R. Valuck - Academia.edu (original) (raw)

Papers by R. Valuck

Research paper thumbnail of Multiple sclerosis prevalence in the United States commercially insured population

Neurology, Jan 17, 2016

To estimate the US commercially insured multiple sclerosis (MS) annual prevalence from 2008 to 20... more To estimate the US commercially insured multiple sclerosis (MS) annual prevalence from 2008 to 2012. The study was a retrospective analysis using PharMetrics Plus, a nationwide claims database for over 42 million covered US representative lives. Annual point prevalence required insurance eligibility during an entire year. Our primary annual MS identification algorithm required 2 inpatient claims coded ICD-9 340 or 3 outpatient claims coded ICD-9 340 or 1 MS-indicated disease-modifying therapy claim. Age-adjusted annual prevalence estimates were extrapolated to the US population using US Census data. The 2012 MS prevalence was 149.2 per 100,000 individuals (95% confidence interval 147.6-150.9). Prevalence was consistent over 2008-2012. Female participants were 3.13 times more likely to have MS. The highest prevalence was in participants aged 45-49 years (303.5 per 100,000 individuals [295.6-311.5]). The East Census region recorded the highest prevalence (192.1 [188.2-196.0]); the Wes...

Research paper thumbnail of Patent medicine muckraking: influences on American pharmacy, social reform, and foreign authors

Pharmacy in history, 1992

Research paper thumbnail of Archives of Pediatrics & Adolescent Medicine

Research paper thumbnail of Factors associated with antibiotic prescribing in a managed care setting: An exploratory investigation

Social Science & Medicine, 1997

This multi-site, cross-sectional, observational study sought to identify attitudinal and social n... more This multi-site, cross-sectional, observational study sought to identify attitudinal and social normative factors associated with the prescribing of oral antibiotics to ambulatory patients in a managed care setting. Participants were 25 physicians specializing in internal medicine, family practice or pediatrics from five ambulatory care clinics within a large, fully integrated health care system in a major midwestern U.S. city. The main outcome measure was number of prescriptions per physician written in the fourth quarter of 1994 for each of seven selected antibiotics. Correlational and multiple regression analyses revealed that behavioral intentions were significantly associated (P < 0.05) with both attitudes and subjective norms. However, physicians' attitudes, subjective norms and intentions were not predictive of actual antibiotic prescribing behavior. Prescribing behavior may have been a function of patient-specific rather than general beliefs about antibiotics. Methodological limitations related to the sample size and the sparseness of the utilization data may also have prevented a significant effect of intentions on behavior from being detected. Alternatively, in managed care settings, it is hypothesized that prescribing behavior may have been influenced more by non-psychological factors, such as management systems, formularies and therapeutic substitution programs, than they were by internal, psychological factors such as attitudes, subjective norms and intentions. Managed care is altering the role of the physician as an autonomous decision-maker. In response, models of prescribing must either incorporate variables such as perceived behavioral control to aid in the prediction of non-volitional behavior, model the decision-making of non-physician managers, or forego psychological models in favor of structural or system-level models of drug utilization.

Research paper thumbnail of An Institution-Specific Heparin Titration Nomogram: Development, Validation, and Assessment of Compliance

Pharmacotherapy, 2001

To develop, validate, and assess compliance with a heparin titration nomogram. Prospective, open-... more To develop, validate, and assess compliance with a heparin titration nomogram. Prospective, open-label trial. University teaching hospital. Patients admitted with heart failure who required therapy with intravenous unfractionated heparin. Intervention. An in vitro concentration-response was determined by measuring activated partial thromboplastin times (aPTTs) on normal pooled plasma containing known concentrations of heparin. The therapeutic aPTT range was determined from the concentration-response by using the therapeutic heparin concentration range of 0.2-0.4 U/ml (protamine neutralization). Patients were consecutively enrolled, and therapy was managed by using the heparin titration nomogram. Paired aPTT-heparin concentrations were obtained, and nomogram validation was performed by comparing the in vitro and the ex vivo concentration-responses with use of linear regression. Nomogram compliance also was assessed. The therapeutic aPTT ranges based on in vitro and ex vivo data were determined to be 45-72 seconds and 47-61 seconds, respectively. The ranges were significantly different (p&lt;0.001). Overall compliance with the nomogram was 88%. These results confirm that, even in a relatively homogeneous disease-state patient population, in vitro data do not accurately predict ex vivo data. If in vitro data are used to develop an institution-specific nomogram, a validation procedure should be used to ensure accuracy. Although 100% compliance to a nomogram may not be attainable, it should be expected. Therefore, a compliance rate of 88% is concerning and suggests a need for increased nursing and physician education.

Research paper thumbnail of Small area variation and geographic and patient-specific determinants of metabolic testing in antipsychotic users

Pharmacoepidemiology and Drug Safety, 2011

The American Diabetes Association and American Psychiatric Association recommend metabolic monito... more The American Diabetes Association and American Psychiatric Association recommend metabolic monitoring for all patients using second-generation antipsychotic (SGA) drugs. We estimated glucose and lipid testing rates among SGA-users from three state Medicaid programs and investigated small area variation and patient and geographic determinants of testing. A retrospective new-user cohort study using Medicaid claims data from California, Missouri, and Oregon was conducted among 30,563 patients in 207 counties starting SGA medication September 2004-December 2005. Adjusted odds ratios for state, county, and patient factors associated with testing were calculated from multivariable hierarchical logistic regression models. Mean 6-month testing rates were 51.6% (glucose) and 26.2% (lipids). Screening rates were positively associated with the number of Type 2 diabetes risk factors (RF) present: glucose -39% (0 RF) to 82% (5 RF); lipids -13% (0 RF) to 66% (5 RF). A four-fold difference in glucose testing rates (21-85%) and a greater than six-fold difference in lipid testing rates (0-62%) were observed between counties. In the adjusted regression models, age, cardiometabolic co-morbidity (diabetes, dyslipidemia), serious mental illness, persistent use of SGAs, and frequency of non-psychiatric medical office visits were significant determinants of glucose and lipid testing. Lipid testing was more likely for children and adults in California, as was glucose testing for children. Glucose and lipid testing among SGA-users varied significantly between states, counties, and by patient characteristics. More effort is needed to understand provider and system reasons for testing disparities in order to inform risk management quality improvement interventions.

