Edward P Armstrong

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• Armstrong, E. (0). Health care professionals' perceptions of the role of pharmacogenomic data. Journal of managed care pharmacy : JMCP, 8(4).
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  To explore the perceptions of health care professionals in examining the uses of pharmacogenomic data.
• Armstrong, E. P., Bakall, M., Skrepnek, G. H., & Boyer, L. V. (2013). Is scorpion antivenom cost-effective as marketed in the United States?. Toxicon, 76, 394-398.
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  Abstract: Purpose The purpose of this study was to analyze the cost-effectiveness of scorpion antivenom compared to no antivenom, in the United States, using a decision analysis framework. Methods A decision analytic model was created to assess patient course with and without antivenom. Costs were determined from the perspective of a health care payer. Cost data used in the model were extracted from Arizona Medicaid. The probability of clinical events occurring with and without antivenom was obtained from the published literature, medical claims obtained from Arizona Medicaid, and results of recent clinical trials. Patients that became so ill that mechanical ventilator support was necessary were considered treatment failures. A Monte Carlo simulation was run 1000 times and sampled simultaneously across all variable distributions in the model. Results The mean success rate was 99.87% (95% CI 99.64%-99.98%) with scorpion antivenom and 94.31% (95% CI 91.10%-96.61%) without scorpion antivenom. The mean cost using scorpion antivenom was $10,708 (95% CI $10,556 - $11,010) and the mean cost without scorpion antivenom was $3178 (95% CI $1627 - $5184). Since the 95% CIs do not overlap for either the success or cost, use of the scorpion antivenom was significantly more effective and significantly more expensive than no antivenom. Cost-effectiveness analysis found that the scorpion antivenom was not cost-effective at its current price as marketed in the United States. Conclusion The scorpion antivenom marketed in the United States is extremely effective, but too costly to justify its use in most clinical situations. Formulary committees should restrict the use of this antivenom to only the most severe scorpion envenomations. © 2013 Elsevier Ltd. All rights reserved.
• Armstrong, E. P., Skrepnek, G. H., Sasane, M., Snodgrass, S. M., & Ballas, S. K. (2013). Long-term persistency and costs associated with the use of iron chelation therapies in the treatment of Sickle cell disease within Medicaid programs. Journal of Medical Economics, 16(1), 10-18.
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  PMID: 22947171;Abstract: Objective: This retrospective study evaluated iron chelating therapy (ICT) discontinuation and costs in Sickle cell disease (SCD) Medicaid recipients using healthcare claims from 2006-2010. Methods: Patients with ≥1 SCD diagnosis claim, ≥2 claims for deferoxamine (DFO) or deferosirox (DFX), and continuous enrollment ≥6 months prior to and 18 months following ICT initiation were included. Outcomes included treatment discontinuation, persistence (i.e., refill gaps ≥6 weeks), and total healthcare costs. Results: The average age among 404 SCD patients meeting study inclusion criteria was 18.7 (±11.0) years, with 45.8% being males and 66.7% being Blacks. Switches or combinations from DFO at index occurred in 124 (74.7%) patients compared to 10 (4.2%) with DFX at index. The Cox regression model that assessed long-term medication persistence indicated a 1.30-times higher likelihood of treatment discontinuation with DFO compared to DFX (95% CI: 1.06-1.61). Some 19.7% of patient remained on DFX relative to 4.8% on DFO. Both inpatient and total costs were similar in DFX and DFO treatment groups. Following 1 year of treatment, 37.4% remained on DFX compared to 15.7% on DFO. Meaningful differences in treatment discontinuation between the two treatment groups did not occur until 220+ days during the study period. At 18-months, treatment discontinuation rates were high in both groups; 95% for DFO and 80% for DFX. Conclusion: This study of SCD Medicaid patients found more therapeutic switches from DFO to DFX and a higher medication persistency rate with DFX than DFO. The conclusions are limited by the study's retrospective nature, which depends on multivariate statistics to account for patient heterogeneity and risk factors. © 2013 Informa UK Ltd.
• 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(1).
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  PMID: 23497373;PMCID: PMC3598564;Abstract: Background: 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. Methods. A prospective study, in cooperation with a pharmacy benefit manager (PBM), was conducted targeting 18 clinically important PDDIs. Fax alerts included an individualized letter to the prescriber with a list of the interacting drugs, PDDI evidence summaries with citations, and recommended clinical management strategies. Among the 18 PDDIs, 13 PDDIs could be assessed for prescription therapy changes using pharmacy claims data. A prospective cohort design was used to evaluate changes in prescription dispensing 90-days following a PDDI fax alert. Results: A total of 8,075 fax alerts were sent to prescribers and there were 4,712 alerts for the 13 PDDIs that could be assessed for change using pharmacy claims data. There were 2,019 patients (interventions) for which fax alerts were sent to their prescribers who were matched with a control group consisting of patients with the same PDDIs but for whom no fax alert was sent. Overall, this study found 154 (7.6%) of patients in the fax alert group compared to 132 (6.5%) in the control group had changes in therapy (p = 0.177). Conclusions: This fax alert intervention program observed no statistically significant differences in prescribing with a fax alert compared to the control group. If PBMs chose to send individualized, evidence-based information to clinicians regarding drug-drug interactions, this study suggests it may not be an effective intervention to mitigate harm. © 2013 Armstrong et al; licensee BioMed Central Ltd.
• Armstrong, N. R., Isaac, A. L., & Armstrong, E. P. (2013). Negative pressure wound therapy and other new therapies for diabetic foot ulceration: the current state of play. The Medical clinics of North America, 97(5).
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  As of 2012, the number of people with diabetes is increasing in every country, and half of the people with diabetes do not know they are afflicted with the malady.1 Furthermore, it is believed that every 20 seconds a lower limb is lost around the world because of complications related to diabetes.6 In a short period, NPWT has transformed wound care across the globe, and other technologies are beginning to emerge that may provide clinicians with the tools necessary for identifying wounds at risk for delayed healing and recurrence. The future of diabetic limb salvage will rely heavily on these and other advances.
• Armstrong, N. R., Tang, D. H., Harrington, A. R., Lee, J. K., Lin, M., & Armstrong, E. P. (2013). A systematic review of economic studies on biological agents used to treat Crohn's disease. Inflammatory bowel diseases, 19(12).
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  Identifying clinical scenarios that maximize the cost-effectiveness of biological treatments can lead to optimized health care cost-saving and clinical effectiveness from a society's perspective.
• 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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  PMID: 23196405;Abstract: Objectives: To investigate health disparities with respect to cost of care across 4 state Medicaid populations. Methods: Data were obtained from Centers for Medicare and Medicaid Services (CMS) for this retrospective study. Patients were enrolled in a California, Florida, New Jersey, or New York Medicaid programs during 2004, with a diagnosis of Alzheimer's disease (International Classification of Diseases, Ninth Revision 331.0). Outcome of interest was cost of care. Decomposition of cost to calculate disparities was estimated using the Oaxaca-Blinder model. An a priori α level of .01 was used. Results: Approximately 158 974 individuals qualified for this study. Disparities were found to exist between blacks and whites (with blacks having higher costs; P < .0001), whites and others (with whites having higher costs; P < .0001), blacks and Hispanics (with blacks having higher costs; P < .0001), blacks and others (with blacks having higher costs; P < .0001), and Hispanics and others (with Hispanics having higher costs; P < .0001). Conclusions: Disparities in cost among minority-to-minority populations were just as prevalent, if not higher, than minority-white disparities. © The Author(s) 2012.
• Harrington, A. R., Armstrong, E. P., Nolan Jr., P. E., & Malone, D. C. (2013). Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation. Stroke, 44(6), 1676-1681.
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  PMID: 23549134;Abstract: Background and Purpose.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. Methods.A Markov decision-analysis model was constructed using data from clinical trials to evaluate lifetime costs and quality-adjusted life-years of novel oral anticoagulants compared with warfarin. The modeled population was a hypothetical cohort of 70-year-old patients with nonvalvular atrial fibrillation, increased risk for stroke (CHADS2 ≥1), renal creatinine clearance ≥50 mL/min, and no previous contraindications to anticoagulation. The willingness-to-pay threshold was $50 000/quality-adjusted life-years gained. Results.In the base case, warfarin had the lowest cost of $77 813 (SD, $2223), followed by rivaroxaban 20 mg ($78 738±$1852), dabigatran 150 mg ($82 719±$1959), and apixaban 5 mg ($85 326±$1512) . Apixaban 5 mg had the highest quality-adjusted life-years estimate at 8.47 (SD, 0.06), followed by dabigatran 150 mg (8.41±0.07), rivaroxaban 20 mg (8.26±0.06), and warfarin (7.97±0.04). In a Monte Carlo probabilistic sensitivity analysis, apixaban 5 mg, dabigatran 150 mg, rivaroxaban 20 mg, and warfarin were cost-effective in 45.1%, 40%, 14.9%, 0% of the simulations, respectively. Conclusions.In patients with nonvalvular atrial fibrillation and an increased risk of stroke prophylaxis, apixaban 5 mg, dabigatran 150 mg, and rivaroxaban 20 mg were all cost-effective alternatives to warfarin. The cost-effectiveness of novel oral anticoagulantss was dependent on therapy pricing in the United States and neurological events associated with rivaroxaban 20 mg. © 2013 American Heart Association, Inc.
• Lee, J. K., Tang, D. H., Mollon, L., & Armstrong, E. P. (2013). Cost-effectiveness of biological agents used in ulcerative colitis. Best Practice and Research: Clinical Gastroenterology, 27(6), 949-960.
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  PMID: 24182613;Abstract: Ulcerative colitis (UC) produces bloody diarrhoea, severe abdominal pain, and need for clinic visits, hospitalizations, and surgeries. UC results in reduced health-related quality of life for patients and large direct medical and indirect costs for health systems and employers. Patients with the most severe disease require the most medical services, and these patients have larger costs than patients with mild or moderate disease. Despite biological therapies being quite expensive, they are indicated for patients unresponsive to initial standard therapies. Future hospitalizations may be reduced by starting a biological treatment. Cost-effectiveness results vary between countries, health systems, and model designs. Since restorative proctocolectomy can be curative, this surgery dominates biological therapy by being both less costly and more effective when measuring health system costs and patient qualityadjusted life years for 20 years. However the dose, duration, and effectiveness of biological treatments significantly impact estimates of their cost-effectiveness. © 2013 Elsevier Ltd. All rights reserved.
• Mace, S. E., Harb, G., Friend, K., Turpin, R., Armstrong, E. P., & Lebel, F. (2013). Cost-effectiveness of recombinant human hyaluronidase-facilitated subcutaneous versus intravenous rehydration in children with mild to moderate dehydration. American Journal of Emergency Medicine, 31(6), 928-934.
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  PMID: 23685056;Abstract: Objective To evaluate the cost-effectiveness of recombinant human hyaluronidase-facilitated subcutaneous (rHFSC) fluid administration compared to intravenous (IV) fluid administration in children with mild to moderate dehydration in the emergency department (ED). Methods A decision analytic model was created based on the results of a controlled clinical trial that compared the administration of isotonic fluids via rHFSC or IV for rehydration. The costs were determined from the hospital's perspective. The effectiveness unit was successful rehydration in the ED without the need for hospitalization for continued hydration. Mean estimates were determined for both the cost and effectiveness of each treatment. The incremental differences in costs and effectiveness were determined between treatments. Sensitivity analysis testing was also conducted. Results The treatment success rate was 93% with rHFSC fluids and 76% for IV fluids. Across all ages, the mean cost of rHFSC fluids was $722, compared to $889 for IV fluids. The difference in effectiveness was due to the larger number of patients for whom IV access could not be established, necessitating a rescue route of administration to deliver parenteral fluids. The difference in the overall cost was primarily due to the shorter time in the ED for patients receiving rHFSC fluids versus those treated with IV fluids. The cost-effectiveness of rHFSC compared to IV was most apparent in younger patients (< 3 years of age), where IV access was more difficult to obtain. Conclusion Analysis of this clinical trial data revealed that rHFSC fluid administration demonstrated greater treatment effectiveness and cost-effectiveness than traditional IV fluid administration in the ED. The primary reasons for this were the ease of obtaining parenteral access via rHFSC in young patients (especially those under 3) where IV access is difficult, and a shorter ED stay with rHFSC fluid administration. © 2013 Elsevier Inc.
• Rymer, M. M., Armstrong, E. P., Meredith, N. R., Pham, S. V., Thorpe, K., & Kruzikas, D. T. (2013). Analysis of the costs and payments of a coordinated stroke center and regional stroke network. Stroke, 44(8), 2254-2259.
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  PMID: 23715961;Abstract: BACKGROUND AND PURPOSE-: An earlier study demonstrated significantly improved access, treatment, and outcomes after the implementation of a progressive, comprehensive stroke program at a tertiary care community hospital, Saint Luke's Neuroscience Institute (SLNI). This study evaluated the costs associated with implementing such a program. METHODS-: Retrospective analysis of total hospital costs and payments for treating patients with ischemic stroke at SLNI (n=1570) as program enhancement evolved over time (2005, 2007, and 2010) and compared with published national estimates. Analyses were stratified by patient demographic characteristics, patient outcomes, treatments, time, and comorbidities. RESULTS-: Controlling for inflation, there was no difference in SLNI total costs between 2005 and either 2007 or 2010, suggesting that while SLNI provided an increased level of services, any additional expenditures were offset by efficiencies. SLNI total costs were slightly lower than published benchmarks. Consistent with previous stroke care cost estimates, the median overall differential between total hospital costs and payments for all ischemic stroke cases was negative. CONCLUSIONS-: SLNI total costs remained consistent over time and were slightly lower than previously published estimates, suggesting that a focused, streamlined stroke program can be implemented without a significant economic impact. This finding further demonstrates that providing comprehensive stroke care with improved access and treatment may be financially feasible for other hospitals. © 2013 American Heart Association, Inc.
• Rymer, M. M., Armstrong, E. P., Walker, G., Pham, S., & Kruzikas, D. (2013). Analysis of a coordinated stroke center and regional stroke network on access to acute therapy and clinical outcomes. Stroke, 44(1), 132-137.
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  PMID: 23150657;Abstract: Background and Purpose-: Compare access and outcomes in a tertiary care community hospital (Saint Luke's Neuroscience Institute) and its stroke network to hospitals in 3 national databases. Methods-: Retrospective analysis of ischemic stroke patients (2005, 2007, 2010) in Saint Luke's (n=1576), Get With The Guidelines-Stroke (n=423 809), Premier (n=91 598), and Merci Registry (n=966). Study measures were use of computed tomography scans and tissue plasminogen activator (tPA), symptomatic intracranial hemorrhage, discharge disposition, discharge National Institutes of Health Stroke Scale scores, and 90-day modified Rankin Scores. Results-: Saint Luke's increased access to care with higher tPA use than other hospitals (17.2% received intravenous tPA therapy compared with 5.8% at Get With The Guidelines-Stroke hospitals, P
• Tang, D. H., Harrington, A. R., Lee, J. K., Lin, M., & Armstrong, E. P. (2013). A systematic review of economic studies on biological agents used to treat Crohn's disease. Inflammatory Bowel Diseases, 19(12), 2673-2694.
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  PMID: 23792552;Abstract: Background: Identifying clinical scenarios that maximize the cost-effectiveness of biological treatments can lead to optimized health care cost-saving and clinical effectiveness from a society's perspective. Methods: Published articles between January 1995 and June 2012 were searched in PubMed, EMBASE, ABI/INFORM, Tuft's Cost-Effectiveness Analysis Registry Database, Cochrane National Health Service Economic Evaluation Database, International Pharmaceutical Abstracts, Web of Science, and Google Scholar. Studies of interest included the following: (1) cost studies, (2) economic evaluations, or (3) narrative or systematic reviews related to economic evaluations of biological treatments for moderate-to-severe Crohn's disease (CD). The primary outcomes of interest included costs associated with biological treatments and cost-effectiveness measures, including incremental cost-effectiveness ratios. A threshold of $100,000/quality-adjusted life year (£60,000/quality- adjusted life year) gained was used for treatment cost-effectiveness. Results: Thirty-eight studies were identified, including 15 economic evaluations and 23 cost studies or reviews of economic evaluations. Economic evaluations found that infliximab and adalimumab were more cost-effective than standard therapy for luminal CD when provided as an induction therapy followed by episodic therapy over 5 or more years. The cost-effectiveness of infliximab and adalimumab versus standard therapy for luminal CD was less certain when used as 1-year maintenance treatment with or without previous induction therapy. Cost studies revealed that infliximab therapy reduced health care resource utilization and cost. Older reviews were inconclusive about the cost-effectiveness of biological treatments used for CD. Conclusions: Current evidence suggests that biological treatments may be cost-effective for CD under certain clinical scenarios. Future studies evaluating all biological treatments are needed to compare their respective benefits and costs. Copyright © 2013 Crohn's & Colitis Foundation of America, Inc.
• 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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  PMID: 22998646;Abstract: Objective: To determine the cost-effectiveness of pharmacologic treatments for overactive bladder (OAB) in the US. Methods: A decision model was constructed based on studies of effectiveness, adverse consequences, co-morbid conditions, and medical costs for the treatment of OAB. Treatment success was defined as no incontinence episodes for 37 days or 37 consecutive dry days. Estimates of treatment success were obtained from clinical trials and included darifenacin, fesoterodine, oxybutynin immediate release (IR), oxybutynin extended release (ER), oxybutynin topical gel, oxybutynin transdermal patch, solifenacin, tolterodine IR, tolterodine ER, trospium IR, and trospium ER. Probabilistic sensitivity analysis was conducted using Monte Carlo simulation. Results: A total of 51 OAB studies were identified and 11 reported treatment success. Mean continence rates varied in the literature from 21.0% with trospium IR to 51.0% with solifenacin. The 95% CI for solifenacin's success rate was statistically higher than other regimens due to the higher continence rates from the clinical trials. Oxybutynin IR and oxybutynin ER were significantly less costly than other products. The product with the lowest incremental cost-effectiveness ratio (ICER) relative to oxybutynin IR was solifenacin at $1338 (±168) per additional continent patient. The cost-effectiveness acceptability curve indicated that oxybutynin IR was the most cost-effective regimen when willingness-to-pay values were less than $10,000 per additional continent patient. Solifenacin was most cost-effective at higher willingness-to-pay values. Conclusion: There was broad overlap in effectiveness among the anti-muscarinic products, except solifenacin had a significantly higher continence rate. Oxybutynin IR and oxybutynin ER were significantly less costly than other anti-muscarinic regimens, and these two products have a useful role to play in the management of OAB. However, for patients unable to tolerate the lower cost products, formularies benefit from solifenacin among branded products since the cost-effectiveness acceptability curve demonstrated it was the product most likely to be cost-effective after oxybutynin IR. © 2012 Informa UK Ltd All rights reserved.
• Chinthammit, C., Armstrong, E. P., & Warholak, T. L. (2012). A cost-effectiveness evaluation of hospital discharge counseling by pharmacists. Journal of Pharmacy Practice, 25(2), 201-208.
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  PMID: 21987529;Abstract: Objectives: This study estimated the cost-effectiveness of pharmacist discharge counseling on medication-related morbidity in both the high-risk elderly and general US population. Methods: A cost-effectiveness decision analytic model was developed using a health care system perspective based on published clinical trials. Costs included direct medical costs, and the effectiveness unit was patients discharged without suffering a subsequent adverse drug event. A systematic review of published studies was conducted to estimate variable probabilities in the cost-effectiveness model. To test the robustness of the results, a second-order probabilistic sensitivity analysis (Monte Carlo simulation) was used to run 10 000 cases through the model sampling across all distributions simultaneously. Results: Pharmacist counseling at hospital discharge provided a small, but statistically significant, clinical improvement at a similar overall cost. Pharmacist counseling was cost saving in approximately 48% of scenarios and in the remaining scenarios had a low willingness-to-pay threshold for all scenarios being cost-effective. In addition, discharge counseling was more cost-effective in the high-risk elderly population compared to the general population. Conclusion: This cost-effectiveness analysis suggests that discharge counseling by pharmacists is quite cost-effective and estimated to be cost saving in over 48% of cases. High-risk elderly patients appear to especially benefit from these pharmacist services. © The Author(s) 2012.
• 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), 869-875.
