Search

Background: Information on the effects of reaching the Medicare Part D standard drug benefit threshold is limited., Objectives: Describe and compare pre- and post-threshold healthcare and medication utilization of Medicare beneficiaries who reach threshold relative to those who do not reach threshold and those who do not have a threshold., Research Design: Retrospective study of 21,349 beneficiaries enrolled into a Medicare Direct Pay Plan with a standard threshold and 9088 Part D-eligible beneficiaries without a threshold. We used Poisson methods to compare utilization and conditional Poisson models to assess utilization changes. Medication adherence was determined., Results: The 1237 (6%) beneficiaries who reached threshold were older, had greater morbidity, received more medications, and had more medical office visits (all P < 0.001) than beneficiaries who did not reach threshold. After adjustment, those who reached threshold had greater incidences of inpatient [risk ratio (IRR) = 1.85; 95% confidence interval (CI): 1.64-2.09] and emergency department use (IRR = 1.60; 95% CI: 1.40-1.83). After reaching threshold, primary care visits decreased compared with the same time frame in 2005 for those who reached threshold (IRR = 0.86; 95% CI: 0.79-0.93) and a matched group with no threshold (IRR = 0.88; 95% CI: 0.84-0.92). Adherence to chronic medications declined over time in both groups, but adherence decline was greater for beneficiaries who reached threshold., Conclusions: Beneficiaries who reach threshold are older, have more morbidity, and use more medications. Although medication adherence declines after reaching threshold, its association with changes in other healthcare utilization is not clear.

Background: Cluster randomized trials (CRTs) offer unique advantages over standard randomized controlled clinical trials (RCTs) and observational methodologies, and may provide a cost-efficient alternative for answering questions about the best treatments for common conditions., Objectives: To describe health plan leaders' views on CRTs, identify barriers to conducting CRTs, and solicit recommendations for increasing the acceptability of CRTs., Research Design: Qualitative in-depth telephone interviews with leaders from 8 health plans., Subjects: : Thirty-four health plan leaders (medical directors, pharmacy directors, Institutional Review Board leaders, ethics leaders, compliance leaders, and others)., Measures: Qualitative analysis of interview transcripts to identify barriers, factors influencing leaders' views, ethical issues, aspects of CRTs that appeal to leaders, and recommendations for increasing acceptability of CRTs., Results: Multiple barriers were identified, including financial costs, concerns about stakeholders' perceptions of CRTs, impact on physicians' prescribing habits, and formulary changes. Most leaders recognized the potential value of studying the comparative effectiveness of therapeutics, and many stressed the need for head-to-head trials. Leaders' views would be influenced by variations in study design and implementation. Recommendations for increasing acceptability of CRTs included ensuring that the fiscal impact of a CRT be budget neutral, and that researchers educate stakeholders and decision-makers about CRTs., Conclusions: Overall, health plan leaders recognized the need for studies of the comparative effectiveness of therapeutics under real world conditions, and many expressed support for CRTs. However, researchers seeking to conduct CRTs in health plans are likely to face numerous barriers, and preparatory work will be essential.

Background: Previous efforts document drug-drug interactions in ambulatory care. Yet little is known about medical record documentation or clinical management when interacting medications are received., Methods: The study population was identified from the HMO Research Network's Centers for Education and Research on Therapeutics (n = 2,020,037). A random subsample of patients > or = 18 years of age with drug coverage in 2000 initiating a co-dispensing for (1) warfarin with a nonsteroidal anti-inflammatory drug (n = 97), (2) digoxin with verapamil or diltiazem (n = 100), or (3) lovastatin/simvastatin with diltiazem or verapamil (n = 89) was identified., Results: The majority (63%-74%) of patients had documentation indicating receipt of both drugs during a single office visit. Documentation of risks and patient education was less common (< or = 14%, with all corresponding upper bounds of the 95% CIs < 23%). Clinical management changes were more frequently documented, ranging from 64% (95% CI: 47-81%) for lovastatin/simvastatin patients to 79% (95% CI: 60-99%) for warfarin patients., Conclusions: The findings, although indicating that clinicians are likely aware of concomitant receipt of interacting medications, call into question the adequacy of medical record documentation as well as clinical management when interacting drugs are co-prescribed in the ambulatory setting.