Research paper thumbnail of Measuring severe adverse events and medication selection using a “PEER Report” for nonpsychotic patients: a retrospective chart review

Neuropsychiatric Disease and Treatment, 2012

We previously reported on an objective new tool that uses quantitative electroencephalography (QE... more We previously reported on an objective new tool that uses quantitative electroencephalography (QEEG) normative-and referenced-electroencephalography sampling databases (currently called Psychiatric EEG Evaluation Registry [PEER]), which may assist physicians in determining medication selection for optimal efficacy to overcome trial-and-error prescribing. The PEER test compares drug-free QEEG features for individual patients to a database of patients with similar EEG patterns and known outcomes after pharmacological interventions. Based on specific EEG data elements and historical outcomes, the PEER Report may also serve as a marker of future severe adverse events (eg, agitation, hostility, aggressiveness, suicidality, homicidality, mania, hypomania) with specific medications. We used a retrospective chart review to investigate the clinical utility of such a registry in a naturalistic environment. Results: This chart review demonstrated significant improvement on the global assessment scales Clinical Global Impression-Improvement and Quality of Life Enjoyment and Satisfaction-Short Form as well as time to maximum medical improvement and decreased suicidality occurrences. The review also showed that 54.5% of previous medications causing a severe adverse event would have been raised as a caution had the PEER Report been available at the time the drug was prescribed. Finally, due to the significant amount of off-label prescribing of psychotropic medications, additional, objective, evidence-based data aided the prescriber toward better choices. Conclusion: The PEER Report may be useful, particularly in treatment-resistant patients, in helping to guide medication selection. Based on the preliminary data obtained from this chart review, additional studies are warranted to establish the safety and efficacy of adding PEER data when making medication decisions.

Research paper thumbnail of Impact of Increased Copayments on the Discontinuation/Switching Rates of Nonformulary Medications

Journal of Pharmacy Technology, 2005

Background: Patients with chronic diseases are particularly affected by prescription copayment in... more Background: Patients with chronic diseases are particularly affected by prescription copayment increases, as they are faced with the decision to switch to formulary alternatives or pay more to stay on their current medication. Objective: To evaluate the impact of increased copayments as a result of a change in formulary status on the continuation rates of nonformulary medications in multitiered pharmacy benefit plans. Methods: A retrospective cohort study was conducted on patients with chronic diseases who were part of a health plan in the western US. Individuals were selected if they were taking a medication that was being removed from the health plan's formulary and, thus, experienced increases in their copayments for nonformulary medications (n = 1,244). The time periods before and after the increase in copayments were studied. Adjusting for demographics, chronic comorbidities, medication use, Medicare + Choice status, and percentage increase in copayment for nonformulary med...

Research paper thumbnail of Prevalence of Baseline Serum Glucose and Lipid Testing in Users of Second-Generation Antipsychotic Drugs

The Journal of Clinical Psychiatry, 2008

Increased risk of diabetes and dyslipidemia is associated with major mental illness and antipsych... more Increased risk of diabetes and dyslipidemia is associated with major mental illness and antipsychotic drug use. This study aimed to determine the prevalence of serum glucose and lipid monitoring in public mental health clients initiating second-generation antipsychotic (SGA) drugs. This retrospective cohort study using Medicaid claims data from California, Oregon, Tennessee, and Utah evaluated 55,436 enrollees with a prescription claim for an SGA drug between January 1, 1998, and December 31, 2003. Serum glucose and lipid testing were identified using Current Procedural Terminology (CPT) procedure codes. Baseline was defined as 14 days before through 28 days after the date of the first SGA prescription. Multivariate logistic regression identified patient characteristics associated with testing. Generalized estimating equations evaluated changes associated with SGA drug initiation compared to background rates of testing. On average, &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 20% of individuals initiating SGA drug therapy received baseline glucose testing, and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 10% received baseline lipid testing. Baseline glucose and lipid testing increased modestly with SGA initiation (glucose: 7%-11% increase; lipids: 2%-3% increase; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Preexisting diabetes and dyslipidemia were associated with a 2- to 3-fold greater likelihood of baseline glucose and lipid testing. The likelihood of glucose testing increased 2-fold between 1998 and 2003 and was 46% more likely in patients with schizophrenia. Enrollees from Oregon, Tennessee, and Utah were 50% to 90% less likely to receive baseline glucose or lipid testing than enrollees from California. Glucose and lipid screening is underutilized in patients initiating SGA drug therapy. Psychiatrists can play an important role to ensure metabolic risk is adequately assessed.

