Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)?

The FDA strongly encourages rigorous safety and efficacy studies in all age groups for which vaccines and treatments for pervasive and severe diseases are intended. Until recently, there had been no safety and efficacy studies conducted in children for human rabies immune globulins. The publication," Safety, and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure", Human Vaccines & Immunotherapeutics, 17:7, 2090-2096, was the first study that prospectively reviewed the use of KEDRAB® 150 IU/ml in 30 pediatric patients ages 0.5-14.9 years old. The results showed that 93.3% achieved RVNA titer >/ = 5 IU/ml, on day 14. Also, no participants reported a serious adverse event (SAE), or an adverse event (AE) leading to study discontinuation, and there were no deaths. The most common treatment emergent adverse events (TEAE) were injection-site pain. Currently there are 3 HRIG products on the US market, KEDRAB®, HyperRab® and Imogam® Rabies HT, but only KEDRAB® has published safety and efficacy data in a pediatric population. While it is common practice to prescribe medications for pediatric patients "off-label" there now exists one product with safety data in children. It is worth considering if this creates a higher medical liability for the prescriber and institution.

Realizing the vision for pediatric pharmacy practice advancement through strategic planning and implementation.

PURPOSE: In a rapidly changing healthcare landscape, pharmacy leaders must be agile and innovative to ensure that patients receive the highest-quality care. Here we describe the benefits of using a structured approach to pediatric pharmacy practice advancement guided by strategic planning and quality improvement principles. SUMMARY: Although there are many profound differences between pediatric and adult pharmacy management practices, many similarities also exist. Small- and large-scale change is most commonly guided by quality improvement methodology at Nationwide Children's Hospital. Using this framework, the pharmacy practice model at Nationwide Children's Hospital was reenvisioned to facilitate best patient outcomes and advance the role of pharmacists in the care of pediatric patients. Through these efforts, the percentage of inpatient hospital services with a pharmacist embedded into the care team increased from 67% to 90%, the number of pharmacists providing direct inpatient care increased from 27 to 50, and the number of ambulatory clinical pharmacists more than tripled, from 3 to 10. Enhanced clinical pharmacy services were developed to provide consistent care on weekends and holidays while striving to reach zero patient harm. Involvement of pharmacists and pharmacy technicians, alignment with the health system's mission, and internal development of pharmacists through focused training programs were vital to successful practice advancement. CONCLUSION: Significant practice model advancement in a pediatric healthcare system is achieved by using the organization's common language for change, involving frontline staff in creating the vision, and leadership steadfastly committing to realize the vision.

Implementation of a medication therapy management collaborative within a pediatric health system.

OBJECTIVES: To describe the implementation of a medication therapy management (MTM) collaborative within a pediatric health system to ensure the safe use of medication. SETTING: Outpatient pharmacies and clinics within a pediatric health system in Central Ohio. PRACTICE DESCRIPTION: The outpatient pharmacies conducted the daily operations of a community pharmacy following a standard, 4-point workflow. The ambulatory clinical pharmacists served on interdisciplinary teams within outpatient clinics to ensure the appropriate use of medication. PRACTICE INNOVATION: A collaborative model was developed to offer MTM services to patients within outpatient pharmacies and clinics throughout the health system. The pharmacist responsibilities varied, with outpatient pharmacists focused on targeted medication reviews (TMRs) and ambulatory clinical pharmacists focused on comprehensive medication reviews (CMRs) and TMRs. EVALUATION: The use of multiple plan-do-study-act cycles allowed for program improvements throughout implementation. Data collection included a pharmacy staff perception survey, mapping of MTM opportunities, and a quantitative report on the number, type, and intervention rate of all MTM activities. RESULTS: Four hundred nine MTM interventions, 349 TMRs (70 clinic based and 279 pharmacy based) and 60 CMRs, were completed throughout the first 6 months. Two hundred thirty-eight of the TMRs were pharmacist-initiated interventions that allowed pharmacists to provide medication counseling and follow-up with patients beginning new therapy. Ambulatory clinical pharmacists identified and resolved drug-related problems in greater than one-half of the CMRs completed. The intervention rates were 39% for CMRs and 44% for TMRs. CONCLUSION: The implementation of a collaborative MTM model provided an opportunity to address drug-related problems to ensure the appropriate use of medication. The model consisted of pharmacy staff members within 2 different patient care environments working together to complete MTM services for patients throughout the health system. The key elements of the program included the use of training sessions tailored to the pharmacy staff member's role in MTM, incorporation of technician champions, and creation of pharmacist-initiated interventions.