Objective: To determine the utility of using administrative data for epidemiologic studies of gout by examining the validity of gout diagnoses in claims data., Methods: From a population of approximately 800,000 members from 4 managed care plans, we identified patients who had at least 2 ambulatory claims for a diagnosis of gout between January 1, 1999 and December 31, 2003. From this group, a random sample of 200 patients was chosen for medical record review. Trained medical record reviewers abstracted gout-related clinical, laboratory, and radiologic data from the medical records. Two rheumatologists independently evaluated the abstracted information and assessed whether the gout diagnosis was probable/definite or unlikely/insufficient information. Discordant physician ratings were adjudicated by consensus. Based on record reviews, patients were also classified according to the American College of Rheumatology (ACR), Rome, and New York gout criteria and these results were compared with the physician global assessments., Results: There were 121 patients rated as having probable/definite gout by physician consensus, leading to a positive predictive value of >or=2 coded diagnoses of gout of 61% (95% confidence interval 53-67). There was low concordance between physician assessments and established gout criteria including ACR, Rome, and New York criteria (kappa = 0.17, 0.16, and 0.20, respectively)., Conclusion: Use of administrative data alone in epidemiologic and health services research on gout may lead to misclassification. Medical record reviews for validation of claims data may provide an inadequate gold standard to confirm gout diagnoses.

Background: Amiodarone can cause liver and thyroid toxicity, but little is known about compliance with laboratory tests to evaluate liver and thyroid function among ambulatory patients who are dispensed amiodarone., Objectives: The primary objective of this study was to identify the proportion of ambulatory patients who had liver aminotransferase and thyroid function tests during amiodarone therapy. Secondary objectives were to (1) describe factors associated with receipt of laboratory tests and (2) determine the accuracy of administrative data for assessing aminotransferase and thyroid function monitoring., Methods: This retrospective cohort study was conducted at 10 health maintenance organizations (HMOs) for the dates of service from January 1, 1999, through June 30, 2001. Participants included 1,055 patients dispensed amiodarone for at least 180 days within this date range; these patients were not necessarily new starts on amiodarone. Administrative claims data were analyzed to assess the percentage of patients with completed alanine/aspartate aminotransferase and thyroid function tests. Depending on the HMO site, electronic or paper medical records were reviewed to evaluate the validity of administrative claims data. Logistic regression models were used to explore factors associated with receipt of laboratory tests., Results: Both aminotransferase and thyroid function tests were completed in 53.3% of patients within a 210-day follow-up period that included the 180-day period of amiodarone dispensings plus 30 days. Thyroid function, with or without liver function (aminotransferase tests), was assessed in 61.9% of patients, and aminotransferase tests, with or without thyroid function, were assessed in 68.2% of patients. After adjusting for patient characteristics and site, the factor most strongly associated with having both types of laboratory tests evaluated was concomitant therapy with a statin (adjusted odds ratio (OR) 1.55; 95% confidence interval (CI), 1.05-2.29). Other factors associated with having both types of laboratory tests evaluated included the number of outpatient visits in the 6 months before the period of amiodarone dispensings (adjusted OR 1.06; 95% CI, 1.00- 1.13 for each additional 5 visits) and living in a neighborhood where a higher median percentage of people had a high school or higher education (adjusted OR 1.09; 95% CI, 1.00-1.18 for every 10% increase in educational level at the block level). There was no association between monitoring and patient illness severity as measured by the number of comorbid conditions. On the basis of an evaluation of a randomly selected subset of 104 patient records, the sensitivity and specificity of automated data were 94.2% and 85.7% for aminotransferase tests and 83.3% and 81.1% for thyroid function tests, respectively., Conclusions: Approximately half of ambulatory patients dispensed amiodarone received both recommended laboratory tests for liver and thyroid function. Improved rates of testing for liver aminotransferase and thyroid function are needed for patients who receive amiodarone.

