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Biomedical subjects

Stan N Finkelstein

Publications and source records attributed to Stan N Finkelstein.

13 recordsLinked to original sources
PubMed2006

Off-label prescribing among office-based physicians.

BACKGROUND: Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice. METHODS: We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use. RESULTS: In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P<.05), few other drug characteristics predicted off-label prescription. CONCLUSIONS: Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.

Adult↗
PubMed2006

A framework to evaluate the economic impact of pharmacogenomics.

INTRODUCTION: Pharmacogenomics and personalized medicine promise to improve healthcare by increasing drug efficacy and minimizing side effects. There may also be substantial savings realized by eliminating costs associated with failed treatment. This paper describes a framework using health claims data for analyzing the potential value of pharmacogenomic testing in clinical practice. METHODS: We evaluated a model of alternate clinical strategies using asthma patients' data from a retrospective health claims database to determine a potential cost offset. We estimated the likely cost impact of using a hypothetical pharmacogenomic test to determine a preferred initial therapy. We compared the annualized per patient costs distributions under two clinical strategies: testing all patients for a nonresponse genotype prior to treating and testing none. RESULTS: In the Test All strategy, more patients fall into lower cost ranges of the distribution. In our base case (15% phenotype prevalence, 200 US dollars test, 74% overall first-line treatment efficacy and 60% second-line therapy efficacy) the cost savings per patient for a typical run of the testing strategy simulation ranged from 200 US dollars to 767 US dollars (5th and 95th percentile). Genetic variant prevalence, test cost and the cost of choosing the wrong treatment are key parameters in the economic viability of pharmacogenomics in clinical practice. CONCLUSIONS: A general tool for predicting the impact of pharmacogenomic-based diagnostic tests on healthcare costs in asthma patients suggests that upfront testing costs are likely offset by avoided nonresponse costs. We suggest that similar analyses for decision making could be undertaken using claims data in which a population can be stratified by response to a drug.

Anti-Asthmatic Agents↗
PubMed2004

Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials.

CONTEXT: In the past, cancer patients entering phase 1 studies confronted the prospects of high risk and unlikely benefit. Over the last decade, cancer drugs under development have become more targeted, and the clinical research environment has become more scrutinized. The impact of these changes on the risks and benefits to patients who participate in phase 1 cancer trials is unknown. OBJECTIVE: To determine trends in the rates of treatment-related (toxic) death, objective response, and serious toxicity and to identify factors associated with these outcomes. DATA SOURCES: We searched abstracts and journal articles reporting the results of phase 1 cancer treatment trials originally submitted to annual meetings of the American Society of Clinical Oncology (ASCO) from 1991 through 2002. STUDY SELECTION: We focused on published single-agent trials that enrolled patients with advanced solid tumors and excluded studies testing agents already approved by the US Food and Drug Administration at the time of the ASCO presentation. DATA EXTRACTION: Multiple observers independently extracted information on trial design, location, sponsorship, types of tumors treated, drug class, route of administration, and clinical outcomes. DATA SYNTHESIS: The overall toxic death rate for 213 studies (involving 6474 cancer patients) published in peer-reviewed journals was 0.54%, while the overall objective response rate was 3.8%. Toxic death rates decreased over the study period, from 1.1% over the first 4 years of the study (1991-1994) to 0.06% over the most recent 4-year period (1999-2002) (P<.01). Response rates also decreased but by proportionally much less. After adjusting for characteristics of the experimental trials and the investigational agents, the odds of a patient dying from an experimental treatment while participating in a trial submitted during the most recent 4-year period were less than one tenth those of a patient participating in a trial submitted during the first 4-year period (odds ratio, 0.09; 95% confidence interval, 0.01-0.67; P = .009). In comparison, the adjusted odds of a patient experiencing an objective response over the same time periods decreased by approximately half (odds ratio, 0.46; 95% confidence interval, 0.32-0.66; P<.001). CONCLUSIONS: The level of risk experienced by cancer patients who participate in phase 1 treatment trials appears to have improved over the 12-year period from 1991 through 2002. Because toxic death rates have decreased more quickly than have objective response rates, the ratio of risk to benefit may have also improved. These changes relate in part to the targeted and less-toxic nature of newer cancer drugs and are coincident with the increased attention that has been paid to the safety of clinical research over the time period we analyzed.

Antineoplastic Agents↗
PubMed2004

Impact of clinical trial results on national trends in alpha-blocker prescribing, 1996-2002.