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  PMID: 22356792;Abstract: 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. © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
• 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. American Journal of Geriatric Pharmacotherapy, 10(5), 303-312.
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  PMID: 23063286;Abstract: Background: Treatment disparities in Alzheimer's disease (AD) have received little attention. Determining whether disparities exist in this subpopulation is an important health policy issue. Objective: The aim was to determine whether an association existed between race/ethnicity and exposure to AD pharmacotherapy across 4 state Medicaid populations. Methods: Data from the Centers for Medicare and Medicaid Services (CMS) were used in this retrospective study. Persons with AD enrolled in California, Florida, New Jersey, or New York Medicaid programs on January 1, 2004, and remained in that program for 1 year. Individuals had an AD diagnosis based on the ICD-9-CM code 331.0. Outcomes of interest were exposure to a cholinesterase inhibitor (ChEI) or memantine. Multivariate logistic regression was used to test for the association between race/ethnicity and exposure to a ChEI or memantine. Variables of interest included demographic characteristics and resource utilization factors. The Oaxaca-Blinder decomposition method was used to test for disparities to determine whether exposure to AD pharmacotherapy was influenced by race. Results: Race, age, long-term care admittance, inpatient care admittance, state of residence, and sex were significant predictors of AD pharmacotherapy exposure (P < 0.0001 for all variables). Racial/ethnic disparities were observed with respect to exposure to a ChEI or memantine between non-Hispanic whites and Hispanics (in favor of Hispanics) in Florida (P < 0.0001), between non-Hispanic blacks and Hispanics (in favor of Hispanics) in California (P < 0.0001) and Florida (P < 0.0001), between non-Hispanic blacks and non-Hispanic others (in favor of non-Hispanic others) in California (P < 0.0001) and New York (P < 0.0001), and between Hispanics and non-Hispanic others (in favor of non-Hispanic others) in California (P = 0.001) and New York (P < 0.0001). Conclusions: Disparities in AD pharmacotherapy exposure among minority populations are just as prevalent, if not of greater magnitude, than minority/white disparities. © 2012 Elsevier HS Journals, Inc.
• Perera, P. N., Armstrong, E. P., Sherrill, D. L., & Skrepnek, G. H. (2012). Acute exacerbations of COPD in the United States: Inpatient burden and predictors of costs and mortality. COPD: Journal of Chronic Obstructive Pulmonary Disease, 9(2), 131-141.
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  PMID: 22409371;Abstract: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a leading cause of hospitalizations in the United States and the major cost driver of COPD. This study determined the national inpatient burden of AECOPD and assessed the association of co-morbidities and hospital characteristics with inpatient costs and mortality. Discharge records from the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample for 2006 was utilized. Outcomes of costs and mortality were assessed for AECOPD hospitalizations in cases ≥40 years of age. Multivariate regression analyses using a generalized linear model framework were conducted to determine predictors of inpatient costs and mortality controlling for patient demographics, primary payer, co-morbidity index, length of stay, hospital region, mechanical ventilation, and admission period. Overall, 1,254,703 hospitalizations for AECOPD were observed with mean costs of $9545(±12,700) and total costs of $11.9 billion. In-hospital mortality was 4.3% (N = 53,748). Discharges averaged 70.6 (±11.9) years of age. The majority were female (52.8%) and of white race (83.6% of reported race). Several co-morbidities were significantly associated with both costs and mortality (p < 0.001): acute myocardial infarction; congestive heart failure; cerebrovascular disease; lung cancer; cardiac arrhythmias; pulmonary circulation disorders; and weight loss. Significantly higher costs (p < 0.001) were associated with large and urban hospitals. The importance of co-morbidities in AECOPD is indicated in their association with prognosis and inpatient costs. Future research should determine if better management of these conditions can favorably impact the COPD disease burden. © 2012 Informa Healthcare USA, Inc.
• Tang, D. H., Armstrong, E. P., & Lee, J. K. (2012). Cost-utility analysis of biologic treatments for moderate-to-severe crohn's disease. Pharmacotherapy, 32(6), 515-526.
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  PMID: 22528603;Abstract: Study Objective. To compare the cost versus utility of four guideline-recommended biologic treatments-infliximab, adalimumab, certolizumab pegol, and natalizumab-for the treatment of Crohn's disease from a United States payer perspective. Design. Cost-utility decision analytic model using a Monte Carlo simulation of 10,000 cases. Data Source. Published primary and tertiary literature. Patients. Patients with moderate-to-severe Crohn's disease, as categorized by the Crohn's Disease Activity Index, that failed to respond to standard therapy and who were treatment naive to biologics. Measurements and Main Results. The decision analytic model base case was a 35-year-old patient weighing 70 kg with moderate-to-severe Crohn's disease. Therapeutic efficacy data were obtained from published clinical trials. Online prescription drug, hospitalization data, and Current Procedural Terminology codes were used to estimate cost. Utility measures were estimated using published data obtained from patients with Crohn's disease. The time end point used for the model was 54 weeks. The analysis demonstrated considerable overlap in quality-adjusted life years gained with the four agents (i.e., mean values across four treatments 0.79 0.80). Although infliximab had the lowest median cost, there was overlap in the 95% confidence intervals (CIs) compared with the other three biologic products: mean (95% CI) cost for infliximab 22,663 (19,105 26,433), adalimumab 27,515 (23,796 31,584), certolizumab pegol 29,062 (24,952 33,882), and natalizumab 31,166 (25,915 37,195). However, the cost-effectiveness acceptability curve demonstrated that infliximab had the most scenarios (95.2%) when it was the most cost-effective biologic therapy using a willingness-to-pay threshold of 100,000/quality-adjusted life years gained. Conclusion. Patients with moderate-to-severe Crohn's disease that failed to respond to standard treatment should preferentially receive infliximab as their initial biologic treatment, since this agent had the highest probability of being the most cost-effective therapy compared with the other biologic treatment options. Copyright © 1999-2012 John Wiley & Sons, Inc.
• Armstrong, E. P., Chemodurow, L., Christensen, S., & Johnson, E. S. (2011). A pre- post-evaluation of implementing an inpatient warfarin monitoring and education program. Pharmacy Practice, 9(2), 101-105.
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  Abstract: Objective: The purpose of this study was to evaluate whether a new anticoagulation management program resulted in better monitoring of warfarin, increased warfarin patient education prior to discharge, and fewer bleeding complications associated with warfarin. Methods: A retrospective chart review was conducted of all patients who were inpatients and received warfarin from April 1, 2008 to July 31, 2008 (control group) and from April 1, 2009 to July 31, 2009 (after implementation of the new anticoagulation program). The frequency of warfarin-related laboratory orders that included international normalized ratios (INRs), complete blood counts (CBCs), and documented patient education by pharmacy, nursing, and dietary services were determined before and after program implementation. Also, data was collected to determine frequencies of bleeding complications associated with warfarin. Results: There were 112 patients in the pre- and 115 patients in the post-program group. After implementation of the inpatient warfarin management program, obtaining baseline INRs increased from 74% to 90% (p=0.001). Orders for baseline CBCs increased from 85% to 94% (p=0.026). Obtaining CBCs every 3 days increased from 54% to 74%, (p
• 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), 939-950.
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  PMID: 21375358;Abstract: Objective: 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. Methods: A 1-year Markov model was constructed for PHN with monthly cycles, including dose titration and management of adverse events. The perspective of the analysis was from a payer perspective, managed-care organization. Clinical trials were used to determine the proportion of patients achieving at least a 30% improvement in PHN pain, the efficacy parameter. The outcome was cost per quality-adjusted life-year (QALY); second-order probabilistic sensitivity analyses were conducted. Results: The effectiveness results indicated that 8% capsaicin patch and topical lidocaine patch were significantly more effective than the oral PHN products. TCAs were least costly and significantly less costly than duloxetine, pregabalin, topical lidocaine patch, 8% capsaicin patch, but not gabapentin. The incremental cost-effectiveness ratio for the 8% capsaicin patch overlapped with the topical lidocaine patch and was within the accepted threshold of cost per QALY gained compared to TCAs, duloxetine, gabapentin, and pregablin. The frequency of the 8% capsaicin patch retreatment assumption significantly impacts its cost-effectiveness results. There are several limitations to this analysis. Since no head-to-head studies were identified, this model used inputs from multiple clinical trials. Also, a last observation carried forward process was assumed to have continued for the duration of the model. Additionally, the trials with duloxetine may have over-predicted its efficacy in PHN. Although a 30% improvement in pain is often an endpoint in clinical trials, some patients may require greater or less improvement in pain to be considered a clinical success. Conclusions: The effectiveness results demonstrated that 8% capsaicin and topical lidocaine patches had significantly higher effectiveness rates than the oral agents used to treat PHN. In addition, this cost-effectiveness analysis found that the 8% capsaicin patch was similar to topical lidocaine patch and within an accepted cost per QALY gained threshold compared to the oral products. © 2011 Informa UK Ltd.
• 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), 827-836.
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  PMID: 21568954;Abstract: Objectives: To determine and compare healthcare utilization and costs for younger and older adults with postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (DPN). Design: Retrospective cohort analysis. Setting: Inpatient and outpatient care. Participants: Patients with PHN or painful DPN were selected from administrative databases of healthcare claims and matched to controls who had a diagnosis of herpes zoster without persistent pain or a diagnosis of diabetes mellitus without neurological complications using propensity scores for demographic and clinical factors. Measurements: Excess per-person utilization and costs attributable to PHN and painful DPN were calculated for diagnostic procedures, medications, and interventional treatments related to neuropathic pain. Results: In both groups, the patterns of significant excess per-patient utilization and excess per-patient costs were similar for diagnostic procedures, medications, and interventional treatments, but patterns of utilization and costs of these procedures and treatments differed depending on age and the specific condition examined. Conclusion: The results contribute to and expand current knowledge of the excess healthcare usage and costs of two prevalent peripheral neuropathic pain conditions and can be used in future studies of the cost-effectiveness of treatment and preventive interventions. © 2011, The American Geriatrics Society.
• 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, 51(1), 82-89.
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  PMID: 21247830;Abstract: Objective: To determine proof of concept for use of a network of pharmacists to evaluate the safety of medications. Design: Pilot, comparative, prospective evaluation. Setting: Community pharmacies and a pharmacist-staffed call center in Arizona during January through August 2006. Patients: Patients filling prescriptions for ipratropium or tiotropium bromide at 1 of 55 Arizona pharmacies were encouraged to call a pharmacist-staffed call center. A total of 67 patients contacted the center and 41 participated. Intervention: A network of community pharmacies and a call center were used to collect data on patients receiving one of two medications for the treatment of chronic obstructive pulmonary disease. Pharmacists in the community pharmacies recruited patients who presented with a prescription or requested a refill for one of the medications. The call center was used to collect patient data. Patients provided data on medication use, completed the chronic respiratory questionnaire (CRQ), and were encouraged to call the center to report health problems. After 30 days, patients were called to determine whether they experienced any adverse events while taking their medication and the CRQ was readministered. Main outcome measure: Knowledge gained on the feasibility of the model using pharmacists to assess drug safety. Results: A total of 67 (6.7%) of a possible 995 patients contacted the call center about participating in the study. Approximately one-half (n = 28) of the 55 pharmacies had one or more patients contact the center about the study. A total of 41 patients met inclusion/exclusion criteria and were enrolled. Six (15%) patients reported an adverse effect, including one serious adverse event (acute glaucoma). Conclusion: This study provides limited evidence that community pharmacies and a pharmacist-staffed call center can be used to assess medication safety; however, a number of issues need to be examined to determine whether the approaches can be sufficiently effective.
• 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), 36-45.
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  PMID: 21397772;Abstract: Background: 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. Objective: The aim of this study was to assess the information regarding warfarin interactions that is included in the official labeling of prescription products that interact with warfarin. Methods: We examined the official labeling information approved by the US Food and Drug Administration for the 50 drugs, biologics, and drug classes that were commonly identified by 3 drug information compendia-Clinical Pharmacology, ePocrates®, and Micromedex®-and the warfarin US prescribing information (PI) as having an interaction with warfarin. The PI of each product was assessed for possible mention of an interaction with warfarin. The data were collected and tabulated by 1 investigator. A clinical investigator evaluated the data for accuracy and consistency. Unresolved issues were discussed with a third investigator and decided by consensus. The interaction listings were compared to determine similarities, differences, and inconsistencies and analyzed by 5 investigators. Results: Of the labeling for 73 products evaluated, 62 (85%) included mention of an interaction with warfarin. Those failing to mention the warfarin interaction were for older generic drugs or influenza vaccine. Among the labels listing an interaction with warfarin, the location of the information, the terminology used, and the inclusion of evidence for the interaction was inconsistent When considering the PI for all 73 products, Fleiss' kappa coefficient (κ = 0.467) suggested moderate concordance according to the method of Landis and Koch. Conclusion: This assessment of official US product labeling for 50 drugs, biologics, and drug classes known to interact with warfarin, comprising 73 distinct agents, found that 15% failed to mention the interaction, even though the interaction was mentioned in the warfarin labeling. © 2011 Elsevier HS Journals, Inc.
• Armstrong, E. P. (2010). Prophylaxis of cervical cancer and related cervical disease: A review of the cost-effectiveness of vaccination against oncogenic HPV types. Journal of Managed Care Pharmacy, 16(3), 217-230.
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  PMID: 20331326;Abstract: BACKGROUND: Vaccines have demonstrated cost-effectiveness in managed care through the prevention of disease. As new vaccines for previously untargeted conditions are developed, pharmacoeconomic modeling is becoming even more critical for the quantification of value in the health care industry. Two recently developed vaccines aimed at prevention of infection from human papillomavirus (HPV) types 16 and 18 have proven to be highly efficacious. HPV 16 and 18 are the 2 most common oncogenic strains of HPV and are responsible for 70% of cervical cancer cases worldwide. Persistent infection with an oncogenic HPV type is a known cause of cervical cancer. Therefore, prevention of cervical cancer via HPV vaccination may have a significant financial impact. OBJECTIVE: To qualitatively review existing mathematical models of the cost-effectiveness of prophylactic HPV vaccination, with an emphasis on the impact on managed care in the United States. METHODS: Mathematical models of the cost-effectiveness of HPV vaccination based on U.S. data were reviewed. A search of the PubMed database was conducted using the search terms "HPV," "vaccine," and "cost-effectiveness" for articles published before February 22, 2010. Studies employing mathematical models to estimate the cost-effectiveness of HPV vaccination in healthy subjects from the United States were included. Models based on data or populations from outside of the United States were excluded. Outcomes were measured with incremental cost-effectiveness ratios (ICERs), typically in units of quality-adjusted life expectancy (quality-adjusted life years [QALYs] gained). Most studies included in this review modeled vaccination of a cohort or population of females aged 12 years. Assessment of catch-up vaccination in females (through aged 24 to 26 years) was included in a couple of reports. One study examined vaccination in older females (aged 35, 40, and 45 years). Models typically compared a strategy of HPV vaccination with the current practice of cervical screening (sampling of cervical cells for disease detection) alone. RESULTS: 11 studies of cost-effectiveness modeling of HPV vaccination were included in this review. A direct quantitative comparison of model results is challenging due to the utilization of different model types as well as differences in variables selected within the same model type. Each model produced a range of cost-effectiveness ratios, dependent on variables included in sensitivity analyses and model assumptions. Sensitivity analyses revealed the lowest ICER to be $997 per QALY gained and the highest ICER to be $12,749,000 per QALY gained. This enormous range highlights the need to clarify what model assumptions are being made. The 2 studies that included modeling of catch-up vaccination scenarios in females older than age 12 years also produced a wide range of ICERs. One study, assuming 90% efficacy, 100% coverage, and lifelong immunity, modeled catch-up vaccination in all females aged 12 to 24 years and yielded an ICER of $4,666 per QALY. If the duration of protection was limited to 10 years, then costs increased to $21,121 per QALY. The other study modeling catch-up HPV vaccination assumed 100% efficacy, 75% coverage, and lifelong immunity. ICERs in this study for outcomes relating to cervical cancer ranged from $43,600 per QALY in the base model vaccinating only 12 year olds with no catch-up vaccination, to $152,700 in a model including catch-up vaccination through age 26 years. Although catch-up to age 21 years resulted in a cost of $120,400 per QALY, the ICER decreased to $101,300 per QALY if model outcomes related to prevention of genital warts were also included. The lone study modeling vaccination in women aged 35 to 45 years resulted in an ICER range of $116,950 to $272,350 per QALY when compared with annual and biennial cytological screening. Cost-effectiveness was defined as an ICER at or below $100,000 per QALY gained. All models of female adolescent vaccination were able to produce vaccination strategies that would be cost-effective according to this definition in addition to many strategies that would be cost-prohibitive. Variables influential in determining cost-effectiveness of HPV vaccination included the frequency of accompanying cervical screening, the age at which screening is initiated, vaccination efficacy, duration of vaccine protection, and the age range of females to be vaccinated. The actual effectiveness of HPV vaccination in the female population will also depend on levels of vaccine uptake or coverage and compliance in completing all vaccine doses. CONCLUSION: Clinical studies have shown HPV vaccination to be highly efficacious and potentially lifesaving if administered to females naïve or unexposed to vaccine HPV types. Modeling studies have also shown that HPV vaccination can be cost-effective with an ICER of $100,000 or less per QALY gained if administered to females aged 12 years in the context of cervical screening intervals typically greater than 1 year. Catch-up vaccination through 21 years of age increases the cost per QALY to more than $100,000. Until real-world coverage rates increase, cost-effectiveness modeling of HPV vaccination underestimates the actual cost per QALY. Copyright © 2010, Academy of Managed Care Pharmacy. All rights reserved.
• Armstrong, E. P., & Dhanda, R. (2010). Cost-effectiveness of early compared to late inhaled nitric oxide therapy in near-term infants. Current Medical Research and Opinion, 26(12), 2795-2800.
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  PMID: 21050057;Abstract: Objective: The purpose of this study was to determine the cost-effectiveness of early versus late inhaled nitric oxide (INO) therapy in neonates with hypoxic respiratory failure initially managed on conventional mechanical ventilation. Research design: A decision analytic model was created to compare the use of early INO compared to delayed INO for neonates receiving mechanical ventilation due to hypoxic respiratory failure. The perspective of the model was that of a hospital. Patients who did not respond to either early or delayed INO were assumed to have been treated with extracorporeal membrane oxygenation (ECMO). The effectiveness measure was defined as a neonate discharged alive without requiring ECMO therapy. A Monte Carlo simulation of 10,000 cases was conducted using first and second order probabilistic analysis. Direct medical costs that differed between early versus delayed INO treatment were estimated until time to hospital discharge. The proportion of successfully treated patients and costs were determined from the probabilistic sensitivity analysis. Results: The mean (±SD) effectiveness rate for early INO was 0.75 (±0.08) and 0.61 (±0.09) for delayed INO. The mean hospital cost for early INO was $21,462 (±$2695) and $27,226 (±$3532) for delayed INO. In 87 of scenarios, early INO dominated delayed INO by being both more effective and less costly. The acceptability curve between products demonstrated that early INO had over a 90 probability of being the most cost-effective treatment across a wide range of willingness to pay values. Conclusions: This analysis indicated that early INO therapy was cost-effective in neonates with hypoxic respiratory failure requiring mechanical ventilation compared to delayed INO by reducing the probability of developing severe hypoxic respiratory failure. There was a 90 or higher probability that early INO was more cost-effective than delayed INO across a wide range of willingness to pay values in this analysis. © 2010 Informa UK Ltd.
• Armstrong, E. P., Campbell, C., Allen, A. V., & Vincent, E. (2010). Skin cancer knowledge and prevention counseling among Arizona pharmacists. Journal of Pharmacy Practice, 23(4), 358-366.
