Effectiveness, safety and treatment adherence of biosimilar follow-on insulin in diabetes management.

AIM: To assess the change in HbA1c after initiation of biosimilar follow-on insulin (Basaglar) or reference insulin (Lantus) among patients with type 2 diabetes. We also compared treatment adherence, safety events and costs at 1 year after initiation of insulin. MATERIALS AND METHODS: Using claims data from a large US health plan during 2016-2020, we identified adults with type 2 diabetes who initiated either Basaglar or Lantus. Generalized linear regression modelling assessed the differences in outcomes between the two groups. A 0.4% margin was used to determine non-inferiority for HbA1c. RESULTS: The study included 1136 Basaglar users and 6304 Lantus users. Both Lantus and Basaglar groups showed more than 1% reduction in HbA1c over 6 months and over 12 months. Reduction in HbA1c with Basaglar was similar (non-inferior) to that with Lantus, with an adjusted difference of Basaglar to Lantus of 0.14% (95% CI -0.02 to 0.30) over 6 months and 0.17% (95% CI 0.02 to 0.32) over 12 months. Rates of adverse events were similar for both hypoglycaemia and vascular events. The Basaglar group showed higher adherence in terms of proportion of days covered (adjusted difference 0.06, 95% CI 0.04 to 0.08). Medical costs were similar, but the cost of Basaglar was lower (adjusted mean cost difference -$462, 95% CI -$556 to -$363) after adjustment. CONCLUSIONS: In patients with type 2 diabetes, Basaglar provided similar glycaemic control compared with Lantus, had a similar safety profile and lower drug costs, and showed more favourable adherence.

Major Bleeding Risk During Anticoagulation with Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients with Nonvalvular Atrial Fibrillation.

BACKGROUND: The use of non-vitamin K oral anticoagulants (NOACs) has increased steadily following marketing approval; however, their relative safety in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice remains unclear. OBJECTIVE: To compare the risk of major bleeding during anticoagulation therapy between warfarin and NOACs. METHODS: This retrospective cohort study analyzed administrative claims data on new NVAF users of warfarin, dabigatran, apixaban, or rivaroxaban in routine clinical care from November 2010 to February 2015 in a commercially insured population in the United States. The primary outcome was time to first major bleeding event requiring hospitalization. Patients were followed until discontinuation or switch of anticoagulants, health plan disenrollment, death, or end of study. All patient characteristics were balanced after propensity score inverse probability of treatment (IPT) weighting. Event rates by type of anticoagulant exposure were compared using IPT-weighted Cox proportional hazards models. RESULTS: The study cohort comprised 44,057 patients who used warfarin (n = 23,431), dabigatran (n = 8,539), apixaban (n = 3,689), and rivaroxaban (n = 8,398). Overall mean (SD) age was 70 (12) years, and 41% of the patients were women. A total of 2,337 major bleeding events occurred during 36,636.2 person-years of follow-up. The unadjusted rate of major bleeding with warfarin was 6.0 per 100 person-years versus 2.8 with dabigatran, 3.3 with apixban, and 5.0 with rivaroxaban. Relative to warfarin, major bleeding risk was lower with dabigatran (HR = 0.67, 95% CI = 0.60-0.76) and apixaban (HR = 0.52, 95% CI = 0.41-0.67). Compared with rivaroxaban, major bleeding risk was also lower with dabigatran (HR = 0.67, 95% CI = 0.58-0.78) and apixaban (HR = 0.52, 95% CI = 0.40-0.68). Major bleeding risk was similar for rivaroxaban and warfarin. Relative to apixaban, dabigatran was associated with a significantly higher risk of major gastrointestinal bleeding (HR = 1.43, 95% CI = 1.09-1.88). CONCLUSIONS: Study results were consistent with safety findings from pivotal clinical trials comparing NOACs with warfarin and added the perspective of a large real-world observational study that compared bleeding risks associated with NOACs during anticoagulation therapy. Apixaban and dabigatran were associated with lower major bleeding risk compared with warfarin or rivaroxaban; however, apixaban had a lower risk of major gastrointestinal bleeding than dabigatran. These findings can help inform the choice of an optimal agent, which must balance effectiveness and bleeding risk in complex patients. DISCLOSURES: This study was funded by Anthem. Adeboyeje, Sylwestrzak, and Barron are employees of HealthCore, a wholly owned and independently operated subsidiary of Anthem. White, Rosenberg, Abarca, and Crawford are employees of Anthem. Study concept and design were primarily contributed by Adeboyeje and Sylwestrzak, along with the other authors. Adeboyeje took the lead in data collection, along with Sylwestrzak and Barron. Data interpretation was performed primarily by Rosenberg, Crawford, and Redberg, with assistance from the other authors. The manuscript was written by all the authors and revised primarily by White, Abarca, and Redberg, along with the other authors.