Research paper thumbnail of A case-control study on adverse effects: H2 blocker or proton pump inhibitor use and risk of vitamin B12 deficiency in older adults

Journal of Clinical Epidemiology, 2004

Objective: Acid-suppressant drugs are commonly prescribed for elderly patients, a population in w... more Objective: Acid-suppressant drugs are commonly prescribed for elderly patients, a population in which vitamin B 12 deficiency is a common disorder. The purpose of this study was to examine the possible association between use of prescription histamine H-2 receptor antagonists (H2RA) or proton pump inhibitors (PPI) and vitamin B 12 deficiency in older adults. Study Design and Setting: This was a case-control study in a University-based geriatric primary care setting. Among patients aged 65 years or older with documented serum vitamin B 12 studies between 1990 and 1997, 53 vitamin B 12-deficient cases were compared with 212 controls for past or current use of prescription H2RA/PPI according to information in subjects' medical records. Results: Controlling for age, gender, multivitamin use, and Helicobacter pylori infection, chronic (у12 months) current use of H2RA/ PPI was associated with a significantly increased risk of vitamin B 12 deficiency (OR 4.45; 95% CI 1.47-13.34). No association was found between past or short-term current use of H2RA/PPI and vitamin B 12 deficiency. Conclusion: These findings support an association between chronic use of H2RA/PPI by older adults and development of vitamin B 12 deficiency. Additional studies are needed to confirm these findings.

Research paper thumbnail of Effect of a closed drug-delivery system on the incidence of nosocomial and catheter-related bloodstream infections in infants

Epidemiology and Infection, 2006

We conducted a prospective, cohort study at two affiliated level III neonatal intensive care unit... more We conducted a prospective, cohort study at two affiliated level III neonatal intensive care units to evaluate the effect of a closed drug-delivery system on the incidence of nosocomial and catheter-related bloodstream infections (CRBSI) in infants. A total of 300 infants (n=150 at each site) were enrolled over a 4-year study period. There was no difference in the rate of CRBSI per 1000 catheter days between the two sites (16·2±39 vs. 8·9±24, P=0·054, 95% CI−14·8 to 0·13). Infants at site A (closed drug-delivery system) had a higher rate of infectious nosocomial respiratory complications per 100 hospital days than infants at site B (open delivery system) (1·1±2·2 vs. 0·5±1·5, P=0·009), however, there was no difference in the overall number of confirmed or suspected nosocomial infection events per patient between study sites. Logistic regression revealed that the number of additional peripheral catheters, gestational age and duration of parenteral nutrition all significantly contribu...

Research paper thumbnail of Evaluation of Off-Label Recombinant Activated Factor VII for Multiple Indications in Children

Clinical and Applied Thrombosis/Hemostasis, 2007

Despite a paucity of safety and efficacy data, the use of recombinant activated factor VII in chi... more Despite a paucity of safety and efficacy data, the use of recombinant activated factor VII in children for off-label indications has now surpassed its use in hemophilia. A retrospective chart review was conducted of 46 subjects (age, 6.7 ± 6 years; weight, 26 ± 20 kg) who received recombinant activated factor VII for nonhemophiliac indications between January 1, 2004, and September 1, 2005. Indications for use included prevention (n = 6) or treatment (n = 40) of bleeding due to general surgery, hepatic failure, gastrointestinal bleeding, severe traumatic brain injury, bone marrow transplant, cardiac, acetaminophen overdose, and multiorgan system failure. Decreases in prothrombin time, partial thromboplastin time, and international normalized ratio were observed. No inappropriate thrombotic events were noted. Administration of recombinant activated factor VII was associated with a reduction in coagulation markers without obvious adverse thrombotic events at cost of $4189 per dose. Th...

Research paper thumbnail of Metabolic Screening in Children Receiving Antipsychotic Drug Treatment

Archives of Pediatrics & Adolescent Medicine, 2010

To estimate metabolic screening rates, predictors of screening, and incidence of metabolic distur... more To estimate metabolic screening rates, predictors of screening, and incidence of metabolic disturbances in children initiating second-generation antipsychotic (SGA) drug treatment.

Research paper thumbnail of Persisting Decline in Depression Treatment After FDA Warnings

Archives of General Psychiatry, 2009

the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidal... more the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidality for pediatric patients taking antidepressants; a boxed warning, package insert, and medication guide were implemented in February 2005. The warning was extended to young adults aged 18 to 24 years in May 2007. Immediately following the 2003 advisory, unintended declines in case finding and nonselective serotonin reuptake inhibitor substitute treatment were shown for pediatric patients, and spillover effects were seen in adult patients, who were not targeted by the warnings. Objective: To determine whether the unintended declines in depression care persisted for pediatric, young adult, and adult patients.

Research paper thumbnail of Metabolic Testing Rates in 3 State Medicaid Programs After FDA Warnings and ADA/APA Recommendations for Second-Generation Antipsychotic Drugs

Archives of General Psychiatry, 2010

In 2003, the Food and Drug Administration (FDA) required a warning on diabetes risk for secondgen... more In 2003, the Food and Drug Administration (FDA) required a warning on diabetes risk for secondgeneration antipsychotic (SGA) drugs. The American Diabetes Association (ADA) and American Psychiatric Association (APA) recommended glucose and lipid testing for all patients starting to receive SGA drugs. Objective: To characterize associations between the combined warnings and recommendations and baseline metabolic testing and SGA drug selection.

