Characterization of Tolerance in Children during Fentanyl Continuous Infusions.

Tolerance is a complication of fentanyl continuous infusions (CINs) in critically ill children, but the incidence and time of onset are lacking. The primary objective was to identify the incidence of tolerance. Secondary objectives were to determine the onset time and compare risk factors between children with tolerance versus no tolerance and between children with early (< 24 hours) versus late tolerance. Children aged 0 to 17 years, receiving fentanyl CIN > 3 days from May 1, 2012 to June 30, 2013 were included. Tolerance was defined as a doubling of the fentanyl CIN dose. Descriptive and inferential statistics were performed. A logistic regression model was used to assess the relationship between the development of tolerance and independent variables. A total of 59 CINs were included. Tolerance occurred in 46 CINs (78%), with median time to tolerance of 26 hours (range: 1-160 hours). Early tolerance was identified in 21 CINs (45.7%). Patients with tolerance had higher peak CIN doses (p < 0.001), final CIN doses (p = 0.031), and cumulative exposure (p = 0.017). No significant differences were noted between those with early versus late tolerance. The regression model noted factors associated with the odds of development of tolerance were lower initial fentanyl dose (p = 0.007; odds ratio [OR]: 0.011, 95% confidence interval [CI]: 0.0004-0.29) and higher cumulative exposure (p = 0.009; OR: 1.01, 95% CI: 1.001-1.01). Tolerance developed in 78% of children, and half developed it within 24 hours. Lower initial opioid dose and higher cumulative exposure were independently associated with tolerance.

Applicability of the Schwartz Equation and the Chronic Kidney Disease in Children Bedside Equation for Estimating Glomerular Filtration Rate in Overweight Children.

STUDY OBJECTIVE: To determine if significant correlations exist between glomerular filtration rate (GFR) prediction equation values, derived by using the original Schwartz equation and the Chronic Kidney Disease in Children (CKiD) bedside equation with a 24-hour urine creatinine clearance (Clcr ) value normalized to a body surface area of 1.73 m(2) in overweight and obese children. DESIGN: Prospective analysis (20 patients) and retrospective analysis (43 patients). SETTING: Pediatric inpatient ward and pediatric nephrology clinic at a comprehensive academic medical center. PATIENTS: Sixty-three pediatric patients (aged 5-17 years), of whom 27 were overweight (body mass index [BMI] at the 85th percentile or higher) and 36 were not overweight (BMI lower than the 85th percentile [controls]) between 2007 and 2012. METHODS AND MAIN RESULTS: Data from the overweight patients were compared with nonoverweight controls. GFR values were calculated by using the original Schwartz equation and the CKiD bedside equation. Each patient's 24-hour urine Clcr value normalized to a body surface area of 1.73 m(2) served as the index value. A Pearson correlation coefficient model was used to determine association between the 24-hour urine Clcr value (index value) with the Schwartz and CKiD GFR estimations. Significant correlation was found to exist between the Schwartz and CKiD bedside GFR estimations relative to the 24-hour urine Clcr in the control subjects (r = 0.85, p<0.0001, and r = 0.85, p<0.0001, respectively). Significant correlation was also found to exist between the Schwartz and CKiD bedside GFR values with the 24-hour urine Clcr value in overweight subjects (r = 0.86, p<0.0001, and r = 0.86, p<0.0001, respectively). The Schwartz equation estimated average GFR 21.75 ml/minute/1.73 m(2) higher than 24-hour urine Clcr (p<0.0001) in overweight children with a kidney disorder. The CKiD bedside GFR estimations were not significantly different compared with 24-hour urine Clcr values for the overweight group with kidney disorder (p=0.85). CONCLUSION: The Schwartz and CKiD bedside estimations of GFR correlated with 24-hour urine Clcr values in both overweight and nonoverweight children. Compared with the Schwartz equation, which tended to overestimate renal function, the CKiD bedside equation appeared to approximate 24-hour urine Clcr more closely in overweight children with kidney disorder.

An evaluation of three statistical estimation methods for assessing health policy effects on prescription drug claims.