Objectives: To identify correlates of laboratory monitoring errors in elderly health maintenance organization (HMO) members at the initiation of therapy with cardiovascular medications., Design: Cross-sectional study in 10 HMOs., Setting: United States., Participants: From a 2 million-member sample, individuals aged 65 and older who received one of seven cardiovascular medications (angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), amiodarone, digoxin, diuretics, potassium supplements, and statins) and did not have recommended baseline monitoring performed during the 180 days before or 14 days after the index dispensing., Measurements: The proportion of members receiving each drug for whom recommended laboratory monitoring was not performed. Laboratory monitoring error rates stratified by sex, age group, chronic disease score, and HMO site were examined, and logistic regression was used to identify predictors of laboratory monitoring errors., Results: Error rates varied by medication class, ranging from 23% of patients receiving potassium supplementation without serum potassium and serum creatinine monitoring to 58% of patients receiving amiodarone who did not have recommended monitoring for thyroid and liver function. Highest error rates occurred in the youngest elderly for ACE inhibitors, ARBs, digoxin, diuretics, and potassium supplements, although in patients receiving amiodarone and statins, errors were most frequent in the oldest elderly. Errors occurred more frequently in patients with less comorbidity., Conclusion: Laboratory monitoring errors occurred frequently in elderly HMO members at the initiation of therapy with cardiovascular medications. Further study must examine the association between these errors and adverse outcomes.

Objective: To assess the benefit of sibutramine hydrochloride monohydrate within a weight management program., Study Design: Prospective randomized controlled trial in a health maintenance organization., Patients and Methods: Obese patients (n = 588) starting a weight management program were enrolled. Patients were randomly assigned to participate in the program alone or to participate in the program and receive sibutramine for 12 months. Outcome measures were change in weight, body mass index (BMI), percentage body fat, serum lipids, serum glucose, and blood pressure., Results: At baseline, there was a younger age and higher weight, BMI, and waist circumference in the drug group. There was more degenerative joint disease in the nondrug group. The mean weight loss at 6 months was 6.8 kg (95% confidence interval [CI], -7.4 to -6.1 kg) in the drug group vs 3.1 kg (95% CI, -3.8 to -2.4 kg) (P < .001) in the nondrug group. Weight loss was maintained at 12 months. Significant reductions in BMI, body fat, and waist circumference occurred in the drug group. There were no significant changes in laboratory values or blood pressure. Patients taking sibutramine experienced a significant increase in heart rate (1.7 beats/min [95% CI, 0.5-2.9 beats/min] vs -0.4 beats/min [95% CI, -1.5 to 0.8 beats/min]; P <.004)., Conclusion: In this managed care setting, the effectiveness and safety of sibutramine were similar to those observed in randomized, double-blind clinical efficacy trials.

To describe a program to study medication safety in pregnancy, the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP). MEPREP is a multi-site collaborative research program developed to enable the conduct of studies of medication use and outcomes in pregnancy. Collaborators include the U.S. Food and Drug Administration and researchers at the HMO Research Network, Kaiser Permanente Northern and Southern California, and Vanderbilt University. Datasets have been created at each site linking healthcare data for women delivering an infant between January 1, 2001 and December 31, 2008 and infants born to these women. Standardized data files include maternal and infant characteristics, medication use, and medical care at 11 health plans within 9 states; birth certificate data were obtained from the state departments of public health. MEPREP currently involves more than 20 medication safety researchers and includes data for 1,221,156 children delivered to 933,917 mothers. Current studies include evaluations of the prevalence and patterns of use of specific medications and a validation study of data elements in the administrative and birth certificate data files. MEPREP can support multiple studies by providing information on a large, ethnically and geographically diverse population. This partnership combines clinical and research expertise and data resources to enable the evaluation of outcomes associated with medication use during pregnancy. Keywords Pregnancy * Birth outcomes * Distributed data network, Introduction Decision-making regarding safe use of medications during pregnancy is challenging for a number of reasons. Pregnant women are generally excluded from clinical trials for ethical concerns about the drug's [...]

