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Background: Oral oxybutynin has been associated with the development of cognitive impairment., Objective: The objective of this study was to describe the use of oral oxybutynin versus other antimuscarinics (e.g., tolterodine, darifenacin, solifenacin, trospium, fesoterodine, transdermal oxybutynin) in older adults with documented cognitive impairment., Methods: This is a population-based retrospective analysis of antimuscarinic new users aged ≥ 66 years from January 2008 to December 2011 (n = 42,886) using a 5% random sample of Medicare claims linked with Part D data. Cognitive impairment was defined as a diagnosis of mild cognitive impairment, dementia, use of antidementia medication, and memory loss/drug-induced cognitive conditions in the year prior to the initial antimuscarinic claim. We used multivariable generalized linear models to assess indicators of cognitive impairment associated with initiation of oral oxybutynin versus other antimuscarinics after adjusting for comorbid conditions., Results: In total, 33% received oral oxybutynin as initial therapy. Cognitive impairment was documented in 10,259 (23.9%) patients prior to antimuscarinic therapy. Patients with cognitive impairment were 5% more likely to initiate another antimuscarinic versus oral oxybutynin (relative risk [RR] 1.05; 95% confidence interval [CI] 1.03-1.06). The proportion of patients with cognitive impairment initiated on oral oxybutynin increased from 24.1% in 2008 to 41.1% in 2011. The total cost of oral oxybutynin, in $US, year 2011 values, decreased by 10.5%, whereas the total cost of other antimuscarinics increased by 50.3% from 2008 to 2011., Conclusion: Our findings suggest opportunities for quality improvement of antimuscarinic prescribing in older adults, but this may be hampered by cost and formulary restrictions.

Background: Concerns about antipsychotic prescribing for children, particularly those enrolled in Medicaid and with Supplemental Security Income (SSI), continue despite recent calls for selective use within established guidelines., Objectives: To (a) examine the application of 6 quality measures for antipsychotic medication prescribing in children and adolescents receiving Medicaid and (b) understand distinctive patterns across eligibility categories in order to inform ongoing quality management efforts to support judicious antipsychotic use., Methods: Using data for 10 states from the 2008 Medicaid Analytic Extract (MAX), a cross-sectional assessment of 144,200 Medicaid beneficiaries aged < 21 years who received antipsychotics was conducted to calculate the prevalence of 6 quality measures for antipsychotic medication management, which were developed in 2012-2014 by the National Collaborative for Innovation in Quality Measurement. These measures addressed antipsychotic polypharmacy, higher-than-recommended doses of antipsychotics, use of psychosocial services before antipsychotic initiation, follow-up after initiation, baseline metabolic screening, and ongoing metabolic monitoring., Results: Compared with children eligble for income-based Medicaid, children receiving SSI and in foster care were twice as likely to receive higher-than-recommended doses of antipsychotics (adjusted odds ratio [AOR] = 2.4, 95% CI = 2.3-2.6; AOR = 2.5, 95% CI = 2.4-2.6, respectively) and multiple concurrent antipsychotic medications (AOR = 2.2, 95% CI = 2.0-2.4; AOR = 2.2, 95% CI = 2.0-2.4, respectively). However, children receiving SSI and in foster care were more likely to have appropriate management, including psychosocial visits before initiating antipsychotic treatment and ongoing metabolic monitoring. While children in foster care were more likely to experience baseline metabolic screening, SSI children were no more likely than children eligible for income-based aid to receive baseline screening., Conclusions: While indicators of overuse were more common in SSI and foster care groups, access to follow-up, metabolic monitoring, and psychosocial services was somewhat better for these children. However, substantial quality shortfalls existed for all groups, particularly metabolic screening and monitoring. Renewed efforts are needed to improve antipsychotic medication management for all children., Disclosures: This project was supported by grant number U18HS020503 from the Agency for Healthcare Research and Quality (AHRQ) and Centers for Medicare & Medicaid Services (CMS). Additional support for Rutgers-based participants was provided from AHRQ grants R18 HS019937 and U19HS021112, as well as the New York State Office of Mental Health. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, CMS, or the New York State Office of Mental Health. Finnerty has been the principle investigator on research grants/contracts from Bristol Myers Squibb and Sunovion, but her time on these projects is fully supported by the New York State Office of Mental Health. Scholle, Byron, and Morden work for the National Committee for Quality Assurance, a not-for-profit organization that develops and maintains quality measures. Neese-Todd was at Rutgers University at the time of this study and is now employed by the National Committee for Quality Assurance. The other authors have no financial relationships relevant to this article to disclose. Study concept and design were contributed by Finnerty, Neese-Todd, and Crystal, assisted by Scholle, Leckman-Westin, Horowitz, and Hoagwood. Scholle, Byron, Morden, and Hoagwood collected the data, and data interpretation was performed by Pritam, Bilder, Leckman-Westin, and Finnerty, with assistance from Scholle, Byron, Crystal, Kealey, and Neese-Todd. The manuscript was written by Leckman-Westin, Kealey, and Horowitz and revised by Layman, Crystal, Leckman-Westin, Finnerty, Scholle, Neese-Todd, and Horowitz, along with the other authors.

Introduction: Simulation studies showed that generic antiretroviral (ARV) drug utilization could lead to significant cost reduction of HIV treatment in developed world. This study aimed to quantify ARV utilization and costs in European countries between 2006 and 2015. We also assessed the impact of generic ARV drug utilization on cost reduction in real-life., Methods: ARV drug utilization in 14 European countries (France, Italy, Germany, Denmark, Netherlands, Norway, Sweden, Finland, Iceland, Croatia, Czech Republic, Estonia, Latvia, and Lithuania) were analysed using defined daily dose (DDD)/1000 inhabitants/year. ARV drug cost was estimated in million euro/year and euro/1000 inhabitants/year. The impact of generics on cost reduction was assessed in three countries: France, Denmark, and Czech Republic, using four parameters: expected savings, observed savings, brand price-reduction savings and overall savings., Results: Between 2006 and 2015, median ARV drug utilization increased from 234 DDDs per 1000 inhabitants per year (IQR 124-388) to 385 (229-670). The median cost increased from €3751/1000 inhabitants/year (1109-4681) to €9158 (3269-10,646). Between 2013 and 2015, overall savings of €0.9, €1.6, and €33.7 million were respectively observed in Denmark, Czech Republic, and France., Conclusion: Overall savings observed in real-life from generic ARV drugs in Denmark were related to high rate of low-price generic utilization, contrarily to France and Czech Republic where these were more related to brand price-reduction than generic utilization itself., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Antipsychotic and benzodiazepine medications are widely used in nursing homes despite only modest efficacy and the risk of severe adverse effects. Numerous interventions have been implemented to reduce their use. However, the outcomes for the residents and staff and the economic impact on the healthcare system remain relatively understudied., Objective: The aim was to examine the clinical and economic outcomes reported within interventions to reduce antipsychotic and/or benzodiazepine use in nursing homes., Methods: Databases searched included PubMed, EMBASE, CINAHL, CENTRAL, Scopus, and ProQuest. We focussed on interventions with professional (e.g. education) and/or organisational (e.g. formation of multidisciplinary teams) components. Data were extracted from the papers that included clinical and/or economic outcomes. Two authors independently reviewed articles for eligibility and quality., Results: Fourteen studies reported on clinical outcomes for the residents: 13 antipsychotic reduction studies and one study focussing exclusively on benzodiazepine reduction. There was substantial heterogeneity in the types of outcomes reported and the method of reporting. Change in behavioural and psychological symptoms was the most commonly reported outcome throughout the antipsychotic reduction interventions (n = 12 studies) and remained stable or improved in ten of 12 studies. Whilst improvements were seen in emotional responsiveness, measures of sleep, cognitive function, and subjective health score remained unchanged upon benzodiazepine reduction. No interventions included an economic analysis., Conclusions: Efforts should be made to improve the consistency in reporting of clinical outcomes within interventions to reduce antipsychotic and/or benzodiazepine medications. Additionally, the economic impact of these interventions should be considered. Nonetheless, evidence suggests that interventions that reduce antipsychotic use are unlikely to have deleterious clinical effects. The clinical and economic effects of benzodiazepine reduction remain under-reported.

