drug information sources used by clinicians should contain accurate, timely, and practical drug interaction information.
• Malone, D., Hines, L. E., Murphy, J. E., Grizzle, A. J., & Malone, D. C. (2011). Critical issues associated with drug-drug interactions: highlights of a multistakeholder conference. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 68(10).
• Malone, D., Hines, L. E., Saverno, K. R., Warholak, T. L., Taylor, A., Grizzle, A. J., Murphy, J. E., & Malone, D. C. (2011). Pharmacists' awareness of clinical decision support in pharmacy information systems: an exploratory evaluation. Research in social & administrative pharmacy : RSAP, 7(4).
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  Clinical decision support (CDS), such as drug-drug interaction (DDI) and drug-allergy checking, has been used in pharmacy information systems for several decades; however, there has been limited research on CDS use by practicing pharmacists.
• Malone, D., Warholak, T. L., Menke, J. M., Hines, L. E., Murphy, J. E., Reel, S., & Malone, D. C. (2011). A drug-drug interaction knowledge assessment instrument for health professional students: a Rasch analysis of validity evidence. Research in social & administrative pharmacy : RSAP, 7(1).
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  It is essential that current and future health professionals be able to evaluate for possible clinically significant drug-drug interactions (DDIs) and when detected, determine appropriate management strategies to prevent patient harm.
• Saverno, K. R., Hines, L. E., Warholak, T. L., Grizzle, A. J., Babits, L., Clark, C., Taylor, A. M., & Malone, D. C. (2011). Ability of pharmacy clinical decision-support software to alert users about clinically important drug-drug interactions. Journal of the American Medical Informatics Association : JAMIA, 18(1), 32-7.
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  Pharmacy clinical decision-support (CDS) software that contains drug-drug interaction (DDI) information may augment pharmacists' ability to detect clinically significant interactions. However, studies indicate these systems may miss some important interactions. The purpose of this study was to assess the performance of pharmacy CDS programs to detect clinically important DDIs.
• Tang, D. H., Warholak, T. L., Slack, M. K., Malone, D. C., & Gau, C. (2011). Science of safety topic coverage in experiential education in US and Taiwan colleges and schools of pharmacy.. American journal of pharmaceutical education, 75(10), 202-.
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  PMID: 22345721;PMCID: PMC3279028;Abstract: To compare the science of safety (SoS) topic coverage and associated student competencies in the experiential education curricula of colleges and schools of pharmacy in the United States and Taiwan. The experiential education director, assistant director, or coordinator at a random sample of 34 US colleges and schools of pharmacy and all 7 Taiwan schools of pharmacy were interviewed and then asked to complete an Internet-based survey instrument. Faculty members in both countries perceived that experiential curricula were focused on the postmarketing phase of the SoS, and that there is a need for the pharmacy experiential curricula to be standardized in order to fill SoS coverage gaps. Inter-country differences in experiential SoS coverage were noted in topics included for safety biomarkers that signal potential for drug-induced problems and pharmacogenomics. Experiential SoS topic coverage and student ability gaps were perceived within and between US and Taiwan colleges and schools of pharmacy.
• Warholak, T. L., Hines, L. E., Saverno, K. R., Grizzle, A. J., & Malone, D. C. (2011). Assessment tool for pharmacy drug-drug interaction software. Journal of the American Pharmacists Association, 51(3), 418-424.
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  PMID: 21555296;Abstract: Objectives: To assess the performance of pharmacy clinical decision support (CDS) systems for drug-drug interaction (DDI) detection and to identify approaches for improving the ability to recognize important DDIs. Practice description: Pharmacists rely on CDS systems to assist in the identification of DDIs, and research suggests that these systems perform suboptimally. The software evaluation tool described here may be used in all pharmacy settings that use electronic decision support to detect potential DDIs, including large and small community chain pharmacies, community independent pharmacies, hospital pharmacies, and governmental facility pharmacies. Practice innovation: A tool is provided to determine the ability of pharmacy CDS systems to identify established DDIs. It can be adapted to evaluate potential DDIs that reflect local practice patterns and patient safety priorities. Beyond assessing software performance, going through the evaluation processes creates the opportunity to evaluate inadequacies in policies, procedures, workflow, and training of all pharmacy staff relating to pharmacy information systems and DDIs. Conclusion: The DDI evaluation tool can be used to assess pharmacy information systems' ability to recognize relevant DDIs. Suggestions for improvement include determining whether the software allows for customization, creating standard policies for handling specific interactions, and ensuring that drug knowledge database updates occur frequently.
• Warholak, T. L., Hines, L. E., Song, M. C., Gessay, A., Menke, J. M., Sherrill, D., Reel, S., Murphy, J. E., & Malone, D. C. (2011). Medical, nursing, and pharmacy students' ability to recognize potential drug-drug interactions: a comparison of healthcare professional students. Journal of the American Academy of Nurse Practitioners, 23(4), 216-21.
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  To evaluate and compare the drug-drug interaction (DDI) knowledge of pharmacy, medical, and nurse practitioner (NP) students who are beginning supervised clinical practice.
• Warholak, T. L., Holdford, D. A., West, D., DeBake, D. L., Bentley, J. P., Malone, D. C., & Murphy, J. E. (2011). Perspectives on educating pharmacy students about the science of safety. American journal of pharmaceutical education, 75(7), 142.
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  To identify opinions about pharmacy graduates' science of safety (SoS) educational needs.
• West-Strum, D., Basak, R., Bentley, J. P., Holdford, D. A., Warholak, T. L., Malone, D. C., & Murphy, J. E. (2011). Teaching the science of safety in U.S. schools of pharmacy. American Journal of Pharmaceutical Education, 75(4).
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  Abstract: Objective. To describe the integration of science of safety (SoS) topics in doctor of pharmacy (PharmD) curricula of US colleges and schools of pharmacy. Methods. A questionnaire that contained items pertaining to what and how SoS topics are taught in PharmD curricula was e-mailed to representatives at 107 US colleges and schools of pharmacy. Results. The majority of the colleges and schools responding indicated that they had integrated SoS topics into their curriculum, however, some gaps (eg, teaching students about communicating risk, Food and Drug Administration [FDA] Sentinel Initiative, utilizing patient databases) were identified that need to be addressed. Conclusions. The FDA and the American Association of Colleges of Pharmacy (AACP) should continue to collaborate to develop resources needed to ensure that topics proposed by the FDA in their SoS framework are taught at all colleges and schools of pharmacy.
• Charland, S. L., & Malone, D. C. (2010). Prediction of cardiovascular event risk reduction from lipid changes associated with high potency dyslipidemia therapy. Current Medical Research and Opinion, 26(2), 365-375.
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  PMID: 19995326;Abstract: Background: Epidemiological data suggests for every 1 reduction in LDL-C there is a corresponding 11.5 reduction in cardiovascular events (CVEs). Additionally, for every 23 increase in HDL-C there is a reduction in CVEs by 24 that is independent of LDL-C. With numerous treatment options for managing dyslipidemia, it is important to evaluate agents that result in the greatest reduction of CVEs. Objective: To compare current high-potency dyslipidemia pharmacotherapy with respect to changes in LDL-C and HDL-C and estimate risk reductions for CVEs. Methods: This study is an analysis of existing published studies for dyslipidemia products marketed in the US. Literature searches were conducted using Medline, International Pharmaceutical Abstracts, Embase, and CINAH to identify trials for niacin extended-release and lovastatin (NER/L); niacin extended-release and simvastatin (NER/S); rosuvastatin (R); and, ezetimibe/simvastatin (E/S) from database inception to 1 May 2009. Demographics and changes from baseline in LDL-C and HDL-C were abstracted and HDL-C to LDL-C change (Δ-lipids) was created for each therapy. Using a previously validated model the percent reduction in CVEs was estimated for each treatment strategy. Results: Data for 177 treatment arms (120 unique reports), accounting for drug and dose were abstracted. The range in mean±SD% Δ-lipids depending on drug dose was: E/S, 58±6 to 67±3; R, 51±5 to 65±5; NER/L, 33±7 to 75±7; and NER/S, 48 to 77±4. Risk reductions were greatest for NER/statin combinations, with percent risk reductions greater than 77 for NER/S, 2000mg/10mg and 83 NER/S, 2000mg/40mg. Ignoring medication strengths, reductions in CVEs ranged from 58 for R, 60 for E/S, 61 for NER/L, and 72 for NER/S. Limitations: There are several potential limitations associated with this study including: publication bias, English only search, limited published studies with NER in combination with L or S, adherent populations, and aggregation of multiple populations. Conclusion: The results of the analysis suggest that greater risk reductions in CVEs occur with combination therapies, especially those including niacin extended-release (NER). Up to an 83 risk reduction was estimated for the highest doses of NER and simvastatin (NER/S). © 2010 Informa UK Ltd All rights reserved.
• Daniel, G. W., Ewen, E., Willey, V. J., Reese, C. L., Shirazi, F., & Malone, D. C. (2010). Efficiency and economic benefits of a payer-based electronic health record in an emergency department. Academic Emergency Medicine, 17(8), 824-833.
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  PMID: 20670319;Abstract: Objectives: The objective was to evaluate the use of a payer-based electronic health record (P-EHR), which is a clinical summary of a patient's medical and pharmacy claims history, in an emergency department (ED) on length of stay (LOS) and plan payments. Methods: A large urban ED partnered with the dominant health plan in the region and implemented P-EHR technology in September 2005 for widespread use for health plan members presenting to the ED. A retrospective observational study design was used to evaluate this previously implemented P-EHR. Health plan and electronic hospital data were used to identify 2,288 ED encounters. Encounters with P-EHR use (n = 779) were identified between September 1, 2005, and February 17, 2006; encounters from the same health plan (n = 1,509) between November 1, 2004, and March 31, 2005, were compared. Outcomes were ED LOS and plan payment for the ED encounter. Analyses evaluated the effect of using the P-EHR in the ED setting on study outcomes using multivariate regressions and the nonparametric bootstrap. Results: After covariate adjustment, among visits resulting in discharge (ED-only), P-EHR visits were 19 minutes shorter (95% confidence interval [CI] = 5 to 33 minutes) than non-P-EHR visits. Among visits resulting in hospitalization, the P-EHR was associated with an average 77-minute shorter ED LOS (95% CI = 28 to 126 minutes), compared to non-P-EHR visits. The P-EHR was associated with an average of $1,560 (95% CI = $43 to $2,910) lower total plan expenditures for hospitalized visits. No significant difference in total payments was observed among discharged visits. Conclusions: In the study ED, the P-EHR was associated with a significant reduction in ED LOS overall and was associated with lower plan payments for visits that resulted in hospitalization. © 2010 by the Society for Academic Emergency Medicine.
• Dworkin, R. H., Malone, D. C., Panarites, C. J., Armstrong, E. P., & Pham, S. V. (2010). Impact of postherpetic neuralgia and painful diabetic peripheral neuropathy on health care costs. The journal of pain : official journal of the American Pain Society, 11(4), 360-8.
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  Knowledge of the health care costs associated with neuropathic pain is limited. Existing studies have not directly compared the health care costs of different neuropathic pain conditions, and patients with neuropathic pain have not been compared with control subjects with the same underlying conditions (for example, diabetes). To determine health care costs associated with postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (DPN), patients with these conditions were selected from 2 different administrative databases of health care claims and respectively matched to control subjects who had a diagnosis of herpes zoster without persisting pain or a diagnosis of diabetes without neurological complications using propensity scores for demographic and clinical factors. Total excess health care costs attributable to PHN and painful DPN and excess costs for inpatient care, outpatient/professional services, and pharmacy expenses were calculated. The results indicated that the annual excess health care costs associated with peripheral neuropathic pain in patients of all ages range from approximately $1600 to $7000, depending on the specific pain condition. Total excess health care costs associated with painful DPN were substantially greater than those associated with PHN, which might reflect the great medical comorbidity associated with DPN.
• Hess, L. M., Malone, D. C., Skrepnek, G. H., Reed, P. G., Armstrong, E., & Coons, S. J. (2010). Oncologist preferences for health states associated with the treatment of advanced ovarian cancer. Applied health economics and health policy, 8(4), 217-23.
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  For advanced epithelial ovarian cancer, oncologists are faced with multiple treatment options that differ in terms of possible clinical and patient-reported outcomes.
• Malone, D. C., Waters, H. C., Van, J., Popp, J., Draaghtel, K., & Rahman, M. I. (2010). A claims-based Markov model for Crohn's disease. Alimentary Pharmacology and Therapeutics, 32(3), 448-458.
