Biomedical subjects

Daniel C Malone

Publications and source records attributed to Daniel C Malone.

32 records · Page 2Linked to original sources

PubMed2003

Gastrointestinal disease control after histamine2-receptor antagonist dose modification for renal impairment in frail chronically ill elderly patients.

OBJECTIVES: To determine whether histamine2-receptor antagonist (H2RA) dose modified for renal impairment affects gastrointestinal (GI) disease control. DESIGN: Concurrent medical record review. SETTING: One hundred forty-six nursing facilities throughout the United States. PARTICIPANTS: Three hundred thirty-six patients aged 65 and older receiving H2RAs for GI disorders. INTERVENTION: H2RA dose modified for renal impairment or no dose change. MEASUREMENTS: Disease control (no H2RA dose increase for 6 months or longer, additional GI medication, hospitalizations, emergency room visits, and unscheduled physician visits for GI symptoms) was evaluated using chart review at 3, 6, 9, and 12 months in nursing home patients aged 65 and older with H2RA dose modified for decreased creatinine clearance (ClCr) according to manufacturer. RESULTS: Three hundred thirty-six patients, mean age +/- standard deviation 85.9 +/- 7.9, with mean ClCr of 33.6 +/- 10.4 mL/min, were recommended to receive lower H2RA doses based upon estimated renal function. Patients were analyzed in two groups: H2RA dose reduced (Group 1) and dose reduction not adopted or implemented (Group 2). There was no difference in baseline characteristics (age, weight, ClCr, or starting H2RA dose and indication) between the two groups. One hundred ninety-eight patients in Group 1 were taking 195.5 +/- 71.0 mg per day of nizatidine or equivalent, compared with 183.7 +/- 66.6 mg for 138 patients in Group 2. For patients with 90 days of follow-up, the mean H2RA dose in Group 1 was 100.2 +/- 44.3 mg, compared with 187.8 +/- 69.9 for Group 2 (P <.0001) The mean decrease in daily dose for Groups 1 and 2 after 365 days were 98.9 +/- 72.9 mg and 22.2 +/- 68.2 mg, respectively (P <.0001). Except for more physician visits in Group 2, disease control was similar for all groups. Major and minor GI bleeding events were similar across both groups and over time. The 12-month mortality rate was 12.1% and 21.7% for Groups 1 and 2, respectively. This difference was statistically significant (P =.02). CONCLUSION: The findings suggest that the dose of H2RAs may be decreased based upon renal function in frail elderly patients without compromising GI disease control.

Aged↗

PubMed2002

Fluticasone is associated with lower asthma-related costs than leukotriene modifiers in a real-world analysis.

STUDY OBJECTIVE: To compare the impact of fluticasone propionate versus three leukotriene modifiers-montelukast, zafirlukast, and zileuton-on the cost of asthma within a managed care organization. DESIGN: Retrospective quasi-experimental comparison. SETTING: Managed care organization with approximately 350,000 enrollees. PATIENTS: Three hundred forty-seven patients with asthma who received at least two prescriptions for either fluticasone or a leukotriene modifier. Patients receiving both fluticasone and a leukotriene modifier were excluded. MEASUREMENTS AND MAIN RESULTS: Multivariate analysis was used to compare total asthma-related costs between treatment groups. A significant difference in total asthma-related costs was found between patients receiving fluticasone (adjusted mean cost $511) compared with those receiving a leukotriene modifier ($1,092; p=0.0001). Other significant predictors of postindex asthma-related costs were pre-index asthma-related costs, a severity adjustment score, and the diagnosis of chronic obstructive pulmonary disease. Patients taking a leukotriene modifier obtained more short-acting beta-agonists than patients receiving fluticasone (6.49 +/- 4.05 vs 4.30 +/- 3.41, p < 0.0001). A survival analysis of time to receive any additional controller therapy revealed that patients receiving fluticasone were significantly less likely to receive another controller than were those receiving a leukotriene modifier (p=0.0014). CONCLUSION: These results suggest that fluticasone is associated with lower asthma-related costs than leukotriene modifiers.