Research paper thumbnail of Factors Associated with Successful Epoetin Alfa Therapy in Premature Infants

The Annals of Pharmacotherapy, 2000

OBJECTIVE: To determine the impact of two different recombinant human erythropoietin (epoetin alf... more OBJECTIVE: To determine the impact of two different recombinant human erythropoietin (epoetin alfa) dosing strategies on the number of red blood cell (RBC) transfusions, and explore relationships between specific patient and drug regimen variables with epoetin alfa therapy outcomes. DESIGN: Retrospective cohort study. SETTING: Level III university neonatal intensive care unit. METHODS: Infants who received epoetin alfa therapy three times weekly for more than one week were categorized into two epoetin alfa dosing strategy groups: group A (300–749 units/kg/wk) and group B (750–1200 units/kg/wk). The following patient variables were collected and their relationship to therapy outcomes (corrected reticulocyte count [%], hematocrit [%], and number of RBC transfusions after therapy was started) were evaluated using independent Student's t-test, correlation analysis, and stepwise linear regression: birth weight (kg), gestational age (weeks), postnatal age at therapy onset (days), duration of mechanical ventilation (days), number of RBC transfusions before epoetin alfa therapy, phlebotomy loss (mL/kg), epoetin alfa dosage (units/kg/dose), iron dosage (mg/kg/d), duration of therapy (days), and postconceptional age at therapy discontinuation (weeks). RESULTS: The charts of 44 patients were reviewed. No significant impact on outcome was attributed to overall dosing strategy (group A vs. group B). Linear regression identified postnatal age at therapy onset as a significant contributor to mean hematocrit (R2 = 0.116; p = 0.023) and postconceptional age at therapy discontinuation as a significant contributor to number of transfusions during and after epoetin alfa use (R2 = 0.118; p = 0.022). A significant positive correlation was found between weekly mean epoetin alfa dosage and mean reticulocyte count (r = 0.326; p = 0.046), mean iron dosage and mean reticulocyte count (r = 0.439; p = 0.006), and ventilator days and total number of transfusions (r = 0.606; p &lt; 0.001). A significant negative correlation was found between number of transfusions and reticulocyte count (r = −0.367; p = 0.023). CONCLUSIONS: Epoetin alfa dosing strategy, as defined in our study, did not significantly affect the number of transfusions. However, postnatal age at therapy initiation, postconceptional age at therapy discontinuation, mean epoetin alfa dosage, and iron dosage correlate with specific outcomes of epoetin alfa therapy in premature infants.

Research paper thumbnail of Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

American Journal of Psychiatry, 2007

In 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the ri... more In 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the risk of suicidality in pediatric patients taking selective serotonin reuptake inhibitors (SSRIs) for depression, and in 2005, the agency mandated a black box warning and medication guide indicating that pediatric and adult patients may be at risk. The authors examine the effects of this pediatric policy on treatment of adult depression in the community. An adult cohort with newly diagnosed episodes of depression was created from a large national integrated claims database of managed care plans from October 1998 to September 2005 (N=475,838 unique episodes). Time-series analyses were used to compare the post-FDA advisory trends to the trends during the 5 years preceding the advisory. The rate of diagnosed depression was significantly lower after the advisory than would have been expected on the basis of the preadvisory historical trend. The average percentage of adults with new (versus recurrent) depressive episodes was 88.6% in the preadvisory period (declining at an annual rate of 1.69%), and it decreased significantly to 77.5% (declining more rapidly, at an annual rate of 7.70%). The percentage of adults with depression who did not receive an antidepressant increased from an average of 20% (declining at 0.45% annually) before the policy action to an average of 30% (increasing at an annual rate of 20.6%). The data did not show any compensatory increases in psychotherapy or prescription of atypical antipsychotics or anxiolytics. The FDA advisory had a significant spillover effect into community treatment for adults with depression, despite the focus of the policy on pediatric patients.

Research paper thumbnail of Frequency of Provider Contact After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

American Journal of Psychiatry, 2007

Objective: The Food and Drug Administration (FDA) issued a public health advisory in October 2003... more Objective: The Food and Drug Administration (FDA) issued a public health advisory in October 2003 on the risk of suicide in pediatric patients taking antidepressants and advised maintaining "close supervision" of such patients. In this study, the authors compared trends in the frequency of provider contacts for patients with depression before and after the advisory was issued. Method: Retrospective cohorts of children (N=27,370) and adults (N=193,151) with new episodes of depression treated with antidepressants were created from a national claims database of managed care plans (1998-2005). Two standards were used in measuring patient monitoring: the Health Plan Employer Data and Information Set (HEDIS) quality-of-care criterion calling for three contacts in 3 months and the FDA-recommended contact schedule totaling seven visits in 3 months. Time-series models compared postadvisory trends to the expected trend based on preadvisory measures.

Research paper thumbnail of Comparison of antidepressant classes and the risk and time course of suicide attempts in adults: propensity matched, retrospective cohort study

The British journal of psychiatry : the journal of mental science, Jan 3, 2015

BackgroundPlacebo-controlled clinical trials have led to concern over possible increased risk of ... more BackgroundPlacebo-controlled clinical trials have led to concern over possible increased risk of suicide-related events in some populations exposed to antidepressants.AimsTo evaluate the risk of suicide attempts by antidepressant drug class and the presence or absence of depression.MethodA retrospective propensity-matched new-user cohort study was used to compare participants with incident depression classified by antidepressant treatment with each other and with the general population.ResultsAmong the treated group, the suicide attempt rate peaked in the month prior to diagnosis then decreased steadily over the next 6 months. Among the pharmacologically untreated group, the highest rate was seen in the second month after diagnosis. Cohorts with depression had significantly higher suicide attempt risk than the general population, but the treated group did not differ significantly from the untreated group.ConclusionsPatients on antidepressants did not have significantly higher risk c...

Research paper thumbnail of PMH6 Differential Rates of Side Effects in Depressed Adults and Adolescents Being Treated With Antidepressants

Value in Health, 2011

to be statistically significant (odds ratio: 1.056; 95% CI: 0.669-1.665) between atypical and typ... more to be statistically significant (odds ratio: 1.056; 95% CI: 0.669-1.665) between atypical and typical antipsychotic users. Similar results were obtained in sensitivity analysis (odds ratio: 1.089; 95% CI: 0.775-1.530). CONCLUSIONS: Typical and atypical antipsychotic drug use in an elderly Medicare population has similar risks of hip fracture.