BACKGROUND: While the choice of analytical approach affects study results and their interpretation, there is no consensus to guide the choice of statistical approaches to evaluate public health policy change. OBJECTIVES: This study compared and contrasted three statistical estimation procedures in the assessment of a U.S. Food and Drug Administration (FDA) suicidality warning, communicated in January 2008 and implemented in May 2009, on antiepileptic drug (AED) prescription claims. METHODS: Longitudinal designs were utilized to evaluate Oklahoma (U.S. State) Medicaid claim data from January 2006 through December 2009. The study included 9289 continuously eligible individuals with prevalent diagnoses of epilepsy and/or psychiatric disorder. Segmented regression models using three estimation procedures [i.e., generalized linear models (GLM), generalized estimation equations (GEE), and generalized linear mixed models (GLMM)] were used to estimate trends of AED prescription claims across three time periods: before (January 2006-January 2008); during (February 2008-May 2009); and after (June 2009-December 2009) the FDA warning. RESULTS: All three statistical procedures estimated an increasing trend (P < 0.0001) in AED prescription claims before the FDA warning period. No procedures detected a significant change in trend during (GLM: -30.0%, 99% CI: -60.0% to 10.0%; GEE: -20.0%, 99% CI: -70.0% to 30.0%; GLMM: -23.5%, 99% CI: -58.8% to 1.2%) and after (GLM: 50.0%, 99% CI: -70.0% to 160.0%; GEE: 80.0%, 99% CI: -20.0% to 200.0%; GLMM: 47.1%, 99% CI: -41.2% to 135.3%) the FDA warning when compared to pre-warning period. CONCLUSIONS: Although the three procedures provided consistent inferences, the GEE and GLMM approaches accounted appropriately for correlation. Further, marginal models estimated using GEE produced more robust and valid population-level estimations.

Prior authorization policies in Medicaid programs: The importance of study design and analysis on findings and outcomes from research.

U.S. State Medicaid programs for the medically indigent strive to deliver quality health care services with limited budgets. An often used cost management strategy is prior authorization of services or prescription medications. The goal of this strategy is to shape the pharmaceutical market share in the most efficient manner for the particular state Medicaid program, much like commercial managed care organizations. These policies are often scrutinized due to the population Medicaid serves, which in the past was largely composed of individuals with vulnerable health status. Unintended consequences can occur if these policies are not carried out in an appropriate manner or if they greatly restrict services. The data used for policy implementation research is prone to certain problems such as skewness and multimodality. Previous guidelines have been published regarding the best practices when analyzing these data. These guidelines were used to review the current body of literature regarding prior authorization in Medicaid. Further discussed are additional characteristics such as therapeutic areas researched and the outcomes identified. Finally, the importance of considering state-specific characteristics when reviewing individual policies and the usefulness of these results for other programs are also considered.

Duration of intrathecal morphine effect in children with idiopathic scoliosis undergoing posterior spinal fusion.

OBJECTIVE: Intrathecal (IT) morphine improves pain control and decreases opioid requirements in children following thoracic and abdominal surgery. However, studies in children report variable durations of analgesia following IT morphine. The purpose of this study is to describe the duration of analgesia in children undergoing surgical correction of idiopathic scoliosis. DESIGN: Retrospective chart review. SETTING: Pediatric hospital within a tertiary care academic medical center. PARTICIPANTS: Forty-four pediatric patients with idiopathic scoliosis who received IT morphine following posterior spinal fusion (PSF). MAIN OUTCOME MEASURE(S): Mean opioid exposure 0-12 hours and 13-24 hours post-IT morphine. RESULTS: Mean opioid exposure was significantly increased during the 13-24-hour compared to the 0-12-hour time period (23.0 ± 12.5 mg parenteral morphine vs 15.9 ± 1.7 mg; p = 0.0006). The only factors significantly associated with morphine exposure during the 0-12-hour period included the median pain score (0-12 hours) (odds ratio [OR], 1.92; 95% confidence interval [CI], 0.033-3.80; p = 0.046) and total acetaminophen dose (OR, 0.003; 95% CI, 0.0008-0.005; p = 0.011). CONCLUSIONS: These data indicate that patients experienced improved analgesia for at least 12 hours following IT morphine. Increased use of adjuvant analgesics such as acetaminophen may reduce opioid requirements following PSF procedures. More studies are needed to investigate the combination of adjuvants and IT morphine to reduce postoperative pain in this population.

