Evaluating catheter complications and outcomes in patients receiving home parenteral nutrition.

RATIONALE, AIMS AND OBJECTIVES: We describe catheter complications and outcomes in patients who received home parenteral nutrition (HPN) therapy. METHODS: Retrospective chart data were obtained from Boston Home Infusion agency that provided HPN therapy to 212 patients [International Classification of Diseases, 9th revision (ICD-9) codes: gastrointestinal (GI)-related disorders and oncology] between 1 January 2005 and 30 September 2011. RESULTS: Of the 163 patients who represented 19104 home-catheter days, 19 (11.7%) patients experienced 25 catheter complications (CCs; 12 occlusions, 11 central line-associated bloodstream infections, one thrombosis and one line dislodgment). The overall CC rate was 1.30 per 1000 peripherally inserted central catheter (PICC)-line days. The mean number of PICC-line days (278.7 ± 335.0 vs. 95.9 ± 154.0) and patients with at least one hospital admission were significantly higher for patients with one or more CCs compared with patients with no CCs (P<0.03). CONCLUSION: Patients who experienced CCs had more PICC-line days, more hospital admissions and had an ICD-9 code for GI-related disorders compared with patients with oncology-related diagnoses.

Comparing patient preferences and healthcare provider recommendations with the pen versus vial-and-syringe insulin delivery in patients with type 2 diabetes.

OBJECTIVES: This study aimed to examine healthcare provider (HCP) recommendations and patient preferences for the insulin pen versus vial-and-syringe in patients with type 2 diabetes mellitus (T2DM) and to assess clinical end points and safety outcomes. SUBJECTS AND METHODS: Using a randomized, open-label, crossover design, in total, 405 insulin-naive adults with T2DM from 60 centers received basal insulin glargine in one of two device treatment sequences (2 weeks of pen followed by 2 weeks of vial-and-syringe, or vice versa). The primary end point, patient device preference, was evaluated at Week 4 (end of the crossover period) using the Insulin Injection Preference Questionnaire. Patient preference and HCP recommendation were assessed with one global item and three subscale items (blood glucose control, reluctance to use insulin, and long-term insulin use) using a 5-point scale ranging from 1=not preferred or not recommended to 5=preferred or recommended. Patients were then re-randomized to either pen or vial-and-syringe for further observation (6, 10, and 30 weeks) to evaluate clinical end points (glycosylated hemoglobin [A1C] and fasting blood glucose levels) and safety outcomes (hypoglycemia and adverse events). RESULTS: Patients reported a significant preference for pens over vial-and-syringe, and HCPs strongly recommended pens over vial-and-syringe (both P<0.001). Consistent response patterns were observed by HCPs and patients for the three subscale items. Fasting blood glucose, A1C levels, and the incidence of hypoglycemia were comparable in the two groups. CONCLUSIONS: Patients preferred pens over vial-and-syringe, with the pen device also recommended by HCPs, when initiating basal insulin treatment in insulin-naive patients with T2DM.

Development of a men's Preference for Testosterone Replacement Therapy (P-TRT) instrument.

BACKGROUND: This study used a standard research approach to create a final conceptual model and the Preference for the Testosterone Replacement Therapy (P-TRT) instrument. METHODS: A discussion guide was developed from a literature review and expert opinion to direct one-on-one interviews with participants who used testosterone replacement therapy and consented to participate in the study. Data from telephone interviews were transcribed for theme analysis using NVivo 9 qualitative analysis software, analyzed descriptively from a saturation grid, and used to evaluate men's P-TRT. Data from cognitive debriefing for five participants were used to evaluate the final conceptual model and validate the initial P-TRT instrument. RESULTS: Item saturation and theme exhaustion was achieved by 58 male participants of mean age 55.0 ± 10.0 (22-69) years who had used testosterone replacement therapy for a mean of 175.0 ± 299.2 days. The conceptual model was developed from items and themes obtained from the participant interviews and saturation grid. Items comprising eight dimensions were used for instrument development, ie, ease of use, effect on libido, product characteristics, physiological impact, psychological impact, side effects, treatment experience, and preference. Results from the testosterone replacement therapy preference evaluation provide a detailed insight into why most men preferred a topical gel product over an injection or patch. CONCLUSION: Items and themes relating to use of testosterone replacement therapy were in concordance with the final conceptual model and 29-item P-TRT instrument. The standard research approach used in this study produced the P-TRT instrument, which is suitable for further psychometric development and use in clinical practice.