Research paper thumbnail of Multiple sclerosis prevalence in the United States commercially insured population

Neurology, Jan 17, 2016

To estimate the US commercially insured multiple sclerosis (MS) annual prevalence from 2008 to 20... more To estimate the US commercially insured multiple sclerosis (MS) annual prevalence from 2008 to 2012. The study was a retrospective analysis using PharMetrics Plus, a nationwide claims database for over 42 million covered US representative lives. Annual point prevalence required insurance eligibility during an entire year. Our primary annual MS identification algorithm required 2 inpatient claims coded ICD-9 340 or 3 outpatient claims coded ICD-9 340 or 1 MS-indicated disease-modifying therapy claim. Age-adjusted annual prevalence estimates were extrapolated to the US population using US Census data. The 2012 MS prevalence was 149.2 per 100,000 individuals (95% confidence interval 147.6-150.9). Prevalence was consistent over 2008-2012. Female participants were 3.13 times more likely to have MS. The highest prevalence was in participants aged 45-49 years (303.5 per 100,000 individuals [295.6-311.5]). The East Census region recorded the highest prevalence (192.1 [188.2-196.0]); the Wes...

Research paper thumbnail of Patent medicine muckraking: influences on American pharmacy, social reform, and foreign authors

Pharmacy in history, 1992

Research paper thumbnail of Archives of Pediatrics & Adolescent Medicine

Research paper thumbnail of Factors associated with antibiotic prescribing in a managed care setting: An exploratory investigation

Social Science & Medicine, 1997

This multi-site, cross-sectional, observational study sought to identify attitudinal and social n... more This multi-site, cross-sectional, observational study sought to identify attitudinal and social normative factors associated with the prescribing of oral antibiotics to ambulatory patients in a managed care setting. Participants were 25 physicians specializing in internal medicine, family practice or pediatrics from five ambulatory care clinics within a large, fully integrated health care system in a major midwestern U.S. city. The main outcome measure was number of prescriptions per physician written in the fourth quarter of 1994 for each of seven selected antibiotics. Correlational and multiple regression analyses revealed that behavioral intentions were significantly associated (P < 0.05) with both attitudes and subjective norms. However, physicians' attitudes, subjective norms and intentions were not predictive of actual antibiotic prescribing behavior. Prescribing behavior may have been a function of patient-specific rather than general beliefs about antibiotics. Methodological limitations related to the sample size and the sparseness of the utilization data may also have prevented a significant effect of intentions on behavior from being detected. Alternatively, in managed care settings, it is hypothesized that prescribing behavior may have been influenced more by non-psychological factors, such as management systems, formularies and therapeutic substitution programs, than they were by internal, psychological factors such as attitudes, subjective norms and intentions. Managed care is altering the role of the physician as an autonomous decision-maker. In response, models of prescribing must either incorporate variables such as perceived behavioral control to aid in the prediction of non-volitional behavior, model the decision-making of non-physician managers, or forego psychological models in favor of structural or system-level models of drug utilization.

Research paper thumbnail of An Institution-Specific Heparin Titration Nomogram: Development, Validation, and Assessment of Compliance

Pharmacotherapy, 2001

To develop, validate, and assess compliance with a heparin titration nomogram. Prospective, open-... more To develop, validate, and assess compliance with a heparin titration nomogram. Prospective, open-label trial. University teaching hospital. Patients admitted with heart failure who required therapy with intravenous unfractionated heparin. Intervention. An in vitro concentration-response was determined by measuring activated partial thromboplastin times (aPTTs) on normal pooled plasma containing known concentrations of heparin. The therapeutic aPTT range was determined from the concentration-response by using the therapeutic heparin concentration range of 0.2-0.4 U/ml (protamine neutralization). Patients were consecutively enrolled, and therapy was managed by using the heparin titration nomogram. Paired aPTT-heparin concentrations were obtained, and nomogram validation was performed by comparing the in vitro and the ex vivo concentration-responses with use of linear regression. Nomogram compliance also was assessed. The therapeutic aPTT ranges based on in vitro and ex vivo data were determined to be 45-72 seconds and 47-61 seconds, respectively. The ranges were significantly different (p&lt;0.001). Overall compliance with the nomogram was 88%. These results confirm that, even in a relatively homogeneous disease-state patient population, in vitro data do not accurately predict ex vivo data. If in vitro data are used to develop an institution-specific nomogram, a validation procedure should be used to ensure accuracy. Although 100% compliance to a nomogram may not be attainable, it should be expected. Therefore, a compliance rate of 88% is concerning and suggests a need for increased nursing and physician education.

Research paper thumbnail of Small area variation and geographic and patient-specific determinants of metabolic testing in antipsychotic users

Pharmacoepidemiology and Drug Safety, 2011

The American Diabetes Association and American Psychiatric Association recommend metabolic monito... more The American Diabetes Association and American Psychiatric Association recommend metabolic monitoring for all patients using second-generation antipsychotic (SGA) drugs. We estimated glucose and lipid testing rates among SGA-users from three state Medicaid programs and investigated small area variation and patient and geographic determinants of testing. A retrospective new-user cohort study using Medicaid claims data from California, Missouri, and Oregon was conducted among 30,563 patients in 207 counties starting SGA medication September 2004-December 2005. Adjusted odds ratios for state, county, and patient factors associated with testing were calculated from multivariable hierarchical logistic regression models. Mean 6-month testing rates were 51.6% (glucose) and 26.2% (lipids). Screening rates were positively associated with the number of Type 2 diabetes risk factors (RF) present: glucose -39% (0 RF) to 82% (5 RF); lipids -13% (0 RF) to 66% (5 RF). A four-fold difference in glucose testing rates (21-85%) and a greater than six-fold difference in lipid testing rates (0-62%) were observed between counties. In the adjusted regression models, age, cardiometabolic co-morbidity (diabetes, dyslipidemia), serious mental illness, persistent use of SGAs, and frequency of non-psychiatric medical office visits were significant determinants of glucose and lipid testing. Lipid testing was more likely for children and adults in California, as was glucose testing for children. Glucose and lipid testing among SGA-users varied significantly between states, counties, and by patient characteristics. More effort is needed to understand provider and system reasons for testing disparities in order to inform risk management quality improvement interventions.