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  PMID: 20491743;Abstract: Aliment Pharmacol Ther 2010; 32: 448-458 SummaryBackground Crohn's disease is a chronic condition that often presents in early adulthood. Aim To evaluate health care costs and costs per quality-adjusted life year (QALY) for Crohn's disease. Methods A Markov model was developed using administrative claims data for patients aged ≥ 18 years with ≥ 3 years of continuous enrolment from 2000 to 2008 and ≥2 Crohn's disease claims. Disease states (remission, mild-moderate, moderate-severe, and severe-fulminant) were defined using the American College of Gastroenterology treatment guidelines criteria. Transition probabilities were calculated from consecutive 6-month periods. Costs were determined from paid claims and QALY utilities were obtained from the literature. The model assumed a 30-year-old patient at the time of entry into the model. Results There were 40 063 patients identified, with a total of 420 773 cycles [remission (197 111; 46.8%), mild-moderate (44 024; 10.5%), moderate-severe (132 695; 31.5%), severe-fulminant (46 925; 11.2%)]. The costsQALY for remission, mild-moderate, moderate-severe, and severe-fulminant disease states respectively were $2896, $8428, $11 518 and $69 277 for males and $2896, $8426, $22 633 and $69 412 for females. Conclusions Overall, health care costs for patients with Crohn's disease increased with disease severity. Although the probabilities of transitioning from other health states to the severe-fulminant disease state were low, the costQALY was high. © 2010 Blackwell Publishing Ltd.
• Olvey, E. L., Clauschee, S., & Malone, D. C. (2010). Comparison of critical drug-drug interaction listings: The department of veterans affairs medical system and standard reference compendia. Clinical Pharmacology and Therapeutics, 87(1), 48-51.
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  PMID: 19890252;Abstract: The objective of this study was to evaluate the agreement among the US Department of Veterans Affairs (VA) listing of criticaĺ drug-drug interactions (DDIs) and two standard drug-interaction compendia. A list of critical DDIs, as defined by the VA, was compared with two standard commercially available compendia (Micromedex DRUG-REAX and Drug Interactions: Analysis and Management (DIAM)) in order to determine the level of agreement among the systems. Of 982 DDIs classified as critical by the VA, only 136 DDIs (13.7%) were considered critical in all three systems. Our conclusion was that, overall, there is poor agreement among the compendia and the VA system. © 2009 American Society for Clinical Pharmacology and Therapeutics.
• Anthony, M., Romero, K., Malone, D. C., Hines, L. E., Higgins, L., & Woosley, R. L. (2009). Warfarin interactions with substances listed in drug information compendia and in the FDA-approved label for warfarin sodium. Clinical Pharmacology and Therapeutics, 86(4), 425-429.
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  PMID: 19587643;Abstract: Interactions of warfarin with other drugs or substances can pose a serious problem. We assessed three drug information compendiaClinical Pharmacology, ePocrates, and Micromedexand the warfarin sodium (Coumadin) product label (August 2007) approved by the US Food and Drug Administration for listings of interactions between warfarin and drugs, biologics, foods, and dietary supplements. The drug information compendia and warfarin label differed greatly as to the total number of substances that interact with warfarin. Of a total of 648 entries from the four sources, only 50 were common to all the sources. The types of substances listed as interacting with warfarin were entire classes of drugs, individual drugs, and combinations; biologics; dietary supplements; foods; alcohol; and tobacco. These sources were then examined for classification by severity of interaction and the underlying evidence base. This study provides evidence that there is little concordance among commonly used drug compendia and product labels with respect to interactions involving warfarin. © 2009 American Society for Clinical Pharmacology and Therapeutics.
• Boudreau, D. M., Malone, D. C., Raebel, M. A., Fishman, P. A., Nichols, G. A., Feldstein, A. C., Boscoe, A. N., Ben-Joseph, R., Magid, D. J., & Okamoto, L. J. (2009). Health care utilization and costs by metabolic syndrome risk factors. Metabolic Syndrome and Related Disorders, 7(4), 305-313.
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  PMID: 19558267;Abstract: Background: This study compared prevalent health utilization and costs for persons with and without metabolic syndrome and investigated the independent associations of the various factors that make up metabolic syndrome. Methods: Subjects were enrollees of three health plans who had all clinical measurements (blood pressure, fasting plasma glucose, body mass index, triglycerides, and high-density lipoprotein cholesterol) necessary to determine metabolic syndrome risk factors over the 2-year study period (n = 170,648). We used clinical values, International Classification of Diseases, Ninth Revision (ICD-9) diagnoses, and medication dispensings to identify risk factors. We report unadjusted mean annual utilization and modeled mean annual costs adjusting for age, sex, and co-morbidity. Results: Subjects with metabolic syndrome (n = 98,091) had higher utilization and costs compared to subjects with no metabolic syndrome (n = 72,557) overall, and when stratified by diabetes (P < 0.001). Average annual total costs between subjects with metabolic syndrome versus no metabolic syndrome differed by a magnitude of 1.6 overall ($5,732 vs. $3,581), and a magnitude of 1.3 when stratified by diabetes (diabetes, $7,896 vs. $6,038; no diabetes, $4,476 vs. $3,422). Overall, total costs increased by an average of 24% per additional risk factor (P < 0.001). Costs and utilization differed by risk factor clusters, but the more prevalent clusters were not necessarily the most costly. Costs for subjects with diabetes plus weight risk, dyslipidemia, and hypertension were almost double the costs for subjects with prediabetes plus similar risk factors ($8,067 vs. $4,638). Conclusions: Metabolic syndrome, number of risk factors, and specific combinations of risk factors are markers for high utilization and costs among patients receiving medical care. Diabetes and certain risk clusters are major drivers of utilization and costs. © Mary Ann Liebert, Inc. 2009.
• Brixner, D. I., Holtorf, A., Neumann, P. J., Malone, D. C., & Watkins, J. B. (2009). Standardizing quality assessment of observational studies for decision making in health care. Journal of managed care pharmacy : JMCP.
• Malone, D. C., Boudreau, D. M., Nichols, G. A., Raebel, M. A., Fishman, P. A., Feldstein, A. C., Ben-Joseph, R. H., Okamoto, L. J., Boscoe, A. N., & Magid, D. J. (2009). Association of cardiometabolic risk factors and prevalent cardiovascular events. Metabolic Syndrome and Related Disorders, 7(6), 585-593.
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  PMID: 19900158;Abstract: Background: Although cardiovascular disease causes substantial morbidity and mortality, how individual and groups of risk factors contribute to cardiovascular outcomes is incompletely understood. This study evaluated cardiometabolic risk factors and their relationship to prevalent diagnosis of acute myocardial infarction (AMI) and stroke. Methods: We used retrospective data from 3 integrated health-care systems that systematically collect and store detailed patient-level data. Adult enrollees were eligible for inclusion if they had all of the following clinical measurements: weight, height, blood pressure, high density lipoproteins, triglycerides, and fasting blood glucose or evidence of diabetes from July 1, 2003, to June 30, 2005. We used National Cholesterol Education Program Adult Treatment Panel III guidelines to determine qualifying levels for cardiometabolic risk factors. Results: A total of 170,648 persons met the inclusion/exclusion criteria; 11,757 had no qualifying risk factors, 25,684 had 1, 38,176 had 2, and 95,031 had 3 or more risk factors. Compared to those without risk factors, persons with any 1 risk factor were 2.21 (95 confidence interval [CI], 1.78-2.74) times more likely to have had a diagnosis of AMI or stroke. The risk increased to 2.79 (95 CI, 2.26-3.42) for persons with 2, 3.45 (95 CI, 2.80-4.24) for persons with 3, 4.35 (95 CI, 3.54-5.35) for persons with 4, and 5.73 (95 CI, 4.65-7.07) for persons with 5 risk factors. The highest risk was conferred by having the combination of risk factors of diabetes, hypertension, and dyslipidemia, with or without weight risk. Conclusions: This study demonstrates a direct association between an increasing number of cardiometabolic risk factors and prevalent diagnosis of AMI and stroke. The combination of risk factors conferring the highest risk was diabetes, hypertension, and dyslipidemia. © 2009 Mary Ann Liebert, Inc.
• Malone, D. C., McLaughlin, T. P., Wahl, P. M., Leibman, C., Arrighi, H. M., Cziraky, M. J., & Mucha, L. M. (2009). Burden of Alzheimer's disease and association with negative health outcomes. American Journal of Managed Care, 15(8), 481-488.
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  PMID: 19670951;Abstract: Objective: To examine the association of Alzheimer's disease (AD) with common chronic conditions, acute care events, and risk of hospitalization. Study Design: Retrospective matched cohort analysis. Methods: Community-dwelling subjects with a diagnosis of and/or medication for AD were matched to subjects without AD based on age, sex, and geographic region. Administrative claims from commercially insured health plans for medical and pharmacy services provided from January 1, 2000, to March 31, 2006 (inclusive) were analyzed.The Deyo Charlson Index (DCI) was used to assess the number of chronic conditions.The outcomes of interest were risk of fractures and hospitalization. Results: Among 5396 persons with AD and a matched cohort of 5396 persons without the condition, subjects with AD were more likely to have a diagnosis for any of the DCI components, had a higher rate of fractures (17.7% vs 7.9%, P
• Murphy, J. E., Malone, D. C., Olson, B. M., Grizzle, A. J., Armstrong, E. P., & Skrepnek, G. H. (2009). Development of computerized alerts with management strategies for 25 serious drug-drug interactions. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 66(1), 38-44.
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  The development of computerized alerts with management strategies for 25 drug-drug interactions (DDIs) is described.
• Saverno, K. R., Malone, D. C., & Kurowsky, J. (2009). Pharmacy students' ability to identify potential drug-drug interactions. American journal of pharmaceutical education, 73(2), 27.
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  To evaluate the ability of third- and fourth-year pharmacy students to identify clinically significant drug-drug interactions (DDIs)
• Smith, K., Warholak, T., Armstrong, E., Leib, M., Rehfeld, R., & Malone, D. (2009). Evaluation of risk factors and health outcomes among persons with asthma. The Journal of asthma : official journal of the Association for the Care of Asthma, 46(3), 234-7.
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  To examine risk factors associated with healthcare utilization in Arizona Medicaid patients with asthma.
• Anthony, M., Lee, K. Y., Bertram, C. T., Abarca, J., Rehfeld, R. A., Malone, D. C., Freeman, M., & Woosley, R. L. (2008). Gender and age differences in medications dispensed from a national chain drugstore. Journal of women's health (2002), 17(5), 735-43.
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  Our objective was to compare sex and age differences in the medications dispensed in pharmacies from a large national drugstore chain.
• Armstrong, E. P., Malone, D. C., & Erder, M. H. (2008). A Markov cost-utility analysis of escitalopram and duloxetine for the treatment of major depressive disorder. Current medical research and opinion, 24(4), 1115-21.
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  To estimate the costs and quality-adjusted life weeks of duloxetine and escitalopram.
• Ko, Y., Malone, D. C., D'Agostino, J. V., Skrepnek, G. H., Armstrong, E. P., Brown, M., & Woosley, R. L. (2008). Potential determinants of prescribers' drug-drug interaction knowledge. Research in social & administrative pharmacy : RSAP, 4(4), 355-66.
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  Health care professionals' ability to recognize potential drug-drug interactions (potential DDIs) is important in reducing the risk of potential DDIs and their adverse consequences. Until now, little is known about the determinants of prescribers' potential DDI knowledge.
• Ko, Y., Malone, D. C., Skrepnek, G. H., Armstrong, E. P., Murphy, J. E., Abarca, J., Rehfeld, R. A., Reel, S. J., & Woosley, R. L. (2008). Prescribers' knowledge of and sources of information for potential drug-drug interactions: a postal survey of US prescribers. Drug safety, 31(6), 525-36.
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  Given the high prevalence of medication use in the US, the risk of drug-drug interactions (DDIs) and potential for patient harm is of concern. Despite the rise in technologies to identify potential DDIs, the ability of physicians and other prescribers to recognize potential DDIs is essential to reduce their occurrence. The objectives of this study were to assess prescribers' ability to recognize potential clinically significant DDIs and to examine the sources of information they use to identify potential DDIs and prescribers' opinions on the usefulness of various DDI information sources.
• Mahmood, M. H., Armstrong, E. P., Malone, D. C., & Skrepnek, G. H. (2008). Relationship between pharmaceutical services characteristics and exposure rates to drug-drug interactions in Veterans Affairs medical centers. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 65(18), 1744-9.
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  The association between the exposure rates of clinically important drug-drug interactions (DDIs) and the structure of pharmaceutical services within the ambulatory care settings of Veterans Affairs medical centers (VAMCs) is discussed.
• Hess, L. M., Benham-Hutchins, M., Herzog, T. J., Hsu, C. -., Malone, D. C., Skrepnek, G. H., Slack, M. K., & Alberts, D. S. (2007). A meta-analysis of the efficacy of intraperitoneal cisplatin for the front-line treatment of ovarian cancer. International Journal of Gynecological Cancer, 17(3), 561-570.