Adult↗

PubMedDate not supplied

Mirtazapine is associated with less anxiolytic use among elderly depressed patients in long-term care facilities.

BACKGROUND: Depression is a common, treatable disorder among nursing facility residents. OBJECTIVE: The purpose of this study was to examine medication use and cost between two groups of patients: (1) persons treated with mirtazapine, as compared with (2) persons taking other antidepressants. DESIGN: This study was a retrospective chart review of long-term care patients. Consultant pharmacists collected data on patients who were receiving selective serotonin reuptake inhibitors (SSRIs), venlafaxine, nefazodone, or mirtazapine. SETTING: Nursing facilities that were geographically dispersed throughout the United States. PARTICIPANTS: We studied patients greater than 65 years of age with major depressive disorder or a depression-related diagnosis and receiving antidepressant treatment for at least 3 months. Patients with bipolar-induced depression were excluded as well as those receiving tricyclic antidepressants. RESULTS: The two groups were similar in terms of age, but those receiving mirtazapine had lower body weight and body mass index. Patients on mirtazapine were less likely to be taking a sedative/hypnotic (P = 0.006). This was primarily the result of fewer patients in the mirtazapine group taking lorazepam (P = 0.03). There was no difference between the two groups regarding their use of other psychotropic medications, including multiple antidepressants, antipsychotics, anticonvulsants, acetylcholinesterase inhibitors, or appetite stimulants. Monthly medication costs were less for those patients receiving mirtazapine ($82.83) as compared with other antidepressants ($97.03) (P <0.0001). CONCLUSIONS: The results of this study suggest that patients receiving mirtazapine are less likely to be on anxiolytic/hypnotic agents. The findings also suggest that medication costs are less when mirtazapine is used compared with other antidepressants.

Aged↗

PubMedDate not supplied

Profiling quality of diabetes care in a Veterans Affairs Healthcare System.

Profiling care on the basis of standard sets of measures has been extensively studied in the inpatient setting. However, less attention has been given to profiling outpatient care. The purpose of this study was to determine the influence of case-mix adjustment when profiling care for persons with diabetes. This is a cross-sectional study using medical and pharmacy data. Four process and 3 outcomes measures were used to assess the quality of care provided between 4 outpatient clinics. Diabetics were predominantly elderly (mean = 66 years), married (61%), white (73%), males (96%), with high body mass index (31 +/- 6.3 kg/m2), and mean comorbidity score of 4.2 +/- 1.8 conditions. Screening for hemoglobin A1c (HbA1c) and microalbuminuria was frequently performed in all clinics. However, 61% (n = 1697) and 36% (n = 254) of study patients had not undergone foot or eye examinations during the study period, respectively. Approximately 27% (n = 408), 41% (n = 643), and 26% (n = 515) of the study patients had poor glycemic, renal function, and lipid control, respectively. Significant differences (P < .05) in poor HbA1c and creatinine clearance rates between the clinics were observed after adjusting for patient case-mix. No differences between the clinics in cholesterol levels were observed after adjusting for patient case-mix. Overall, these clinics performed well in process of care measures, except for foot screening. After adjusting for patient case-mix, significant disparities between the clinics were observed with respect to glycemic control and renal function measures, whereas differences were nullified with respect to cardiovascular outcome measure.

Aged↗

PubMedDate not supplied

Studying pharmaceutical care: difficult but necessary.

Research into the impact of pharmaceutical care need not be complex, but it is difficult in real-world settings. Pharmaceutical care projects need a committed project manager, dedicated pharmacists, an involved payer, and patients who believe they have a problem that needs to be addressed. Significant differences in outcomes are more likely with some chronic diseases than with others. Adequate funding of pharmaceutical care studies is needed to support identification of drug-related problems and outcomes in larger numbers of patients and over longer time periods. Demonstrating changes in patient satisfaction with providers and in health-related quality of life is difficult.

Health Services Research↗

PubMedDate not supplied

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.

Adverse Drug Reaction Reporting Systems↗

PubMedDate not supplied

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.

Community Pharmacy Services↗

PubMedDate not supplied

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.

Automation↗

PubMedDate not supplied

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.

