International Journal of Risk & Safety in Medicine - Volume 19, 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: Background: A short course of antitubercular drugs in 1960s offered the prospect of eradicating this disease. By late 1980s HIV pandemic lead to a rapid upsurge of tuberculosis (TB) and shattered this hope. In the 1990s, multidrug-resistant (MDR) tuberculosis received widespread attention and in this present decade, we are heading towards an emergence of extensively drug-resistant (XDR) TB and adding a new chapter to the history of this disease. Methods: The emergence of XDR-TB, spread and the reasons for its emergence was studied from the available and published literature from January 1996 till December 2006. Search strategy involved primary,…secondary literatures with search term: XDR-TB, spread of XDR-TB. Official websites of WHO and Global TB Alliance were also accessed for latest updates. Data extraction was independently done by the authors. Available relevant information was pooled and arranged with respect to XDR-TB emergence, reasons, clinical studies and preventive measures. Current status on anti-TB drug research was also looked into. Results: A total of 14 articles were obtained. However, these were clinical studies from single or multicenters highlighting the incidence of XDR-TB. Information on reasons for drug resistance, preventive measures, status in developing countries were obtained from WHO website. Global TB Alliance mentioned only 3 compounds under clinical testing against TB. Major causes for XDR-TB emergence included an incorrect prescription of drug regimens, poor drug quality, erratic drug supply, non-adherence by patients and poor infection control. Conclusion: XDR-TB has emerged due to negligent case-management and poorly functioning public-health services. An acquisition and transmission of drug-resistant strains add to their incidence. However till date the overall incidence is arguably infrequent. The real problem from a public-health perspective therefore is to prevent transmission of resistant strains. The need of the hour is to gear up a sound public-health practice. Major attention to issues like research in developing safe and effective newer anti-TB compounds, which should be made available at an economical rate, is what we recommend.
Abstract: Background: Following the Institute of Medicine report on medication errors, pharmacovigilance activity is focusing more on patient safety. The aim of this study is to assess the ability to collect and identify Medication Errors “ME” from Adverse Drug Events “ADRs” reported to Pharmacovigilance Centre of Morocco. Methods: It is a retrospective analysis of ADEs reported to Pharmacovigilance Centre of Morocco from 2003 to 2006. Results: 1300 cases of ADEs were reported to the Moroccan Pharmacovigilance Centre of which 14.4% (n=187) were considered as preventable. ME associated with preventable ADEs “pADEs” and related to the medication use system, occurred…most often at the stage of prescribing (36.3%), and administration (34.8%). Regarding the type of ME, most of them were related to dose errors (49.3%) following by therapeutic and clinic monitoring errors (15.9%). Among the pADEs, 41.7% were serious and the outcome was favourable in 93%. Conclusion: Mutual cooperation between various source organizations is key for detecting ME and building an extensive database. The database will helps identify situations that are most prone to errors, and hence define preventive strategies. Thus, the quality of health care delivery is more likely to improve, thereby ensuring patient safety.
Abstract: Objective: The study was conducted to estimate and to analyze the medications errors because of look-alike & sound-alike brand names confusion and prepare the list of such brand names and further to suggest methods to reduce errors arising out of such confusion. Materials and methods: The study was conducted in a general hospital in Delhi over a period of six months. The possibilities of errors because of brand name confusion was high when the staff nurses were sending drug orders to the pharmacy because these drug orders were send electronically. In the used software the brand names of drugs…were displayed alphabetically and the nurse had to select the drug by clicking on it. After making the list of prescribed drugs, it is sent to the pharmacy for dispensing. The errors in the drug ordering method were assessed for six months and a list of commonly involved brand names was made which was further classified into different categories (Category 1 – Look alike drugs with same generic name, Category 2 – Look alike drugs with different generic name, Category 3 – Sound alike drugs with same generic name, Category 4 – Sound alike drugs with different generic name, Category 5 – Identical brand names with same generic name) and analyzed for seriousness on the basis of there potential to cause patient harm. Results: The occurrence of these 5 different categories in percentages was: Category 1 – 4.51%, Category 2 – 4.92%, Category 3 – 0%, Category 4 – 6.56% and Category 5 – 84.01%. Category 5 errors were most commonly seen. Further, the monthly trend for category 5 errors showed a decreasing number of errors and improvement in quality of drug order entry. Conclusion: Most commonly brand name confusion is seen with almost identical brand names for combination drugs. Such type of errors could be dangerous (e.g., in antihypertensive or hypoglycemic drug combinations). They also increase the cost of therapy and unnecessary exposure of the patient to more drugs and there side effects. Brand name confusion could be prevented by strict adherence to the hospital drug formulary. It would be a good practice to write the generic name of the prescribed drug in brackets along with the brand name. This matter requires some serious legal steps to stop the marketing of those brand names with intentional look alike and sound alike names.
