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Safety Surveillance (safety + surveillance)

Distribution by Scientific Domains

Medical Sciences	100%

Selected Abstracts

Renal Transplantation in Indo-Asian Patients in the UK

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 4 2006
M. D. Dooldeniya
Membership of some ethnic groups has an effect on renal transplant outcome but little is known about the impact of Indo-Asian ethnicity, despite this group's high incidence of renal disease. We compared outcomes in Indo-Asians and Caucasians at the Hammersmith Hospital (Indo-Asians, N = 46; Caucasians, N = 90), in the Long-Term Efficacy and Safety Surveillance (LOTESS) database of cyclosporin-treated renal transplant recipients (Indo-Asians, N = 254; Caucasians, N = 4262) and the National Transplant Database held by UK Transplant (Indo-Asians, N = 459; Caucasians, N = 4831). The baseline demographic and co-morbid characteristics of the two ethnic groups were comparable, save for more diabetes in the Indo-Asian community. Following transplantation, the incidence of delayed graft function and steroid-resistant acute rejection were also comparable, as were graft and patient survival (out to 5 years) and graft function. In addition, post-transplant blood pressure, levels of cholesterol and triglycerides and exposure to corticosteroids and cyclosporin were comparable. However, when patients who were not diabetic before transplantation were studied separately, there was an increased incidence of diabetes in the Indo-Asian community (Hammersmith data: Indo-Asians 10.9% vs. Caucasians 3.3%, p = 0.02; LOTESS data Indo-Asians 5.5% vs. Caucasians 1.6%, p < 0.0001). Subsequent management of this group should pursue immunosuppressive regimens less likely to impair post-transplant glucose tolerance. [source]

Pharmacovigilance in traditional chinese medicine safety surveillance,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2009
Hainan Wang MD
Abstract Purpose To give an overview of the current status including problems and efforts about pharmacovigilance in Traditional Chinese Medicine (TCM) safety surveillance. Methods It is based on literature review and publicly available data in China. Results TCM led to several adverse drug reactions (ADRs) during the past few years and pharmacovigilance about TCM remained as a problem though great effort had been made to improve it. Conclusions Pharmacovigilance in TCM is still facing many challenges in playing critical roles in China. More attention should be paid to pharmacovigilance in TCM safety surveillance. Copyright © 2009 John Wiley & Sons, Ltd. [source]

The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 9 2006
Willemijn M. Meijer PharmD
Abstract Background European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than 1 million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for pharmacoepidemiology and drug safety surveillance. Methods The 34 full members and 6 associate members of the EUROCAT network were sent a questionnaire about their data sources on drug exposure and on drug coding. Available data on drug exposure during the first trimester available in the central EUROCAT database for the years 1996,2000 was summarised for 15 out of 25 responding full members. Results Of the 40 registries, 29 returned questionnaires (25 full and 4 associate members). Four of these registries do not collect data on maternal drug use. Of the full members, 15 registries use the EUROCAT drug code, 4 use the international ATC drug code, 3 registries use another coding system and 7 use a combination of these coding systems. Obstetric records are the most frequently used sources of drug information for the registries, followed by interviews with the mother. Only one registry uses pharmacy data. Percentages of cases with drug exposure (excluding vitamins/minerals) varied from 4.4% to 26.0% among different registries. The categories of drugs recorded varied widely between registries. Conclusions Practices vary widely between registries regarding recording drug exposure information. EUROCAT has the potential to be an effective collaborative framework to contribute to post-marketing drug surveillance in relation to teratogenic effects, but work is needed to implement ATC drug coding more widely, and to diversify the sources of information used to determine drug exposure in each registry. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Comparing data mining methods on the VAERS database,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 9 2005
David Banks PhD
Abstract Purpose Data mining may enhance traditional surveillance of vaccine adverse events by identifying events that are reported more commonly after administering one vaccine than other vaccines. Data mining methods find signals as the proportion of times a condition or group of conditions is reported soon after the administration of a vaccine; thus it is a relative proportion compared across vaccines, and not an absolute rate for the condition. The Vaccine Adverse Event Reporting System (VAERS) contains approximately 150,000 reports of adverse events that are possibly associated with vaccine administration. Methods We studied four data mining techniques: empirical Bayes geometric mean (EBGM), lower-bound of the EBGM's 90% confidence interval (EB05), proportional reporting ratio (PRR), and screened PRR (SPRR). We applied these to the VAERS database and compared the agreement among methods and other performance properties, particularly focusing on the vaccine,event combinations with the highest numerical scores in the various methods. Results The vaccine,event combinations with the highest numerical scores varied substantially among the methods. Not all combinations representing known associations appeared in the top 100 vaccine,event pairs for all methods. Conclusions The four methods differ in their ranking of vaccine,COSTART pairs. A given method may be superior in certain situations but inferior in others. This paper examines the statistical relationships among the four estimators. Determining which method is best for public health will require additional analysis that focuses on the true alarm and false alarm rates using known vaccine,event associations. Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance. Copyright © 2005 John Wiley & Sons, Ltd. [source]