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Reporting System (reporting + system)
Kinds of Reporting System Selected AbstractsDISTINCTIVE CHARACTERISTICS OF ASSAULTS MOTIVATED BY BIAS,CRIMINOLOGY, Issue 3 2004STEVEN F. MESSNER This research examines the ways in which assaults motivated by bias are similar to and different from other types of assault. Analyses are based on data from the National Incident Based Reporting System (NIBRS), pooled across eleven states. We find evidence suggesting that offenders motivated by racial and ethnic bias are more likely to be versatile offenders than specialists: they are more (not less) likely to be using drugs and alcohol during the crime than conventional offenders. Bias offenders are also more likely to seriously injure the victim. Finally, we find that the risks of bias crime victimization (relative to the risk of assault victimization generally) are similar for blacks and other racial minorities. [source] Intrapartum fever and chorioamnionitis as risks for encephalopathy in term newborns: a case,control studyDEVELOPMENTAL MEDICINE & CHILD NEUROLOGY, Issue 1 2008Heidi K Blume MD MPH In this study we examined the relationship between diagnoses of isolated intrapartum fever or chorioamnionitis and the risk of encephalopathy in term newborns. We conducted a population-based, case,control study in Washington State using 1994 to 2002 linked data from the Washington State Birth Registry and the Comprehensive Hospital Abstract Reporting System (CHARS). We identified 1060 singleton, term newborns (602 males, 458 females) with International Classification of Diseases (ICD-9) diagnoses consistent with encephalopathy, and 5330 unaffected control newborns (2756 males, 2574 females). Intrapartum fever was defined by a diagnosis of intrapartum temperature of >38°C in the birth registry or CHARS databases. Chorioamnionitis was defined using ICD-9 diagnoses recorded in CHARS. We identified 2.2 cases of encephalopathy per 1000 births. Isolated intrapartum fever was associated with a 3.1-fold (95% confidence interval [CI] 2.3-4.2) increased risk of newborn encephalopathy. Chorioamnionitis was associated with a 5.4-fold (95% CI 3.6-7.8) increased risk of encephalopathy. We found that isolated intrapartum fever and chorioamnionitis were independently associated with an increased risk of encephalopathy in term infants. Our data also indicate that there is a spectrum of risk for encephalopathy in term infants exposed to intrapartum fever. Infants born to women with signs of chorioamnionitis other than isolated intrapartum fever may be at higher risk of encephalopathy than those exposed only to isolated intrapartum fever. [source] The use of drug detection dogs in Sydney, AustraliaDRUG AND ALCOHOL REVIEW, Issue 6 2009MATTHEW DUNN Abstract Introduction and Aims. At present there is little research into the use of drug detection dogs. The present study sought to explore the use of detection dogs in Sydney, Australia, utilising multiple data sources. Design and Methods. Data were taken from interviews with 100 regular ecstasy users and 20 key experts as part of the 2006 New South Wales arm of the Ecstasy and Related Drugs Reporting System, and secondary data sources. Results. The majority of regular ecstasy users reported taking some form of precaution if made aware that dogs would be at an event they were attending. A small proportion of the sample reported consuming their drugs when coming into contact with detection dogs. One group of key experts viewed the use of detection dogs as useful; one group disliked the use of detection dogs though cooperated with law enforcement when dogs were used; and one group considered that detection dogs contribute to greater harm. Secondary data sources further suggested that the use of detection dogs do not significantly assist police in identifying and apprehending drug suppliers. Discussion and Conclusions. The present study suggests that regular ecstasy users do not see detection dogs as an obstacle to their drug use. Future research is necessary to explore in greater depth the experiences that drug users have with detection dogs; the effect detection dogs may have on deterring drug consumption; whether encounters with detection dogs contribute to drug-related harm; and the cost,benefit analysis of this law enforcement exercise. [Dunn M, Degenhardt L. The use of drug detection dogs in Sydney, Australia. Drug Alcohol Rev 2009] [source] Trends in morphine prescriptions, illicit morphine use and associated harms among regular injecting drug users in AustraliaDRUG AND ALCOHOL REVIEW, Issue 5 2006LOUISA DEGENHARDT Abstract This paper examines population trends in morphine prescriptions in Australia, and contrasts them with findings from annual surveys with regular injecting drug users (IDU). Data on morphine prescriptions from 1995 to 2003 were obtained from the Drug Monitoring System (DRUMS) run by the Australian Government Department of Health and Ageing. Data collected from regular IDU as part of the Australian Illicit Drug Reporting System (IDRS) were analysed (2001,2004). The rate of morphine prescription per person aged 15,54 years increased by 89% across Australia between 1995 and 2003 (from 46.3 to 85.9 mg per person). Almost half (46%) of IDU surveyed in 2004 reported illicit morphine use, with the highest rates in jurisdictions where heroin was less available. Recent morphine injectors were significantly more likely to be male, unemployed, out of treatment and homeless in comparison to IDU who had not injected morphine. They were also more likely to have injected other pharmaceutical drugs and to report injection related problems. Among those who had injected morphine recently, the most commonly reported injecting harms were morphine dependence (38%), difficulty finding veins into which to inject (36%) and scarring or bruising (27%). Morphine use and injection is a common practice among regular IDU in Australia. In some cases, morphine may be a substitute for illicit heroin; in others, it may be being used to treat heroin