Big Data in Health Care: An Interprofessional Course.

BACKGROUND: The widespread adoption of the electronic health record (EHR) has resulted in vast repositories of EHR big data that are being used to identify patterns and correlations that translate into data-informed health care decision making. PROBLEM: Health care professionals need the skills necessary to navigate a digitized, data-rich health care environment as big data plays an increasingly integral role in health care. APPROACH: Faculty incorporated the concept of big data in an asynchronous online course allowing an interprofessional mix of students to analyze EHR big data on over a million patients. OUTCOMES: Students conducted a descriptive analysis of cohorts of patients with selected diagnoses and presented their findings. CONCLUSIONS: Students collaborated with an interprofessional team to analyze EHR big data on selected variables. The teams used data visualization tools to describe an assigned diagnosis patient population.

Interprofessional education tracks: One schools response to common IPE barriers.

BACKGROUND: Implementing meaningful interprofessional education (IPE) experiences into the curriculum often requires overcoming barriers and challenges. To overcome these challenges on a non-medical center campus, school of pharmacy IPE faculty implemented a longitudinal, three-semester, multi-track series. The goals of forming a multi-track series were: (1) to overcome the pharmacy class size compared to the other available disciplines, (2) to utilize disciplines available on a liberal arts campus, and (3) to address varying academic calendars between disciplines. INTERPROFESSIONAL ACTIVITY: In 2018, the IPE course series was developed and imbedded within the first- and second-year, required, one-credit hour IPE courses. Tracks included community wellness involving accelerated bachelor of science in nursing students on the liberal arts campus, health law involving juris doctorate candidates on the liberal arts campus, and quality management involving masters of science in nursing administration and doctor of medicine students on the medical campus. Each pharmacy student was assigned a track spring semester of the first year based on preference. DISCUSSION: Creation of the track series successfully overcame barriers for IPE implementation. The use of multiple partners, smaller cohorts, and virtual technology allowed faculty greater flexibility, smaller student cohorts, and group autonomy to determine best time and method for meetings, assignment completion, and events. IMPLICATIONS: Utilization of a non-traditional course structure allowed for creative solutions to common barriers related to implementation of IPE on a liberal arts campus. This concept can be applied to a wide variety of curriculums to implement meaningful interprofessional experiences.

Development and Evaluation of a Pharmacist-Driven Vitamin D Protocol for a Cystic Fibrosis Clinic.

OBJECTIVE: Vitamin D deficiency is commonly found in patients with cystic fibrosis (CF) and can have a negative effect on patients who are not at target goal according to Cystic Fibrosis Foundation's Vitamin D Deficiency Clinical Care Guidelines. The objective of this study is to determine the effectiveness of a pharmacist-driven vitamin D protocol (PDVDP) in improving, achieving, and maintaining 25-hydroxyvitamin D levels of patients in a pediatric CF clinic. METHODS: A retrospective chart review was conducted for pediatric patients with CF from August 2018 to March 2020 to determine the percent of patients with improvement in 25-hydroxyvitamin D levels to target goal (≥ 30 ng/mL). Patients' 25-hydroxyvitamin D levels at 6, 12, and 18 months after automatic enrollment into the PDVDP were compared to determine if improvement occurred, and to calculate relative percent increase of 25-hydroxyvitamin D levels for these patients. RESULTS: The mean 25-hydroxyvitamin D levels of the patients at baseline before the protocol and 6, 12, and 18 months after enrollment in the protocol were 23.2, 33.3, 32.7, and 34.6 ng/mL, respectively. These results demonstrate mean 25-hydroxyvitamin D levels at all follow-up time points were significantly greater than baseline (p < 0.001). At 6 months, 50% (n = 20) of pediatric patients reached the target 25-hydroxyvitamin D levels. CONCLUSIONS: The PDVDP was effective in increasing the number of patients able to reach target 25-hydroxyvitamin D levels. Our PDVDP process may also be used at other CF clinics to improve vitamin D outcomes collaboratively with the interprofessional CF team.