Background and Aim: Biologicals are potent drugs for immune-mediated inflammatory diseases. After discontinuation or switch of therapy, many patients have unused biological injectors left. This study aimed to evaluate potential redistribution of unused injectors to prevent spillage of these costly drugs by assessing (i) the quality of transport and home storage through the proportion of injectors stored within the recommended temperature range (2-8 °C) and (ii) acceptance of redistribution by patients., Methods: All golimumab users, irrespective of the indication, at Maastricht University Medical Center were eligible for inclusion. Patients received golimumab in a sealed bag containing a validated temperature sensor, measuring temperature every 5 min. Patients were asked to store their medication as usual. Deviations from the recommended range were defined as any duration below 0 °C and > 30 min below 2 °C or above 8 °C. After 3 months, patients completed a questionnaire on their opinion towards potential redistribution of unused biologicals., Results: Fifty patients (42.0% male, mean age 53.2 ± 14.3 years) received 276 injectors. The mean storage time was 30.9 ± 33.1 days. Only 11.6% of the injectors were stored within the recommended temperature range. In addition, 11.2% were stored > 30 min below 0 °C and 33.2% were stored > 1 week above 8 °C. Of all patients, 95% would accept redistributed medication when product quality is ensured., Conclusions: During transport and home storage, only one in eight biological injectors was stored within the recommended temperature range. This hinders redistribution of unused injectors but also raises concern regarding drug effectiveness in immune-mediated inflammatory disease patients., (© 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Infective endocarditis (IE) is a rare condition which is associated with considerable morbidity and mortality. Almost 100 years ago, the links between endocarditis and procedures, particularly dental procedures, were postulated. Over 50 years ago the first guidelines recommending antibiotic prophylaxis (AP), with the aim of preventing IE developing after procedures, were proposed. However, there has only ever been circumstantial evidence in humans that AP prevents IE. The rarity of IE has made a randomised controlled clinical trial impractical to date. This article outlines the history of AP and reviews the evidence base for the use of AP to prevent IE., (Copyright © 2017 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. All rights reserved.)

Purpose: Inappropriate use of medicines causes increased morbidity, mortality, adverse drug reactions, therapeutic failures and drug resistance as well as wastes valuable resources. Evidence-based cost-effective treatment recommendations of essential medicines are a way of avoiding these. We assessed primary care prescribers' knowledge about and perceptions of an essential medicines formulary, as well as the reasons for adhering to the recommendations., Methods: We conducted a web based questionnaire survey targeting all physicians working in the primary healthcare of the Stockholm healthcare region (2.3 million inhabitants), regarding the knowledge of, attitudes to and usefulness of the essential medicines formulary of the Stockholm Drug and Therapeutics Committee, the so-called Wise List., Results: Of the 1862 physicians reached by our e-mail invitations, 526 (28%) participated in the survey. All but one respondent knew of the formulary, and 72% used it at least once a week when prescribing. The main reason for using the formulary was evidence-based prescribing; 97% trusted the guidelines, and almost all (98%) found the content easy to understand. At the same time, many prescribers thought that the annual changes of some recommendations were too frequent, and some felt that a national formulary would increase its trustworthiness., Conclusions: We found that the essential medicines formulary was widely used and trusted by the prescribers. The high uptake of the treatment recommendations could be due to the Stockholm Drug and Therapeutics Committee's transparent process for developing recommendations involving respected experts and clinicians using strict criteria for handling potential conflicts of interest, feedback to prescribers, continuous medical education and minor financial incentives.

Objective: To study the prescription pattern (using applicable WHO indicators), cost analysis and off-label use of drugs in neonatal intensive care unit (NICU) of a tertiary-care hospital., Methods: The prescriptions of 460 neonates admitted to a NICU during July 2014-March 2015 were studied prospectively., Results: Of 460 neonates, 54.8% were preterm and 73% were low birth weight (LBW). The mean (SD) prescription items per neonate were 5.7 (3.6). Overall off-label use was 12.3%, while 38% neonates received at least one off-label drug. Of 326 off-label drugs, antibiotics (69.6%) followed by non-steroid anti-inflammatory drugs (7%) were commonly used. Premature and LBW babies required more drugs with higher cost and longer stay, compared to full term and normal weight babies (P<0.01), while the pattern of off-label use was similar across both these categories (P>0.05)., Conclusion: Off-label antibiotics use was common, and prescribing practices were uniform in NICU.

Purpose: To characterize family physicians (FPs) who are stewards of care by consistently prescribing omeprazole over esomeprazole., Methods: Cross-sectional analysis of physicians prescribing omeprazole or esomeprazole under Medicare Part D in 2014., Results: There was a regional trend with 49% of Western FPs but only 6% of Southern FPs rarely prescribing esomeprazole. Physicians had increased odds of being a steward if they worked with a care coordinator ( P < .001), at a patient-centered medical home ( P < .001), or in a large practice ( P < .001)., Conclusions: If these findings are replicated across multiple drugs, future outreach could be conducted based on provider prescribing patterns., Competing Interests: Conflict of interest: none declared., (© Copyright 2017 by the American Board of Family Medicine.)

Objective: To update a past systematic review on whether Medicare Part D changed drug utilization and out-of-pocket (OOP) costs overall and within subpopulations, and to identify evidence gaps., Data Sources/study Setting: Published and gray literature from 2010 to 2015 meeting prespecified screening criteria, including having a comparison group, and utilization or OOP cost outcomes., Study Design: We conducted a systematic literature review with a quality assessment., Data Collection/extraction Methods: For each study, we extracted information on study design, data sources, analytic methods, outcomes, and limitations. Because outcome measures vary across studies, we did a qualitative synthesis rather than meta-analysis., Principal Findings: Sixty-five studies met screening criteria. Overall, Medicare Part D enrollees have increased drug utilization and decreased OOP costs, but coverage gaps limit the program's impact. Beneficiaries whose insurance becomes more generous after enrollment had disproportionately increased drug utilization and decreased OOP costs. Outcomes among dual-eligibles were mixed., Conclusions: There is strong evidence on how Medicare Part D and the donut hole coverage gap affect utilization and OOP costs, but weak evidence on how effects vary among dual-eligibles or across diseases. Findings suggest that the Affordable Care Act's provisions to expand coverage and reduce the donut hole should improve patient outcomes., (© Health Research and Educational Trust.)

Background: As the growth of antibiotic resistance has resulted in large part from widespread use of antibiotics, every effort must be made to ensure their sustainable use., Aims: This narrative review aims to assess the potential contribution of health economic analyses to sustainable use efforts., Sources: The work draws on existing literature and experience with health economic tools., Content: The study examines some of the weaknesses in the health, regulatory, and industry arenas that could contribute to inappropriate or suboptimal prescribing of antibiotics and describes how economic analysis could be used to improve current practice by comparing both costs and health outcomes to maximize societal wellbeing over the longer-term. It finds that economic considerations underpinning current antibiotic prescribing strategies are incomplete and short-termist, with the result that they may foster suboptimal use. It also stresses that perverse incentives that drive antibiotic sales and inappropriate prescribing practices must be dis-entangled for sustainable use policies to gain traction. Finally, payment structures can be used to re-align incentives and promote optimal prescribing and sustainable use more generally. In particular, eliminating or altering reimbursement differentials could help steer clinical practice more deliberately towards the minimization of selection pressure and the resulting levels of antibiotic resistance., Implications: This work highlights the need for appropriately designed cost-effectiveness analyses, incentives analysis, and novel remuneration systems to underpin sustainable use policies both within and beyond the health sector., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

By analyzing the current hospital anti hepatitis drug use, dosage, indications and drug resistance, this article studied the drug inventory management and cost optimization. The author used drug utilization evaluation method, analyzed the amount and kind distribution of anti hepatitis drugs and made dynamic monitoring of inventory. At the same time, the author puts forward an effective scheme of drug classification management, uses the ABC classification method to classify the drugs according to the average daily dose of drugs, and implements the automatic replenishment plan. The design of pharmaceutical services supply chain includes drug procurement platform, warehouse management system and connect to the hospital system through data exchange. Through the statistical analysis of drug inventory, we put forward the countermeasures of drug logistics optimization. The results showed that drug replenishment plan can effectively improve drugs inventory efficiency.