Analysis of the comparative effectiveness of 3 oral bisphosphonates in a large managed care organization: adherence, fracture rates, and all-cause cost.

BACKGROUND: Despite widespread availability and use of oral bisphosphonates, fracture rates and associated medical costs are still high. Differences in fracture risk among these agents, if any, have not been quantified due to the lack of high-quality, head-to-head, randomized, controlled trials assessing this outcome. Randomized, placebo-controlled trials have shown that alendronate and risedronate reduce rates of both vertebral and nonvertebral fractures, whereas only reduction in vertebral fractures has been found for ibandronate. OBJECTIVE: To determine if there were any differences among 3 oral bisphosphonates in adherence, total cost of care, and effectiveness in reducing fracture rates in a large managed care population. METHODS: Administrative, longitudinal pharmacy and medical claims data were obtained from 14 geographically diverse health plans in the United States covering approximately 14 million members. Sampled members had at least 1 pharmacy claim for alendronate, risedronate, or ibandronate during the intake period (January 1, 2005, through October 31, 2007). The date of the first pharmacy claim for osteoporosis medications within the intake period was the index date. Members were followed for either 12, 24, or 36 months, depending on length of continuous health plan eligibility. Medication possession ratio (MPR) was measured using a total days supply that was calculated by multiplying the total quantity dispensed by the suggested days supply per unit of dispensing based on manufacturer-recommended dosing. For members who switched bisphosphonate strengths or medications, the estimated days supply was summed for all osteoporosis medications during the follow-up, including overlapping days supply. Outcomes included (a) the first incident fracture and percentages of members with at least 1 fracture after 6 months post-index; (b) the number of days from index to the first incident fracture, measured as time to event in Cox proportional hazards regression analysis; and (c) total all-cause health care costs (health plan allowed amount including member cost share). RESULTS: A total of 45,939 members were included (n = 24,909 alendronate, n = 13,834 risedronate, n = 7,196 ibandronate). In the 12-month analysis, MPRs were comparable (means = 0.57-0.58) for the 3 medications. After 24 months, MPRs had dropped for all medications, but those of both alendronate (mean = 0.50, 95% CI = 0.49-0.50) and risedronate (mean = 0.50, 95% CI = 0.49-0.51) were slightly higher than that of ibandronate (mean = 0.47, 95% CI = 0.46-0.48). At 36 months, again the MPRs had dropped for all 3 medications (means = 0.44-0.47) but were similar. There were no statistically significant differences among agents in the percentages of subjects with at least 1 fracture at 12, 24, or 36 months (36-month rates: alendronate 4.41%, risedronate 4.38%, ibandronate 6.28%, P = 0.102). The numbers of subjects with fracture(s) per month of follow-up were 0.0020 for alendronate, 0.0021 for risedronate, and 0.0022 for ibandronate (P = 0.087 overall). However, after adjusting for member characteristics, alendronate users had a 12% lower risk of experiencing any incident fracture than ibandronate users (hazard ratio = 0.88, 95% CI = 0.78-0.99, P = 0.034) within the follow-up period. In the first 12 post-index months, ibandronate users had higher mean [SD] unadjusted total all-cause health care costs ($7,464 [$15,975]) compared with alendronate ($7,233 [$16,671]) and risedronate ($ 6,983 [$16,870], P less than 0.001 for both comparisons), differences of approximately $19 per month and $40 per month, respectively. The results of the unadjusted 24-month analysis were similar, but there were no significant cost differences at 36 months. Total cost differences for the 3 medication groups were nonsignificant at 12, 24, and 36 months after adjusting for member characteristics. CONCLUSIONS: This retrospective analysis of an administrative claims database in a large managed care population showed similar rates of adherence and total adjusted all-cause health care costs for alendronate, risedronate, and ibandronate. Absolute unadjusted rates of fracture were small and did not significantly differ among agents, but after controlling for differences in member characteristics, the risk of fracture was 12% lower for alendronate users than for ibandronate users.

Gender and age differences in medications dispensed from a national chain drugstore.