Newest lipoglycopeptides for the management of acute bacterial skin and skin structure infections.

Acute bacterial skin and skin structure infections (ABSSSIs) are some of the most commonly encountered infections worldwide. Hospitalizations as a result of ABSSSIs are associated with high mortality. This article discusses the role of oritavancin and dalbavancin, the two newest lipoglycopeptides, in the context of the other available I.V. infusion standard therapy options.

Managing acute bacterial skin and skin structure infections: Focus on new lipoglycopeptides.

Acute bacterial skin and skin structure infections (ABSSSI) are some of the most commonly encountered infections worldwide. Hospitalizations as a result of ABSSSI are associated with high mortality. This article discusses the role of oritavancin and dalbavancin, two new lipoglycopeptides, in the context of the other I.V. available standard therapy options.

Pathways to Improve Student Pharmacists' Experience in Research.

OBJECTIVE: To describe the implementation of a student research program and to provide outcomes from the initial 4 years' experience. DESIGN: Students conducted individual research projects in a 4-year longitudinal program (known as Pathway), with faculty member advising and peer mentoring. A prospective assessment compared perceptions of those who completed the Pathway program with those of students who did not. Descriptive statistics, t tests, and analysis of variance (ANOVA) were used. ASSESSMENT: The class of 2013 was the first to complete the Pathway program. In the Pathway assessment project, 59% (n=47) of students who responded reached self-set goals. Pathway students agreed that this research experience improved their ability to work/think independently, evaluate literature, and distinguish themselves from other students. CONCLUSION: The Pathway program helped students understand the research process and reach other self-set goals.

Do Illustrations Improve Children's Comprehension of Assent Documents?

OBJECTIVE: The purpose of this study was to assess children's comprehension of a new assent booklet, (K(id)S(ent)), which uses pictures and written information. STUDY DESIGN: A randomized, crossover study evaluated the comprehension of assent documents by children, 7 to 11 years of age at a local elementary school. The two types of documents tested were the standard assent form and the K(id)S(ent) Assent Booklet. Participants were randomized as to which test document they received first by using a cluster randomization design. Participants read the document and then took a short quiz. The process was repeated for the other document on a separate day. Study participants were assigned a percentage score and a binary perfect score for each quiz. Mixed effects logistic and linear regression models with random intercepts were applied to the continuous percent quiz scores and binary perfect quiz scores, respectively. RESULTS: A total of 190 participants completed the standard quiz, and 195 students completed the booklet quiz. A statistically significant difference in perfect quiz scores (p=0.004) and percent quiz scores (p≤0.001) between booklet and standard form was noted. CONCLUSIONS: The quiz scores may indicate that the style of document is not the only factor influencing participant understanding.

Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease.

BACKGROUND AND OBJECTIVE: The primary objective of this study was to characterize the pharmacokinetic profile of pantoprazole delayed-release granules in infants and children aged 1 month to <6 years with gastro-oesophageal reflux disease (GORD). The studies described in this manuscript were conducted to fulfil the requirements of the paediatric written request for pantoprazole by the US FDA. METHODS: Two randomized, open-label, multicentre studies were conducted in infants aged 1 month to <12 months (study 1) and children aged 1 year through <6 years (study 2) with GORD. Patients were randomly assigned to either the low-dose pantoprazole group (0.6 mg/kg equivalent) or the high-dose pantoprazole group (1.2 mg/kg equivalent) in a 1 : 1 fashion. Pantoprazole granules were administered approximately 30 minutes before breakfast for at least five consecutive doses. Blood samples were obtained at prespecified intervals. Plasma pantoprazole concentration-time data were analysed by non-compartmental methods. Descriptive statistics were calculated for pharmacokinetic parameters. Patients in study 2 additionally received pantoprazole for 28 days. Safety was monitored throughout. RESULTS: In study 1, 43 patients were randomized; 42 were included in the single-dose pharmacokinetic evaluation (15 females, 27 males; mean postnatal age 6.3 months). In study 2, 17 patients were randomized, and all were included in the single-dose pharmacokinetic evaluation (6 females, 11 males; mean age 3.2 years). In both studies, exposure increased with dose. Mean (standard deviation) maximum (peak) plasma concentration values for the low and high doses were 503 (506) ng/mL and 1318 (1307) ng/mL, respectively, in study 1, and 229 (196) ng/mL and 653 (645) ng/mL, respectively, in study 2. Area under the plasma concentration-time curve values for the low and high doses were 1046 (1043) ng · h/mL and 3602 (3269) ng · h/mL, respectively, in study 1, and 293 (146) ng · h/mL and 2448 (2170) ng · h/mL, respectively, in study 2. There was a trend for increasing clearance with increasing age across the ages 1 month through <6 years. There was no evidence of drug accumulation after multiple doses. On-treatment adverse events (AEs) occurred in 19 of 43 patients in study 1 and in 11 of 17 patients in study 2. Serious AEs occurred in two patients in study 1 (gastroenteritis in one patient and acute gastroenteritis from rotavirus infection resulting in discontinuation of one patient); the serious AEs resolved and were not considered by the investigators to be drug related. No other safety-related discontinuations occurred in either study. CONCLUSIONS: Exposure increased with increasing doses of pantoprazole granules, even though wide interindividual variability was observed. Compared with that in adults receiving pantoprazole 40 mg, exposure obtained with the 1.2 mg/kg dose was similar in study 1 and slightly lower in study 2. Pantoprazole was generally well tolerated in infants and children aged 1 month through <6 years with GORD. Trial registration numbers (ClinicalTrials.gov): NCT00259012 (study 1) and NCT00141817 (study 2).

Single-dose pharmacokinetics of oral and intravenous pantoprazole in children and adolescents.

The primary objective was to determine the pharmacokinetics of single oral and intravenous doses of pantoprazole in children 2 to 16 years of age. The secondary objective was to assess the safety and tolerability of these doses. Male and female hospitalized and nonhospitalized patients from ages 5 to 16 years received single oral doses (20 mg or 40 mg), and those from ages 2 to 16 years received single intravenous doses (0.8 mg/kg or 1.6 mg/kg) of pantoprazole. The plasma concentration-time data for each patient were analyzed using noncompartmental methods. Routine safety and tolerability assessments were also obtained. The mean values for peak plasma concentration and total area under the plasma concentration-time curve increased with increasing dose. Pharmacokinetic values were similar in patients from ages 2 to 16 years and to those previously obtained in adults. Statistically significant differences were observed for dose-normalized pantoprazole area under the plasma concentration-time curve when compared between CYP2C19 extensive metabolizers with 1 versus 2 functional alleles. All adverse events were mild in severity and considered to be unrelated to study drug. The pharmacokinetic profile of oral and intravenous pantoprazole was similar in children ages 2 to 16 years. The doses used here were safe and well tolerated in this population.

Extrinsic iron staining in infant teeth from iron-fortified formula and rice cereal.

Extrinsic staining of teeth due to excessive iron intake has been reported previously in the literature. We describe a 7-month-old infant who presented with extrinsic teeth staining due to inadvertent over consumption of dietary iron. The infant was fed iron-fortified formula and rice cereal. Rice cereal, fortified with iron, was being used as part of a normal infant diet and as a thickening agent when added to the formula for treatment of gastroesophageal reflux. After several months of administration, "blackening" of the infant's teeth was noted by the mother. The stain was removed by the pediatric dentist who simply scraped the affected teeth. No further staining occurred after the amount of dietary iron was reduced.

Pharmacokinetics of intranasal and intratracheal pentoxifylline in rabbits.