Research paper thumbnail of Measuring severe adverse events and medication selection using a “PEER Report” for nonpsychotic patients: a retrospective chart review

Neuropsychiatric Disease and Treatment, 2012

We previously reported on an objective new tool that uses quantitative electroencephalography (QE... more We previously reported on an objective new tool that uses quantitative electroencephalography (QEEG) normative-and referenced-electroencephalography sampling databases (currently called Psychiatric EEG Evaluation Registry [PEER]), which may assist physicians in determining medication selection for optimal efficacy to overcome trial-and-error prescribing. The PEER test compares drug-free QEEG features for individual patients to a database of patients with similar EEG patterns and known outcomes after pharmacological interventions. Based on specific EEG data elements and historical outcomes, the PEER Report may also serve as a marker of future severe adverse events (eg, agitation, hostility, aggressiveness, suicidality, homicidality, mania, hypomania) with specific medications. We used a retrospective chart review to investigate the clinical utility of such a registry in a naturalistic environment. Results: This chart review demonstrated significant improvement on the global assessment scales Clinical Global Impression-Improvement and Quality of Life Enjoyment and Satisfaction-Short Form as well as time to maximum medical improvement and decreased suicidality occurrences. The review also showed that 54.5% of previous medications causing a severe adverse event would have been raised as a caution had the PEER Report been available at the time the drug was prescribed. Finally, due to the significant amount of off-label prescribing of psychotropic medications, additional, objective, evidence-based data aided the prescriber toward better choices. Conclusion: The PEER Report may be useful, particularly in treatment-resistant patients, in helping to guide medication selection. Based on the preliminary data obtained from this chart review, additional studies are warranted to establish the safety and efficacy of adding PEER data when making medication decisions.

Research paper thumbnail of Impact of Increased Copayments on the Discontinuation/Switching Rates of Nonformulary Medications

Journal of Pharmacy Technology, 2005

Background: Patients with chronic diseases are particularly affected by prescription copayment in... more Background: Patients with chronic diseases are particularly affected by prescription copayment increases, as they are faced with the decision to switch to formulary alternatives or pay more to stay on their current medication. Objective: To evaluate the impact of increased copayments as a result of a change in formulary status on the continuation rates of nonformulary medications in multitiered pharmacy benefit plans. Methods: A retrospective cohort study was conducted on patients with chronic diseases who were part of a health plan in the western US. Individuals were selected if they were taking a medication that was being removed from the health plan's formulary and, thus, experienced increases in their copayments for nonformulary medications (n = 1,244). The time periods before and after the increase in copayments were studied. Adjusting for demographics, chronic comorbidities, medication use, Medicare + Choice status, and percentage increase in copayment for nonformulary med...

Research paper thumbnail of Prevalence of Baseline Serum Glucose and Lipid Testing in Users of Second-Generation Antipsychotic Drugs

The Journal of Clinical Psychiatry, 2008

Increased risk of diabetes and dyslipidemia is associated with major mental illness and antipsych... more Increased risk of diabetes and dyslipidemia is associated with major mental illness and antipsychotic drug use. This study aimed to determine the prevalence of serum glucose and lipid monitoring in public mental health clients initiating second-generation antipsychotic (SGA) drugs. This retrospective cohort study using Medicaid claims data from California, Oregon, Tennessee, and Utah evaluated 55,436 enrollees with a prescription claim for an SGA drug between January 1, 1998, and December 31, 2003. Serum glucose and lipid testing were identified using Current Procedural Terminology (CPT) procedure codes. Baseline was defined as 14 days before through 28 days after the date of the first SGA prescription. Multivariate logistic regression identified patient characteristics associated with testing. Generalized estimating equations evaluated changes associated with SGA drug initiation compared to background rates of testing. On average, &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 20% of individuals initiating SGA drug therapy received baseline glucose testing, and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 10% received baseline lipid testing. Baseline glucose and lipid testing increased modestly with SGA initiation (glucose: 7%-11% increase; lipids: 2%-3% increase; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Preexisting diabetes and dyslipidemia were associated with a 2- to 3-fold greater likelihood of baseline glucose and lipid testing. The likelihood of glucose testing increased 2-fold between 1998 and 2003 and was 46% more likely in patients with schizophrenia. Enrollees from Oregon, Tennessee, and Utah were 50% to 90% less likely to receive baseline glucose or lipid testing than enrollees from California. Glucose and lipid screening is underutilized in patients initiating SGA drug therapy. Psychiatrists can play an important role to ensure metabolic risk is adequately assessed.