Improvement of medication event interventions through use of an electronic database.

PURPOSE: Patient safety enhancements achieved through the use of an electronic Web-based system for responding to adverse drug events (ADEs) are described. SUMMARY: A two-phase initiative was carried out at an academic pediatric hospital to improve processes related to "medication event huddles" (interdisciplinary meetings focused on ADE interventions). Phase 1 of the initiative entailed a review of huddles and interventions over a 16-month baseline period during which multiple databases were used to manage the huddle process and staff interventions were assigned via manually generated e-mail reminders. Phase 1 data collection included ADE details (e.g., medications and staff involved, location and date of event) and the types and frequencies of interventions. Based on the phase 1 analysis, an electronic database was created to eliminate the use of multiple systems for huddle scheduling and documentation and to automatically generate e-mail reminders on assigned interventions. In phase 2 of the initiative, the impact of the database during a 5-month period was evaluated; the primary outcome was the percentage of interventions documented as completed after database implementation. During the postimplementation period, 44.7% of assigned interventions were completed, compared with a completion rate of 21% during the preimplementation period, and interventions documented as incomplete decreased from 77% to 43.7% (p < 0.0001). Process changes, education, and medication order improvements were the most frequently documented categories of interventions. CONCLUSION: Implementation of a user-friendly electronic database improved intervention completion and documentation after medication event huddles.

Lean methodology in i.v. medication processes in a children's hospital.

PURPOSE: The impact of lean methodology in i.v. medication processes in a children's hospital was studied. METHODS: Medication orders at a children's hospital were analyzed for 30 days to identify the specific times when most medications were changed or discontinued. Value-stream mapping was used to define the current state of preparation and identify non-value-added tasks in the i.v. medication preparation and dispensing processes. An optimization model was created using specific measurements to establish the optimal number of batches and batch preparation times of batches. Returned i.v. medications were collected for 7 days before and after implementation of the lean process to determine the impact of the lean process changes. RESULTS: Patient-days increased from 1,836 during the first collection period to 2,017 during the second, and the total number of i.v. doses dispensed increased from 8,054 to 9,907. Wasted i.v. doses decreased from 1,339 (16.6% of the total doses dispensed) to 853 (8.6%). With the new process, Nationwide Children's Hospital was projected to realize a weekly savings of $8,197 ($426,244 annually), resulting in a 2.6% reduction in annual drug expenditure. The annual savings is a conservative estimate, due to the 10% increase in patient-days after the lean collection period compared with baseline. The differences in wasted doses and their costs were significant (p < 0.05). CONCLUSION: Implementing lean concepts in the i.v. medication preparation process had a positive effect on efficiency and drug cost.

Pharmacists' perceptions of computerized prescriber-order-entry systems.

PURPOSE: Computerized prescriber order entry (CPOE) from the pharmacy perspective was examined to determine how well current expectations are being met for facilities with CPOE and the importance of CPOE features for facilities currently without CPOE. METHODS: An online survey with 21 variables was developed. Five-point Likert-type scales were used to measure the responses. For those facilities currently with CPOE systems, respondents were asked how well their expectations were being met. Respondents without CPOE were asked to rate the importance of each feature if they were to install CPOE in the future. The respondents were directors or managers of pharmacies in hospitals or health systems. Three types of facilities were examined: freestanding pediatric facilities, adult facilities with pediatric wards, and adult facilities with CPOE. RESULTS: Of 2178 surveys, 662 were usable. Demographics revealed that 17.4% of the respondents currently had CPOE in their facilities. Expectations were somewhat lower than average in facilities with CPOE. Overall satisfaction was rated just above the midpoint of 3, indicating a perception of reduced medication errors from the use of CPOE. CONCLUSION: Pharmacy directors and managers in hospitals with CPOE reported that expectations for most CPOE features were met at a moderate level. Respondents from facilities with CPOE reported a reduction in medication errors for the prescribing, dispensing, and administrative components of CPOE.