OBJECTIVES: Our objective was to compare sex and age differences in the medications dispensed in pharmacies from a large national drugstore chain. METHODS: Using a list for the 200 most commonly prescribed medicines, we assessed prescriptions dispensed by a large national chain drug store over 1 year (2002-2003). The analysis used U.S. census data adjusted for the population by sex and age and weighted by the number of pharmacies per state. Results are reported as an odds ratio (OR) of prescriptions dispensed to females and males. RESULTS: Under age 18, 24 drug classes were dispensed more commonly to females (OR > 1) and 18 drug classes more commonly to males (OR < 1). In the 18-24 age group, 48 of 53 drug classes were dispensed more frequently to females. Across other adult groups, females were dispensed more medications than males for 156 of 180 medications. There was greater dispensing to females of antibiotics (OR = 1.74, 95% confidence interval [CI] 1.74-1.74), analgesics (OR = 1.70, 95% CI 1.70-1.70), antihistamines and sympathomimetics (OR = 1.46, 95% CI 1.45-1.46), benzodiazapines (OR = 2.08, 95% CI 2.07-2.08), antidepressants (OR = 2.40, 95% CI 2.39-2.40), diuretics (OR = 1.9328, 95% CI 1.93-1.94), and thyroid drugs (OR = 4.80, 95% CI 4.78-4.82). However, males had higher dispensing of antianginal drugs (OR = 0.84, 95% CI 0.83-0.85), anticoagulants (OR = 0.89, 95% CI 0.88-0.90), glycosides (OR = 0.80, 95% CI 0.79-0.81), and antihypertensives (OR = 0.91, 95% CI 0.91-0.91). More females were dispensed propoxyphene with acetaminophen (OR = 2.23, 95% CI 2.23-2.24), which has been associated with adverse outcomes (hospitalizations, emergency department visits, and deaths). CONCLUSIONS: Females, especially during the reproductive years, are dispensed more medications than males.

Prescribers' knowledge of and sources of information for potential drug-drug interactions: a postal survey of US prescribers.

BACKGROUND: Given the high prevalence of medication use in the US, the risk of drug-drug interactions (DDIs) and potential for patient harm is of concern. Despite the rise in technologies to identify potential DDIs, the ability of physicians and other prescribers to recognize potential DDIs is essential to reduce their occurrence. The objectives of this study were to assess prescribers' ability to recognize potential clinically significant DDIs and to examine the sources of information they use to identify potential DDIs and prescribers' opinions on the usefulness of various DDI information sources. METHODS: A postal questionnaire was developed to assess prescriber knowledge of medications that may interact and prescribers' usual sources of DDI information. Recipients were asked to classify 14 drug pairs as 'contraindicated', 'may be used together but with monitoring' or 'no interaction'. A response option of 'not sure' was also provided. The questionnaires were sent to a national sample of 12 500 prescribers based on past history of prescribing drugs associated with known potential for DDI, who were identified using data from a pharmacy benefit manager covering over 50 million individuals. RESULTS: Usable questionnaires were obtained from 950 prescribers. The percentage of prescribers who correctly classified specific drug pairs ranged from 18.2% for warfarin and cimetidine to 81.2% for paracetamol (acetaminophen) with codeine and amoxicillin, with 42.7% of all combinations classified correctly. The number of drug pairs correctly classified by the prescribers ranged from 0 to 13. For half of the drug pairs over one-third of the respondents answered 'not sure'; among those drug pairs, two were contraindicated. When asked what source was used to learn more about a potential DDI, a quarter of the prescribers reported using personal digital assistants and another quarter used printed material. The majority of the prescribers (68.4%) reported that they were usually informed by pharmacists about their patients' potential exposure to DDIs. Compared with the prescribers who used other sources, those who used computerized DDI alerts as their usual source of DDI information consistently gave a lower rating score to the five statements that assessed the usefulness of the information. CONCLUSION: This study suggests that prescribers' knowledge of potential clinically significant DDIs is generally poor. These findings are supported by other research and emphasize the need to develop systems that alert prescribers about potential interactions that are clinically relevant. Physicians most commonly reported learning about potential DDIs from pharmacists, suggesting further work is needed to improve the drug-prescribing process to identify potential safety issues earlier in the medication use process.

Impact of delayed initiation of erythropoietin in critically ill patients.

BACKGROUND: The purpose of this study was to evaluate the impact of recombinant human erythropoietin (rHuEPO) use for anemia of critical illness at a practice site where delayed initiation is common. METHODS: Retrospective medical record review involving patients treated with rHuEPO for anemia of critical illness. Those patients given rHuEPO or diagnosed with end-stage renal disease (ESRD) prior to ICU admission were excluded. The primary endpoints were rHuEPO use and RBC transfusion patterns. RESULTS: Complete data were collected for consecutive admissions of 126 patients. Average age (SD) and APACHE II score were 56.5 (18.6) years and 25 (7.8), respectively. The median ICU (IQR) and hospital length of stay (LOS) were 24 (11.25, 39) and 29 (17, 44.75) days, respectively. Treatment with rHuEPO was started an average of 12.5 +/- 10.5 days after ICU admission and given for 3.8 +/- 3.8 doses. Eighty percent of patients were transfused with an average total of 5.42 +/- 5.08 units received. RBC exposure inversely correlated with a lower mean hemoglobin response to rHuEPO. ICU LOS (p < 0.0001), hemoglobin at 24 hours (p = 0.055), transfusion within 48 hours of admit (p < 0.0001), and postoperative status (p = 0.019) were the best predictors of transfusion requirements (r2 = 0.37). CONCLUSION: Delayed initiation of rHuEPO for anemia of critical illness resulted in comparable hemoglobin and transfusion benefits. Future studies are needed to establish clinical benefit and role in therapy. RBC exposure may blunt the erythropoietic effects of rHuEPO, potentially frustrating benefits to those of greatest apparent need.