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  PMID: 21507836;Abstract: Skin cancer is particularly prevalent in Arizona, with incidence rates ranking number 2 worldwide. This study assessed pharmacists' knowledge of skin cancer and factors that impacted skin cancer prevention patient counseling. Participants were recruited using a listserv of pharmacists that were members of the Arizona Pharmacy Alliance (AzPA) or preceptors of the University of Arizona College of Pharmacy. Subjects completed an online questionnaire consisting of knowledge-based questions, questions about patient counseling preferences, and subject demographics. The mean correct score on the Skin Cancer and Sun Exposure Knowledge Indicator was 5.8 ± 1.9. Pharmacists living in Arizona for longer duration were more likely to know the minimum recommended sunscreen sun protection factor (SPF) for adults when outdoors (P =.003) and factors associated with malignant melanoma prognosis/survival (P =.004) but were less likely to know the definition of ABCD acronym (P =.027). Having a family or friend diagnosed with any form of skin cancer or precancerous skin condition led to more pharmacists knowing the risk factors for developing melanoma (P =.046) and knowing how often to apply water resistant sunscreen (P =.035). In conclusion, the length of pharmacy practice in Arizona and having a family member or close friend affected by skin cancer significantly impacted a pharmacists' knowledge of skin cancer. © The Author(s) 2010.
• 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. Journal of Pain, 11(4), 360-368.
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  PMID: 19853529;Abstract: 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. Perspective: The data demonstrate that the health care costs associated with 1 peripheral neuropathic pain condition cannot be extrapolated to other neuropathic pain conditions. The results also increase understanding of the economic burden of PHN and painful DPN and provide a basis for evaluating the impact on health care costs of new interventions for their treatment and prevention. © 2010 American Pain Society.
• Malone, D., Armstrong, E. P., & Rahman, M. I. (2010). Health Economics. Principles and Practice of Pharmaceutical Medicine: Third Edition, 301-314.
• Olvey, E. L., Armstrong, E. P., & Grizzle, A. J. (2010). Contemporary Pharmacologic Treatments for Spasticity of the Upper Limb After Stroke: A Systematic Review. Clinical Therapeutics, 32(14), 2282-2303.
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  PMID: 21353101;Abstract: Background: Muscle spasticity after stroke may be painful and severe and may restrict the patient's ability to perform routine daily tasks, particularly when the affected muscles are in the upper limbs. Treatments targeted at reducing this spasticity have evolved over time. Objective: This was a systematic review of recent studies focusing on contemporary pharmacologic therapies for upper limb spasticity after stroke. Methods: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched for clinical trials published in English from January 1995 to July 2010 using search terms that included spasticity, stroke, hemiplegia, phenol, baclofen, tizanidine, dantrolene, benzodiazepine, and botulinum toxin. The level of evidence of the identified publications was assessed using the Oxford Centre for Evidence-Based Medicine criteria. Results: A total of 113 potentially relevant articles were identified by the search; of these, 54 studies were included in the review (23 randomized controlled trials [RCTs] and 31 open-label, nonrandomized, or observational studies). Of these, 51 involved treatment with botulinum toxin (BTX). All studies assessed spasticity; some also assessed additional outcomes, such as pain, disability, and functional status. Thirty-eight clinical trials reported a significant reduction in spasticity with BTX, either compared with baseline or with placebo (P < 0.05). A head-to-head comparison found a significant reduction in spasticity with BTX injections compared with oral tizanidine (TZD) (P < 0.001). Two studies of intrathecal baclofen (ITB) reported significant reductions in upper limb spasticity after 12 months of treatment, and 1 study of tizanidine reported significant reductions in upper limb spasticity after 16 weeks of treatment (all, P < 0.001). General or local weakness, injection-site pain, and fatigue were the most frequently reported adverse events with BTX type A, and dry mouth was the most frequently reported adverse event with BTX type B. No serious or life-threatening adverse events were reported in any trial of BTX. Conclusions: The 54 studies included in this systematic review of treatments for upper limb spasticity after stroke measured multiple outcomes using a variety of instruments. Fifty-one studies focused on treatment with a BTX formulation. BTX appeared to be an effective and well-tolerated focal treatment for reducing tonicity in patients with upper limb spasticity after stroke, supporting current guideline recommendations. © 2010 Elsevier HS Journals, Inc.
• 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, 66(1), 38-44.
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  PMID: 19106343;Abstract: Purpose. The development of computerized alerts with management strategies for 25 drug-drug interactions (DDIs) is described. Summary. To ensure that clinicians, when confronted with any of 25 serious DDIs in the ambulatory care setting, can avoid these DDIs while treating patients with appropriate medications, management strategies were developed using a consensus approach. Several methods were used to ensure that the recommended alternatives were truly safe. Four well-established drug-interaction compendia were screened, and any potential alternative agent that was listed as having an interaction (moderate or serious in nature) was excluded from the list of alternative agents. Case reports, case series, and clinical studies that focused on the alternative combinations were reviewed to determine if the alternative posed interaction risks. If an interaction for the alternative combination had not been identified in the compendia or in the literature search, other potential mechanisms for drug interactions were explored such as alterations in absorption, distribution, metabolism, or excretion. Pharmacology and therapeutics textbooks and other drug information sources also served as resources. In general, the strategies included alternatives to both medications, changing dosage or increasing monitoring of one of the agents, situations where one of the medications had no alternative but alternatives were available for the other medication, and alternative methods of birth control. In some situations the two drugs were contraindicated, while in others the two drugs should be avoided if at all possible and alternatives used. Conclusion. Consensus-based management strategies for 25 serious DDIs were developed for inclusion in computerized alert messages. Copyright © 2009, American Society of Health-System Pharmacists, Inc. All rights reserved.
• Smith, K., Warholak, T., Armstrong, E., Leib, M., Rehfeld, R., & Malone, D. (2009). Evaluation of risk factors and health outcomes among persons with asthma. Journal of Asthma, 46(3), 234-237.
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  PMID: 19373629;Abstract: Objective: To examine risk factors associated with healthcare utilization in Arizona Medicaid patients with asthma. Methods: Data were obtained from Arizona Medicaid between 1/1/2002 and 12/31/2003. Inclusion criteria consisted of persons with an asthma diagnosis (ICD9-CM 493.XX), 5 to 62 years of age; and were new users of inhaled-corticosteroids (ICS), combination ICS+long-acting beta-agonist, or leukotriene-modifiers. Factors examined included age, geographic location (urban/rural), race/ethnicity (White, non-Hispanic Black, Hispanic, other), medication adherence, pre-period short-acting beta-agonist use (SABA), and co-morbidities. Utilization measures examined included SABA use; exacerbations measured by hospital visits; and asthma-related and total healthcare costs. Analyses for utilization measures were performed using negative binomial, logistic regression, and generalized linear modeling gamma-family, log-link, respectively. Results: A total of 3,013 subjects met inclusion/exclusion criteria and had a mean age (SD) of 24.7 13.7 years. Urban residents were 55% more likely to have an exacerbation than rural residents (odds ratio-OR 0.45, 95%CI: 0.27-0.78). Age (years 18 to 62) was a significant predictor for SABA use (incidence rate ratio-IRR 1.22, 95% CI: 1.06-1.41); and exacerbations (OR 2.07, 95% CI: 1.28-3.38). Mean predicted asthma cost was $530 (95% CI: $461-608) for ages 5 to 17, $702 (95% CI $600-822) for ages 18 to 39), and $583 (95% CI $468-726) for ages 40 to 62. Males were 46% less likely to have an exacerbation than females (OR 0.54, 95% CI: 0.31-0.94). Exacerbations were not different between race/ethnicity categories. Predicted mean asthma-related costs were not different between Whites ($591, 95% CI: $509-686), Blacks ($638, 95% CI: $499-815), or Hispanics ($535, 95% CI: $466-614). Conclusions: Results of these analyses found urban areas had higher rates of asthma-related hospital visits compared to rural counties, but no difference in asthma-costs between urban and rural areas which may suggest rural exacerbations may be more costly or severe. Persons with asthma aged 18 to 62 had higher rates of asthma-related emergency-room visits/hospitalizations than those aged 5 to 18. Persons 18 to 39 years of age had higher costs than person 5 to 17 or 40 to 62. Race/ethnicity in this population was not a significant predictor of outcomes or asthma-related costs.
• 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), 1115-1121.
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  PMID: 18331669;Abstract: Objective: To estimate the costs and quality-adjusted life weeks of duloxetine and escitalopram. Research design: A probabilistic Markov cost-utility analysis with a time horizon of 1 year using data from placebo controlled randomized clinical trials for both products. Methods: Efficacy was defined as remission of depressive symptoms and converted to utilities. Side effects were incorporated using rates from clinical trials and converted to utilities to define treatment effectiveness. The effectiveness outcome was quality adjusted life weeks (QALWs). Estimates of effectiveness (efficacy and side effects) used beta distributions and costs used gamma distributions. Using a managed care perspective, medication costs and physician office visits were included in the model, along with costs associated with treatment failure. Antidepressant costs were obtained using average wholesale price minus 20%. Physician visit costs were obtained from the 2006 US Medicare fee schedule for physician services. A Monte Carlo simulation was conducted using 1000 trials with both first- and second-order sampling. Results: Over 1 year, the estimated mean quality-adjusted life weeks was 41.0 (95% confidence interval [CI]; 40.7-41.3) for escitalopram and 38.2 (95% CI; 37.9-38.4) for duloxetine. The mean annual total medical cost for escitalopram was $907 (95% CI: $894-$919) and $1633 (95% CI: $1614-$1654) for duloxetine. Limitations to this analysis include using separate studies examining the efficacy and adverse events of either escitalopram or duloxetine, assuming the switch, augmentation, and titration rates for duloxetine to be similar to escitalopram, and using utility estimates from published literature for the antidepressant adverse events. Conclusion: This analysis suggests that escitalopram was more effective in terms of QALWs and less costly than duloxetine for treatment of depression. © 2008 Informa UK Ltd. All rights reserved.
• Kapol, N., Maitreemit, P., Pongcharoensuk, P., & Armstrong, E. P. (2008). Evaluation of curricula content based on Thai pharmacy competency standards. American Journal of Pharmaceutical Education, 72(1).
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  PMID: 18322571;PMCID: PMC2254234;Abstract: Objective. To evaluate the curricula content of Thai pharmacy schools based on the Thai pharmacy competency standards. Methods. Course syllabi were collected from 11 pharmacy schools. A questionnaire was developed based on the Thai pharmacy competency standards. Course coordinators completed the questionnaire assessing the curricula content. Results. The curricula for both the bachelor of science in pharmacy degree (BS Pharm) and doctor of pharmacy (PharmD) degree programs included the minimum content required by the 8 competency domains. The dominant content area in BS Pharm degree programs was product-oriented material. The content ratio of patient to product to social and administrative pharmacy in the BS Pharm degree programs was 2:3:1, respectively. However, the content ratio suggested by the Thai Pharmacy Council was 3:2:1, respectively. For the PharmD programs, the largest content area was patient-oriented material, which was in agreement with the framework suggested by the Thai Pharmacy Council. Conclusions. The curricula of all Thai pharmacy schools met the competency standards; however, some patient-oriented material should be expanded and some product-oriented content deleted in order to meet the recommended content ratio.
• 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, 65(18), 1744-1749.
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  PMID: 18769002;Abstract: Purpose. 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. Methods. The structure of pharmaceutical services in VAMCs was assessed using a questionnaire that was distributed by mail to chief pharmacists at 182 facilities. The questionnaire focused on the total volume of prescriptions dispensed at each VAMC, the level and characteristics of pharmacy staffing, the characteristics and distribution of available pharmaceutical services, the availability of specialty ambulatory clinics, and the extent of clinical pharmacist coverage within these clinics. A list of 25 clinically important DDIs that were most likely to be encountered in ambulatory care settings was used in this study. Multivariate regression was used to assess the relationship in the structure of pharmaceutical services and the exposure rate to clinically important DDIs. Results. A total of 790,541 patients were treated by the 52 VAMCs included in this study, with a total of 17,447 patients exposed to DDIs of interest. VAMCs with a lower prescription volume, a higher number of pharmacists in ambulatory care settings, and a higher number of ambulatory specialty clinics had significantly lower rates of potential DDIs. Conclusion. Exposure to clinically important DDIs was significantly lower in VAMCs with a higher number of pharmacists in ambulatory care settings, a higher number of ambulatory specialty clinics, and facilities with lower prescription volumes. Copyright © 2008, American Society of Health-System Pharmacists, Inc. All rights reserved.
• Maitreemit, P., Pongcharoensuk, P., Kapol, N., & Armstrong, E. P. (2008). Pharmacist perceptions of new competency standards. Pharmacy Practice, 6(7), 113-120.
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  Abstract: Objective: To suggest revisions to the Thai pharmacy competency standards and determine the perceptions of Thai pharmacy practitioners and faculty about the proposed pharmacy competency standards. Methods: The current competency standards were revised by brainstorming session with nine Thai pharmacy experts according to their perceptions of society's pharmacy needs. The revised standards were proposed and validated by 574 pharmacy practitioners and faculty members by using a written questionnaire. The respondents were classified based on their practice setting. Results: The revision of pharmacy competency standard proposed the integration and addition to current competencies. Of 830 distributed questionnaires, 574 completed questionnaires were received (69.2% response rate). The proposed new competency standards contained 7 domains and 46 competencies. The majority of the respondents were supportive of all 46 proposed competencies. The highest ranked domain was Domain 1 (Practice Pharmacy within Laws, Professional Standards, and Ethics). The second and third highest expectations of pharmacy graduates were Domain 4 (Provide pharmaceutical care) and Domain 3 (Communicate and disseminate knowledge effectively). Conclusion: The expectation for pharmacy graduates' competencies were high and respondents encouraged additional growth in multidisciplinary efforts to improve patient care.
• Wang, M., Skrepnek, G. H., Armstrong, E., Sherrill, D. L., Harris, R. B., Tsai, C., & Malone, D. C. (2008). Use of salmeterol with and without concurrent use of inhaled corticosteroids and the risk of asthma-related hospitalization among patients with asthma. Current Medical Research and Opinion, 24(3), 859-867.
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  PMID: 18267052;Abstract: Rationale: Studies evaluating the safety of salmeterol are inconclusive, which might be the result from not taking into account the impact of concomitant inhaled corticosteroids (ICS). Objective: To study whether salmeterol use with and without concomitant ICS, respectively, was associated with an increased risk of asthma-related hospitalizations among patients with asthma. Methods: A case-control study nested within a cohort of patients with asthma, identified in the year 2000, over a 2-year period was conducted. Cases were subjects who had a first-time hospitalization for asthma in the year 2001, and were matched with up to five controls by age (± 5 years), sex, and number of asthma-related outpatient visits. Measurements: Hospitalizations and medication use were extracted from the MEDSTAT's MarketScan database. Main results: There were 333 cases of asthma-related hospitalizations and 1607 matched control subjects. Any use of salmeterol with concomitant ICS use during the prior year was associated with a 32% risk reduction for being hospitalized due to asthma (OR = 0.68; 95% CI = 0.48, 0.96). In the presence of concomitant ICS use, patients who either used salmeterol currently or used seven or more canisters of salmeterol during the prior year had 46% (OR = 0.54, 95% CI = 0.32, 0.92), and 59% (OR = 0.41, 95% CI = 0.21, 0.79) reductions in the risk of hospital admissions for asthma, respectively. Limitations: Though indirect measure of asthma severity was adjusted during the analyses, the lack of information on lung function might result in a selection bias. Additionally, only a small sample size of patients was found to use salmeterol without concomitant ICS use, and this introduced the issue of lack of power. Conclusions: Use of salmeterol in conjunction with ICS is associated with a decreased risk of hospital admission for asthma. © 2008 Librapharm Limited All rights reserved.
• Yu, K. o., 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 and Administrative Pharmacy, 4(4), 355-366.
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  PMID: 19064242;Abstract: Background: 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. Objectives: This study was conducted to develop interval scales to evaluate prescribers' potential DDI knowledge and perceived usefulness of various potential DDI information sources, and to examine demographic and practice factors that may be related to prescribers' knowledge of potential DDIs. Methods: Data were obtained from a national mail survey of prescribers who were determined from pharmacy claims obtained from a pharmacy benefits manager to have prescribed at least 1 drug involved in a potential DDI, and a control group who had prescribed either 1 of the medications in the drug combinations of interest. The survey instrument included 14 drug-drug pairs that evaluated prescribers' ability to recognize clinically important potential DDIs and 5-point Likert scale-type questions that assessed prescribers' perceived usefulness of potential DDI information provided by various sources. The knowledge and usefulness questions were examined via Rasch dichotomous and rating scale models, respectively. Results: A total of 950 completed surveys were included in the analysis (overall adjusted response rate: 7.9%). Rasch analysis of knowledge and usefulness items revealed satisfactory model-data-fit (infit mean square [MNSQ] ≦ 1.5 and outfit MNSQ ≦ 2.0) and moderate person reliability of 0.72 and 0.61, respectively. Multiple regression analysis revealed that compared with generalists, specialists had lower potential DDI knowledge test scores. In addition, poorer potential DDI knowledge was associated with a lack of clinical experience witnessing harm caused by a potential DDI. Also, the prescribers whose drug selections were affected by the risk of potential DDIs "very much" scored higher than those who reported that their prescribing was affected by the risk "a little" or "not at all.". Conclusions: This study found that specialists were less likely to correctly identify interactions compared with generalists. Other important predictors of potential DDI knowledge included the experience of seeing a potential DDI-caused harm and the extent to which the risk of potential DDIs affected prescribers' drug selection. © 2008 Elsevier Inc. All rights reserved.
• Yu, K. o., 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), 525-536.
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  PMID: 18484786;Abstract: Background: 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. Methods: A postal questionnaire was developed to assess prescriber knowledge of medications that may interact and prescribers' usual sources of DDI information. Recipients were asked to classify 14 drug pairs as 'contraindicated', 'may be used together but with monitoring' or 'no interaction'. A response option of 'not sure' was also provided. The questionnaires were sent to a national sample of 12 500 prescribers based on past history of prescribing drugs associated with known potential for DDI, who were identified using data from a pharmacy benefit manager covering over 50 million individuals. Results: Usable questionnaires were obtained from 950 prescribers. The percentage of prescribers who correctly classified specific drug pairs ranged from 18.2% for warfarin and cimetidine to 81.2% for paracetamol (acetaminophen) with codeine and amoxicillin, with 42.7% of all combinations classified correctly. The number of drug pairs correctly classified by the prescribers ranged from 0 to 13. For half of the drug pairs over one-third of the respondents answered 'not sure'; among those drug pairs, two were contraindicated. When asked what source was used to learn more about a potential DDI, a quarter of the prescribers reported using personal digital assistants and another quarter used printed material. The majority of the prescribers (68.4%) reported that they were usually informed by pharmacists about their patients' potential exposure to DDIs. Compared with the prescribers who used other sources, those who used computerized DDI alerts as their usual source of DDI information consistently gave a lower rating score to the five statements that assessed the usefulness of the information. Conclusion: This study suggests that prescribers' knowledge of potential clinically significant DDIs is generally poor. These findings are supported by other research and emphasize the need to develop systems that alert prescribers about potential interactions that are clinically relevant. Physicians most commonly reported learning about potential DDIs from pharmacists, suggesting further work is needed to improve the drug-prescribing process to identify potential safety issues earlier in the medication use process. © 2008 Adis Data Information BV. All rights reserved.
• Armstrong, E. P. (2007). Economic benefits and costs associated with target vaccinations. Journal of Managed Care Pharmacy, 13(7 SUPPL.), S12-S15.
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  PMID: 17955624;Abstract: BACKGROUND: As a therapeutic class, vaccines are generally considered to be the health care intervention that provides the best value. In the pharmacoeconomic study of vaccines, it is common for researchers to conduct their analyses from a societal perspective, including direct medical costs as well as indirect costs. OBJECTIVE: To discuss the data elements of pharmacoeconomic analyses of vaccines and review recently published analyses of emerging vaccines. SUMMARY: Myriad pharmacoeconomic analyses of vaccines currently in use have been conducted with varying results. A number of products, such as the diphtheria-tetanus-acellular pertussis, hepatitis B, and varicella vaccines, have been shown to be cost-effective from a societal perspective. Yet, other products, such as the pneumococcal conjugate vaccine, have demonstrated less benefit than the cost of their respective vaccination programs. In general, these analyses can be used as a starting point to frame the benefits of specific vaccines in managed care with a balanced view of the necessary societal perspectives. To date, 6 pharmacoeconomic models have evaluated vaccination against human papillomavirus, with all demonstrating some cost benefit when the vaccine was used in female patients who fell within the indicated age range. CONCLUSIONS: In general, as a therapeutic class, vaccines are extremely cost-effective agents. In addition, they are one of the few public health interventions that may directly lower medical costs. In conducting pharmacoeconomic analyses for agents in this class, researchers must consider costs incurred at both the health system and societal levels, as well as cost savings realized through the prevention of disease. Copyright© 2007, Academy of Managed Care Pharmacy. All rights reserved.
