Research On The Evaluation Of Adverse Drug Reaction

Drug is a special and important medical product which plays an immeasurable role in the prevention and treatment of human disease. Constant innovation and development of new drugs has greatly improved the health and even changes the history of human being. Drugs can be considered as a two-edged sword, which has therapeutic effects as well as adverse reactions. Because of the limitation of the R&D levels of new drugs, as well as the special need of drug therapy, adverse drug reactions still heppan inevitably.If an ADR occurs, it can add the suffering to the patients, increases hospitalization, morbidity and mortality, and ultimately becomes a huge financial burden to the society. For this reason, how to monitor adverse drug reactions timely and effectively and provide the sufficient evidence for clinical medication decision is one of urgent problems.ADR monitoring has been started for more than 20 years in China. However, compared to the developed countries, it is relatively delayed and lack of systemic consideration and researches, both theoretically and practicably. The present dissertation was, therefore, designed to study these issuses in China as followings.Firstly, the theoretical researches for ADR were undertaken, including the definition of drugs, adverse drug reaction and monitoring and evaluation of ADR. This dissertation also introduced the causes, type of clinical manifestations and clinical classification of ADR, elaborated the monitoring methods of ADR, the current situation of the ADR monitoring in foreign countries and the principles for the evaluation of ADR.Secondly, the adverse drug reaction evaluation work was investigated in China. Thirty-one questioners were issued to the 31 provincial ADR monitoring centers by E-mail, fax and other means. The contents in this survey were categorized as four parts as follows:The general situation of the ADR monitoring centers, the natural condition of evaluators in ADR monitoring centers, the knowledge and technique of the ADR evaluators and the state of the evaluating work. The results were analyzed with the statistics software of SPSS 11.5. From the result of the survey, it was realized that there were some problems in the ADR evaluation work, such as, the insufficient funds for ADR evaluation, insufficient ADR evaluators, irrational knowledge structure of ADR evaluators, and lack of advanced ADR evaluation methods and so on.Thirdly, the empirical research for global inspection and standardized assessment methods of ADR was undertaken. The sample of ADRs were extracted from the database of Liaoning ADR monitoring center and three experts were chosen to evaluate the probability between the ADR and the drug by the global inspection and standardized assessment methods. The Kappa test was used to test the consistency between the experts. Results showed that the global inspection method, similar to any other clinical diagnosis methods, showed low consistency and reproducibility (Kappa=0.02). The empirical research of Naranjo method showed that the consistent rate between the experts was 59.15%, and the result of Kappa analysis showed the strength grade of consistency is fair(Kappa=0.21). Although the degree of consistency was not highly desirable, compared to the global inspection method, the consistency has been greatly improved.Fourthly, the ADR signal detection methods were researched. The roles of data mining in ADR signal detection and the steps of it were discussed. The ADR signals were detected by using two most often used ADR signal detection methods, namely PRR and ROR. The results of the two methods showed that 32 and 36 signals among 71 samples were detected respectively, with 91.43% consistency rate between them. In addition, the new ADR signals detected have strong practical significance and should be paid attention by related departments.Lastly, the four-grade evaluation model was put forwarded on the basis of comprehensive research on the ADR evaluation work, especially the various evaluation methods and signal detection methods of ADR. Some suggestions were therefore proposed about the components in this model for Chinese ADR monitoring and evaluation:(1)increasing the number of personnel of ADR evaluation, implementing the qualification certification system of the evaluators and strengthening the continuing education of ADR evaluators; (2)establishing and perfecting the standard operating procedures of ADRs, strengthening the propagation, train and education work of ADR, valuing the important role of clinical pharmacists in ADR evaluation,carrying on the discussion and exchange of ADR reports and establishing the quality evaluation criteria of ADR reports; (3)formulating specific implementation rules of ADR monitoring and evaluation and drawing up construction standard of ADR technical monitoring institutions.In conclusion, Indubitablely, ADR is inevitable and drug safety is the most important issue related to human health. Evaluating the causality between the drugs and ADRs timely and accurately, constructing ADR evaluating model applicable to our country can provide technical support for pharmaceutical supervisory and administrative departments to formulate relevant regulations. compared with developed countries, there is still some way to go for the ADR evaluating work in China, such as policy-making, management level and technological capability. Remedying that discrepancy timely will promote the clinical and public medication decisional level...