The Promise of Health Information Technology: Ensuring that Florida's Children Benefit

Substantial policy interest in supporting the adoption of Health Information Technology (HIT) by the public and private sectors over the last 5 -- 7 years, was spurred in particular by the release of multiple Institute of Medicine reports documenting the widespread occurrence of medical errors and poor quality of care (Institute of Medicine, 1999 & 2001). However, efforts to focus on issues unique to children's health have been left out of many of initiatives. The purpose of this report is to identify strategies that can be taken by public and private entities to promote the use of HIT among providers who serve children in Florida

Using a computerized provider order entry system to meet the unique prescribing needs of children: description of an advanced dosing model

<p>Abstract</p> <p>Background</p> <p>It is well known that the information requirements necessary to safely treat children with therapeutic medications cannot be met with the same approaches used in adults. Over a 1-year period, Duke University Hospital engaged in the challenging task of enhancing an established computerized provider order entry (CPOE) system to address the unique medication dosing needs of pediatric patients.</p> <p>Methods</p> <p>An advanced dosing model (ADM) was designed to interact with our existing CPOE application to provide decision support enabling complex pediatric dose calculations based on chronological age, gestational age, weight, care area in the hospital, indication, and level of renal impairment. Given that weight is a critical component of medication dosing that may change over time, alerting logic was added to guard against erroneous entry or outdated weight information.</p> <p>Results</p> <p>Pediatric CPOE was deployed in a staggered fashion across 6 care areas over a 14-month period. Safeguards to prevent miskeyed values became important in allowing providers the flexibility to override the ADM logic if desired. Methods to guard against over- and under-dosing were added. The modular nature of our model allows us to easily add new dosing scenarios for specialized populations as the pediatric population and formulary change over time.</p> <p>Conclusions</p> <p>The medical needs of pediatric patients vary greatly from those of adults, and the information systems that support those needs require tailored approaches to design and implementation. When a single CPOE system is used for both adults and pediatrics, safeguards such as redirection and suppression must be used to protect children from inappropriate adult medication dosing content. Unlike other pediatric dosing systems, our model provides active dosing assistance and dosing process management, not just static dosing advice.</p

Population Pharmacokinetics of Olanzapine in Children

Aims The aim of this study was to evaluate the population pharmacokinetics (PopPK) of olanzapine in children and devise a model-informed paediatric dosing scheme. Methods The PopPK of olanzapine was characterized using opportunistically collected plasma samples from children receiving olanzapine per standard of care for any indication. A nonlinear mixed effect modelling approach was employed for model development using the software NONMEM (v7.4). Simulations from the developed PopPK model were used to devise a paediatric dosing scheme that targeted comparable plasma exposures to adolescents and adults. Results Forty-five participants contributed 83 plasma samples towards the analysis. The median (range) postnatal age and body weight of participants were 3.8 years (0.2–19.2) and 14.1 kg (4.2–111.7), respectively. The analysis was restricted to pharmacokinetic (PK) samples collected following enteral administration (oral and feeding tube). A one-compartment model with linear elimination provided an appropriate fit to the data. The final model included the covariates body weight and postmenstrual age (PMA) on apparent olanzapine clearance (CL/F). Typical CL/F and apparent volume of distribution (scaled to 70 kg) were 16.8 L/h (21% RSE) and 663 L (13% RSE), respectively. Developed dosing schemes used weight-normalized doses for children ≤6 months postnatal age or \u3c15 kg and fixed doses for children ≥15 kg. Conclusion We developed a paediatric PopPK model for enterally-administered olanzapine. To our knowledge, this analysis is the first study to characterize the PK of olanzapine in participants ranging from infants to adolescents. Body weight and PMA were identified as influential covariates for characterizing developmental changes in olanzapine apparent clearance

Improving Pharmacist-Led Pediatric Patient Education on Oral Chemotherapy at Home

Oral chemotherapy (OC) has been increasingly used in pediatric patients diagnosed with cancer, which is primarily managed in the outpatient setting. Different from adults, pediatric patients face unique challenges in administering these hazardous medications at home. Because of the complexity of pediatric pharmaceutical care and the hazardous nature of chemotherapy agents, comprehensive patient education is imperative to mitigate the potential safety risks associated with OC administration at home. Pharmacists play a vital role in patient education and medication consultations. However, the lack of practice guidelines and limited resources supporting OC counseling are noted. Additional barriers include insufficient knowledge and training on OC, which can be improved by continuing education. In a regional children’s hospital, a comprehensive OC education checklist was developed for pediatric patients and their caregivers to standardize consultations led by pharmacists. An infographic OC handout was also formulated to improve patient knowledge and awareness. Moreover, innovative approaches such as using telepharmacy, smartphone applications, and artificial intelligence have been increasingly integrated into patient care, which can help optimize OC consultations for children and adolescents. Further studies are warranted to enhance oral chemotherapy education specifically tailored for pediatric patients in outpatient settings