• Armstrong, E. P., Skrepnek, G. H., & Erder, M. H. (2007). Cost-utility comparison of escitalopram and sertraline in the treatment of major depressive disorder. Current Medical Research and Opinion, 23(2), 251-258.
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  PMID: 17288678;Abstract: Objective: To construct a cost-utility model comparing escitalopram with sertraline in the treatment of major depressive disorders. Methods: A decision analytic model was created to compare the cost-utility of these two antidepressants from the perspective of a managed-care organization. The model was designed to compare 10-20 mg/day of escitalopram to 50-200 mg/day of sertraline. Benefits (utility) scores were calculated based on clinical and utility data obtained from the literature. Direct medical costs included costs of the antidepressants, titration, treatment failures, and adverse events. Costs and benefits were modeled for a 6-month period and the model was subjected to thorough sensitivity analyses. Results: The estimated 6-month total cost was $919 for escitalopram and $1351 for sertraline. The estimated QALYs were 0.40296 for escitalopram and 0.39268 for sertraline. These differences were mostly due to differences in drug acquisition costs and adverse events. The robustness of the cost-utility model results were tested in a Monte Carlo simulation of 10 000 patients and it indicated an 88.5% probability that escitalopram was the dominant therapy, suggesting both lower costs and greater QALYs. Conclusion: This cost-utility model that incorporated the costs of titration and impact of side-effects comparing escitalopram 10-20 mg per day and sertraline 50-200 mg per day shows that escitalopram appeared to be less costly and produced efficacy (utility) at least as good as and maybe slightly better than that of sertraline. © 2007 Librapharm Limited.
• Grizzle, A. J., Mahmood, M. H., Yu, K. o., 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. American Journal of Managed Care, 13(10), 573-580.
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  PMID: 17927462;Abstract: Objectives: 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. Study Design: An observational retrospective database analysis was conducted using override reasons derived from a computerized system at 6 Veterans Affairs medical centers. Methods: Data on DDI alerts (for interactions designated as "critical" and "significant") were obtained from ambulatory care pharmacy records from July 1, 2003, to June 30, 2004. Prescribers' reasons for overriding alerts were organized into 14 categories and were then rated as clinically useful or not to the pharmacist in the assessment of potential patient harm. Results: Of 291 890 overrides identified, 72% were for critical DDIs. Across the Veterans Affairs medical centers, only 20% of the override reasons for critical DDI alerts were rated as clinically useful for order verification. Despite a mandatory override reason for critical DDI alerts, 53% of the responses were "no reason provided." The top response categories for critical and significant DDI alerts were "no reason provided," "patient has been taking combination," and "patient being monitored." Conclusions: When given the opportunity to provide a reason for overriding a DDI alert, prescribers rarely enter clinical justifications that are useful to order verification pharmacists. This brings into question how computerized physician order entry systems should be designed.
• Mahmood, M., Malone, D. C., Skrepnek, G. H., Abarca, J., Armstrong, E. P., Murphy, J. E., Grizzle, A. J., Yu, K. o., & Woosley, R. L. (2007). Potential drug-drug interactions within Veterans Affairs medical centers. American Journal of Health-System Pharmacy, 64(14), 1500-1505.
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  PMID: 17617500;Abstract: Purpose. 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). Methods. This study was a retrospective, cross-sectional database analysis of pharmacy records to assess the prevalence of 25 clinically important DDIs. For each DDI, the object drug was defined as the medication that has its therapeutic effect modified by the drug interaction process. The precipitant drug was defined as the medication responsible for affecting the pharmacologic action or the pharmacokinetic properties of the object drug. Rates of interactions for each VAMC facility were calculated as the number of patients with a DDI divided by the total number of individual patients exposed to the object or precipitant medications. The 25 DDIs were categorized into four main categories on the basis of the therapeutic classification of the medications involved in the drug pairs. Results. The study population included 2,795,345 patients who filled prescriptions for medications involved in potential DDIs across 128 VAMCs. The highest DDI exposure rate was 129.2 per 1,000 recipients of monoamine oxidase inhibitors (MAOIs) that occurred with combinations of selective serotonin-reuptake inhibitors (SSRIs). The lowest DDI exposure rate was 0.01 per 1,000 warfarin recipients who had the warfarin and sulfinpyrazone combination. Conclusion. The analysis of pharmacy records of veterans who filled prescriptions at the outpatient settings within VAMC found an overall rate of 2.15% for potential DDIs. Case-exposure rates were greatest for veterans receiving SSRIs and MAOIs, ganciclovir and zidovudine, anticoagulants and thyroid hormones, and warfarin and nonsteroidal antiinflammatory drugs. Copyright © 2007, American Society of Health-System Pharmacists, Inc. All rights reserved.
• 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), 456-462.
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  PMID: 17446832;Abstract: BACKGROUND:: 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. METHODS:: This study combined survey data from community pharmacies in 18 metropolitan statistical areas with pharmacy claims submitted to 4 pharmacy benefit managers (PBMs) over a 3-month period from January 1, 2003 to March 31, 2003. Pharmacy characteristics of interest included prescription volume, the number of full-time equivalent pharmacists and pharmacy staff, computer software programs, and the ability to modify those programs with respect to DDI alerts, the use of technologies to assist in receiving, filling and dispensing medication orders, and prescription volume. The dependent variable in this study was the rate of dispensed medications that may interact. RESULTS:: A total of 672 pharmacies were included in the analysis. On average (±SD), the respondents filled 1375 ± 691 prescriptions per week, submitted 17,948 ± 23,889 pharmacy claims to the participating PBMs, had 1.2 ± 0.3 full-time equivalent pharmacists per hour open, and 545 (81%) were affiliated with a chain drug store organization. Factors significantly related to an increased risk of dispensing a potential DDI included pharmacist workload (odds ratio [OR] 1.03; 95% confidence interval [CI] 1.028ĝ€"1.048), pharmacy staffing (OR 1.10; 95% CI: 1.09ĝ€"1.11), and various technologies (eg, sophisticated telephone systems, internet receipt of orders, and refill requests) that assist with order processing, and the ability to modify DDI alert-screening sensitivity and detailed pharmacological information about DDIs. CONCLUSIONS:: This study found that there was an increase in the risk of dispensing a potential DDI with higher pharmacist and pharmacy workload, use of specific automation, and dispensing software programs providing alerts and clinical information. Copyright © 2007 by Lippincott Williams & Wilkins.
• Skrepnek, G. H., Armstrong, E. P., Brookler, K., Roper, J., Martin, B. E., Karabatsos, L., & Hunter, C. (2007). Cost analysis of a disease management programme for adult Medicaid clients with schizophrenia. Journal of Medical Economics, 10(4), 411-426.
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  Abstract: This investigation assessed changes in direct medical costs, from the perspective of a public payer, associated with a comprehensive, field-based disease management programme for adult Medicaid clients with schizophrenia in the US State of Colorado. A propensity score-matching algorithm was employed in this retrospective analysis owing to the inherent non-randomisation of enrollees. Of the 126 clients initially enrolled, 73 (58%) remained within the programme continuously for 6-12 months. These participants were associated with 30% lower overall per member per month medical costs (p
• Ventura, D., Armstrong, E. P., Skrepnek, G. H., & Erder, M. H. (2007). Escitalopram versus sertraline in the treatment of major depressive disorder: A randomized clinical trial. Current Medical Research and Opinion, 23(2), 245-250.
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  PMID: 17288677;Abstract: Objective. This trial was conducted to compare the efficacy and tolerability of a fixed dose of escitalopram 10mg/day with sertraline optimally dosed within its recommended dose range (50-200 mg/day) for the treatment of major depressive disorder. Methods. In this multicenter trial, depressed patients (DSM-IV defined; baseline Montgomery-Asberg Depression Rating Scale [MADRS] ≥ 22) aged 18-80 years were randomly assigned to 8 weeks of double-blind treatment with escitalopram (10 mg/day) or sertraline (50-200 mg/day) following a 1-week single-blind placebo lead-in period. There was no placebo comparison arm. Sertraline was initiated at 50 mg/day, and could be increased by 50 mg/day at weekly intervals based on clinical need and tolerability at the lower dose level. The blind was maintained with matching double-blind placebo capsules for the escitalopram group. Change from baseline to endpoint in MADRS total score (last observation carried forward) was the primary efficacy measure. Results. A total of 212 patients received double-blind medication. At week 8, the mean sertraline dosage was 144 mg/day (median = 150mg/day). Mean changes from baseline to endpoint in MADRS scores were -19.1 and -18.4 for the escitalopram and sertraline groups, respectively. At endpoint, 75% and 70% of escitalopram- and sertraline-treated patients, respectively, were responders (≥ 50% improvement from baseline in mean MADRS scores). Both treatments were generally well tolerated; only 2% and 4% of patients prematurely discontinued escitalopram and sertraline treatment respectively, due to adverse events. Conclusion: No differences in efficacy were observed for fixed-dose escitalopram 10mg/day and sertraline flexibly dosed from 50-200 mg/day. At these doses, both escitalopram and sertraline were generally well tolerated. © 2007 Librapharm Limited.
• 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), 813-824.
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  PMID: 17542764;Abstract: Study Objective. 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. Design. Cost-utility analysis using a Markov model. Setting. Veterans Affairs health care system. Data Source. Data for the model were obtained from clinical trials and published literature. Data from the VA health care system were used to define the patient cohorts. Measurements and Main Results. A Markov model incorporating transition probabilities between disease health states that depend only on the current health state was developed to simulate the progression of HCV disease. The patient cohorts were a 45-year-old male cohort and a 55-year-old male cohort, each with liver fibrosis but no cirrhosis. The lifetime expected costs, quality-adjusted life-years (QALYs) gained, and incremental net monetary benefit (INMB) with HCV treatments were determined for each cohort by genotype (genotype 1, and genotypes 2 and 3). Both peginterferon regimens were significantly more cost-effective than no treatment, although no significant differences in costs or QALYs were noted between peginterferon regimens. For the 45-year-old cohort with a genotype 1 infection, the INMB was $128,583 (95% confidence interval [CI] $79,279-$177,308) and $128,025 (95% CI $80,425- $173,448) versus no treatment for peginterferon alfa-2a plus ribavirin and peginterferon alfa-2b plus ribavirin, respectively. Treatment with either peginterferon regimen produced significantly lower lifetime HCV-related medical costs for genotype 2 or 3 infections, but not genotype 1. Conclusions. Peginterferon alfa-2a plus ribavirin and peginterferon alfa-2b plus ribavirin were found to be cost-effective treatments for patients with HCV infections, particularly with genotypes 2 and 3. However, no significant differences in costs or efficacy were observed between these peginterferon treatment regimens.
• Abarca, J., Colón, 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, 12(5), 383-389.
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  PMID: 16792445;Abstract: BACKGROUND: Computerized drug-drug interaction (DDI) screening is widely used to identify potentially harmful drug combinations in the inpatient and outpatient setting. OBJECTIVE: To evaluate the performance of drug-drug interaction (DDI) screening software in identifying select clinically significant DDIs in pharmacy computer systems in community and hospital pharmacies. METHODS: Ten community pharmacies and 10 hospital pharmacies in the Tucson metropolitan area were invited to participate in the study in 2004. To test the performance of each of the systems used by the pharmacies, 25 medications were used to create 6 mock patient profiles containing 37 drug-drug pairs, 16 of which are clinically meaningful DDIs that pose a potential risk to patient safety. Each profile was entered into the computer pharmacy system, and the system response in terms of the presence or absence of a DDI alert was recorded for each drug pair. The percentage of correct responses and the sensitivity, specificity, positive predictive value, and negative predictive value of each system to correctly classify each drug pair as a DDI or not was calculated. Summary statistics of these measures were calculated separately for community and hospital pharmacies. RESULTS: Eight community pharmacies and 5 hospital pharmacies in the Tucson metropolitan area agreed to participate in the study. The median sensitivity and median specificity for community pharmacies was 0.88 (range, 0.81-0.94) and 0.91 (range, 0.67-1.00), respectively. For hospital pharmacies, the median sensitivity and median specificity was 0.38 (range, 0.15-0.94) and 0.95 (range, 0.81-0.95), respectively. CONCLUSION: Based on this convenience sample of 8 community pharmacies and 5 hospital pharmacies in 1 metropolitan area, the performance of community pharmacy computer systems in screening DDIs appears to have improved over the last several years compared with research published previously in 2001. However, significant variation remains in the performance of hospital pharmacy computer systems, even among systems manufactured by the same vendor. Future research should focus on improving the performance of these systems in accurately and precisely identifying DDIs with a high probability of resulting in true potential adverse effects on clinical outcomes and creating a low "noise" ratio associated with false-positive alerts. Copyright© 2006, Academy of Managed Care Pharmacy. All rights reserved.
• 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, 46(2), 148-153.
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  PMID: 16602224;Abstract: Objective: To examine community pharmacists' attitudes toward computerized drug-drug interaction (DDI) alerts and identify factors associated with more favorable perceptions of these alerts. Design: Cross-sectional postal survey. Setting: 18 metropolitan statistical areas (MSAs) in the United States. Participants: 3,000 community pharmacy managers. Interventions: 34-item survey instrument designed to collect data about the pharmacy including demographics, workload issues, handling of DDIs, and pharmacists' attitudes toward computerized DDI alerts. Main Outcome Measure: Responses to items concerning community pharmacy managers' attitudes toward DDI alerts and factors associated with more favorable attitudes toward these alerts. Results: A total of 736 usable surveys were returned (25.3% response rate). Pharmacy managers generally disagreed that DDI alerts were a waste of time (mean ± SD, 2.1 ± 1.1 on a scale of 1, strongly disagree, to 6, strongly agree). However, they were not completely confident that their computer systems provided them with meaningful DDI alerts (mean ± SD, 4.5 ± 1.2). They were confident in their ability to identify DDIs (mean ± SD, 4.9 ± 0.9) and discuss DDIs with physicians (mean ± SD, 5.2 ± 0.7). Pharmacy software that provided detailed DDI information as well as the ability to customize DDI alerts were associated with more favorable perceptions of DDI alerts. Conclusion: Despite being presented with a large proportion of clinically unimportant alerts, community pharmacy managers did not believe DDI alerts were meaningless or a waste of time. Incorporation of features that streamline DDI alerts may improve their effectiveness in community pharmacy practice.
• Hoxsie, D. M., Keller, A. E., & Armstrong, E. P. (2006). Analysis of community pharmacy workflow processes in preventing dispensing errors. Journal of Pharmacy Practice, 19(2), 124-130.
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  Abstract: The objectives of this analysis were to determine the compliance rate with dispensing workflow criteria and note if any dispensing errors occurred. Observations were made within 18 community retail pharmacies having at least 50 out-window (ie, prescription pickup window) transactions per store. Based on the historic pharmacy error incidence reports, pharmacies were categorized as being either high- or low-risk pharmacies. The compliance rates for the dispensing workflow criteria were observed between high- and low-risk pharmacies and also between different employee categories. Employee categories included pharmacists, pharmacy interns, and pharmacy technicians who were involved in the dispensing process. Between August 2004 and January 2005, 950 out-window transactions were observed. There were statistically significant differences seen between high- and low-risk pharmacies and between the various categories of employees. Based on this study, the lack of the verification of patient's name and number of prescriptions being picked up was the procedure that was more commonly associated with pharmacies reported to have high dispensing error rates. © 2006 Sage Publications.
• Kerschen, A. M., Armstrong, E. P., & Hillman, T. N. (2006). Job satisfaction among staff, clinical, and integrated hospital pharmacists. Journal of Pharmacy Practice, 19(5), 306-312.
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  Abstract: Purpose: To determine whether staff, clinical, or integrated hospital pharmacists have greater job satisfaction and if sex, years worked as a pharmacist, or having children changes job satisfaction. Methods: A prospective study was performed by distributing a 63-item questionnaire to inpatient pharmacists working at 2 hospitals. Respondents mailed the completed questionnaires to the investigators. Results: Questionnaires were completed by 38 participants (mean age [SD]= 38.36 [10.97]). Fourteen (36.85%) participants who spent 0% to 40% of their time in clinical activities were categorized as staff, 10 (26.30%) who spent 41% to 60% of their time in clinical activities were integrated, and 14 (36.85%) who spent greater than 61% of their time in clinical activities were clinical pharmacists. All pharmacists reported mean satisfaction scores above 2.5, indicating that all were satisfied in their jobs. Differences were noted in the amount of satisfaction. For work environment and professional interaction, integrated pharmacists were more satisfied than staff (P
• Murphy, J. E., Malone, D. C., Skrepnek, G. H., Armstrong, E. P., Abarca, J., Grizzle, A. J., Rehfeld, R. A., & Woosley, R. L. (2006). The role of technicians in managing computerized drug-drug interaction alerts in community pharmacies and the relationship to pharmacist managers' attitudes. Journal of Pharmacy Technology, 22(3), 155-160.
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  Abstract: Background: Community pharmacies are where identification and prevention of drug-drug interactions (DDIs) typically occur. Technicians have been shown to play some role in the initial screening of DDIs in community pharmacies. Objectives: To examine the role of technicians in the management of DDI alerts in community pharmacies and the possible relationship to the attitudes of pharmacy managers toward DDI alerts. Methods: A national survey of pharmacist managers in 3,000 community pharmacies was conducted. Data collected included demographics, workload issues, handling of DDIs, and pharmacists' attitudes toward computerized DDI alerts. Results: Of questionnaires returned, 736 could be used. Technicians were more often allowed or sometimes allowed to override lower level DDI alerts without prior review by a pharmacist. However, some pharmacies (2.1%) allowed or sometimes allowed technicians to override interactions with the highest potential clinical significance. Stores with the highest use of technology were less likely to allow technicians to override insignificant interactions. Stores that allow technicians to override clinically significant interactions were less confident in their program's ability to provide meaningful alerts and more likely to agree that alerts are a waste of time and that the volume of alerts makes differentiating important from unimportant DDIs more difficult. Conclusions: Pharmacy technicians play a limited role in the management of DDI alerts, but could be used to help ensure that a patient's profile of medications is up-to-date and determine whether the patient had already been receiving the combination without notable problem.
• Perkins, N. A., Murphy, J. E., Malone, D. C., & Armstrong, E. P. (2006). Performance of drug-drug interaction software for personal digital assistants. Annals of Pharmacotherapy, 40(5), 850-855.
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  PMID: 16622155;Abstract: BACKGROUND: 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. OBJECTIVE: To examine the ability of DDI software programs manufactured for Palm OS-compatible PDAs in detecting clinically important DDIs. METHODS: Eight PDA software programs were assessed for sensitivity, specificity, and positive and negative predictive values for 16 well-documented DDIs contained within 6 simulated patient profiles. RESULTS: Sensitivity of the software programs ranged from 0.81 to 1.0, specificity ranged from 0.52 to 1.0, positive predictive values ranged from 0.62 to 1.0, and negative predictive values ranged from 0.88 to 1.0. Five programs scored perfect sensitivity scores: Druglx, ePocrates Rx, ePocrates Rx Pro, Lexi-Interact, and the Tarascon pocket Pharmacopoeia. Of these, the ePocrates programs scored the highest in specificity (0.9), while Lexi-lnteract and the Tarascon pocket Pharmacopoeia scored considerably lower (0.52). Mosbylx was the only program to score a 1.0 in specificity; however, its sensitivity was just 0.81. CONCLUSIONS: ePocrates Rx and ePocrates Rx Pro scored greater than or equal to 90% in regard to both sensitivity and specificity, making them the most reliable in detecting the clinically relevant interactions studied without the distraction of detecting those of no clinical significance. In addition, ePocrates Rx is updated regularly and is easily accessible on the Internet at no cost.
• Skrepnek, G. H., Armstrong, E. P., Malone, D. C., Abarca, J., Murphy, J. E., Grizzle, A. J., Rehfeld, R. A., & Woosley, R. L. (2006). Workload and availability of technology in metropolitan community pharmacies. Journal of the American Pharmacists Association, 46(2), 154-160.