Impact of a prior authorization policy for montelukast on clinical outcomes for asthma and allergic rhinitis among children and adolescents in a state Medicaid program.

BACKGROUND: Public policymakers often struggle with increased membership and limited budgets. Restrictions, commonly in the form of prior authorizations, are often placed on more costly pharmaceuticals, especially when lower cost or more effective products are available. Restrictions placed on products for difficult-to-manage disease states must be reviewed in order to ensure that unintended clinical consequences do not occur. OBJECTIVE: To assess the impact of a prior authorization policy for montelukast on clinical outcomes for asthma and allergic rhinitis among children and adolescent members of Oklahoma Medicaid (MOK) from 2007 through 2010. METHODS: Monthly individual-level utilization data were collected from MOK paid pharmacy and medical claims from January 1, 2007, through December 31, 2010, for members with asthma and/or allergic rhinitis. Members who were continuously eligible for the entire 48-month review period were included. The effect of a prior authorization policy for montelukast on emergency room (ER) utilization, disease-related physician office visits (DRV), and antibiotic prescription utilization (ABX) was analyzed using segmented logistic regression. RESULTS: For all 3 outcomes, decreases in mean number of claims per member per month were detected when comparing the pre-implementation and post-implementation prior authorization periods for all 3 disease states of asthma, allergic rhinitis, or both. Odds of having an ER event at the point of prior authorization implementation were 0.71 (P less than 0.001) and were 1.29 (P less than 0.001) and 1.26 (P less than 0.001) for DRV and ABX, respectively. Overall trend in odds was 1.02 (P less than 0.001), 0.93 (P less than 0.001), and 0.95 (P less than 0.001) for ER, DRV, and ABX, but during the post-implementation period, the odds were 0.92 (P less than 0.001) for ER and 1.03 (P less than 0.001) for both DRV and ABX. The final result was an increasing trend prior to implementation for ER, a decrease at implementation, and a continued decrease in odds of an event in the post-implementation period. However, for DRV and ABX, there was an overall decrease in trend regardless of period, with a small increase in odds at the point of implementation. CONCLUSIONS: While there was a point increase at implementation for DRV and ABX, the overall trend remained negative, indicating that no unexpected adverse clinical outcomes occurred. Additionally, no signal was found in ER use after implementation to indicate that unintended consequences occurred, particularly for those patients with asthma.

Ethacrynic Acid continuous infusions in critically ill pediatric patients.

OBJECTIVES: The purpose of this study was to describe dosage regimens and treatment outcomes in critically ill children receiving ethacrynic acid continuous infusions (CI). METHODS: This retrospective cross-sectional study evaluated patients less than 18 years of age who received ethacrynic acid CI with a duration exceeding 12 hours, from January 1, 2007, through January 31, 2012. The primary objective was to determine the mean/median doses of ethacrynic acid CI. Secondary objectives were to assess surrogate efficacy markers (e.g., urine output [UOP], fluid balance) and the number of patients with electrolyte abnormalities or metabolic alkalosis. Descriptive statistics were used. A series of repeated measures analyses of variance were conducted to assess differences in surrogate efficacy markers and in adverse events that occurred pre-, mid-, and posttherapy. RESULTS: Nine patients were included. The mean ± SD initial and maximum doses (mg/kg/hr) were 0.13 ± 0.07 (median 0.1; range, 0.08-0.3) and 0.17 ± 0.08 (median, 0.16; range 0.09-0.3), respectively. The median UOP (mL/kg/hr) pre-, mid-, and postinfusions (interquartile range [IQR]) were 2.4 (1.8-3.2), 4.2 (3.5-6), and 4 (3.4-5.3), respectively. The median fluid balance (mL; IQR) was 189 (90-526), -258 (-411.7 to 249) and -113.5 (-212.5 to 80.2), respectively. There were statistically significant differences in UOP and fluid balance pre- versus mid-therapy (0.014) and pre- versus posttherapy (p=0.010). No significant differences were noted with magnesium and potassium. Five children (55.6%) developed metabolic alkalosis. CONCLUSIONS: This study provides preliminary evidence for ethacrynic acid CI in children. The median initial dose and maximum dose in this cohort were 0.13 mg/kg/hr and 0.17 mg/kg/hr, respectively. Larger prospective studies are needed to confirm these findings.