EQUITABLE PHARMACOGENETIC TESTING IMPLEMENTATION FOR RURAL AND UNDERSERVED POPULATIONS

Pharmacogenetic testing has potential to transform healthcare, yet implementation strategies have been limited to major academic medical centers serving metropolitan communities and large health systems. In contrast, rural, community-based health systems are slow to implement these advances, threatening to exacerbate existing healthcare disparities for rural populations. A majority of Montanans live in rural areas, with unique challenges in providing access to pharmacogenetics. We have established partnerships with three clinical sites who serve rural, underserved populations including American Indian, pediatric, and low socioeconomic status patients. We conducted a needs assessment for pharmacogenetic testing implementation by interviewing 48 key stakeholders. Interview questions were centered around participants opinions regarding pharmacogenetics and their perceived barriers and facilitators for implementation of testing. A codebook was created by analysis and organization of common themes. Positive opinions on using pharmacogenetics to guide therapy were common. Perceived benefits included reduced time to symptom management, fewer adverse events, and improved adherence. Concerns expressed in similar studies based in larger medical centers were also present, including conflicts with reimbursement and test turnaround time. Unique concerns for vulnerable, underserved populations included equitable access based on socioeconomic status and sensitivity to culture and historical injustices, particularly for tribal people. Participants were enthusiastic about using telehealth to implement pharmacogenetics in these communities. This will provide an innovative strategy for pharmacogenetic testing and consultations. Participants were eager to implement testing in their facilities. Many concerns can be mitigated with a strategic implementation plan targeted for underserved patients. Our model will implement pharmacogenetics using a telehealth delivery model centered at the University of Montana with outreach to rural health systems and providers. This has the potential to expand as new health innovations are translated into practice. Future work in this area will involve assisting partner sites with implementation efforts and measuring clinical outcomes related to testing services. Our study will help overcome the unique challenges in delivering pharmacogenetics to rural and underserved communities and we aim to provide a model for states with similar patient populations. Our goal is to pave the way for equitable access to pharmacogenetics for all

Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA

In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market. These two missions create an inherent tension within the agency and between the agency and key stakeholders. Oftentimes, communications and interactions between regulated companies and the FDA suffer. The focus of this research is on the interactions between the FDA and the biopharmaceutical companies that perform drug R&D. To assess the current issues and state of communication and interaction between the FDA and industry, we carried out a survey of industry leadership in R&D and regulatory positions as well as senior leadership at the FDA who have responsibility for drug evaluation and oversight. Based on forty-nine industry and eight FDA interviews we conducted, we found that industry seeks additional structured and informal interactions with the FDA, especially during Phase II of development. Overall, industry placed greater value on additional communication than did the FDA. Furthermore, industry interviewees indicated that they were willing to pay PDUFA-like fees during clinical development to ensure that the FDA could hire additional, well-qualified staff to assist with protocol reviews and decision-making. Based on our survey and discussions, we uncovered several thematic opportunities to improve interactions between the FDA and industry and to reduce clinical development times: 1) develop metrics and goals at the FDA for clinical development times in exchange for PDUFA like fees; 2) establish an oversight board consisting of industry, agency officials, and premier external scientists (possibly at NIH or CDC) to evaluate and audit retrospectively completed and terminated drug projects; and 3) construct a knowledge database that can simultaneously protect proprietary data while allowing sponsor companies to understand safety issues and problems of previously developed/failed drug programs. While profound scientific and medical challenges face the FDA and industry, the first step to reducing development times and associated costs and facilitating innovation is to provide an efficient regulatory process that reduces unnecessary uncertainty and delays due to lack of communication and interaction.

Design and Process Development for Smart Phone Medication Dosing Support System and Educational Platform in HIV/Aids-TB Programs in Zambia

The widespread adoption of cell phones and other mobile platforms represents an opportunity to extend the benefits of personalized, point-of-care, healthcare applications to providers and patients in the developing world. However, the challenges facing the effective deployment of mobile health care applications are complex, and thus require a scalable, flexible, and configurable approach. A service-oriented-architecture-based conceptual framework is proposed to address the challenges of developing and deploying mobile health care applications. A particular emphasis of the framework is a service-agent-modeling-based composite process-personalization support that is needed to support the diverse and adaptable needs of the users

Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy

<p>Abstract</p> <p>Background</p> <p>Decision analysis in hospital-based settings is becoming more common place. The application of modeling and simulation approaches has likewise become more prevalent in order to support decision analytics. With respect to clinical decision making at the level of the patient, modeling and simulation approaches have been used to study and forecast treatment options, examine and rate caregiver performance and assign resources (staffing, beds, patient throughput). There us a great need to facilitate pharmacotherapeutic decision making in pediatrics given the often limited data available to guide dosing and manage patient response. We have employed nonlinear mixed effect models and Bayesian forecasting algorithms coupled with data summary and visualization tools to create drug-specific decision support systems that utilize individualized patient data from our electronic medical records systems.</p> <p>Methods</p> <p>Pharmacokinetic and pharmacodynamic nonlinear mixed-effect models of specific drugs are generated based on historical data in relevant pediatric populations or from adults when no pediatric data is available. These models are re-executed with individual patient data allowing for patient-specific guidance via a Bayesian forecasting approach. The models are called and executed in an interactive manner through our web-based dashboard environment which interfaces to the hospital's electronic medical records system.</p> <p>Results</p> <p>The methotrexate dashboard utilizes a two-compartment, population-based, PK mixed-effect model to project patient response to specific dosing events. Projected plasma concentrations are viewable against protocol-specific nomograms to provide dosing guidance for potential rescue therapy with leucovorin. These data are also viewable against common biomarkers used to assess patient safety (e.g., vital signs and plasma creatinine levels). As additional data become available via therapeutic drug monitoring, the model is re-executed and projections are revised.</p> <p>Conclusion</p> <p>The management of pediatric pharmacotherapy can be greatly enhanced via the immediate feedback provided by decision analytics which incorporate the current, best-available knowledge pertaining to dose-exposure and exposure-response relationships, especially for narrow therapeutic agents that are difficult to manage.</p