Abstract: Pregnant women should avoid taking SSRI antidepressants – they are hazardous to the developing fetus, cause withdrawal symptoms in the newborn baby, and induce biochemical and morphological abnormalities in the brain. If pregnant mothers need help with sad or anxious feelings, they should seek counseling or psychotherapy, especially family therapy involving the child's father, as well as other sources of emotional support.
Abstract: In the past decade bipolar disorder in children has been diagnosed with rapidly increasing frequency in North America, despite a century of psychiatric consensus that manic-depressive illness rarely had its onset before adolescence. This emergence has happened against a background of vigorous pharmaceutical company marketing of bipolar disorder in adults. In the absence of a license demonstrating efficacy for their compound for bipolar disorder in children, however, companies cannot actively market pediatric bipolar disorder. This paper explores some mechanisms that play a part in spreading the recognition of a disorder in populations for which pharmaceutical companies do not have a…license. These include the role of academic experts, parent pressure groups, measurement technologies and the availability of possible remedies even if not licensed.
Abstract: ADRs usually do not present with unique clinical and laboratory findings making it difficult to demarcate them from the concurrent illness. For the estimation of the probability that a drug caused an adverse event several methods have been developed namely, the WHO-UMC criteria, the Naranjo probability scale, the Kramer scale and the Karch and Lasagna scale. But none of the available assessment methods have been shown to produce a precise and reliable quantitative estimation of relationship likelihood. The present study was planned to compare the WHO-UMC causality assessment criteria and the Naranjo probability scale for determining causal relationship between…the drug and the event. Randomly 100 Adverse Drug Event (ADE) reports were selected and assessed first by the WHO-UMC criteria and second, by using the Naranjo probability scale. Time needed for evaluation by these methods was also recorded. A disagreement in causality assessment was found in 31% cases (κ=0.214). Mean time taken while using WHO-UMC criteria was 5.3±0.37 minutes vs. 13.26±1.33 minutes while using the Naranjo probability scale. In conclusion disagreement exists amongst the WHO-UMC criteria and the Naranjo probability scale but the former method is simple and less time consuming.
Abstract: In spite of several advances made in the last two decades in obstetric management, diabetes complicating pregnancy remains a high risk obstetric situation irrespective of whether the medical condition is pre-existing (pre-DM) or develops during pregnancy (GDM). The study reviews the outcome parameters of pre-DM (maternities = 98; infants born = 106) and GDM (mat. = 480; infants = 498) and compares these to those presumed to have normal metabolic profiles (mat. = 23668; infants = 23993) who delivered in the Maltese Islands during the six-year period 1999–2004. The study confirms that pre-DM carries definite obstetric morbidity risks for the…mother and child – the mother showing significantly higher incidences of hypertensive disease and need for Caesarean delivery; while the infant shows a significantly higher morbidity arising from prematurity and attendant complications of low Apgar scores and respiratory distress. There was also a significant risk of macrosomia in these infants; congential malformations were only slightly increased though the difference did not show statistical significance. GDM similarly showed significant obstetric maternal morbidity risks with a significantly higher incidence of hypertensive disease, induction of labour and Caesarean deliveries. The infant similarly had significantly higher risks from prematurity, respiratory distress and macrosomia. The study confirms that in spite of the increased obstetric and metabolic intervention, the diabetic mother and her child remain at significant obstetric morbidity risks. St. Vincent's Declaration goal for diabetic pregnancies has yet to be achieved and may have been overambitious.