Ergogenic aids: a review of basic science, performance, side effects, and status in sports

The use of drugs and supplements to enhance performance has become a part of mainstream athletics. Many team physicians and sports medicine practitioners are unfamiliar with the benefits and risks of these products and thus are unable to educate young athletes on this topic. In spite of numerous reports on the health risks of anabolic steroid use, 1 to 3 million Americans have used them. Human growth hormone has been tried by up to 5% of 10th graders, although no scientific study has shown that it is an effective performance-enhancing drug. Amphetamines and similar compounds may be the most widely abused drug in baseball; recently, they have come under increased scrutiny in sport. Erythropoietin is a highly effective aerobic enhancer that has been linked to multiple deaths in cyclists and other endurance athletes. The neutraceutical industry, led by supplements such as creatine, ephedra, and androstenedione, remains unregulated by the Food and Drug Administration and has serious issues with quality and side effects. An understanding of these products is essential for the sports medicine practitioner to provide sound, safe advice to the athlete.     

Patients' safety, privacy and effectiveness--a conflict of interests in health care information systems?

Information technology (IT) is finding its way into daily clinical work. IT is primarily seen as a tool for providing quality of service, cutting costs and promoting efficiency in every aspect of health care, but improvements for patients' safety are also a driving force. IT-solutions can be found both at an administrative and a clinical level, supporting everything from documentation, distribution and storing of patient data to workflows, monitoring and decision making. However, the increasing use of IT in health care raises questions. What is the impact on patients' rights and privacy? Does the law benefit IT-solutions in health care, or does it raise barriers for optimized use? Which interests does the law safeguard in the health care sector, and in the light of an increasing use of IT, do any of these identified interests collide? In conjunction with a governmental national project (InfoVU) during 2001-2004, the Swedish National Board of Health and Welfare (NBHW) had to address these issues and other legal aspects of IT use in health care. The agency's analysis was published in November 2005. The purpose of this article is to present some of the agency's conclusions on legal issues pertaining to the management and processing of patient data. It will show, from a Swedish legislative point of view, the need for a common information security strategy for health care information management as well as discussing other legislative issues in order to meet both the patients' and the health care provider's interests in an electronic environment.     

Balancing the need for innovative drugs while providing lower cost alternatives to consumers: Hatch-Waxman reviewed

There is a long continuum of differing positions amongst academia, the private sector, and the public sector in determining the appropriate balance between providing incentives to both innovator drug companies and generic drug manufacturers, while at the same time also protecting legitimate patent rights. Juxtaposed to these issues is the fact that the cost of biomedical research is enormous and it continues to grow as the government seeks to provide for the health and welfare of a public that not only seeks therapeutic medicine and medical care when sick, but also wants prophylactic and diagnostic products. Furthermore, personalized medicine, resulting from the advances in functional genomics and new and increased use of lifestyle drugs providing therapies ranging from male pattern baldness to erectile dysfunction, is indicative of the ever-increasing expectations for a greater range of products. The debate then is not only how to make such products available but also how to make them affordable. With more than 500 drug patents scheduled to expire between 2004 and 2009 (with 26 of these drugs accounting for more than 38 billion dollars in sales annually), the stakes are high, for not only the generic and brand name manufacturers, but also for the consumer.     

Illicit drugs, testing, prevention and work in France: ethical and legal issues

The use of illicit drugs in the workplace raises issues pertaining to prevention and safety and the responsibility of the various members of staff. It also brings into question the interface between work and private life. If employees are in theory responsible for their own safety and risk heavy penalties in the event of the consumption of illicit drugs in the workplace, such behaviour has to be proved. In reality, the worker can only be partially and marginally held liable, given the fact that the employer is prohibited from infringing on their rights and liberties (restrictions on the searching of their personal belongings and lockers as well as on the carrying out of breath testing and saliva testing under restrictive conditions). Employers have for their part a broader range of responsibilities and, above all, an absolute obligation to achieve specific goals in terms of health and safety resulting in the need to take action. In accordance with the International Labour Organization recommendations, European and national legislation, the employer has to implement a suitable preventive policy. However, where is the balance between prevention and repression? Very few studies have raised these issues and our aim is to precisely situate the place of drug testing in the employer's repressive arsenal in France and to try to answer the legal and ethical issues raised. Thus, for example, repression can only be acceptable when it deals with moderate and non-addicted users, or it could be tantamount to discrimination.     