Have antiepileptic drug prescription claims changed following the FDA suicidality warning? An evaluation in a state Medicaid program.

OBJECTIVE: In January 2008, the Food and Drug Administration (FDA) communicated concerns and, in May 2009, issued a warning about an increased risk of suicidality for all antiepileptic drugs (AEDs). This research evaluated the association between the FDA suicidality communications and the AED prescription claims among members with epilepsy and/or psychiatric disorder. METHODS: A longitudinal interrupted time-series design was utilized to evaluate Oklahoma Medicaid claims data from January 2006 through December 2009. The study included 9289 continuously eligible members with prevalent diagnoses of epilepsy and/or psychiatric disorder and at least one AED prescription claim. Trends, expressed as monthly changes in the log odds of AED prescription claims, were compared across three time periods: before (January 2006 to January 2008), during (February 2008 to May 2009), and after (June 2009 to December 2009) the FDA warning. RESULTS: Before the FDA warning period, a significant upward trend of AED prescription claims of 0.01% per month (99% CI: 0.008% to 0.013%, p<0.0001) was estimated. In comparison to the prewarning period, no significant change in trend was detected during (-20.0%, 99% CI: -70.0% to 30.0%, p=0.34) or after (80.0%, 99% CI: -20.0% to 200.0%, p=0.03) the FDA warning period. After stratification, no diagnostic group (i.e., epilepsy alone, epilepsy and comorbid psychiatric disorder, and psychiatric disorder alone) experienced a significant change in trend during the entire study period (p>0.01). CONCLUSIONS: During the time period considered, the FDA AED-related suicidality warning does not appear to have significantly affected prescription claims of AED medications for the study population.

Incidence of transmitted antiretroviral drug resistance in treatment-naive HIV-1-infected persons in a large South Central United States clinic.

BACKGROUND: Transmitted drug resistance (TDR) can limit effective treatment options to antiretroviral-naive HIV-infected persons and increase the risk of treatment failure. Limited estimates of TDR have been reported from the South Central United States. OBJECTIVE: To describe the incidence of TDR in Oklahoma and to examine whether TDR rates have increased with time. METHODS: This was a retrospective observational study of antiretroviral-naive patients at the Infectious Diseases Institute, a large infectious diseases clinic in Oklahoma City, Oklahoma, who had received baseline antiretroviral resistance testing. Mutations were screened using the 2011 International Antiviral Society-USA Drug Resistance Mutation (DRM) update, and categorized using the 2009 World Health Organization (WHO) Surveillance Drug Resistance Mutation (SDRM) list. RESULTS: Genotypic sequences from 428 patients revealed a 6.0% to 13.6% incidence of SDRMs between 2007 and 2011, though no progression in the frequency was apparent during the study period. Primary DRMs were detected in 12.6% of the sampled patients, most commonly involving nonnucleoside reverse transcriptase inhibitors (NNRTIs; 8.2%), followed by protease inhibitors (PIs; 3.5%) and nucleoside reverse transcriptase inhibitors (NRTIs; 3.3%). The K103N/S and E138A reverse transcriptase mutations were the most common DRMs identified, both present in 3.5% of patients. The L90M mutation was the most frequently observed PI SDRM (1.6%), while the T215C/D/I mutation was the most common NRTI SDRM identified (1.9%). This study was limited by the fact that the WHO SDRM list was last updated in 2009. CONCLUSIONS: The frequency of DRMs in central and western Oklahoma is similar to recently reported rates in the United States which lack data from this region. However, the frequency of second-generation NNRTI DRMs (4.4%) suggests the need to closely monitor epidemiologic trends for increasing resistance rates to individual classes of ARVs in order to predict the impact of TDR on therapeutic options.