dependence where other pharmacotherapies, such as methadone and buprenorphine, are perceived as being unavailable or undesirable by IDU. Morphine injection appears to be associated with polydrug use, and with it, a range of problems related to drug injection. Further research is required to monitor and reduce morphine diversion and related harms by such polydrug injectors. [source] Documenting the heroin shortage in New South WalesDRUG AND ALCOHOL REVIEW, Issue 4 2006CAROLYN DAY Abstract Australian heroin markets have recently undergone dramatic change, sparking debate about the nature of such markets. This study aimed to determine the onset, peak and decline of the heroin shortage in New South Wales (NSW), using the most appropriate available methods to detect market level changes. The parameters of the heroin shortage were determined by reviewing: reports of heroin users about availability and price (derived from the existing literature and the Illicit Drug Reporting System); qualitative interviews with injecting drug users, and health and law enforcement professionals working in the illicit drug field; and examining data on heroin seizures over the past decade. There was a marked reduction in heroin supply in NSW in early 2001. An increase in the price of heroin occurred in 2001, whereas it had decreased steadily since 1996. A reduction in purity also occurred, as reported by drug users and heroin seizures. The peak period of the shortage appears to have been January to April 2001. The market appears to have stabilised since that time, although it has not returned to pre-2001 levels: heroin prices have decreased in NSW for street grams, but not to former levels, and the price of ,caps' (street deals) remain elevated. Heroin purity in NSW has remained low, with perhaps a 10% increase above the lowest recorded levels. These data support the notion that the heroin market in NSW underwent significant changes, which appear to have involved a lasting shift in the nature of the market. [source] Changes in the initiation of heroin use after a reduction in heroin supplyDRUG AND ALCOHOL REVIEW, Issue 4 2006CAROLYN DAY Abstract Increasing heroin use in Australia over the past 30 years has been associated with a decline in the age of initiation to heroin use. The 2001 Australian heroin shortage was used to assess the effects of a reduction in heroin supply on age of initiation into heroin injecting. Data collected from regular injecting drug users (IDU) over the period 1996,2004 as part of the Australian Illicit Drug Reporting System were examined for changes in self-reported age of first heroin use after the onset of the heroin shortage. Estimates were also made of the number of young people who may not have commenced injecting heroin during the heroin shortage. The proportion of IDU interviewed in the IDRS who were aged ,24 years decreased from 46% in 1996 to 12% in 2004, with the most marked drop in 2001, the year in which there was an abrupt and marked reduction in heroin availability. Of those who reported first injecting between 1993 and 2000, similar proportions reported heroin and amphetamine as the first drug injected. After 2000, methamphetamine was the drug most often reported as being the first injected. Estimates suggested that between 2745 and 10 560 young people may not have begun to inject heroin in 2001 as a result of reduced heroin supply. If around one in four of these young users had progressed to regular or dependent heroin use, then there may have been a reduction of between 700 and 2500 dependent heroin users. There was an increase in amphetamine injecting but it is unclear to what extent any reduction in heroin injecting has been offset by increased amphetamine injecting. Reduced heroin availability probably resulted in a reduction in the number of new heroin injectors in Australia. Efforts need to be made to reduce the chances that young people who have initiated methamphetamine injecting do not move to heroin injecting when the heroin supply returns. [source] Impact of the heroin ,drought' on patterns of drug use and drug-related harmsDRUG AND ALCOHOL REVIEW, Issue 2 2004Dr MARIE C. LONGO Senior Research Officer Abstract Since late 2000, anecdotal reports from drug users and health professionals have suggested that there was a reduction in the supply of heroin in Adelaide in the first half of 2001, referred to as a heroin ,drought'. The aim of this paper was to critically review evidence for this, using data obtained from 100 injecting drug users surveyed for the 2001 Illicit Drug Reporting System (IDRS). This project is carried out annually in all Australian jurisdictions, and collects up-to-date information on the markets for heroin, methamphetamine, cocaine and cannabis. This paper also investigates the possible implications of this ,drought' on patterns of drug use and drug-related harms. The 2001 IDRS found consistent reports by users of an increase in the price of heroin, together with decreases in purity and availability. These factors resulted in a decrease in the frequency of self-reported heroin use among those surveyed in 2001, and a concomitant increase in the use of other drugs, in particular methamphetamine and morphine. The heroin ,drought' appears to have had a substantial impact on several indices of drug-related harm. There was a marked decrease in the number of opioid-related fatalities, and hospital data also showed reductions in heroin-related presentations. Treatment service data showed an increase in the number of admissions related to amphetamines. There is a need for health promotion and education on the adverse effects of methamphetamine use, and the development of improved treatment protocols for methamphetamine abuse and dependence. [source] Influence of the Unbelted Rear-seat Passenger on Driver Mortality: "The Backseat Bullet"ACADEMIC EMERGENCY MEDICINE, Issue 2 2005James Mayrose PhD Abstract Objectives: This study examined whether unrestrained left rear-seat passengers increase the risk of death of belted drivers involved in serious crashes with at