Comparing the cost of community pharmacy and mail-order pharmacy in a US retirement system.

Although community pharmacies have been the mainstay for drug distribution in the USA, plan members are encouraged to use mail-order pharmacies as a cost-containment strategy. Both channels differ with respect to reimbursement rates, utilization, and costs. We evaluated the differences in reimbursement rates and in ingredient costs between the two dispensing channels. We used pharmacy claims from a large Midwestern retirement system for the period 2000-2005. A representative sample of drug products was selected. We estimated the aggregated gross reimbursement, the ingredient cost, dispensing fee, pharmacy incentives for drug substitution, professional fee for other services, sales tax, and reimbursement per payer. The sample contained 1964 observations-four million claims. There were 58.5% observations for single source brands and 39.0% for generics. Observations with lower unit gross reimbursement rate in community pharmacy increased from 10.3% to 16.5%. Unit ingredient cost and dispensing fees were higher in community pharmacy than in mail-order pharmacy. Community pharmacy had a lower reimbursement rate per unit of medication (33.5-44.6% observations) compared with mail-order pharmacy. There were 87.3-98.1% observations with a higher patient co-financing per unit of medication in community pharmacy. Gross pharmaceutical reimbursement rates and unit ingredient costs were higher in community pharmacy than in mail-order pharmacy; but in more than 10% of the observations, the costs were higher in mail-order pharmacy than in community pharmacy.

Daily average consumption of 2 long-acting opioids: an interrupted time series analysis.

BACKGROUND: Oxycodone controlled release (CR) and oxymorphone extended release (ER) are frequently prescribed long-acting opioids, which are approved for twice-daily dosing. The US Food and Drug Administration approved a reformulated crush-resistant version of oxycodone CR in April 2010. OBJECTIVE: To compare the daily average consumption (DACON) for oxycodone CR and for oxymorphone ER before and after the introduction of the reformulated, crush-resistant version of oxycodone CR. METHODS: This was a retrospective claims database analysis using pharmacy claims from the MarketScan database for the period from January 2010 through March 2011. The interrupted time series analysis was used to evaluate the impact of the introduction of reformulated oxycodone CR on the DACON of the 2 drugs-oxycodone CR and oxymorphone ER. The source of the databases included private-sector health data from more than 150 medium and large employers. All prescription claims containing oxycodone CR and oxymorphone ER dispensed to members from January 1, 2010, to March 31, 2011, were included in the analysis. Prescription claims containing duplicate National Drug Codes, missing member identification, invalid quantities or inaccurate days supply of either drug, and DACON values of <1 and >500 were removed. RESULTS: The database yielded 483,063 prescription claims for oxycodone CR and oxymorphone ER from January 1, 2010, to March 31, 2011. The final sample consisted of 411,404 oxycodone CR prescriptions (traditional and reformulated) dispensed to 85,150 members and 62,656 oxymorphone ER prescriptions dispensed to 11,931 members. Before the introduction of reformulated oxycodone CR, DACON values for the highest strength available for each of the 2 drugs were 0.51 tablets higher for oxycodone CR than for oxymorphone ER, with mean DACON values of 3.5 for oxycodone CR and 3.0 for oxymorphone ER (P <.001). The differences of mean DACON between the 2 drugs for all lower strengths were 0.46 tablets, with mean DACON values of 2.7 for oxycodone CR and 2.3 for oxymorphone ER (P <.001). After the introduction of the new formulation, the difference in mean DACON between the 2 drugs was slightly lower: 0.45 tablets for the highest-strength and 0.40 tablets for the lower-strength pairs. Regression analyses showed that the immediate and overall impact of the reformulation of oxycodone CR on the DACON of oxycodone CR was minimal, whereas no changes were seen in the DACON of oxymorphone ER. The estimated DACON for oxycodone CR decreased by 0.1 tablets, or 3.7% (P <.001), 6 months after the new formulation was introduced. CONCLUSION: The mean DACON was 0.4 tablets per day higher for oxycodone CR compared with oxymorphone ER for all dosage strengths for the entire study period. After the introduction of the reformulated oxycodone CR, the DACON for this drug was slightly mitigated; however, there was a minimal impact on the mean differences between oxycodone CR and oxymorphone ER.

Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.

PURPOSE: Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS: Data were obtained from the FDA, Micromedex, Medline, and Lexis-Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal. RESULTS: There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo-skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti-infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals). CONCLUSIONS: Approximately one in seven approved NMEs were discontinued from the market in the period of 1980-2009. Less than one-quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society.

A Comparison of Daily Average Consumption Of Oxycodone Controlled Release (OxyContin CR) And Oxymorphone Extended Release (Opana ER) In Patients With Low Back Pain.

OBJECTIVE: Our goal was to examine the daily average consumption (DACON) of oxycodone controlled-release tablets (OxyContin CR)and oxymorphone extended-release tablets (Opana ER) in patients with low back pain. STUDY DESIGN: An observational, retrospective cohort study enrolled patients with multiple prescriptions for oxycodone CR or oxymorphone ER tablets. These patients also had International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for low back pain. Pharmacy prescription medication claims data were obtained from a large commercially insured health plan in the U.S. Mean daily consumption was calculated for a 90-day period. METHODS: We used descriptive statistics to evaluate patient demographics and health plan characteristics. Univariate analyses were used to examine the data as observed. A generalized linear model with a gamma distribution and log-link function provided a sensitivity measure, adjusting for heterogeneity among patients and the skewed nature of the DACON variable. RESULTS: A total of 4,023 patients received oxycodone CR, and 374 patients received oxymorphone ER. The mean age of patients (standard deviation, SD) was 49.0 (11.6) years for oxycodone CR and 47.3 (10.6) years for oxymorphone ER. DACON of oxycodone CR was 3.2 tablets per day, and DACON of oxymorphone ER was 2.7 tablets per day (P < 0.01). Utilization of maximum-strength tablets of oxycodone CR 80 mg was 3.9 tablets per day, which was significantly higher, by one tablet per day, than the utilization of equipotent oxymorphone ER maximum-strength tablets of 40 mg at 2.9 tablets per day (P < 0.01). CONCLUSION: The use of oxycodone CR, measured as mean daily consumption over a 90-day period, was significantly higher than that for oxymorphone ER in these patients, a finding that could have financial implications for health care systems.

Utilization, spending, and price trends for short- and long-acting Beta-agonists and inhaled corticosteroids in the medicaid program, 1991-2010.

BACKGROUND: Asthma is a chronic respiratory disease that afflicts millions of people and accounts for substantial utilization of healthcare resources in most industrialized countries, including in the United States. However, the exact cost and utilization of anti-asthma medications in Medicaid in the past 2 decades have not been well studied. Considering the safety issues surrounding the long-acting beta-agonists, guideline updates, and the increase in asthma prevalence, understanding anti-asthma medication prescribing trends is important to payers and patients. GOAL: The purpose of this study was to analyze the utilization and spending trends for anti-asthmatic agents in the US Medicaid program over the past 2 decades. METHODS: This study was based on a retrospective, descriptive analysis of trends in utilization of and spending on anti-asthma medications, including short-acting beta-agonists, inhaled corticosteroids, long-acting beta-agonists, and inhaled corticosteroid/long-acting beta-agonist combinations. Quarterly utilization and expenditure data were obtained from the national Medicaid pharmacy files provided by the Centers for Medicare & Medicaid Services from quarter 1 of 1991 through quarter 2 of 2010. Average reimbursement per prescription was calculated each quarter as a proxy for drug price. RESULTS: The total number of prescriptions for the studied anti-asthma medications rose from 8.9 million in 1991 to 15.6 million in 2009, peaking at 20.8 million in 2005, the year before Medicare and Medicaid dual-eligible beneficiaries were moved to Medicare Part D. From 1991 to 2009, Medicaid spending on anti-asthma medications overall rose from $180.7 million to $1.3 billion, and spending on inhaled corticosteroid/long-acting beta-agonist combinations rose from $52.8 million in 2001-their first year on the market-to $411.7 million in 2009. The average price per prescription has risen in all the anti-asthma drug classes: overall, spending per prescription has increased 4-fold between 1991 and 2009, significantly faster than the consumer price index (57.5%) over the same period. In quarter 2 of 2010, Medicaid spent more on the combination medication fluticasone-salmeterol-$60 million-than on any other anti-asthma medication. CONCLUSION: Anti-asthma medications are a major and growing expense for state Medicaid programs and can be expected to be the same for Medicare Part D in the future. Increased disease prevalence has in part contributed to the rise in pharmacotherapy cost. Nevertheless, drug therapy is crucial for managing asthma and asthma exacerbations.