External validation of the medication taper complexity score for methadone tapers in children with opioid abstinence syndrome.

BACKGROUND: Methadone is commonly prescribed for children with opioid abstinence syndrome (OAS) as a taper schedule over several days to weeks. The Medication Taper Complexity Score (MTCS) was developed to evaluate outpatient methadone tapers. OBJECTIVE: To further validate the MTCS and determine if it is a reliable tool for clinicians to use to assess the complexity of methadone tapers for OAS. METHODS: An expert panel of pediatric clinical pharmacists was convened. Panel members were provided 9 methadone tapers (ie, "easy," "medium," and "difficult") to determine construct and face validity of the MTCS. The primary objective was to further establish reliability and construct/face validity of the MTCS. The secondary objective was to assess the reliability of the MTCS within and between tapers. Instrument reliability was assessed using a Pearson correlation coefficient; with 0.8 as the minimum acceptable coefficient. Construct (divergent) validity was assessed via a repeated-measures ANOVA analysis (Bonferroni post hoc analyses) of the mean scores provided by panel members. RESULTS: Six panel members were recruited from various geographical locations. Panel members had 18.3 ± 5.5 years of experience, with practice expertise in general pediatrics, hematology/oncology, and the pediatric and neonatal intensive care unit. The MTCS had a reliability coefficient of .9949. There was vivid discrimination between the easy, medium, and difficult tapers; P = .001. The panel recommended minor modifications to the MTCS. CONCLUSIONS: The MTCS was found to be a reliable and valid tool. Overall, the panel felt that the MTCS was easy to use and had potential applications in both practice and research.

Collaborative practice model between cardiologists and clinical pharmacists for management of patients with cardiovascular disease in an outpatient clinic.

The increasing prevalence of cardiovascular disease (CVD) has prompted leading cardiovascular organizations to advocate utilization of a team approach to patient care that includes nonphysician providers. In spite of that, the American College of Cardiology reported that nonphysician providers are underutilized in the management of patients with CVD. A survey of cardiologists revealed that the underutilization is a result of lack of understanding of how best to involve nonphysician providers in the health care team. Clinical pharmacists are one category of nonphysician providers that have recognized effectiveness in managing patients with CVD. No example of a comprehensive model of collaboration between cardiologists and clinical pharmacists is described in the literature that could serve to close this gap in understanding. The objective of this report is to describe a model of cardiologist-clinical pharmacist collaboration in the longitudinal management of patients with CVD that has been successfully implemented in 2 diverse settings. The implementation, evolution, scope of practice, required pharmacist training, logistical elements needed for success, and implementation barriers are reviewed. A summary of the patients referred to the clinic are examined as well.

National antidepressant prescribing in children and adolescents with mental health disorders after an FDA boxed warning.

BACKGROUND: In October 2004, the U.S. Food and Drug Administration (FDA) issued a boxed warning about an increased risk of suicidality (i.e., suicidal ideation, behavior, or attempts) related to all antidepressants in children and adolescents. OBJECTIVE: To describe national antidepressant prescribing patterns in children and adolescents before, during, and after the introduction of the FDA boxed warning. METHODS: Cross-sectional data from the 2002-2009 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) were used to describe antidepressant prescribing patterns within a nationally-representative sample of 4035 physician visits for children and adolescents diagnosed with depression or other psychiatric disorder(s) [i.e., anxiety disorders or attention deficit/hyperactivity disorder (ADHD)]. RESULTS: In 2002-2003, antidepressants were prescribed in 4.1 million (36.1%) visits, followed by 3.2 million (28.8%) visits in 2004-2005 and 2.8 million (26.8%) visits in 2006-2007. However, antidepressant prescribing patterns reversed during 2008-2009, with an increase to 3.6 million (32.5%) visits. Compared to the period preceding the FDA boxed warning (2002-2003), a significant decline in visits related to antidepressant prescribing detected in the immediate post-FDA boxed warning period (2006-2007) (AOR = 0.67, 95% CI: 0.47-0.96). No association between the FDA boxed warning and antidepressant prescribing visits was detected during the FDA boxed warning period (2004-2005) (AOR = 0.80, 95% CI: 0.53-1.21) and in the late post-FDA boxed warning period (2008-2009) (AOR = 1.01, 95% CI: 0.63-1.60). CONCLUSIONS: After a 2-year lag period, antidepressant prescribing for visits of children and adolescents diagnosed with depression or other psychiatric disorder(s) in community-based and outpatient clinic settings declined when compared to the period preceding the FDA boxed warning. This decline was not sustained in the period of five years after implementation of the FDA boxed warning.