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  PMID: 16602225;Abstract: Objective: To assess workload characteristics and the presence of prescription processing technologies within metropolitan community pharmacies in the United States. Design: Cross-sectional postal survey. Setting: 18 metropolitan statistical areas (MSAs) in the United States. Participants: 3,000 managers located in community pharmacies processing at least 500 third-party claims per month for four major pharmacy benefits managers. Interventions: 34-item survey instrument designed to collect data about the pharmacy including demographics, workload issues, handling of drug-drug interactions (DDIs), and pharmacists' attitudes toward computerized DDI alerts. Main Outcome Measures: Workload (hours of operation, prescription volume, staffing hours, prescription processing intensity) and prescription processing technologies (telecommunication systems, automated counting/filling or verification devices, number of computer terminals, and computer software vendors). Results: Overall, 736 usable surveys were returned (response rate, 25.3%). On average, respondents reported a volume of approximately 1,340 prescriptions per week processed at a rate of almost 17 prescriptions per hour. Independent pharmacies processed approximately 3 prescriptions per hour more than chain pharmacies even though a statistically equal or slightly lower proportion of those pharmacies had automated technologies. The presence of technology was generally high for all pharmacies, particularly countertop tablet/capsule-counting devices and telefacsimile machines. The most common software vendors differed considerably between chain and independent pharmacies. Conclusion: The number of prescriptions processed per hour and number of technologies available increased with the total weekly volume of prescriptions processed in this national survey. A majority of pharmacies had at least one type of automated prescription processing technology and an automated telecommunication system for accepting new or refill prescriptions. Independent pharmacies processed more prescriptions per hour than did chains but did so with fewer categories of technologies.
• Yu, K. o., Malone, D. C., & Armstrong, E. P. (2006). Pharmacoeconomic evaluation of antimuscarinic agents for the treatment of overactive bladder. Pharmacotherapy, 26(12 I), 1694-1702.
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  PMID: 17125433;Abstract: Study Objective. To compare the cost-effectiveness of various antimuscarinic agents for the treatment of overactive bladder (OAB). Methods. A decision-analysis model was developed and included clinical outcomes (i.e., therapy continued or discontinued, treatment success or failure, OAB-induced comorbidities) and costs for drugs and treatment of OAB-induced comorbidities (i.e., urinary tract infections, fractures, depression, and skin infections). Treatment success was defined as complete continence. A systematic MEDLINE literature search from January 1990-January 2006 identified English-language articles concerning the eight antimuscarinic drugs: darifenacin, solifenacin, trospium, immediate-release oxybutynin, extended-release oxybutynin, transdermal oxybutynin, immediate-release tolterodine, and extended-release tolterodine. Probabilities and cost data for these drugs were retrieved from the literature, and drug costs were based on 2005 average wholesale prices. The analysis was constructed from a payer's perspective. The time frame for the model was 3 months. Results. Expected costs for each patient with OAB ranged from $3373 when treated with solifenacin to $3769 when treated with immediate-release oxybutynin. The average cost/patient with continued and successful treatment was lowest for solifenacin ($6863). Solifenacin dominated all other antimuscarinic agents because they were associated with high costs and low effectiveness. Success rates were the key parameters driving the sensitivity analysis. Conclusion. Among various antimuscarinic agents, solifenacin 5 mg had the lowest costs and highest effectiveness in the treatment of OAB.
• Malone, D. C., Abarca, J., Hansten, P. D., Grizzle, A. J., Armstrong, E. P., C., R., Duncan-Edgar, B. S., Solomon, S. L., & Lipton, R. B. (2005). Identification of serious drug-drug interactions: Results of the partnership to prevent drug-drug interactions. American Journal Geriatric Pharmacotherapy, 3(2), 65-76.
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  Abstract: Objective: To develop a list of clinically important drug-drug interactions (DDIs) likely to be encountered in community and ambulatory pharmacy settings and detected by a computerized pharmacy system. Design: Cross-sectional, one-time evaluation. Setting: United States in fall 2001. Participants: An expert panel comprising two physicians, two clinical pharmacists, and an expert on DDIs. Interventions: Systematic review of drug interaction compendia and published literature, ratings (on a 1 to 10 scale) of various clinical aspects of DDIs (e.g., clinical importance, quality and quantity of evidence, causal relationship, risk of morbidity and mortality), and a modified Delphi consensus-building process. Main outcome measure: Panelists' opinions about clinical importance of DDIs. Results: The expert panel considered 56 DDIs. Of these, 28 had a mean clinical importance score of 8.0 or more. The ratings for clinical importance ranged from 3.2 to 9.6, with a mean ± SD of 7.5 ± 1.5 across the combinations examined. The mean score for the quality of literature suggesting the interaction exists ranged from 1.0 to 9.6, with a mean ± SD of 5.8 ± 2.5. In terms of substantiation of the interactions evaluated, the mean ± SD rating was 6.3 ± 2.2, with a range from 1.4 to 9.2. Through the modified Delphi process, the panel determined that 25 interactions were clinically important. Conclusion: Using an expert panel and a standard evaluation tool, 25 clinically important drug interactions that are likely to occur in the community and ambulatory pharmacy settings were identified. Pharmacists should take steps to prevent patients from receiving these interacting medications, and computer software vendors should focus interaction alerts on these and similarly important DDIs. © 2004 American Pharmacists Association (APhA).
• 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. Annals of Pharmacotherapy, 39(11), 1785-1791.
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  PMID: 16219900;Abstract: BACKGROUND: Inappropriate medication use in patients with heart failure (HF) presents challenges in providing optimal, evidence-based care. OBJECTIVE: To evaluate the incremental differences of concurrent and persistent use of angiotensin-converting enzyme (ACE) inhibitors, β-blockers, loop diuretics, and digoxin on the one-year, all-cause risk of hospitalization and total healthcare costs associated with treatment of HF in patients enrolled in a managed care organization within the US. METHODS: A retrospective database analysis was conducted spanning from January 1, 1997, to December 31, 1999. Multivariate regression methods were used to examine the association between treatment regimens and hospitalizations or costs after controlling for patient demographics and risk factors. RESULTS: Of the 1903 patients meeting inclusion criteria, 32.3% (n = 615) received none of the 4 HF agents studied and were associated with a 2.5 times greater risk (p ≤ 0.001) of hospitalization and 43.6% higher (p ≤ 0.001) total costs compared with all other patients with HF Comparatively, 13.9% (n = 264) utilized the HF medications investigated for at least 6 months. Of those with persistent use of ≥3 agents, approximate decreases in hospitalizations were noted of 80% (p ≤ 0.001) and total costs of 70% (p ≤ 0.001) relative to patients receiving no HF therapy. CONCLUSIONS: A substantial portion of patients with HF may be receiving suboptimal pharmacotherapeutic care in real-world practice settings, potentially incurring large increases in hospitalizations and total costs. Quality improvement initiatives should seek to identify and manage those not being treated according to guideline recommendations.
• 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), 261-270.
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  PMID: 15801997;Abstract: Objective: 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. Study design: Retrospective managed care database analysis. Patients and methods: Subjects included patients within a managed care setting over 18 years of age with an initial diagnosis of community-acquired pneumonia from January 1995 to April 2002. Multivariate linear and logistic regression models were used to examine associations with treatment success rates and direct medical costs between antibiotic treatments after controlling for patient demographics and pneumonia risk factors. Main results: Overall, treatment success rates were high (95.8%), the use of second antibiotics was uncommon (2.3%), and hospitalizations were infrequent (2.0%) among the 1952 subjects studied. After controlling for patient characteristics and risk factors, significantly lower total costs were associated with erythromycin (92.7% lower, p < 0.001), azithromycin (48.7% lower, p < 0.001), and clarithromycin (21.3% lower, p = 0.015) relative to levofloxacin, with no difference in treatment success between groups. Among newer agents, azithromycin (49.2% lower, p < 0.001) and clarithromycin (21.7% lower, p = 0.013) treatment groups were associated with significantly lower total costs than levofloxacin in the full sample. However, in subjects with a chronic disease score above the sample's mean, only azithromycin was associated with significantly lower total costs (47.9% lower, p < 0.001) relative to levofloxacin. Conclusion: Erythromycin, azithromycin, and clarithromycin were associated with significantly lower total costs than levofloxacin, although treatment success rates did not differ between groups. Following stratification based upon various subset criteria, erythromycin and azithromycin were observed to have significantly lower total costs than levofloxacin. Although these findings may augment clinical guidelines and evidence-based approaches, health plans should consider evaluating their own patient data to see if similar differences exist in their populations. © 2005 LIBRAPHARM LIMITED.
• Sullivan, P. W., Valuck, R., Brixner, D. I., & Armstrong, E. P. (2005). A pharmacoeconomic model for making value-based decisions about serotonin reuptake inhibitors. P and T, 30(2), 96-101+104-106.
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  Abstract: Managed care organizations and pharmacy benefit managers often use tiered formularies to contain drug costs. Cost is one factor used to decide tier placement. Drug prices alone may not reflect the true cost of using particular drugs within a class. A decision-analytic model of the serotonin reuptake inhibitor (SRI) class of antidepressants was reviewed. SRIs include selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). The model uses rates of adverse drug reactions (ADRs) and discontinuation rates found in the products' prescribing information, along with other probabilities derived from the literature. The model estimates the overall direct medical costs and cost-effectiveness of SRIs in a managed care setting, taking into account the medical consequences of treatment-emergent ADRs. This paper discusses the context in which the model was constructed and its strengths and weaknesses as a tool for pharmacy and therapeutics (P&T) committees that are faced with the challenge of evaluating new and current drugs in this class.
• Sullivan, P. W., Valuck, R., Brixner, D. I., & Armstrong, E. P. (2005). Managed care's response to a pharmacoeconomic model of serotonin reuptake inhibitors. P and T, 30(3), 178-181.
• Abarca, J., Malone, D. C., Armstrong, E. P., & M., W. (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), 351-357.
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  PMID: 15040648;Abstract: Study Objective. 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. Design. Retrospective medical and pharmacy claims analysis. Patients. One thousand five hundred seventy-three patients with heart failure enrolled in a managed care organization. Measurements and Main Results. Medical and pharmacy claims from January 1, 1997-December 31, 1999, from a managed care organization covering approximately 350,000 individuals were analyzed. Patients aged 35 years or older with a diagnostic code for heart failure and 18 months of continuous eligibility were selected. From this group (1573 patients), two cohorts were selected based on exposure to an ACE inhibitor. Dependent variables of interest were all-cause hospitalization and total direct medical costs during the 12-month study period. A logistic regression model and an ordinary least-squares model adjusting for patient demographics, comorbidities, and concomitant drug therapy were used to analyze the risk of all-cause hospitalization and total direct medical costs, respectively. Therapy with an ACE inhibitor for 180 days was associated with a decreased risk of all-cause hospitalization (odds ratio 0.65, p
• 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), 538-542.
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  PMID: 15548126;Abstract: OBJECTIVE: To describe the dosing of etanercept and infliximab for the treatment of rheumatoid arthritis (RA). METHODS: Adult patients with a diagnosis of RA who were treated with either etanercept or infliximab between 1999 and 2002 were selected from 16 rheumatology practices in the western and southeastern United States. Patients with a terminal illness or those receiving a tumor necrosis factor (TNF)-alpha inhibitor for an indication other than RA were excluded. Data were collected through a review of the patient medical records. Data collected on each patient included demographics, concurrent disease-modifying antirheumatic drug therapy, TNF-alpha inhibitor dose, frequency, duration of TNF-alpha inhibitor therapy, and discontinuation of TNF-alpha inhibitor therapy. RESULTS: A total of 244 patients were included in the evaluation (etanercept only [n=128; 52%], infliximab only [n=89; 36%], both [n=27; 11%]). The mean age of these patients was 55.1+/-13.3 years, 54.9+/-13.5 years, and 52.8+/-14.0 years, respectively; the mean duration of RA was 13.3 +/- 8.8 years, 13.4+/-8.0 years, and 14.0 +/- 9.9 years, respectively. Female patients constituted 70% of the sample. Health maintenance organization insurance was the most common form of medical insurance (45.8%), followed by Medicare (22.3%). The mean duration of follow-up for etanercept and infliximab treatment was 29.3+/-14.1 months and 14.8+/-6.9 months, respectively. Among patients who were still receiving therapy at the time of review, the mean initial and last etanercept doses were 25.0 mg versus 25.8 mg (P=0.16); the mean initial and last infliximab doses were 3.38 mg/kg versus 4.51 mg/kg (P
• Abarca, J., Malone, D. C., Armstrong, E. P., Grizzle, A. J., Hansten, P. D., C., R., & Lipton, R. B. (2004). Concordance of severity ratings provided in four drug interaction compendia. Journal of the American Pharmacists Association, 44(2), 136-141.
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  PMID: 15098847;Abstract: Objective: To evaluate the agreement among drug-drug interaction (DDI) compendia as to designation of interactions as having the greatest clinical importance ("major" DDIs). Design: Cross-sectional, one-time evaluation. Setting: United States in fall 2001. Participants: Not applicable. Interventions: Major DDIs involving prescription medications likely to be dispensed in the community and ambulatory pharmacy settings were identified as listed in four compendia that provide specific, detailed information about DDIs (Drug Interaction Facts, Drug Interactions: Analysis and Management, Evaluations of Drug Interactions, and the MicroMedex DRUG-REAX program). Main Outcome Measure: Level of agreement between DDI compendia as assessed by the intraclass correlation coefficient (ICC). Results: Overall, 406 major DDIs were listed in one or more of the four compendia. Only 9 (2.2%) of these major DDIs were listed in all four compendia; in fact, the majority of interactions were listed in only one compendium (291 DDIs, 71.7%), despite these interactions being considered of greatest clinical relevance by at least one compendium. The ICC among the compendia was -0.092, indicating low agreement on the classification of major DDIs. Conclusion: Little agreement exists among commonly used drug interaction compendia for DDIs that were classified in fall 2001 as having the highest clinical relevance and importance. A concerted effort to identify DDIs of the highest clinical importance is needed to design effective strategies to avoid and manage them.
• Adams, R. J., Armstrong, E. P., & Erstad, B. L. (2004). Prescribing and self-administration of morphine in Hispanic and non-Hispanic Caucasian patients treated with patient-controlled analgesia. Journal of Pain and Palliative Care Pharmacotherapy, 18(2), 29-38.
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  PMID: 15257973;Abstract: The purpose of this study was to determine whether differences in either prescribing or self-administration of morphine exist between Hispanic and White (Caucasian) post-operative patients treated with patient-controlled analgesia (PCA). A review of the medical records of 30 Hispanic and 30 White patients who received postoperative PCA was conducted. Both prescribed and self-administered morphine were analyzed using a two-sided, two-sample Student's t-test. No differences in the amount of morphine prescribed (11.23 ± 3.22 mg/hr in Hispanic patients, 11.05 ± 4.28 mg/hr in White patients; p = 0.8503) or self-administered (2.58 ± 2.02 mg/hr in Hispanic patients, 3.32 ± 3.00 mg/hr in White patients; p = 0.2711) were discovered. This study identified no statistically significant difference in either opioid prescribing or self-administration between Hispanic and White post-operative patients. © 2004 by The Haworth Press, Inc. All rights reserved.
• Armstrong, E. P., & Charland, S. L. (2004). Burden of illness of hepatitis C from a managed care organization perspective. Current Medical Research and Opinion, 20(5), 671-679.
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  PMID: 15140332;Abstract: Objectives: The objectives of this study were to: (1) determine the total hepatitis C virus (HCV)-related and total healthcare costs (HCV plus other co-morbidities) of patients with HCV in a managed care organization; (2) determine total healthcare costs of HCV patients with and without a human immunodeficiency virus (HIV) infection as a co-morbidity. Methods: The study design was a retrospective analysis of a medical and pharmacy claims database of patients diagnosed with HCV in a 325 000 member managed care organization. Patients diagnosed with HCV and 12 months of continuous eligibility in the managed care organization from January 1997 through December 1999 were included in the study. The main outcome measures of the study were the total healthcare costs and HCV-related healthcare costs and the impact of HIV as a co-morbidity on these costs. Results: The study identified 614 patients meeting the inclusion criteria. The study population was 58% male and had a mean age of 46 (± 10.6)years. In patients receiving interferon-α, their median total healthcare costs exceeded $4600 and the median HCV-related costs exceeded $2470. The total healthcare costs of HCV patients with HIV as a co-morbidity were significantly larger than patients without this co-morbidity. Conclusion: HCV represents a very important disease to managed care organizations. Patients with this disease require costly drug therapies and consume significant health care resources. Additional research is needed to more fully characterize future clinical and economic outcomes as new agents become available.
• Armstrong, E. P., M, W., & Malone, D. C. (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), 251-258.
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  PMID: 15228376;Abstract: OBJECTIVE: 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. METHODS: A decision-analytic model compared the cost-effectiveness of simvastatin and lovastatin/extended-release niacin. The perspective of the analysis was that of a health system. Product labeling was used to determine changes in cholesterol concentrations and frequencies of clinically important adverse events. The Third National Health and Nutrition Examination Survey (NHANES III) adult data were used for baseline cholesterol levels. Each product was titrated to achieve LDL and HDL goals unless an adverse effect occurred. Direct medical costs were determined for each treatment to determine cost-effectiveness. RESULTS: For both the 130 mg/dL and 100 mg/dL LDL goal analyses (and HDL e40 mg/dL), lovastatin/extended-release niacin had higher success rates and lower estimated direct-medical costs than simvastatin. Simvastatin had the highest success rate in achieving LDL level
• Kopp, B. J., Nix, D. E., & Armstrong, E. P. (2004). Clinical and economic analysis of methicillin-susceptible and -resistant Staphylococcus aureus infections. Annals of Pharmacotherapy, 38(9), 1377-1382.
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  PMID: 15266044;Abstract: BACKGROUND: The rate of methicillin-resistant Staphylococcus aureus (MRSA) has increased significantly over the last decade. Previous cohort studies of patients with MRSA bacteremia have reported higher mortality rates, increased morbidity, longer hospital length of stay (LOS), and higher costs compared with patients with methicillin-susceptible S. aureus (MSSA) bacteremia. The clinical and economic impact of MRSA involving other sites of infection has not been well characterized. OBJECTIVE: To determine the clinical and economic implications of MRSA compared with MSSA infections across a variety of infection sites and severity of illnesses. METHODS: A retrospective, case-control analysis comparing differences in clinical and economic outcomes of patients with MRSA and MSSA infections was conducted at an academic medical center. Case patients with MRSA infection were matched (1:1 ratio) to control patients with MSSA infection according to age, site of infection, and type of care. RESULTS: Thirty-six matched pairs of patients with S. aureus infection were identified. Baseline characteristics of patients with MSSA and MRSA infection were similar. Patients with MRSA infections had a trend toward longer hospital LOS (15.5 vs 11 days; p = 0.05) and longer antibiotic-related LOS (10 vs 7 days; p = 0.003). Median hospital cost associated with treatment of patients with MRSA infections was higher compared with patients with MSSA infections ($16 575 vs $12 862; p = 0.11); however, this difference was not statistically significant. Treatment failure was common in patients with MRSA infection. Among patients with MSSA infections, treatment failure was associated with vancomycin use. CONCLUSIONS: Patients with MRSA infections had worse clinical and economic outcomes compared with patients with MSSA infections.
• Malone, D. C., Abarca, J., Hansten, P. D., Grizzle, A. J., Armstrong, E. P., C., R., Duncan-Edgar, B. S., Solomon, S. L., & Lipton, R. B. (2004). Identification of serious drug-drug interactions: Results of the partnership to prevent drug-drug interactions. Journal of the American Pharmacists Association, 44(2), 142-151.
