International Journal of Risk & Safety in Medicine - Volume 23, 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: Understanding the hazards associated with long-term exposure to psychiatric drugs is very important but rarely emphasized in the scientific literature and clinical practice. Drawing on the scientific literature and clinical experience, the author describes the syndrome of Chronic Brain Impairment (CBI) which can be caused by any trauma to the brain including Traumatic Brain Injury (TBI), electroconvulsive therapy (ECT), and long-term exposure to psychiatric medications. Knowledge of the syndrome should enable clinicians to more easily identify long-term adverse effects caused by psychiatric drugs while enabling researchers to approach the problem with a more comprehensive understanding of the common elements of…brain injury as they are manifested after long-term exposure to psychiatric medications. Treatment options are also discussed.
Abstract: Objective: To examine the epidemiological association between sudden deterioration leading to death and Tamiflu use. Design: Proportional mortality study. Setting: Japan. Participants: 162 deaths without deterioration before the first consultation among all 198 deaths of mostly confirmed 2009A/H1N1 influenza. Population at risk: Age-specific population of influenza patients prescribed Tamiflu and Relenza. Main outcome measure: Age-stratified pooled odds ratio (OR) for early (within 12 hours) deterioration and overall death of Tamiflu prescribed to Relenza prescribed patients. Results: Of 119 deaths after Tamiflu was prescribed, 38 deteriorated within 12 hours (28 within 6 hours), while of 15 deaths after Relenza, none deteriorated…within 12 hours. Pooled OR for early deterioration and overall death were 5.88 (95% CI: 1.30 to 26.6, p = 0.014) and 1.91 (p = 0.031) respectively. Baseline characteristics including risk factors did not contribute to early deterioration after Tamiflu use. Conclusions: These data suggest Tamiflu use could induce sudden deterioration leading to death especially within 12 hours of prescription. These findings are consistent with sudden deaths observed in a series of animal toxicity studies, several reported case series and the results of prospective cohort studies. From “the precautionary principle” the potential harm of Tamiflu should be taken into account and further detailed studies should be conducted.
Abstract: Appropriate practice of pharmacovigilance in Nigeria will require total involvement of the private medical practitioners considering their number and closeness to the community. Thus, the understanding and attitude of Doctors practicing in the private sectors, towards Pharmacovigilance, was investigated. A consecutive sampling was used to distribute two hundred and seventy questionnaires to consenting doctors in the private hospitals of the Lagos West Senatorial District. The response rate was 93% and the results showed that majority of the respondents, 208 (82.9%), have heard about pharmacovigilance and a large percentage (79.3%) defined pharmacovigilance correctly. However, most of the respondents, 141 (56.2%), did…not know how to report ADRs and where to obtain the ADR forms (71.7%). Only 14 (5.6%) of the respondents reported ADRs in the last one month. However, the majority of the respondents (89.6%) were willing to practice pharmacovigilance if they are trained. There were significant associations (p < 0.05) between previous areas of practice of the respondents; the respondents' academic qualifications; years of experience and reporting of ADRs. The NPC has already been organizing series' of trainings for doctors on pharmacovigilance, however, more periodic trainings should be organized for doctors especially those practicing in private hospitals. The curriculum of medical schools should be reviewed for its pharmacovigilance content.
Abstract: Aim: This study was aimed at investigating the knowledge, attitude and practices associated with adverse drug reaction (ADR) reporting among doctors in a teaching hospital. Methods: A total of 100 doctors working in a teaching hospital were evaluated with a questionnaire for their knowledge, attitude and practices related to ADR reporting and pharmacovigilance programmes. Results: Nearly two third (66%) of the doctors knew the definition of ADR. Only one third (38%, 40%) could correctly define pharmacovigilance and adverse drug event (ADE) respectively. Although 100% of the doctors felt the need for a National Pharmacovigilance Programme (NPP) only approximately three fourth…(73%) were aware of the existing programme in India and nearly half of the them (47%) actually knew the current status of the NPP at their institute. Surprisingly only one tenth of the doctors (10%) knew what should be reported. The majority (74.4%) felt that reactions to new drug should be reported and also those reactions that are serious and unusual. Only one third (30%) knew whom to report to and less than half (30%) had actually ever reported an ADR. Conclusion: The knowledge of ADRs and how to report them is inadequate among doctors. More awareness should be created regarding the purpose and usefulness of ADR reporting through Continuous Medical Education, training and integration of ADR reporting into the clinical activities of the doctors.
