Assessment of adverse drug events among patients in a tertiary care medical center.

PURPOSE: Specific patient and clinical characteristics associated with an increased risk of sustaining an adverse event (AE) were identified. METHODS: AE reports for patients in a 658-bed tertiary care medical center between January 1, 2000, and June 30, 2002, were analyzed. The data collected from each report included medical record number, patient sex, patient age, clinical service, date of occurrence, diagnoses, type of error, suspected medication, and severity of the AE. A three-stage logistic regression model with high-risk indicators was used to evaluate key indicators of the most vulnerable patient populations. RESULTS: The number of control patients and those with AEs totaled 60,206. This population was then randomly split into two equal groups of patients: the training data set (n = 30,103) and the validation data set (n = 30,103). AEs occurred in a higher percentage of patients who were age <1 year, 1-15, 47-59, and > or =60 years than in other groups. A higher percentage of AEs were reported in men than women, but the groups were not significantly different when comparing those with an AE and those without an AE. Asian Indian patients demonstrated a high rate of AEs, but this may be a statistical artifact, reflecting their very small percentage in the study. Evaluation of admission sources revealed that doctors' offices, clinic referrals, and local hospital transfers accounted for higher rates of AEs than other sources. CONCLUSION: Certain age groups, diagnoses, admission sources, types of insurance, and the use of specific medications or medication classes were associated with increased AE rates at a tertiary care medical center.

Staging a reflective capstone course to transition PharmD graduates to professional life.

OBJECTIVE: To develop and implement a capstone course that would allow students to reflect on their development as a professional, assess and share their achievement of the college's outcomes, complete a professional portfolio, establish a continuing professional development plan, and prepare to enter the pharmacy profession. DESIGN: Students were required to complete a hybrid course built around 4 online and inclass projects during the final semester of the curriculum. ASSESSMENT: Faculty used direct measures of learning, such as reading student portfolios and program outcome reflections, evaluating professional development plans, and directly observing each student in a video presentation. All projects were evaluated using standardized rubrics. Since 2012, all graduating students met the course's minimum performance requirements. CONCLUSION: The course provided an opportunity for student-based summative evaluation, direct observation of student skills, and documentation of outcome completion as a means of evaluating readiness to enter the profession.

Parental misinterpretations of over-the-counter pediatric cough and cold medication labels.

OBJECTIVE: Concerns about the safety and efficacy of over-the-counter cold medications have led to a recent US Food and Drug Administration public health advisory against their use in children <2 years of age. Our goal was to examine caregiver understanding of the age indication of over-the-counter cold medication labels and identify factors, associated with caregiver understanding. METHODS: Caregivers of infant children (< or =1 year old) were recruited from clinics at 3 institutions. Questions were administered regarding the use of 4 previously common "infant" over-the-counter cold and cough medicines labeled to consult a physician if used in children <2 years of age. Literacy and numeracy skills were assessed with validated instruments. RESULTS: A total of 182 caregivers were recruited; 87% were the infants' mothers. Mean education level was 12.5 years, and 99% had adequate literacy skills, but only 17% had >9th-grade numeracy skills. When examining the front of the product label, 86% of the time parents thought these products were appropriate for use in children <2 years of age. More than 50% of the time, parents stated they would give these over-the-counter products to a 13-month-old child with cold symptoms. Common factors that influenced parental decisions included label saying "infant," graphics (eg, infants, teddy bears, droppers), and dosing directions. Caregivers were influenced by the dosing directions only 47% of the time. Caregivers with lower numeracy skills were more likely to provide inappropriate reasons for giving an over-the-counter medication. CONCLUSIONS: Misunderstanding of over-the-counter cold products is common and could result in harm if medications are given inappropriately. Label language and graphics seem to influence inappropriate interpretation of over-the-counter product age indications. Poorer parental numeracy skills may increase the misinterpretation of these products. Opportunities exist for the Food and Drug Administration and manufacturers to revise existing labels to improve parental comprehension and enhance child safety.

The effect of implementing computerized provider order entry on medication prescribing errors in an emergency department.