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  PMID: 17504373;Abstract: Ovarian cancer is the fourth leading cause of cancer death among women in the United States. First-line chemotherapy offered to patients with ovarian cancer generally consists of an intravenous (IV) platinum plus taxane regimen and has remained virtually unchanged for the past 10 years. A number of recently completed phase III randomized trials in the United States have reported improved progression-free survival (PFS) and/or overall survival (OS) with the intraperitoneal (IP) administration of cisplatin. The purpose of this study was to pool the published data to perform a meta-analysis of randomized trials of IP cisplatin in the initial chemotherapy treatment of ovarian cancer patients. This study was initiated to obtain a more valid estimate of the therapeutic impact of IP treatment for these patients. A search strategy was initiated that searched published findings of randomized trials of IP cisplatin therapy from multiple sources from January 1990 through January 2006. Six randomized trials of 1716 ovarian cancer patients were identified and included in this analysis. The pooled hazard ratio (HR) for PFS of IP cisplatin as compared to IV treatment regimens is 0.792 (95% CI: 0.688-0.912, P = 0.001), and the pooled HR for OS is 0.799 (95% CI: 0.702-0.910, P = 0.0007). These findings strongly support the incorporation of an IP cisplatin regimen to improve survival in the front-line treatment of stage III, optimally debulked ovarian cancer. © 2007, IGCS and ESGO.
• Mahmood, M., Malone, D. C., Skrepnek, G. H., Abarca, J., Armstrong, E. P., Murphy, J. E., Grizzle, A. J., Ko, Y., & Woosley, R. L. (2007). Potential drug-drug interactions within Veterans Affairs medical centers. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 64(14), 1500-5.
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  This study assessed the prevalence of 25 clinically important drug-drug interactions (DDIs) in the ambulatory care clinics of the Department of Veterans Affairs medical centers (VAMCs).
• Malone, D. C. (2007). Using indirect comparisons in pharmacoeconomic studies-Time for implementation. Clinical Therapeutics, 29(11), 2454-2455.
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  PMID: 18158086;
• Malone, D. C., Abarca, J., Skrepnek, G. H., Murphy, J. E., Armstrong, E. P., Grizzle, A. J., Rehfeld, R. A., & Woosley, R. L. (2007). Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions. Medical care, 45(5), 456-62.
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  Drug-drug interactions (DDIs) are preventable medical errors, yet exposure to DDIs continues despite systems that are designed to prevent such exposures. The purpose of this study was to examine pharmacy characteristics that may be associated with dispensed potential DDIs.
• Malone, D., & Malone, D. C. (2007). A budget-impact and cost-effectiveness model for second-line treatment of major depression. Journal of managed care pharmacy : JMCP, 13(6 Suppl A).
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  Depressed patients who initially fail to achieve remission when placed on a selective serotonin reuptake inhibitor (SSRI) may require a second treatment.
• Malone, D., Daniel, G. W., & Malone, D. C. (2007). Characteristics of older adults who meet the annual prescription drug expenditure threshold for medicare medication therapy management programs. Journal of managed care pharmacy : JMCP, 13(2).
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  The Medicare Modernization Act of 2003 requires drug plan sponsors to provide medication therapy management programs (MTMPs) to beneficiaries with (1) drug expenditures above $4,000, (2) multiple comorbidities, and (3) multiple prescription drugs. The Medical Expenditure Panel Survey (MEPS) is a national probability survey conducted annually by the Agency for Healthcare Research and Quality and the National Center for Health Statistics to provide nationally representative estimates of health care use, expenditures, sources of payments, and insurance coverage for the U.S. civilian noninstitutionalized population. MEPS comprises 3 components, including the household component (HC) in which households and individuals within households are sampled. The medical provider component (MPC) supplements the HC by contacting providers (hospitals, outpatient offices, home health agencies, and pharmacies) reported in the HC, and the insurance component collects data on health insurance plans and is separate from the HC.
• Malone, D., Grizzle, A. J., Mahmood, M. H., Ko, Y., Murphy, J. E., Armstrong, E. P., Skrepnek, G. H., Jones, W. N., Schepers, G. P., Nichol, W. P., Houranieh, A., Dare, D. C., Hoey, C. T., & Malone, D. C. (2007). Reasons provided by prescribers when overriding drug-drug interaction alerts. The American journal of managed care, 13(10).
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  To investigate prescribers' rationales for overriding drug-drug interaction (DDI) alerts and to determine whether these reasons were helpful to pharmacists as a part of prescription order verification.
• Malone, D., Yeh, W., Armstrong, E. P., Skrepnek, G. H., & Malone, D. C. (2007). Peginterferon alfa-2a versus peginterferon alfa-2b as initial treatment of hepatitis C virus infection: a cost-utility analysis from the perspective of the Veterans Affairs Health Care System. Pharmacotherapy, 27(6).
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  To assess the cost-utility of peginterferon alfa-2a plus ribavirin, peginterferon alfa-2b plus ribavirin, and no therapy for treatment-naïve patients with chronic hepatitis C virus (HCV) infection from the perspective of the Veterans Affairs (VA) health care system by using patient-reported utility scores.
• Yu, K. o., Abarca, J., Malone, D. C., Dare, D. C., Geraets, D., Houranieh, A., Jones, W. N., Nichol, W. P., Schepers, G. P., & Wilhardt, M. (2007). Practitioners' Views on Computerized Drug-Drug Interaction Alerts in the VA System. Journal of the American Medical Informatics Association, 14(1), 56-64.
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  PMID: 17068346;PMCID: PMC2215077;Abstract: Objectives: To assess Veterans Affairs (VA) prescribers' and pharmacists' opinions about computer-generated drug-drug interaction (DDI) alerts and obtain suggestions for improving DDI alerts. Design: A mail survey of 725 prescribers and 142 pharmacists from seven VA medical centers across the United States. Measurements: A questionnaire asked respondents about their sources of drug and DDI information, satisfaction with the combined inpatient and outpatient computerized prescriber order entry (CPOE) system, attitude toward DDI alerts, and suggestions for improving DDI alerts. Results: The overall response rate was 40% (prescribers: 36%; pharmacists: 59%). Both prescribers and pharmacists indicated that the CPOE system had a neutral to positive impact on their jobs. DDI alerts were not viewed as a waste of time and the majority (61%) of prescribers felt that DDI alerts had increased their potential to prescribe safely. However, only 30% of prescribers felt DDI alerts provided them with what they needed most of the time. Both prescribers and pharmacists agreed that DDI alerts should be accompanied by management alternatives (73% and 82%, respectively) and more detailed information (65% and 89%, respectively). When asked about suggestions for improving DDI alerts, prescribers most preferred including management options whereas pharmacists most preferred making it more difficult to override lethal interactions. Prescribers and pharmacists reported primarily relying on electronic references for general drug information (62% and 55%, respectively) and DDI information (51% and 79%, respectively). Conclusion: Respondents reported neutral to positive views regarding the effect of CPOE on their jobs. Their opinions suggest DDI alerts are useful but still require additional work to increase their clinical utility. © 2007 J Am Med Inform Assoc.
• Abarca, J., Colon, L. R., Wang, V. S., Malone, D. C., Murphy, J. E., & Armstrong, E. P. (2006). Evaluation of the performance of drug-drug interaction screening software in community and hospital pharmacies. Journal of managed care pharmacy : JMCP, 12(5), 383-9.
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  Computerized drug-drug interaction (DDI) screening is widely used to identify potentially harmful drug combinations in the inpatient and outpatient setting.
• Abarca, J., Malone, D. C., Skrepnek, G. H., Rehfeld, R. A., Murphy, J. E., Grizzle, A. J., Armstrong, E. P., & Woosley, R. L. (2006). Community pharmacy managers' perception of computerized drug-drug interaction alerts. Journal of the American Pharmacists Association : JAPhA, 46(2), 148-53.
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  To examine community pharmacists' attitudes toward computerized drug-drug interaction (DDI) alerts and identify factors associated with more favorable perceptions of these alerts.
• Hess, L. M., Raebel, M. A., Conner, D. A., & Malone, D. C. (2006). Measurement of adherence in pharmacy administrative databases: A proposal for standard definitions and preferred measures. Annals of Pharmacotherapy, 40(7-8), 1280-1288.
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  PMID: 16868217;Abstract: BACKGROUND: A variety of measures have been developed to calculate refill adherence from administrative data such as pharmacy claims databases. These measures have focused on improving the accuracy of adherence measures or clarifying the evaluation time frame. As a result, there are many measures used to assess adherence that may or may not be comparable or accurate. OBJECTIVE: To compare available refill adherence measures. METHODS: A systematic literature review was conducted to identify current or recently used measures of calculating adherence from administrative data. A MEDLINE search (January 1990-March 2006) was undertaken using the search terms adherence or compliance in the title combined with administrative, pharmacy, or records in any field, including subheadings medical, nursing, and hospital records. Non-English articles were excluded. Seven hundred fifteen articles were available for review. Review articles and letters were excluded from measure selection, but were included in the search terms and used to identify additional research articles. Adherence measures were excluded if they were incompletely described, produced non-numeric values, or were duplicates. Eleven refill adherence measures were identified and compared using data from the LOSE Weight (Long-term Outcomes of Sibutramine Effectiveness on Weight) study. Measures compared include Continuous Measure of Medication Acquisition (CMA); Continuous Multiple Interval Measure of Oversupply (CMOS); Medication Possession Ratio (MPR); Medication Refill Adherence (MRA); Continuous Measure of Medication Gaps (CMG); Continuous, Single Interval Measure of Medication Aquisition (CSA); Proportion of Days Covered (PDC); Refill Compliance Rate (RCR); Medication Possession Ratio, modified (MPRm); Dates Between Fills Adherence Rate (DBR); and Compliance Rate (CR). RESULTS: The results suggest that the CMA, CMOS, MPR, and MRA are identical in terms of measuring adherence to prescription refills throughout the study period, each with a value of 63.5%; CMG and PDC are slightly lower (63.0%) and are equivalent to MRA when oversupply is truncated. CR, MPRm, RCR, and CSA result in higher adherence values of 84.4%, 86.6%, 104.8%, and 109.7%, respectively. CONCLUSIONS: Five measures produce equivalent results for measuring prescription refill adherence over the evaluation period. Of these, MRA has the fewest calculations, is easily truncated if one desires to exclude surplus medication issues, and requires the least amount of data. MRA is therefore recommended as the preferred measure of adherence using administrative data.
• Johnson, L., Strich, H., Taylor, A., Timmermann, B., Malone, D., Teufel-Shone, N., Drummond, R., Woosley, R., Pereira, E., & Martinez, A. (2006). Use of herbal remedies by diabetic hispanic women in the Southwestern United States. Phytotherapy Research, 20(4), 250-255.
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  PMID: 16557605;Abstract: Objective: The primary purpose of this study was to examine the use and documentation of herbal remedies used by Hispanic women with Type II diabetes enrolled in two Community Health Centers in the Southwest USA. A secondary purpose was to review the literature on identified herbs to assess their likely effects on diabetes. Design: Open-ended structured interviews were conducted on a convenience sample (n = 23) of participants. Medical and medication charts were reviewed for the interviewed participants, and for a random sample of enrolled Hispanic diabetic patients (n = 81) who were not interviewed. Setting: Two Community Health Centers in the Southwest USA. Participants: Enrolled patient, Hispanic females with Type II diabetes. Intervention: Subjects were interviewed about their use of herbal therapies and supplements. Information collected from medical and pharmaceutical charts included documented use of herbal remedies; standard therapies prescribed and diabetes control (hemoglobin A1C values). For those herbal remedies reported, literature reviews were conducted to determine if there was supporting evidence of harm or efficacy for the stated condition. Main Outcome Measures: Reports of herbal use, and types of remedies used. Results: Among the interviewed participants, 21 of 23 (91%) reported using one or more herbal remedies. Among a random sample of patient medical charts, seven (6.7%) contained documentation of diabetes-specific herbs, and 16 (15.4%) had documented general herb use. A total of 77 different herbal remedies were identified, most of which were contained as part of commercial preparations, and appeared to supplement, rather than replace standard medical therapy for diabetes. Conclusion: Use of herbal therapies is not uncommon among diabetic patients. Many of the herbs reported have potential efficacy in treating diabetes or may result in adverse effects or interactions. In practical use, however, the herbs reported in this study are unlikely to have a significant effect on clinical outcomes in diabetes, either positively or negatively. Copyright © 2006 John Wiley & Sons, Ltd.
• Ko, Y., Malone, D. C., & Armstrong, E. P. (2006). Pharmacoeconomic evaluation of antimuscarinic agents for the treatment of overactive bladder. Pharmacotherapy, 26(12), 1694-702.
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  To compare the cost-effectiveness of various antimuscarinic agents for the treatment of overactive bladder (OAB).
• Perkins, N. A., Murphy, J. E., Malone, D. C., & Armstrong, E. P. (2006). Performance of drug-drug interaction software for personal digital assistants. The Annals of pharmacotherapy, 40(5), 850-5.
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  Personal digital assistants (PDAs) allow healthcare professionals to check for potential drug-drug interactions (DDIs) at the point of care, reducing the need to consult traditional references. However, PDAs can only be as effective as the software programs they use.