least one fatality. Methods: The information from every fatal crash in the United States between 1995 and 2001 was analyzed. Variables such as point of impact, restraint use, seat position, vehicle type, occupant age, gender, and injury severity were extracted from the Fatality Analysis Reporting System. Results: The odds of death for a belted driver seated directly in front of an unrestrained passenger in a serious head-on crash was 2.27 times higher (95% confidence interval [CI] = 1.94 to 2.66) than if seated in front of a restrained passenger. In contrast, a belted driver seated in front of an unrestrained passenger in a driver-side lateral-impact crash had no increase in mortality over a driver with a restrained rear-seat passenger (odds ratio, 0.8; 95% CI = 0.6 to 1.06). Logistic regression showed that passenger restraint, point of impact, vehicle type, passenger age, and driver age had a statistically significant influence on the outcome (death) of belted drivers. Adjusting for confounders (other than point of impact), the odds of fatality for a belted driver in a head-on crash was 2.28 times greater (95% CI = 1.93 to 2.7) with an unbelted rear-seat passenger. The unbelted rear-seat passenger also had an increased risk of death (odds ratio, 2.71; 95% CI = 2.44 to 3.01) when compared with restrained rear-seat passengers. Conclusions: Unrestrained rear-seat passengers place themselves and their driver at great risk of fatal injury when involved in a crash. [source] The Quality of Local District Assessments Used in Nebraska's School-Based Teacher-Led Assessment and Reporting System (STARS)EDUCATIONAL MEASUREMENT: ISSUES AND PRACTICE, Issue 2 2005Susan M. Brookhart A sample of 293 local district assessments used in the Nebraska STARS (School-based Teacher-led Assessment and Reporting System), 147 from 2004 district mathematics assessment portfolios and 146 from 2003 reading assessment portfolios, was scored with a rubric evaluating their quality. Scorers were Nebraska educators with background and training in assessment. Raters reached an agreement criterion during a training session; however, analysis of a set of 30 assessments double-scored during the main scoring session indicated that the math ratings remained reliable during scoring, while the reading ratings did not. Therefore, this article presents results for the 147 mathematics assessments only. The quality of local mathematics assessments used in the Nebraska STARS was good overall. The majority were of high quality on characteristics that go to validity (alignment with standards, clarity to students, appropriateness of content). Professional development for Nebraska teachers is recommended on aspects of assessment related to reliability (sufficiency of information and scoring procedures). [source] Introduction to the Special Issue on Nebraska's Alternative Approach to Statewide AssessmentEDUCATIONAL MEASUREMENT: ISSUES AND PRACTICE, Issue 2 2004Deborah L. Bandalos Nebraska's Standards-based, Teacher-led Assessment and Reporting System (STARS) is unique in its focus on locally developed, classroom-based assessments in lieu of a state test. The purpose of this special issue is to introduce the STARS model and discuss the problems inherent in such a system. Other articles in this issue address issues of quality control and comparability of assessments, the development of teacher assessment literacy, and teachers' reactions to the implementation of STARS. [source] History and Background of Nebraska's School-based Teacher-led Assessment and Reporting System (STARS)EDUCATIONAL MEASUREMENT: ISSUES AND PRACTICE, Issue 2 2004Pat Roschewski Nebraska's approach to standards, assessment, and accountability, the School-based Teacher-led Assessment and Reporting System (STARS) is based upon local control and the belief that classrooms and teachers must be at the heart of student learning and accountability. STARS relies on locally-developed assessment systems to accurately measure and report student performance on state content standards. Each local system in Nebraska's 500+ school districts is reviewed for technical quality, and districts are publicly rated for assessment quality and student performance. The purpose of this article is to establish the historical background. [source] State motor vehicle laws and older driversHEALTH ECONOMICS, Issue 4 2005Michael A. Morrisey Abstract After teenage males, elderly individuals have the highest per capita motor vehicle fatality rate in the United States. Surprisingly, there has been only limited work examining the effect of state motor vehicle laws on older driver fatalities. This paper uses state-level data from the 1985,2000 Fatality Analysis Reporting System to examine the effects of changes in state laws dealing with license renewal, seatbelt use, speed limits, and driving while intoxicated on fatalities among drivers and others aged 65 and over. Negative binomial regressions are estimated using alternatively state and year fixed effects, or age and year fixed effects. In-person license renewal reduced fatalities among the oldest drivers, but vision tests, road tests and the length of the license renewal cycle generally did not. In terms of policies that apply to all drivers, seatbelt laws, particularly with primary enforcement, were generally the only policies that reduced older driver fatalities. These results are noteworthy because a number of policies that have been effective towards increasing younger driver safety are not relevant for older drivers, implying that policymakers must think broadly about using state laws to improve older driver safety. Copyright © 2004 John Wiley & Sons, Ltd. [source] Changing Trends in Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome in the Population Aged 50 and OlderJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 9 2007Sindy M. Paul MD OBJECTIVES: To alert persons in the public and private healthcare professions to the increasing trends in higher proportions of persons aged 50 and older who are newly diagnosed with human immunodeficiency virus (HIV) and who are living with HIV and acquired immunodeficiency syndrome (AIDS). DESIGN: Data from the period 1992 through 2004 from the HIV/AIDS Reporting System (HARS) were analyzed. SETTING: New Jersey is the eleventh-most-populous state, with the highest density of persons per square mile. It also has the fifth-highest number of AIDS cases. PARTICIPANTS: All persons residing in New Jersey and reported to HARS with HIV infection or who are considered to have AIDS. MEASUREMENTS: Trends in persons aged 50 and older were compared with those in the population younger than 50 during 1992 through 2004 for the numbers of persons living with HIV/AIDS and the number of persons newly diagnosed with HIV infection. RESULTS: The proportion of all persons aged 50 and older living with HIV/AIDS in 2004 was significantly greater than the comparable proportion of persons in 1992. Proportionally, more persons were newly diagnosed with HIV who were aged 50 and older according to sex and for each of the three major race or ethnicity groups (white non-Hispanic, black non-Hispanic, and Hispanic) than were persons younger than 50. Each of these increases was statistically significant. CONCLUSION: HIV/AIDS social marketing campaigns should include images and issues related to older persons in educational and prevention efforts. New methods that reach older populations should be considered. Physicians and other healthcare providers should be made aware of their role in prevention and education about HIV. Testing of older populations with risk factors should be encouraged. [source] Evaluation of the Utah Student Injury Reporting SystemJOURNAL OF SCHOOL HEALTH, Issue 2 2002Rebecca S. Spicer ABSTRACT: The Utah Student Injury Reporting System (SIRS), implemented in 1984 to monitor injuries to students in grades K-12 in Utah schools, has served as a model for surveillance systems created by other states and some European countries. This paper evaluates the Utah experience in developing and administering the SIRS. The evaluation identifies usefulness of the system, discusses the sensitivity of the system in detecting school injuries, estimates the system's costs, and provides suggestions to other states and districts interested in building a cost-effective and efficient surveillance instrument. (J Sch Health. 2002;72(2):47-50) [source] Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting SystemPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2010John A. Clark MD Abstract Purpose To review topical bovine thrombin spontaneous adverse event (AE) reports that were forwarded to the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) between January 1986 and December 2006. Methods Forty-one spontaneous AE reports were summarized for reported AE profile and chronological reporting patterns. Each AE report was adjudicated by a hematologist for the topical bovine thrombin product that was given and the AE(s) that were reported. AEs were grouped as allergic, coagulopathy/bleeding, and all other AEs combined. Grouped AE serial analyses were carried out using successive 3-year time increments between 1986 (the year an AE report was first noted for a bovine thrombin product) and 2006 (the first full year that was available at the time of initiation of the data summary). Main outcome measures The primary outcome measures were every 3-year trend lines for all-AE reports, all reporters, and topical bovine thrombin brand mentions for 2 AE groups of interest (allergic events and coagulopathy/bleeding events). Results The all-AE spontaneous reporter trend showed a downward appearance for AE reporting activity that started in 1995,1998 and continued through 2004,2006. The all-AE reports trend showed two potential safety signals that could be identified serially: (1) a prominent 1989,1991 peak that was attributable to allergic events (in particular, anaphylaxis), and (2) a small 1995,2000 broad peak that was attributable in part to coagulopathy/bleeding events. Allergic events were predominantly reported with products approved prior to 1995, were not temporally associated with prior medical literature case reports, and continued to be forwarded to the FDA at low levels up to the end of this study in 2006. Coagulopathy/bleeding events were reported only with products approved prior to 1995, were temporally associated with medical literature case reports, and were not forwarded to the FDA after 2000. Conclusions Overall, spontaneous AE reporting for topical bovine thrombin occurs at very low levels, and appears to have been decreasing since 1995. The serial reporting patterns for topical bovine thrombin are best explained as a strong safety signal for allergic events with ongoing, low level reporting, and a weak safety signal for coagulopathy/bleeding events that ceased on or before 2000. Although this descriptive trend analysis cannot measure associations or causation, the coagulopathy/bleeding signal may have been prompted by multiple, antecedent published case reports. The subsequent diminishment of signal attributed to thrombin likewise may coincide with lack of such reporting in larger follow-up clinical trials or, alternatively, in the introduction and growing market share of thrombin brands of greater purity. Currently marketed topical bovine thrombin formulations are rarely volunteered as possible causes of adverse events. Copyright © 2009 John Wiley & Sons, Ltd. [source] Case series of liver failure associated with rosiglitazone and pioglitazone,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 12 2009James S. Floyd MD Abstract Purpose The thiazolidinedione drugs rosiglitazone and pioglitazone are not widely known to be hepatotoxic. We evaluated the FDA Adverse Event Reporting System (AERS) to determine the number of reported cases of liver failure associated with rosiglitazone and pioglitazone between 1997 and 2006, and described their clinical characteristics. Methods Adverse event reports spontaneously submitted to the FDA AERS from 1997 to 2006 were examined. Liver failure associated with rosiglitazone or pioglitazone