Research paper thumbnail of A case-control study on adverse effects: H2 blocker or proton pump inhibitor use and risk of vitamin B12 deficiency in older adults

Journal of Clinical Epidemiology, 2004

Objective: Acid-suppressant drugs are commonly prescribed for elderly patients, a population in w... more Objective: Acid-suppressant drugs are commonly prescribed for elderly patients, a population in which vitamin B 12 deficiency is a common disorder. The purpose of this study was to examine the possible association between use of prescription histamine H-2 receptor antagonists (H2RA) or proton pump inhibitors (PPI) and vitamin B 12 deficiency in older adults. Study Design and Setting: This was a case-control study in a University-based geriatric primary care setting. Among patients aged 65 years or older with documented serum vitamin B 12 studies between 1990 and 1997, 53 vitamin B 12-deficient cases were compared with 212 controls for past or current use of prescription H2RA/PPI according to information in subjects' medical records. Results: Controlling for age, gender, multivitamin use, and Helicobacter pylori infection, chronic (у12 months) current use of H2RA/ PPI was associated with a significantly increased risk of vitamin B 12 deficiency (OR 4.45; 95% CI 1.47-13.34). No association was found between past or short-term current use of H2RA/PPI and vitamin B 12 deficiency. Conclusion: These findings support an association between chronic use of H2RA/PPI by older adults and development of vitamin B 12 deficiency. Additional studies are needed to confirm these findings.

Research paper thumbnail of Effect of a closed drug-delivery system on the incidence of nosocomial and catheter-related bloodstream infections in infants

Epidemiology and Infection, 2006

We conducted a prospective, cohort study at two affiliated level III neonatal intensive care unit... more We conducted a prospective, cohort study at two affiliated level III neonatal intensive care units to evaluate the effect of a closed drug-delivery system on the incidence of nosocomial and catheter-related bloodstream infections (CRBSI) in infants. A total of 300 infants (n=150 at each site) were enrolled over a 4-year study period. There was no difference in the rate of CRBSI per 1000 catheter days between the two sites (16·2±39 vs. 8·9±24, P=0·054, 95% CI−14·8 to 0·13). Infants at site A (closed drug-delivery system) had a higher rate of infectious nosocomial respiratory complications per 100 hospital days than infants at site B (open delivery system) (1·1±2·2 vs. 0·5±1·5, P=0·009), however, there was no difference in the overall number of confirmed or suspected nosocomial infection events per patient between study sites. Logistic regression revealed that the number of additional peripheral catheters, gestational age and duration of parenteral nutrition all significantly contribu...

Research paper thumbnail of Evaluation of Off-Label Recombinant Activated Factor VII for Multiple Indications in Children

Clinical and Applied Thrombosis/Hemostasis, 2007

Despite a paucity of safety and efficacy data, the use of recombinant activated factor VII in chi... more Despite a paucity of safety and efficacy data, the use of recombinant activated factor VII in children for off-label indications has now surpassed its use in hemophilia. A retrospective chart review was conducted of 46 subjects (age, 6.7 ± 6 years; weight, 26 ± 20 kg) who received recombinant activated factor VII for nonhemophiliac indications between January 1, 2004, and September 1, 2005. Indications for use included prevention (n = 6) or treatment (n = 40) of bleeding due to general surgery, hepatic failure, gastrointestinal bleeding, severe traumatic brain injury, bone marrow transplant, cardiac, acetaminophen overdose, and multiorgan system failure. Decreases in prothrombin time, partial thromboplastin time, and international normalized ratio were observed. No inappropriate thrombotic events were noted. Administration of recombinant activated factor VII was associated with a reduction in coagulation markers without obvious adverse thrombotic events at cost of $4189 per dose. Th...

Research paper thumbnail of Metabolic Screening in Children Receiving Antipsychotic Drug Treatment

Archives of Pediatrics & Adolescent Medicine, 2010

To estimate metabolic screening rates, predictors of screening, and incidence of metabolic distur... more To estimate metabolic screening rates, predictors of screening, and incidence of metabolic disturbances in children initiating second-generation antipsychotic (SGA) drug treatment.

Research paper thumbnail of Persisting Decline in Depression Treatment After FDA Warnings

Archives of General Psychiatry, 2009

the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidal... more the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidality for pediatric patients taking antidepressants; a boxed warning, package insert, and medication guide were implemented in February 2005. The warning was extended to young adults aged 18 to 24 years in May 2007. Immediately following the 2003 advisory, unintended declines in case finding and nonselective serotonin reuptake inhibitor substitute treatment were shown for pediatric patients, and spillover effects were seen in adult patients, who were not targeted by the warnings. Objective: To determine whether the unintended declines in depression care persisted for pediatric, young adult, and adult patients.

Research paper thumbnail of Metabolic Testing Rates in 3 State Medicaid Programs After FDA Warnings and ADA/APA Recommendations for Second-Generation Antipsychotic Drugs

Archives of General Psychiatry, 2010

In 2003, the Food and Drug Administration (FDA) required a warning on diabetes risk for secondgen... more In 2003, the Food and Drug Administration (FDA) required a warning on diabetes risk for secondgeneration antipsychotic (SGA) drugs. The American Diabetes Association (ADA) and American Psychiatric Association (APA) recommended glucose and lipid testing for all patients starting to receive SGA drugs. Objective: To characterize associations between the combined warnings and recommendations and baseline metabolic testing and SGA drug selection.

