Comprehensive Analysis Of Adverse Drug Reaction And ADR Signal Detection In A Medical Institution In Wuxi

Objective:It is necessary to investigate the connections between drug and adverse drug reaction and conclude the universality of ADR by comprehensive analysis of ADR reports in a medical institution in Wuxi from the year of 2013-2015. The regression analysis model is used to explore the risk factors of ADR caused by cefodizime.Adopting ADR signal detection is to find out the ADR signals of antibacterial agents effectively.Methods:It is significative to survey gender, age, reported department, reported staff, drug delivery route, dosage form, ADR evaluation, ADR consequence, ADR influence, drug classification, involved classification of organ system and top 10 drugs distribution by retrospective analysis of 845 ADR reports. It is better to investigate the connections between ADR and the above factors. To use the binary logistic regression is to analyze the risk factors for adverse reactions of cefodizime. To detect the signals of top 5antibacterial drugs by adopting MHRA(Medicines and Healthcare Products Regulatory Agency) comprehensive standard measures is to excavate ADR signals.Results:1. After analysis of 845 ADR reports, the following results have been founded.Male/Female ratio: 1.06:1. Ages of 60-69 and 0-7 are high risk population. Top 3 ADR reported departments: pharmacy department, burn and plastic surgery department,pediatrics department. 48.52% of all ADR reports are reported by pharmacist. ADR drug delivery route is mainly intravenous infusion. Most of drug dosage form is injection. In evaluation column of the report of ADR, “possibly” and “likely” are themost, 62.13% and 35.15% respectively. After occurrence of ADR, mostly the patients turned “improved” or “cured” and ADR has no obvious influence on the original diseases. ADR involved drugs mainly are antibacterial agents, Chinese patent medicine,cardiovascular system drugs, vitamins、minerals、trace elements and nutritional drugs,and nervous system drugs, the ratio is 53.86%, 8.76%, 7.48%, 6.43%, 4.09%respectively. Involved organ system mainly are skin and appendages disorders,gastro-intestinal system disorders, body as a whole- general disorders, central &peripheral nervous system disorders, and respiratory system disorders, the ratio is47.78%, 16.65%, 13.30%, 7.35%, 4.22% respectively. Nine of top 10 ADR drugs are antibacterial agents: cefpiramide, levofloxacin, cefodizime, piperacillin, ceftriaxone,mezlocillin, amoxicillin, azithromycin, and ornidazole.2. Patients’ age, history of allergy, and the types of solvent have statistical significance to adverse reaction of cefodizime.3. Eight signals have been tested through ADR signal detection: cefpiramide-rash erythematous, cefpiramide-rash, levofloxacin-nausea, levofloxacin-abdominal pain,cefodizime-anaphylactoid reaction, piperacillin-anaphylactic shock, piperacillin-rash,and ceftriaxone-pruritus.Conclusion:1. It is necessary to monitor children and elderly patient intensively. Intravenous infusion has the highest rate in ADR, and it should be reasonable used. It is important to increase ADR reported rate in each department. To adopt antibiotics classification management system is to avoid abuse of the antibacterial agents and strictly regulate the antibacterial agents which caused ADR mostly.2. Adverse reactions of cefodizime are related to patients’ age, history of allergy,and the types of solvent. The risk of adverse reactions will be greater, if the patients are younger with a previous history of allergy, as well more kinds of solvent are used.3、The ADR signals of antibacterial agents show that there is a certain degree of correlation between the drug and the adverse reactions, and to provide reference for using drug rationally.