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  PMID: 15098848;Abstract: Objective: To develop a list of clinically important drug-drug interactions (DDIs) likely to be encountered in community and ambulatory pharmacy settings and detected by a computerized pharmacy system. Design: Cross-sectional, one-time evaluation. Setting: United States in fall 2001. Participants: An expert panel comprising two physicians, two clinical pharmacists, and an expert on DDIs. Interventions: Systematic review of drug interaction compendia and published literature, ratings (on a 1 to 10 scale) of various clinical aspects of DDIs (e.g., clinical importance, quality and quantity of evidence, causal relationship, risk of morbidity and mortality), and a modified Delphi consensus-building process. Main Outcome Measure: Panelists' opinions about clinical importance of DDIs. Results: The expert panel considered 56 DDIs. Of these, 28 had a mean clinical importance score of 8.0 or more. The ratings for clinical importance ranged from 3.2 to 9.6, with a mean ± SD of 7.5 ± 1.5 across the combinations examined. The mean score for the quality of literature suggesting the interaction exists ranged from 1.0 to 9.6, with a mean ± SD of 5.8 ± 2.5. In terms of substantiation of the interactions evaluated, the mean ± SD rating was 6.3 ± 2.2, with a range from 1.4 to 9.2. Through the modified Delphi process, the panel determined that 25 interactions were clinically important. Conclusion: Using an expert panel and a standard evaluation tool, 25 clinically important drug interactions that are likely to occur in the community and ambulatory pharmacy settings were identified. Pharmacists should take steps to prevent patients from receiving these interacting medications, and computer software vendors should focus interaction alerts on these and similarly important DDIs.
• Armstrong, E. P. (2003). Antidepressant treatment patterns and success rates in a managed care organization. Disease Management and Health Outcomes, 11(3), 173-180.
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  Abstract: Objective: The purpose of this study was to evaluate the treatment patterns and success rates with antidepressants utilized by patients in a managed care organization (MCO). Methods: Data were extrapolated from a claims database from an MCO with 225 000 members. Treatment patterns were determined by creating episodes of care for each patient. Successful treatment was defined as a therapeutic dose for at least 180 days of continuous therapy. Success rates were stratified by the type of antidepressant used. Depression-related and total healthcare costs were analyzed in relation to whether a patient's treatment was successful. Results: A minority of patients received continuous therapeutic doses for 180 days for their first treatment episode (26.5%) or all treatment episodes of depression (32.9%). Monotherapy was the most common treatment pattern. Treatment with a selective serotonin reuptake inhibitor (SSRI) was associated with a significantly higher success rate than treatment with a tricyclic antidepressant (TCA), in patients with depression (36.6 vs 13.3%). In patients with depression who were receiving SSRIs, the success rates were 37.2% with fluoxetine, 36.2% with paroxetine, and 36.1% with sertraline; there were no significant differences in the success rates among the SSRIs. Patients completing a successful treatment episode were associated with higher pharmacy, depression-related, and total healthcare costs. Conclusions: Only a minority of patients with depression attained a satisfactory treatment episode with their antidepressant therapy. SSRI therapy was associated with a significantly higher success rate than TCAs. Although monotherapy regimens were the most commonly used treatment strategy, the multivariate analysis reveals that multiple regimen changes (defined as complex in this analysis) may be required to achieve successful treatment. Physicians and MCOs need to monitor patients and be open to necessary regimen changes. Physicians and MCOs must also work together to develop improved strategies to monitor and detect patients with depression who do not comply with their antidepressant regimen.
• 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), 1-18.
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  PMID: 12637109;Abstract: Background: Both nonselective and selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to increase blood pressure (BP). Objective: This review summarizes the most recent data regarding the BP changes that may occur with routine dosing of nonselective or selective NSAIDs, with a focus on the latter. The review includes both clinical trials and studies having more naturalistic designs. Methods: Relevant articles were identified through a search of MEDLINE emphasizing NSAIDs and hypertension. Results: It is well established that NSAIDs increase BP in certain patients. Patients with existing hypertension seem to be at greatest risk for this adverse event. There seem to be differences between nonselective NSAIDs with regard to their effect on BP; indomethacin, naproxen, and piroxicam have been associated with clinically significant changes in BP. Most of the available evidence concerning the selective NSAIDs suggests that rofecoxib is more likely than celecoxib to raise systolic BP. Based on the results of trials in the treatment of BP, increases in systolic BP produced by these NSAIDs may be associated with significant morbidity and mortality. The adverse effects of NSAIDs on BP may be related to the specific drug or to the dose or duration of therapy, as well as to patient-specific characteristics. Conclusions: Clinically significant BP changes may occur after treatment with either nonselective or selective NSAIDs. The observed BP changes are not the same for ali products, however. Copyright © 2003 Excerpta Medica, Inc.
• Armstrong, E. R., Goodman, N. M., & M., W. (2003). Community Pharmacists' Opinions about Having Diagnostic Data Provided with Prescriptions. Journal of Pharmacy Practice, 16(5), 361-365.
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  Abstract: Objectives. To determine if community pharmacists felt that diagnostic information provided with prescriptions would (1) help provide pharmaceutical care, (2) help reduce dispensing errors, and (3) violate patient confidentiality. Methods. A mail questionnaire was distributed to 200 metropolitan community pharmacists in Arizona. The questionnaire consisted of 14 opinion statements and 6 demographic items. Results. A total of 75 usable questionnaires were returned (a 38.5% response rate). Pharmacists agreed that they were responsible for providing pharmaceutical care and that diagnostic data would help them provide this care. Pharmacists believed that receiving diagnostic data with prescriptions would help reduce dispensing errors, help them counsel patients, and help them abide by state and federal laws. Pharmacists felt that diagnostic data would not violate patient confidentiality. The majority of pharmacists (73.6%) believed that the indication for prescribing a medication was the most important information that could be included on a prescription. Conclusion. Overall, community pharmacists had positive perceptions of the value of diagnostic data being provided with prescriptions. Additional research is needed to evaluate how providing this important information will affect other members of health care teams.
• Lai, L. K., Armstrong, E. P., Salcido, A. L., French, R., & Skrepnek, G. H. (2003). Women's Perception of Bone-Mineral Density Testing and Osteoporosis Education in the Community Pharmacy. Consultant Pharmacist, 18(11), 968-976.
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  PMID: 16563068;Abstract: Objective: The objective of this study was to assess women's level of acceptance and attitudes toward bone-mineral density (BMD) testing and osteoporosis education in the community pharmacy. Design: The study design was a questionnaire with 13 statements using a five-point scale anchored from "strongly disagree" to "strongly agree." The statements focused an the value and comfort level of BMD testing in a pharmacy, confidence in pharmacists, osteoporosis education in the pharmacy, and payment for such services. One-sample t-tests were used to assess whether the responses statistically differed from the midpoint scale value. Comparisons also were made between demographic characteristics (education level, family history of osteoporosis, and daily calcium intake). Setting: An independently owned grocery store chain (Bashas') in the Phoenix, and Tucson, Arizona, metropolitan areas. Patients: The survey was administered to women upon completion of a BMD screening. Main Outcome Measures: Responses to 13 statements and demographic questions. Results: Eighty women completed the survey. Women strongly agreed that BMD testing in community pharmacies was valuable and that it would increase the public's awareness of osteoporosis. For all 13 statements, respondents strongly agreed or agreed with the importance and role of BMD testing. All responses were statistically significantly greater than the midpoint scale value (P0.05). Conclusions: These women's opinions suggest that BMD testing has a useful role in community pharmacies.
• Olson, B. M., Armstrong, E. P., Grizzle, A. J., & Nichter, M. A. (2003). Industry's perception of presenting pharmacoeconomic models to managed care organizations.. Journal of managed care pharmacy : JMCP, 9(2), 159-167.
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  PMID: 14613345;Abstract: BACKGROUND: Previous research has shown that pharmacoeconomic (PE) data are considered important but may not be optimally utilized by decision makers. No research has compared the effectiveness of different types of PE models. OBJECTIVES: The purpose of this study was to examine the perceived value and understanding of PE models among decision makers in managed care organizations. The perspective of this study was from research scientists working in the pharmaceutical industry who present PE models to managed care clients. The study objectives were to (1) examine what types of models are best received by decision makers, (2) investigate the barriers to using PE models, and (3) recommend methods for improving PE models. METHODS: A telephone survey of 39 items was conducted with 20 PE research scientists from various U.S. pharmaceutical and biotechnology companies. Topics addressed included factors contributing to how well PE models are received, barriers to using PE models, and recommendations for improving PE models. RESULTS: Models have an impact on health policy decision making. Nineteen of 20 respondents had at least one experience where a PE model played a role in optimizing the formulary positioning of a product. No single model format (e.g., decision analytic tools, spreadsheet analyses, Markov models, multivariate regression models) was regarded as the most effective model type. Although 7 of 20 respondents said simple spreadsheet models were most effective, well-designed, scientifically sound regression models were also reported to be very effective. CONCLUSIONS: The respondents commonly used models to share PE information, which was said to play a role in making health policy decisions by decision makers in managed care. There was no consensus regarding the type of model that was most effective. Study participants indicated that a variety of model designs are effective, ranging from simple spreadsheet models to multivariate regression models. Recommendations for improving PE models include (1) producing scientifically sound models, (2) customizing models where possible, (3) making models transparent, (4) making models user friendly, and (5) involving a nonbiased third party for model development.
• Armstrong, E. (2002). Newer drugs and overall costs of treating onychomycosis. Revista iberoamericana de micología, 19(3).
• 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 I), 1117-1123.
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  PMID: 12222547;Abstract: Study Objective. 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. Design. Retrospective quasi-experimental comparison. Setting. Managed care organization with approximately 350,000 enrollees. Patients. Three hundred forty-seven patients with asthma who received at least two prescriptions for either fluticasone or a leukotriene modifier. Patients receiving both fluticasone and a leukotriene modifier were excluded. Measurements and Main Results. Multivariate analysis was used to compare total asthma-related costs between treatment groups. A significant difference in total asthma-related costs was found between patients receiving fluticasone (adjusted mean cost $511) compared with those receiving a leukotriene modifier ($1092; p=0.0001). Other significant predictors of postindex asthma-related costs were pre-index asthma-related costs, a severity adjustment score, and the diagnosis of chronic obstructive pulmonary disease. Patients taking a leukotriene modifier obtained more short-acting β-agonists than patients receiving fluticasone (6.49 ± 4.05 vs 4.30 ± 3.41, p
• Joish, V. N., & Armstrong, E. P. (2002). Newer drugs and overall costs of treating onychomycosis. Revista Iberoamericana de Micologia, 19(3), 130-132.
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  PMID: 12825989;
• Abarca, J., & Armstrong, E. P. (2001). Improving the use of data sources in disease management programs. Disease Management and Health Outcomes, 9(9), 459-471.
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  Abstract: Disease management has become an increasingly popular tool used to manage people with chronic diseases in managed care organizations. The implementation of these programs, coupled with pressures to document quality and control costs, has increased the need for information regarding the health services provided to patients. This paper gives an overview of selected topics involved in data collection, including medical record review, databases, automated systems, and disease management software. The preliminary uses of the Internet and wireless technology are also discussed. Efficient data collection requires the identification of pertinent information from clinical, patient-reported, and economic data. Several sources provide this. The medical record is considered the gold standard for providing clinical information. However, collecting this data can be time consuming and expensive. Claims that databases have gained popularity for their comprehensiveness and accessibility are eroded by the lack of detailed clinical information. Direct communication with patients via telephone is commonly used in disease management programs, but its effectiveness as a data collection tool is not well documented. The use of the Internet and wireless technology in data collection is an exciting opportunity, since it provides interactive access between providers, patients, and the managed care organization. In most cases, a combination of data sources will be required to collect all the necessary information. However, claims databases, medical chart review, and telephone interviews are the backbone of data collection in disease management. The computerization of medical information systems, and use of the Internet and wireless technologies, should facilitate future data collection.
• Armstrong, E. P. (2001). Analysis of antidepressant use through hierarchical disease analysis using a managed care administrative database. Disease Management and Health Outcomes, 9(5), 255-267.
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  Abstract: Objective: The purpose of this study was to evaluate the use of antidepressants through use of mutually exclusive disease indications using a managed care database. Design and setting: A claims database from a 225 000 member managed care organisation was used for the study. A hierarchy of mutually exclusive antidepressant indications was developed: 'Depression', 'Other Approved Indication', 'Mental Health', 'Surrogate Diagnosis', 'Other Uses', 'Chronic Disease', and a residual 'Unclassified' hierarchical indication group. Main outcome measures and results: Patients in the Depression and Other Approved Indication hierarchical groups likely received the antidepressant drugs primarily for these indications and frequently received selective serotonin reuptake inhibitors (SSRIs). Use of antidepressants in the Mental Health Disorders hierarchical group may have been for a related disease. The patients in the Surrogate Diagnosis, Other Uses, Chronic Diseases, and Unclassified hierarchical groups were significantly older than those patients in the Depression group and tricyclic antidepressant (TCA) use was more frequent than the SSRIs. The patients in the Unclassified diagnosis group may represent antidepressant use that is not adequately documented or not indicated. The Surrogate Diagnosis and Chronic Diseases hierarchical groups total healthcare costs were significantly higher than those observed in patients with a Depression diagnosis. Conclusions: Use of mutually exclusive hierarchical diagnosis groups proved to be a useful strategy for assessing antidepressant drug use. SSRI use was more common in the Depression and Other Approved Indication hierarchical groups. Patients in the Surrogate Diagnosis, Other Uses, Chronic Diseases, and Unclassified hierarchical groups used TCAs more frequently.
• Armstrong, E. P. (2001). Clinical and economic outcomes of an ambulatory urinary tract infection disease management program. American Journal of Managed Care, 7(3), 269-280.
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  PMID: 11258144;Abstract: Objective: To evaluate the effectiveness of a urinary tract infection disease management program. Study design: A pre-post design was used. One year of data before and after promoting the treatment guideline were compared. Participants and methods: A 300,000-member managed care organization introduced an antibiotic treatment guideline designed to change the antibiotic prescribing practices of community physicians. The study intervention was the promotion of a treatment guideline through mailings and face-to-face interventions by 2 disease management specialists. A relational database was created to measure changes in health-care resources, use of antibiotics, and health event profiles. Results: The study demonstrated that prescribing patterns could be modified through treatment guideline distribution and face-to-face discussions. The study also found similar success rates across a range of antibiotics. Average health event costs decreased by 36% for kidney infections (P = .696) and by 7% for bladder infections (P < .05) after the treatment guideline was implemented; however, when controlling for patient age, sex, and comorbidities, the econometric model did not find a reduction in health event costs for either kidney or bladder infections. Fluoroquinolones were a cost driver compared with other antibiotics used to treat kidney and bladder infections. Conclusions: Considerations should be given to expanding the number of well-established antibiotics on the treatment guideline. Also, fluoroquinolones should be reserved for patients with sulfa allergies or failures with initial antibiotic treatment. In addition, it is recommended that future costs and outcomes be assessed after changes are made to the treatment guideline.
• Armstrong, E. P., & Abarca, J. (2001). An examination of the relationship between non-depression-related costs and uninterrupted Tx. Formulary, 36(6), 461-468.
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  Abstract: Depression is an important disease for many managed care organizations and can be one of the largest cost drivers in their drug budget. A number of studies have focused on the cost impact of anti-depressant treatment. One previously published study showed that significant savings in office-based service costs was likely in patients who completed at least 6 months of antidepressant therapy. The purpose of this study was to determine if these results could be replicated in another managed care population. The methodology from the previously published study was adopted as a framework for this analysis. No analyses in the current study demonstrated that uninterrupted antidepressant treatment was associated with a large reduction in non-depression-related costs.
• Armstrong, E. P., Abarca, J., & Grizzle, A. J. (2001). The role of pharmacoeconomic information from the pharmaceutical industry perspective. Drug Benefit Trends, 13(3), 39-45.
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  Abstract: The purpose of this study was to determine the factors that pharmaceutical industry representatives believe are important in the drug benefit decisions of MCOs. Respondents indicated that a drug's clinical features and acquisition cost were the most important factors in making drug-coverage decisions. Ninety percent of respondents indicated that they provide some type of pharmacoeconomic data on either some or almost every visit with their customers. Twenty (95%) of 21 respondents thought that current pharmacoeconomic information was helpful to MCOs in making drug benefit decisions. However, 80% thought important barriers existed to using health outcome and pharmacoeconomic data.
• Armstrong, E. P., Krueger, K., & Langley, P. C. (2001). Analysis of asthma-related costs and patterns of resource utilization in a managed-care population. Disease Management and Health Outcomes, 9(3), 161-171.
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  Abstract: Objectives: To identify the asthma prevalence rate, the total healthcare and asthma-related treatment costs, and the medical and pharmacy costs associated with different asthma medication usage patterns in a managed-care organisation (MCO). Study design and participants: The medical and pharmacy claims databases from a 40 000 member MCO were used. The medical claims database was searched from 1994 to 1996 for patients having at least one asthma medical claim in either the first or second diagnosis field of the medical claims, and the total healthcare and asthma-related costs were determined. A subpopulation with a more restrictive asthma definition was identified and their costs were also determined. In addition, the patterns of drug treatment were identified. Study perspective: MCO perspective. Results: The mean total healthcare cost of caring for patients with asthma was significant and approximately twice the mean cost of all patients enrolled in the MCO. Using a broad definition of asthma, the mean (±standard deviation) annual total per patient healthcare cost was $US2511±7314 and the annual asthma-related cost was $US679±2247 (1996 values). Using a more restrictive definition of asthma, the mean annual total per patient healthcare cost was $US2653±5268 and the asthma-related cost was $1026±2447. There appeared to be a low overall use of asthma medications, especially anti-inflammatory formulations;
• Armstrong, E. P., Patrick, K. L., & Erstad, B. L. (2001). Comparison of preoperative skin preparation products. Pharmacotherapy, 21(3 I), 345-350.
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  PMID: 11253858;Abstract: We compared application, drying, and removal times as well as user satisfaction of four preoperative skin preparation products. All products were applied to 25 subjects, allowed to dry, and removed. Operating room personnel who applied the products were asked to complete a user-satisfaction survey. Application and drying times were longest with the povidone iodine paint and scrub product (p
• Joish, V. N., & Armstrong, E. P. (2001). Which Antifungal Agent for Onychomycosis? A Pharmacoeconomic Analysis. PharmacoEconomics, 19(10), 983-1002.
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  PMID: 11735669;Abstract: The incidence of fungal nail infections is increasing and this is possibly because of several factors: better methods of detection, a growing population of immunocompromised patients who have a greater susceptibility to such infections, the increased use of immunosuppressive drugs, the increasing number of elderly people, worldwide travel, and the use of communal bathing facilities. Onychomycosis is a fungal infection of the fingernails and toenails that accounts for about 30% of all superficial fungal infections. It is characterised by nail discoloration, thickening and ultimately destruction of the nail plate. Management of this disease has improved significantly and treatment patterns have dramatically changed in recent years as a result of advances in new treatment options (e.g. oral antifungal agents) and changes in treatment regimens (e.g. pulse therapy). Also, newer drugs for onychomycosis have improved tolerability profiles compared with older agents. The overall costs of treating onychomycosis are substantial, and it has been estimated that direct cost for US Medicare patients with the disease is $US43 million per year (year of costing not available). Pharmacoeconomic studies help in the decision-making process when selecting the most cost-effective antifungal agents to treat onychomycosis. To date there have been a number of national and international economic studies aimed at effectively assessing the efficacy and costs of the treatment options available to cure onychomycosis. The objectives of this paper are to (i) review the published findings regarding the epidemiology of onychomycosis; (ii) summarise the original pharmacoeconomic studies that describe the economic impact of the disease; and (iii) address the impact of the disease on patients' health-related quality of life.
• Joish, V. N., Limcangco, M. R., & Armstrong, E. P. (2001). Cost-benefit analysis of a pharmacist-advocated pneumococcal vaccination program. Formulary, 36(2), 147-156.
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  Abstract: Pharmacists are increasingly taking on immunization roles in their communities as advocates, facilitators, and immunizers. Between 50% and 94% of people who receive a pharmacist's recommendation to be immunized accept that recommendation. Pneumococcal diseases impose a heavy burden on the health of adults in developed and developing countries. There are sound reasons for believing that much of this burden could be reduced by widespread use of the current pneumococcal vaccine. This month's column presents a cost-benefit analysis, using both published and hypothetical figures, to compare a traditional pneumococcal vaccination program with one that uses pharmacists as advocates for pneumococcal vaccination.
• Krueger, K. P., Armstrong, E. P., & Langley, P. C. (2001). The accuracy of asthma and respiratory disease diagnostic codes in a managed care medical claims database. Disease Management, 4(4), 155-161.
