Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64

Get Book Here

Book Description
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64

Get Book Here

Book Description
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Prescription Drugs: Alternative Uses, Alternative Cures

Prescription Drugs: Alternative Uses, Alternative Cures PDF Author: Kevin R. Loughlin
Publisher: Simon and Schuster
ISBN: 0743286715
Category : Medical
Languages : en
Pages : 1715

Get Book Here

Book Description
This first-of-its-kind drug reference gives consumers an easy way to research the prescription drug options that might best suit their unique needs.

Legal and Forensic Medicine

Legal and Forensic Medicine PDF Author: Roy G. Beran
Publisher: Springer
ISBN: 9783642323379
Category : Medical
Languages : en
Pages : 0

Get Book Here

Book Description
This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.​

Off-label Prescribing

Off-label Prescribing PDF Author: David Cavalla
Publisher: John Wiley & Sons
ISBN: 1118912071
Category : Science
Languages : en
Pages : 211

Get Book Here

Book Description
Today’s medicines are regulated for their efficacy and safety and, once approved, they can be marketed for certain uses as justified by the data. Regulatory bodies in developed countries are constituted by legal statute and operate as parts of government, ostensibly in the interests of the people as patients. But once approved, medicines can be used for any purpose the prescriber thinks fit and appropriate for the patient. One in five prescriptions is therefore written outside regulatory purview. Off-label Prescribing looks into the corners of our medicated lives, where drug regulation runs up against medical practice, and concerns the use of a drug that has been approved for one use (in medical parlance, ‘indication’) being used for a different indication; alternatively, being used on a different set of patients from the ones it is approved for, or at a different dose. Usually the patient is unaware of what is going on, having not been informed by their doctor of this aspect of his or her prescribing choice. The book examines how and why this occurs, what the various medical professions have to say about it, and how pharmaceutical companies benefit by moving into this poorly regulated area. Off-label Prescribing pulls these complex issues together in one volume, to highlight current practice, its advantages and weaknesses and how the author suggests practice should evolve in the future. It will therefore be of interest to all those who prescribe (and receive) medicines, combined with a greater objective to provide more transparency and discussion for professionals.

Health Literacy

Health Literacy PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309371570
Category : Medical
Languages : en
Pages : 190

Get Book Here

Book Description
In 2004, the Institute of Medicine released Health Literacy: A Prescription to End Confusion, a report on the then-underappreciated challenge of enabling patients to comprehend their condition and treatment, to make the best decisions for their care, and to take the right medications at the right time in the intended dose. That report documented the problems, origins, and consequences of the fact that tens of millions of U.S. adults are unable to read complex texts, including many health-related materials, and it proposed possible solutions to those problems. To commemorate the anniversary of the release of the 2004 health literacy report, the Institute of Medicine's Roundtable on Health Literacy convened a 1-day public workshop to assess the progress made in the field of health literacy over the past decade, the current state of the field, and the future of health literacy at the local, national, and international levels. Health Literacy: Past, Present, and Future summarizes the presentation and discussion of the workshop.

Putting Pediatric Off-label Prescribing on the Map

Putting Pediatric Off-label Prescribing on the Map PDF Author: Alicia Theresa Francesca Bazzano
Publisher:
ISBN:
Category :
Languages : en
Pages : 104