Research paper thumbnail of Factors Associated with Successful Epoetin Alfa Therapy in Premature Infants

The Annals of Pharmacotherapy, 2000

OBJECTIVE: To determine the impact of two different recombinant human erythropoietin (epoetin alf... more OBJECTIVE: To determine the impact of two different recombinant human erythropoietin (epoetin alfa) dosing strategies on the number of red blood cell (RBC) transfusions, and explore relationships between specific patient and drug regimen variables with epoetin alfa therapy outcomes. DESIGN: Retrospective cohort study. SETTING: Level III university neonatal intensive care unit. METHODS: Infants who received epoetin alfa therapy three times weekly for more than one week were categorized into two epoetin alfa dosing strategy groups: group A (300–749 units/kg/wk) and group B (750–1200 units/kg/wk). The following patient variables were collected and their relationship to therapy outcomes (corrected reticulocyte count [%], hematocrit [%], and number of RBC transfusions after therapy was started) were evaluated using independent Student's t-test, correlation analysis, and stepwise linear regression: birth weight (kg), gestational age (weeks), postnatal age at therapy onset (days), duration of mechanical ventilation (days), number of RBC transfusions before epoetin alfa therapy, phlebotomy loss (mL/kg), epoetin alfa dosage (units/kg/dose), iron dosage (mg/kg/d), duration of therapy (days), and postconceptional age at therapy discontinuation (weeks). RESULTS: The charts of 44 patients were reviewed. No significant impact on outcome was attributed to overall dosing strategy (group A vs. group B). Linear regression identified postnatal age at therapy onset as a significant contributor to mean hematocrit (R2 = 0.116; p = 0.023) and postconceptional age at therapy discontinuation as a significant contributor to number of transfusions during and after epoetin alfa use (R2 = 0.118; p = 0.022). A significant positive correlation was found between weekly mean epoetin alfa dosage and mean reticulocyte count (r = 0.326; p = 0.046), mean iron dosage and mean reticulocyte count (r = 0.439; p = 0.006), and ventilator days and total number of transfusions (r = 0.606; p &lt; 0.001). A significant negative correlation was found between number of transfusions and reticulocyte count (r = −0.367; p = 0.023). CONCLUSIONS: Epoetin alfa dosing strategy, as defined in our study, did not significantly affect the number of transfusions. However, postnatal age at therapy initiation, postconceptional age at therapy discontinuation, mean epoetin alfa dosage, and iron dosage correlate with specific outcomes of epoetin alfa therapy in premature infants.

Research paper thumbnail of Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

American Journal of Psychiatry, 2007

In 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the ri... more In 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the risk of suicidality in pediatric patients taking selective serotonin reuptake inhibitors (SSRIs) for depression, and in 2005, the agency mandated a black box warning and medication guide indicating that pediatric and adult patients may be at risk. The authors examine the effects of this pediatric policy on treatment of adult depression in the community. An adult cohort with newly diagnosed episodes of depression was created from a large national integrated claims database of managed care plans from October 1998 to September 2005 (N=475,838 unique episodes). Time-series analyses were used to compare the post-FDA advisory trends to the trends during the 5 years preceding the advisory. The rate of diagnosed depression was significantly lower after the advisory than would have been expected on the basis of the preadvisory historical trend. The average percentage of adults with new (versus recurrent) depressive episodes was 88.6% in the preadvisory period (declining at an annual rate of 1.69%), and it decreased significantly to 77.5% (declining more rapidly, at an annual rate of 7.70%). The percentage of adults with depression who did not receive an antidepressant increased from an average of 20% (declining at 0.45% annually) before the policy action to an average of 30% (increasing at an annual rate of 20.6%). The data did not show any compensatory increases in psychotherapy or prescription of atypical antipsychotics or anxiolytics. The FDA advisory had a significant spillover effect into community treatment for adults with depression, despite the focus of the policy on pediatric patients.

Research paper thumbnail of Frequency of Provider Contact After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

American Journal of Psychiatry, 2007

Objective: The Food and Drug Administration (FDA) issued a public health advisory in October 2003... more Objective: The Food and Drug Administration (FDA) issued a public health advisory in October 2003 on the risk of suicide in pediatric patients taking antidepressants and advised maintaining "close supervision" of such patients. In this study, the authors compared trends in the frequency of provider contacts for patients with depression before and after the advisory was issued. Method: Retrospective cohorts of children (N=27,370) and adults (N=193,151) with new episodes of depression treated with antidepressants were created from a national claims database of managed care plans (1998-2005). Two standards were used in measuring patient monitoring: the Health Plan Employer Data and Information Set (HEDIS) quality-of-care criterion calling for three contacts in 3 months and the FDA-recommended contact schedule totaling seven visits in 3 months. Time-series models compared postadvisory trends to the expected trend based on preadvisory measures.

Research paper thumbnail of Comparison of antidepressant classes and the risk and time course of suicide attempts in adults: propensity matched, retrospective cohort study

The British journal of psychiatry : the journal of mental science, Jan 3, 2015

BackgroundPlacebo-controlled clinical trials have led to concern over possible increased risk of ... more BackgroundPlacebo-controlled clinical trials have led to concern over possible increased risk of suicide-related events in some populations exposed to antidepressants.AimsTo evaluate the risk of suicide attempts by antidepressant drug class and the presence or absence of depression.MethodA retrospective propensity-matched new-user cohort study was used to compare participants with incident depression classified by antidepressant treatment with each other and with the general population.ResultsAmong the treated group, the suicide attempt rate peaked in the month prior to diagnosis then decreased steadily over the next 6 months. Among the pharmacologically untreated group, the highest rate was seen in the second month after diagnosis. Cohorts with depression had significantly higher suicide attempt risk than the general population, but the treated group did not differ significantly from the untreated group.ConclusionsPatients on antidepressants did not have significantly higher risk c...

Research paper thumbnail of PMH6 Differential Rates of Side Effects in Depressed Adults and Adolescents Being Treated With Antidepressants

Value in Health, 2011

to be statistically significant (odds ratio: 1.056; 95% CI: 0.669-1.665) between atypical and typ... more to be statistically significant (odds ratio: 1.056; 95% CI: 0.669-1.665) between atypical and typical antipsychotic users. Similar results were obtained in sensitivity analysis (odds ratio: 1.089; 95% CI: 0.775-1.530). CONCLUSIONS: Typical and atypical antipsychotic drug use in an elderly Medicare population has similar risks of hip fracture.