• Hess, L. M., Saboda, K., Malone, D. C., Salasche, S., Warneke, J., & Alberts, D. S. (2005). Adherence assessment using medication weight in a phase IIb clinical trial of difluoromethylornithine for the chemoprevention of skin cancer. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology.
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  Adherence is a common and essential measurement in clinical trials. This study evaluates the association between participant self-reported study diary records and the weight of the medication vessel at each study visit, in the setting of a phase IIb topical chemoprevention trial.
• Joish, V. N., Malone, D. C., Wendel, C., Draugalis, J. R., & Mohler, M. J. (2005). Development and validation of a diabetes mellitus severity index: A risk-adjustment tool for predicting health care resource use and costs. Pharmacotherapy, 25(5 I), 676-684.
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  PMID: 15899729;Abstract: Study Objective. To develop and validate a diabetes mellitus-specific risk-adjustment tool-the diabetes severity index (DSI)-to assist in predicting health care costs and resources within populations of patients with diabetes. Design. Retrospective analysis of clinical and resource use for patients with a diagnosis of diabetes mellitus. Model estimation was conducted with half the sample, and validation analysis was conducted with the other half. Setting. Southern Arizona Veterans Affairs Health Care System. Patients. Seven hundred thirty-four patients with diabetes (710 men, 24 women; mean age 66 yrs). Measurements and Main Results. Clinical measures of diabetes severity (known as the DSI) were used to predict three health care resource outcomes: risk of hospitalization, and total and ambulatory health care costs. Validity of the DSI was assessed by comparing the DSI with the revised chronic disease score (CDS). The DSI weights ranged from -471.5-3081.2 for total health care costs, from -304.3-1582.1 for outpatient costs, and -0.19-0.93 for risk of hospitalization. The DSI explained 6-8% of the variance in total and ambulatory costs and performed significantly (p
• Malone, D. C. (2005). Managing the spectrum of premenstrual symptoms. American Journal of Managed Care, 11(SUPPL. 16), S471-S472.
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  PMID: 16336055;
• Malone, D. C., Hutchins, D. S., Haupert, H., Hansten, P., Duncan, B., C., R., Solomon, S. L., & Lipton, R. B. (2005). Assessment of potential drug-drug interactions with a prescription claims database. American Journal of Health-System Pharmacy, 62(19), 1983-1991.
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  PMID: 16174833;Abstract: Purpose. The prevalence of 25 clinically important potential drug-drug interactions (DDIs) in a population represented by the drug claims database of a pharmacy benefit management company (PBM) was studied. Methods. A retrospective cross-sectional analysis of pharmaceutical claims for almost 46 million participants in a PBM was conducted to determine the frequency of 25 DDIs previously identified as clinically important. A DDI was counted when drugs in potentially interacting combinations were dispensed within 30 days of each other during a 25-month period between April 2000 and June 2002. Results. The number of DDIs ranged from 37 for pimozide and an azole antifungal to 127,684 for warfarin and a nonsteroidal antiinflammatory drug (NSAID). The highest prevalence (278.56 per 100,000 persons) and highest case-exposure rate (242.7 per 1,000 warfarin recipients) occurred with the warfarin-NSAID combination. The combination with the lowest overall prevalence (cyclosporine and a rifamycin, 0.10/100,000) differed from the combination with the lowest case-exposure rate (pimozide and an azole antifungal, 0.028 per 1,000 azole antifungal recipients). Number of cases, prevalence, and case-exposure rates for both sexes generally increased with age. An estimated 374,000 plan participants were exposed to a clinically important DDI during a 25-month period. Between 20% and 46% of prescription drug claims were reversed (canceled) for a medication with a drug interaction when a warning about the interaction was sent to the pharmacy. Conclusion. Analysis of prescription claims data from a major PBM found that 374,000 of 46 million plan participants had been exposed to a potential DDI of clinical importance.
• Malone, D. C., Raebel, M. A., Porter, J. A., Lanty, F. A., Conner, D. A., Gay, E. C., Merenich, J. A., & Vogel, E. A. (2005). Cost-effectiveness of sibutramine in the LOSE Weight Study: evaluating the role of pharmacologic weight-loss therapy within a weight management program.. Journal of managed care pharmacy : JMCP, 11(6), 458-468.
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  PMID: 15998163;Abstract: the cost-effectiveness of drug therapy when used in conjunction with a weight management program (WMP) for treatment of obesity. The objective was to compare the cost-effectiveness of sibutramine (Meridia) plus a structured WMP versus only a structured WMP in both overweight and obese individuals. The core WMP was a physician-supervised, multidisciplinary program for which each enrollee paid $100 out of pocket. METHODS: A cost-effectiveness analysis was performed based upon the results of a previously published randomized controlled trial conducted within a managed care organization. The target population for this study was obese or overweight persons. The perspective of the study was that of a managed care organization. The intervention consisted of subjects receiving a WMP with or without sibutramine. The primary outcomes of this study were (a) absolute change in body weight and percentage change in body weight over 12 months, (b) change in obesity-related and total medical costs from 12 months prior to enrollment through 12 months after enrollment, and (c) cost-effectiveness in terms of cost per pound of weight loss. All costs were adjusted to 2004 dollars using the respective components of the consumer price index for each medical service or medication. RESULTS: A total of 501 evaluable subjects were enrolled in the study, with 281 receiving sibutramine plus a structured WMP and 220 receiving only the structured WMP. The meanSD weight loss was significantly greater in the sibutramine (13.715.5 pounds, 4.8%) group than in the nondrug group (513.2 pounds, 2.2%) (P < 0.001). The change in obesity-related total cost was a median increase of $408 for the sibutramine group compared with $31 for the nondrug group (P < 0.001). The change in total health care cost was a median $1,279 increase in the sibutramine group compared with $271 for the nondrug group (P < 0.001). Adding sibutramine to the WMP increased the total cost by $44 per additional pound of weight loss (95% confidence interval, 42-46). Sensitivity analyses found that the results were sensitive to the price of sibutramine, whereas varying the cost of clinic visits did not substantially change the results. CONCLUSION: Patients enrolled in a WMP receiving sibutramine had greater weight loss and decrease in body mass index at greater cost than did patients enrolled in the same program who did not receive sibutramine. There were no observed savings in total health care resource utilization or cost in the sibutramine group compared with the nondrug group.
• Malone, D. C., Tran, T. T., & Poordad, F. F. (2005). Cost-efficacy analysis of peginterferon alfa-2b plus ribavirin compared with peginterferon alfa-2a plus ribavirin for the treatment of chronic hepatitis C.. Journal of managed care pharmacy : JMCP., 11(8), 687-694.
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  PMID: 16194133;Abstract: OBJECTIVE: Combination therapy with pegylated interferon (Peg) and ribavirin (RBV) is the standard of care for the treatment of chronic hepatitis C virus (HCV) infection. This analysis compares the cost efficacy of treatment with pegylated interferon alfa-2b plus ribavirin (Peg-2b plus RBV) with pegylated interferon alfa-2a plus ribavirin (Peg-2a plus RBV) in hypothetical cohorts of 100 chronic HCV patients comprised 75% of genotype 1. METHODS: A decision analysis model was constructed from the viewpoint of a managed care organization to compare Peg-2b plus RBV (1.5 mcg per kilogram per week plus RBV 800 mg per day) and Peg-2a plus RBV (180 mcg per week plus RBV 1,000-1,200 mg per day) pursuant to the label dosing approved by the U.S. Food and Drug Administration. The model also included the so-called weight-based dosing regimen with Peg-2b plus RBV (1.5 mcg per kilogram per week plus RBV 10.6 mg/kg per day). Patient weight was assumed to be 80 kg. For purposes of this analysis, early virologic response (EVR), defined as viral negative or 2-log drop in viral load, was assessed at 12 weeks for only genotype 1 patients, and nonresponders were assumed to discontinue therapy. The positive predictive value (PPV) was calculated for each treatment group for genotype 1 patients, which is determined from the values for EVR and sustained viral response (SVR). Genotype 2 and genotype 3 patients were assumed to be treated for 24 weeks. Treatment duration and efficacy data were obtained from the published literature. Product pricing was based on average wholesale price, October 2004, and sensitivity analysis was performed using prices from the Federal Supply Schedule. Economic outcomes were determined from hypothetical 100-patient cohorts assumed to be comprised 75% of genotype 1 HCV. RESULTS: Taking into account both EVR and SVR, the PPV for genotype 1 patients was 0.63 and 0.57 for Peg-2b plus RBV and Peg-2a plus RBV, respectively. The proportion of treated patients achieving SVR would be nearly identical, (53.6%) and (53.8%) for Peg-2a plus RBV and Peg-2b plus flat RBV, respectively. For Peg- 2b plus weight-based RBV, the proportion of patients achieving SVR was higher (61.4%). Consequently, this leads to fewer overall treatment weeks for the Peg- 2b plus RBV cohorts. Therefore, the cost per successful treatment (defined as SVR) was 19.4% less (37,638 US dollars) for Peg-2b plus flat dosing of RBV as compared with Peg-2a plus RBV (46,717 US dollars). When Peg-2b plus RBV was dosed 1.5 mcg per kilogram per week plus RBV 10.6 mg/kg/day, then the cost per SVR was 39,045 US dollars. The cost for the 100-patient cohort was 2,024,846 US dollars for Peg-2b plus RBV, 2,397,529 US dollars for Peg-2b plus weight-based RBV, and 2,505,317 US dollars for Peg-2a plus RBV. This difference is due to a lower PPV in the Peg-2a plus RBV groups and hence more patients treated in spite of a low probability of achieving SVR. CONCLUSION: The results of this cost-efficacy analysis suggest that treating HCV genotype 1 patients with Peg-2b plus RBV may result in savings to a health care system because fewer of these patients are treated beyond 12 weeks when achieving sustained viral clearance is unlikely.
• Malone, D., & Malone, D. C. (2005). The role of pharmacoeconomic modeling in evidence-based and value-based formulary guidelines. Journal of managed care pharmacy : JMCP, 11(4 Suppl).
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  To review evidence-based medicine (EBM) in the context of pharmacoeconomic (PE) decision making by health care organizations.
• Olson, B. M., Malone, D. C., Zachary, W. M., & Coons, S. J. (2005). Consumer understanding and satisfaction associated with a 3-tier prescription drug benefit.. Journal of managed care pharmacy : JMCP, 11(6), 480-492.
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  PMID: 15998165;Abstract: OBJECTIVE: The purpose of this research was to investigate consumer understanding and satisfaction associated with a 3-tier prescription drug benefit among users of the prescription drug benefit. METHODS: This study involved a self-administered postal questionnaire and the use of prescription drug claims to evaluate utilization of prescription medications. Fifteen hundred subjects were randomly selected based on the following inclusion criteria. Each subject had to (1) be enrolled in a 3-tier copayment ($10 generic, $20 formulary brand, $35 nonformulary brand) prescription drug benefit; (2) be the primary beneficiary (cardholder); (3) be >18 years of age; (4) have received at least 1 prescription medication using his or her prescription drug insurance; and (5) have a mailing address on file. RESULTS: A total of 479 usable responses were returned (35% response rate). The mean (SD) understanding score was 2.22 (1.54) (range: 0 to 6). Fewer than 1% of respondents correctly answered all 6 items used to measure the level of understanding. The mean (SD) satisfaction score was 54.32 (19.69) (range: 0 to 100). Experience with purchasing a medication within a particular copayment tier was predictive of correctly answering the item related to that tier.s copayment amount. Multiple regression analysis revealed a relationship between the amount of use of the drug benefit and the degree of satisfaction with the drug benefit. There was no significant relationship between the level of understanding and the degree of satisfaction with prescription drug insurance. CONCLUSION: The average level of beneficiary understanding of the 3-tier copayment prescription drug benefit was very low, and the average degree of respondent satisfaction appeared to be near neutral. There was no significant relationship between the level of understanding and the degree of satisfaction with prescription drug benefits. The level of understanding was proportional to the amount of drug benefit use, but the degree of satisfaction was not related to the amount of drug benefit use.
• Romero, A. V., & Malone, D. C. (2005). Accuracy of adverse-drug-event reports collected using an automated dispensing system. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 62(13), 1375-80.
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  The accuracy of adverse-drug-event (ADE) reports collected using an automated dispensing system was evaluated.
• Skrepnek, G. H., Abarca, J., Malone, D. C., Armstrong, E. P., Shirazi, F. M., & Woosley, R. L. (2005). Incremental effects of concurrent pharmacotherapeutic regimens for heart failure on hospitalizations and costs. The Annals of pharmacotherapy, 39(11), 1785-91.
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  Inappropriate medication use in patients with heart failure (HF) presents challenges in providing optimal, evidence-based care.
• Skrepnek, G. H., Armstrong, E. P., Malone, D. C., & Ramachandran, S. (2005). An economic and outcomes assessment of first-line monotherapy in the treatment of community-acquired pneumonia within managed care. Current medical research and opinion, 21(2), 261-70.