Get Book Here

Book Description
Background: Prescribing medications for an indication or age outside of the terms of U.S. Food and Drug Administration (FDA) approval is called off label prescribing. In children, off label prescribing has resulted in drug disasters and increased adverse events and has been the subject of recent legislation promoting medication study. Off label prescribing appears to be a very common pediatric practice; nonetheless, the pharmacoepidemiology of off label prescribing has not been systematically studied and could inform approaches to interventions. Methods: The National Ambulatory Medical Care Surveys (NAMCS), a nationally representative population based sample of U.S. outpatient medical visits collected by the Centers for Disease Control and Prevention (CDC) were utilized over a four year period (2001 2004). We evaluated an estimated 312 million prescription visits by children 0-17 years old (based on a sample of 7901 prescription visits). FDA approved age and indication were compared to the to the child's age and diagnoses. Descriptive and regression analyses were used to determine epidemiological characteristics and predictors of: (1) pediatric off label prescribing in general, (2) prescribing to infants and toddlers (0-3 yrs; n=81 million visits) and (3) off label prescribing for age versus off label prescribing for indication. Results: Sixty two percent of U.S. outpatient pediatric prescription visits included off label prescribing, with 25% (95% CI: 23%, 27%) including off label prescribing for age and 53% (95% CI: 50%, 56%) off label prescribing for indication. Approximately 96% of cardiovascular renal, 86% of pain, 80% of gastrointestinal, and 67% of pulmonary and dermatologic prescriptions were off label. Anti infectives, upper respiratory and pulmonary medications were much more commonly prescribed off label for indication (41%, 52%, and 61%) than for age (6%, 16%, and 24%). For infants and toddlers, off label prescribing occurred in 65% of prescription visits (52.7 million), with a higher risk of exposure to off label prescribing for age than older children. Physician specialists were 14% (95% CI: 7%, 20%) more likely to prescribe off label for age than general pediatricians or family physicians. Most top prescribed off label medications have remained unchanged over time. Conclusions: Despite legislation resulting in studies and labeling changes of pediatric medications, the majority of pediatric outpatient visits involve off label prescribing, across all medication categories, to the youngest children, especially by physician specialists, and with medications that are off label for indication; this exposure is disproportionate compared to adults. Many off label prescriptions are for medications with unproven benefit or safety concerns. FDA policies should be strengthened to require prioritized study of all medications commonly prescribed off label; mandate patient registries to assess off label prescribing over time; and provide physicians more accessible prescribing information. Medical education and prescribing incentives and tools should target the most commonly off label prescribed drugs. Future research should determine outcomes, causes, and appropriateness of off label prescribing to children.

Ethical Issues in Mental Health

Ethical Issues in Mental Health PDF Author: Steve Baldwin
Publisher: Springer
ISBN: 1489932704
Category : Medical
Languages : en
Pages : 217

Get Book Here

Book Description
Why write another book on ethics? As practitioners we are involved both in the design and delivery of services to people with mental health problems. In common with all other professionals, our work has led to the experience of ethical dilemmas: typically, these have involved major confrontations, either with our col leagues or our consciences. This book, however, is not limited to a discussion of such major themes. Rather, we have tried to use a broader canvas: ethics, in our view, is really about the judgement of right and wrong in ordinary, everyday life. Ethics are highly personal: we fashion our own personal code from our experi ence of others, and from the 'tests' which bring meaning to our lives. Such experiences shape our individual values. We bring these codes and values to our work. We are not always aware of their influence in our dealings with people. Although we may not always be aware of it, all our actions pose an ethical question. Given that our work involves us in helping others to live ordinary, satisfying lives, this challenge heightens the intensity of our ethical dilemmas. This is most evident where our personal code conflicts with the implicit code of the health setting.

Drug Safety

Drug Safety PDF Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 12

Get Book Here

Book Description


Prescription Drugs

Prescription Drugs PDF Author: Sarah F. Jagger
Publisher:
ISBN:
Category : Drug utilization
Languages : en
Pages : 12

Get Book Here

Book Description


The Life-Cycle of Pharmaceuticals in the Environment

The Life-Cycle of Pharmaceuticals in the Environment PDF Author: B.M. Peake
Publisher: Elsevier
ISBN: 190881845X
Category : Medical
Languages : en
Pages : 272

Get Book Here

Book Description
The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship. Encompasses the full lifecycle of common pharmaceuticals, from prescription and dispensing practices to their occurrence in a range of different types of natural waters and their environmental impact Explores the role of the healthcare system and its affect on users Beneficial for environmental engineers involved in the design and operation of appropriate degradation technologies of the pharmaceutical prescription and disposal practices