Evaluation of dabigatran exposures reported to poison control centers.

BACKGROUND: Dabigatran is a novel oral anticoagulant for which a well-defined range of toxicity and proven antidote has not been established. OBJECTIVE: The primary objective of this study was to characterize dabigatran exposures reported to poison centers by dose ingested, clinical effects, treatments used, and managment sites to gain a better understanding of patient outcomes. METHODS: A retrospective database review was conducted for dabigatran exposures reported to the National Poison Data System for the American Association of Poison Control Centers (AAPCC) over the period October 2010 to December 2012. RESULTS: There were 802 human dabigatran exposures involving adults predominantly (91% of cases). Exposure chronicity was acute in 43%, acute-on-chronic in 46%, and chronic in 11%, with the most common reason for an exposure call being an unintentional therapeutic error (70.6%). The most common management sites were on-site in 72% of cases and within a health care facility for 26%. Bleeding events and coagulopathies were the most commonly observed clinical effects. Treatments administered included activated charcoal, blood and coagulation products, hemodialysis, and supportive measures. Confirmed outcomes included death in 13 patients (1.6%), major effects in 23 (2.9%), and moderate effects in 50 (6.2%). More severe outcomes were significantly associated with adverse drug reactions, patients ≥65 years of age, those treated with blood and coagulation products and/or dialysis, and renal dysfunction (P < .05). Children experienced few moderate effects and no major effects or deaths. CONCLUSIONS: Severe outcomes from dabigatran exposures were not common, occurring in approximately 5% of cases.

Acetazolamide in critically ill neonates and children with metabolic alkalosis.

BACKGROUND: Acetazolamide is an option for hypochloremic metabolic alkalosis, but there are limited reports in children. OBJECTIVE: To describe the acetazolamide regimen and outcomes in critically ill children with metabolic alkalosis. METHODS: This was a descriptive, retrospective study of patients <18 years of age who received ≥3 doses of acetazolamide for metabolic alkalosis (ie, pH > 7.45 and bicarbonate [HCO3] > 26 mEq/L). Patients receiving other treatments for metabolic alkalosis within 24 hours of acetazolamide were excluded. The primary objective was to identify the mean dose and duration of acetazolamide. Secondary objectives were to determine the number of patients with treatment success (ie, serum HCO3 22-26 mEq/L) and occurrence of adverse events. RESULTS: Thirty-four patients were included for analysis, the median age was 0.25 years (range = 0.05-12 years). The acetazolamide regimen included a mean dose of 4.98 ± 1.14 mg/kg for a mean number of 6.1 ± 5.3 (range = 3-24) doses. The majority (70.6%) received acetazolamide every 8 hours. Treatment success was achieved in 10 (29.4%) patients. Statistically significant differences were noted between the pre-acetazolamide and post-acetazolamide pH and HCO3, 7.51 ± 0.05 versus 7.37 ± 0.05 (P < .001) and 39.4 ± 6.1 mEq/L versus 31.4 ± 7.5 mEq/L (P < .001), respectively. CONCLUSIONS: This is the first study to evaluate acetazolamide dosing for metabolic alkalosis in children with and without cardiac disease. Acetazolamide treatment resulted in improved HCO3, but the majority of patients did not achieve our definition of treatment success. Future studies should elucidate the optimal acetazolamide regimen.

The Björk-Shiley convexo-concave heart valve experience from the perspective of the supervisory panel.