Potential drug-drug interactions within Veterans Affairs medical centers.

PURPOSE: This study assessed the prevalence of 25 clinically important drug-drug interactions (DDIs) in the ambulatory care clinics of the Department of Veterans Affairs medical centers (VAMCs). METHODS: This study was a retrospective, cross-sectional database analysis of pharmacy records to assess the prevalence of 25 clinically important DDIs. For each DDI, the object drug was defined as the medication that has its therapeutic effect modified by the drug interaction process. The precipitant drug was defined as the medication responsible for affecting the pharmacologic action or the pharmacokinetic properties of the object drug. Rates of interactions for each VAMC facility were calculated as the number of patients with a DDI divided by the total number of individual patients exposed to the object or precipitant medications. The 25 DDIs were categorized into four main categories on the basis of the therapeutic classification of the medications involved in the drug pairs. RESULTS: The study population included 2,795,345 patients who filled prescriptions for medications involved in potential DDIs across 128 VAMCs. The highest DDI exposure rate was 129.2 per 1,000 recipients of monoamine oxidase inhibitors (MAOIs) that occurred with combinations of selective serotonin-reuptake inhibitors (SSRIs). The lowest DDI exposure rate was 0.01 per 1,000 warfarin recipients who had the warfarin and sulfinpyrazone combination. CONCLUSION: The analysis of pharmacy records of veterans who filled prescriptions at the outpatient settings within VAMC found an overall rate of 2.15% for potential DDIs. Case-exposure rates were greatest for veterans receiving SSRIs and MAOIs, ganciclovir and zidovudine, anticoagulants and thyroid hormones, and warfarin and nonsteroidal antiinflammatory drugs.

Reliability evaluation of the adapted national coordinating council medication error reporting and prevention (NCC MERP) index.

PURPOSE: Adapted National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index criteria were used in a study undertaken to evaluate commercial computerized provider order entry (CPOE) system impact on community hospital medication errors. This article describes: (1) adaptation of the Index, (2) classification criteria and processes used to assess the adapted Index, and (3) inter-rater reliability results. METHODS: A random sample of 130 (17%) of 2251 medication safety events (MSEs) were classified based on event type, that is, adverse drug event (ADE) or potential ADE (PADE); preventability, that is, 'yes' or 'no,' and outcome severity. Event outcome severity was categorized using adapted Index categories E-I (ADEs) and B-D (PADEs). Decision rules were used for rule-based classification, while an MSE Case Review Panel used judgment-based classification when decision rules did not apply. Inter-rater reliability for both classification approaches was assessed with kappa coefficients, percentage agreement, and confidence intervals (CI). RESULTS: Level of agreement was substantial for both rule-based and judgment-based MSE classification for event type (6 = 0.70-0.90), preventability (6 = 0.67-0.82), and decision rule application (6 = 0.79). Rule-based agreement for ADE and PADE severity was almost perfect for discrete (6 = 0.83-0.84) and combined (6 = 0.87-0.90) Index categories. Judgment-based agreement was substantial for discrete (6 = 0.63-0.67) and combined (6 = 0.66-0.84) Index categories. CONCLUSIONS: The adapted Index yielded substantial agreement for event type, preventability, and severity. Adaptation of the Index to support classification of non-preventable ADEs was an important improvement.

Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions.

BACKGROUND: Drug-drug interactions (DDIs) are preventable medical errors, yet exposure to DDIs continues despite systems that are designed to prevent such exposures. The purpose of this study was to examine pharmacy characteristics that may be associated with dispensed potential DDIs. METHODS: This study combined survey data from community pharmacies in 18 metropolitan statistical areas with pharmacy claims submitted to 4 pharmacy benefit managers (PBMs) over a 3-month period from January 1, 2003 to March 31, 2003. Pharmacy characteristics of interest included prescription volume, the number of full-time equivalent pharmacists and pharmacy staff, computer software programs, and the ability to modify those programs with respect to DDI alerts, the use of technologies to assist in receiving, filling and dispensing medication orders, and prescription volume. The dependent variable in this study was the rate of dispensed medications that may interact. RESULTS: A total of 672 pharmacies were included in the analysis. On average (+/-SD), the respondents filled 1375 +/- 691 prescriptions per week, submitted 17,948 +/- 23,889 pharmacy claims to the participating PBMs, had 1.2 +/- 0.3 full-time equivalent pharmacists per hour open, and 545 (81%) were affiliated with a chain drug store organization. Factors significantly related to an increased risk of dispensing a potential DDI included pharmacist workload (odds ratio [OR] 1.03; 95% confidence interval [CI] 1.028-1.048), pharmacy staffing (OR 1.10; 95% CI: 1.09-1.11), and various technologies (eg, sophisticated telephone systems, internet receipt of orders, and refill requests) that assist with order processing, and the ability to modify DDI alert-screening sensitivity and detailed pharmacological information about DDIs. CONCLUSIONS: This study found that there was an increase in the risk of dispensing a potential DDI with higher pharmacist and pharmacy workload, use of specific automation, and dispensing software programs providing alerts and clinical information.

