National landscape of HIV+ to HIV+ kidney and liver transplantation in the United States

The HIV Organ Policy Equity (HOPE) Act, enacted on November 21, 2013, enables research on the transplantation of organs from donors infected with human immunodeficiency virus (HIV) (HIV+) into HIV+ individuals who, prior to transplantation, are infected with HIV. In 2015, the Organ Procurement and Transplantation Network revised organ allocation policies on November 21, and on November 23, the Secretary of Health and Human Services published research criteria and revised the Final Rule accordingly. The HOPE Act appears to be underutilized to date. As of December 31, 2018, there were 56 donors recovered (50 donors transplanted) resulting in 102 organs transplanted (31 liver, 71 kidney). As of December 31, 2018, 212 registrations were indicated on the waiting list as willing to accept an HIV+ kidney or liver, most of which were waiting in active status. Due to the limited number of transplants performed to date, definitive safety conclusions cannot be reached at this time, though current data suggest that 1‐year patient and graft survival does not deviate in a major way from that observed in HIV+ recipients of non‐HIV+ organs or non‐HIV+ recipients. As safety data are reviewed and disseminated, it is anticipated that HOPE participation will increase should safety signals remain low.     

Confidentiality, 'no blame culture' and whistleblowing, non-physician practice and accountability

Confidentiality is a core tenet of medical professionalism, which enables the maintenance of trust in a doctor-patient relationship. However, both the amount of personal data stored and the number of third parties who might access this data have increased dramatically in the digital age, necessitating the introduction of various national data protection acts. Paradoxically, the Freedom of Information Act 2000 allows United Kingdom citizens to access information held by public bodies, including hospitals. Furthermore, the Public Interest Disclosure Act 1998 actively protects physicians who breach their duty of confidentiality in the name of public interest ('whistleblowing'). This article explores the evolution of the law and ethics in this area, and draws attention to the difficulties in balancing confidentiality against freedom of information. In addition, the role and responsibilities of the non-physician anaesthetist are examined.     

Lead toxicity

Lead is one of the oldest known and most widely studied occupational and environmental toxins. Despite intensive study, there is still vigorous debate about the toxic effects of lead, both from low-level exposure in the general population owing to environmental pollution and historic use of lead in paint and plumbing and from exposure in the occupational setting. The majority of industries historically associated with high lead exposure have made dramatic advances in their control of occupational exposure. However, cases of unacceptably high exposure and even of frank lead poisoning are still seen, predominantly in the demolition and tank cleaning industries. Nevertheless, in most industries blood lead levels have declined below levels at which signs or symptoms are seen and the current focus of attention is on the subclinical effects of exposure. The significance of some of these effects for the overt health of the workers is often the subject of debate. Inevitably there is pressure to reduce lead exposure in the general population and in working environments, but any legislation must be based on a genuine scientific evaluation of the available evidence.     

Driving and arrhythmias: implications of new data

Patients with ventricular arrhythmias are often restricted from driving by their physicians for several months. These recommendations are based more on convention than evidence, due to the paucity of data previously available on the safety of driving in these patients. Over the past few years, however, more data have become available that suggests that it is safe to drive within three months of their ventricular tachyarrhythmia. In this paper, we look at this more recent data and make the suggestion that patients with well maintained cardiac function, no recurrent ventricular arrhythmias (i.e. electrical storm) and no persistent medical condition predisposing them to ventricular arrhythmias should be allowed to resume driving soon after their ventricular tachyarrhythmia.     

A Regulatory Framework for Controlling Effluent Discharges Using Toxicity Testing in The UK

Legislation designed to regulate effluent discharges is expressed in terms of minimising the risk of harm of that discharge to the environment. Practical implementation is usually based on the control and measurement of a limited number of individual chemicals. However, this is not always effective because of the complex nature of some discharges or the lack of data for some chemicals, preventing the definition of acceptable levels in the environment. Direct Toxicity Assessment (DTA) clearly has a role in such circumstances because it avoids the need for a comprehensive chemical characterisation of effluent discharges. Several scenarios in which DTA can play a useful role in water quality management under current legislation have been identified. A 'generic' framework for the implementation of bioassays for effluent control is proposed. This provides a number of options in terms of the level of environmental protection afforded and the 'starting point' for a DTA programme (i.e. whether it is based on local measurable impacts on water quality or directed from the outset towards the risk assessment of particular discharges). A DTA programme can be developed that meets both the technical and regulatory requirements of these different scenarios. Guidance on the design of such programmes for different scenarios is provided.     

