International Journal of Risk & Safety in Medicine - Volume 16, issue 2
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: A medical system is called traditional, among others, when it is practiced within the country of its origin. The increasing use of Traditional Medicine (TM) worldwide and the growth of the related pharmaceutical industry has led to an activation of research regarding its quality, efficacy and safety. The Ayurveda and Siddha systems of traditional medicine have their origin in India. Of these, Ayurveda is one of the oldest systems of medicine in the world and the most commonly practiced form of traditional medicine in India. Subjects to be discussed comprise of issues related to herb–drug interactions, misuse of TM,…variations in the action of a drug due to natural and deliberated reasons and the documentation of adverse drug reaction. Combined efforts, without any bias, by scholars from both traditional and modern medicine to optimize the risk benefit profile and to serve as guards for optimal use of TM, is the prerequisite for global harmonization.
Abstract: Objective. To gain insight into the motives and experiences of women who had decided to continue with the pregnancy after Down's Syndrome had been diagnosed in the foetus. Design. In depth interviews with ten women who had made this choice. Results. The result of the diagnostic procedure put those concerned in the position of having to make a difficult decision. Some women were rather unexpectedly confronted with an increased risk as the result of maternal serum screening or nuchal translucency and they hoped that the amniocentesis could reduce their uncertainty. After the definite test result the women had…to make the choice between having to bring up a child with intellectual limitations or allowing the termination of an already well advanced pregnancy. For our respondents, the latter proved to be unacceptable. Initially, little understanding was shown for the parents' decision by some social and medical workers; however, after this initial reaction, sufficient help and support were usually given. The respondents received a lot of support from members of the family, friends and acquaintances, but there were also negative and disapproving reactions. Almost no‐one regretted the examination. Conclusion. The technological possibilities for determining individual risks during pregnancy are increasing rapidly. It is important that pregnant women have all the necessary information about the diagnostic procedures which will enable them to make the right decision.
Keywords: Prenatal diagnosis, Down's Syndrome, abortion, psychological and social consequences
Abstract: To evaluate antibiotic prescribing practices for children diagnosed with upper respiratory infections (URIs). Twenty‐eight physicians (15 pediatricians and 13 family physicians) from eight clinics in the central region of Israel participated in the study. Information was obtained from the database of 13,919 children under the age of 15 diagnosed with acute respiratory infections. In the eight clinics, the variability of antibiotics prescribed for acute respiratory infections ranged from 4–30% (the common cold and URI), 45–99% (AOM), 37–93% (acute pharyngitis or tonsillitis), 6–55% (acute bronchitis), and 50–100% (acute sinusitis). Antibiotics were prescribed more frequently for children over 5 years of age…(p>0.08) and the rates were significantly higher in the Arab pediatric population (p>0.001). There is a wide variability in antibiotic prescribing for children with URIs and the antibiotic prescribing rate is high. Effective intervention is needed to encourage the judicious use of antibiotics in Israel.
Abstract: The DCA (Drug Control Authority), Malaysia has implemented the phase 3 registration of traditional medicines on 1 January 1992 in all pharmaceutical dosage forms of traditional medicine preparations. A total of 100 products of a herbal preparation, containing Smilax calophylla were analyzed for mercury content using cold vapor atomic absorption spectrophotometer. Results showed that 15% of the above products possessed 0.62–2.32 ppm of mercury, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. Out of these 15 products, six products with 0.62–2.32 ppm of mercury were in fact have already registered with the DCA Malaysia.…The quality requirement for traditional medicines in Malaysia is not exceeding 0.5 ppm for mercury. Although this study showed that only 85% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to mercury, however, they cannot be assumed safe from mercury contamination because of batch‐to‐batch inconsistency.
Keywords: Atomic absorption spectrophotometer, Drug Control Authority Malaysia, herbal preparations, mercury, quality requirement for traditional medicines, Smilax calophylla
Abstract: The manufacture of medical devices made in whole or part of a man‐made material (biomaterial) has expanded experientially in the last several decades. This expansion has led to an increasing number of adverse effects of medical devices, with estimates being that the number may be as high as 100,000 each year, from minor injuries to those very serious causing deaths. Since the 1976 Medical Device Amendment to the US Food, Drug and Cosmetic Act. This act requires that a new medical device to enter the American market place must be safe and effective for its intended use. The first step…in designing a medical device is the selection of a suitable material that has the mechanical and the physical‐chemical properties appropriate for the device. After the selection of the material, consideration must be given to the biocompatibility of the material, which in turn will require that appropriate toxicity tests be conducted on the material to ensure safety. Under the section on “Adverse effects from medical devices”, a summary of the laws governing medical devices and various definitions used in regard to biomaterials and devices is given. This is followed by discussing, some in greater details than others, examples of selected adverse effects of medical devices. Finally, attention is given to reporting and monitoring of medical devices to help reduce the number of adverse effects, which in turn may lead to the removal of the device from the market place or to have the device redesigned to prevent the adverse effect.
Keywords: Medical devices, adverse effects, biomaterials, biocompatibility, toxicity tests, cancer studies, monitoring and reporting, rules regulations, Food and Drug Administration