Practitioners' views on computerized drug-drug interaction alerts in the VA system.

OBJECTIVES: To assess Veterans Affairs (VA) prescribers' and pharmacists' opinions about computer-generated drug-drug interaction (DDI) alerts and obtain suggestions for improving DDI alerts. DESIGN: A mail survey of 725 prescribers and 142 pharmacists from seven VA medical centers across the United States. MEASUREMENTS: A questionnaire asked respondents about their sources of drug and DDI information, satisfaction with the combined inpatient and outpatient computerized prescriber order entry (CPOE) system, attitude toward DDI alerts, and suggestions for improving DDI alerts. RESULTS: The overall response rate was 40% (prescribers: 36%; pharmacists: 59%). Both prescribers and pharmacists indicated that the CPOE system had a neutral to positive impact on their jobs. DDI alerts were not viewed as a waste of time and the majority (61%) of prescribers felt that DDI alerts had increased their potential to prescribe safely. However, only 30% of prescribers felt DDI alerts provided them with what they needed most of the time. Both prescribers and pharmacists agreed that DDI alerts should be accompanied by management alternatives (73% and 82%, respectively) and more detailed information (65% and 89%, respectively). When asked about suggestions for improving DDI alerts, prescribers most preferred including management options whereas pharmacists most preferred making it more difficult to override lethal interactions. Prescribers and pharmacists reported primarily relying on electronic references for general drug information (62% and 55%, respectively) and DDI information (51% and 79%, respectively). CONCLUSION: Respondents reported neutral to positive views regarding the effect of CPOE on their jobs. Their opinions suggest DDI alerts are useful but still require additional work to increase their clinical utility.

Evaluation of the performance of drug-drug interaction screening software in community and hospital pharmacies.

BACKGROUND: Computerized drug-drug interaction (DDI) screening is widely used to identify potentially harmful drug combinations in the inpatient and outpatient setting. OBJECTIVE: To evaluate the performance of drug-drug interaction (DDI) screening software in identifying select clinically significant DDIs in pharmacy computer systems in community and hospital pharmacies. METHODS: Ten community pharmacies and 10 hospital pharmacies in the Tucson metropolitan area were invited to participate in the study in 2004. To test the performance of each of the systems used by the pharmacies, 25 medications were used to create 6 mock patient profiles containing 37 drug-drug pairs, 16 of which are clinically meaningful DDIs that pose a potential risk to patient safety. Each profile was entered into the computer pharmacy system, and the system response in terms of the presence or absence of a DDI alert was recorded for each drug pair. The percentage of correct responses and the sensitivity, specificity, positive predictive value, and negative predictive value of each system to correctly classify each drug pair as a DDI or not was calculated. Summary statistics of these measures were calculated separately for community and hospital pharmacies. RESULTS: Eight community pharmacies and 5 hospital pharmacies in the Tucson metropolitan area agreed to participate in the study. The median sensitivity and median specificity for community pharmacies was 0.88 (range, 0.81-0.94) and 0.91 (range, 0.67-1.00), respectively. For hospital pharmacies, the median sensitivity and median specificity was 0.38 (range, 0.15-0.94) and 0.95 (range, 0.81-0.95), respectively. CONCLUSION: Based on this convenience sample of 8 community pharmacies and 5 hospital pharmacies in 1 metropolitan area, the performance of community pharmacy computer systems in screening DDIs appears to have improved over the last several years compared with research published previously in 2001. However, significant variation remains in the performance of hospital pharmacy computer systems, even among systems manufactured by the same vendor. Future research should focus on improving the performance of these systems in accurately and precisely identifying DDIs with a high probability of resulting in true potential adverse effects on clinical outcomes and creating a low .noise. ratio associated with false-positive alerts.

Pharmacologic management of constipation in the critically ill patient.

STUDY OBJECTIVE: To compare the effectiveness of common laxatives in producing a bowel movement in patients admitted to a medical intensive care unit (MICU). DESIGN: Retrospective medical record review. SETTING: MICU of an academic medical center. PATIENTS: Ninety-five patients admitted to the MICU from July 1-October 31, 2004. MEASUREMENTS AND MAIN RESULTS: Fifty patients satisfied the inclusion criteria. Patient-specific data such as age, weight, sex, length of MICU stay, Acute Physiology and Chronic Health Evaluation (APACHE) II score, dietary intake, opioid intake, laxative intake, and bowel movements were recorded during the first 96 hours of admission. Logistic regression analysis was used to compare patients who did and did not have a bowel movement. Of the 50 patients, 25 did not have a bowel movement during the first 96 hours of MICU admission. Patients given a stimulant laxative (senna, bisacodyl) and/or an osmotic laxative (lactulose, milk of magnesia) were more likely to have a bowel movement (odds ratio [OR] 26.6, 95% confidence interval [CI] 3.2-221, p=0.002). Opioid intake, expressed as logarithmic morphine equivalents, was negatively associated with occurrence of a bowel movement (OR 0.76, 95% CI 0.59-0.97, p=0.027). Disease severity, as determined by APACHE II score, was also negatively associated with a bowel movement (OR 0.84, 95% CI 0.7-0.99, p=0.04). CONCLUSION: Critically ill patients have a high frequency of constipation, and opioid therapy is a significant risk factor. Routine administration of stimulant or osmotic laxatives should be considered for this patient population.

Workload and availability of technology in metropolitan community pharmacies.

OBJECTIVE: To assess workload characteristics and the presence of prescription processing technologies within metropolitan community pharmacies in the United States. DESIGN: Cross-sectional postal survey. SETTING: 18 metropolitan statistical areas (MSAs) in the United States. PARTICIPANTS: 3000 managers located in community pharmacies processing at least 500 third-party claims per month for four major pharmacy benefits managers. INTERVENTIONS: 34-item survey instrument designed to collect data about the pharmacy including demographics, workload issues, handling of drug-drug interactions (DDIs), and pharmacists' attitudes toward computerized DDI alerts. MAIN OUTCOME MEASURES: Workload (hours of operation, prescription volume, staffing hours, prescription processing intensity) and prescription processing technologies (telecommunication systems, automated counting/filling or verification devices, number of computer terminals, and computer software vendors). RESULTS: Overall, 736 usable surveys were returned (response rate, 25.3%). On average, respondents reported a volume of approximately 1340 prescriptions per week processed at a rate of almost 17 prescriptions per hour. Independent pharmacies processed approximately 3 prescriptions per hour more than chain pharmacies even though a statistically equal or slightly lower proportion of those pharmacies had automated technologies. The presence of technology was generally high for all pharmacies, particularly countertop tablet/capsule-counting devices and telefacsimile machines. The most common software vendors differed considerably between chain and independent pharmacies. CONCLUSION: The number of prescriptions processed per hour and number of technologies available increased with the total weekly volume of prescriptions processed in this national survey. A majority of pharmacies had at least one type of automated prescription processing technology and an automated telecommunication system for accepting new or refill prescriptions. Independent pharmacies processed more prescriptions per hour than did chains but did so with fewer categories of technologies.

Community pharmacy managers' perception of computerized drug-drug interaction alerts.

OBJECTIVE: To examine community pharmacists' attitudes toward computerized drug-drug interaction (DDI) alerts and identify factors associated with more favorable perceptions of these alerts. DESIGN: Cross-sectional postal survey. SETTING: 18 metropolitan statistical areas (MSAs) in the United States. PARTICIPANTS: 3000 community pharmacy managers. INTERVENTIONS: 34-item survey instrument designed to collect data about the pharmacy including demographics, workload issues, handling of DDIs, and pharmacists' attitudes toward computerized DDI alerts. MAIN OUTCOME MEASURE: Responses to items concerning community pharmacy managers' attitudes toward DDI alerts and factors associated with more favorable attitudes toward these alerts. RESULTS: A total of 736 usable surveys were returned (25.3% response rate). Pharmacy managers generally disagreed that DDI alerts were a waste of time (mean +/- SD, 2.1 +/- 1.1 on a scale of 1, strongly disagree, to 6, strongly agree). However, they were not completely confident that their computer systems provided them with meaningful DDI alerts (mean +/- SD, 4.5 +/- 1.2). They were confident in their ability to identify DDIs (mean +/- SD, 4.9 +/- 0.9) and discuss DDIs with physicians (mean +/- SD, 5.2 +/- 0.7). Pharmacy software that provided detailed DDI information as well as the ability to customize DDI alerts were associated with more favorable perceptions of DDI alerts. CONCLUSION: Despite being presented with a large proportion of clinically unimportant alerts, community pharmacy managers did not believe DDI alerts were meaningless or a waste of time. Incorporation of features that streamline DDI alerts may improve their effectiveness in community pharmacy practice.

