Assessing the Understanding of Pediatric-Oriented Medication Education Materials Versus Standard Available Education Materials.

OBJECTIVES: The objective of this study was to determine if education material targeting children would improve understanding of medication indication, administration, and common side effects in pediatric subjects. METHODS: This cross-sectional pilot study included students 7 to 11 years old from a suburban elementary school. Study participants were read either the US Food and Drug Administration-approved adult medication leaflet or a pediatric medication leaflet created at a first-grade reading level for levetiracetam (Keppra, UCB, Inc, Atlanta, GA). Students were asked a set of standardized survey questions to evaluate comprehension of side effects, medication indication, dosing frequency, administration, and overall impression of the leaflet. RESULTS: Fifty-eight children were included. Fifty percent of the children were male, 79% were Caucasian, and the average age was 9 years. There was no statistical difference for demographics in the adult leaflet versus the pediatric leaflet group. Children correctly stated the indication for the medication in 30% of participants (9/30) in the adult leaflet group and 79% of participants (22/28) in the pediatric leaflet group, p = 0.002. The administration frequency question was answered correctly in 93% of the pediatric leaflet group (26/28) as compared to 73% in the adult leaflet group (22/30), p = 0.05. For questions about side effects and how to administer the medication, there was no difference between the groups. The responses regarding readability and understanding of the leaflets were significantly different in the pediatric leaflet group compared to the adult leaflet group, p = 0.001 and p = 0.001, respectively. CONCLUSIONS: Leaflets designed for pediatric patients resulted in an improvement in the understanding of the indication for levetiracetam.

Randomized controlled evaluation of an insulin pen storage policy.

PURPOSE: Results of a quality-improvement project to enhance safeguards against "wrong-pen-to-patient" insulin pen errors by permitting secure bedside storage of insulin pens are reported. METHODS: A cluster-randomized controlled evaluation was conducted at an academic medical center to assess adherence with institutional policy on insulin pen storage before and after implementation of a revised policy allowing pen storage in locking boxes in patient rooms. In phase 1 of the study, baseline data on policy adherence were captured for 8 patient care units (4 designated as intervention units and 4 designated as control units). In phase 2, policy adherence was assessed through direct observation during weekly audits after lock boxes were installed on intervention units and education on proper insulin pen storage was provided to nurses in all 8 units. RESULTS: Phase 1 rates of adherence to insulin pen storage policy were 59% in the intervention units and 49% in the control units (p = 0.56). During phase 2, there was no significant change from baseline in control unit adherence (67%, p = 0.26), but adherence in intervention units improved significantly, to 89% (p = 0.005). Common types of observed nonadherence included pens being unsecured in patient rooms or nurses' pockets or left in patient-specific medication drawers after patient discharge. CONCLUSION: An institutional policy change permitting secure storage of insulin pens close to the point of care, paired with nurse education, increased adherence more than education alone.

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.

During drug development, matching adult systemic exposures of drugs is a common approach for dose selection in pediatric patients when efficacy is partially or fully extrapolated. This is a systematic review of approaches used for matching adult systemic exposures as the basis for dose selection in pediatric trials submitted to the US Food and Drug Administration (FDA) between 1998 and 2012. The trial design of pediatric pharmacokinetic (PK) studies and the pediatric and adult systemic exposure data were obtained from FDA publicly available databases containing reviews of pediatric trials. Exposure-matching approaches that were used as the basis for pediatric dose selection were reviewed. The PK data from the adult and pediatric populations were used to quantify exposure agreement between the 2 patient populations. The main measures were the pediatric PK studies' trial design elements and drug systemic exposures (adult and pediatric). There were 31 products (86 trials) with full or partial extrapolation of efficacy with an available PK assessment. Pediatric exposures had a range of mean Cmax and AUC ratios (pediatric/adult) of 0.63 to 4.19 and 0.36 to 3.60, respectively. Seven of the 86 trials (8.1%) had a predefined acceptance boundary used to match adult exposures. The key PK parameter was consistently predefined for antiviral and anti-infective products. Approaches to match exposure in children and adults varied across products. A consistent approach for systemic exposure matching and evaluating pediatric PK studies is needed to guide future pediatric trials.