ABSTRACT
While the world rushed to develop treatments for COVID-19, some turned hopefully to drug repurposing (drug repositioning). However, little study has addressed issues of drug repurposing in emergency situations from a broader perspective, taking into account the social and ethical ramifications. When drug repurposing is employed in emergency situations, the fairness of resource distribution becomes an issue that requires careful ethical consideration.This paper examines the drug repurposing in emergency situations focusing on the fairness using Japanese cases. Ethical issues under these circumstances addressed by the authors include: maintaining the evidence level, integrity of clinical research ethics, and voluntary consent by original indication patients. In order to address these issues, they argue that rapid accumulation of ethically and scientifically valid evidence is required, as is obtaining information on resource quantity.
Subject(s)
COVID-19 Drug Treatment , Drug Repositioning/ethics , Humans , Resource Allocation/ethics , SARS-CoV-2ABSTRACT
As the coronavirus disease 19 (COVID-19) global pandemic rages across the globe, the race to prevent and treat this deadly disease has led to the "off-label" repurposing of drugs such as hydroxychloroquine and lopinavir/ritonavir, which have the potential for unwanted QT-interval prolongation and a risk of drug-induced sudden cardiac death. With the possibility that a considerable proportion of the world's population soon could receive COVID-19 pharmacotherapies with torsadogenic potential for therapy or postexposure prophylaxis, this document serves to help health care professionals mitigate the risk of drug-induced ventricular arrhythmias while minimizing risk of COVID-19 exposure to personnel and conserving the limited supply of personal protective equipment.
Subject(s)
Death, Sudden, Cardiac , Hydroxychloroquine , Long QT Syndrome , Lopinavir , Risk Adjustment/methods , Ritonavir , Torsades de Pointes , Anti-Infective Agents/administration & dosage , Anti-Infective Agents/adverse effects , Betacoronavirus/drug effects , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , Drug Combinations , Drug Monitoring/methods , Drug Repositioning/ethics , Drug Repositioning/methods , Electrocardiography/methods , Humans , Hydroxychloroquine/administration & dosage , Hydroxychloroquine/adverse effects , Long QT Syndrome/chemically induced , Long QT Syndrome/mortality , Long QT Syndrome/therapy , Lopinavir/administration & dosage , Lopinavir/adverse effects , Pandemics , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Ritonavir/administration & dosage , Ritonavir/adverse effects , SARS-CoV-2 , Torsades de Pointes/chemically induced , Torsades de Pointes/mortality , Torsades de Pointes/therapySubject(s)
Betacoronavirus , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Pandemics , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , COVID-19 , Clinical Trials as Topic/ethics , Clinical Trials as Topic/methods , Compassionate Use Trials/ethics , Compassionate Use Trials/methods , Drug Repositioning/ethics , Drug Repositioning/methods , Drugs, Investigational/therapeutic use , Ebola Vaccines/therapeutic use , Hemorrhagic Fever, Ebola/epidemiology , Hemorrhagic Fever, Ebola/prevention & control , Hemorrhagic Fever, Ebola/therapy , Humans , SARS-CoV-2ABSTRACT
Nowadays, medical and biomedical research provides new scientifics results to improve the quality of life. The protection of humans and their fundamental rights is part of the tasks of the biomedical and legal fields. In particular, the right to protect the human person and its human dignity. In this article, we discuss if the minimum content of that right can be the recognition of the primacy of the patient's will, and then whether it is legitimate to always protect the expectations of the individual, even when asking for a treatment that science has not already validated (AU)
Il progresso scientifico apre scenari inattesi, offendo alla società nuove opportunità, in vista del miglioramento della qualità della vita dell'uomo. L' obiettivo di proteggere la persona umana e di salvaguardarne i diritti inviolabili è comune sia alle scienze biomediche che a quelle giuridiche. In particolare il diritto tutela la persona umana e i suoi diritti fondamentali, primo fra tutti la dignità umana. Nella specie, si discute se il contenuto minimo di tale diritto possa spingersi fino al riconoscimento di un primato della volontà del paziente, cioè della persona umana, in ordine alla cura ed alla scelta della terapia e quindi se sia legittimo tutelare sempre e comunque l'aspettativa pretensiva del singolo, anche ove si richieda come cura una terapia (rectius: un trattamento) che la scienza non abbia già od ancora preventivamente "validato"