Comprehensive Analysis On15145Cases Of Adverse Drug Reaction Reports

Objectives:The purpose of this research is to have a comprehensive analysis on the reports of adverse drug reactions from15145cases of some pharmaceutical enterprises in Hunan Province and to probe into the relevance between pharmaceutical products produced by some Hunan pharmaceutical plants and adverse drug reactions. To provide reference for the pharmaceutical enterprise and drug safety supervision and clinical rational drug useMethods:Such research methods as documentation, retrospective and descriptive analysis have been applied to generally analyze the reports of adverse drug reactions from15145cases of some pharmaceutical enterprises in Hunan Province which are provided by the National Monitoring Center for Adverse Drug Reactions in year2011. Specifically, a comprehensive and analytic evaluation has been done on the involved group of people, the principal varieties of drugs, cause and result relation, the drug administration approaches, and the relevance between them and ADR(adverse drug reaction) has also been investigated.Results:Reports of adverse drug reactions from15145cases of some pharmaceutical enterprises in Hunan Province in year2011involve91enterprises,38types of drugs among which there are12495cases of chemical drugs, accounting for82.50%of all the cases, and among which there are2650cases of Chinese Traditional medicine accounting for17.50%of all the cases. Reports of adverse drug reactions from medical institutions, pharmaceutical production and management enterprises and individuals account for85.6%,11.0%and3.4%respectively. The ratio between male and female cases is1:1. The ratio difference of adverse drug reaction based on the comparison between different age groups of both men and women has kind of statistical significance, the number of reported cases of30years old to50year old age group ADR was significantly higher than other age groups (χ2=364.602, P<0.001).ADR most medicines for levofloxacin hydrochloride injection, a total of795cases, accounting for5.82%.The second is Azithromycin injection were682cases, accounting for4.50%.Reports of adverse drug reaction from anti-infectious chemicals top the list and account for56.59%of all the chemical drug cases. The major anti-infectious chemical drugs which cause adverse drug reaction are antibiotics and chemically synthesized anti-bacterial agents. Antibiotic drugs which can cause adverse drug reaction mostly involve macrolides, cephalosporin and penicillin and chemically synthesized anti-bacterial agents are seen more like quinolone and Nitrate imidazole.The occurrence of ADR mainly for administration of intravenous infusion, followed by oral administration.The main system/organ is the digestive system, followed by skin and its accessories, the number of ADR cases were5629cases and5146cases, accounting for the total ADR case number37.17%and33.98%respectively, taken together accounted for71.15%.Among the Chinese traditional medicine oral preparations have the highest rate of causing adverse drug reaction accounting for60.53%in all the cases of ADR resulted from taking Chinese traditional medicine, with cases of ADR resulted from applying Chinese injection medicine accounting for34.04%. The adverse drug reaction from the15145cases is also associated with the administration approaches of medications, with the incidence rates of adverse drug reaction are49.40%and43.48%respectively when drugs are given by intravenous dripping and orally taken.Doctors, pharmacists and nurses are the major groups of people to report about the adverse drug reaction of medications; in the reports of adverse drug reaction, regarding the evaluation of cause and effect relation,"very possible" is marked the most, then is "possible" and the least is "for sure". The results of the15145cases from adverse drug reaction are "cured "and "improved" with a percentage of99.83%; cases with sequelae and mortality account for only0.07%.Conclusions:1. Hunan Province91pharmaceutical enterprises, ranking the top ten pharmaceutical companies reported a total of9957cases of ADR in2011, the total number of reported incidence of65.74%, most of the ADR pharmaceutical companies throughout the year a total of2668ADR cases were reported, accounted for17.62%.2. In2011, Hunan Province pharmaceutical enterprise production of drugs to fight the infection of ADR report in the first place, the highest drug of ADR occurrence was levofloxacin hydrochloride injection, followed by Azithromycin Injection, the highest frequency of ADR were intravenous administration and oral administration. The highest risk of ADR was antibiotics and chemical synthesis of antibacterial drugs, especially the macrolides, penicillins, cephalosporins, quinolones and nitrate of imidazoles.3. The main system/ADR involved organs is the digestive system, followed by skin and its accessories. Hunan pharmaceutical enterprise production of drugs have serious adverse reactions were less, accounted for only0.17%.