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  To evaluate the resource consumption and outcomes associated with first-line monotherapy for community-acquired pneumonia, focusing specifically on the use of erythromycin, azithromycin, clarithromycin, and levofloxacin.
• Abarca, J., Malone, D. C., Armstrong, E. P., & Zachry, W. M. (2004). Angiotensin-converting enzyme inhibitor therapy in patients with heart failure enrolled in a managed care organization: effect on costs and probability of hospitalization. Pharmacotherapy, 24(3), 351-7.
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  To evaluate the effect of angiotensin-converting enzyme (ACE) inhibitor therapy on risk of hospitalization and resource utilization in patients with heart failure enrolled in a managed care organization.
• Abarca, J., Malone, D. C., Armstrong, E. P., Grizzle, A. J., & Cohen, M. D. (2004). Longitudinal analysis of the use of etanercept versus infliximab determined from medical chart audit. Journal of managed care pharmacy : JMCP, 10(6), 538-42.
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  To describe the dosing of etanercept and infliximab for the treatment of rheumatoid arthritis (RA).
• Gardner, M. E., Malone, D. C., Sey, M., & Babington, M. A. (2004). Mirtazapine is associated with less anxiolytic use among elderly depressed patients in long-term care facilities. Journal of the American Medical Directors Association, 5(2), 101-106.
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  PMID: 14984621;Abstract: Background: Depression is a common, treatable disorder among nursing facility residents. Objective: The purpose of this study was to examine medication use and cost between two groups of patients: (1) persons treated with mirtazapine, as comparedwith (2) persons taking other antidepressants. Design: This study was a retrospective chart review of long-term care patients. Consultant pharmacists collected data on patients who were receiving selective serotonin reuptake inhibitors (SSRIs), venlafaxine, nefazodone, or mirtazapine. Setting: Nursing facilities that were geographically dispersed throughout the United States. Participants: We studied patients greater than 65 years of age with major depressive disorder or a depression-related diagnosis and receiving antidepressant treatment for at least 3 months. Patients with bipolar-induced depression were excluded as well as those receiving tricyclic antidepressants. Results: The two groups were similar in terms of age, but those receiving mirtazapine had lower body weight and body mass index. Patients on mirtazapine were less likely to be taking a sedative/hypnotic (P = 0.006). This was primarily the result of fewer patients in the mirtazapine group taking lorazepam (P = 0.03). There was no difference between the two groups regarding their use of other psychotropic medications, including multiple antidepressants, antipsychotics, anticonvulsants, acetylcholinesterase inhibitors, or appetite stimulants. Monthly medication costs were less for those patients receiving mirtazapine ($82.83) as compared with other antidepressants ($97.03) (P
• Joish, V. N., Malone, D. C., Wendel, C., & Mohler, M. J. (2004). Profiling quality of diabetes care in a veterans affairs healthcare system. American Journal of Medical Quality, 19(3), 112-120.
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  PMID: 15212316;Abstract: Profiling care on the basis of standard sets of measures has been extensively studied in the inpatient setting. However, less attention has been given to profiling outpatient care. The purpose of this study was to determine the influence of case-mix adjustment when profiling care for persons with diabetes. This is a cross-sectional study using medical and pharmacy data. Four process and 3 outcomes measures were used to assess the quality of care provided between 4 outpatient clinics. Diabetics were predominantly elderly (mean = 66 years), married (61%), white (73%), males (96%), with high body mass index (31 ± 6.3 kg/m2), and mean comorbidity score of 4.2 ± 1.8 conditions. Screening for hemoglobin A1c (HbA1c) and microalbuminuria was frequently performed in all clinics. However, 61% (n = 1697) and 36% (n = 254) of study patients had not undergone foot or eye examinations during the study period, respectively. Approximately 27% (n = 408), 41% (n = 643), and 26% (n = 515) of the study patients had poor glycemic, renal function, and lipid control, respectively. Significant differences (P < .05) in poor HbA1c and creatinine clearance rates between the clinics were observed after adjusting for patient case-mix. No differences between the clinics in cholesterol levels were observed after adjusting for patient case-mix. Overall, these clinics performed well in process of care measures, except for foot screening. After adjusting for patient case-mix, significant disparities between the clinics were observed with respect to glycemic control and renal function measures, whereas differences were nullified with respect to cardiovascular outcome measure.
• Malone, D. C., Armstrong, E. P., & Zachry, W. M. (2004). Cost-effectiveness analysis of simvastatin and lovastatin/extended- release niacin to achieve LDL and HDL goal using NHANES data. Journal of managed care pharmacy : JMCP, 10(3), 251-8.
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  The Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, Adult Treatment Panel III (ATP III) encouraged reduced low-density lipoprotein (LDL) cholesterol levels for a greater number of patients and reemphasized the benefits of high-density lipoprotein (HDL) cholesterol. The purpose of this study was to compare 2 regimens achieving simultaneous LDL and HDL goals.
• Raebel, M. A., Malone, D. C., Conner, D. A., Stanley, X. u., Porter, J. A., & Lanty, F. A. (2004). Health services use and health care costs of obese and nonobese individuals. Archives of Internal Medicine, 164(19), 2135-2140.
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  PMID: 15505127;Abstract: Background: Obesity has clinical and economic consequences. Few studies have compared health care resource utilization between age- and sex-matched obese and nonobese persons. Methode: We conducted a retrospective study in obese and nonobese individuals matched by age, sex, medical clinic, and selected exclusionary diagnoses. Data collected included hospitalizations, outpatient visits, professional claims, and prescriptions over 1 year. Costs were assigned to medical resources based on market prices using publicly available costs. Comorbid conditions were determined using a chronic disease score (CDS) index. Groups were compared on types and costs of resources consumed. Regression models were used to examine the effect of body mass index (BMI) on costs while controlling for age and chronic diseases. Results: A total of 539 obese and 1225 nonobese persons were examined. Obese patients had more hospitalizations (P
• Christensen, D. B., Ferguson, M. S., Garrett, D. G., Bunting, B. A., Malone, D. C., & Cranor, C. W. (2003). Studying pharmaceutical care: difficult but necessary.. Journal of the American Pharmacists Association : JAPhA, 43(5 Suppl 1), S36-37.
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  PMID: 14626526;Abstract: Research into the impact of pharmaceutical care need not be complex, but it is difficult in real-world settings. Pharmaceutical care projects need a committed project manager, dedicated pharmacists, an involved payer, and patients who believe they have a problem that needs to be addressed. Significant differences in outcomes are more likely with some chronic diseases than with others. Adequate funding of pharmaceutical care studies is needed to support identification of drug-related problems and outcomes in larger numbers of patients and over longer time periods. Demonstrating changes in patient satisfaction with providers and in health-related quality of life is difficult.
• Joish, V. N., Malone, D. C., & Miller, J. M. (2003). A cost-benefit analysis of vision screening methods for preschoolers and school-age children. Journal of AAPOS, 7(4), 283-290.
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  PMID: 12917617;Abstract: Introduction: The purpose of this study was to determine costs and benefits of visual acuity screening (VAS) or photoscreening (PS) in children. Methods: A societal-perspective, decision-analytic model compared VAS and PS conducted in three age groups: children 6 to 18 months, 3 to 4 years, and 7 to 8 years old. Literature estimates of sensitivity, specificity, and prevalence were used. Cost estimates and referral rates for surgical treatment were derived from a managed care database and the United States Social Security Administration. Results: All the benefit-to-cost ratios exceeded 1.0, meaning that all screening programs studied had benefits that exceeded the cost of screening. The total net benefit was highest for PS in children of 3 to 4 years of age ($19,412) and the least for VAS in children 7 to 8 years of age ($15,179). The benefit-to-cost ratio was highest for the VAS in children 3 to 4 years of age ($162) and least for PS in infants 6 to 18 month old ($140). Sensitivity of the PS instrument and VAS charts were the most influential variables in determining the most cost-beneficial program. Conclusions: Based on the best available data, the net benefit of PS in 3 to 4 year old preschool children is greater than VAS in children 7 to 8 years of age, PS in toddlers, and VAS in children 3 to 4 years of age.
• Lackner, T. E., Heard, T., Glunz, S., Gann, N., Babington, M., & Malone, D. C. (2003). Gastrointestinal disease control after histamine₂-receptor antagonist dose modification for renal impairment in frail chronically Ill elderly patients. Journal of the American Geriatrics Society, 51(5), 650-656.
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  PMID: 12752840;Abstract: OBJECTIVES: To determine whether histamine2-receptor antagonist (H2RA) dose modified for renal impairment affects gastrointestinal (GI) disease control. DESIGN: Concurrent medical record review. SETTING: One hundred forty-six nursing facilities throughout the United States. PARTICIPANTS: Three hundred thirty-six patients aged 65 and older receiving H2RAs for GI disorders. INTERVENTION: H2RA dose modified for renal impairment or no dose change. MEASUREMENTS: Disease control (no H2RA dose increase for 6 months or longer, additional GI medication, hospitalizations, emergency room visits, and unscheduled physician visits for GI symptoms) was evaluated using chart review at 3, 6, 9, and 12 months in nursing home patients aged 65 and older with H2RA dose modified for decreased creatinine clearance (ClCr) according to manufacturer. RESULTS: Three hundred thirty-six patients, mean age ± standard deviation 85.9 ± 7.9, with mean ClCr of 33.6 ± 10.4 mL/min, were recommended to receive lower H2RA doses based upon estimated renal function. Patients were analyzed in two groups: H2RA dose reduced (Group 1) and dose reduction not adopted or implemented (Group 2). There was no difference in baseline characteristics (age, weight, ClCr, or starting H2RA dose and indication) between the two groups. One hundred ninety-eight patients in Group 1 were taking 195.5 ± 71.0 mg per day of nizatidine or equivalent, compared with 183.7 ± 66.6 mg for 138 patients in Group 2. For patients with 90 days of follow-up, the mean H2RA dose in Group 1 was 100.2 ± 44.3 mg, compared with 187.8 ± 69.9 for Group 2 (P < .0001) The mean decrease in daily dose for Groups 1 and 2 after 365 days were 98.9 ± 72.9 mg and 22.2 ± 68.2 mg, respectively (P < .0001). Except for more physician visits in Group 2, disease control was similar for all groups. Major and minor GI bleeding events were similar across both groups and over time. The 12-month mortality rate was 12.1% and 21.7% for Groups 1 and 2, respectively. This difference was statistically significant (P = .02). CONCLUSION: The findings suggest that the dose of H2RAs may be decreased based upon renal function in frail elderly patients without compromising GI disease control.
• Lee, E. K., & Malone, D. C. (2003). Comparison of peptic-ulcer drug use and expenditures before and after the implementation of a government policy to separate prescribing and dispensing practices in South Korea. Clinical Therapeutics, 25(2), 578-592.
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  PMID: 12749515;Abstract: Background: The South Korean government instituted a new policy, the separation of prescribing and dispensing (SPD) of medications, on July 1, 2000, to provide greater differentiation between the roles of physicians and pharmacists than had historically existed in South Korea. It was hoped that this policy would promote the rational use of medications and reduce medication expenditures, which accounted for ∼30% of the total health care expenditures before the implementation of SPD. Objective: The purpose of this study was to assess the effects of SPD on drug market share and expenditures for branded and generic medications by comparing the use of and expenditures for peptic-ulcer medications before and after the implementation of SPD. Methods: Data on expenditures and quantity of use in January and December 2000 (in terms of defined daily dose [DDD]) of peptic-ulcer medications were obtained from the Korean National Health Insurance claims database. These data were derived using a 3-stage probability sample of prescription data from medical clinics in South Korea. Results: The number of prescription drug claims for peptic-ulcer drugs increased by 13.9% after the introduction of SPD. Medication expenditures increased by 98.4% for peptic-ulcer medications. The use of more expensive drugs and branded products, even when generic products were available, accounted for most of this increase. In particular, the use of branded ranitidine 150 mg (measured by DDD) increased from 6.3% of the market share before SPD to 27.6% of the market share after the implementation of SPD. Conclusions: The implementation of SPD increased both prescription drug claims and expenditures for peptic-ulcer medications. A principal factor contributing to the increase in expenditures was the use of branded medications. Copyright © 2003 Excerpta Medica, Inc.
• Malone, D. C., & Luskin, A. T. (2003). Hydrofluoroalkane-134a beclomethasone as a dominant economic asthma therapy. Respiratory Medicine, 97(12), 1269-1276.