Regional methamphetamine use among U.S. Army personnel stationed in the continental United States and Hawaii: a six-year retrospective study (2000-2005)

Substance use disorders constitute a serious and persistent threat to military readiness and to the health and safety of military personnel and their families. Methamphetamine is among the most addictive and damaging of commonly abused drugs; this is of great concern for military health providers in Hawaii due to the unusually high prevalence in the local community. The effect of regional drug use on active duty subpopulations has not been previously studied. This study includes a 6-year retrospective sample of laboratory-confirmed methamphetamine-, cocaine-, and marijuana-positive drug tests among Army soldiers stationed in Hawaii and western and eastern continental U.S. installations. The findings suggest that active duty members are significantly affected by the local drug climate. However, current military drug policies also deter use as evidenced by low absolute drug-positive rates even in regions of high civilian prevalence.     

The ethics of blood testing as an element of doping control in sport

Sport authorities continue to confront a variety of perplexing issues as they attempt to address effectively and efficiently the problems posed by doping. The emergence of the phenomena of blood doping and the administration of erythropoietin have added to the challenges faced by doping control authorities. Some sport organizations have introduced blood tests in an attempt to deal with these issues despite the absence of any effective test for the detection of the administration of homologous blood products or eythropoietin. A number of ethical issues are raised by such developments. Even in the presence of an effective test it is suggested that the decision to implement a specific testing approach can be reached by considering the wishes of a hypothetical "Fair Competitor" and an analysis of the costs involved. In this respect the Fair Competitor assumes in the sport community the role that the "reasonable person" occupies in law, permitting an analysis of a proposed course of action. In making any decision regarding the implementation of any test, a Fair Competitor would be guided by considerations of the postulated advantage and incidence of a doping technique, the likelihood of false positive and negative results, the risk of unwanted consequences of a testing process, and a concern that a specific test not accelerate the likelihood of the use of other doping methods. This approach is applied to a consideration of the appropriateness of blood testing in sport. It is concluded, using such an analysis, that in their present state of development, blood tests should not be implemented. It is recognized that certain sport authorities currently use blood tests to exclude competitors whose blood values exceed certain predetermined levels on the grounds of concerns regarding health and safety. Screening of this kind is beyond the purview of this discussion.     

Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU

The purpose of this guideline is to help investigators by giving an overview of relevant current EU requirements concerning the quality of starting materials and final drug products (the radiopharmaceuticals), the non-clinical safety studies and dosimetry considerations whilst designing a human clinical trial which includes the use of radiopharmaceutical compounds. Under the auspices of the Drug Development Committee of the European Association of Nuclear Medicine.     

Occupational health and safety issues in military field hospitals.

This paper considers the occupational health and safety issues that apply within a military field hospital. It considers NHS occupational health and safety activities and examines how these might be applied within an Army Medical Services unit. Areas that are unique to field hospitals are highlighted in comparison with a static NHS hospital. Some issues for future work are also considered.     

Possible dangers for patients using homeopathy: may a homeopathic medicinal product contain active substances that are not homeopathic dilutions?

OBJECTIVE: To conclude in an objective and reasonable way whether, from an ethical and legal point of view, in homeopathic medicinal products all the active components have to be in homeopathic dilutions or if it is correct and appropriate for one, some or all of the active components to exist in homeopathic medicinal products without having been subjected to homeopathic potentisations (dilutions followed by succussion). METHODS: Collection and analysis of Spanish and European Union legislation regarding this topic. Revision of the European Pharmacopoeia. Criteria from the homeopathic bibliography. Analysis from the standpoint of ethical principles. RESULTS AND CONCLUSIONS: "Mother tinctures", and other products containing substances that have not been subjected to homeopathic dilutions, cannot be accepted as constitutive components of homeopathic medicinal products. We consider unacceptable the existence of products under the denomination of homeopathic medicinal product if they do not meet the minimal requirements to be considered as such: manufacture by a homeopathic production procedure, which means that all its active components are present in homeopathic dilutions. We recommend that physicians should ask their patients not only if they use homeopathic pharmaceuticals in general but to specify which products they are using, bearing in mind the possibility that they may contain "mother tinctures" or products at such low dilutions that they may interfere with conventional treatment.     