To examine the risks of genital herpes and antiherpes treatment during pregnancy in relation to preterm delivery (PTD), we conducted a multicenter, member-based cohort study within 4 Kaiser Permanente regions: northern and southern California, Colorado, and Georgia. The study included 662,913 mother-newborn pairs from 1997 to 2010. Pregnant women were classified into 3 groups based on genital herpes diagnosis and treatment: genital herpes without treatment, genital herpes with antiherpes treatment, and no herpes diagnosis or treatment (unexposed controls). After controlling for potential confounders, we found that compared with being unexposed, having untreated genital herpes during first or second trimester was associated with more than double the risk of PTD (odds ratio (OR) = 2.23, 95% confidence interval (CI): 1.80, 2.76). The association was stronger for PTD due to premature rupture of membrane (OR = 3.57, 95% CI: 2.53, 5.06) and for early PTD (≤35 weeks gestation) (OR = 2.87, 95% CI: 2.22, 3.71). In contrast, undergoing antiherpes treatment during pregnancy was associated with a lower risk of PTD compared with not being treated, and the PTD risk was similar to that observed in the unexposed controls (OR = 1.11, 95% CI: 0.89, 1.38). The present study revealed increased risk of PTD associated with genital herpes infection if left untreated and a potential benefit of antiherpes medications in mitigating the effect of genital herpes infection on the risk of PTD. [ABSTRACT FROM PUBLISHER]

Background and Objectives: Product labeling and published guidelines reflect the importance of monitoring laboratory parameters for drugs with a risk of organ system toxicity or electrolyte imbalance. Limited information exists about adherence to laboratory monitoring recommendations. The objective of this study was to describe laboratory monitoring among ambulatory patients dispensed medications for which laboratory testing is recommended at therapy initiation.Design and Subjects: We conducted a retrospective cross-sectional analysis of patients in 10 geographically distributed health maintenance organizations who were newly prescribed medications with recommended laboratory test monitoring. The main outcome measure was the proportion of initial drug dispensing without recommended baseline laboratory monitoring for 35 newly initiated drugs or drug classes.Results: One hundred seven thousand, seven hundred sixty-three of 279,354 (39%) initial drug dispensings occurred without recommended laboratory monitoring. Patients without monitoring were younger than patients who had monitoring (median 57 vs 61 years, P<.001). Thirty-two percent of dispensings where a serum creatinine was indicated did not have it evaluated (range across drugs, 12% to 61%); 39% did not have liver function testing (range 10% to 75%); 32% did not have hematologic monitoring (range 9% to 51%); and 34% did not have electrolyte monitoring (range 20% to 62%) (P<.001).Conclusions: Substantial opportunity exists to improve laboratory monitoring of drugs for which such monitoring is recommended. This study emphasizes the need for research to identify the clinical implications of not conducting recommended laboratory monitoring, existing barriers to monitoring, and methods to improve practice. [ABSTRACT FROM AUTHOR]

Background. Widespread use of broad-spectrum antibiotics contributes to increasing rates of bacterial resistance to antibiotics. Second-generation macrolides have become popular for use among children because of their broad spectrum and favorable dosing and side-effect profiles, although experts do not generally recommend them for use as initial treatment of infections among younger children. Objective. To assess trends in second-generation macrolide use from 1996 to 2000 among children treated as outpatients in 9 US health plans, including associated diagnoses and use as initial treatment. Methods. We sampled claims data for 25 000 children, 3 months to <18 years of age, who were enrolled between September 1, 1995, and August 31, 2000, in each of 9 US health plans. Medications dispensed were linked with ambulatory visit claims to assign diagnoses. Dispensings without another antibiotic dispensing recorded in the previous 42 days were analyzed as initial treatment of a new illness episode. We analyzed trends in prescribing overall, for initial therapy, and, within specific diag-noses, for differences among health plans. Results. From 1995-1996 to 1999-2000, although overall antibiotic use decreased from 1.15 to 0.91 dispensings per person-year, second-generation macrolide use increased from 0.022 to 0.063 dispensings per person-year. Use as a proportion of all antibiotic dispensings in-creased from 1.9% to 6.9%, and use as initial therapy increased from 1.4% to 6%. For children <6 years of age, second-generation macrolide use as initial therapy increased from 0.9% to 5.0% for otitis media and from 5.2% to 24.0% for pneumonia. There was a wide range of prescribing rates among health plans during the last year of the study, from 0.006 to 0.135 dispensings per person-year. Conclusions. Despite recent trends toward decreased antibiotic use among children, the use of second-generation macrolides among children has increased dramatically, even among younger... [ABSTRACT FROM AUTHOR]