The 20-year activities of a medical supervisory panel appointed under the terms of a settlement agreement of the Bowling v. Pfizer class action suit involving the Björk-Shiley convexo-concave (BSCC) heart valve are detailed. Of approximately 86,000 valves implanted, catastrophic failure of the valve was reported in 663 patients from 1978 to 2012. In 1994, a 7-member medical panel consisting of cardiologists, cardiovascular surgeons, epidemiologists, and a nontechnical chairman was appointed by the federal court. The panel collected clinical and manufacturing data, supported epidemiologic studies assessing risk factors for valve fracture, and developed guidelines for payment for explanting potentially defective valves in patients. Three sets of guidelines, based on comparisons of estimated risks of valve fracture versus risks of valve replacement surgery, were issued by the panel to help guide patients and their physicians in decisions about explanting valves. In addition, the panel supported research directed at identifying valves at risk for outlet strut fracture. The primary techniques evaluated included analyzing acoustic signals from the valves, imaging valves for potential cracks in the struts, and structural analyses of Björk-Shiley convexo-concave valves, but none proved applicable for large-scale surveillance of the patient population. The panel also became a patient advocate and acted as an intermediary between the manufacturer and the attorneys initiating the legal settlement. The panel's experiences may help inform future strategies for guideline development for other medical devices or procedures involving risk-benefit comparisons.

Participant perspectives from the Indian Health Service Anticoagulation Training Program.

BACKGROUND: The Indian Health Service Anticoagulation Training Program serves to improve patient safety through advanced anticoagulation management training. Although post-program evaluations of program content were conducted at the time of program delivery, little is known about translation of these learned skills into clinical practice. OBJECTIVE: This research sought to describe levels of self-reported participant confidence in anticoagulation management; development, implementation, and performance management of both core and supplemental activities of anticoagulation clinics or services; and current anticoagulation clinical practices subsequent to participating in the Anticoagulation Training Program. SETTING: A federal Indian Health Service healthcare facility in Oklahoma, USA. METHODS: A cross-sectional, electronic mail survey was designed, pretested, and administered to 267 eligible Anticoagulation Training Program participants from 1999 to 2009. Data were analyzed using descriptive statistics and interpreted to identify areas of strength and opportunities for improvement. MAIN OUTCOME MEASURES: Information about confidence in anticoagulation management skills; development, implementation and improvement of both core and supplemental activities of anticoagulation clinics or services; and current anticoagulation clinical practices was collected. RESULTS: After training, over 90 % of participants reported agreement/strong agreement with statements about confidence in performing patient-care related anticoagulation activities. A smaller proportion (83.3-85.4 %) reported agreement/strong agreement with confidence in measuring, analyzing and reporting anticoagulation outcomes. Improvement activities were more common than development or implementation activities (65.4, 31.9 and 35.1 %, respectively). Not having well established reimbursement procedures, lack of dedicated clinic space, and lack of dedicated personnel salaries (47.3, 38.3 and 32.6 %, respectively) were reported as the most common barriers to developing, implementing or improving an anticoagulation clinic. Participants indicated that anticoagulation outcomes tracking was the most common supplemental development, implementation and improvement activity (37.9, 37.0 and 43.8 % respectively). Benchmarking was the least commonly reported outcomes-related activity by participants (33.6 %). Although there was only a modest gain in the number of established anticoagulation clinics after attending the Anticoagulation Training Program, approximately 21 % of participants reported using skills learned to establish other disease state management clinics. CONCLUSION: In general, a majority of participants reported high levels of confidence related to direct patient care activities after attending the Anticoagulation Training Program. However there is a need to raise confidence in performance improvement and outcomes management activities to align with current accreditation standards in anticoagulation management as the Anticoagulation Training Program evolves.

Mental health treatment associated with community-based depression screening: considerations for planning multidisciplinary collaborative care.

