International Journal of Risk & Safety in Medicine - Volume 18, issue 4
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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: With emerging globalisation and increase in use of the Attention Deficit Hyperactivity Disorder (ADHD) diagnosis resulting in reliance upon psychotropic drugs, particularly amphetamine for the behaviour modification, consideration of the rights and interests of the child must be paramount. This article documents the emerging globalisation of the ADHD diagnosis and problems associated with the ADHD diagnosis. The claims and counter-claims in relation to efficacy and safety of treatment are delineated. Discussion of medical and sociological issues suggest that it is time for the ADHD phenomenon to be brought under the scrutiny of an independent international inquiry to establish the real…nature of risks and threats associated with the diagnosis and treatment by drugs to modify the behaviour of children. The conclusions also suggest that research needs to be supported for the further development of non-drug based interventions for children in need and also to investigate the long-term risks associated with drug treatments of children labelled as ADHD.
Abstract: In the light of increased incidences of cardiovascular diseases world wide, there is also an increase in number of percutaneous interventions (PCI) and many new devices are introduced that may be expensive. Distal Protection Device (DPD) is one of them with costs that are twice those of conventional devices. In the present study we evaluated the usefulness of DPD after acute coronary syndrome (ACS) in patients undergoing PTCA and to analyze the effect on major adverse cardiac events (MACE) at the end of three months and consider its requirement as compared to the conventional stents. 109 patients with ACS were…divided into two groups: PTCA done using DPD and PTCA done without DPD. Patients having active significant bleeding, major surgery within the previous six weeks or those who were participating in other trials using investigational drugs or devices were excluded. All patients without DPD required the administration of intracoronary (IC) adenosine and sodium nitroprusside to avoid no-reflow but in patients with DPD only 7.7% patients required IC vasodilators. In patients with DPD only 29% patients required the additional use of glycoprotein IIb/IIIa (Gp IIb/IIIa) receptor antagonists as compared to 100% usage in patients without DPD. On studying the MACE data it was found that amongst the patients with DPD no patient had either dysnea or needed repeat revascularization or urgent Coronary Artery Bypass Grafting (CABG). Amongst the patients without DPD four patients had angina and one had dysnea. In conclusion, although one can suggest that the use of DPD is safe and, it cannot be used indiscriminately because it is an expensive modality.
Abstract: Purpose: The aim of the study was to examine the feasibility of applying the Edinburgh Postnatal Depression Scale (EPDS) in hospital, soon after delivery, to identify women at risk of postpartum depression. Methods: The study sample included 278 healthy, married women after an uncomplicated pregnancy: 121 primiparas, 109 multiparas, and 48 mothers of slightly preterm (34–36 weeks) infants. Participants were asked to complete the self-report EPDS and an ad hoc sociodemographic scale in hospital, on day 2 after vaginal delivery or on day 4 after caesarean section. Infant-related data were taken from the medical files. Results: There were…significant differences among the groups in all the background variables except education and ethnic origin. No significant difference was observed in the birth-related variables (gestational age, birth weight, infant sex) except type of delivery. Mean scores on the EPDS were similar in the three groups. Scores above the mean ±2SD were documented in 4% of the primiparas, 3% of the multiparas, and 11% of the mothers of slightly preterm infants. These differences were not significant. Variables found to be associated with less or no depression were longer duration of marriage, vaginal delivery, full-term gestation, male infant, and rooming-in. Conclusions: Women with an EPDS score above the mean ±2SD might be at risk for depression and should be carefully followed.
Keywords: Postpartum depression, early screening, Edinburgh Postnatal Depression Scale (EPDS)
Abstract: Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care…and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics.