International Journal of Risk & Safety in Medicine - Volume 16, issue 1
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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: We have previously described the value of patients' reports relating to withdrawal problems and dependence, and violent or suicidal ideation or acts, and their linkage with paroxetine . Here we describe how Yellow Card reporters – health professionals – perceived and reported suspicions of the same kinds of harm. This analysis was made possible only because the organisers of the Yellow Card scheme – the Medicines and Healthcare Products Agency (MHRA) and Committee on Safety of Medicines (CSM) – agreed to release data. National drug regulatory agencies rarely do so, and we believe this to be the first such analysis…of the operation of the scheme. This analysis had two main objectives: to compare the value of professionals' reports with patients' reports of the same suspected adverse drug reactions (ADRs), and to learn more about the effects of paroxetine. Our analysis was limited for many reasons, but sufficient to form a robust preliminary view. In this particular case, the overall quality of professional reporting and interpretation of data seemed poor, providing intelligence that was in some ways inferior to that provided in spontaneous reports from patients. We give new evidence to suggest that miscoding and flawed analyses of Yellow Cards have led to under‐estimation of the risk of suicidal behaviour, and have impeded recognition of what appears to be a close relationship between suicidal behaviour and changes in drug concentration. An increased risk of suicidal behaviour during the first few days of treatment with an SSRI has been suspected for some years: we suggest that comparable risks may also exist outside this ‘window’, when drug dosages are either increased or lowered (during withdrawal). The implications for dosing strategies are discussed. Our analysis relates only to one drug and to two suspected ADRs, but suggests that the Yellow Card scheme is, in important respects, both chaotic and misconceived. Further research is essential.
Abstract: Pharmacovigilance in India began in the mid eighties with an initiative by the drug regulatory authorities (DRAs) to set up centers for safety monitoring in India. Pharmacovigilance in India is hampered by the problems of a large population that is predominantly rural, extensive use of traditional medicines, poor spontaneous reporting, lack of physician and consumer awareness, rapid introduction of several new molecules, and inadequate post marketing surveillance. In recent times, the DRAs have taken significant steps to improve safety monitoring. In 1995, the Government of India created the Department of the Indian Systems of medicine and this department works towards…standardization, enhancement of the availability, and quality of raw materials, research and development, information dissemination, communication and involvement of the practitioners of alternative systems of medicine into national health care. The release of good manufacturing guidelines (GMP) for non‐allopathic systems of medicine is yet another step in this direction. The DRAs are working towards the setting up of several regional centers that would cover the entire country and be linked with the national centre. They are also looking into modifying the existing regulations to improve drug safety and post marketing surveillance. The ADR monitoring centres are working towards improving patient and physician awareness. However, the ultimate responsibility of ADR monitoring rests with the physician whose good reporting practices will go a long way in improving safety monitoring in the country.
Keywords: Pharmacovigilance, Indian health care, post marketing surveillance, drug safety, non‐allopathic medicine, spontaneous reporting, safety regulations
Abstract: Evidence from many sources confirms that selective serotonin reuptake inhibitors (SSRIs) commonly cause or exacerbate a wide range of abnormal mental and behavioral conditions. These adverse drug reactions include the following overlapping clinical phenomena: a stimulant profile that ranges from mild agitation to manic psychoses, agitated depression, obsessive preoccupations that are alien or uncharacteristic of the individual, and akathisia. Each of these reactions can worsen the individual's mental condition and can result in suicidality, violence, and other forms of extreme abnormal behavior. Evidence for these reactions is found in clinical reports, controlled clinical trials, and epidemiological studies in children and…adults. Recognition of these adverse drug reactions and withdrawal from the offending drugs can prevent misdiagnosis and the worsening of potentially severe iatrogenic disorders. These findings also have forensic application in criminal, malpractice, and product liability cases.
Abstract: Objectives: We examined sociodemographic characteristics of single unmarried mothers at delivery in a large maternity hospital in Israel. Methods: The study sample included all unmarried mothers who gave birth between April 1, 1999 and March 31, 2000 at Rabin Medical Center. The mothers were interviewed by social worker using a sociodemographic questionnaire covering: age, ethnic origin, education, occupation, income, and housing and living accommodations, with a focus on the detection of those who required social and economic support. Results: Single unmarried mothers accounted for 1.24% of the total population of new mothers during the study period at our…center. Women were classified into three groups: never married–planned pregnancy; never married–unplanned pregnancy; and divorced/widowed–planned and unplanned pregnancy. Analysis by socioeconomic characteristics revealed that the never‐married women with unplanned pregnancies were younger than the other two groups, originating mainly from the former Soviet Union, had a high school education, did not work, and had a low income (p=0.001, 0.001, 0.001, 0.009, 0.002, 0.05, respectively). All three groups were referred to community social and medical services at discharge for further support. Conclusions: Single unmarried mothers, especially those with unplanned pregnancy, should be considered at high risk because of the known high mortality and morbidity of the offspring in infancy and their high rate of social problems in childhood. Thus should be given early social and psychological support with close follow‐up throughout pregnancy and postpartum.
Keywords: Single, unmarried, social, demographic, infants
Abstract: The turning point in the control of puerperal sepsis in the Maltese Islands occurred in the last decade of the nineteenth century and received a major impetus after 1935 with the introduction of antimicrobials. With the realisation of a medical or paramedical contribution towards the spread of infection, legislative measures were undertaken at the turn of the century to ensure control of this important contributor to maternal mortality. The legislative efforts were rewarded by a significant fall in the puerperal sepsis incidence rate to reach a rate of about 2 per 1000 births within two years. This level was maintained…until the First World War after which a gradual rise in incidence became apparent. This rise continued steadily in the subsequent decade to reach the mean figure of 7.51 per 1000 births in 1937–39, suggesting increasingly poor standards of practice, particularly in domiciliary practice. The Second World War served as a turning point as it was followed by a fall in incidence of puerperal sepsis that can only be attributed to better supervision of peri‐puerperal care. At this period a drop in case fatality rate could also be observed reflecting the introduction of antimicrobial agents such as the sulphonamides (1935) and penicillin (1944). The continued emphasis of tackling this infectious disease on two fronts – namely that of prevention and that of cure – have ensured that puerperal sepsis has become a very rare cause of maternal mortality.