Medication errors are a major concern in the Emergency Department (ED). We examined medication prescribing errors among consecutive adult ED patients during two 10-day periods before and during one 9-day period after implementing computerized provider order entry in an adult ED. 2,073 patients had 5,950, orders. Before (after) implementation there were 3.7 (2.8) potential adverse drug events, 222.0 (21.0) medication prescribing errors, and 5.1 (0) rule violations per 100 orders.

Behind-the-scenes of patient-centered care: content analysis of electronic messaging among primary care clinic providers and staff.

BACKGROUND: Transitions to patient-centered health care, the increasing complexity of care, and growth in self-management have all increased the frequency and intensity of clinical services provided outside office settings and between visits. Understanding how electronic messaging, which is often used to coordinate care, affects care is crucial. A taxonomy for codifying clinical text messages into standardized categories could facilitate content analysis of work performed or enhanced via electronic messaging. OBJECTIVE: To codify electronic messages exchanged among the primary care providers and the staff managing diabetes patients at an academic medical center. RESEARCH DESIGN: Retrospective analysis of 27,061 electronic messages exchanged among 578 providers and staff caring for a cohort of 639 adult primary care patients with diabetes between April 1, 2003 and October 31, 2003. SUBJECTS: Providers and staff using locally developed electronic messaging in an academic medical center's adult primary care clinic. MEASURES: Raw data included clinical text message content, message ID, thread ID, and user ID. Derived measures included user job classification, 35 flags codifying message content, and a taxonomy grouping the flags. RESULTS: Messages contained diverse content: communications with patients, families, and other providers (47.2%), diagnoses (25.4%), documentation (33%), logistics and support functions (29.6%), medications (32.9%), and treatments (28.9%). All messages could be classified; 59.5% of messages addressed 2 or more content areas. CONCLUSIONS: Systematic content analysis of provider and staff electronic messages yields specific insight regarding clinical and administrative work carried out via electronic messaging.

The epidemiology of medication prescribing errors in the emergency department.

Medication errors are a major concern in the Emergency Department (ED). We examined the epidemiology of medication prescribing errors among consecutive adult ED patients during two 10-day periods in the adult ED prior to implementing computerized provider order entry. 479 patients had no medication orders and 1,301 had 3,393 orders. Per 100 orders there were 3.7 potential adverse drug events, 337.1 medication prescribing errors, and 24.2 rule violations.

Impact of citrus soft drinks relative to grapefruit juice on ciclosporin disposition.

AIMS: A recent case report had suggested a citrus soft drink (Sun Drop) may have caused clinically relevant elevations in ciclosporin levels through a grapefruit juice-like mechanism via inactivation of intestinal cytochrome P450 3A4 (CYP3A4). This study was conducted to investigate the effect of grapefruit juice and citrus sodas Sun Drop and Fresca, the latter soda containing 83-fold higher concentration of the proposed CYP3A4 inhibitor bergamottin than Sun Drop, relative to water on oral ciclosporin pharmacokinetics. METHODS: In a randomized four-way crossover study with a washout of at least 1 week, 12 healthy volunteers received a single oral dose of ciclosporin (Neoral) with Sun Drop, Fresca, grapefruit juice and water (control). Each drink (591 ml) was consumed twice on the prior day and three times on the study day. Whole blood concentrations of ciclosporin were measured up to 24 h with a fluorescence polarization immunoassay. RESULTS: Grapefruit juice increased area under the concentration-time curve by 186% (P < 0.0001; 95% confidence interval of mean difference 3302-6240 ng ml h(-1)) and peak concentration by 150% (P < 0.0001) of ciclosporin with a significant decrease in oral clearance of 43% (P < 0.0001) when compared with water. Neither citrus soda altered significantly ciclosporin pharmacokinetic variables; changes in mean values ranged from +/- 3 to 11% of the corresponding water value. CONCLUSION: Although our results do not support a clinically relevant grapefruit juice-like interaction between oral ciclosporin and citrus constituent containing sodas Sun Drop or Fresca, an effect in the setting of chronic ciclosporin therapy cannot be ruled out.