Background: New Joint Commission antimicrobial stewardship requirements took effect on January 1, 2017, promoted as a central strategy for coping with the emerging problems of antimicrobial resistance and Clostridium difficile infection. Our objective was to measure the effects of a new antimicrobial stewardship program (ASP) in a rural community hospital with no prior ASP, in the context of having a new infectious disease specialist on staff., Methods: An ASP team was formed to implement a prospective audit with health care provider feedback and targeting 12 antimicrobial agents in a rural hospital in Georgia. An educational grand rounds lecture series was provided before implementation of the ASP to all prescribers. After implementation, algorithms to aid the selection of empirical antibiotics for specific infectious disease syndromes based on local antibiograms were provided to prescribers to improve this selection. Rates of C difficile infections, total targeted antimicrobial costs, and drug utilization rates were calculated for 1 year pre-ASP implementation (2013) and 1 year post-ASP implementation (October 2014-December 2015)., Results: The patient safety metric of C difficile infections decreased from 3.35 cases per 1,000 occupied bed days (OBDs) in 2013 to 1.35 cases per 1,000 OBDs in 2015. Total targeted antimicrobial costs decreased 50% from $16.93 per patient day in 2013 to $8.44 per patient day in 2015. Overall antimicrobial use decreased 10% from before the ASP initiative to 1 year after it. Annualized savings were $280,000 in 1 year, based on drug savings only., Conclusions: Judicious use of antimicrobials and resources can improve a patient safety metric and decrease costs dramatically in rural institutions where the average hospital census is <100 patients per day. The savings would allow the institutions to spend better while improving the use of antimicrobials., (Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Since the 2011 French guidance updates, cholinesterase inhibitors and memantine are considered optional in the management of dementia and leave physicians free to prescribe based on their clinical expertise., Objectives: The aims of this study were to analyze the influence of these recent guidance updates on the prescription rates of these drugs and to quantify the impact of potential changes on healthcare expenditures., Methods: Patients over 65 years old from a representative sample of a national administrative claims database, the French national health insurance database, were retrospectively included from 2006 to 2014. Trends of annual prescription rates were tested using adjusted segmented regression analysis. Drug costs with and without prescribers' behavioral changes were estimated., Results: A total of 119,731 individuals were included and followed during the study period. Among them, 5514 individuals were treated for dementia. According to the unadjusted segmented regression model, there was a significant increase in prescription rates between 2006 and 2010, from 2.23% (95% confidence interval 2.13-2.34) to 2.73% (95% confidence interval 2.62-2.84) of the study population. Since 2011, the trend has reversed with a significant decrease until 2014, from 2.64% (95% confidence interval 2.54-2.75) to 1.92% (95% confidence interval 1.84-2.01). In the multivariate analysis, we also found a gradual decline since 2011, particularly for patients aged 65-69 years and with one or more other chronic diseases. Cost savings associated with prescribers' behavioral changes were estimated at €108 million., Conclusion: Drugs prescribed for dementia are on a declining trend with important cost savings, and this was concomitant with guidance updates that left physicians to rely on their clinical expertise while managing dementia.

Objectives: To evaluate the effects of formulary restrictions on utilization and costs of oral hypoglycemic agents (OHAs), statins, and renin-angiotensin system (RAS) antagonists among low-income subsidy (LIS) recipients in Medicare Part D plans., Study Design: We analyzed a 5% sample of 2012 Medicare data from the Chronic Conditions Data Warehouse together with a customized dataset capturing beneficiaries' histories of plan assignment., Methods: We constructed 3 nonexclusive study cohorts comprising of users of OHAs, statins, and RAS antagonists. Eligible study subjects were LIS recipients randomized to benchmark plans. Formulary restrictions of interest were noncoverage, prior authorization, and step therapy. Study outcomes included generic dispensing rate (GDR), mean cost per prescription fill, and medication adherence based on proportion of days covered (PDC). Random intercept regression models were performed to estimate the effects of formulary restrictions on the study outcomes by drug class., Results: After covariate adjustment, beneficiaries who were subject to formulary restrictions on brand name pioglitazone and single-source brand name dipeptidyl peptidase-4 inhibitors (saxagliptin, sitagliptin, and sitagliptin-metformin) had a GDR 3 percentage points higher and a cost per prescription fill $10.8 less, but similar PDC compared with those who faced no restrictions. Restricting access to brand name atorvastatin and single-source brand name statins (rosuvastatin and ezetimibe-simvastatin) was associated with a GDR 14.9 percentage points higher and a cost per prescription fill $29.6 less, but with no impact on PDC. Restricting use of single-source brand name RAS antagonists (olmesartan, valsartan, and valsartan-hydrochlorothiazide) was associated with a GDR 15.0 percentage points higher, a cost per prescription fill $27.2 less, and a PDC 1.3 percentage points lower., Conclusions: Placing formulary restrictions on brand name drugs shifts utilization toward generic drugs, lowers the overall cost per prescription fill, and has minimal impact on overall adherence for OHAs, statins, and RAS antagonists among LIS recipients.

Background: The use of statins has increased substantially over the last 2 decades in England and represents a significant cost burden to the National Health Service. Therefore, it is important to understand what influences prescribers' choice., Objectives: This study examines the changes in use pattern of all statins in England (1998-2015). The study focuses on the use of simvastatin and atorvastatin before and after their patent expiry and rosuvastatin, to investigate the impact of the reduced acquisition costs on prescribing., Methods: Interrupted time series analysis of primary care use data from the health and social care information centre database from 1998 to 2015., Results: Primary care expenditure on statins increased by 125% during the period 1998 to 2004 driven by branded simvastatin and atorvastatin. Before 2003, the rate of use of more potent branded atorvastatin exceeds branded simvastatin. Between 2004 and 2011, the less potent but less expensive agent generic simvastatin has the higher utilisation rate (66%). Since 2012, the more potent agent but less expensive generic atorvastatin has the higher utilisation rate (50%). The more potent branded rosuvastatin failed to make a significant impact on the English statins market., Conclusions: The availability of generic statins has reduced overall expenditure significantly. When there is a significant price difference, acquisition cost appears to be the main influencing factor in prescribing statins, but, when costs are similar, potency is a key factor. This suggests that English prescribers are cost sensitive and appear to be prepared to trade marginal benefit for savings., (Copyright © 2017 John Wiley & Sons, Ltd.)

Objectives: In the UK, patients who require intravenous antimicrobial (IVA) treatment may receive this in the community through outpatient parenteral antimicrobial therapy (OPAT) services. Services include: IVA administration at a hospital outpatient clinic (HO); IVA administration at home by a general nurse (GN) or a specialist nurse (SN); or patient self-administered (SA) IVA administration following training. There is uncertainty regarding which OPAT services represent value for money; this study aimed to estimate their cost-effectiveness., Methods: A cost-effectiveness decision-analytic model was developed using a simulation technique utilizing data from hospital records and a systematic review of the literature. The model estimates cost per QALY gained from the National Health Service (NHS) perspective for short- and long-term treatment of infections and service combinations across these., Results: In short-term treatments, HO was estimated as the most effective (0.7239 QALYs), but at the highest cost (£973). SN was the least costly (£710), producing 0.7228 QALYs. The combination between SN and HO was estimated to produce 0.7235 QALYs at a cost of £841. For long-term treatments, SN was the most effective (0.677 QALYs), costing £2379, while SA was the least costly at £1883, producing 0.666 QALYs. A combination of SA and SN was estimated to produce 0.672 QALYs at a cost of £2128., Conclusions: SN and SA are cost-effective for short- and long-term treatment of infections, while combining services may represent the second-best alternative for OPAT in the UK., (© The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Formulary restrictions are implemented to reduce pharmacy costs and ensure appropriate use of pharmaceutical products. As adoption of formulary restrictions increases with rising pharmacy costs, there is a need to better understand the potential effect of formulary restrictions on patient and payer outcomes., Objective: To conduct a systematic literature review that assesses the effect of formulary restrictions on the following outcomes: medication adherence, clinical outcomes, treatment satisfaction, drug utilization, health care resource utilization, and economic outcomes., Methods: Studies published in 2005 or later were identified from the MEDLINE, Embase, and Cochrane databases and the National Health Service Economic Evaluation Database, using 2 sets of search terms. A total of 17 formulary restriction terms (e.g., step therapy [ST] and prior authorization [PA]) and 55 outcome terms were included, resulting in 935 unique search term combinations. Two reviewers independently conducted analyses of the titles, abstracts, and full-text articles. The search was limited to English-language articles that evaluated the effect of ST and/or PA placed by U.S. third-party payers on the following outcomes: patient outcomes (medication adherence, clinical outcomes, and treatment satisfaction) and payer outcomes (drug utilization, health care resource utilization, and economic outcomes)., Results: Of 2,321 reviewed articles, 59 articles met the study inclusion criteria. The included studies assessed the effect of ST (n = 18), PA (n = 35), or both (n = 6) on medication adherence (n = 14), clinical outcomes (n = 12), treatment satisfaction (n = 2), drug utilization (n = 39), health care resource utilization (n = 18), and economic outcomes (n = 42). The 59 articles measured 164 outcomes across the patient, health care resource utilization, and economic outcome categories of interest. Of the total number of outcomes, 50.6% (n = 83) were negative in direction or were unfavorable, whereas 40.2% (n = 66) were positive in direction or were favorable, when the perspectives of patients and payers were considered. Of the total number of drug utilization outcomes reported (n = 46), the majority showed lower drug utilization (> 90%). However, in some of the articles, pharmacy cost savings resulting from lower drug utilization appeared to be offset by increased medical costs., Conclusions: Formulary coverage decisions may have unintended consequences on patient and payer outcomes despite lower drug utilization and pharmacy cost savings; therefore, careful evaluation of restrictions before policy implementation and continued reevaluation after implementation is warranted., Disclosures: This study was funded by Novartis Pharmaceuticals. Park and Ko are employed by Novartis Pharmaceuticals in East Hanover, New Jersey, and Ko holds stock in Novartis. Raza, George, and Agrawal are employed by Novartis Healthcare in Hyderabad, India. Study concept and design were contributed primarily by Park and Ko, along with the other authors. Raza, George, and Agrawal collected the data, along with Park and Ko. Data interpretation was performed by Agrawal, Raza, George, Park, and Ko. The manuscript was written and revised by Raza, George, and Park, along with Ko and Agrawal. Results from this systematic literature review were presented at the AMCP Annual Meeting 2016; San Francisco, California; April 19-22, 2016.