was defined as liver injury accompanied by hepatic encephalopathy, liver transplantation, placement on a liver transplant list, or death in which all other likely etiologies were excluded. Using prescribing data, the number of reported cases of liver failure per million patient-years of exposure was calculated for each drug. Results Twenty-one cases met our case definition. Clinical characteristics, outcomes, and pathologic data were similar between cases of liver failure associated with rosiglitazone and with pioglitazone. The median duration of therapy was 9 weeks and 85% of cases were acute, defined as symptom onset to liver failure in less than 26 weeks. The case-fatality rate was 81% (17/21), and only 14% (3/21) spontaneously recovered. Accounting for underreporting, the number needed to harm (NNH) for each case of liver failure was 44,000 patient-years of exposure for rosiglitazone and 52,000 patient-years of exposure for pioglitazone. Conclusions This is the largest case series of liver failure associated with rosiglitazone or pioglitazone reported to date, strengthening the evidence that these drugs can cause severe hepatotoxicity. Copyright © 2009 John Wiley & Sons, Ltd. [source] Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2007Onchee Yu MS Abstract Purpose Hepatitis B vaccine has been postulated as a possible cause of autoimmune disorders, including autoimmune thyroid diseases (ATD). Cases of Graves' disease and Hashimoto's thyroiditis, following hepatitis B vaccine have been reported to the Vaccine Adverse Events Reporting System (VAERS). To test the hypothesis that hepatitis B vaccine increases the risk of ATD, we conducted a case-control study, within the Vaccine Safety Datalink project. Methods We identified potential cases of Graves' disease and Hashimoto's thyroiditis, among persons aged 18,69 years from administrative data recorded by three health maintenance organizations (HMOs) and verified cases by medical record review. Controls were frequency-matched to cases by birth year, sex, and study site. Vaccine information was collected from administrative records, chart review, and telephone interviews with study subjects. We enrolled 355 Graves' disease cases, 418 Hashimoto's thyroiditis cases, and 1102 controls. We assessed the association between ever-receipt of hepatitis B vaccine, as well as receipt of hepatitis B vaccine less than 1 year, 1,5 years and at least 5 years prior to the index date, and the risk of ATD. Results Ever-receipt of hepatitis B vaccine was not associated with risk of Graves' disease (odds ratio (OR), 0.90; 95% confidence interval (CI), 0.62,1.32) or Hashimoto's thyroiditis (OR, 1.23; 95%CI, 0.87,1.73). There was also no association between the time interval since receipt of hepatitis B vaccination and either outcome. Conclusions We did not observe an increased risk of Graves' disease or Hashimoto's thyroiditis, following receipt of hepatitis B vaccine. Copyright © 2007 John Wiley & Sons, Ltd. [source] Comparison of military and civilian reporting rates for smallpox vaccine adverse events,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2007A. W. McMahon MD Abstract Introduction US smallpox vaccination (SMA) started most recently in December 2002. Military and civilian personnel report adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS), a surveillance system that relies on spontaneous reports. Although reported rates of probable myo/pericarditis after SMA in the literature are similar between military personnel and civilian healthcare workers, some civilian AE reporting rates after SMA appeared higher than those in the military. Objective Determine if SMA-associated reporting rates are different in civilians than in the military, considering age, sex, seriousness, and expectedness of the AE, as well as self-reporting. Methods Numerators were SMA reports in VAERS from 12/12/02 to 3/1/04. Limitations of VAERS include underreporting and lack of diagnostic confirmation. Denominators were number of military and civilian vaccinees. Results Reporting rates stratified by age and sex of serious and non-serious AEs were significantly higher in civilian than military personnel ages <55 years (rate ratios 4,27). These rate ratios decreased with increasing age. Conclusions Reporting rates in VAERS differed significantly and substantially in civilians compared to military personnel <55 years of age. Differences in stimulated passive surveillance systems, and AE reporting practices, including the ,threshold' for reporting most likely explain these findings. These results suggest that in the case of smallpox vaccine AEs, there may be systematic differences in reporting completeness between the civilian and military sectors, and that passive surveillance data should be interpreted with caution. Copyright © 2006 John Wiley & Sons, Ltd. [source] New guideline for tramadol usage following adverse drug reactions reported to the Iranian pharmacovigilance center,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007K. Gholami Pharm D Abstract Background Tramadol was introduced as injection and oral form to Iranian Pharmaceutical Market in 2002. Shortly after, the injection form of the drug was observed at the top of suspected drug list of Adverse Drug Reactions (ADRs) received monthly by Iranian Pharmacovigilance Center (IPC). Objectives To detect, assess and report total number of Tramadol-induced ADRs received by IPC. To assess the frequency of reported Tramadol-induced ADRs before and after interventions. To design a guideline for prevention of probable ADRs due to Tramadol injection. Methods A descriptive study was conducted on spontaneous reporting received by IPC from April 2002 to February 2005. All ADRs suspected to be induced by Tramadol registered in the database during mentioned period were analysed. To assess the effect of different interventions based on Spontaneous Reporting System, the trend of reporting frequency of Tramadol-induced ADRs was evaluated before and after interventions. Results There were 337 cases of Tramadol-induced ADRs