Attitude to Computers↗

PubMedDate not supplied

Measurement of adherence in pharmacy administrative databases: a proposal for standard definitions and preferred measures.

BACKGROUND: A variety of measures have been developed to calculate refill adherence from administrative data such as pharmacy claims databases. These measures have focused on improving the accuracy of adherence measures or clarifying the evaluation time frame. As a result, there are many measures used to assess adherence that may or may not be comparable or accurate. OBJECTIVE: To compare available refill adherence measures. METHODS: A systematic literature review was conducted to identify current or recently used measures of calculating adherence from administrative data. A MEDLINE search (January 1990-March 2006) was undertaken using the search terms adherence or compliance in the title combined with administrative, pharmacy, or records in any field, including subheadings medical, nursing, and hospital records. Non-English articles were excluded. Seven hundred fifteen articles were available for review. Review articles and letters were excluded from measure selection, but were included in the search terms and used to identify additional research articles. Adherence measures were excluded if they were incompletely described, produced non-numeric values, or were duplicates. Eleven refill adherence measures were identified and compared using data from the LOSE Weight (Long-term Outcomes of Sibutramine Effectiveness on Weight) study. Measures compared include Continuous Measure of Medication Acquisition (CMA); Continuous Multiple Interval Measure of Oversupply (CMOS); Medication Possession Ratio (MPR); Medication Refill Adherence (MRA); Continuous Measure of Medication Gaps (CMG); Continuous, Single Interval Measure of Medication Aquisition (CSA); Proportion of Days Covered (PDC); Refill Compliance Rate (RCR); Medication Possession Ratio, modified (MPRm); Dates Between Fills Adherence Rate (DBR); and Compliance Rate (CR). RESULTS: The results suggest that the CMA, CMOS, MPR, and MRA are identical in terms of measuring adherence to prescription refills throughout the study period, each with a value of 63.5%; CMG and PDC are slightly lower (63.0%) and are equivalent to MRA when oversupply is truncated. CR, MPRm, RCR, and CSA result in higher adherence values of 84.4%, 86.6%, 104.8%, and 109.7%, respectively. CONCLUSIONS: Five measures produce equivalent results for measuring prescription refill adherence over the evaluation period. Of these, MRA has the fewest calculations, is easily truncated if one desires to exclude surplus medication issues, and requires the least amount of data. MRA is therefore recommended as the preferred measure of adherence using administrative data.

Appetite Depressants↗

PubMedDate not supplied

Cost-effectiveness analysis of simvastatin and lovastatin/extended- release niacin to achieve LDL and HDL goal using NHANES data.

OBJECTIVE: The Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, Adult Treatment Panel III (ATP III) encouraged reduced low-density lipoprotein (LDL) cholesterol levels for a greater number of patients and reemphasized the benefits of high-density lipoprotein (HDL) cholesterol. The purpose of this study was to compare 2 regimens achieving simultaneous LDL and HDL goals. METHODS: A decision-analytic model compared the cost-effectiveness of simvastatin and lovastatin/extended-release niacin. The perspective of the analysis was that of a health system. Product labeling was used to determine changes in cholesterol concentrations and frequencies of clinically important adverse events. The Third National Health and Nutrition Examination Survey (NHANES III) adult data were used for baseline cholesterol levels. Each product was titrated to achieve LDL and HDL goals unless an adverse effect occurred. Direct medical costs were determined for each treatment to determine cost-effectiveness. RESULTS: For both the 130 mg/dL and 100 mg/dL LDL goal analyses (and HDL e40 mg/dL), lovastatin/extended-release niacin had higher success rates and lower estimated direct-medical costs than simvastatin. Simvastatin had the highest success rate in achieving LDL level <160 mg/dL and HDL e40 mg/dL; however, its estimated direct-medical cost was approximately twice that of lovastatin/extended-release niacin (665 US dollars versus 333 US dollars). CONCLUSION: For the LDL goals <130 mg/dL and <100 mg/dL (and HDL e40 mg/dL) required of the majority of U.S. residents, lovastatin/extended-release niacin was both more successful and less costly than simvastatin.

Aged↗

PubMedDate not supplied

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.