Incremental effects of concurrent pharmacotherapeutic regimens for heart failure on hospitalizations and costs.

BACKGROUND: Inappropriate medication use in patients with heart failure (HF) presents challenges in providing optimal, evidence-based care. OBJECTIVE: To evaluate the incremental differences of concurrent and persistent use of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, loop diuretics, and digoxin on the one-year, all-cause risk of hospitalization and total healthcare costs associated with treatment of HF in patients enrolled in a managed care organization within the US. METHODS: A retrospective database analysis was conducted spanning from January 1, 1997, to December 31, 1999. Multivariate regression methods were used to examine the association between treatment regimens and hospitalizations or costs after controlling for patient demographics and risk factors. RESULTS: Of the 1903 patients meeting inclusion criteria, 32.3% (n = 615) received none of the 4 HF agents studied and were associated with a 2.5 times greater risk (p < or = 0.001) of hospitalization and 43.6% higher (p < or = 0.001) total costs compared with all other patients with HF. Comparatively, 13.9% (n = 264) utilized the HF medications investigated for at least 6 months. Of those with persistent use of > or =3 agents, approximate decreases in hospitalizations were noted of 80% (p < or = 0.001) and total costs of 70% (p < or = 0.001) relative to patients receiving no HF therapy. CONCLUSIONS: A substantial portion of patients with HF may be receiving suboptimal pharmacotherapeutic care in real-world practice settings, potentially incurring large increases in hospitalizations and total costs. Quality improvement initiatives should seek to identify and manage those not being treated according to guideline recommendations.

Using community indicators to assess nutrition in Arizona-Mexico border communities.

INTRODUCTION: Community indicators are used to measure and monitor factors that affect the well-being of a community or region. Community indicators can be used to assess nutrition. Evaluating nutrition in communities along the Arizona-Mexico border is important because nutrition is related to an individual's risk of overweight or obesity; obesity is a risk factor for developing type 2 diabetes. METHODS: Local grocery store purchases were selected as a community indicator for nutrition. A structured 26-question interview was developed and administered to grocery store managers in communities along the Arizona-Mexico border that were targeted by the Border Health Strategic Initiative, a program implemented by community groups and the University of Arizona. In addition, data from milk distributors serving the border communities were collected. RESULTS: Residents of these communities favor food items with a higher fat and higher caloric content. This trend held across several food categories. Major barriers to customer acceptance of healthier food items include lack of knowledge concerning healthy foods and their prices. CONCLUSION: The demand for healthy food items is relatively low along the Arizona-Mexico border. Interventions should continue to target this population with the aim of changing dietary patterns as one method of improving the health of the community and preventing and controlling diabetes.

Longitudinal analysis of the use of etanercept versus infliximab determined from medical chart audit.

OBJECTIVE: To describe the dosing of etanercept and infliximab for the treatment of rheumatoid arthritis (RA). METHODS: Adult patients with a diagnosis of RA who were treated with either etanercept or infliximab between 1999 and 2002 were selected from 16 rheumatology practices in the western and southeastern United States. Patients with a terminal illness or those receiving a tumor necrosis factor (TNF)-alpha inhibitor for an indication other than RA were excluded. Data were collected through a review of the patient medical records. Data collected on each patient included demographics, concurrent disease-modifying antirheumatic drug therapy, TNF-alpha inhibitor dose, frequency, duration of TNF-alpha inhibitor therapy, and discontinuation of TNF-alpha inhibitor therapy. RESULTS: A total of 244 patients were included in the evaluation (etanercept only [n=128; 52%], infliximab only [n=89; 36%], both [n=27; 11%]). The mean age of these patients was 55.1+/-13.3 years, 54.9+/-13.5 years, and 52.8+/-14.0 years, respectively; the mean duration of RA was 13.3 +/- 8.8 years, 13.4+/-8.0 years, and 14.0 +/- 9.9 years, respectively. Female patients constituted 70% of the sample. Health maintenance organization insurance was the most common form of medical insurance (45.8%), followed by Medicare (22.3%). The mean duration of follow-up for etanercept and infliximab treatment was 29.3+/-14.1 months and 14.8+/-6.9 months, respectively. Among patients who were still receiving therapy at the time of review, the mean initial and last etanercept doses were 25.0 mg versus 25.8 mg (P=0.16); the mean initial and last infliximab doses were 3.38 mg/kg versus 4.51 mg/kg (P<0.001). CONCLUSION: The dosing of etanercept and infliximab therapy was consistent with the approved labeling of both medications.

Concordance of severity ratings provided in four drug interaction compendia.