Assessing the reliability and validity of a newly developed insomnia treatment satisfaction questionnaire (ITSAT-Q).

PURPOSE: To produce a valid insomnia treatment satisfaction questionnaire (ITSAT-Q) to assess treatment satisfaction with pharmacotherapy for use in patients with insomnia. PATIENTS AND METHODS: Items developed for a self-administered questionnaire were analyzed using exploratory factor analysis (EFA), which produced 5 dimensions. Confirmatory factor analysis was used to verify results from EFA, and structural equation modeling was used to test the hypothesized relationship among the dimensions. Data were collected from patients as part of a Sleep Research Project from January 2008 until October of 2008. RESULTS: Approximately 69.8% of the sample (n=298) was female. Item-to-total correlations were 0.66 for convenience, ranged from 0.52 to 0.62 for expectations, from 0.54 to 0.69 for value, from 0.50 to 0.57 for effectiveness, and from 0.58 to 0.72 for treatment satisfaction. All standardized parameter estimates from confirmatory factor analysis were significant (p<0.01). Goodness of fit measures for the final structural equation model were chi(2)=45.2 (d.f.=45); p=0.465; CFI=1.00; TLI=1.00; and RMSEA=0.004. Treatment satisfaction was a strong and significant predictor of value, and effectiveness was a strong predictor of treatment satisfaction (p<0.01). Expectations were a strong and equal predictor of both treatment satisfaction and value (p<0.001). CONCLUSION: The ITSAT-Q provided acceptable results for instrument reliability and validity. Findings from this study will provide additional insight regarding patient perceptions of treatment satisfaction and other related therapeutic dimensions to help prescribers assess pharmacotherapy.

Analysis of the impact of the Uruguay Round Agreements Act on pharmaceutical patents.

The Uruguay Round Agreements Act (URAA) was enacted by the United States Congress in 1994. The URAA provided substantial modifications to the framework for U.S. patent law that came into effect January 1, 1953. Changes in patent regulation are especially important in the pharmaceutical sector because the patent system determines, in large part, the reward that an inventor can derive from discovery of a new drug. Most pharmaceutical patents are classified as utility patents. Pharmaceutical patents may include claims for the active ingredient per se, for the formulation of the active ingredient for use as a pharmaceutical, for therapeutic indications and uses, and for methods of manufacturing the drug. The U.S. has a First-to-Invent system to establishing the right of priority of an invention, but most countries have a First-to-File priority system. The First-to-Invent system allows for public disclosure of inventions prior to patent filing. In contrast, the First-to-File system encourages early filing of patent applications. In both systems, filing an application for a patent as soon as the drug is discovered allows inventors to obtain an earlier date of invention relative to potential competitors and establish the right of priority over the invention.

Evaluation of causes and frequency of medication errors during information technology downtime.

