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Itskov v. New York Fertility Institute, Inc.
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[Are children getting the right drugs?].
In recent years there has been increased attention to the fact that pharmacotherapy in children does not have the same evidence based platform as in adults. This is mainly due to the fact that most drugs being developed are only studied in adults before they are approved, both because of practical and technical difficulties in doing research on (small) children as well as ethical considerations on the inclusion of children in the testing of a new drug. Furthermore, the pharmaceutical industry has also not been very interested in developing drugs specifically for children. In 1998 the American Food and Drug Administration (FDA) established that studies in children should also be included in the development of new drugs. This was legally formalised by Congress in the Best Pharmaceuticals for Children Act (BPCA) in 2002. This has resulted in a re-evaluation of several drugs primarily developed for adults but frequently used in children. So far the FDA has changed the product information for 87 drugs, 17 drugs have been given new dosage recommendations for children, for 21 drugs the description of side effects have been changed, and 11 drugs are no longer recommended for use in children because of lack of any demonstrable effect. There has also been increased focus on better drug formulations for children. Also in Europe the need for better and safer drugs for children is given attention. The European Commission has submitted a proposal for a legal approach to the problem similar to the BPCA legislation in USA, which will probably be approved by the EU parliament and take effect in 2006. Furthermore, there is a strong commitment to establish co-operation between the pharmaceutical industry and paediatric and pharmacological networks in order to increase and facilitate drug studies in children. The European Medicines Agency will have a central role in this work by developing lists of drugs for which paediatric studies are needed and prevent unnecessary competition and duplication of studies.
The views of the judiciary regarding life-sustaining medical treatment decisions.
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The impact of the HIPAA Privacy Rule on research participation.
HIPAA Privacy Rule significantly reduces the number of participants in research.
Medical and judicial perceptions of the risks associated with use of antipsychotic medication.
To determine whether occupational perspective influences the decision to prescribe antipsychotic medications, we presented a group of psychiatrists and judges with a hypothetical case involving a potentially psychotic patient. The subjects were asked what probability of drug-induced tardive dyskinesia they would accept in order to prevent psychotic decompensation. The subjects were then asked to estimate the actual probability that tardive dyskinesia would occur if the patient received antipsychotic medications. From the responses to these questions we inferred their treatment decisions. Although the psychiatrists and judges agreed on an acceptable level of risk, they differed significantly in their estimates of the actual risk involved and, by inference, their decisions concerning treatment. Our findings have several implications for adjudication of cases involving treatment decisions and the right to refuse treatment.
Involuntary patients' right to refuse medication: impact of the Riese decision on a California inpatient unit.
On June 22, 1989, the California Supreme Court allowed the Appellate Court decision in the right to refuse treatment case, Riese v. St. Mary's Hospital to stand. The court ruled that absent a judicial determination of incompetence, antipsychotic drugs cannot be administered to involuntarily committed mental patients in non-emergency situations without their informed consent. Much concern was expressed by the California Psychiatric Association and the California Alliance for the Mentally Ill about the decision's negative impact on patient care. In this paper, the authors review the decision, elucidate the anticipated concerns about the impact of the decision, and then describe the decision's actual impact on an acute inpatient unit in California. The authors report that Riese hearings were held on 7 percent of admissions to their locked inpatient facility. Only 1 percent of the patients were found to be competent to refuse medications. The authors give clinical examples of patients who were affected by the Riese decision and review the benefits and risks of this decision from the perspective of actual clinical practice.
Desperately seeking donors: the 'saviour sibling' decision in Quintavalle v Human Fertilisation and Embryology Authority (UK).
The recent House of Lords decision in Quintavalle v Human Fertilisation and Embryology Authority has raised difficult and complex issues regarding the extent to which embryo selection and reproductive technology can be used as a means of rectifying genetic disorders and treating critically ill children. This comment outlines the facts of Quintavalle and explores how the House of Lords approached the legal, ethical and policy issues that arose out of the Human Fertilisation and Embryology Authority's (UK) decision to allow reproductive and embryo technology to be used to produce a 'saviour sibling' whose tissue could be used to save the life of a critically ill child. Particular attention will be given to the implications of the decision in Quintavalle for Australian family and medical law and policy. As part of this focus, the comment explores the current Australian legislative and policy framework regarding the use of genetic and reproductive technology as a mechanism through which to assist critically ill siblings. It is argued that the present Australian framework would appear to impose significant limits on the medical uses of genetic technology and, in this context, would seem to reflect many of the principles that were articulated by the House of Lords in Quintavalle.
Getting ready for the PSDA: what are hospitals and nursing homes doing?
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The judicial role in life-sustaining medical treatment decisions.
Although there has been speculation regarding the pervasiveness and nature of judicial decisions regarding life-sustaining medical treatment (LSMT), no attempt has been made to empirically assess their prevalence or the issues they address. An exploratory study utilizing a mail survey of a nationwide random sample (N = 905) of state trial court judges was conducted to provide initial information regarding this decision-making process. Twenty-two percent of the responding judges had heard at least one LSMT case, and judicial review did not appear endemic to particular states. The number of judges hearing LSMT cases dropped from 1975 to 1981 but has increased since then. Three major issues predominate: patient competency, appointment of a surrogate decisionmaker, and resolution of the ultimate issue of forgoing LSMT. Relatively few cases either contested a prior directive's validity or involved imposing sanctions for instituting or forgoing LSMT. Although subject to different interpretations, the results suggest the courts are having a significant impact on certain aspects of the LSMT decision-making process. However, the infrequency with which any one judge is called upon to make an LSMT decision causes concern about the judiciary's ability to respond in a timely and appropriate manner. With their potential for a profound effect on the actions of health care providers, greater attention to this decision-making process is warranted.
Deel v. Syracuse Veterans Administration Medical Center.
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Medical decision-making and the "right to die" after Cruzan.
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Cruzan v. Director, Missouri Dept. of Health.
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In the Circuit Court of Jasper County, Missouri probate division at Carthage.
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The Baby Doe regulations: views from perinatal social workers.
In 1984 the federal government issued the "Baby Doe" regulations, designed to protect the rights of handicapped infants. Members of the National Association of Perinatal Social Workers were asked to evaluate these regulations and were given the opportunity to comment on their impact. The authors present and discuss these comments with respect to the helpfulness of the regulations, physician discretion, parental rights, and the social work role.