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  PMID: 14682406;Abstract: Inhaled corticosteroids for asthma treatment have become mainstay of therapy for patients with persistent asthma. Numerous inhaled corticosteroids are available but to date no prospective cost-effectiveness studies have been reported using exclusively US patients and costs. The purpose of this study was to examine the cost-effectiveness of HFA-beclomethasone (QVAR™) compared to CFC-beclomethasone (Vanceril™) using data from a year-long prospective randomized, open label, parallel multicenter trial. Eligibility criteria required patients to have been on a stable dose of CFC-BDP prior to enrollment. Patients were randomized to either HFA-BDP at approximately half their previous daily dose of CFC-BDP or to continue CFC-BDP. Effectiveness data, in terms of symptom-free days (SFDs), were used in a cost-effectiveness analysis conducted from the viewpoint of managed care. Patients receiving HFA-BDP reported a greater increase (median = 22.1) in the number of SFDs than those receiving CFC-BDP (median = 14.3) (P = 0.03). Total costs of care were less for patients taking HFA-BDP (median = $668) compared to CFC-BDP (median = $977). The median incremental cost-effectiveness ratio was -$5.77 (95% CI:-$68.08 to -$4.08). The results of this analysis indicate that HFA-BDP was a dominant therapy (more effective, less costly) compared to CFC-BDP. © 2003 Elsevier Ltd. All rights reserved.
• Malone, D., Armstrong, E. P., & Malone, D. C. (2003). The impact of nonsteroidal anti-inflammatory drugs on blood pressure, with an emphasis on newer agents. Clinical therapeutics, 25(1).
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  Both nonselective and selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to increase blood pressure (BP).
• Malone, D., Armstrong, E. P., & Malone, D. C. (2002). Fluticasone is associated with lower asthma-related costs than leukotriene modifiers in a real-world analysis. Pharmacotherapy, 22(9).
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  To compare the impact of fluticasone propionate versus three leukotriene modifiers-montelukast, zafirlukast, and zileuton-on the cost of asthma within a managed care organization.
• Carter, B. L., Malone, D. C., Billups, S. J., Valuck, R. J., Barnette, D. J., Sintek, C. D., Ellis, S., Covey, D., Mason, B., Jue, S., Carmichael, J., Guthrie, K., Dombrowski, R., Geraets, D. R., & Amato, M. (2001). Interpreting the findings of the IMPROVE study. American Journal of Health-System Pharmacy, 58(14), 1330-1337.
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  PMID: 11471481;Abstract: Various findings of the Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers (IMPROVE) study are reviewed. Suggestions for future methodologies that will enhance this study are discussed. The IMPROVE study is one of the largest pharmaceutical care studies conducted. Although it was an intervention study that examined global outcomes following management by pharmacists, it was designed as an effectiveness study. Several new practice and research methods were developed, including a method to identify patients at high risk for drug-related problems utilizing pharmacy databases, a method to identify chronic diseases using pharmacy databases, a method to evaluate the structure and process for delivering pharmaceutical care in Veterans Affairs medical centers (VAMCs), and guidelines for providing care to patients in the IMPROVE study. Nine VAMCs participated in the study, and 1054 patients were randomized to either an intervention group (n = 523) or a control group (n = 531). Pharmacists documented a total of 1855 contacts with the intervention group patients and made 3048 therapy-specific interventions over the 12-month study period. There was no meaningful difference in patient satisfaction or quality of life in the two groups. Selected disease-specific indicators found an improved rate of measurement of hemoglobin A1c tests and better control of total and low-density-lipoprotein (LDL) cholesterol levels in the intervention group compared with the control group. Total health care costs increased in both groups over the 12-month period. The mean increase in costs in the intervention group was $1020, which was lower than the control group's value of $1313. The lessons learned from the IMPROVE study suggest to future investigators how to study and measure the effects of clinical pharmacy services on patient outcome.
• Malone, D. C., & Armstrong, E. P. (2001). Economic burden of asthma: implications for outcomes and cost-effectiveness analyses. Expert review of pharmacoeconomics & outcomes research, 1(2), 177-86.
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  Asthma is a disease of chronic airway inflammation. It is of importance to clinicians and health systems because the hospitalization and death rate due to asthma have increased since 1980. Cost of illness studies have estimated that the total cost of asthma (direct and indirect costs) exceed USD 10 billion annually, in the USA. Since 1985, the proportion of asthma costs in hospitals have decreased and the proportion of costs due to asthma medications have increased. However, approximately half of direct medical costs of asthma are due to hospitalizations. The mean direct cost of asthma per year per patient has been estimated to be approximately USD 1,100. As the implementation of national and international guidelines continues, future costs for asthma will likely come from the treatment and management of the disease. Adequate assessments of treatment and cost-effectiveness analysis are important. Recommendations promoting the use of cost-effective anti-inflammatory medications are crucial to efficiently managing asthma.
• Malone, D. C., & Shaban, H. M. (2001). Adherence to ATS guidelines for hospitalized patients with community-acquired pneumonia. Annals of Pharmacotherapy, 35(10), 1180-1185.
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  PMID: 11675841;Abstract: OBJECTIVES: To compare outcomes of care and antibiotic utilization for community-acquired pneumonia (CAP) throughout a group of not-for-profit hospitals. METHODS: A retrospective review of patients from community hospitals with a diagnosis of pneumonia at discharge admitted from December 1997 to May 1998. Data were collected based on American Thoracic Society (ATS) criteria. RESULTS: Medical records of 330 patients were reviewed; mortality was 7%. Using ATS guidelines, 51 (15.5%) patients were not treated with recommended antimicrobial therapy. Of these patients, 14 had nonsevere cases of CAP and 37 cases were severe. Factors found to be associated with in-hospital mortality included nonadherence to ATS guidelines. (OR 4.46; 95% CI 1.38 to 14.43), decreased urine output (OR 7.72; 95% CI 1.70 to 35.04), and increasing age (OR 1.06; 95% CI to 1.01 to 1.12). Significant predictors of length of stay (LOS) included age, nonadherence to ATS criteria, suspected aspiration, discharge status, low pulse oximetry on admission, decreased urine output, use of vasopressor medications, and interstitial lung disease. More than 80% of patients had at least one culture performed, but only 27.5% of these cultures were positive. The most commonly prescribed antibiotic was cefuroxime injection, representing 25% of the antibiotic orders. CONCLUSIONS: Patients with CAP treated inconsistently with ATS guidelines had a 4.46-fold higher risk inpatient mortality and had significantly longer LOS.
• Malone, D. C., Carter, B. L., Billups, S. J., Valuck, R. J., Barnette, D. J., Sintek, C. D., Okano, G. J., Ellis, S., Covey, D., Mason, B., Jue, S., Carmichael, J., Guthrie, K., Sloboda, L., Dombrowski, R., Geraets, D. R., & Amato, M. G. (2001). Can clinical pharmacists affect SF-36 scores in veterans at high risk for medication-related problems?. Medical Care, 39(2), 113-122.
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  PMID: 11176549;Abstract: BACKGROUND. An objective of pharmaceutical care is for pharmacists to improve patients' health-related quality of life (HRQOL) by optimizing medication therapy. OBJECTIVES. The objective of this study was to determine whether ambulatory care clinical pharmacists could affect HRQOL in veterans who were likely to experience a drug-related problem. RESEARCH DESIGN. This was a 9-site, randomized, controlled trial involving Veterans Affairs Medical Centers (VAMCs). Patients were eligible if they met ≥3 criteria for being at high risk for drug-related problems. Enrolled patients were randomized to either usual medical care or usual medical care plus clinical pharmacist interventions. HRQOL was measured with the SF-36 questionnaire administered at baseline and at 6 and 12 months. RESULTS. In total, 1,054 patients were enrolled; 523 were randomized to intervention, and 531 to control. After patient age, site, and chronic disease score were controlled for, the only domain that was significantly different between groups over time was the bodily pain scale, which converged to similar values at the end of the study. Patients' rating of the change in health status in the past 12 months was statistically different between groups, intervention patients declining less (-2.4 units) than control subjects (-6.3 units) (P
• Malone, D. C., Sullivan, S. D., & Veenstra, D. L. (2001). Determining unit cost values for health care resources in pharmacoeconomic studies. Formulary, 36(4), 294-304.
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  Abstract: The purpose of pharmacoeconomics is to enhance pharmaceutical decision-making within a patient population. One major and ongoing criticism decision-makers have about pharmacoeconomic studies is that the costs used in the studies don't apply to "their" environment. Obtaining cost estimates for many types of commonly used health care resources can be difficult. This article reviews common and not-so-common sources of cost information within three main health care resource areas often involved in pharmacoeconomic evaluations: pharmaceuticals, physician services, and hospitalization.
• Okano, G. J., Malone, D. C., Billups, S. J., Carter, B. L., Sintek, C. D., Covey, D., Mason, B., Jue, S., Carmichael, J., Guthrie, K., Dombrowski, R., Geraets, D. R., & Amato, M. G. (2001). Reduced quality of life in veterans at risk for drug-related problems. Pharmacotherapy, 21(9 I), 1123-1129.
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  PMID: 11560202;Abstract: The relationships between drug therapy and health-related quality of life in 1054 patients who received care from Department of Veterans Affairs medical centers (VAMCs) were assessed. Patients at high risk for drug-related problems were enrolled into a pharmaceutical care study at nine VAMCs. On enrollment, the short form (SF)-36 was completed and medical records were examined for evidence of coexisting illness. Drug therapy in the year before enrollment was analyzed in relation to SF-36 scores. Mean ± SD SF-36 scores ranged from 37.99 ± 41.70 for role physical to 70.78 ± 18.97 for mental health domains, with all domain scores significantly below age-adjusted national norms (p
• Reith, C. H., & Malone, D. C. (2001). Understanding the fundamental concepts for interpreting or conducting meta-analyses. Formulary, 36(8), 594-609.
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  Abstract: Meta-analysis has become an increasingly popular method of quantifying overall drug treatment effects and of enhancing the information obtained through traditional literature review. By statistically combining several individual study results into an aggregate result, the meta-analysis method becomes particularly beneficial when evaluating multiple studies reporting outcomes. Because of the increasing number of meta-analysis studies, it is important that those reading the studies or conducting their own study comprehend some of the their basic concepts and pitfalls. This article reviews the steps of a meta-analysis method and illustrates the steps with a simple example of clonidine's use in smoking cessation.
• Billups, S. J., Malone, D. C., & Carter, B. L. (2000). The relationship between drug therapy noncompliance and patient characteristics, health-related quality of life, and health care costs. Pharmacotherapy, 20(8 I), 941-949.
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  PMID: 10939555;Abstract: The objectives of this study were to determine the relationship between drug therapy compliance and risk of hospitalization and economic outcomes, and to identify potential indicators of compliance. We used computerized prescription records from 1054 patients at high risk for drug-related problems. We calculated a compliance ratio for a 12-month period and correlated it with health care use, demographic variables, drug-related variables, and scores for health-related quality of life. Univariate results suggested that increased age (p=0.05), high number of chronic conditions (p
• Billups, S. J., Okano, G., Malone, D., Carter, B. L., Valuck, R., Barnette, D. J., & Sintek, C. D. (2000). Assessing the structure and process for providing pharmaceutical care in Veterans Affairs medical centers. American Journal of Health-System Pharmacy, 57(1), 29-39.
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  PMID: 10630554;Abstract: The structure and process used in providing pharmaceutical care to ambulatory care patients at nine Veterans Affairs medical centers (VAMCs) were studied. Institutions participating in the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study were selected. To assess the level of pharmaceutical care services provided to ambulatory care patients, 10 critical domains were identified. Six instruments with questions related to each domain were then designed, including a clinical pharmacist survey and an outpatient pharmacist survey. Each center was assessed through three surveys and an onsite visit. The investigators used both direct observation and a consensus approach to score the level of ambulatory care pharmaceutical services provided. The clinics in which IMPROVE study patients would be seen were run by pharmacists (33%), physicians (44%), and multidisciplinary teams (22%). Of the 51 clinical pharmacists surveyed, 23 (45%) had prescribing authority via protocols, 14 (28%) had unrestricted prescribing privileges, and 14 did not have prescribing authority. The sites varied greatly in referral patterns, methods of identifying patients, and whether patient visits were scheduled or on a walk-in basis. There was a strong correlation between observed activities by clinical pharmacists and their self-reports and between observed activities by outpatient pharmacists and their self-reports. Activities reported by clinical pharmacists were moderately but not significantly correlated with consensus scores, and activities reported by out patient pharmacists were poorly correlated with consensus scores. The structure and process for providing pharmaceutical care to ambulatory care patients at VAMCs were evaluated with surveys, direct observation, and a consensus-based scoring system.
• Ellis, S. L., Billups, S. J., Malone, D. C., Carter, B. L., Covey, D., Mason, B., Jue, S., Carmichael, J., Guthrie, K., Sintek, C. D., Dombrowski, R., Geraets, D. R., & Amato, M. (2000). Types of interventions made by clinical pharmacists in the improve study. Pharmacotherapy, 20(4), 429-435.