PURPOSE: The causes and frequency of medication errors occurring during information technology downtime were evaluated. METHODS: Individuals from a convenience sample of 78 hospitals who were directly responsible for supporting and maintaining clinical information systems (CISs) and automated dispensing systems (ADSs) were surveyed using an online tool between February 2007 and May 2007 to determine if medication errors were reported during periods of system downtime. The errors were classified using the National Coordinating Council for Medication Error Reporting and Prevention severity scoring index. The percentage of respondents reporting downtime was estimated. RESULTS: Of the 78 eligible hospitals, 32 respondents with CIS and ADS responsibilities completed the online survey for a response rate of 41%. For computerized prescriber order entry, patch installations and system upgrades caused an average downtime of 57% over a 12-month period. Lost interface and interface malfunction were reported for centralized and decentralized ADSs, with an average downtime response of 34% and 29%, respectively. The average downtime response was 31% for software malfunctions linked to clinical decision-support systems. Although patient harm did not result from 30 (54%) medication errors, the potential for harm was present for 9 (16%) of these errors. CONCLUSION: Medication errors occurred during CIS and ADS downtime despite the availability of backup systems and standard protocols to handle periods of system downtime. Efforts should be directed to reduce the frequency and length of down-time in order to minimize medication errors during such downtime.

Psychometric development and validation of the chronic constipation treatment satisfaction questionnaire (CTSAT-Q).

OBJECTIVES: To develop and validate the constipation treatment satisfaction questionnaire (CTSAT-Q) for use in patients with chronic constipation and irritable bowel syndrome with constipation (IBS-c). METHODS: Questionnaire development included item representation from the reviewed literature, focus groups, and pretesting. Dimensions related to treatment satisfaction were identified with exploratory factor analysis, verified with confirmatory factor analysis (CFA), and tested with structural equation modeling. RESULTS: A total of 31,988 email invitations were disseminated to obtain 311 qualified respondents with diagnoses for chronic constipation and IBS-c using ROME II criteria, which required that two of the following symptoms: fewer than 3 bowel movements per week, hard or lumpy stools, straining with defecation, and a sensation of incomplete evacuation, a sensation of anorectal obstruction, and the use of manual maneuvers to assist defecation be present 25% of the time during the last year. Approximately 84% of the sample was female. Item-to-total correlations were 0.66 for activities, ranged from 0.60 to 0.67 for expectations, from 0.59 to 0.69 for value, from 0.56 to 0.60 for effectiveness, and 0.68 to 0.79 for treatment satisfaction. All standardized parameter estimates from CFA were significant (P < 0.01). The chi-square was 46.98, df = 41, P = 0.241, comparative fit index = 0.996, Tucker-Lewis Index = 0.994, root mean square error of approximation = 0.022, indicating an excellent fit between the sample data and proposed model. Treatment satisfaction was a strong and significant predictor of effectiveness, activities, and value (P < 0.001). CONCLUSIONS: The CTSAT-Q was demonstrated to be reliable and valid, and appears to assess treatment satisfaction for patients with chronic constipation and patients with IBS-c.

Incentives for orphan drug research and development in the United States.

BACKGROUND: The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. METHODS: Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. RESULTS: The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. CONCLUSION: Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

Testing for allergic disease: parameters considered and test value.

BACKGROUND: Test results for allergic disease are especially valuable to allergists and family physicians for clinical evaluation, decisions to treat, and to determine needs for referral. METHODS: This study used a repeated measures design (conjoint analysis) to examine trade offs among clinical parameters that influence the decision of family physicians to use specific IgE blood testing as a diagnostic aid for patients suspected of having allergic rhinitis. Data were extracted from a random sample of 50 family physicians in the Southeastern United States. Physicians evaluated 11 patient profiles containing four clinical parameters: symptom severity (low, medium, high), symptom length (5, 10, 20 years), family history (both parents, mother, neither), and medication use (prescribed antihistamines, nasal spray, over-the-counter medications). Decision to recommend specific IgE testing was elicited as a "yes" or "no" response. Perceived value of specific IgE blood testing was evaluated according to usefulness as a diagnostic tool compared to skin testing, and not testing. RESULTS: The highest odds ratios (OR) associated with decisions to test for allergic rhinitis were obtained for symptom severity (OR, 12.11; 95%CI, 7.1-20.7) and length of symptoms (OR, 1.46; 95%CI, 0.96-2.2) with family history having significant influence in the decision. A moderately positive association between testing issues and testing value was revealed (beta = 0.624, t = 5.296, p < or = 0.001) with 39% of the variance explained by the regression model. CONCLUSION: The most important parameters considered when testing for allergic rhinitis relate to symptom severity, length of symptoms, and family history. Family physicians recognize that specific IgE blood testing is valuable to their practice.

