This chapter addresses the issue of the balance between protection of children submitted to research and children's access to new treatments, focusing on the field of antiepileptic drugs. Due to the lack of interest pharmaceutical companies have for such an unrewarding market, ethical and legal problems, difficulties recruiting patients, and in Europe insufficient public resources, many infants and children with epilepsy are still exposed to off-label drugs. The incentives and regulations specifically directed toward research in children in the United States and EU provided the first step to change this condition. The challenge is to perform trials determined by the needs of children and to obtain benefits in the same order of magnitude as for adults but with reduced risks. In order to optimize the development of new AEDs in pediatrics, the new European guidelines (2010) recommend the identification of adult clinical trial results that can be extrapolated to the pediatric population (i.e., those in partial epilepsies) and the use of innovative strategies that help limit the number of pediatric patients enrolled in trials (i.e., those with epileptic encephalopathies). A key step will be to develop international networks of pediatric epilepsy centers with the shared purpose of optimizing development and execution of clinical trials.
This chapter addresses the issue of the balance between protection of children submitted to research and children's access to new treatments, focusing on the field of antiepileptic drugs. Due to the lack of interest pharmaceutical companies have for such an unrewarding market, ethical and legal problems, difficulties recruiting patients, and in Europe insufficient public resources, many infants and children with epilepsy are still exposed to off-label drugs. The incentives and regulations specifically directed toward research in children in the United States and EU provided the first step to change this condition. The challenge is to perform trials determined by the needs of children and to obtain benefits in the same order of magnitude as for adults but with reduced risks. In order to optimize the development of new AEDs in pediatrics, the new European guidelines (2010) recommend the identification of adult clinical trial results that can be extrapolated to the pediatric population (i.e., those in partial epilepsies) and the use of innovative strategies that help limit the number of pediatric patients enrolled in trials (i.e., those with epileptic encephalopathies). A key step will be to develop international networks of pediatric epilepsy centers with the shared purpose of optimizing development and execution of clinical trials.
Pediatric Injectable Drugs, also known as “The Teddy Bear Book,” is one of the ASHP’s most recognized and trusted resources dedicated to helping pharmacists treat pediatric patients with injectable drugs. For more than 20 years, pharmacists and hospital pediatric teams have looked to Pediatric Injectable Drugs (The Teddy Bear Book) for the most comprehensive research-based information on pediatric intravenous infusions. Now for the first time since 2013, a new edition of this trusted resource is available! The “Teddy Bear Book”, is the only reference of its kind that focuses on the unique issues that pediatric practitioners face when dealing with pediatric injectable drugs, such as limited fluid amounts, limited intravenous sites, and maximum doses. The updated edition of this comprehensive resource by respected editors Stephanie J. Phelps, PharmD, BCPS, Kelley R. Lee, PharmD, Amanda Jill Thompson, PharmD, and Tracy M. Hagemann, PharmD, FCCP, includes 15 new monographs and updates based on the latest evidence-backed literature.
The only comprehensive interviewing and counseling text grounded in a strong multi-theoretical foundation Structured around CACREP standards, Essential Interviewing and Counseling Skills Second Edition uniquely encompasses both theory and practice from the perspectives of a diverse array of theoretical schools and practice strategies. While continuing to disseminate counseling fundamentals, the second edition focuses extensively on the acquisition of robust interviewing and counseling skills including special preparation for the initial assessment and counseling session. It is also distinguished by its integration of cognitive behavioral and psychodynamic therapy approaches. Throughout, the text emphasizes the importance of multicultural humility and a multicultural orientation to counseling—including challenging students to examine their own backgrounds and biases. This latest edition also addresses key aspects of telehealth that have come to the fore during the COVID pandemic. The use of case examples throughout highlights multiple theoretical approaches and illustrates how to integrate a wide range of perspectives. With an emphasis on counseling clients from diverse cultural backgrounds, each chapter focuses on strategies for working with varied populations, with an emphasis on intersectionality. The authors consider many forms of diversity including race, ethnicity, immigration, and country of origin along with age, gender, sexual orientation, religion, language, and physical and cognitive abilities. Purchase includes digital access for use on most mobile devices or computers. Updates to the instructor's resources include an Instructor's Manual, Power Points and a new test bank. New to the Second Edition: Includes a new chapter on Theoretical Integration of Approaches in Counseling New discussions on how to successfully use telehealth for interviewing and counseling Includes "Hot off the Press" boxes highlighting cutting edge research to inform strategies for counseling and professional development The entire text has been updated with the latest research and clinical references. Key Features: Includes an emphasis on multicultural competence and humility throughout the text and features a "Spotlight on Culture" focusing on specific cultural considerations in each chapter Provides a balanced, integrated theoretical and practical approach to interviewing and counseling with a focus on skills development Discusses evidence-based practice, assessment, diagnosis, and when/how to end treatment Teaches the fundamental skills of empathy, active listening, treatment planning and developing a strong therapeutic alliance with the client
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