CONTEXT: Research on factors that influence prescribing patterns and the extent of change produced by clinical trial findings is limited. OBJECTIVE: To examine the changes in prescribing of alpha-blockers for hypertension treatment before and after the April 2000 publication of the unfavorable Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) early termination involving the study's doxazosin mesylate arm. Changes in prescribing were considered in the context of other potential concurrent influences on medication use between 1996 and 2002, including changes in alpha-blocker drug prices, generic conversion, drug promotion, and competition. DESIGN, SETTING, AND PATIENTS: Using 2 national pharmaceutical market research reports published by IMS HEALTH, alpha-blocker prescription orders reported in the National Prescription Audit-a random computerized sample of about 20 000 of 29 000 retail, independent, and mail order pharmacies and mass merchandise and discount houses--and office-based physician alpha-blocker prescribing patterns reported in the National Disease and Therapeutic Index--a random stratified sample of about 3500 physician offices--were tracked. OUTCOME MEASURES: Trends in physician-reported use of alpha-blockers and alpha-blocker prescribing and dispensing by US pharmacies. RESULTS: There were steady increases in alpha-blocker new prescriptions, dispensed prescriptions, and physician drug use from 1996 through 1999. There was a moderate reversal in these trends following ALLHAT early termination and subsequent publications in early 2000. Between 1999 and 2002, new annual alpha-blocker prescription orders declined by 26% (from 5.15 million to 3.79 million), dispensed prescriptions by 22% (from 17.2 million to 13.4 million), and physician-reported drug use by 54% (from 2.26 million to 1.03 million). Other potential influences did not appear to have contributed significantly to this decline although cessation of alpha-blocker marketing may have hastened the decline. CONCLUSIONS: Modest yet statistically significant declines in the use of doxazosin and other alpha-blockers coincided with the early termination of the ALLHAT doxazosin arm. Although physicians responded to this new evidence, strategies to augment the impact of clinical trials on clinical practice are warranted.

Adrenergic alpha-Antagonists↗
PubMed2004

The use of disease-modifying new drugs for multiple sclerosis treatment in private-sector health plans.

OBJECTIVES: The aims of this study were to estimate the effects of demographics, location, severity of multiple sclerosis (MS), comorbidities, plan type, coinsurance levels, and time of entry into the sample on the use of disease-modifying agents. METHODS: A retrospective analysis of medical claims data from 1996 through 2000 was conducted with a sample of MS patients covered by self-insured, employer-sponsored health plans. Proportional hazard analysis with the SAS procedure for proportional hazards regression was used to estimate the impact of the factors of interest on the use of disease-modifying agents. A simulation was conducted to assess the impact of changing drug copayments on the use of disease-modifying agents for MS. RESULTS: The sample included 1807 patients. Patients were followed for as long as possible, but most were observed for <3 years; the mean (SD) follow-up time was 972.88 (440.59) days. Most factors associated with the use of disease-modifying agents were immutable. They included the following: high severity of illness (only marginally related; P = NS); history of seizures (P = 0.03), depression (P < 0.01), or heart disease (P = 0.01); census region of location (P < 0.01); union membership or association with a union member (P < 0.01); drug copayment requirements (P < 0.05); and year of entry into the sample (P < 0.01). In the simulation, a 50% reduction in drug copayments was associated with an increase of the proportion of patients treated with disease-modifying drugs from 41.2% to 54.7%. Patients' and physicians' preferences for treatment could not be measured directly. The true onset of MS may be unknown for many patients, but this would be the case even if medical records or other data were used for this study. CONCLUSIONS: Our analyses showed an association between copayments and the use of disease-modifying drugs for MS. Insurance policies can be tailored to influence the use of disease-modifying drugs, enhancing the quality of care for MS patients and reducing price-related barriers to beneficial treatment. Future research should test whether reducing copayments for MS treatment would reduce the use of other health care services (via better MS treatment that modifies the course of illness), or whether the use of disease-modifying drugs would increase total costs to the plan, resulting in slightly higher premiums.

Adolescent↗
PubMed2004

Benefit plan design and prescription drug utilization among asthmatics: do patient copayments matter?

The ratio of controller-to-reliever medication use has been proposed as a measure of treatment quality for asthma patients. In this study we examine the effects of plan-level mean out-of-pocket asthma medication patient copayments and other features of benefit plan design on the use of controller medications alone, controller and reliever medications (combination therapy), and reliever medications alone. The 1995--2000 MarketScan claims data were used to construct plan-level out-of-pocket copayment and physician/practice prescriber preference variables for asthma medications. Separate multinomial logit models were estimated for patients in fee-for-service (FFS) and non-FFS plans relating benefit plan design features, physician/practice prescribing preferences, patient demographics, patient comorbidities, and county-level income variables to patient-level asthma treatment patterns. We find that the controller-to-reliever ratio rose steadily over 1995--2000, along with out-of-pocket payments for asthma medications, which rose more for controllers than for relievers. After controlling for other variables, however, plan-level mean out-of-pocket copayments were not found to have a statistically significant influence on patient-level asthma treatment patterns. On the other hand, physician/practice prescribing patterns strongly influenced patient-level treatment patterns. There is no strong statistical evidence that higher levels of out-of-pocket copayments for prescription drugs influence asthma treatment patterns. However, physician/practice prescribing preferences influence patient treatment.