Late pregnancy termination within a legislated medical environment

AIMS: To review the indications and outcomes for abortion beyond 20 weeks' gestation within an environment of legislated notifiable pregnancy termination. METHODS: In Western Australia legislation allowing abortion > or = 20 weeks' gestation for serious maternal-fetal conditions was enacted in May 1998. Late abortions are only permitted in a single state institution and are notifiable by law. All pregnancy terminations > or = 20 weeks' gestation performed since this legislation were prospectively identified with the indications and outcomes reviewed. RESULTS: During the study period, 219 women underwent abortion > or = 20 weeks' gestation, representing 0.5% of all abortions in the state. Comparison with 438 contemporanous medical abortions for fetal anomaly at 14-20 weeks' gestations was made. Misoprostol was the primary abortifacient for both. The median maternal age for termination at 14-20 weeks was 32 years (interquartile range (IQR) 27, 36) and 30 years (IQR 26, 34) at > or = 20 weeks' gestation (P < 0.001). There was no significant difference in maternal gravidity or parity. The principal indications for terminations > or = 20 weeks were: karyotypic (28.8%); cardiac anomalies (15.5%) and neural tube defects (11.9%). Cardiac anomalies represented 5.0% of fetal anomaly terminations at 14-20 weeks (P < 0.01). The median time for medical abortion was 15.4 h (IQR 11.5, 23.2) at 14-20 weeks' gestation compared with 18.3 h (IQR 13.3, 26.1) at gestations greater than 20 weeks (P < 0.001). A total of 13.2% of terminations were performed at gestations beyond 24 weeks. CONCLUSIONS: Abortion > or = 20 weeks' gestation under medically regulated legislation is used primarily for serious fetal anomalies. The women are younger and the abortion duration is greater for late pregnancy termination compared with those conducted at earlier gestations. The majority of late terminations occur < 23 weeks' gestation and the incidence has remained stable since the legislation was enacted.     

The rationale for a post-marketing surveillance

Post-marketing surveillance is essential in order to protectpatients against avoidable risks from medication. Complete assessmentof a drug cannot, for practical reasons, be made before marketing.There are several methods which can be used in post-marketingsurveillance. Spontaneous reporting on adverse drug reactionsis a quick method, but underreporting is a problem. Intensivemonitoring gives high quality data but is expensive. Healthregisters can be used to trace cases for case-control studiesbut diagnoses are sometimes incorrect. Prospective studies isan informative way to obtain results but they take time. Dataon drug utilization are also valuable because they give an estimateof the size of the population using a particular drug. Theyalso reveal whether warnings about adverse drug reactions havehad any effect on the prescribing pattern.     

Proceedings of the AMSAD workshop on Cannabis, Melbourne, August 1986

This document is a summary of the proceedings of a workshop on cannabis convened by the Australian Medical Society on Alcohol and Drugs at St. Vincent's Hospital, Melbourne, Victoria on August 11-12, 1986. The aim of the workshop was to review present knowledge about cannabis and to consider the options available for the use and/or control of cannabis in Australian society. Representatives of various disciplines (pharmacology, law enforcement, forensic medicine, clinical medicine, sociology, law, criminology) presented an up-to-date assessment of the use and control of cannabis. Three discussion groups considered issues involving clinical medicine and pharmacology, law enforcement and forensic medicine, and law, sociology and criminology respectively. Reports from each group were presented at a plenary session, from which a draft statement was prepared and approved by all participants. This, together with a draft report was circulated to all participants for final approval. The final outcome of the workshop was an approved statement to advise the Council of AMSAD about the control of cannabis use in the Australian community.