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.

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.

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.

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.

Cardiovascular disease and non-steroidal anti-inflammatory drug prescribing in the midst of evolving guidelines.

RATIONALE, AIMS AND OBJECTIVES: Responding to safety concerns, the American Heart Association (AHA) published guidelines for non-steroidal anti-inflammatory drug (NSAID) use in patients with pre-existing cardiovascular disease (CVD) during 2005 and revised them in 2007. In the revision, a stepped approach to pain management recommended non-selective NSAIDs over highly selective NSAIDs. This research evaluated NSAID prescribing during and after guideline dissemination. METHOD: A cross-sectional sample of 8666 adult, community-based practice visits with one NSAID prescription representing approximately 305 million visits from the National Ambulatory Medical Care Survey (NAMCS) from 2005 to 2010 was studied. Multivariable logistic regression controlling for patient, provider and visit characteristics assessed the associations between diagnosis of CVD and NSAID type prescribed during each calendar year. Visits were stratified by arthritis diagnosis to model short-term/intermittent and long-term NSAID use. RESULTS: Approximately one-third (36.8%) of visits involving a NSAID prescription included at least one of four diagnoses for CVD (i.e. hypertension, congestive heart failure, ischaemic heart disease or cerebrovascular disease). Visits involving a CVD diagnosis had increased odds of a prescription for celecoxib, a highly selective NSAIDs, overall [adjusted odds ratio (AOR) = 1.29, 95% confidence interval (CI): 1.06-1.57] and in the subgroup of visits without an arthritis diagnosis (AOR = 1.45, 95% CI: 1.11-1.89). Results were not statistically significant for visits with an arthritis diagnosis (AOR = 1.10, 95% CI: 0.47-2.57). When analysed by year, the relationship was statistically significant in 2005 and 2006, but not statistically significant in each subsequent year. CONCLUSION: National prescribing trends suggest partial implementation of AHA guidelines for NSAID prescribing in CVD from 2005 to 2010.

Implementation of a bowel regimen protocol in critically ill children: A pilot study.

No studies have evaluated the outcomes of a bowel regimen (BR) in critically ill children receiving enteral nutrition. In fall 2010, a comprehensive feeding protocol and BR protocol were initiated in our institution. Six age-based BR protocols were developed, each of which included a four-step approach. This retrospective study evaluated children <18 years of age who received the BR between July 18, 2010 and April 31, 2012. The primary objective was to determine the percentage of patients requiring BR escalation beyond the initial step in the protocol (Step 1). Secondary objectives included the number of patients with a protocol deviation and the frequency of adverse events. Fifty-four patients were included. The majority were male with a median age of 0.25-year-old (range 0.08-15 yr). Forty-three (79.6%) patients received opioid continuous infusions. The BR was initiated on pediatric intensive care unit day 1 (range 1-25 d). Thirty patients (55.6%) required escalation beyond "Step 1". All patients who received "Step 2" and "Step 3" had a protocol deviation. Opioid duration was significantly associated with protocol escalation (odds ratio, 0.83; 95% confidence interval 0.689-0.997; P = 0.047). This pilot study is the first to describe the outcomes of the implementation of a four-step BR in critically ill children. Future studies should focus on the optimal regimen to alleviate constipation in critically ill children.

Evaluation of a diabetes management program using selected HEDIS measures.

OBJECTIVE: To evaluate the efficacy of a community-based, pharmacist-directed diabetes management program among managed care organization enrollees using National Committee for Quality Assurance (NCQA)-Healthcare Effectiveness Data and Information Set (HEDIS) performance measures. DESIGN: Randomized controlled trial. SETTING: Regional community pharmacy chain in Tulsa, OK, from November 2005 to July 2007. PATIENTS: 52 participants with diabetes and hypertension who were enrolled in a managed care organization. INTERVENTION: Diabetes management versus standard care. MAIN OUTCOME MEASURES: Comprehensive diabetes care measures of glycosylated hemoglobin (A1C <7.0%), blood pressure (<130/80 mm Hg), and low-density lipoprotein (LDL) cholesterol (<100 mg/dL). A composite research outcome of success was created by determining whether a participant achieved two of the three HEDIS goals at the end of 9 months. RESULTS: 46.7% of intervention group participants achieved the A1C goal, while 9.1% of control group participants achieved the goal ( P < 0.002). More than one-half (53.3%) of intervention participants achieved the blood pressure goal compared with 22.7% of control participants ( P < 0.02). Among control group participants, 50% achieved the LDL cholesterol goal compared with 46.67% of intervention group participants. The odds of the intervention group attaining the composite goal were 5.87 times greater than the control group. CONCLUSION: A community pharmacy-based diabetes management program was effective in achieving A1C and blood pressure goals measured by NCQA-HEDIS performance standards. Program participants were statistically significantly more likely to achieve two of three HEDIS standards during a 9-month period.

Integration of an introductory pharmacy practice experience with an advanced pharmacy practice experience in adult internal medicine.

