Drugs in Aviation - A Review

The Aviation Medicine Department of the South African Civil Aviation Authority (SACAA), Aviation Medical Examiners (AME), and Institute for Aviation Medicine (IAM) receive numerous inquiries regarding the use of medication in the aviation environment. Flying an aircraft or controlling aircraft on the ground are highly demanding cognitive and psychomotor tasks, performed in an often inhospitable environment, with exposure to various sources of stress. It is therefore important for aviation personnel (i.e. aviation medical examiners, pilots, cabin crew and air traffic services personnel) to consider the effects that medicine or drugs may have on performance. Studies confirm that some pilots, and other crew members while on duty, used prohibited medications or illegal substances or performed duties while suffering significant unreported medical conditions. When considering aircraft mishaps and their causes, we tend to focus on the pilot. After all, he's in the driver's seat, there to troubleshoot any problems that may arise, and he's expected to bring the “on-loan” aircraft back to base, in one piece, after a mission. If a mishap occurs, investigators look for causes related to pilot error along with evidence of mechanical failure, weather factors, and runway condition and air traffic control (ATC) issues. Reviews of data from general aviation, commercial and military aircraft mishaps show that the two most often cited causal issues are pilot error and mechanical/logistical factors. If pilot error was identified, the question now arises: Are some instances of incorrect controlling of an aircraft due to human factors, such as poor diet or insufficient rest (self-imposed), fatigue, poor concentration, shift-work problems, inadequate training or lack of motivation? More specifically, the following in terms of pilot error have been identified in the USA: • Flying under the influence of alcohol – 15% • Conducting unwarranted manoeuvers – 30% • Penetrating known adverse weather conditions beyond pilot and aircraft capabilities – 40% • Drug impairment of the pilot (includes prescribed medication) – 6% • Miscellaneous – 9% Although these statistics relate to the pilot, they can no doubt be extended to other aviation personnel e.g. ATC, cabin crew (CC) and aircraft maintenance officers (AMO). Of note is that up to 6% of aircrew are ‘under the influence of medication' while operating an aircraft. Aircrew, like all of us, are prone to illness, but those who take medicine on an inadequately informed basis or undertake self-medication, not only endanger their lives but also jeopardise the safety of passengers and costly aircraft. The Aviation Medicine Department of the South African Civil Aviation Authority, Aviation Medical Examiners, and the Institute for Aviation Medicine receive numerous inquiries regarding the use of medication in the aviation environment. In addition, reports have been received relating to aviation personnel using unapproved medication or illegal drugs. Furthermore, a physician may prescribe medication for a patient while being unaware that the patient is performing duties within the aviation environment. Or, a pilot self-medicates because consulting an AME may result in flying privileges being withdrawn. Flying an aircraft or controlling aircraft on the ground are highly demanding cognitive and psychomotor tasks, performed in an inhospitable environment, with exposure to various sources of stress. It is therefore important for aviation personnel (i.e. aviation medical examiners, pilots, cabin crew and air traffic controllers) and non-aviation medical examiners to consider the effect that medicine or drugs may have on aviation performance. A study performed in 1994 by the FAA revealed that an estimated 14 000 US pilots flew while using prohibited medications or illegal substances or flew with significant unreported medical conditions.1 Greater understanding of the effects of medication in humans, and advances in drug development have now made possible the use of various medications by aircrew. In this context assessment of side effects which a drug may have on performance, has become an important part of its clinical profile and provides increased and more informed availability of potential therapy for aircrew. The aim of this review is to make the non-aviation medical examiner aware of, and to provide an understanding of the issues involved rather than to provide recommendations for drug use in aviation and to outline the various approaches that can be adopted to assess whether a drug can be used safely.South African Family Practice Vol. 49 (9) 2007: pp. 4

Anaemia – a pale ale?

