Off-Label Drug Use as a Consent and Health Regulation Issue in New Zealand

Abstract The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996 and the common law, which require that off-label drug use is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions.
Source: Journal of Bioethical Inquiry - Category: Medical Ethics Source Type: research

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Conclusion: The patient number is not large enough to make a broad conclusion. However, the individualized treatments and long follow-ups, together with detailed literature review, suggest that CSM requires individualized staged treatments based on each patient's condition. A period of "wait and see" before starting with either surgery or radiation treatment can benefit the patient. PMID: 31819821 [PubMed]
Source: Surgical Neurology International - Category: Neurosurgery Tags: Surg Neurol Int Source Type: research
ConclusionsStudies have focused predominantly on assessing transcription or translation/text generation skills with little systematic attention to relationships between writing and language domain or mediational systems skills. Reviewed studies offer preliminary findings, areas of needed future research, and implications for continued research into understanding and supporting the writing skill development of children with ASD.
Source: Research in Autism Spectrum Disorders - Category: Psychiatry Source Type: research
In the 1990s patients with psoriasis were suffering with few options. To complement their treatment, we started a psoriasis support group, engaging a psychologist, Dr Stephen Rapp, to support our efforts. Dr Rapp was intrigued by the enormous impact that he saw psoriasis having on our patients. Together, we embarked on a quantitative study of that impact. Dr Rapp brought to this project his expertise in formal quality of life assessment; at the time, such patient-reported outcomes were just beginning to be used in dermatology.
Source: Journal of the American Academy of Dermatology - Category: Dermatology Authors: Tags: Celebrating 40 years in publication Source Type: research
ConclusionKnockdown PEG10 remitted H2O2-injury of PC-12 cells by targeting miR-34a-5p/TLX, and the behavior may be involved in Smad and Wnt/β-catenin pathways.
Source: Molecular Immunology - Category: Allergy & Immunology Source Type: research
ConclusionsFindings are discussed regarding research and practice.
Source: Research in Developmental Disabilities - Category: Disability Source Type: research
Conclusion: Our results demonstrated that a significant percentage of patients affected by both mood disorders and schizophrenia shows relevant social dysfunction. Social dysfunction is related, but not completely explained by psychopathological severity. In several patients, it tends to persist also during remission state. Socio-demographic and lifestyle factors were also found to play a role and should therefore be taken into consideration in further studies investigating social dysfunction.
Source: Progress in Neuro Psychopharmacology and Biological Psychiatry - Category: Psychiatry Source Type: research
Publication date: Available online 10 December 2019Source: Journal of Psychiatric ResearchAuthor(s): Madhukar H. Trivedi, Cherise Chin Fatt, Manish K. Jha, Crystal M. Cooper, Joseph M. Trombello, Brittany L. Mason, Jennifer Hughes, Bharathi S. Gadad, Andrew H. Czysz, Russell T. Toll, Anne K. Fuller, Sangita Sethuram, Taryn L. Mayes, Abu Minhajuddin, Thomas Carmody, Tracy L. GreerAbstract:Depression has a chronic and recurrent course often with early onset and is the leading cause of disability worldwide. In contrast to diagnoses for other conditions which rely on precise medical tests, the diagnosis of depression still foc...
Source: Journal of Psychiatric Research - Category: Psychiatry Source Type: research
CONCLUSION: Supervised progressive SE improved the activity of deep abdominal muscles in standing postural tasks in the patients with CLBP. PMID: 31821992 [PubMed - as supplied by publisher]
Source: Journal of Sport Rehabilitation - Category: Sports Medicine Tags: J Sport Rehabil Source Type: research
This study aimed to understand the experiences of people with dementia and their family members with respect to decision-making and their views on supported decision-making. Thirty-six interviews (twenty-one dyadic and fifteen individual) were undertaken with fifty-seven participants (twenty-five people living with dementia and thirty-two family members) across three states in Australia. Interpretative Phenomenological Analysis (IPA) was used as the methodological approach, with relational autonomy as a theoretical perspective. We identified two overarching themes relating to participants ’ experiences with decision-...
Source: Journal of Bioethical Inquiry - Category: Medical Ethics Source Type: research
Hippotherapy (hippo is Greek for horse) continues to gain recognition in our profession, but several misconceptions exist about this approach used by speech-language pathologists and other clinicians. Hippotherapy is a treatment tool—it is not a type of treatment. Compare it to using a swing or ball or other similar tool in sessions. Also used by occupational therapists and physical therapists, the tool involves placing clients on horses while providing intervention. The approach aims to engage sensory, neuromotor, and cognitive systems to enhance outcomes, according to the American Hippotherapy Association (AHA). A ...
Source: American Speech-Language-Hearing Association (ASHA) Press Releases - Category: Speech-Language Pathology Authors: Tags: Health Care Private Practice Slider Speech-Language Pathology Feeding Disorders Language Disorders Speech Disorders Swallowing Disorders Voice Disorders Source Type: blogs
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