Purpose: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1.1 billion in fines and settlements and one criminal conviction. No prior study, to our knowledge, has reported on the use of darbepoetin versus epoetin for CIA., Methods: We evaluated the dosing, utilization, and costs of erythropoiesis-stimulating agents among 3,761 South Carolina Medicaid patients with CIA., Results: Epoetin and darbepoetin utilization rates were 22% and 28% in 2003, 10% and 33% in 2007, and 3% and 7% in 2010, respectively. Mean per-patient per-administration epoetin and darbepoetin doses were 40,983 IU and 191 µg, respectively, in 2003 and 47,753 IU and 369 µg, respectively, in 2010. Mean monthly patient costs for epoetin and darbepoetin were $1,030 and $981, respectively, in 2003 and $932 and $1,352, respectively, in 2010. Epoetin use decreased steadily between 2002 and 2010; darbepoetin use increased steadily between 2003 and 2007 and then decreased steadily thereafter. Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010., Conclusion: To our knowledge, our findings are the first data reporting on epoetin versus darbepoetin use for CIA and support recently concluded lawsuits involving allegations of illegal marketing practices of the manufacturer of darbepoetin.

Background: Treatment modifications are necessary for addressing issues related to efficacy and tolerance of first-line monotherapy, but they increase the economic burden on patients and their health plans. Understanding the differences in costs between alternative treatment modification strategies, if any, can serve as a guideline for clinical decision making and for designing cost-containment strategies., Objective: To compare the health care utilization costs between (a) addition (i.e., use of free-pill combinations [FPCs] or fixed-dose combinations [FDCs]) and uptitration as alternatives for addressing efficacy issues and (b) switching and downtitration as alternatives for addressing tolerance issues with first-line antihypertensive monotherapy., Methods: This is a retrospective cohort study that used the 2008-2012 BlueCross BlueShield of Texas claims database. Patients who had a treatment modification within 12 months of initiating antihypertensive monotherapy were identified. All-cause and disease-related health care utilization costs and drug costs were estimated from the BlueCross BlueShield health plan's perspective over a 12-month period, starting from the date of treatment modification. Propensity score-adjusted generalized linear models were used to compare costs between alternative treatment modification strategies., Results: We identified 5,998 patients who met study criteria and had a modification of treatment: FPC (n = 1,395), FDC (n = 1,207), uptitration (n = 1,659), switching (n = 1,282), and downtitration (n = 455). All-cause and disease-related health services utilization costs were estimated for 12 months following treatment modification. Mean annual drug utilization costs were highest for the FDC strategy. All-cause inpatient and outpatient services utilization costs were significantly different between strategies used for addressing issues of tolerance and efficacy, respectively. Disease-related inpatient services utilization costs were lower for the FDC strategy compared with the uptitration strategy. However, disease-related inpatient services utilization costs were not significantly different for the downtitration strategy compared with the switch strategy., Conclusions: Health care costs following treatment modifications vary by type of strategy. The high costs of FDCs may be offset by the reduction of inpatient services utilization costs. Careful consideration should be given to the differences in costs between alternative strategies., Disclosures: No outside funding supported this study. The dataset used in this study was created for dissertational research on the patterns and outcomes of treatment modification in hypertensive patients. Data and database support were provided by University of Texas School of Public Health/BlueCross BlueShield of Texas research program in payment systems and policy. Sonawane Deshmukh was an employee of Anthem BlueCross BlueShield from August 2015 to August 2016. Hansen has received consulting funds from Daichii Sankyo and has provided expert testimony for Allergan and Boehringer Ingelheim. All other authors have no known conflicts of interest. Study concept and design were contributed by Sonawane Deshmukh, Garza, Wright, and Hansen. Sonawane Deshmukh and Ganduglia Cazaban collected the data, and data interpretation was performed by Sonawane Deshmukh, Qian, Wright, and Zeng. The manuscript was written primarily by Sonawane Deshmukh, along with Qian and Garza, and revised by Sonawane Deshmukh, Qian, Ganduglia Cazaban, and Hansen.

Current literature does not consistently show a benefit to providing medication cost information to inpatient health care prescribers. This study assessed the effectiveness of computerized provider order entry alerts that displayed the cost of a high-cost medication alongside a lower cost alternative, targeting 3 high-cost medications. Medication utilization during the one year prior to the intervention was compared to usage in the year after implementation. Reduced utilization of high-cost medications was found when comparing pre to post. Ipratropium hydrofluoroalkane and fluticasone hydrofluoroalkane metered dose inhaler utilization were reduced by 29% and 62%, respectively ( P < .001 for both). A 71% decrease in intravenous chlorothiazide was observed ( P < .001); however, its effect was unable to be separated from implementation of a heart failure diuretic protocol during the study period. Overall, these results suggest computerized medication cost alerts that recommend a lower cost therapeutic alternative are effective in changing prescribing practices.

Rational use of antimicrobial agents can reduce the burden of patients, reduce adverse drug reactions and effectively cure bacterial infections. In this paper the analysis is done on the antimicrobial use and cost-benefit rationality in medical emergency department. Based on the analysis of the use of antibiotics in hospital emergency department, Antimicrobial prescription accounting for 44.26% of the total prescription, involving cephalosporins, fluoroquinolones, macrolides, cephalosporins. According to the stakeholder theory, the use of antimicrobial agents involves multiple interests, too much emphasis on any party also affect the rational use of antimicrobial drugs. Pharmacy management departments need to develop a reasonable and scientific list of antimicrobial drugs, standard training people to correctly use the knowledge of antimicrobial drugs.

Introduction and Objectives: This study has two objectives: (1) to examine healthcare resource utilization in heart failure (HF) patients; and (2) to examine the treatment costs associated with HF in China., Methods: The data used in this study was from the 2014 national insurance database sponsored by the China Health Insurance Research Association (CHIRA), that covers national urban employees and residents. ICD-10 codes and keywords indicating heart failure diagnoses were used to identify patients with heart failure. Drug utilization, hospital visits, re-admission, and treatment costs in different service categories were examined., Results: A total of 7,847 patients were included in this analysis, of which 1,157 patients had a 1-year complete follow-up period. In total, 48.16% of patients received the combination treatment of angiotensin-converting-enzyme inhibitor (ACEI)/angiotensin II receptor blockers (ARB) and beta-blockers (BB); and 22.87% of patients received the combination treatment of ACEI/ARB, beta-blockers and Mineralocorticoid receptor antagonists (MRAs). The annual treatment cost per patient with HF diagnosis was RMB 28,974, of which 66% was for inpatient care. The cost on HF medications accounted for 8.2% of annual cost. Treatment cost was much higher in provincial-level municipalities than that of prefecture-level and other cities., Discussion and Conclusion: Hospitalization is a major driver of HF treatment cost. Compared to the requirements in international treatment guidelines, HF standard of care medication treatment was under-utilized among HF patients in China. The high re-admission rate among Chinese patients indicates that the management of HF needs to be improved. The percentage of GDP spent on treating HF patients was much lower than that in the developed countries.