describing 939 reactions, reported to IPC during the study period. Although causal relationship had not been established, three cases of deaths appeared among the reports. The severity of reactions led to implementation of limitations on injectable Tramadol distribution to community pharmacies and the restriction of its use to hospitals only. Since most adverse reactions were dose-dependent, the drug potency of injectable Tramadol available in the country changed from 100,mg to 50,mg. The assessment of ADR reports received by IPC showed that the frequency of adverse reactions registered in the centre was reduced considerably following these interventions. Conclusion Designing a detailed programme by Pharmacovigilance Centres and closely monitoring of newly marketed pharmaceutical products is highly recommended. Copyright © 2006 John Wiley & Sons, Ltd. [source] Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS),,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 12 2004John L. Sever Abstract Purpose To assess the safety of a licensed anthrax vaccine (AVA) given to more than 500,000 US military personnel, through review and medical evaluation of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS). Methods AEs were summarized by person, vaccine lot, type, frequency and impact. A Delphic approach was used to tentatively assess causality in an effort to detect serious AEs (SAEs) or other medically important AEs (OMIAEs) possibly attributable to AVA. Results The Anthrax Vaccine Expert Committee (AVEC) reviewed 1841 reports describing 3991 AEs (9.4 reports/10,000 doses of AVA) that were submitted to VAERS from 1Q1998 through 4Q2001. One hundred forty-seven reports described an SAE or OMIAE, of which 26 were tentatively rated as possible, probable or certain consequences of vaccination (injection-site reaction [12], ,anaphylactic-like reaction' [5] and eight other systemic AEs [1,2 each]). Conclusions This review produced no evidence for an unusual rate of any SAE or OMIAE attributable to AVA. It supported an earlier impression that AVA may cause significant local inflammation and should be administered over the deltoid rather than the triceps to avoid direct or compression injury to the ulnar nerve. The subjects of VAERS reports tended to be older than all recipients of AVA. Females generally had and/or reported AEs more often than males, but transient articular reactions were surprisingly more common in males. Variations in the frequency or severity (as judged by hospitalization and/or loss of duty) of reported AEs did not suggest a significant problem with (1) a particular lot of AVA, (2) recurrent AEs after multiple doses or (3) vaccination of persons with a concomitant illness or those given other vaccines or medications. Copyright © 2004 John Wiley & Sons, Ltd. [source] Safety of anthrax vaccine: a review by the Anthrax Vaccine Expert Committee (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2002John L. Sever Abstract Purpose To assess the safety of a licensed anthrax vaccine given to nearly 400,000 US military personnel, reports of adverse events (AEs) submitted to the Vaccine Adverse Event Reporting System (VAERS) were reviewed and evaluated medically. Methods The Anthrax Vaccine Expert Committee (AVEC), a civilian panel of private-sector physicians and other scientists, reviewed 602 VAERS reports using a Delphic approach (structured expert consensus) to assess the causal relationship between vaccination and the reported AEs and sought to identify unexpected patterns in the occurrence of medically important events. Reports were entered into a database and used to profile AEs with respect to person, type/location, relative frequency, severity/impact, concomitant illness or receipt of other drugs or vaccines, and vaccine lot. Results Nearly half the reports noted a local injection-site AE, with more than one-third of these involving a moderate to large degree of inflammation. Six events qualified as serious AEs (SAEs), and all were judged to be certain consequences of vaccination. Three-quarters of the reports cited a systemic AE (most common: flu-like symptoms, malaise, rash, arthralgia, headache), but only six individual medically important events were judged possibly or probably due to vaccine (aggravation of spondyloarthropathy (2), anaphylactoid reaction, arthritis (2), bronchiolitis obliterans organizing pneumonia) Conclusions Since some cases of local inflammation involved distal paresthesia, AVEC recommends giving subcutaneous injections of AVA over the inferior deltoid instead of the triceps to avoid compression injury to the ulnar nerve. At this time, ongoing evaluation of VAERS reports does not suggest a high frequency or unusual pattern of serious or other medically important AEs. Copyright © 2002 John Wiley & Sons, Ltd. [source] Fatal Passenger Vehicle Crashes With At Least 1 Driver Younger Than 15 Years: A Fatality Analysis Reporting System StudyTHE JOURNAL OF RURAL HEALTH, Issue 2 2007Larry Frisch MD ABSTRACT:,Context: A small number of fatalities continue to occur due to motor vehicle crashes on highways in which at least 1 passenger vehicle (automobile, van, or small truck) is driven by a child younger than 15 years. Purpose: The purpose of this study was to extend previous work suggesting that such crashes occur frequently in the Southern states and have relatively high rates in rural areas in the South and Great Plains. Methods: This study utilizes data for the 5-year period 1999-2003 from the National Highway Transportation Safety Administration's online Fatality Analysis Reporting System. All cases were identified in which at least 1 conventional passenger vehicle in a fatal crash was being driven by a child younger than 15 years. Findings: During the 5-year period, 350 fatal crashes occurred with at least 1 driver younger than 15 years involved. Twenty-one of these drivers were licensed (11) or driving with a learner's permit (10). A total of 987 individuals in 419 vehicles were involved in these crashes, and 402 deaths resulted (1.16 deaths/crash). These