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  PMID: 10772374;Abstract: The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study. A total of 523 patients were randomized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug-related problems. Patients randomized to the control group had no interventions and they are not reported. Using a standard form, pharmacists were asked to document the length of visit, method of contact, medical conditions addressed, and drug- related problems addressed and resolved during each contact. Seventy-eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months, an average of 3.54 ± 2.31/patient. The length of visits was 15 minutes or more for 73% of contacts. In-person contacts accounted for 1421 visits (76.6%), with the remainder being telephone contacts. During each contact the average number of drug-related problems addressed and resolved were 1.64 ± 1.16 and 1.14 ± 0.98, respectively. More drug-related problems were addressed and resolved when visits were 15 minutes or longer (p = 0.001) and when the contact was in person (p = 0.001). These data may provide information to clinical pharmacists developing pharmacy-managed clinics for patients at high risk for drug-related problems. The information may be a benchmark for types of interventions that can be made, as well as the time commitments required to make them.
• Ellis, S. L., Carter, B. L., Malone, D. C., Billups, S. J., Okano, G. J., Valuck, R. J., Barnette, D. J., Sintek, C. D., Covey, D., Mason, B., Jue, S., Carmichael, J., Guthrie, K., Dombrowski, R., Geraets, D. R., & Amato, M. (2000). Clinical and economic impact of ambulatory care clinical pharmacists in management of dyslipidemia in older adults: The IMPROVE study. Pharmacotherapy, 20(12), 1508-1516.
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  PMID: 11130223;Abstract: We examined the impact of ambulatory care clinical pharmacist interventions on clinical and economic outcomes of 208 patients with dyslipidemia and 229 controls treated at nine Veterans Affairs medical centers. This was a randomized, controlled trial involving patients at high risk of drug-related problems. Only those with dyslipidemia are reported here. In addition to usual medical care, clinical pharmacists were responsible for providing pharmaceutical care for patients in the intervention group. The control group did not receive pharmaceutical care. Seventy-two percent of the intervention group and 70% of controls required secondary prevention according to the National Cholesterol Education Program guidelines. Significantly more patients in the intervention group had a fasting lipid profile compared with controls (p=0.021). The absolute change in total cholesterol (17.7 vs 7.4 mg/dl, p=0.028) and low-density lipoprotein (23.4 vs 12.8 mg/dl, p=0.042) was greater in the intervention than in the control group. There were no differences in patients achieving goal lipid values or in overall costs despite increased visits to pharmacists. Ambulatory care clinical pharmacists can significantly improve dyslipidemia in a practice setting designed to manage many medical and drug-related problems.
• MacLaughlin, E. J., Saseen, J. J., & Malone, D. C. (2000). Costs of β-lactam allergies: Selection and costs of antibiotics for patients with a reported β-lactam allergy. Archives of Family Medicine, 9(8), 722-726.
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  PMID: 10927711;Abstract: Objective: To evaluate antibiotic selection and the cost effect of reported β-lactam allergies. Design: Retrospective medical records review comparing antimicrobial selection and costs in patients with a reported β-lactam allergy with a group in which no such allergy had been documented. Setting: University-based family medicine clinic. Patients: Patients who were prescribed at least 1 antibiotic for an upper respiratory tract infection, otitis media, sinusitis, and/or a urinary tract infection were eligible. One thousand two hundred one patients were identified via ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) codes. Four hundred sixty-five patients were initially identified and an additional 195 family members were eligible for inclusion. Main Outcome Measures: Comparison of antimicrobial selection and costs (by average wholesale price) between patients with and without a reported β-lactam allergy. Results: Of the 660 patients eligible for inclusion, 99 (15%) had a documented β-lactam allergy. Of the patients with a documented allergy, only 33% had a description of their purported reaction. The mean antibiotic cost for patients with a β-lactam allergy was significantly higher compared with those without a β-lactam allergy ($26.81 vs $16.28, respectively; P = .004). Patients with a β-lactam allergy were more likely to have received a cephalosporin, macrolide, or a miscellaneous agent (eg, quinolone, tetracycline, or nitrofurantoin) (P = .001). Conclusions: Patients with a β-lactam allergy had higher antibiotic costs and were more likely to receive a broader-spectrum antibiotic. Most patients with a reported allergy did not have a description of their reaction. Skin testing may be of use in detecting true β-lactam allergies; however, further study is needed to determine its cost-effectiveness.
• Malone, D. C., Carter, B. L., Billups, S. J., Valuck, R. J., Barnette, D. J., Sintek, C. D., Okano, G. J., Ellis, S., Covey, D., Mason, B., Jue, S., Carmichael, J., Guthrie, K., Sloboda, L., Dombrowski, R., Geraets, D. R., & Amato, M. G. (2000). An economic analysis of a randomized, controlled, multicenter study of clinical pharmacist interventions for high-risk veterans: The IMPROVE study. Pharmacotherapy, 20(10 I), 1149-1158.
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  PMID: 11034037;Abstract: Study Objective. To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory, high-risk population. Design. Prospective, randomized, controlled study. Setting. Nine Veterans Affairs medical centers. Patients. Patients who were at high risk for medication-related problems. Intervention. Patients were randomized to usual medical care with input from a clinical pharmacist (intervention group) or just usual medical care (control group). Measurements and Main Results. Of 1054 patients enrolled, 523 were randomized to the intervention group and 531 to the control group. The number of clinic visits increased in the intervention group (p=0.003), but there was no difference in clinic costs. Mean increases in total health care costs were $1020 for the intervention group and $1313 for the control group (p=0.06). Conclusion. Including the cost of pharmacist interventions, overall health care expenditures were similar for patients randomized to see a clinical pharmacist versus usual medical care.
• Malone, D. C., Lawson, K. A., & Smith, D. H. (2000). Asthma: an analysis of high-cost patients.. Pharmacy practice management quarterly, 20(1), 12-20.
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  PMID: 10947538;Abstract: OBJECTIVE: To examine characteristics of asthma patients who accounted for 80 percent of national expenditures in 1994 dollars. STUDY DESIGN: Data were extracted from a comprehensive data source, the 1987 National Medical Expenditure Survey (NMES) of approximately 35,000 individuals. PATIENTS AND METHODS: Persons of interest were identified using any occurrence of the ICD-9 code 493 or subcategories. Population weighting factors were used to estimate the population in the United States who sought care for the treatment of asthma. Two groups were identified: a high-cost group, which accounted for 80 percent of the direct medical expenditures, and a low-cost group, which represented 20 percent of expenditures. All analyses were performed using SUDAAN software, which takes into account the complex sampling design used in NMES. RESULTS: Individuals who rated their health as poor or fair were more likely to be in the high-cost group, as compared with those who rated their health as good or excellent (p < .0009). Persons who reported having Medicare, other government, or private insurance were more likely to be in the high-cost group as compared to those with Medicaid and self-pay (p = .01). A person was more likely to be in the high-cost group if he or she used four or more different medications to treat asthma (p < .0001). CONCLUSIONS: Persons with asthma are more likely to have greater medical expenditures if they use four or more medications and have deteriorated health status. Managed care organizations and public programs may find these characteristics useful in targeting asthma prevention and management programs.
• Isaksen, S. F., Jonassen, J., Malone, D. C., Billups, S. J., Carter, B. L., & Sintek, C. D. (1999). Estimating risk factors for patients with potential drug-related problems using electronic pharmacy data. Annals of Pharmacotherapy, 33(4), 406-412.
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  PMID: 10332529;Abstract: OBJECTIVE: To validate a computer-based program to identify patients at high risk for drug-related problems. DESIGN: Computerized analysis of pharmacy dispensing records and manual review of medical records. SETTING: Ambulatory clinics at a Veterans Affairs Medical Center. PATIENTS: 246 randomly selected patients who were receiving at least one outpatient medication in the previous 24 months. MAIN OUTCOME MEASURES: Presence of six previously established criteria regarding medication use. These criteria are five or more medications, ≥12 doses per day, four or more changes to the medication regimen, three or more chronic diseases, history of noncompliance, and presence of a drug requiring therapeutic drug monitoring (TDM). RESULTS: Spearman rho rank order correlation coefficients ranged from 0.63 to 0.91 for criteria pertaining to the number of medications, daily doses, changes in the medication regimen, and number of chronic diseases (all significant, p = 0.0001). The computer program underestimated the number of chronic diseases and overestimated the number of daily doses. The level of agreement between the computer program and chart review for patient noncompliance was low (Kappa = 0.38), with the computer more likely to indicate a patient was noncompliant. A high level of agreement was seen between the computer program and chart review for the presence of a drug requiting TDM (Kappa = 0.83). For all six criteria, the computer program had a sensitivity of 65.7% and specificity of 88.2%. CONCLUSIONS: When compared with medical records, the use of this program to evaluate electronic pharmacy data can be efficient to screen large numbers of patients who may be at high risk for drug-related problems. This method may be useful for clinical pharmacists in providing pharmaceutical services to patients who are most likely to benefit.
• Malone, D. C., & Okano, G. J. (1999). Treatment of urge incontinence in Veterans Affairs medical centers. Clinical Therapeutics, 21(5), 867-877.
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  PMID: 10397381;Abstract: Urinary incontinence has far-reaching medical, psychological, social, and economic effects. The objectives of this descriptive study were to examine utilization patterns and discontinuation rates of various pharmacologic agents used to treat symptoms of overactive bladder, primarily urge incontinence (UI), and to estimate the prevalence of urinary incontinence in the study population. Patient-level data regarding specific drugs used to treat UI and the use of diapers or pads over a 9-month period from October 1995 to May 1996 were retrospectively extracted from the medication databases of 9 Department of Veterans Affairs medical centers. A total of 2233 male patients were included in the analyses. Most patients were receiving oxybutynin chloride (39.8%), dicyclomine hydrochloride (16.0%), or imipramine hydrochloride (13.9%), and the remaining 30.3% were using flavoxate hydrochloride, propantheline bromide, hyoscyamine sulfate, and adult diapers or pads. Overall, 72.1% of patients had been prescribed daily dosages within the recommended dosing ranges for these medications. The majority (91.3%) of patients had not switched to another UI medication during the study period. Based on a chronic disease index, 47.6% of patients had 2 or fewer chronic diseases. Using pooled prevalence estimates, the estimated percentage of patients who had ever experienced UI in this population ranged from 7.4% to 20.8%; however, a considerably smaller percentage were taking medications for the treatment of UI. The results of this study suggest that oxybutynin, dicyclomine, and imipramine are the agents most commonly used to treat urinary incontinence within Veterans Affairs medical centers. The majority of patients who received a prescription for one of these drugs did not routinely refill the medication over the course of the study. There are many reasons for patients not to refill a prescription (eg, ineffectiveness, side effects, complications, obtaining the drug from another source), but the present study did not address the causes.
• Malone, D. C., Billups, S. J., Valuck, R. J., & Carter, B. L. (1999). Development of a chronic disease indicator score using a veterans affairs medical center medication database. Journal of Clinical Epidemiology, 52(6), 551-557.
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  PMID: 10408995;Abstract: Objective: Develop a chronic disease index that approximates the number of chronic diseases a patient has using a medication database. Methods: An expert panel determined whether specific medication classes could be indicative of a chronic disease. Those classes identified were incorporated into a computer program and then used to screen the medication records of 246 randomly selected patients to estimate the number of chronic diseases present in each patient. This number was designated as the chronic disease index (CDI). The CDI was then validated against chart review. The CDI and a measure of disease severity, the chronic disease score (CDS) also were compared. The sensitivity and specificity of the computer program was analyzed for seven common chronic diseases. Results: The expert panel designated 54 drug classes containing medications used to treat chronic diseases. The CDI correlated moderately with the number of chronic diseases found via chart review (r = 0.65; P = 0.001) and highly with the CDS (r = 0.81; P = 0.001). The index predicted the presence of three common diseases with a sensitivity of ≥75%, and of six common diseases with a specificity of ≥75%. Conclusions: The CDI correlates moderately well with the actual number of chronic disease states present. This tool may be useful for researchers when trying to identify patients with specific diseases and also for risk adjustment. Copyright (C) 1999 Elsevier Science Inc.
• Alsuwaidan, S., Malone, D. C., Billups, S. J., & Carter, B. L. (1998). Characteristics of ambulatory care clinics and pharmacists in Veterans Affairs medical centers. American Journal of Health-System Pharmacy, 55(1), 68-72.
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  PMID: 9437478;Abstract: The type and extent of ambulatory care clinical pharmaceutical services in selected Veterans Affairs medical centers (VAMCs) were studied as part of a larger project. Questionnaires were sent to the 174 VAMCs to determine the extent of clinical pharmacy activity in ambulatory care clinics, characteristics of outpatient pharmacies and clinics, and characteristics of ambulatory care pharmacists in VAMCs and to identify sites for the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) project. Fifty VAMCs responded to the survey. There were 512 ambulatory care clinics within these VAMCs. There was some pharmacist coverage in 75% of the clinics. The highest pharmacist coverage was in walk-in refill, therapeutic drug monitoring, and anticoagulation clinics. Clinical pharmacists at 68% of the VAMCs had prescribing privileges in ambulatory care clinics. Clinical pharmacists managed 29.9% of the clinics. The types of clinics most commonly managed by pharmacists were therapeutic drug monitoring, anticoagulation, walk-in refill and lipid clinics. Nurse practitioners or physician assistants also were providing primary care in 41% of the clinics. There were 242 ambulatory care clinical pharmacy specialists practicing in the 50 VAMCs. Of these. 41.3% had three years or less of ambulatory care experience. Most pharmacists were in the clinic five days per week. A Pharm. D. degree was the highest degree obtained for 76.9%. Ambulatory care pharmaceutical services are common in VAMCs and are being provided by numerous clinical pharmacists.