Background: The improvement of medication use is a critical mechanism that accountable care organization (ACO) could use to save overall costs. Currently pharmaceutical spending is not part of the calculation for ACO-shared savings and risks. Thus, ACO providers may have strong incentives to prescribe more medications hoping to avoid expensive downstream medical costs., Methods: We designed a quasinatural experiment study to evaluate the effects of Pioneer ACOs on Medicare Part D spending and utilization. Medicare fee-for-service beneficiaries with Part D drug coverage who were aligned to a Pioneer ACO were compared with a random 5% sample of non-ACO beneficiaries. Outcomes included changes in Part D spending, number of prescription fills, percent of brand medications, and total Part A and B medical spending. We utilized a generalized linear model with a difference-in-differences approach to estimate 2011-2012 changes in these outcomes among beneficiaries aligned with Pioneer ACOs, adjusting for all beneficiary-level demographics, income and insurance status, clinical characteristics, and regional fixed effects., Results: Being in an ACO did not significantly affect Part D spending (-$23.52; P=0.19), total prescriptions filled (-0.12; P=0.27), and the percent of claims for brand-name drugs (0.06%; P=0.23). The ACO group was associated with savings in Parts A and B spending of $345 (P<0.0001) per person per year., Conclusions: We found that beneficiaries aligned to Pioneer ACOs were not associated with changes in pharmaceutical spending and use, but were associated with savings in Parts A and B spending in 2012.

Spending on prescription drugs (Rx) represents one of the fastest growing components of US healthcare spending and has coincided with an expansion of pharmaceutical promotional spending. Most (83%) of Rx promotion is directed at physicians in the form of visits by pharmaceutical representatives (known as detailing) and drug samples provided to physicians' offices. Such promotion has come under increased public scrutiny, with critics contending that physician-directed promotion may play a role in raising healthcare costs and may unduly affect physicians' prescribing habits towards more expensive, and possibly less cost-effective, drugs. In this study, we bring longitudinal evidence to bear upon the question of how detailing impacts physicians' prescribing behaviors. Specifically, we examine prescriptions and promotion for a particular drug class based on a nationally representative sample of 150,000 physicians spanning 24 months. The use of longitudinal physician-level data allows us to tackle some of the empirical concerns in the extant literature, virtually all of which have relied on aggregate national data. We estimate fixed-effects specifications that bypass stable unobserved physician-specific heterogeneity and address potential targeting bias. In addition, we also assess differential effects at both the extensive and intensive margins of prescribing behaviors and differential effects across physician-level and market-level characteristics, questions that have not been explored in prior work. The estimates suggest that detailing has a significant and positive effect on the number of new scripts written for the detailed drug, with an elasticity magnitude of 0.06. This effect is substantially smaller than those in the literature based on aggregate information, suggesting that most of the observed relationship between physician-directed promotion and drug sales is driven by selection bias. We find that detailing impacts selective brand-specific demand but does not have any substantial effects on class-level demand. The increase in brand-specific demand appears to crowd out demand for the substitute branded drug although not for the generic alternative. Results also indicate that most of the detailing response may operate at the extensive margin; detailing affects the probability of prescribing the drug more than it affects the number of prescriptions conditional on any prescribing. We draw some implications from these estimates with respect to effects on healthcare costs and public health. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Importance: The use of antiemetic drugs for patients receiving chemotherapy with low or minimal emetic risk has been recognized as a growing concern for health care costs and patients' welfare. Relatively few studies have examined antiemetic prophylaxis or treatment of emesis associated with chemotherapy with lower emetic risk., Objective: To describe the pattern in Japan of overprescribing prophylactic antiemetic drugs to patients who have received intravenous chemotherapy with minimal or low emetic risk., Design, Setting, and Participants: This secondary analysis of a health insurance claims database linked with the hospital-based cancer registry of 122 designated cancer care hospitals covered the period from September 1, 2010, to December 31, 2012. Data were included from patients who (1) were diagnosed with breast, lung, colorectal, stomach, cervical, or prostate cancer; (2) were 20 years or older at the time of the diagnosis; and (3) received intravenous chemotherapy with minimal or low emetic risk. The data from patients with advanced stage cancer (stage IV) were excluded. Data were analyzed from March 20, 2014, to June 30, 2016., Main Outcomes and Measures: The percentage of chemotherapy administration involving patients prescribed prophylactic antiemetic drugs, namely, a neurokinin 1 receptor antagonist, serotonin receptor antagonist, and/or dexamethasone, was calculated. The costs of potentially unnecessary antiemetic drugs were estimated using the National Health Insurance drug price list for 2011., Results: A total of 8545 patients (5886 women [68.9%] and 2659 men [31.1%]; mean [SD] age, 61.9 [12.8] years) undergoing 73 577 administrations of chemotherapy with minimal emetic risk (2464 patients; 22 619 administrations) or low emetic risk (6081 patients; 50 958 administrations) were identified. Of these, patients who received 24 373 administrations of chemotherapy with a low emetic risk (47.8%) and 633 administrations of chemotherapy with a minimal emetic risk (2.8%) were prescribed serotonin receptor antagonists and dexamethasone. Outpatients in the low emetic risk group underwent more frequent administration of chemotherapy that included prescription of both drugs (53.1% of the chemotherapy; 95% CI, 51.6%-54.7%) compared with inpatients (33.7% of the chemotherapy; 95% CI, 31.7%-35.9%). Consequently, approximately ¥170 million (US $1.6 million) was unnecessarily spent on prophylactic antiemetic drugs for these patients., Conclusions and Relevance: A substantial number of patients receiving chemotherapy with minimal and low emetic risk were prescribed potentially unnecessary prophylactic antiemetic drugs. The judicious use of these drugs could spare the burden of extra costs and the potential risk for adverse effects for patients.

Background: The Affordable Care Act (ACA) expanded health care and medication insurance coverage through Medicaid expansion in select states. Expansion has the potential to increase the availability of health services to patients, including prescription medications. However, limited studies have examined how expansion affected prescription drug utilization and reimbursement., Objective: To compare prescription drug utilization (number of prescriptions filled) and reimbursement trends between states that did and did not expand Medicaid coverage in 2014, while accounting for known effects of expansion on Medicaid enrollment., Methods: We conducted a comparative interrupted time series using retrospective Medicaid state drug utilization data from 2011 to 2014. After inclusion/exclusion criteria, 8 states that expanded Medicaid in 2014 and 10 states that did not expand Medicaid were studied. Primary outcomes were changes in quarterly prescription drug utilization and quarterly total prescription drug reimbursement before and after expansion. To account for increases in enrollment in expansion states, secondary outcomes were per-member-per-quarter (PMPQ) utilization and reimbursement before and after expansion., Results: Expansion states experienced a 1.4 million prescriptions per quarter and $163 million per quarter increase in utilization and reimbursement above the change in rates observed in nonexpansion states after expansion (P < 0.001). Specifically, 1 year after ACA implementation, expansion states used 17.0% more prescriptions and spent 36.1% more in reimbursement than the quarter preceding expansion. Expansion and nonexpansion states experienced significant drops in PMPQ prescriptions immediately after expansion (P < 0.001), but PMPQ prescriptions and reimbursement trends increased by the end of the postexpansion period in expansion states (P < 0.029 and P < 0.001, respectively)., Conclusions: Study results suggest that Medicaid expansion offers vulnerable patients who were previously uninsured increased access to health care resources, specifically prescription drugs. Although this hypothesis would benefit from further testing, it aligns with previous studies that have shown that Medicaid expansion has led to increased access to coverage and care. While enrollment contributes to the increase in prescription utilization and reimbursement, the drop in PMPQ utilization suggests that the patients entering the program are healthier than existing patients. This shows that risk pooling is working. However, the increase in PMPQ reimbursement suggests that new enrollment may not be the only factor driving reimbursement changes. Factors such as changes in product mix, risk pool composition, and drug pricing and their effects on total and per-member reimbursement should be evaluated in future studies., Disclosures: No outside funding supported this study. Mahendraratnam is currently a Worldwide Health Economics and Outcomes Research Pre-doctoral Fellow at Bristol-Myers Squibb and previously provided advisory services to public and private sector clients while employed at Avalere Health, an Inovalon Company, as well as completed an internship at Genentech, a member of the Roche Group. Farley and Dusetzina have no conflicts of interest to report. Preliminary results of this study were presented at the 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 21st Annual Meeting in Washington, DC, on May 21-25, 2016, and the 2016 AcademyHealth Annual Research Meeting (ARM) in Boston, Massachusetts, on June 26-28, 2016. Study concept and design were contributed by Farley, Mahendraratnam, and Dusetzina. Mahendraratnam, Farley, and Dusetzina collected the data, and data interpretation was performed by all the authors. The manuscript was written by Mahendraratnam, Farley, and Dusetzina and revised by Farley, Dusetzina, and Mahendraratnam.