Adult↗
PubMed2004

Prescriber intent, off-label usage, and early discontinuation of antidepressants: a retrospective physician survey and data analysis.

BACKGROUND: Many patients discontinue antidepressant therapy long before the 6-month minimum duration recommended for the treatment of major depression and many other diagnoses. We explore various possibilities, including prescriber intent and patient diagnosis, to explain some of this early discontinuation. METHOD: Patients from a single health maintenance organization who filled at least 1 prescription for an antidepressant during the first 4 months of 2001 and who did not fill an antidepressant prescription in the 6 months prior were identified retrospectively. Prescribers of those patients' antidepressants were surveyed for patient diagnosis and length of intended treatment with antidepressant medication. Actual length of treatment was then obtained from pharmacy data and correlated with survey data and other variables. RESULTS: Prescriber surveys were returned for 51% (485/951) of the patients identified. Surveys indicated that for 34% of initial antidepressant prescriptions, < 6 months of treatment was intended. Important determinants of the length of antidepressant therapy included prescriber specialty area, number of prescribers, prescriber intent, diagnosis, specific antidepressant used, and concomitant benzodiazepine use. CONCLUSIONS: Prescriber intention to treat many patients with short courses of antidepressants, often for off-label, non-mental health indications, was correlated with early discontinuation and needs further study of both its rationale and efficacy. Although less prevalent, short-term treatment of mental health disorders, including depression, was also intended by psychiatrists and other prescribers. The widespread practice of intended short-term treatment with antidepressants needs to be understood better, since it results in guideline-incompatible, early antidepressant discontinuation.

Adolescent↗
PubMed2004

Costs of antidepressant medications associated with inadequate treatment.

OBJECTIVE: To determine the costs of antidepressant medications used during inadequate treatment. STUDY DESIGN: Retrospective database analysis of pharmacy claims made by patients who were treated under routine clinical conditions from July 1, 1999, through September 30, 2002. PATIENTS AND METHODS: Our participants included 21,632 patients enrolled in a commercial HMO who had a primary care physician associated with our healthcare system. Patients never receiving at least a minimum likely effective antidepressant dose for at least 90 days were defined as having inadequate treatment. This study calculated the costs of antidepressants involved with inadequate treatment at the level of the patient and the medication trial. RESULTS: A majority of patients (51%) received inadequate treatment. Of overall antidepressant costs, 16% were incurred during trials for patients never adequately treated. The majority of inadequate trials were short and unlikely to have been effective. Most patients (64%) had only a single trial of antidepressants. Venlafaxine, fluoxetine, and sertraline had significantly lower first-trial inadequacy rates compared with the most commonly prescribed agent, citalopram. CONCLUSIONS: Improved patient care quality and lower antidepressant costs could result if clinicians and healthcare systems focus on reducing short trial rates. Initiating treatment with agents least likely to be discontinued prematurely may be helpful.

Antidepressive Agents↗
PubMed2003

A statistical analysis of the magnitude and composition of drug promotion in the United States in 1998.

BACKGROUND: Although pharmaceutical industry marketing and other factors may influence physician decisions regarding medication prescribing in the United States, little information is available about the composition of promotional efforts by promotional mode and medication class. OBJECTIVES: The aims of this study were to determine the magnitude of expenditures for common modes of promotion and to delineate patterns of promotional strategies for particular classes of medications. METHODS: Nationally representative data on expenditures (in US $) for the 250 most promoted medications in the United States in 1998 were available from an independent pharmaceutical market research company for the 5 most commonly used modes of promotion. Key patterns of drug promotion were identified by descriptive statistics, a cluster analysis of expenditures by class, and an analysis of expenditure concentration. RESULTS: In 1998, the pharmaceutical industry spent $12,724 million promoting its products in the United States, of which 85.9% was accounted for by the top 250 drugs and 51.6% by the top 50 drugs. Direct-to-consumer (DTC) advertising was more concentrated on a small subset of medications than was promotion to professionals. Overall, 1998 expenditures were dominated by free drug samples provided to physicians (equivalent retail cost of $6602 million) and office promotion ($3537 million), followed by DTC advertising ($1337 million), hospital promotion ($705 million), and advertising in medical journals ($540 million). Four distinct patterns of expenditures were observed: promotion to office physicians with little consumer promotion (14 drug classes); dual focus on office physicians and consumer advertising (4 drug classes); predominant DTC advertising (1 class: smoking-cessation products); and promotion to office- and hospital-based professionals without consumer advertising (1 class: narcotic analgesics). CONCLUSIONS: The present findings reinforce the perception that the pharmaceutical industry invests heavily in promoting its products and demonstrates that promotional expenditures are concentrated on a small number of medications. Although promotion to professionals remains dominant, DTC advertising has become key for a subset of common medications

Advertising↗
PubMed2003

National trends in asthma visits and asthma pharmacotherapy, 1978-2002.

