International Journal of Risk & Safety in Medicine - Volume 21, issue 3
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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: Background: Because type II diabetes is currently more prevalent in schizophrenics than non-schizophrenics, some investigators have postulated a more fundamental association between these two disorders. However, there is a paucity of evidence concerning the association between diabetes and schizophrenia that is not confounded by the use of antipsychotic drugs, many of which have been linked to diabetes or pre-diabetes. Clinical literature from the pre-antipsychotic era (PAPE) may provide insights that help better define the risks currently associated with antipsychotic drugs. Aims and methods: After reviewing approximately 140 articles that addressed metabolic derangements in serious mental illness, we analyzed 20…English language clinical studies from the PAPE (all pre-1950 to assure that none of the patients had been exposed to neuroleptics) that specifically commented on glucose regulation in patients with schizophrenia and severe depression. From these, data from 5 studies that used uniform methodology and presented blood glucose (BG) data en toto were selected for quantitative evaluation. Fasting blood glucose (FBG) values and results from oral glucose tolerance tests (OGTTs), corrected by a factor of 20 mg% for the presence of non-glucose reducing substances, were pooled from patients with schizophrenia, schizophrenia sub-classified as catatonic, patients with psychotic depression and age-matched controls. BG data were evaluated with reference to current diagnostic standards for diabetes mellitus (DM), impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) from the American Diabetes Association. Results: The mean FBG from the schizophrenic group (n=148; 88.1±17.8 mg% (range 50–140 mg%)) was not materially different from the mean FBG of contemporaneous age-matched healthy controls (n=27; 82.3±10.4 mg% (range 58–105 mg%); p>0.05). Descriptions of patients by the original authors did not indicate clinical signs of DM. However, these acutely ill schizophrenics were nearly 4 times as likely as controls (relative risk 3.74) to manifest a moderate elevation in FBG not inconsistent with IFG according to current diagnostic standards (i.e., FBG 100–125 mg%), and were also approximately 3 times as likely as controls (relative risk 2.9) to have fasting hypoglycemia (i.e., FBG<65 mg%). With the notable exception of a subgroup with active catatonia, OGTT results from schizophrenics provided equivocal evidence of IGT. Evidence is presented which suggests that, in the setting of acute or sub-acute serious mental illness, hyperglycemia was often transitory, tending to resolve spontaneously or in apparent response to non-pharmacologic psychotherapy. Summary and conclusions: Insights from studies performed in the PAPE cast doubt on the clinical relevance and putative specificity of association between diabetes or pre-diabetes and schizophrenia. Moderate fasting hyperglycemia, moderate fasting hypoglycemia and equivocally abnormal OGTTs were present in substantial minorities of schizophrenics early in the course of hospitalization, but these findings were nonspecific and appear to have been transitory in many instances. We conclude that it is inappropriate to refer to available BG data from the PAPE as supporting the hypothesis that a diagnosis of schizophrenia per se is an independent risk factor for diabetes. Additional research is needed to better define environmental and iatrogenic factors that may explain the higher rates of true diabetes and related morbidity that have been reported recently in schizophrenic cohorts, and in particular the attributable risk of antipsychotic drugs.
Abstract: African women delivering in the Maltese Islands are either regular or irregular migrants. The latter group presents significant socio-economic problems. Objective: This study sets out to compare the obstetric outcomes of African-nationals delivering in Malta to the general population. Study design: The obstetric data of three subgroups of women – those from the Maghreb region; the sub-Saharan and Horn of Africa; and the overall population registered for the Maltese Islands were obtained using the computerised National Obstetrics Information System. Results: Women from the sub-Saharan regions were statistically younger than those from the Maghreb region or the general…population. African women from both regions were more likely to be multiparous; and were more likely to have experienced a previous perinatal loss. The multiple pregnancy rates were significantly higher in both African groups. Women from the sub-Saharan region were more likely to suffer from sexual and blood-borne infections. African women had lower obstetric intervention rates but higher operative deliveries. Infants born to African women were more likely to be premature and of low birth weight. Conclusion: Women originating from the African continent particularly from the sub-Saharan regions present socio-biological and cultural differences which can contribute towards adverse obstetric and perinatal outcomes.
Abstract: Objective: To assess the incidence and risk factors for liver toxicity in patients on anti-tuberculosis treatment. Method: All patients with a diagnosis of tuberculosis, who were to receive ATT during the study period, were included in the present study for prospective periodic laboratory monitoring for the development of hepatotoxicity. Results: Of the 352 patients studied, 61 patients (17%) had elevated hepatic transaminases value after starting antituberculous therapy (ATT), 36 grade 1 (10%), 7 grade 2 (2%), 12 grade 3 (3.4%), and 6 patients grade 4 (1.7%). The incidence of severe hepatotoxicity (grades 3, 4) among treated patients was…5.1% (18 patients). The mean duration of treatment before onset of hepatotoxicity was 36 days. Although the majority of patients developed hepatic dysfunction within the first 2 months of treatment, significant hepatotoxicity (grades 3, 4) did occur at a later date in some patients (28%). Univariate analysis did not show any significant relationship between age, sex, and ethnic origin with hepatotoxicity in this study. The only significant risk factor was coexisting hepatitis B or C. None of our patients died from complications of liver-related illness attributed to anti-TB drugs.
Keywords: Tuberculosis, Saudi Arabia, hepatitis, toxicity
Abstract: Objective: In a previous paper, we described the major health tragedy that occurred in Japan involving the use of gefitinib, and recommended steps to prevent such problems occurring again. In that paper, we argued that erlotinib should only be approved on the condition that all users are subject to surveillance. Erlotinib was subsequently approved for use in Japan on October 19, 2007. In the present paper, we examine whether our recommendations have been implemented in the safety measures established for erlotinib use. Methods: We comprehensively reviewed reports regarding erlotinib treatment published between 2007 and 2009 by regulatory agencies and…the manufacturer of the erlotinib-containing drug. We evaluated the safety measures established for erlotinib in view of three problems we identified with the treatment of gefitinib marketing: (1) the results of animal experiments and pre-marketing clinical trials, and reports of adverse drug reactions from other countries were not properly incorporated into the product information; (2) indications for the drug were expanded without strict evaluation of the external validity of pre-marketing clinical trials; and (3) despite many serious cases of interstitial lung disease being spontaneously reported, well-designed post-marketing surveillance was not conducted immediately after these problems became evident. Results: We found that appropriate measures were taken for erlotinib in relation to each of the three above-mentioned problems. We found that there were fewer fatal adverse reactions to erlotinib after marketing relative to the pre-marketing period. Conclusions: Our recommendations following the health tragedy caused by gefitinib were implemented in the safety measures for erlotinib, which probably explains the smaller number of fatal adverse reactions to erlotinib in post-marketing surveillance than in pre-marketing trials.