Antimicrobial use in animals is known to contribute to the global burden of antimicrobial resistance. Therefore, it is critical to monitor antimicrobial sales for livestock and pets. Despite the availability of veterinary antimicrobial sales data in most European countries, surveillance currently lacks consumption monitoring at the animal species level. In this study, alternative methods were investigated for stratifying antimicrobial sales per species using Swiss data (2006-2013). Three approaches were considered: (i) Equal Distribution (ED) allocated antimicrobial sales evenly across all species each product was licensed for; (ii) Biomass Distribution (BMD) stratified antimicrobial consumption, weighting the representativeness of each species' total biomass; and (iii) Longitudinal Study Extrapolation (LSE) assigned antimicrobial sales per species based on a field study describing prescription patterns in Switzerland. LSE is expected to provide the best estimates because it relies on field data. Given the Swiss example, BMD appears to be a reliable method when prescription data are not available, whereas ED seems to underestimate consumption in species with larger populations and higher treatment intensity. These methods represent a valuable tool for improving the monitoring systems of veterinary antimicrobial consumption across Europe., (This article is copyright of The Authors, 2017.)

Background: Value-based benefit design has been suggested as an effective approach to managing the high cost of pharmaceuticals in health insurance markets. Premera Blue Cross, a large regional health plan, implemented a value-based formulary (VBF) for pharmaceuticals in 2010 that explicitly used cost-effectiveness analysis (CEA) to inform medication copayments., Objective of the Study: The objective of the study was to determine the impact of the VBF., Design: Interrupted time series of employer-sponsored plans from 2006 to 2013., Subjects: Intervention group: 5235 beneficiaries exposed to the VBF., Control Group: 11,171 beneficiaries in plans without any changes in pharmacy benefits., Intervention: The VBF-assigned medications with lower value (estimated by CEA) to higher copayment tiers and assigned medications with higher value to lower copayment tiers., Measures: Primary outcome was medication expenditures from member, health plan, and member plus health plan perspectives. Secondary outcomes were medication utilization, emergency department visits, hospitalizations, office visits, and nonmedication expenditures., Results: In the intervention group after VBF implementation, member medication expenditures increased by $2 per member per month (PMPM) [95% confidence interval (CI), $1-$3] or 9%, whereas health plan medication expenditures decreased by $10 PMPM (CI, $18-$2) or 16%, resulting in a net decrease of $8 PMPM (CI, $15-$2) or 10%, which translates to a net savings of $1.1 million. Utilization of medications moved into lower copayment tiers increased by 1.95 days' supply (CI, 1.29-2.62) or 17%. Total medication utilization, health services utilization, and nonmedication expenditures did not change., Conclusions: Cost-sharing informed by CEA reduced overall medication expenditures without negatively impacting medication utilization, health services utilization, or nonmedication expenditures.

Objectives: The aim of this study was to examine submissions made to the Pharmaceutical Benefits Advisory Committee (PBAC) and assess whether the predicted financial impact was associated with a recommendation. The second objective was to assess whether the financial and utilization estimates for listing the proposed medicine were reliable., Methods: Data were extracted from public summary documents of major submissions considered by the PBAC from 2012 to 2014. Information collected included whether submissions were accepted, rejected, or deferred; estimated use; and financial impact. For those submissions that were recommended in 2012 and listed on the Pharmaceutical Benefits Scheme (PBS) by January 2014, a comparison was made between predicted and actual use and cost in 2014, based on PBS utilization., Results: In 2012 to 2014, the PBAC considered 142 unique major submissions; of those, 65 were recommended for listing. A higher financial cost to the government was a statistically significant factor in predicting rejection (p = .004 for cost > AUD 30 million Australian dollars [20.7 million Euros] compared with cost-saving). Of the submissions that were recommended in 2012 and listed by 2014, the actual use was higher than predicted for 5/19 medications. The estimated cost was outside the predicted bracket of cost for 10/19 medications, with 8/19 medications having threefold underestimated expenditure, and 2/19 items having lower than predicted expenditure., Conclusions: This study highlights that the predicted financial impact of a medication to the PBS budget is associated with a PBAC recommendation and also highlights that predicted use may not reflect actual prescribing practices.

Background: The Affordable Care Act (ACA) include provisions that reduce beneficiaries' cost sharing and eventually closes the coverage gap-known as the "doughnut hole"-that was originally part of Medicare prescription drug coverage implemented in 2006., Objectives: This study examines changes in overall prescription drug utilization and out-of-pocket spending as well as by manufacturer type (brand vs. generic), through 2013 as a result of the doughnut hole provisions of the ACA., Materials and Methods: This analysis is based on data from Medical Expenditure Panel Survey and the sample for this analysis includes all individuals 55 years of age and older. A difference-in-differences methodology was adopted to measure changes in drug utilization and out-of-pocket spending among both the treatment group and the comparison group after the ACA., Results: The findings from this study suggest that overall out-of-pocket spending significantly decreased after closing the coverage gap, mainly because of a significant reduction in out-of-pocket spending on brand-name drugs. Conversely, the results show that generic drug utilization increased after closing the coverage gap. As expected, the effects were considerably larger for people who fell into the doughnut hole., Conclusions: The ACA doughnut hole provisions likely contributed to a reduction in out-of-pocket spending for prescription drugs for part D beneficiaries, especially for people who fell into the doughnut hole.

Background: Although contractors that offer prescription drug plans through the Medicare Part D program are evaluated in part on enrollees' medication adherence scores, little evidence addresses contractors' ability to influence these scores., Objective: We used data from the Centers for Medicare and Medicaid Services and US Census to investigate contractors' ability to influence their medication adherence scores. In accordance with a conceptual model, we hypothesized that contractors can directly and indirectly influence their medication adherence scores based on how effectively they manage prescription drug benefits for enrollees. We focused on 4 plan management variables: service reliability, stability/accuracy of drug prices, accessibility of prescription drugs, and availability of drug information. We examined indirect effects via enrollees' satisfaction with the plan., Research Design: We conducted a cross-sectional study based on 2012 data for which the contractor was the unit of analysis. We conducted path regression models that accounted for plan type (ie, Medicare Advantage vs. stand alone) and enrollee characteristics., Results: Among contractors, enrollee satisfaction scores were positively and significantly associated with medication adherence scores. Two of the 4 plan management variables were observed to have both direct and indirect effects on medication adherence scores: accessibility of prescription drugs and service reliability., Conclusions: Our study indicates that Part D contractors do appear to have some level of influence over their medication adherence scores based on how effectively they manage prescription drug benefits for enrollees. Accessibility to prescriptions and better service delivery appear important in this regard and should be explored further in future research.

Background: The impact of formulary management strategies on utilization and expenditures in overactive bladder (OAB) treatment has not been extensively investigated. In 2013, step therapy (ST) policies for 2 branded OAB treatments, mirabegron and fesoterodine, were removed from Humana Medicare Advantage Prescription Drug (MAPD) plans and Medicare prescription drug plans (PDP), allowing for an examination of the effect of ST policies on OAB medication use patterns and costs., Objective: To assess the impact of removal of formulary restriction policies for mirabegron and fesoterodine on medication utilization patterns and costs associated with OAB treatment in Medicare patients., Methods: A retrospective cross-sectional study design was utilized. Subjects included individuals enrolled in Humana MAPD plans or PDPs, aged ≥ 65 years, with ≥ 1 prescription for an OAB medication in 2013. Patient demographic characteristics, OAB medication utilization, and pharmacy cost trends in 2013 were described. OAB medication use was calculated as the number of 30-day-supply equivalent medication claims and reported as a percentage of the total number of 30-day-supply equivalent claims across all OAB products. OAB medication expenditures were calculated as a percentage of the sum of pharmacy costs for OAB medications and reported separately for each month and drug during 2013. Temporal trends of OAB medication utilization and expenditures in 2013 were calculated using ordinary least squares regression., Results: Of 194,511 patients, trends in utilization of OAB medications indicated that on average, there was a statistically significant monthly increase in utilization of mirabegron (regression coefficient [B] = 274; P < 0.001; 95% CI: 218, 330), fesoterodine (B = 167; P < 0.001; 95% CI = 129, 205), oxybutynin extended release (ER; B = 357; P = 0.011; 95% CI = 99, 614), and trospium ER (B = 33; P = 0.001; 95% CI = 17, 50) and statistically significant decreases in utilization of solifenacin (B = -202; P = 0.048; 95% CI = -402, -2), tolterodine ER (B = -287; P = 0.002; 95% CI = -437, -137), darifenacin (B = -94; P < 0.001; 95% CI = -128, -61), and trospium immediate release (IR; B = -22; P = 0.001; 95% CI = -32, -12). Total OAB medication expenditures significantly increased an average of 0.12% for each month during the course of 2013 (B = 0.12; P = 0.026; 95% CI = 0.017, -0.223). While monthly oxybutynin IR utilization did not change significantly throughout 2013 (B = 228; P = 0.169; 95% CI = -114, -570), it demonstrated the largest average monthly expenditure increase (B = 0.082; P < 0.001; 95% CI = 0.056, 0.108). When removing oxybutynin IR costs from the total OAB medication costs, the trend in total OAB medication average monthly expenditures was not significant (B = 0.038; P = 0.365; 95% CI = -0.051, -0.126). An over 4-fold per-unit-cost increase for oxybutynin IR was noted., Conclusions: Utilization of 2 branded OAB products increased in the months after ST removal with minimal cost impact. One of the possible reasons total OAB expenditures increased may have been due to the increased cost of the largest-volume generic product, oxybutynin IR., Disclosures: This research was funded by Astellas Pharma Global Development and was conducted as part of the Astellas-Humana Research Collaboration. Ng, Kristy, Schermer, and Bradt are employees of Astellas. Astellas manufactures mirabegron (Myrbetriq) and solifenacin (VESIcare). Abbass, Caplan, Collins, and Suehs are employees of Comprehensive Health Insights, a subsidiary of Humana, which received funding from Astellas for this study. Suehs owns stock in Humana. Chan is an employee of Humana Pharmacy Solutions. Portions of this study were presented as a poster at Academy of Managed Care Pharmacy Nexus 2015; October 26-29, 2015; Orlando, Florida. Study concept and design were contributed by Ng, Chan, Suehs, and Abbass, along with Collins. Abbass took the lead in data collection, along with Collins and with assistance from Caplan, Chan, and Suehs. Data interpretation was provided by Kristy and Bradt, along with Abbass, Caplan, Ng, Suehs, Collins, and Chan. The manuscript was written primarily by Caplan, along with Schermer, Suehs, and Abbass, and revised by Caplan, Schermer, and Ng, along with the other authors.