OBJECTIVE: To describe the development, implementation, and assessment of an internal medicine introductory pharmacy practice experience (IPPE) that was integrated with an existing advanced pharmacy practice experience (APPE) in internal medicine. DESIGN: A structured IPPE was designed for first-, second-, and third-year pharmacy (P1, P2, and P3) students. Activities for the IPPE were based on the established APPE and the individual learner's educational level. ASSESSMENT: Students reported a greater understanding of clinical pharmacists' roles, increased confidence in their clinical skills, and better preparation for APPEs. Peers viewed the approach as innovative and transferable to other practice settings. Participating faculty members provided a greater number of contact hours compared to traditional one-time site visits. CONCLUSIONS: Integrating an IPPE with an existing APPE is an effective and efficient way to provide patient care experiences for students in the P1-P3 years in accordance with accreditation standards.

A pilot study assessing the frequency and complexity of methadone tapers for opioid abstinence syndrome in children discharged to home.

BACKGROUND: Methadone is often prescribed as a taper schedule to prevent/treat opioid abstinence syndrome (OAS) or neonatal abstinence syndrome (NAS). OBJECTIVE: The objective of this study was to determine the percentage of children discharged home on methadone tapers and to develop, assess, and implement an instrument for measuring the complexity of the methadone regimens. METHODS: This study used a descriptive retrospective design to examine patients younger than 18 years from January 1, 2008, to December 31, 2008, administered methadone for prevention/treatment of OAS/NAS and discharged home on a methadone taper. Data collection included demographics and characteristics of methadone regimen. The primary objective was to determine the percentage of children discharged on methadone. Secondary objectives included characterization (ie, number of dosage and interval changes), duration, and complexity of the methadone taper. Descriptive statistics were performed using Stata v10 (StataCorp LP, College Station, TX). Complexity was evaluated using the medication taper complexity score (MTCS) between 4 raters. Reliability of the MTCS was established using interrater correlation analyses of the regimen complexity scores. RESULTS: Thirty-three patients (41.8%) were discharged on methadone. The median (range) age was 0.42 (0-12) years, with most patients (75.8%) initiated on methadone for prevention of OAS. Thirty-one patients were included for further analysis of medication complexity. The median (range) duration of the home taper was 8 days (2-48), which included a median (range) of 4 (1-11) dose changes and at least 1 (0-2) change in the interval. MTCS ranged from 7 to 42, with the tool demonstrating 95% interrater reliability. CONCLUSIONS: More than one-third of patients were discharged home on methadone. The median taper duration was 8 days and included a median of 5 adjustments in either the dose or interval. The MTCS demonstrated very good interrater reliability to measure wide variability in the complexity of individual tapers. Future studies should determine the construct validity of the MTCS and the applicability of this tool for further research and clinical application.

Communicating non-steroidal anti-inflammatory drug risks: verbal counseling, written medicine information, and patients' risk awareness.

OBJECTIVE: To assess potential associations among physician counseling, pharmacist counseling, written medicine information (WMI) and patient awareness of non-steroidal anti-inflammatory drug (NSAID) risks. METHODS: Three-hundred and eighty-two older, white and African American patients prescribed NSAIDs were surveyed regarding their NSAID risk awareness defined as an index score ranging from zero to four correctly identified risks (i.e., gastrointestinal bleeding, heart attack, hypertension, and kidney disease). Associations among NSAID risk awareness and patient-reported physician counseling, pharmacist counseling, and reading of WMI were evaluated in multivariable ordered logistic regression models and confirmed using path analysis. RESULTS: Physician counseling was positively associated with reading WMI (p<0.001) and NSAID risk awareness (p<0.001). Pharmacist counseling was not associated with reading WMI (p=0.622) and neither pharmacist counseling (p=0.366) nor reading WMI (p=0.916) was associated with NSAID risk awareness. CONCLUSIONS: Physicians play a prominent role in facilitating NSAID risk awareness whereas pharmacist counseling and WMI may have limited impact. PRACTICE IMPLICATIONS: The lack of significant associations among pharmacist counseling and reading WMI with NSAID risk awareness suggests a missed opportunity to improve patient understanding. There is a need for coordinated and effective strategies to communicate risk information among physicians and pharmacists and to better integrate WMI into this process.

Relationship of depression screening and physician office visit duration in a national sample.

OBJECTIVE: Although depression screening in primary care is recommended by the U.S. Preventive Services Task Force, it may increase the duration of primary care physician visits that are often at or exceeding capacity. This study was conducted to evaluate the relationship between depression screening and physician visit duration in community-based, primary care physician office visits while controlling for important covariates. METHODS: Cross-sectional data from the 2005-2007 National Ambulatory Medical Care Survey were used to examine the relationship between physician-indicated depression screening and office visit duration among adults (≥18 years of age) with multivariable, ordered logistic regression. Predicted probabilities of visit duration (by 15-minute increments of one to 15, 16-30, 31-45, and 46-60 minutes) were estimated for visits where depression screening was and was not documented. RESULTS: In a sample of 14,736 physician office visits, representing an estimated population of more than 641 million visits, depression screening was significantly associated with increased visit duration (adjusted odds ratio=3.66, 95% confidence interval=2.25-5.95). A prominent shift in the proportion of visits that were from one to 15 minutes long to visits that were at least 16-30 minutes long was observed when depression screening was documented. CONCLUSIONS: Depression screening may increase the duration of physician visits. Given demands on physicians' time, the impact of increased depression screening, including the costs and benefits of using alternative methods and technologies to reduce physician time burden associated with depression screening, should be evaluated.