Ketamine for procedural sedation and analgesia by nonanesthesiologists in the field: a review for military health care providers

Military health care providers located in field environments frequently face situations in which procedural sedation and analgesia are necessary, without the advantage of sophisticated monitoring equipment. Ketamine is a unique agent that can be administered either intravenously or intramuscularly to produce predictable and profound analgesia, with an exceptional safety profile. We review the issues unique to ketamine and provide a practical guide for the use of ketamine for adult and pediatric patients in a field environment.     

The duty of the pharmacist and the pharmaceutical industry

The common law duty of care, an essential element of the tort of negligence, focuses on conduct. Accordingly, any discussion of the existence, nature and content of the duty of care of a pharmaceutical manufacturer and of a pharmacist, requires analysis of their respective functions. Also relevant are the special nature and effects of drug products and their approval for and acceptance in, human therapy based upon a balancing of risks and benefits. Critical to a manufacturer's potential tortuous liability is the so-called 'learned intermediary, role of pharmacists, prescribers and other health professionals and whether they have current and accurate drug product information. Manufacturers are not necessarily the only source of drug information available to health professionals. These responsibilities serve patients who also need to be adequately informed so as to achieve optimal safety and efficacy when using prescribed medications.     

Preservation of food products by irradiation

The use of irradiation to preserve food has the potential to significantly enhance our capacity to maximize the quality and quantity of the food we consume. In a world in which distribution of food occurs across continents and in which malnourished populations are in dire need of basic food products, any safe, effective, and efficient means of preserving food is more than welcome. Irradiation, as a method for food preservation, has been studied for more than 30 years. This discussion focuses on this most recent method for the preservation of food with particular emphasis on its effects on the safety, nutritive, and aesthetic values of the food preserved by irradiation. The use of ionizing radiation as a method to preserve foods is one that has been demonstrated to be effective for a variety of food classes. Irradiation offers a means to decontaminate, disinfest, and retard the spoilage of the food supply. At the same time, it appears that the wholesomeness of these food products is maintained. Nutritive value can be sustained by use of effective doses of radiation. Concerns over the safety of irradiated food are rooted in questions regarding the potential induction of radioactivity, harmful radiolytic products, and pathogenic radiation-resistant or mutant strains of microorganisms. Research findings have allayed concerns over safety. However, more research is necessary to conclusively resolve these safety issues. Food irradiation is a promising technology that has and will contribute to our ability to feed the people of this world. This technology is but one of many available ways to preserve our greatest natural resource, the food supply. Enhancement of the ability to preserve food by irradiation will facilitate the distribution of food from fertile developed regions to the malnourished peoples of underdeveloped countries. It is in diminishing the problem of malnourishment and starvation that irradiation as a means to preserve food may find the greatest acceptance.     

壳聚糖—诺氟沙星烧伤生物敷料的研究

介绍医用壳聚糖的制备方法,并以此为成膜材料,掺加药物诺氟沙星,研制成壳聚糖-诺氟沙星烧伤生物敷料。经安全性试验和烧伤临床使用证明,本敷料对人体无毒、不过敏,贴附性好,而且透湿、透气性能适中,有明显促进创面愈合的作用。     

Thorium in the workplace measurement intercomparison.

The monitoring of radionuclides in the nuclear industry has been recognized as the most straightforward way of assessing health and safety issues associated with the exposure of the workforce to potentially harmful radiation doses. Much of this is achieved by measurements in the workplace itself and by the bioassay and monitoring of workers in the industry. However, there also exists a significant 'non-nuclear' industry where workers are exposed to radioactive materials, for example where this involves thorium, which is made wide use of in the aerospace and other high technology industries. As such work involves the processing of thorium bearing materials, the workforce is potentially exposed to 232Th and its daughter nuclides. Thus, to monitor the workforce effectively, it is important to be able to measure both 232Th and the decay products of 232Th where they are in an unknown state of radioactive equilibrium and this is where monitoring laboratories may experience some difficulty. Accordingly, the Health and Safety Laboratory in the UK has organized a EC wide project on the monitoring of thorium in the 'non-nuclear' workplace; this project is currently ongoing. We report the results of the first intercomparison of this project involving two solutions of 232Th, one in radioactive equilibrium and one not in equilibrium with its daughters. The results are presented with some comments on how this intercomparison has progressed and how these first results will inform the rest of the project.     