STUDY OBJECTIVE: To evaluate the disposition of pentoxifylline and its metabolite, lisofylline, in New Zealand rabbits after two alternative routes of administration, intranasal and intratracheal. DESIGN: Pharmacokinetics study in an animal model. SETTING: University-affiliated animal care facility. SUBJECTS: Twenty New Zealand white rabbits divided into four groups of five rabbits each: group 1 did not receive study drug (control group), and groups 2, 3, and 4 evaluated intravenous, intranasal, and intratracheal routes of administration, respectively. INTERVENTION: Each rabbit in groups 2-4 received pentoxifylline as a single 20-mg/kg dose by their respective route of administration. MEASUREMENTS AND MAIN RESULTS: Blood samples were collected over a 24-hour period and were analyzed by using high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters evaluated were area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-infinity)), maximum concentration (Cmax), time to maximum concentration (Tmax), elimination rate constant (k(el)), and half-life (t1/2). Median pentoxifylline pharmacokinetic parameters after intravenous administration were AUC(0-infinity) 5420 ng x hr/ml, Cmax 16,727 ng/ml, Tmax 5 minutes, k(el) 0.036 minute(-1), and t1/2 19 minutes. Median pharmacokinetic parameters after intranasal and intratracheal administration, respectively, were AUC(0-infinity) 4224 and 6824 ng x hr/ml, Cmax 11,181 and 16,758 ng/ml, Tmax 5 and 5 minutes, k(el) 0.028 and 0.032 minute(-1), and t1/2 25 and 22 minutes. The metabolite, lisofylline, displayed a similar disposition after the three different routes of administration. CONCLUSION: The pharmacokinetic profiles after intranasal and intratracheal administration of pentoxifylline appear similar to those after intravenous administration. These data provide support for development of pentoxifylline intranasal and intratracheal dosage formulations that would be suitable for use in premature neonates.

Weekly rotation of facilitators to improve assessment of group participation in a problem-based learning curriculum.

OBJECTIVES: To determine whether implementing a rotating facilitator structure provides a reliable method of assessing group participation and assigning grades to third-professional year pharmacy students in a problem-based learning curriculum. DESIGN: In the 2004-2005 school year, a "one block, one facilitator" structure was replaced by a "weekly rotating facilitator" structure. Each student received a grade from the assigned facilitator each week. The 8 weekly grades were then averaged for a final course grade. Student grades were reviewed weekly and at the end of each block. Facilitators and students completed survey instruments at the end of each of four 8-week blocks. ASSESSMENT: Student grades were reviewed, and the class average was compared to the class averages from the 2 previous years. For example, in block I the class average was 86 which compared to averages of 88 and 87 for 2002-03 and 2003-04 respectively. Survey data revealed a 40% agreement by facilitators in block I that student performance was improved compared to student performance prior to this change. This agreement increased to 71%, 72%, and 71% respectively for blocks II - IV. Student survey data at the end of the academic year supported weekly facilitator rotation and revealed that a majority of students agreed that exposure to a variety of facilitators enhanced their group participation. CONCLUSION: As confirmed by student grades and student and faculty members' feedback, the change to a rotating facilitator structure resulted in a reliable method of assigning student grades for group participation.

Use of liquid chromatography-tandem mass spectrometry for the analysis of pentoxifylline and lisofylline in plasma.

A method was developed for the quantitation of pentoxifylline [1-(5-oxohexyl)-3,7-dimethylxanthine] and a primary active metabolite, lisofylline [1-(5-hydroxyhexyl)-3,7-dimethylxanthine], using high-performance liquid chromatography (HPLC)-tandem mass spectrometry. This method was developed in order to overcome problems encountered with HPLC-ultraviolet detection. The operating parameters of the electrospray interface (PE SCIEX, TurboIon Spray) and lens voltages of the triple-quadrupole detector (PE SCIEX 365) were optimized in positive ion mode to obtain the best sensitivity of the analytes. Collision-induced dissociation was used to produce fragment ions, and multiple reaction monitoring was used to quantitate pentoxifylline (m/z 279/181) and lisofylline (m/z 263/181). Dichloromethane was used to extract the drug, metabolite, and the internal standard (3-isobutyl-1-methylxanthine) from plasma. A reverse-phase C8(2) 150 x 1.0 mm HPLC column was used to resolve all three compounds in less than 6 min. Calibration curves were generated using peak area and were linear from 1 to 1000 ng/mL (R(2) > 0.99). The small sample volume, ease of extraction, and sensitivity provide advantages over more conventional methods of quantitation.