crashes occurred primarily in Texas, Florida, Arkansas, and Arizona, but the highest rates per 100,000 children were found in North and South Dakota and predominantly in a band of Intermountain and Plains states. There was a strong correlation between crash rates and several measures of rurality. Conclusions: Crashes involving young, largely unlicensed, drivers account for about 70 deaths yearly. [source] Crime, drugs and distress: patterns of drug use and harm among criminally involved injecting drug users in AustraliaAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 3 2009Stuart A. Kinner Abstract Objective: Explore demographic characteristics, patterns of drug use and psychological distress among regular injecting drug users (IDUs) in Australia, as a function of recent criminal activity. Methods: Structured, face-to-face interviews with 909 regular IDUs recruited from every capital city in Australia, between June and August 2007, as part of the annual Illicit Drug Reporting System (IDRS). Criminal activity in the past month was assessed using the Opiate Treatment Index (OTI); psychological distress was assessed using the Kessler psychological distress scale (K10). Results: Forty-three per cent of IDUs reported recent (past month) criminal activity. Those who had committed crime recently were younger, exhibited riskier patterns of drug use, reported more drug-related problems and were more likely to exhibit significant psychological distress. In a multivariate model the most important correlates of recent criminal activity were use of more than three drug types recently (OR=2.66, 95% CI 1.96-3.61), initiation to injecting before age 18 (OR=1.93, 95% CI 1.42-2.61) and daily drug injection (OR=1.55, 95% CI 1.13-2.13). Conclusions and Implications: Criminal activity among regular IDUs in Australia is not restricted to a particular demographic group, and is a marker for riskier patterns of drug use, greater drug-related harm and psychological distress. Contact between IDUs and the criminal justice system provides opportunities for the delivery of targeted harm reduction messages, and for screening and diversion into appropriate treatment services. [source] The 2005 Wellington influenza outbreak: syndromic surveillance of Wellington Hospital Emergency Department activity may have provided early warningAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 3 2009Melissa McLeod Abstract Objectives: To assess whether the Wellington Emergency Department (ED) Respiratory Syndromic Surveillance System may have provided early warning of the influenza outbreak in Wellington schools during 2005, and as a result might have provided the opportunity for an earlier or more effective public health response. Methods: All events of respiratory syndrome, as defined by selected ICD 10 codes, were extracted from Wellington Hospital ED for the dates 1 January 2004 to 31 December 2006, and analysed using the Centers for Disease Control and Prevention (CDC) surveillance program, Early Aberration Reporting System (EARS). Daily events were analysed for total counts and by lifecycle age group. Seven day moving averages of the numbers of events were also calculated. Results: This study indicated that the surveillance system may have provided early warning of a potential respiratory outbreak. Regular exceedance flags were generated nine days prior to the initial notification received by Regional Public Health (RPH). The surveillance system also provided information on the type of illness (respiratory), the groups affected (5-14 year olds), and the progression of the outbreak (peak, end). Conclusions: The surveillance system might have worked by providing early notification of the outbreak. This may have prompted RPH to earlier investigate the potential outbreak and may have led to an earlier response. Implications: Surveillance of Emergency Department activity may be useful for early public health response. [source] Emergency Department Utilization in the United States and Ontario, CanadaACADEMIC EMERGENCY MEDICINE, Issue 6 2007DrPH, Guohua Li MD Objectives:The current crisis in the emergency care system is characterized by worsening emergency department (ED) overcrowding. Lack of health insurance is widely perceived to be a major contributing factor to ED overcrowding in the United States. This study aimed to compare ED visit rates in the United States and Ontario, Canada, according to demographic and clinical characteristics. Methods:This was a cross sectional study consisting of a nationally representative sample of 40,253 ED visits included in the 2003 National Hospital Ambulatory Medical Care Survey in the United States, and all ED visits recorded during 2003 by the National Ambulatory Care Reporting System in Ontario, Canada. The main outcome was the number of ED visits per 100 population per year. Results:The annual ED visit rate in the United States was 39.9 visits (95% confidence interval = 37.2 to 42.6) per 100 population, virtually identical to the rate in Ontario, Canada (39.7 visits per 100 population). In both the United States and Ontario, Canada, those aged 75 years and older had the highest ED visit rate and women had a slightly higher ED visit rate than men. The most common discharge diagnosis was injury/poisoning, accounting for 25.6% of all ED visits in the United States and 24.7% in Ontario, Canada. Overall, 13.9% of ED patients in the United States were admitted to hospitals, compared with 10.5% in Ontario, Canada. Conclusions:ED visit rates and patterns are similar in the United States and Ontario, Canada. Differences in health insurance coverage may not have a substantial impact on the overall utilization of emergency care. [source] Detecting Adverse Events in Dermatologic SurgeryDERMATOLOGIC SURGERY, Issue 1 2010DANIEL PINNEY BS BACKGROUND Despite increasing awareness of and public attention to patient safety, little is documented about how adverse events (AEs) can or should be monitored in dermatologic surgery. Data to address this shortcoming are needed, although well-defined methodologies have