Antibodies, Monoclonal↗

PubMedDate not supplied

Cost-effectiveness of sibutramine in the LOSE Weight Study: evaluating the role of pharmacologic weight-loss therapy within a weight management program.

UNLABELLED: the cost-effectiveness of drug therapy when used in conjunction with a weight management program (WMP) for treatment of obesity. The objective was to compare the cost-effectiveness of sibutramine (Meridia) plus a structured WMP versus only a structured WMP in both overweight and obese individuals. The core WMP was a physician-supervised, multidisciplinary program for which each enrollee paid $100 out of pocket. METHODS: A cost-effectiveness analysis was performed based upon the results of a previously published randomized controlled trial conducted within a managed care organization. The target population for this study was obese or overweight persons. The perspective of the study was that of a managed care organization. The intervention consisted of subjects receiving a WMP with or without sibutramine. The primary outcomes of this study were (a) absolute change in body weight and percentage change in body weight over 12 months, (b) change in obesity-related and total medical costs from 12 months prior to enrollment through 12 months after enrollment, and (c) cost-effectiveness in terms of cost per pound of weight loss. All costs were adjusted to 2004 dollars using the respective components of the consumer price index for each medical service or medication. RESULTS: A total of 501 evaluable subjects were enrolled in the study, with 281 receiving sibutramine plus a structured WMP and 220 receiving only the structured WMP. The meanSD weight loss was significantly greater in the sibutramine (13.715.5 pounds, 4.8%) group than in the nondrug group (513.2 pounds, 2.2%) (P < 0.001). The change in obesity-related total cost was a median increase of $408 for the sibutramine group compared with $31 for the nondrug group (P < 0.001). The change in total health care cost was a median $1,279 increase in the sibutramine group compared with $271 for the nondrug group (P < 0.001). Adding sibutramine to the WMP increased the total cost by $44 per additional pound of weight loss (95% confidence interval, 42-46). Sensitivity analyses found that the results were sensitive to the price of sibutramine, whereas varying the cost of clinic visits did not substantially change the results. CONCLUSION: Patients enrolled in a WMP receiving sibutramine had greater weight loss and decrease in body mass index at greater cost than did patients enrolled in the same program who did not receive sibutramine. There were no observed savings in total health care resource utilization or cost in the sibutramine group compared with the nondrug group.

Adult↗

PubMedDate not supplied

Consumer understanding and satisfaction associated with a 3-tier prescription drug benefit.

OBJECTIVE: The purpose of this research was to investigate consumer understanding and satisfaction associated with a 3-tier prescription drug benefit among users of the prescription drug benefit. METHODS: This study involved a self-administered postal questionnaire and the use of prescription drug claims to evaluate utilization of prescription medications. Fifteen hundred subjects were randomly selected based on the following inclusion criteria. Each subject had to (1) be enrolled in a 3-tier copayment ($10 generic, $20 formulary brand, $35 nonformulary brand) prescription drug benefit; (2) be the primary beneficiary (cardholder); (3) be >18 years of age; (4) have received at least 1 prescription medication using his or her prescription drug insurance; and (5) have a mailing address on file. RESULTS: A total of 479 usable responses were returned (35% response rate). The mean (SD) understanding score was 2.22 (1.54) (range: 0 to 6). Fewer than 1% of respondents correctly answered all 6 items used to measure the level of understanding. The mean (SD) satisfaction score was 54.32 (19.69) (range: 0 to 100). Experience with purchasing a medication within a particular copayment tier was predictive of correctly answering the item related to that tier.s copayment amount. Multiple regression analysis revealed a relationship between the amount of use of the drug benefit and the degree of satisfaction with the drug benefit. There was no significant relationship between the level of understanding and the degree of satisfaction with prescription drug insurance. CONCLUSION: The average level of beneficiary understanding of the 3-tier copayment prescription drug benefit was very low, and the average degree of respondent satisfaction appeared to be near neutral. There was no significant relationship between the level of understanding and the degree of satisfaction with prescription drug benefits. The level of understanding was proportional to the amount of drug benefit use, but the degree of satisfaction was not related to the amount of drug benefit use.

Adolescent↗