Meeting the global demand of sports safety: the intersection of science and policy in sports safety

Sports and physical activity are transforming, and being transformed by, the societies in which they are practised. From the perspectives of both competitive and non-competitive sports, the complexity of their integration into today's society has led to neither sports federations nor governments being able to manage the safety problem alone. In other words, these agencies, whilst promoting sport and physical activity, deliver policy and practices in an uncoordinated way that largely ignores the need for a concurrent overall policy for sports safety. This article reviews and analyses the possibility of developing an overall sports safety policy from a global viewpoint. Firstly, we describe the role of sports in today's societies and the context within which much sport is delivered. We then discuss global issues related to injury prevention and safety in sports, with practical relevance to this important sector, including an analysis of critical policy issues necessary for the future development of the area and significant safety gains for all. We argue that there is a need to establish the sports injury problem as a critical component of general global health policy agendas, and to introduce sports safety as a mandatory component of all sustainable sports organizations. We conclude that the establishment of an explicit intersection between science and policy making is necessary for the future development of sports and the necessary safety gains required for all participants around the world. The Safe Sports International safety promotion programme is outlined as an example of an international organization active within this arena.     

U.S. Food and Drug Administration and off-label use of expandable metal biliary stents within the peripheral vasculature

Expandable metal stents are used to maintain the patency of compromised ducts, lumens, and vessels. As medical devices, there products are regulated by the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA). During the past several years, the FDA has become aware of the increasing prevalence of off-label use of expandable metal stents cleared for biliary use within the peripheral vasculature. The authors provide an overview of how the FDA regulates medical devices and expandable stents and summarize safety issues reported to the Agency with regard to the off-label use of these biliary stents.     

美国医用激光产品的监管及对我国的启示

随着激光技术的发展及其用途的拓展,医用激光产品的应用愈加广泛,其安全有效性直接关系到患者的健康。比较分析美中两国医用激光产品的监管,为我国医用激光产品监管提供可借鉴的信息。     

Beliefs and behaviours of radiographers and other health professionals concerning radiation protection safety in a high-volume Greek public hospital. Development of a new measuring instrument

IntroductionThe use of fluoroscopy-assisted surgical procedures has been increasing recently. The extensive use of fluoroscopy, combined with the lack of knowledge about radiation risks among operating room (OR) personnel (surgeons, anaesthetists, nurses, and radiographers), may lead to misconceptions. The perceptions and beliefs of any health professional concerning radiation protection safety (RPS) may affect their behaviour during surgery, leading to negative outcomes. The aim of this study was to construct a new, original, reliable, and valid instrument to record the beliefs, perceptions, and behaviours of health professionals during surgery, which reflects the established culture of RPS.MethodsA questionnaire was designed, consisting of 95 questions grouped into six coherent sections. The study was performed at a Greek public hospital with a high workload in terms of fluoroscopically guided surgical operations.ResultsIt was distributed among 136 people, and 132 completed questionnaires were collected (response rate 97%). Exploratory factor analysis was performed separately for each scale studied and Cronbach's Alpha reliability analysis was also performed. The reliability of the greater part of the new measurement tool ranged from very good to acceptable.ConclusionThe questionnaire developed in this study is a valid and reliable option for recording health professionals’ perceptions, beliefs, and behaviours concerning the RPS culture.Implications for practiceThis study helps clinical radiographers to understand a possible knowledge gap about RPS and locates the specific fields that the OR personnel misunderstand. It also can support and establish local learning organisations with regular targeted staff training for health professionals, thereby leading to a generally improved RPS culture.     

新疆畜产品生产现状及质量安全控制对策

近年来,在我国畜产品对外贸易中,畜产品质量安全问题是影响畜产品出口的主要因素。本文结合国内畜产品生产与贸易情况。分析了畜产品质量安全对我区畜产品出口的影响以及影响新疆畜产品质量安全的主要因素,并就如何控制和保障畜产品质量安全提出了一些措施与对策。     

Pharmacovigilance: what to do if you see an adverse reaction and the consequences

With outset in a recently identified safety signal – the association between gadolinium and nephrogenic systemic fibrosis – the article highlights the aim of pharmacovigilance and provides an overview of the European regulatory drug safety network. The main objective of the article is to provide appropriate information concerning the regulatory environment to health care professionals working in a clinical setting. The important role played by health care professionals in drug safety surveillance, as well as examples of how the regulatory decision making is functioning in practice, are described and exemplified by means of the gadolinium case.