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  Abstract: Asthma database research is being conducted by many managed care organizations (MCOs) without knowing the accuracy of the diagnostic codes. The purpose of this study was to assess the accuracy of asthma and respiratory disease diagnostic codes by comparing the medical claims database to the medical record. Two groups were identified from the medical claims database of a 300,000-member MCO. The asthma group included patients with a medical claim containing an asthma ICD-9-CM code filed between August 1994 and July 1995. The respiratory group included patients with at least one claim containing an ICD-9-CM code for respiratory conditions other than asthma. The ICD-9-CM code from the medical claims database was compared to the diagnosis reported in the medical record. Criteria were used to classify the level of agreement of ICD-9-CM codes with the medical record. A random sample of 300 patients was chosen, for a total of 1,337 claims. Medical records were available for 217 patients, providing 616 claims available for analysis. Seventy percent of the claims contained one of the ICD-9-CM codes being studied, and 25% contained two codes. The diagnostic codes contained in 85.4% of all claims were in moderate to complete agreement with the medical record. Four percent of the claims were not in agreement with the medical record. The level of agreement for 10% of the claims could not be determined. Asthma ICD-9-CM codes found in a managed care medical claims database are reasonably accurate and quite adequate for research purposes and disease management monitoring.
• Malone, D. C., & Armstrong, E. P. (2001). Economic burden of asthma: Implications for outcomes and cost-effectiveness analyses. Expert Review of Pharmacoeconomics and Outcomes Research, 1(2), 177-186.
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  PMID: 19807405;Abstract: 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 $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 $1100. 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.
• Olson, B. M., Malone, D. C., & Armstrong, E. P. (2001). Modeling the cost-effectiveness of doubling atorvastatin's dose versus adding niacin ER. Formulary, 36(10), 730-746.
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  Abstract: Decision-analytic models are useful tools that are helpful in making formulary decisions and comparing treatment pathways, especially when a level of uncertainty exists as to which clinical strategy is most appropriate for patients with a given health state. The purpose of this article is to provide an example of how a decision-analysis model is designed and interpreted for the treatment of coronary heart disease (CHD). A step-by-step approach to conducting decision analysis is presented so that readers can apply this technique in their own practice settings.
• Poulios, N. S., Song, J., Ackermann, S. P., Armstrong, E. P., Khan, Z. M., Perry, A. S., & Perri, L. R. (2001). Zanamivir vs Oseltamivir: Which drug is more cost-effective?. Formulary, 36(5), 383-384+387.
• Abarca, J., & Armstrong, E. P. (2000). How to use multiple logistic regression in retrospective database analyses. Formulary, 35(10), 832-841.
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  Abstract: Accurately measuring the effectiveness of medical or pharmacological interventions is essential in economic evaluations. Many economic evaluations are performed retrospectively using medical and pharmacy claims databases. A challenge to using this approach is that variation in treatment patterns prevents simple comparisons between patient groups. Multiple logistic regression is a powerful technique that can overcome this challenge and is suited for evaluating dichotomous outcomes (eg, disease/no disease). An example is presented that applies multiple logistic regression to determine the impact of different drug therapies on hospitalization risk for heart failure among patient with congestive heart failure.
• Armstrong, E. P., & Abarca, J. (2000). Pharmacoeconomic model to evaluate new influenza treatments. Formulary, 35(2), 169-181.
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  Abstract: Zanamivir and oseltamivir are two agents of a new class of drugs - neuraminidase inhibitors - to receive FDA approval for the treatment of influenza. Because the two agents are more expensive yet have a more favorable side effect profile than the older treatments amantadine and rimantidine, coverage decisions can be difficult to make. This month's column presents a decision-analytic model of influenza treatments, using zanamivir as the main example. This approach is helpful for health care systems that wish to assess clinical and economic outcomes to make informed decisions between competing products.
• Armstrong, E. P., & Cherrick, R. E. (2000). Epoetin alfa drug use evaluation using a software system: Lessons learned. Disease Management and Health Outcomes, 8(5), 287-295.
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  Abstract: Objective: To assess the utility of using a computer software program to determine whether epoetin alfa therapy drug use evaluation (DUE) criteria were met. Study design: Computer software was designed to allow pharmacists to enter patient data such as haematocrit results and iron stores into a database, DUE data were collected upon entry into the study (through medical record review), at 6 months and at 12 months after enrollment for both the treatment and control groups (see Interventions section). The analyses of the 6- and 12-month DUE process and outcome criteria were conducted through an automated algorithm that was part of the software. The DUE evaluation was collected as part of a randomised, prospective, controlled study conducted at 32 sites across the US. Interventions: At least 1 pharmacist at each study site completed a 4-day training session on end-stage renal disease and haemodialysis treatment, principles of anaemia management, use of an epoetin alfa software program, and review of specific DUE criteria. The treatment group consisted of patients managed by a trained pharmacist working in collaboration with a nephrologist being responsible for monitoring, evaluating and recommending epoetin alfa dosage regimens for patients. The control group consisted of patients for whom pharmacists monitored and collected haematocrit data but did not recommend therapy to the nephrologists. Main outcome measures and results: There were no statistically significant differences between patients in both the treatment and control groups with regard to the DUE results. However, the study demonstrated that computer databases can assist in determining whether specific DUE criteria have been met at multiple patient care sites. The computer software applied the same consistent methodology across a broad range of hospital practice sites and thus may have minimised investigator bias or site to site variations in criteria application. Conclusions: Future DUE software algorithms should allow investigators/pharmacists to adjust important parameters such as the criterion threshold, time period of monitoring, ability to code 'excused' gaps in data and flexibility to modify criterion parameters.
• Armstrong, E. P., & Chrischilles, E. A. (2000). Electronic prescribing and monitoring are needed to improve drug use. Archives of Internal Medicine, 160(18), 2713-2714.
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  PMID: 11025780;
• Armstrong, E. P., Khan, Z. M., Perry, A. S., Hons, M. A., & Perri, L. R. (2000). The cost effectiveness of zanamivir and oseltamivir for influenza treatment. Formulary, 35(12), 979-989.
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  Abstract: In this month's column, the authors evaluate the cost effectiveness of oseltamivir and zanamivir, compared with standard care, for the treatment of influenza. Using efficacy data from randomized, placebo-controlled clinical trials, a cost-effectiveness model was constructed. In an influenza-positive patient population, the cost per symptom free day was $16 for zanamivir-treated patients compared with $39 for oseltamivir-treated patients. Considering a hypothetical drug budget of $100,000, 919 additional patients could be treated with zanamivir than with oseltamivir. Treatment with zanamivir would result in a gain of 1,714 symptom-free days and 52 fewer influenza-related complications than if oseltamivir were used.
• Joish, V. N., & Armstrong, E. P. (2000). Use of decision analysis in modeling the cost-effectiveness of oral vs SC sumatriptan. Formulary, 35(6), 532-539.
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  Abstract: Sumatriptan products have been shown to be effective agents in treating migraine headaches. This month's column presents a cost-effectiveness analysis of two different formulations of sumatriptan using a decision-tree approach. The analysis introduces a new concept, rank-order stability analysis (ROSA), in assessing the sensitivity of a decision-tree model. The ROSA showed that the results of the cost-effectiveness analysis were elastic to variation in the primary clinical efficacy measure. However, because the incremental cost-effectiveness ratio was not large, most health care organizations will likely want to make both sumatriptan products available.
• Malone, D. C., Armstrong, E. P., & Grizzle, A. J. (2000). Cost-effectiveness analysis of interferon α-2b with ribavirin for chronic hepatitis C infection. Formulary, 35(8), 681-689.
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  Abstract: Hepatitis C infection is often referred to as the 'silent epidemic' because so many persons are unaware they are infected with the virus. Interferon α (IFN) has been the mainstay treatment for hepatitis C, but IFN monotherapy generally does not result in sustained normalization of serum alanine aminotransferase. Recently, combination therapy with IFN plus ribavirin has been shown to increase therapeutic response, but at a substantial increase in drug acquisition costs. This article provides a critique of a recently published economic analysis comparing IFN and ribavirin combination therapy with IFN monotherapy.
• Motheral, B. R., Grizzle, A. J., Armstrong, E. P., Cox, E., & Fairman, K. (2000). Role of pharmacoeconomics in drug benefit decision-making: Results of a survey. Formulary, 35(5), 412-421.
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  Abstract: The ultimate measure of the value of pharmacoeconomic data is determining whether and how this information is being used in drug benefit decision-making activities. This survey of formulary readers in managed care settings identifies their use of and views toward pharmacoeconomic studies, preferences for various types and sources of pharmacoeconomic information, and impact of such information on the actual drug benefit decision-making process. Among the interesting findings - published pharmacoeconomic studies showing short-term medical savings were rated the most important to drug benefit decision-making; unsolicited pharmacoeconomic information was deemed just as important as solicited information; and more changes still need to be made in the ways pharmacoeconomic studies are conducted and distributed to make the results more applicable to users' needs.
• Armstrong, E. P. (1999). Critical evaluation of a decision-analytic model of major depression treatment. Formulary, 34(8), 683-687.
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  Abstract: Antidepressants are typically one of the most costly drug classes in the drug budget. Due to the higher costs of many of the newer antidepressants, a number of studies have been conducted to evaluate the clinical and cost aspects of depression treatment. The purpose of this month's Practical Pharmacoeconomics column is to assist readers in interpreting a cost- effectiveness evaluation of antidepressant drugs that used a decision tree model to assess the treatment of major depression.
• Armstrong, E. P. (1999). Disease management: State of the art and future directions. Clinical Therapeutics, 21(3), 593-609.
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  PMID: 10321425;Abstract: Disease management (DM) programs have become common in health systems, especially in managed care organizations and hospitals. These programs are designed to improve both the quality of care and the efficiency of health care delivery. However, there may be controversy about the most important outcomes to consider. Furthermore, the effectiveness of DM initiatives is largely undocumented in the literature. The purpose of this paper is to review the issues, methods, and outcomes involved in creating and instituting DM programs. To improve DM efforts within health systems, constructive relationships with practitioners need to be built by involving important individuals early in the process. It is hoped that evidence-based guidelines will further enhance DM efforts. Beneficial DM initiatives require a multidisciplinary focus of cooperation and willingness to share data between distinct professional groups. More thorough analysis of DM programs is needed in many health systems.
• Armstrong, E. P. (1999). Evaluating low molecular weight heparins within a health system: Issues and strategies. Formulary, 34(2), 144-148.
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  Abstract: Health organizations interested in designing an outcomes or pharmacoeconomic study on the low molecular weight heparins (LMWHs) first need to clearly define the study questions they wish to answer, which may vary based on study perspective and organizational setting. Important clinical endpoints to assess include development of pulmonary emboli, recurrent thrombosis, improvement in clinical signs and symptoms, major bleeding episodes, and length of hospitalization. Important economic endpoints to assess include drug costs, laboratory monitoring costs, administration costs, and complication costs. Results obtained from properly designed studies will assist health systems in more clearly defining the role of LMWHs within their organizations.
• Armstrong, E. P., & Langley, P. C. (1999). The impact of a disease management intervention on the treatment of infectious disease in a managed care organization. Disease Management, 2(3), 61-77.
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  Abstract: The purpose of this study was to examine the implications of a disease management intervention in treating patients with infectious diseases, in terms of both drug and medical resources and the costs associated with those resources. A managed care organization introduced a treatment guideline that was designed to influence the pattern of antibiotic prescribing by providers. The primary intervention was the promotion of treatment guidelines through mailings and face-to-face interventions by two disease management specialists. A relational database was created to assess changes in healthcare resource consumption, antibiotic use, and their respective costs. All patients being treated for the eight most common ambulatory infectious diseases were included. One year of data before and after promoting the treatment guideline was compared to assess the changes in medical and antibiotic resources and costs. The study demonstrated that there were important changes in antibiotic prescribing toward those antibiotics on the treatment guideline. However, the net effect was an increase in antibiotic and medical costs on a per member per month basis after the treatment guidelines were implemented. Analysis of antibiotic prices indicated that if antibiotic costs would have remained constant, the shifts in antibiotic patterns would have resulted in a reduction in total antibiotic costs. This study demonstrates that promotion of an infectious disease treatment guideline is effective in altering prescribing behavior. However, changes in drug prices or use of certain expensive products can overwhelm cost savings from other products.
• Armstrong, E. P., & Langley, P. C. (1999). Treatment of pneumonias in a managed care organisation. The impact of a treatment guideline promotion on physician prescribing behaviour. Disease Management and Health Outcomes, 6(3), 159-173.
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  Abstract: Objective: To evaluate a pneumonia disease management programme in a naturalistic setting. Design and Setting: A 300,000 member managed-care organisation introduced an antibacterial treatment guideline designed to change antibacterial prescribing by physicians. A relational database was created to measure changes in healthcare resources, use of antibacterials and health event profiles. One year of data before and after promoting the treatment guideline was compared. Intervention: The primary disease management intervention was the promotion of the guideline through mailings and face-to-face interventions by 2 disease management specialists. Participants: All patients with pneumonia diagnoses on the medical claims database were included in the analysis. Results: The study demonstrated that medical costs increased by 5 to 10% after the treatment guideline was implemented. Health event analysis demonstrated changes in antibacterial prescribing and average cost per antibacterial selected. In both years, the highest success rate was with the amoxicillin group. Although there were fewer patients, doxycycline also had success rates of at least 70%. The econometric model demonstrated that holding other variables constant, including patient age and the presence of any comorbidities, treatment with amoxicillin was associated with a statistically significant reduction in health event costs. Conclusions: The study identified the need for validating treatment guidelines with results from actual practice. The data also demonstrate the use and importance of measuring clinical and economic outcomes from disease management interventions by using databases readily available within most managed-care organisations. In addition, the econometric model was useful in comparing different drug groups with these retrospective data.
• Armstrong, E. P., Sauer, K. A., & Downey, M. J. (1999). Phenytoin and fosphenytoin: A model of cost and clinical outcomes. Pharmacotherapy, 19(7), 844-853.
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  PMID: 10417033;Abstract: We developed a pharmacoeconomic model to compare costs and clinical outcomes of administering phenytoin and fosphenytoin alone and in combination in hospitalized patients. Effectiveness data were obtained by distributing a questionnaire to 33 registered nurses at three acute care hospitals who worked in critical care, neurology services, or emergency department. The questionnaire addressed methods of phenytoin and fosphenytoin administration, frequency of adverse reactions, methods of treating adverse reactions, and demographic information. The model estimated that if 50% of phenytoin loading doses were substituted with fosphenytoin, a reduction in adverse events resulted in an estimated increase of $36/patient cost to the hospital. If phenytoin maintenance dosages were substituted with fosphenytoin, the model predicted essentially no change in cost to the hospital. It appears that fosphenytoin reduces adverse events at a reasonable increase in total hospital costs.
• Cox, E. R., Armstrong, E. P., & Motheral, B. R. (1999). Using decision analysis to evaluate the cost effectiveness of GP IIb/IIIa antagonists. Formulary, 34(6), 515-522.
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  Abstract: The GP IIb/IIIa receptor antagonists have been shown to significantly increase the success rate of invasive cardiovascular procedures, such as percutaneous transluminal coronary angioplasty. However, this benefit comes at a significant cost. The number of alternatives in this therapeutic area necessitates comparative evaluation of the costs and benefits of these products. Several study designs and methodological approaches can be used to evaluate the cost effectiveness of these products, including clinical trials, naturalistic trials, retrospective claims data, and modeling. This article discusses the advantages and disadvantages of the various approaches. Using decision analysis, this article takes the reader through the steps necessary to obtain average and incremental cost-effectiveness ratios. The analysis follows a step-by-step process that decision makers should be able to use as a framework to conduct a full comparative cost-effectiveness analysis.
• Armstrong, E. P., & Denemark, C. R. (1998). How pharmacists respond to on-line, real-time DUR alerts.. Journal of the American Pharmaceutical Association (Washington,D.C. : 1996), 38(2), 149-154.
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  PMID: 9654846;Abstract: OBJECTIVE: To quantify the type and frequency of drug utilization review (DUR) alerts sent by one claims processor to pharmacists; identify how pharmacists respond to these on-line, real-time DUR messages; and quantify the interventions taken by these pharmacists as a result of these alerts. DESIGN: Retrospective analysis of Medicaid claims from July 1, 1995, through June 30, 1996. SETTING: State of Delaware. PARTICIPANTS: 55,000 Medicaid recipients served by 170 participating pharmacies and 2,000 physicians. INTERVENTIONS: All on-line DUR alerts sent to pharmacists and the pharmacists' responses were categorized by alert type and analyzed by drug class. MAIN OUTCOME MEASURES: Pharmacists' response (dispensed prescription, contacted prescriber, talked with patient, consulted own reference sources) and drug classes. RESULTS: During the study period, 807,017 claims generated 83,260 DUR alerts involving 73,554 (9.1%) prescriptions. Prescriptions were not dispensed in 20.9% of cases because of the DUR message. Prescriptions were dispensed 17.7% of the time after the pharmacist contacted the prescriber, in 20.6% of cases after the pharmacist talked with the patient, and 37.2% of the time after reviewing internal resources. Action taken by pharmacists varied among and within DUR criteria categories. Specific examples of alerts generated in high-frequency and high-profile areas are reviewed, some of which generated inconsistent responses. CONCLUSION: Among Delaware Medicaid providers, drug alerts resulted in pharmacists not dispensing prescriptions in a surprising percentage of situations. Pharmacists' responses varied according to the drug class involved and the type of alert received.
• Kortt, M. A., & Armstrong, E. P. (1998). Cholesterol-lowering therapy interventions. A pharmacoeconomic assessment. Disease Management and Health Outcomes, 4(4), 193-203.
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  Abstract: Elevated cholesterol levels are associated with an increased risk of cardiovascular diseases. Treatment strategies promoting the associated health benefits from a reduction in elevated cholesterol levels have been outlined in guidelines published by the National Cholesterol Education Program. Clinicians and researchers have also examined the economic benefits associated with reducing elevated cholesterol levels. Most of these studies have employed traditional pharmacoeconomic techniques like cost-effectiveness analysis. Results from these studies indicated that certain types of therapy interventions (such as the use of cholesterol-lowering pharmaceutical agents) are cost effective. However, the majority of these studies are clinically driven and rely heavily on cost-outcome ratios as decision variables. This traditional approach to pharmacoeconomic evaluation is starting to be questioned by managed care organisations in the US. These organisations are increasingly interested in assessing the global (or health systems-based) impact associated with the introduction of a therapy intervention (such as cholesterol lowering agents). Subsequently, there is a need for pharmacoeconomic studies to provide a health systems-based view to assess a range of competing cholesterol lowering treatment options.
• Schwarz, H. O., Armstrong, E. P., & Savelli, A. V. (1998). Workshop for developing drug formularies in Russia. American Journal of Health-System Pharmacy, 55(12), 1308-1311.
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  PMID: 9640475;
• Armstrong, E. P., & Manuchehri, F. (1997). Ambulatory care databases for managed care organizations. American Journal of Health-System Pharmacy, 54(17), 1973-1983.
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  PMID: 9290895;Abstract: The uses, advantages, and limitations of ambulatory care databases are discussed, and processes for extracting and using the data are described. Claims databases allow health systems, including managed care organizations, to generate descriptive statistics on patients, providers, and diseases; to conduct comprehensive cost and resourceuse analyses; and to build economic models of diseases. The use of health care data-bases has several advantages over clinical trials, including lower data collection costs, shorter times for analysis, larger numbers of patients, and less inconvenience to patients and providers. These databases allow the effectiveness of a treatment, instead of its efficacy, to be assessed and drug-switching patterns within disease categories to be detected. This information can be used for determining the cost and outcome implications of new treatments and formulary changes, as well as for monitoring disease management programs. Limitations of health care data bases include the omission of services not covered by health plans, the risk of coding errors, the absence of indicators of disease severity, and the lack of data that would assist with clinical outcome analysis. Medical and pharmacy claims data do not contain all the information contained in patients' medical records. Despite their limitations, ambulatory care databases are useful for describing patient, provider, and disease characteristics. The databases are also useful for predicting and estimating the implications of a change in the formulary, measuring the effects of treatment guidelines, and monitoring disease management programs.
• Armstrong, E. P., & Markson, T. J. (1997). On-line DUR messages: pharmacists' attitudes and actions in response.. Journal of the American Pharmaceutical Association (Washington,D.C. : 1996), NS37(3), 315-320.