In recent years, hospitals have routinely implemented antimicrobial stewardship (AS) programs, and it is important that these programs are effective. Consequently, we utilized a customized computer system to support infection management and implemented a pharmacist-driven AS program in our hospital. Using this computer system, a pharmacist monitored the daily usage of carbapenems and agents against anti-methicillin-resistant Staphylococcus aureus and generated a patient database. With the use of this computer system, we found that the patient database entry time significantly decreased from 24 to 12 min (p<0.01). Subsequently, we were also able to monitor tazobactam/piperacillin usage owing to the increased efficiency of our AS program. As a result, the average number of monitored patients significantly increased from 51 to 72 per month (p<0.01) and the number of proposed prescriptions increased from 189 to 238 per year. Additionally, the usage of carbapenems and tazobactam/piperacillin significantly decreased (p<0.01) after implementation of this computer support system. In summary, we recommend that pharmacists utilize computer systems to implement AS programs because they increase the efficiency of interventions and monitoring of patients and promote appropriate antibiotic use.

Background: Improper antibiotic use is one of the main drivers of bacterial resistance to antibiotics, increasing infectious diseases morbidity and mortality and raising costs of healthcare. The level of antibiotic consumption has been shown to vary according to socioeconomic determinants (SED) such as income and access to education. In many Latin American countries, antibiotics could be easily purchased without a medical prescription in private pharmacies before enforcement of restrictions on over-the-counter (OTC) sales in recent years. Brazil issued a law abolishing OTC sales in October 2010. This study seeks to find SED of antibiotic consumption in the Brazilian state of São Paulo (SSP) and to estimate the impact of the 2010 law., Methods: Data on all oral antibiotic sales having occurred in the private sector in SSP from 2008 to 2012 were pooled into the 645 municipalities of SSP. Linear regression was performed to estimate consumption levels that would have occurred in 2011 and 2012 if no law regulating OTC sales had been issued in 2010. These values were compared to actual observed levels, estimating the effect of this law. Linear regression was performed to find association of antibiotic consumption levels and of a greater effect of the law with municipality level data on SED obtained from a nationwide census., Results: Oral antibiotic consumption in SSP rose from 8.44 defined daily doses per 1,000 inhabitants per day (DID) in 2008 to 9.95 in 2010, and fell to 8.06 DID in 2012. Determinants of a higher consumption were higher human development index, percentage of urban population, density of private health establishments, life expectancy and percentage of females; lower illiteracy levels and lower percentage of population between 5 and 15 years old. A higher percentage of females was associated with a stronger effect of the law., Conclusions: SSP had similar antibiotic consumption levels as the whole country of Brazil, and they were effectively reduced by the policy., Competing Interests: The authors have declared that no competing interests exist.

Objective: After sumatriptan was approved by the Food and Drug Administration in 1992, triptans became first-line anti-migraine therapies. Rapidly rising triptan expenditures, however, led payers, including Medicaid, to implement cost-containment policies. We describe triptan utilization and reimbursement trends in Medicaid., Methods: Using national summary files for outpatient drug utilization, utilization and expenditure data from 1993 to 2013 were extracted and summed for all triptan national drug codes reimbursed by Medicaid. Data were collected separately for tablets, injections and sprays., Results: The number of triptan prescriptions increased from 87,348 in 1993 to 0.9 million in 2004; fell to 0.4 million in 2009; rose to 1 million in 2011; and rose 1.2 million in 2013. In 2013, Medicaid spent $96.8 million on triptans: 74.4%, 18.4% and 7.2% for tablets, injections and sprays, respectively. Average reimbursement per prescription was $54 for tablets, $351 for injections and $235 for sprays in 2013. From 1993 to 2013, sumatriptan was the most widely prescribed among the triptans., Conclusions: The substantial increase in triptan prescriptions from 2009 to 2011, without being convincingly explained by either rising migraine prevalence or rising Medicaid enrollment, is suggestive of reduced access to these medications prior to 2009. Cost-containment policies may have inadvertently prevented Medicaid migraineurs from obtaining appropriate pharmacotherapy., Prior Presentations: An earlier version of this paper was presented as a poster at the Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Philadelphia, PA, May 2015, where it received a finalist award., (© International Headache Society 2016.)

Objectives: The main objective was to assess resource use and costs of starting treatment with insulin or injectable GLP-1 receptor analogues (GLP-1 RAs) in a Spanish population of patients with type 2 diabetes mellitus. Treatment adherence and persistence were also determined for both treatment groups., Patients and Methods: A retrospective, non-interventional, observational study was conducted. Patients aged ≥20 years who started treatment with insulin or GLP-1 RAs in the 2010-2012 period were recruited. Use of healthcare resources was estimated to evaluate healthcare costs in these two groups of patients (medical visits, hospital stay, emergency visits, diagnostic or treatment requests, medication). Clinical information including body mass index (BMI, kg/m 2 ), metabolic control (HbA1c), adherence, persistence, and complications (hypoglycemia, and cardiovascular events (CVE) was collected. The follow-up period was 12 months. Only direct healthcare costs were considered., Results: A total of 1301 patients with a mean age of 67.6 years (51.6% males) were recruited. Of these, 71.9% and 28.1% were on treatment with insulin and GLP-1 RA respectively. After one year of follow-up, patients treated with GLP-1 RAs were found less visits to primary care (8 vs. 11; P<.001) and specialized care (1.0 vs. 1.8; P<.001), hospital stays (0.3 vs. 0.7; P=.030) and less visits to the emergency room (0.8 vs. 1.6; P<.001). Patients treated with GLP-1 showed greater adherence (88.1% vs. 82.7%; P<.001) and persistence (62.0% vs. 55.9%; P=.046), and had less hypoglycemia episodes (13.4% vs. 18.7%; P=.022), with similar metabolic control (HbA1c: 7.2% vs. 7.4%; P=.049), BMI (29.1 vs. 30.9kg/m 2 ), and CVE rate (9.1% vs. 11.5%; P=.330) respectively. The mean corrected direct healthcare cost per patient was €1787 vs. €2005 (P=.046.) CONCLUSIONS: Patients treated with GLP-1 RAs caused lower direct healthcare costs for the National Health System than patients treated with insulin. The results may be explained by greater treatment adherence and lower hypoglycemia rates in patients treated with GLP-1 RAs. Additional studies are needed to confirm these possibilities., (Copyright © 2016. Publicado por Elsevier España, S.L.U.)