BACKGROUND: Research is limited on physicians' compliance with recent clinical guidelines for asthma treatment. OBJECTIVE: Our purpose was to investigate the relationships among clinical guidelines, asthma pharmacotherapy, and office-based visits through use of nationally representative data. METHODS: Nationally representative data on prescribing patterns by office-based US physicians were extracted from the National Disease and Therapeutic Index. We tracked 1978-2002 trends in the frequency of asthma visits and patterns of asthma pharmacotherapy, focusing on the use of controller and reliever medications. RESULTS: The estimated annual number of asthma visits in the United States increased continuously from 1978 through 1990 (18 million visits); since 1990, it has remained relatively stable. Controller medication use increased 8-fold between 1978 and 2002, inhaled corticosteroids manifesting the biggest increases. The use of reliever medications, particularly short-acting oral beta(2)-agonists, decreased modestly over this period. The aggregate use of controllers (83% of visits) superseded that of relievers (80%) for the first time in 2001. Improved appropriateness of asthma pharmacotherapy was also suggested by an increase in the controller-to-reliever ratio, which reached 92% in 2002. Xanthines, which once dominated asthma therapy (63% of visits in 1978), were used in only 2% of visits in 2002. More recent drug entrants have been adopted rapidly, single-entity long-acting inhaled beta(2)-agonists being used in 9% of visits and leukotriene modifiers in 24% of visits in 2002. CONCLUSION: Asthma pharmacotherapy has changed extensively in the past 25 years. Practices over the last decade are increasingly consistent with evidence-based guidelines. These changes in medication use might have contributed to the lack of a recent increase in asthma visits.

Adolescent↗
PubMed2002

Treatment costs of venlafaxine and selective serotonin-reuptake inhibitors for depression and anxiety.

In this article, health care expenditures are assessed for patients diagnosed with depression who are being treated with either venlafaxine (immediate or extended release) or a selective serotonin-reuptake inhibitor (SSRI). Patients beginning treatment for a new depressive episode were identified retrospectively from 1994 to 1998. Before beginning therapy, patients prescribed venlafaxine (N = 353) had more nonmental illnesses (0.84 vs. 0.75 clinical events/patient, respectively; P < .01) and hospitalizations for mental illness (0.56 vs. 0.30 hospitalizations/patient; P = .06) than patients prescribed SSRIs (N = 7,330). In the six months after initiating treatment, venlafaxine was associated with lower hospitalization expenditures for nonmental illness than were SSRIs ($206 vs. $472, respectively; P = .02), but total health care expenditures were not significantly different.

Adult↗
PubMedDate not supplied

The economic burden of anemia in cancer patients receiving chemotherapy.

BACKGROUND: Anemia is one of the most common hematologic complications of cancer and cytotoxic treatment. The economic burden associated with anemia in patients with malignancy has not yet been extensively studied. METHODS: Patients receiving chemotherapy within 6 months of initial cancer diagnosis were identified in a database of commercial health-care service claims and encounters. Patients with anemia were identified through a coded diagnosis of anemia, transfusion, or erythropoietin treatment. Exponential conditional mean models and a decomposition analysis were used to analyze mean 6-month health-care expenditures. RESULTS: Twenty-six percent (26%) of 2760 cancer patients with recently diagnosed invasive cancer treated with chemotherapy had anemia. Mean (SD) 6-month unadjusted total expenditures were 62,499 dollars (78,016 dollars) for anemic patients and 36,871 dollars (52,308 dollars) for nonanemic patients (P < 0.0001), with inpatient services representing the largest cost differential between the groups. The adjusted mean 6-month expenditure for the average anemic patient receiving chemotherapy was 57,209 dollars. If anemic patients had the same average health status as nonanemic patients, their predicted 6-month expenditures would have been 19% lower (46,237 dollars). Alternatively, if anemic patients had the same expenditure structure or parameter estimates as nonanemic patients, their predicted expenditures would have been 51% lower (27,847 dollars). Thus, for any given health status, treating a patient who is anemic is associated with considerably higher expenditures. CONCLUSIONS: Anemia among cancer patients receiving chemotherapy is associated with a substantial burden in terms of direct medical costs. Implications for the treatment of anemia are suggested by this research and should be confirmed in prospective studies.

Aged↗