BACKGROUND: Depression places a large economic burden on the US health care system. Routine screening has been recognized as a fundamental step in the effective treatment of depression, but should be undertaken only when support systems are available to ensure proper diagnosis, treatment, and follow-up. OBJECTIVE: To estimate differences in prescribing new antidepressants and referral to stress management, psychotherapy, and other mental health (OMH) counseling at physician visits when documented depression screening was and was not performed. METHODS: Cross-sectional physician visit data for adults from the 2005-2007 National Ambulatory Medical Care Survey were used. The final analytical sample included 55,143 visits, representing a national population estimate of 1,741,080,686 physician visits. Four dependent variables were considered: (1) order for new antidepressant(s), and referral to (2) stress management, (3) psycho therapy, or (4) OMH counseling. Bivariable and multivariable associations between depression screening and each measure of depression follow-up care were evaluated using the design-based F statistic and multivariable logistic regression models. RESULTS: New antidepressant prescribing increased significantly (2.12% of visits without depression screening vs 10.61% with depression screening resulted in a new prescription of an antidepressant). Referral to stress management was the behavioral treatment with the greatest absolute change (3.31% of visits without depression screening vs 33.10% of visits with depression screening resulted in a referral to stress management). After controlling for background sociodemographic characteristics, the adjusted odds ratio of a new antidepressant order remained significantly higher at visits involving depression screening (AOR 5.36; 99.9% CI 2.92-9.82), as did referrals for all behavioral health care services (ie, stress management, psychotherapy, and OMH counseling). CONCLUSIONS: At the national level, depression screening was associated with increased new antidepressant prescribing and referral for behavioral health care. It is critical for policy planners to recognize changes in follow-up depression care when implementing screening programs to ensure adequate capacity. Pharmacists are poised to assume a role in collaborative depression care, particularly with antidepressant medication therapy management.

Evaluation of 99mTc-succimer dosing in pediatric patients.

UNLABELLED: Balancing image quality with radiation dose is a goal with every diagnostic procedure requiring radiation. Our institution compared the dosing of (99m)Tc-labeled succimer, commonly referred to as dimercaptosuccinic acid ((99m)Tc-DMSA), to pediatric patients using 2 methods of calculation, body surface area (BSA, the method we used from 2009 to 2010) and body weight (BW, the method we used in 2011). METHODS: A retrospective study was conducted in a 230-bed inpatient, tertiary-care academic pediatric hospital to obtain objective data on patients under the age of 17 y who received a renal nuclear medicine procedure with (99m)Tc-DMSA using a 300,000-count parallel image and four 150,000-count pinhole images. Data collection included patient age, sex, height, weight, calculated activity, assayed activity, administered activity, residual syringe activity, imaging time, and notable patient or equipment factors affecting the procedure. RESULTS: Calculated activities based on BSA were higher than calculated activities based on BW. (99m)Tc-DMSA adsorption to the plastic syringes was significant, with a range of 3%-82%. Because of the adsorption, an average of 23.7 MBq (SD, ±31 MBq) was added to the patients' calculated dose when the order was placed. Therefore, assayed activities were significantly higher than calculated activities in both groups. Administered activity correlations to BSA and BW calculations were 0.75 and 0.83, respectively. Administered activities from BSA and BW groups were outside the American College of Radiology (ACR)-recommended guidelines 59% and 45% of the time, respectively. Overall, children less than 2 y old were above the ACR recommendations 80% of the time. There was a poor correlation between administered activity and total imaging time (r = 0.23). Average imaging time overall for 5 planar views was 14.8 min (±7.1 min). Patients receiving less than the ACR-recommended administered activities (<1.85 MBq/kg) had an average increase in imaging time of 4.5 min (±3.4 min). CONCLUSION: The activity administered to patients was significantly affected by the amount of (99m)Tc-DMSA activity adsorbed to the syringe. Syringe residual should be considered when standardizing (99m)Tc-DMSA imaging protocols and calculating patient dose. Although (99m)Tc-DMSA adsorption was variable, the administered activities correlated with calculated activities. In all but one of our patients, the total imaging time was far less than recommended by the ACR and European Association of Nuclear Medicine guidelines. The study indicates that using the BW calculation of 3.7 MBq/kg resulted in a range of administered activity of 1.85-2.59 MBq/kg. (99m)Tc-DMSA dosing of 3.7 MBq/kg for pinhole imaging should be appropriate for most studies.