We evaluated changes in the use of non-steroidal anti-inflammatory drugs (NSAIDs), non-opioid analgesics and cough and cold medicines and its relation with the use of antibiotics after the over-the-counter (OTC) antibiotic sales restrictions in Mexico and Brazil. IMS Health provided retail quarterly data from the private sectors in Mexico and Brazil from the first quarter of 2007 to the first quarter of 2013. Data of each active substance of antibiotics, easily accessible medicines perceived as antibiotics substitutes (cough and cold medicines, analgesics and NSAIDs-the latter two being combined in the analyses), and medicines to control for external factors that can affect the medicines usage trend (antihypertensives) were converted from kilograms to defined daily doses per 1000 inhabitants days (DDD/TID). Interrupted time series were used to estimate changes in level of medicines use at the intervention point and slope after the regulation. The Gregory-Hansen cointegration test was used to explore the relation between the use of antibiotics and perceived substitutes. After the regulation in Mexico NSAIDs-analgesics usage level increased by 1.1 DDD/TID with a slope increase of 0.2 DDD/TID per quarter and the cough and cold medicines usage level increased by 0.4 DDD/TID. In Brazil NSAIDs-analgesics usage level increased by 1.9 DDD/TID, and cough and cold medicines did not change. In the two countries, NSAIDs-analgesics usage changes were related with antibiotic usage changes; in Mexico cough and cold medicines usage changes had a relation with the antibiotics usage changes. These results showed a substitution effect on the use of other medicines, especially NSAIDs and analgesics, after reinforcement of OTC antibiotics sales restrictions. These regulations aimed to improve the antibiotics use and as a consequence reduce antimicrobial resistance; however, this type of policies should be comprehensive and take into account the potential substitution effects on the use of other medicines., (© The Author 2016. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: We evaluated the consumption of specific medications for treating cognitive symptoms associated with AD and other types of dementia in individuals over 60 years of age between 2006 and 2011 in the Basque Country., Methods: A retrospective descriptive study was conducted. The pharmacy division of the Basque Government Department of Health provided the prescribing data for the following drugs: donepezil, rivastigmine, galantamine, and memantine. The number of defined daily doses (DDDs) and the number of DDDs per 1000 inhabitants/day (DHD) were calculated., Results: Consumption increased by 49.72% between 2006 and 2011. There were marked differences between drugs (13.02% donepezil; 93.18% rivastigmine; 37.79% galantamine; 70.40% memantine) and Basque provinces (16.34% in Áraba; 50.49% in Bizkaia; 57.37% in Gipuzkoa). Likewise, expenditure increased from €11.5 million in 2006 to € 18.1 million in 2011., Conclusions: This study shows increased consumption of these drugs, although there are also marked differences by province which may be due to differences in prescribing habits. Spending for these drugs rose parallel to this increase in consumption; drug prices remained stable throughout the study period., (Copyright © 2014 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.)

Over-prescription has become one major problem in China's health care sector. Incorporating interview data from hospitals in Shanghai, this paper provided empirical evidence on how the process of over-prescription was carried out in day-to-day clinical settings, and demonstrates various mechanisms that allow over-prescription to continue vigorously in the context of the Chinese health care system. In particular, this study identified four levels of incentives that over-prescription was carried out: hospital, medical department, doctors and pharmaceutical companies. Due to the insufficient funding from the government and rising operational costs, hospitals had to rely on the sales of drugs and provision of medical services to survive. This funding pressure then transferred to specific revenue targets for medical departments. A combination of incentives, including drug remunerations, bonus system, low pay and high workloads motivated over-prescription at doctor level. At pharmaceutical company level, high profits of pharmaceuticals products as well as lack of emphasis on efficacy of drugs led to under-table payments and illicit drug remunerations. The study argued that the way that the Chinese health care system operates was based on the profit-seeking principle rather than on fulfilling its social functions, and called for a systematic reform of provider incentives to eradicating the problem of over-prescription.

Introduction: Hypertension has been reported as the strongest modifiable risk factor for cardiovascular morbidity and mortality., Aims: The aim of the study was to identify the most prescribed antihypertensive drugs, its patterns, comorbidities, cost of medications, and laboratory investigations., Settings and Design: This study was a cross-sectional, descriptive study of hypertensive patients conducted at the Lagos State University Teaching Hospital, Ikeja., Subjects and Methods: A total of 200 case notes were retrieved from the medical records unit over a period of 8 weeks. Information on antihypertensive prescriptions and comorbidities was retrieved. The average cost of medications and laboratory investigations was calculated. Statistical Analysis Tool Used: SPSS software version 16., Results: The mean age of the patients was 58.44 ± 12.65 years. Of the 200 patients, 5 (2.5%) were on monotherapy and 195 (97.5%) were on combination therapy. One hundred and twenty (60%) patients had comorbidities which included congestive heart failure 55 (27.5%), diabetes mellitus 22 (11%), hyperlipidemia 15 (7.5%), and cardiovascular disease 13 (6.5%). The various classes of antihypertensive drugs prescribed were diuretics 128 (64.0%), beta-blockers 126 (63.0%), calcium channel blockers 106 (53.0%), angiotensin-converting enzymes inhibitors 103 (51.5%), angiotensin receptor blockers 33 (16.5%), alpha blockers 9 (4.5%), and fixed drug combinations 2 (1.0%). The average cost per month of the antihypertensive medications was ₦ 2045 (US$10.2)., Conclusions: Antihypertensive prescription pattern was in accordance with the seventh report of Joint National Committee on Prevention, Detection, Evaluation, and Treatment of high blood pressure. Community-based insurance scheme should be encouraged and effective implementation of integrated noncommunicable diseases screening into the primary health care services would be helpful.

Objective To explore trends in demographics, comorbidities, anti-diabetic drug usage, and healthcare utilization costs in patients with newly-diagnosed type 2 diabetes mellitus (T2DM) using a large US claims database. Methods For the years 2007 and 2012, Truven Health Marketscan Research Databases were used to identify adults with newly-diagnosed T2DM and continuous 12-month enrollment with prescription benefits. Variables examined included patient demographics, comorbidities, inpatient utilization patterns, healthcare costs (inpatient and outpatient), drug costs, and diabetes drug claim patterns. Results Despite an increase in the overall database population between 2007-2012, the incidence of newly-diagnosed T2DM decreased from 1.1% (2007) to 0.65% (2012). Hyperlipidemia and hypertension were the most common comorbidities and increased in prevalence from 2007 to 2012. In 2007, 48.3% of newly-diagnosed T2DM patients had no claims for diabetes medications, compared with 36.2% of patients in 2012. The use of a single oral anti-diabetic drug (OAD) was the most common diabetes medication-related claim (46.2% of patients in 2007; 56.7% of patients in 2012). Among OAD monotherapy users, metformin was the most commonly used and increased from 2007 (74.7% of OAD monotherapy users) to 2012 (90.8%). Decreases were observed for sulfonylureas (14.1% to 6.2%) and thiazolidinediones (7.3% to 0.6%). Insulin, predominantly basal insulin, was used by 3.9% of patients in 2007 and 5.3% of patients in 2012. Mean total annual healthcare costs increased from $13,744 in 2007 to $15,175 in 2012, driven largely by outpatient services, although costs in all individual categories of healthcare services (inpatient and outpatient) increased. Conversely, total drug costs per patient were lower in 2012 compared with 2007. Conclusions Despite a drop in the rate of newly-diagnosed T2DM from 2007 to 2012 in the US, increased total medical costs and comorbidities per individual patient suggest that the clinical and economic trends for T2DM are not declining.

Prescription drugs are a major source of US health care expenditure. "Me too" brand-name medications contribute to the cost of drugs, which is substantial for consumers. In 2013 patient copayments averaged 10.5 times more for two commonly prescribed brand-name medications versus generic therapeutic alternatives., (Project HOPE—The People-to-People Health Foundation, Inc.)

Objectives: The French pay-for-performance (P4P) contract CAPI implemented by the national health insurance included a target-goal which aims at reducing benzodiazepines prescriptions. In this investigation, we would like to assess whether: (1) the general practitioners (GPs) having signed P4P contract obtain better results regarding the target-goal than non-signatories; (2) (part of) this progression is due to the CAPI contract itself (tentative measurement of a "causal effect"); (3) (part of) the money spent on this P4P incentive can be self-financed with the amount of pharmaceuticals saved., Methods: We matched cross-sectional and longitudinal data including 4622 French GPs from June 2011 to December 2012. A treatment effect model using instrumental variables was performed to take into account potential self-selection issue in signing. After having identified the NET impact of the P4P, we calculate the cost of an avoided benzodiazepines treatment., Results: In our study, GPs who have signed the CAPI contract (36 % of the sample) are more numerous in achieving benzodiazepines target goal than non-signatories: 90.7 vs. 85.5 %. After controlling for the self-selection bias, the propensity of GPs to achieve the benzodiazepines target is only 0.31 % higher for signatories than for their non-signing counterparts-estimate for June 2012, which yields a statistically significant gap. Our economic analysis demonstrates that the CAPI contract does not allow savings, but presents in 2012 a NET cost of 93.6€ per avoided benzodiazepines treatment (291€ in 2011)., Conclusions: The P4P contract has a positive but modest impact on the achievement of GPs regarding benzodiazepines indicator.