The relative importance of health related quality of life and prescription insurance coverage in the decision to pharmacologically manage symptoms of overactive bladder.

PURPOSE: Patient decisions to seek treatment for overactive bladder are influenced by the impact of the condition on health related quality of life and the presence of prescription insurance coverage. This study uses conjoint analysis to examine the relative importance of health related quality of life dimensions of the overactive bladder questionnaire and the presence of prescription insurance coverage on patient preference for treatment. MATERIALS AND METHODS: Patient preferences were elicited using a study questionnaire that included 9 hypothetical profiles containing an orthogonal array of attributes relating to coping with symptoms, symptom concern, sleep disturbances, problems with social interactions and prescription insurance coverage. This questionnaire was administered to 150 patients with self-reported symptoms of overactive bladder. Patients responded to each profile with the likelihood that they would prefer drug therapy to control overactive bladder symptoms versus doing nothing. RESULTS: A total of 133 usable responses were obtained from participants. Analysis was conducted with a linear random effects model. Of the 5 included attributes prescription insurance coverage was the most important attribute followed by sleep disturbances, symptom concern, social interaction problems and coping. Responses obtained from attribute ratings using visual analog scaling and a holdout profile demonstrated study validity. CONCLUSIONS: Prescription insurance coverage and sleep disturbances are important considerations underlying patient preferences for the treatment of overactive bladder.

Drug utilization and cost in a Medicaid population: a simulation study of community vs. mail order pharmacy.

BACKGROUND: Outpatient drugs are dispensed through both community and mail order pharmacies. There is no empirical evidence that substitution of community pharmacy with mail order reduces overall drug expenditures. The need for evaluating the potential effects on utilization and costs of the possible extension of mail order services in Medicaid provides the rationale for conducting this study. This study compares drug utilization and drug product cost in community vs. mail order pharmacy dispensing services in a Medicaid population. METHODS: This study is a retrospective cohort study comparing utilization and cost patterns in community vs. mail order pharmacy. A simulation model was employed to assess drug utilization and cost in mail order pharmacy using community pharmacy claim data. The model assumed that courses of drug therapy (CDT) in mail order pharmacy would have utilization patterns similar to those found in community pharmacy. A 95% confidence interval surrounding changes in average utilization and average cost were estimated using bootstrap analysis. A sensitivity analysis was performed by varying drug selection criteria and supply, fill point, and medication possession ratio (MPR). Sub-analyses were performed to address differences between mail order and community pharmacy related to therapeutic class and dual-eligible patients. Data for the study derived from pharmacy claims database of Ohio Medicaid State program for the period January 2000-September 2004. Drug claims were aggregated to obtain a set of CDTs representing unique patient IDs and unique drug products. Drug product cost estimates excluded dispensing fees and were used to estimate the cost reduction required in mail order to become cost neutral in comparison with community pharmacy. RESULTS: The baseline model revealed that the use of mail order vs. community pharmacy would result in a 5.5% increase in drug utilization and a 5.4% cost reduction required in mail order to become cost neutral. Results from Ohio Medicaid drugs for chronic use revealed a 5.1% increase in utilization and a 4.9% cost reduction required to become cost neutral in comparison with community pharmacy. CONCLUSION: The results of the simulation model indicate that mail order pharmacy increases drug utilization and can also increase drug product cost if the cost per unit is not reduced accordingly. Prior consideration should be given to the patient population, day-supply, disease, therapy, and insurance characteristics to ensure the appropriate use of mail order pharmacy services.