Elevated platelet-derived growth factor-BB concentrations in premature neonates who develop chronic lung disease.

BACKGROUND: Chronic lung disease (CLD) in the preterm newborn is associated with inflammation and fibrosis. Platelet-derived growth factor-BB (PDGF-BB), a potent chemotactic growth factor, may mediate the fibrotic component of CLD. The objectives of this study were to determine if tracheal aspirate (TA) concentrations of PDGF-BB increase the first 2 weeks of life in premature neonates undergoing mechanical ventilation for respiratory distress syndrome (RDS), its relationship to the development of CLD, pulmonary hemorrhage (PH) and its relationship to airway colonization with Ureaplasma urealyticum (Uu). METHODS: Infants with a birth weight less than 1500 grams who required mechanical ventilation for RDS were enrolled into this study with parental consent. Tracheal aspirates were collected daily during clinically indicated suctioning. Uu cultures were performed on TA collected in the first week of life. TA supernatants were assayed for PDGF-BB and secretory component of IgA concentrations using ELISA techniques. RESULTS: Fifty premature neonates were enrolled into the study. Twenty-eight infants were oxygen dependent at 28 days of life and 16 infants were oxygen dependent at 36 weeks postconceptual age. PDGF-BB concentrations peaked between 4 and 6 days of life. Maximum PDGF-BB concentrations were significantly higher in infants who developed CLD or died from respiratory failure. PH was associated with increased risk of CLD and was associated with higher PDGF-BB concentrations. There was no correlation between maximum PDGF-BB concentrations and Uu isolation from the airway. CONCLUSIONS: PDGF-BB concentrations increase in TAs of infants who undergo mechanical ventilation for RDS during the first 2 weeks of life and maximal concentrations are greater in those infants who subsequently develop CLD. Elevation in lung PDGF-BB may play a role in the development of CLD.

Tumor necrosis factor alpha -- 308 polymorphism associated with increased sepsis mortality in ventilated very low birth weight infants.

BACKGROUND: Sepsis commonly complicates the clinical course of critically ill very low birth weight infants, with as many as 30% developing hospital-acquired bacteremia. The tumor necrosis factor alpha (TNF-alpha) -- 308 G/A single nucleotide polymorphism (SNP) is associated with adverse outcome in septic adult patients. METHODS: One hundred seventy-three mechanically ventilated very low birth weight infants were genotyped for the TNF-alpha -- 308 G/A SNP. RESULTS: One hundred twenty (69%) infants were homozygous GG, 45 (26%) were heterozygous AG and 8 (5%) were homozygous AA; 2 of 120 (2%) infants developed early bacteremia in the GG group, and 1 of 53 (2%) developed early bacteremia in the AA/AG group (P = 0.919). One or more episodes of late bacteremia/fungemia developed in 59 of 120 (49%) infants with the GG genotype and 23 of 53 (43%) infants with the AG/AA genotype (P = 0.484). Endotracheal tube colonization rates were 65 of 120 (54%) for infants with the GG genotypes and 28 of 53 (53%) for infants with the AG/AA genotypes (P = 0.871). Nosocomial pneumonia developed in a similar number of infants in both genotype groups (9 of 120 infants vs. 3 of 53 infants; P = 0.461). Mortality from sepsis was 3 times greater in infants with the AA/AG genotypes than in those with the GG genotype (10%vs. 3%; P = 0.038). This difference in sepsis mortality was even greater when only bacteremic/fungemic infants are considered (4 of 59 infants vs. 6 of 23 infants; P = 0.026). CONCLUSIONS: These data suggest that the TNF-alpha -- 308 A allele does not affect the development of sepsis in ventilated premature infants but may increase mortality once sepsis develops.