yet to be implemented. OBJECTIVE To summarize current strategies in detecting adverse outcomes of dermatologic surgical procedures. MATERIALS AND METHODS A Medline literature search was conducted using the terms "adverse event,""detection,""reporting,""monitoring," and "surgery." Articles selected addressed the efficacy of one or more AE reporting techniques in surgical patients. RESULTS Prospective and retrospective reporting methods were identified, with morbidity and mortality conference being the most commonly used method of AE reporting. Retrospective medical record review, the retrospective trigger tool approach, and an anonymous electronic reporting system were more sensitive approaches. The Surgical Quality Improvement Program, a program that has successfully translated AE data into lower postoperative morbidity and mortality, was analyzed. CONCLUSIONS Although generally considered safe, dermatologic surgery has no current standard for AE reporting. Standard definitions and high-quality data regarding AEs" currently limit this analysis. Pilot studies are needed to develop feasible measures, with the goal of increasing the sensitivity of AE detection and ultimately improving patient outcomes. The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories. [source] Point process methodology for on-line spatio-temporal disease surveillanceENVIRONMETRICS, Issue 5 2005Peter Diggle Abstract We formulate the problem of on-line spatio-temporal disease surveillance in terms of predicting spatially and temporally localised excursions over a pre-specified threshold value for the spatially and temporally varying intensity of a point process in which each point represents an individual case of the disease in question. Our point process model is a non-stationary log-Gaussian Cox process in which the spatio-temporal intensity, ,(x,t), has a multiplicative decomposition into two deterministic components, one describing purely spatial and the other purely temporal variation in the normal disease incidence pattern, and an unobserved stochastic component representing spatially and temporally localised departures from the normal pattern. We give methods for estimating the parameters of the model, and for making probabilistic predictions of the current intensity. We describe an application to on-line spatio-temporal surveillance of non-specific gastroenteric disease in the county of Hampshire, UK. The results are presented as maps of exceedance probabilities, P{R(x,t)c|data}, where R(x,t) is the current realisation of the unobserved stochastic component of ,(x,t) and c is a pre-specified threshold. These maps are updated automatically in response to each day's incident data using a web-based reporting system. Copyright © 2005 John Wiley & Sons, Ltd. [source] Governmental Accounting in Spain and the European Monetary Union: A Critical PerspectiveFINANCIAL ACCOUNTABILITY & MANAGEMENT, Issue 2 2000Vicente Montesinos During the last twenty-five years, the changes in Spanish accounting have been radical and significant, especially since 1986 when Spain joined the European Union. Those changes were first introduced in business accounting, following the patterns of the Fourth Directive, but governmental accounting has also been affected by structural reforms that have modified the financial reporting system, the accounting standards and the accounting principles to be applied. However, the governmental accounting system needs further improvement, particularly given the EMU framework and the relationship between governmental accounting and national accounting. [source] Pathology reporting in head and neck cancer,Snapshot of current statusHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 2 2009Bronwyn King MBBS Abstract Background Currently there is no standardized head and neck pathology reporting system in Victoria, Australia. The aim of this study was to document deficiencies in head and neck pathology reports at our institution. Methods The pathology reports of all patients with head and neck squamous cell carcinoma (HNSCC) who presented to Peter MacCallum Cancer Centre for postoperative radiotherapy (PORT) between January 1, 2004, and March 31, 2006, were critically assessed for 16 key pathological items. Results Only 37% reports contained all the 16 items. The most commonly missing items were "diameter of the largest involved lymph node" (38%), "presence/absence of lymphovascular space invasion" (30%), "presence/absence of peri-neural invasion" (28%), "clearance of margins in millimeters" (27%), and "presence/absence of extracapsular extension" (27%). The most variable item was the clearance in millimeters used to determine "clear margins". Conclusions Several of the most important pathological factors predicting locoregional relapse in HNSCC are currently the least reliably reported items in head and neck pathology reports. © 2008 Wiley Periodicals, Inc. Head Neck, 2009 [source] Audit Reports on Financial Statements Prepared According to IASB Standards: Empirical Evidence from the European UnionINTERNATIONAL JOURNAL OF AUDITING, Issue 3 2004Maria A. Garcia-Benau This paper examines the audit report of 147 firms from the European Union that prepare their financial statements in compliance with the standards developed by the International Accounting Standards Board. Bearing in mind that the consolidated accounts of listed companies will follow IAS from 2005 onwards, the purpose of this paper is to provide some insight into the current outcome of the statutory audit on this information. Interesting conclusions are drawn from this empirical study with regard to the auditing standards applied, the wording used and the differences observed between reports produced by auditors from the big firms and reports from different European countries. The need to harmonise the auditing field is discussed under the results obtained, with the final aim to contribute to the standard-setting debate on the creation of a high quality financial reporting system in the European Union. [source] | ||||||||||||||||||||||||||||||||||