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  PMID: 9170808;Abstract: Community pharmacists are encountering on-line drug utilization review (DUR) messages with increasing frequency. DUR messages are sent by third party claims processors and generated by pharmacies' in-house computer systems. The purpose of this study was to ascertain community pharmacists' attitudes toward on-line DUR messages and the actions most often taken by pharmacists after receiving these messages. A 28-item questionnaire was mailed to a random sample of 1,500 community pharmacies throughout the United States. Four hundred twenty-seven questionnaires were returned and analyzed (a 28.5% response rate). The majority of respondents were male pharmacists practicing in independent community pharmacies in cities with populations of less than 50,000. The low response rate from chain pharmacies was an important limitation of this study. The results indicate that pharmacists find DUR messages related to medication overuse and drug interactions to be the most useful. Interventions are not performed for all DUR messages received, and interventions usually consist of telephoning physicians and talking to patients. This study demonstrates that many types of DUR messages are useful to pharmacists; however, additional research and further refinement of DUR messages appear necessary.
• Armstrong, E. P., Akaho, E., & Tysinger, J. W. (1997). Computer experiences and attitudes of Japanese pharmacy students. Education and Information Technologies, 2(2), 155-163.
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  Abstract: The purpose of this study was to evaluate the computer experiences and attitudes of first- and fourth-year Japanese pharmacy students. An existing questionnaire that asked questions about computer hardware and software owned, reported level of expertise with software applications, attitudes and concerns about computers, and demographic information was translated into Japanese. After ensuring the accuracy of the translation, first- and fourth-year pharmacy students completed the survey. This study found that most of these Japanese pharmacy students did not frequently use computers. About one-quarter of the students owned a home computer. Slightly more than 10% of the students reported that they could use word processing programs. Their attitudes about computers were positive. Most stated that they should possess basic computer skills when graduating from pharmacy school. The students also indicated that they would rather learn from computers than attend lectures or read texts or journals. However, 63 first-year (32%) and 45 fourth-year (43.7%) students said that microcomputers were too complicated for them to use. © 1997 IFIP.
• Armstrong, N. R., Dunphy, D. R., Mendes, S. B., Saavedra, S. S., & Armstrong, E. P. (1997). The electroactive integrated optical waveguide:  ultrasensitive spectroelectrochemistry of submonolayer adsorbates. Analytical chemistry, 69(15).
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  Highly sensitive spectroelectrochemistry of adsorbed films on ITO is demonstrated with the electroactive integrated optical waveguide (EA-IOW). The EA-IOW, a single-mode planar waveguide coated with an ITO layer, is ∼10(4)-fold more sensitive to changes in absorbance occurring during electrochemical events versus a single-pass transmission spectroelectrochemical experiment, as demonstrated by reduction of surface-adsorbed methylene blue. Furthermore, the EA-IOW is selective to near-surface events, as it is relatively insensitive to absorbance by solutions of dissolved chromophores at
• Else, B. A., Armstrong, E. P., & Cox, E. R. (1997). Data sources for pharmacoeconomic and health services research. American Journal of Health-System Pharmacy, 54(22), 2601-2608.
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  PMID: 9397224;Abstract: Different types of databases available for health-related research, the data contained in these databases, and potential applications for pharmacists or researchers are discussed. Case studies that demonstrate uses for health databases are presented. Databases can be organized by facility, by health care provider, by disease or organ, or by sector. The types of data they contain include financial data, utilization data, demographic data, and outcomes data. Data can be obtained from the public sector, the private sector, or the researcher's own health system. The costs and time associated with using existing databases are often less than those required to collect data, but the quality and accessibility of the data must also be considered. The researcher's choice of database will depend on the research question. Health care databases can be used for health management and decision-making, quality review and evaluation, outcomes research, episode-of-illness studies, and evaluation of treatment protocols. Researchers must comply with patient- confidentiality and other agreements when accessing data. The format of the data needs to be matched with the hardware and software to be used in the analysis, and the data need to be loaded, verified, and cleaned before use. In deciding which of the many available data sources to use, researchers must determine the appropriate balance between external data and data available within their own health systems. The decision on whether to use existing data sources or to collect data prospectively will depend on the research question, the available resources, and the scope of the study.
• Akaho, E., Armstrong, E. P., & Fujii, M. (1996). Pharmaceutical care innovations in Japan. Journal of the American Pharmaceutical Association, 36(2), 123-127.
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  PMID: 8742010;
• Armstrong, E. P. (1996). Monitoring and evaluating disease management: Information requirements. Clinical Therapeutics, 18(6), 1327-1333.
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  PMID: 9001848;Abstract: This paper addresses information essential to the creation, monitoring, and evaluation of disease management programs within managed-care organizations. Sound procedures for the collection and analysis of data are vital components of any effective disease management program. This presentation argues for a systemwide, rather than an atomistic, approach to data collection and analysis. Because every health system serves different populations, reliable demographic and health resource use data must be collected. Similarly, baseline data on physician prescribing behavior, patient compliance, and treatment costs are necessary to identify areas in need of improvement. Particular care must be taken to ensure that valid statistical models are developed to reflect the realities of the health system. The strengths and weaknesses of various internal and external data sources are discussed, with an emphasis on correlating and integrating information to provide comprehensive analyses of treatments and outcomes. The effects of different financial arrangements on data issues are also discussed, particularly in terms of contracting issues at successive stages in the development of a disease management program. This paper examines, in detail, data issues relating to monitoring prescribing behavior, modeling therapy interventions, classifying outcomes, and utilization of resources and treatments. Finally, this presentation makes specific recommendations for designing valid procedures for data collection and analysis.
• Armstrong, E. P., & Langley, P. C. (1996). Disease management programs. American Journal of Health-System Pharmacy, 53(1), 53-58.
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  PMID: 8719290;Abstract: Disease management (DM) activities are described, and their implementation and monitoring in managed care organizations are discussed. DM programs involve systematic evaluation of the relationships between treatment options and the associated resource use and patient outcomes for the purpose of providing a given standard of health care at the lowest possible resource cost. A DM arrangement covers a specified disease or therapy intervention for a patient group that may be defined by diagnosis, drug use, prior resource use, or patient characteristics. Often, the partners in a DM arrangement are a managed care organization and a pharmaceutical industry representative or division. The development and monitoring of disease management arrangements are dependent on access to several types of data, and these data are available in managed care plans. A DM arrangement includes interventions to change prescribing patterns or patient compliance and assessment of the effects of these interventions against target outcomes specified in the contract. The agreement that is developed specifies guidelines for treatment and requirements for data collection, monitoring, and reporting that are consistent with the target outcomes. In many DM arrangements, the partners share cost savings and risk; other arrangements involve case management on a capitated basis. A pharmaceutical company involved in risk sharing must change its focus from market share to optimal use of drugs within the total cost of treatment. If a risk-sharing contract covers an entire therapeutic class of drugs, a pharmaceutical company may share risk for the use of other manufacturers' products as well as its own. Disease management contracts must consider the full impact of each treatment option on the health system; the goal should be not simply to decrease the drug budget, but to decrease overall costs for treatment that achieves desired outcomes for specific diseases.
• Armstrong, E. P., & Proteau, D. (1996). Retrospective drug utilization review software systems: Perspectives of state Medicaid DUR directors. Annals of Pharmacotherapy, 30(10), 1088-1091.
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  PMID: 8893113;Abstract: OBJECTIVE: To determine the desirability or perceived need of retrospective drag utilization review (DUR) software system characteristics. DESIGN: A 32-item questionnaire. SETTING: Ambulatory DUR directors covering more than 33 million patients. PARTICIPANTS: Medicaid DUR directors from 49 states and the District of Columbia. MAIN OUTCOME MEASURES: Five-point Liken scale measures of importance of system and vendor characteristics. RESULTS: A 100% response rate was achieved. Respondents rated the ability to change or modify criteria as very important and thought it was important to receive criteria sets from software vendors. Respondents believed cost-savings methodologies should be clearly defined and false positive DUR criteria should be minimized. CONCLUSIONS: Through the implementation of the Omnibus Budget Reconciliation Act of 1990, considerable experience in ambulatory DUR programs has been achieved. Respondents believed the ability to change DUR criteria was very important and they thought it was important to have a set of criteria supplied from software vendors. Critical issues of criteria development, cost-savings methodologies, minimizing false positive criteria, and outcomes assessment from DUR programs were important issues to DUR directors.
• Armstrong, E. P., Bykov, A., & Savelli, A. V. (1996). Introducing formulary drug selection in Russia. American Journal of Health-System Pharmacy, 53(4), 426-428.
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  PMID: 8673665;
• Armstrong, N. R., Yang, L., Saavedra, S. S., & Armstrong, E. P. (1996). Sol-gel-based, planar waveguide sensor for gaseous iodine. Analytical chemistry, 68(11).
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  A novel sensor for gaseous iodine has been developed using a combination of sol-gel processing and planar integrated optical waveguiding technologies. The sensing principle is based on the detection of a charge transfer complex formed between iodine and phenyl groups that have been incorporated into a porous, methylated glass film. The glass film was prepared from siloxane precursors by the sol-gel method. Sensors were fabricated by coating the film over a single-mode planar waveguide. Light was coupled into and out of the laminate structure using integral grating couplers, and formation of the charge transfer complex was monitored as attenuated total reflection of the guided wave. The sensor exhibits a linear response to I(2) in the range of 100 ppb to 15 ppm with response and recovery times less than 15 s. The response is selective to 4 ppm iodine in the presence of 10 ppm chlorine and is stable for at least 3 months.
• Grant, K. L., Herrier, R. N., & Armstrong, E. P. (1996). Teaching a Systematic Search Strategy Improves Literature Retrieval Skills of Pharmacy Students. American Journal of Pharmaceutical Education, 60(3), 281-286.
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  Abstract: The present investigation tested a lecture/computerized demonstration of a systematic approach to computerized literature retrieval. Forty-eight students in their third professional year who had been taught how to use OVID (version 3.0) in a one hour class, were tested on their ability to construct search strategies using a paper/pencil examination. Results of the pretest demonstrated that students were able to define Boolean operators but were unable to use them in constructing search strategies. After a lecture and computerized demonstration of search strategies was presented, homework using OVID was assigned. A paper/pencil posttest was given after the homework was returned and discussed. The posttest showed a statistically significant increase in scores (P
• Langley, P. C., Langley-Hawthorne, C. E., Martin, R. E., & Armstrong, E. P. (1996). Establishing the basis for successful disease management contracting. American Journal of Managed Care, 2(8), 1099-1108.
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  Abstract: Healthcare delivery in the United States has undergone significant changes during the last two decades. In the 1990s, we are witnessing a new phenomenon - contracts between healthcare providers and pharmaceutical manufacturers or disease management companies for disease-specific intervention programs. Although the concept of disease-specific patient care is not new, increasingly, healthcare providers are considering introducing disease management programs and are evaluating the benefits of contracting with outside organizations for specific disease management interventions. If these interventions are to be operationally and contractually successful, then a contract must be negotiated that meets the requirements of both parties, and that minimizes the probability of default and the possibility of dispute. The purpose of this paper is to identify the key requirements for any disease management contract. These requirements are considered in terms of (1) type of contractual agreement; (2) identification of the patient group for the disease management intervention; (3) time frame for retrospective analyses to establish contract cost baselines; (4) profiling of disease or therapy areas; (5) requirements for resource costing and the identification of cost drivers; (6) seasonal adjustment procedures; and (7) definition of terms, contract dynamics and the management and arbitration of the contract. Because few disease management companies appear to have recognized the need to include many of these seemingly obvious requirements in a standard contract framework, this paper emphasizes the importance of incorporating all seven elements in any contract. These requirements are not onerous; rather, the principal obstacle is the failure of prospective contracting parties to recognize their significance.
• Armstrong, E. P., Akaho, E., & Fujii, M. (1995). Japanese Pharmacy: Innovation mixed with tradition. Annals of Pharmacotherapy, 29(2), 181-185.
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  PMID: 7756718;Abstract: OBJECTIVE: To report the current status of pharmacy practice in Japan. DATA SOURCES: Published conference reports, journal articles, human resource consultation with medical and pharmacy practitioners, and site visitation by the authors. DATA EXTRACTION and SYNTHESIS: Data on areas related to Japanese history, practice of pharmacy, and professional innovations were obtained through interviews and the literature. Information is provided to give an appreciation of current pharmacy practice in Japan. CONCLUSIONS: Japanese pharmacy practice is a strong combination of tradition and professional innovation. The potential for professional growth is immense; Japanese pharmacy has successfully established payment for nondistributive pharmacy services. Payment for cognitive services creates many positive incentives for the future practice of pharmacy in Japan.
• Armstrong, E. P., & Newberg, D. A. (1994). Discussing pharmaceutical care on a grass-roots basis.. American Pharmacy, NS34(9), 38-39, 43.
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  PMID: 7977025;
• Armstrong, E. P. (1992). DUE software highlights therapeutic issues. American Pharmacy, 32(10), 42-46.
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  PMID: 1442528;
• Armstrong, E. P., Bootman, J. L., & Al-Dhewalia, H. (1992). Pharmacy practice in eastern Saudi Arabia. American Journal of Hospital Pharmacy, 49(9), 2252-2254.
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  PMID: 1524072;
• Armstrong, E. P., Terry, A. K., Rivera, G. C., & Laplante, S. (1992). Impact of drug use evaluation upon ambulatory pharmacy practice. Annals of Pharmacotherapy, 26(12), 1546-1553.
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  PMID: 1482814;Abstract: OBJECTIVE: To review the expansion of ambulatory drug use evaluation (DUE). A description of ambulatory DUE characteristics and methodology is included. In addition, DUE computer usage, documentation concerns, and future research issues are addressed. DATA SOURCES: A MEDLINE search was used to identify pertinent literature, including reviews. STUDY SELECTION: Primary and secondary literature describing ambulatory DUE was selected. Articles describing inpatient DUE were excluded. DATA EXTRACTION: Rigorous studies evaluating current ambulatory DUE programs are limited, but the available literature and a description of existing program characteristics are included. All studies available at the time of publication were reviewed. DATA SYNTHESIS: Ambulatory DUE can provide useful information to assist in providing pharmaceutical care. The Omnibus Budget Reconciliation Act of 1990 has prompted an expansion of DUE programs, and most of the formalized programs are retrospective in design. Prospective programs provide online, patient-specific drug use assessment whenever new prescriptions are entered into point-of-service databases. CONCLUSIONS: Although more well-designed evaluations of existing ambulatory DUE programs are needed, initial results indicate these programs may be extremely useful in identifying significant medication therapy problems and improving patients' drug therapy.
• Armstrong, E. P. (1990). Pseudomonal osteomyelitis. Case history. Hospital Therapy, 15(2), 273-280.
• Plezia, P. M., Thornley, S. M., Kramer, T. H., & Armstrong, E. P. (1990). The influence of enteral feedings on sustained-release theophylline absorption. Pharmacotherapy, 10(5), 356-361.
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  PMID: 2122422;Abstract: In a randomized, crossover study the influence of enteral feedings (Ensure) on the absorption of theophylline from a sustained-release preparation (Theo-24) was evaluated. Six healthy, male subjects, age 22 to 37 years, participated. In phase 1 the subjects received a single oral dose of Theo-24 6 mg/kg with 100 ml of water at 8:00 A.M. In phase 2, they received 100 ml boluses of Ensure hourly, beginning 3 hours prior to the oral dose and continuing for a total of 1000 ml. In phase 3, subjects received a single 30-minute intravenous infusion of an equivalent dose of aminophylline. After each dose, serial blood samples were collected for 72 hours. No statistically significant differences in area under the curve (AUC0(∞)) (126.0 vs 127.3 μg hr/ml), maximum concentration (3.80 vs 4.08 μg/ml), or time to peak plasma level (13 vs 11 hrs) were found between phases 1 and 2. Mean AUC0(∞) for the intravenous phase (161.4 μg hr/ml) was significantly higher than the AUC for either oral study (p < 0.05). The mean bioavailability was 81% for phase 1 and 80% for phase 2. Percent absorbed versus time plots revealed no difference in rate of absorption between treatments. We conclude that short-term administration of the enteral feeding Ensure does not influence the absorption of theophylline when administered as the sustained-release product Theo-24.
• Nishimura, L. Y., Armstrong, E. P., Plezia, P. M., & Iacono, R. P. (1988). Influence of enteral feedings on phenytoin sodium absorption from capsules. Drug Intelligence and Clinical Pharmacy, 22(2), 130-133.
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  PMID: 3127188;Abstract: The influence of enteral feeding (with Ensure) on the absorption of phenytoin sodium from capsules was studied. Six healthy and adult volunteers were given a single dose of phenytoin capsules 400 mg po on two occasions. Blood specimens were collected for 48 hours after each dose. In a randomized, crossover fashion, each subject completed the following two phases: (1) phenytoin without enteral feedings, and (2) concomitant enteral feedings before phenytoin and continued at 100 ml/h for ten hours. The areas under the concentration versus time curves from 0-48 hours (AUC0-48) were not significantly different between the two phases (p > 0.5). The percent relative bioavailability of phenytoin with enteral feedings was 101.7 percent. This study suggests that enteral feedings do not affect the serum concentrations of phenytoin after a single dose given in capsule form.
• Armstrong, E. P., Nako, N., Plezia, P. M., Kramer, T. H., & Jones, W. N. (1987). Steady-state pharmacokinetics of two sustained-release theophylline products during once-daily and twice-daily dosing. Clinical Pharmacy, 6(10), 800-804.
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  PMID: 3505842;
• Armstrong, E. P., & Bailie, M. (1985). Clinical comparison of three volumetric infusion pumps. NITA, 8(4), 305-308.
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  PMID: 3852086;
• Armstrong, E. P., & Kopp, D. L. (1985). A survey of prophylactic antibiotic use for total joint replacements in a community hospital. Drug Intelligence and Clinical Pharmacy, 19(10), 753-757.
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  PMID: 4053982;Abstract: This study was conducted in a nonteaching community hospital to characterize the use of prophylactic antibiotics in patients undergoing total joint replacement by orthopedic surgeons in private practice. Of the 101 patients studied, 43 were started on antibiotics too early, 32 were left on the drugs for too long a period, and 33 received subsequent oral antibiotics without identifiable reason. Seventy-nine (78.2 percent) received 8 g/d of a first- or second-generation cephalosporin for prophylaxis. None of the patients received cefazolin 1 g q8h.
• Armstrong, E. P., & Rush, D. R. (1983). Treatment of osteomyelitis. Clinical Pharmacy, 2(3), 213-224.
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  PMID: 6349907;Abstract: The etiology, pathophysiology, and treatment of osteomyelitis are reviewed. Osteomyelitis may result from hematogenous bacterial emboli from a distant source lodging in the bone, the contiguous spread of an adjoining soft-tissue infection, or direct bacterial inoculation secondary to trauma or surgery. Hematogenous osteomyelitis most commonly occurs in children, and it usually is caused by a single organism, Staphylococcus aureus. Adults are most commonly affected by contiguous-spread osteomyelitis, and many infections occur in adults with vascular insufficiency. Staphylococcus aureus is the most common organism, but unlike hematogenous osteomyelitis, multiple organisms (including gram-negative bacteria) generally are involved. Successful treatment is predicated upon accurate classification of the disease, identification of the offending organism(s), surgical debridement if necessary, and prompt initiation of antibiotic therapy. Adults with acute osteomyelitis usually are given a penicillinase-resistant penicillin, ampicillin, or cephalosporin in doses of 8-12 g/day for four to six weeks. Carefully monitored oral drug therapy following initial injectable antibiotic therapy has been shown to be effective in children. Chronic osteomyelitis requires both surgery to remove infected tissue and high-dose injectable antibiotic therapy for four to six weeks; it is recommended that follow-up oral antibiotic therapy be continued for one to two months, or possibly as long as two years. Home antibiotic administration programs, oral antibiotic therapy, and investigational injectable antibiotics with once-daily dosing may allow patients with osteomyelitis who previously were hospitalized for prolonged periods to be treated at home in the future.
• Armstrong, E., & Elenbaas, J. (1983). Lysine for herpes simplex virus. Drug Intelligence and Clinical Pharmacy, 17(3), 186-.