Despite some modest improvements described recently, anaemia remains a significant global public health concern affecting both developed and developing countries. It affects a quarter of the global population, including 293 million (47%) children who are younger than five years of age. A prevalence of 42% and 30% has been described in pregnant and non-pregnant women, respectively. Children and women of reproductive age are at high risk, partly because of physiological vulnerability, followed by the elderly. Africa and Asia are the most heavily affected regions, accounting for 85% of the absolute anaemia burden in highrisk groups. According to the World Health Organization global database on anaemia (1993–2005), this disorder was considered to be a moderate public health problem in South African preschool children, pregnant women and non-pregnant women of reproductive age

Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial

Background. Panic disorder (PD) and generalized anxiety disorder (GAD) are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual. Methods/design. The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC) or care as usual (CAU). In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1) guided self-help, 2) cognitive behavioral therapy and 3) antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI). Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. Discussion. It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options for GAD and PD in the primary care setting. Results will become available in 2011. Trial registration. NTR1071

Statistical design and analysis in trials of proportionate interventions: a systematic review

Background: In proportionate or adaptive interventions, the dose or intensity can be adjusted based on individual need at predefined decision stages during the delivery of the intervention. The development of such interventions may require an evaluation of the effectiveness of the individual stages in addition to the whole intervention. However, evaluating individual stages of an intervention has various challenges, particularly the statistical design and analysis. This review aimed to identify the use of trials of proportionate interventions and how they are being designed and analysed in current practice. Methods: We searched MEDLINE, Web of Science and PsycINFO for articles published between 2010 and 2015 inclusive. We considered trials of proportionate interventions in all fields of research. For each trial, its aims, design and analysis were extracted. The data synthesis was conducted using summary statistics and a narrative format. Results: Our review identified 44 proportionate intervention trials, comprising 28 trial results, 13 protocols and three secondary analyses. These were mostly described as stepped care (n=37) and mainly focussed on mental health research (n=30). The other studies were aimed at finding an optimal adaptive treatment strategy (n=7) in a variety of therapeutic areas. Further terminology used included adaptive intervention, staged intervention, sequentially multiple assignment trial or a two-phase design. The median number of decision stages in the interventions was two and only one study explicitly evaluated the effect of the individual stages. Conclusions: Trials of proportionate staged interventions are being used predominantly within the mental health field. However, few studies consider the different stages of the interventions, either at the design or the analysis phase, and how they may interact with one another. There is a need for further guidance on the design, analyses and reporting across trials of proportionate interventions

A summary overview of the new, direct, target-specific oral anticoagulants

In the past 10 years or so, many alternatives to warfarin have been developed the first being the novel oral anticoagulants (NOAC) or better referred to as direct oral anticoagulants (DOAC) or target-specific oral anticoagulants (TSOAC). These drugs have some definite advantages and disadvantages that should be clear to physicians before prescribing any of them for patients. Many clinical trials have provided definitive information about the efficacy and safety of DOACs, yet many physicians remain sceptical about prescribing these drugs due to lack of answers to real world questions. The concerns are directed towards appropriate patient selection (the choice should be made according to age, renal function, compliance, cost, clinical condition, intake of other drugs), the mechanism of switching between agents, how these drugs affect routine laboratory tests and when monitoring is needed. Knowledge of other drugs that interact with the DOAC and management of severe bleeding will be reviewed and recommendations will be given to all of these concerns

“Alpha-1, are you in? (C)harlie (O)scar (P)appa (D)elta, over!”

Chronic obstructive pulmonary disease (COPD) is characterised by chronically poor air flow. Typically, it worsens over time. The main symptoms include shortness of breath, coughing and sputum production. Most people with chronic bronchitis have COPD. Tobacco smoking is the most common cause of COPD. A number of other factors, such as air pollution and genetics, play a smaller role. One of the common sources of air pollution is poorly vented cooking and heating fires in the developing world. Longterm exposure to these irritants causes an inflammatory response in the lungs, resulting in narrowing of the small airways and breakdown of the lung tissue, leading to emphysema. Genetic involvement, i.e. alpha-1 antitrypsin deficiency, is now a recognized cause. The diagnosis is based on poor air flow, as measured by lung function tests. In contrast to asthma, the air flow reduction does not improve significantly with the administration of a bronchodilator. COPD can be prevented by reducing exposure to known environmental risk factors. This includes an effort to decrease the rate of smoking and to improve indoor and outdoor air quality. COPD treatment includes stopping smoking, vaccinations, rehabilitation, and often inhaled bronchodilators and steroids. Some people may benefit from long-term oxygen therapy or lung transplantation. Increased use of medication and hospitalization may be needed in those who have periods of acute worsening. Worldwide, COPD effects 329 million people, or nearly 5% of the population. In 2013, it resulted in 2.9 million deaths, up from 2.4 million deaths in 1990. The number of deaths is projected to increase owing to higher smoking rates and an ageing population in many countries. New treatments are also emerging very slowly