• Carter, B. L., Malone, D. C., Valuck, R. J., Barnette, D. J., Sintek, C. D., & Billups, S. J. (1998). The IMPROVE study: Background and study design. American Journal of Health-System Pharmacy, 55(1), 62-67.
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  PMID: 9437477;Abstract: An ongoing study of the impact of ambulatory care clinical pharmacists on patient outcomes at selected Veterans Affairs medical centers (VAMCs) is described. The IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study will examine the effects of referring patients at high risk for drug-related problems to a pharmacist-managed monitoring program. Nine study sites from diverse geographic locations and small and large urban areas have been selected. Investigators visited each site to evaluate the structure of care, observe pharmacist-patient interactions and assess the level and documentation of pharmacists activities. A coordinating center will collect and process patient-specific data from the study sites to identify high-risk patients. It is expected that 500 intervention patients and 500 control patients from the nine VAMCs will complete all portions of the study. Intervention patients will be scheduled for medication assessments by ambulatory care pharmacists and will be monitored by pharmacists for at least 12 months. The coordinating center will track refill histories for intervention patients. Investigators will assess the activities performed by ambulatory care pharmacists to determine predictors of successful patient outcomes. The two groups will be compared with respect to change from baseline in quality of life and satisfaction with health care providers. A cost-benefit analysis will be undertaken to determine the impact of pharmaceutical care relative to total patient care costs. The main outcome results of the IMPROVE study are expected to be available in 1999. The IMPROVE project will be the first study of the impact of ambulatory care clinical pharmacists on patient outcomes.
• Lousberg, T. R., Witt, D. M., Beall, D. G., Carter, B. L., & Malone, D. C. (1998). Evaluation of excessive anticoagulation in a group model health maintenance organization. Archives of Internal Medicine, 158(5), 528-534.
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  PMID: 9508231;Abstract: Background: The fourth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy recently published guidelines that included recommendations regarding the management of excessive anticoagulation. Limited data are available to support these recommendations. Objectives: To assess management and outcomes of excessive anticoagulation in a group model health maintenance organization, compare management with the published guidelines, and analyze the cost of treatment strategies. Methods: A search of computerized laboratory information identified patients with an international normalized ratio (INR) of greater than 6.0 during the 9-month study. Pertinent data were collected through a retrospective medical record review. Information was concurrently collected for cost analyses. Results: The analysis included 301 episodes of excessive anticoagulation among 248 patients. Most (83%) episodes of elevated INRs were managed conservatively by a temporary discontinuation of warfarin sodium therapy until the INR was in a therapeutic range. Conservative management resulted in no sequelae in 212 (85.1%) of 249 episodes. Two episodes (0.8%) of major bleeding evolved in patients managed conservatively. No sequelae were documented in 23 (44%) of 52 episodes of phytonadione (vitamin K1) administration. Sixteen (31%) episodes of major bleeding were documented, but bleeding occurred before phytonadione administration in all cases. Administering phytonadione resulted in hospital admission for 3 patients - 2 (3.8%) because of thromboembolism and 1 (1.9%) for the administration of heparin sodium. Cost-effectiveness analysis determined that treatment with phytonadione is 7 times more costly than conservative management when INRs are between 6.0 and 10.0. Conclusions: Most episodes of excessive anticoagulation were not managed per consensus guidelines. The higher the INR, the more likely were interventions to adhere to the guidelines. Administering phytonadione to patients with a moderate elevation of INRs (6.0-10.0) may be unnecessary. Based on this study, conservative management is a viable option.
• Malone, D. C., Lawson, K. A., Smith, D. H., Arrighi, H. M., & Battista, C. (1997). A cost of illness study of allergic rhinitis in the United States. Journal of Allergy and Clinical Immunology, 99(1 I), 22-27.
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  PMID: 9003207;Abstract: Background: Allergic rhinitis is a common condition, but the burden of this condition on the national economy is not well understood. Objective: The purpose of this study was to estimate the national direct and indirect costs of allergic rhinitis. Methods: Data from the National Medical Expenditure Survey were used to provide estimates of resource utilization, medical expenditures, and lost productivity. With the complex survey design, variance estimates were used to construct confidence intervals for cost estimates of resource utilization and lost productivity. Results: It is estimated that approximately 39 million persons in the United States experienced allergic rhinitis in 1987. However, only 12.3% (4.8 million) sought medical treatment for allergic rhinitis. The total estimated cost of the condition, in 1994 dollars, was $1.23 billion (95% confidence interval, $846 million to $1.62 billion). Direct medical expenses accounted for 94% of total costs. Allergic rhinitis resulted in approximately 811,000 missed workdays, 824,000 missed school days, and 4,230,000 reduced activity days. Conclusion: Allergic rhinitis clearly creates a burden in terms of the number of persons affected, total expenditures, and lost productivity. It also appears that a relatively large proportion of persons with allergic rhinitis were not seeking medical treatment.
• Smith, D. H., Malone, D. C., Lawson, K. A., Okamoto, L. J., Battista, C., & Saunders, W. B. (1997). A national estimate of the economic costs of asthma. American Journal of Respiratory and Critical Care Medicine, 156(3 I), 787-793.
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  PMID: 9309994;Abstract: This cost of illness analysis examines national cost and resource utilization by persons with asthma using a single, comprehensive data source, the 1987 National Medical Expenditure Survey. Direct medical expenditures included payments for ambulatory care visits, hospital outpatient services, hospital inpatient stays, emergency department visits, physician and facility payments, and prescribed medicines. Indirect medical costs included costs resulting from missed work or school and days with restricted activity at work. Point estimates and 95% confidence intervals (CI) were calculated and inflated to 1994 dollars. The total estimated cost was $5.8 billion (95% CI, $3.6 to $8 billion). The estimated direct expenditures were $5.1 billion (95% CI, $3.3 to $7.0 billion), and indirect expenditures were valued at $673 million (95% CI, $271 to $1,076 million). Hospitalization accounted for more than half of all expenditures. More than 80% of resources were used by 20% of the population (defined as 'high-cost patients'). The estimated annual per patient cost for those high-cost patients was $2,584, in contrast with $140 for the rest of the sample. Findings from this study indicate that future asthma research and intervention efforts directed at hospitalizations and high-cost patients could help to decrease health care resource use and provide cost savings.
• Malone, D. C., Rascati, K. L., & Gagnon, J. P. (1993). Consumers' evaluation of value-added pharmacy services.. American Pharmacy, NS33(3), 48-56.
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  PMID: 8475848;Abstract: One proposal for community pharmacies to survive in an increasingly competitive market is to offer services that consumers want and need. This study examined the effects of such a value-added pharmacy services (VAPS) program implemented at 19 experimental pharmacies; another 16 pharmacies served as a control group. The study found that patrons of VAPS pharmacies received more pharmacy services and were more likely to report that the pharmacist talked to them about their medication than patrons of control pharmacies. This study demonstrates that a value-added services program can have an impact on pharmaceutical services.

Presentations

• Malone, D. C. (2018, October). Drug Interaction Clinical Decision Support: Mending the Medication Safety Net. UA College of Pharmacy Skaggs Symposium. Tucson: University of Arizona College of Pharmacy.
• Malone, D. C. (2018, September). Cost and Outcome Data Source. University of Arizona Center for Pharmacoeconomic and Outcomes Research Certificate Program. Tucson: University of Arizona College of Pharmacy.
• Malone, D. C. (2018, September). Performance-based risk-sharing agreements. University of Arizona Center or Healthoutcomes and Pharmacoeconomic Research. Tucson: HOPE Center.
• Malone, D. C. (2018, September). United States Pharmaceutical Value Frameworks. ISPOR Dubia 2018. Dubai, UAE: ISPOR.
• Malone, D. C. (2018, September). United States Pharmaceutical Value Frameworks. University of Arizona Center for Health Outcomes and Pharmacoeconomic Research. Tucson: HOPE Center.
• Lo Ciganic, W. H., Westra, J., Bell, M. L., Lindermann, J., Lee, J. K., Bhattacharjee, S., Malone, D. C., Hines, L., Roubal, A., Donohue, J. M., Gellad, W. F., Kwoh, C. K., & Zhou, L. (2017, May). Geographic Variation of Inappropriate Prescription Opioid Use Among Disabled Medicare Beneficiaries. PODIUM presentation at the ISPOR 22nd Annual International Meeting. Boston, MA, USA.
• Ip, Q., & Malone, D. C. (2016, May 24). Are non-randomized controlled studies being published in top medical journals?. ISPOR 21st Annual International Meeting. Washington, DC.
• Malone, D. C., Hurwitz, J. T., Brown, M., Peters, L., & Graff, J. (2016, April 18). Is real-world evidence cited in P&T monographs and therapeutic class reviews?. Academy of Managed Care Pharmacy Annual Meeting. San Francisco, CA.
• Malone, D. C. (2015, May). Identifying Patients with Rare Disorders. ISPOR 20th Annual Meeting. Philadelphia, PA: International Society of Pharmacoeconomics and Outcomes Research.

Poster Presentations

• Malone, D. C. (2018, May). An appraisal of the quality of economic evidence in cost-effectiveness and cost-utility studies identified via systematic review for B-type natriuretic peptide-guided therapy in heart failure management patients. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C. (2018, May). Cost-effectiveness analysis of biologic therapies for treatment of psoriatic arthritis. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C. (2018, May). Extent and predictors of potentially inappropriate antidepressant use among older adults with dementia and major depressive disorder.. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C. (2018, May). Prescription drug prices and source of payments in the US from 1997 to 2015. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C. (2018, May). The relationship between insurance coverage and medication payments in the US from 1997 to 2015. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C. (2018, November). COST EFFECTIVENESS ANALYSIS OF SECUKINUMAB VERSUS USTEKINUMAB FOR THE TREATMENT OF PSORIATIC ARTHRITIS IN THE UNITED STATES. ISPOR European Meeting. Barcelona, ESP: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C., & Velez, F. (2018, May). Estimating the current costs of endoscopic sinus surgery in the US – a claims-based approach. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Malone, D. C., Warholak, T. L., & Bhattacharjee, S. (2018, May). Comparison of all-cause mortality and all-cause hospitalization risk for medications to treat Alzheimer’s disease.. International Society for Pharmacoeconomic and Outcomes Research 23rd Annual Meeting. Baltimore, MD: International Society for Pharmacoeconomic and Outcomes Research.
• Burke, W. J., Lee, J. K., Lo Ciganic, W. H., Knapp, S., Warholak, T. L., Malone, D. C., & Bhattacharjee, S. (2017, October). Comparison of Fall and Fracture Risk for Medications to Treat Alzheimer’s Disease. AMCP Nexus Meeting 2017. Dallas, TX: Alzheimer's Association.
• Malone, D. C., Hurwitz, J. T., Brown, M., Peters, L., & Graff, J. S. (2016, April 18,). Is real-world evidence cited in P&T monographs and therapeutic class reviews?. Academy of Managed Care Pharmacy Annual Meeting. San Francisco, CA,.
• Malone, D. C., & Gharaibeh, M. (2014, November). Economic evaluation of paclitaxel albumin, paclitaxel, and docetaxel as a second line treatment for metastatic breast cancer.. International Society for Pharmacoeconomics and Outcomes Research - European Meeting. Amsterdam, The Netherlands: None.
• Malone, D. C., & Schulz, N. (2014, Juen). A PROBABILISTIC BUDGET IMPACT ANALYSIS OF CYSTIC FIBROSIS THERAPY ON HEALTH PLAN PHARMACY BUDGETS. International Society for Pharmacoeconomics and Outcomes Research Annual Meeting. Montreal, Canada: ISPOR.
• Malone, D. C., Cheng, Y., Divino, V., Hallinan, s., Munakata, J., Taylor, C., McGarry, L., & Ng, D. (2014, June). INCREASING BURDEN OF TYROSINE KINASE INHIBITOR (TKI) TREATMENT FAILURE WITH LATER LINES OF THERAPY (LOT) IN CHRONIC MYELOID LEUKEMIA (CML): A REAL WORLD RETROSPECTIVE DATABASE ANALYSIS. ISPOR Annual Meeting. Montreal, CA.
• Malone, D. C., Nelson, S., & LaFluer, J. (2014, June). CALCULATING THE BASELINE FRACTURE INCIDENCE IN NON-RISK PATIENTS: A STRATEGY FOR COST-EFFECTIVENESS MODELING. ISPOR Annual Meeting. Montreal, Canada.

Reviews

• Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A. C., Devlin, N., Flechtner, H. H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J. F., King, M., , Kluetz, P. G., et al. (2016. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards(pp e510-e514).
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  Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.