Abstract: Drug companies aggressively market their products to increase sales and economic rewards. Different countries have different regulatory regimes for controlling promotion. In the United States control rests directly with the Food and Drug Administration whereas Canada relies on a mixture of voluntary self-regulation and an autonomous agency. Each method has significant weaknesses. We examine these weaknesses by analyzing the promotion of OxyContin (the time release version of the opioid oxycodone) by Purdue in Canada and the United States. We then look at the association between promotion and the misuse and abuse of OxyContin in both countries. Finally, we advance specific…recommendations for regulating promotion for drugs that may have a high abuse potential.
Keywords: Canada, United States, OxyContin, promotion, pharmaceutical industry, drug regulation
Abstract: Objective: This study is aimed to assess the influence of body shape on Body Mass Index (BMI) estimations by determining the Sitting Height to Standing height ratio. Methods: The study population included 291 non-pregnant premenopausal Maltese women aged 20–54 years. These women were assessed using the following anthropometric measurements: Body weight (Kg), standing height (cm) and sitting height (cm). The Sitting-to-Standing Height (SH/S) ratio, the observed BMI (oBMI) based on the standing height, and the SH/S ratio-corrected BMI (cBMI) were calculated. The SPSS package version 18.0 was used for statistical calculations. Results: The average SH/S ratio of the Maltese premenopausal…women is 0.44. The mean oBMI is 25.06, while the mean cBMI is 34.49 (P value < 0.001). Applying the linear regression prediction model with either oBMI or cBMI as dependent variables and the SH/S ratio as independent variable proved that the sitting height is a significant predictor of both oBMI and cBMI (P value < 0.00001). Conclusions: The results suggest that the cohort of this study tend to have long legs relative to torso-length (low SH/S ratio). Thus, the oBMI will underestimate the actual BMI value. The correction of BMI for the sitting height in Maltese population will more correctly identify individuals at greater risk for chronic diseases.
Abstract: Background: Vaccination of health-care workers (HCWs) against seasonal influenza has been consistently recommended worldwide in order to prevent nosocomial transmission and ensure delivery of health-care services during outbreaks. Overall, immunization rates were low across all nation, including among HCWs. Little is known about the acceptability and compliance with seasonal influenza vaccine among HCWs after the A(H1N1) 2009 pandemic. Participants and setting: Between 1st and 31 January 2011, we conducted a questionnaire-based survey at the Ibn Sina regional center (Rabat, Morocco). Seven hundred twenty one HCWs have answered about their influenza immunization during the 2010/2011 season, as well as the reasons…for accepting or declining this vaccine. Finally, we compare our results with previous moroccan survey. Results: A total of 122 HCWs (17%) reported having received the 2010/2011 seasonal vaccine; “self-protection” and “protection of the patient” were the most frequently adduced reasons for acceptance of the influenza vaccination, whereas media controversy during the pandemic was the main argument for refusal. Discussion: The post pandemic seasonal influenza vaccination coverage among the HCWs in our institution was very low. The role of media, specific attitudinal barriers and misconceptions about immunization in a global pandemic scenario is clear. The nearly constant media coverage of the A (H1N1) 2009 pandemic, reported with varying degrees of accuracy, and sometimes portraying dramatic scenarios caused some to question whether unnecessary alarm and public panic resulted. We suggest that international or national health authorities have a clear speech over looked media and to own these institutions, which will air fair and real time information about the disease.
Keywords: A(H1N1) pandemic, attitudes, health care workers, vaccination