OBJECTIVE: To evaluate the agreement among drug-drug interaction (DDI) compendia as to designation of interactions as having the greatest clinical importance ("major" DDIs). DESIGN: Cross-sectional, one-time evaluation. SETTING: United States in fall 2001. PARTICIPANTS: Not applicable. INTERVENTIONS: Major DDIs involving prescription medications likely to be dispensed in the community and ambulatory pharmacy settings were identified as listed in four compendia that provide specific, detailed information about DDIs (Drug Interaction Facts, Drug Interactions: Analysis and Management, Evaluations of Drug Interactions, and the MicroMedex DRUG-REAX program). MAIN OUTCOME MEASURE: Level of agreement between DDI compendia as assessed by the intraclass correlation coefficient (ICC). RESULTS: Overall, 406 major DDIs were listed in one or more of the four compendia. Only 9 (2.2%) of these major DDIs were listed in all four compendia; in fact, the majority of interactions were listed in only one compendium (291 DDIs, 71.7%), despite these interactions being considered of greatest clinical relevance by at least one compendium. The ICC among the compendia was -0.092, indicating low agreement on the classification of major DDIs. CONCLUSION: Little agreement exists among commonly used drug interaction COMPENDIA for DDIs that were classified in fall 2001 as having the highest clinical relevance and importance. A concerted effort to identify DDIs of the highest clinical importance is needed to design effective strategies to avoid and manage them.

Identification of serious drug-drug interactions: results of the partnership to prevent drug-drug interactions.

OBJECTIVE: To develop a list of clinically important drug-drug interactions (DDIs) likely to be encountered in community and ambulatory pharmacy settings and detected by a computerized pharmacy system. DESIGN: Cross-sectional, one-time evaluation. SETTING: United States in fall 2001. PARTICIPANTS: An expert panel comprising two physicians, two clinical pharmacists, and an expert on DDIs. INTERVENTIONS: Systematic review of drug interaction compendia and published literature, ratings (on a 1 to 10 scale) of various clinical aspects of DDIs (e.g., clinical importance, quality and quantity of evidence, causal relationship, risk of morbidity and mortality), and a modified Delphi consensus-building process. MAIN OUTCOME MEASURE: Panelists' opinions about clinical importance of DDIs. RESULTS: The expert panel considered 56 DDIs. Of these, 28 had a mean clinical importance score of 8.0 or more. The ratings for clinical importance ranged from 3.2 to 9.6, with a mean +/- SD of 7.5 +/- 1.5 across the combinations examined. The mean score for the quality of literature suggesting the interaction exists ranged from 1.0 to 9.6, with a mean +/- SD of 5.8 +/- 2.5. In terms of substantiation of the interactions evaluated, the mean +/- SD rating was 6.3 +/- 2.2, with a range from 1.4 to 9.2. Through the modified Delphi process, the panel determined that 25 interactions were clinically important. CONCLUSION: Using an expert panel and a standard evaluation tool, 25 clinically important drug interactions that are likely to occur in the community and ambulatory pharmacy settings were identified. Pharmacists should take steps to prevent patients from receiving these interacting medications, and computer software vendors should focus interaction alerts on these and similarly important DDIs.

Angiotensin-converting enzyme inhibitor therapy in patients with heart failure enrolled in a managed care organization: effect on costs and probability of hospitalization.

STUDY OBJECTIVE: To evaluate the effect of angiotensin-converting enzyme (ACE) inhibitor therapy on risk of hospitalization and resource utilization in patients with heart failure enrolled in a managed care organization. DESIGN: Retrospective medical and pharmacy claims analysis. PATIENTS: One thousand five hundred seventy-three patients with heart failure enrolled in a managed care organization. MEASUREMENTS AND MAIN RESULTS: Medical and pharmacy claims from January 1, 1997-December 31, 1999, from a managed care organization covering approximately 350,000 individuals were analyzed. Patients aged 35 years or older with a diagnostic code for heart failure and 18 months of continuous eligibility were selected. From this group (1573 patients), two cohorts were selected based on exposure to an ACE inhibitor. Dependent variables of interest were all-cause hospitalization and total direct medical costs during the 12-month study period. A logistic regression model and an ordinary least-squares model adjusting for patient demographics, comorbidities, and concomitant drug therapy were used to analyze the risk of all-cause hospitalization and total direct medical costs, respectively. Therapy with an ACE inhibitor for 180 days was associated with a decreased risk of all-cause hospitalization (odds ratio 0.65, p<0.0001) and lower total costs (mean dollars 2397, p<0.001) compared with no ACE inhibitor therapy. CONCLUSION: In patients with a diagnosis of heart failure, exposure to ACE inhibitor therapy is associated with fewer hospitalizations and lower total costs than no ACE inhibitor exposure.