Study On Damage Compensation System Of Adverse Drug Reaction

Objectives: Establishing the damage compensation system of the adverse drug reaction (ADR)according to our national condition can guarantee the right of subsistence and health of thepatients and reflect the social equality and justice. At present, our country has not done theresearch in the ADR compensation system. This study defines the ADR compensation, comparesthe domestic and foreign theories and the practice related to the ADR compensation; andsummarizes its characteristic. By qualitatively investigating the status of the ADR compensation inHubei Province, this study has a good knowledge of the different people's opinions on establishingthe ADR compensation system and how to raise the fund, analyzes the existing problems anddiscusses its theoretical foundation and the responsibilities of the different administrativedepartments in our country. Based on the analyses and investigation, the paper gives the modeldesign of ADR compensation in our country and calculates its fund in hope to provide the theorybasis and the policy suggestions for the government.Methods: (1) Literatures. The study refers to the many literatures related to the ADRcompensation. (2) Spot investigation. We collect the related data and statistical forms, design theoutline of the interview, make the individual interviews and the group interviews, design theoutline of the seminar, carry on the groups(made up of 10-12 persons) discussions andsimultaneously fill in the questionnaires, and collect typical cases and the related policydocuments. (3) Qualitative study: We mainly analyze the materials which obtain from theinterviews and the questionnaires. (4) Quantitative analysis: We carry on the statistical analysis tothe collected data and the questionnaires. Take the case analysis based on the data in Hubei andcalculate the fund of the ADR compensation.Results: (1) By analyzing the literatures, we know the main models of the international ADRinclude: Social security pattern; Compensation fund pattern; Liability insurance pattern andadministrative compensation pattern. Although their applicable scope is different respectively,their suitable condition is just the same. Moreover, the ADR compensation must be taken intoeffect after the legislation. If the drugs have the unreasonable danger, the non-mistakeresponsibility principle will be used and the responsibility and the loss will be shared through the fund or the insurance form. The scope of pays compensation is approximately the same, mainlyincluding the death, serious physical disabilities and pays which the human needs to behospitalized or in hospital extension. The amount of the compensation reaches the upper limit,which does not include the mental damage compensation. (2) We define the ADR and the ADRcompensation in the theory research. The paper goes into detail about the ADR theory basis andthe responsibility constitution of other countries and provides the theory basis in order to make itclear why the victims should get the compensation and who should undertake the responsibility. (3)According to the analysis of the data statistical and the investigation, most reports come from themedical institutions while the reports from the production and operation enterprises are extremelyfew, only making up 1%. The speakers are mostly doctors. The serious ADR is about 2% andoccur at different ages. 50 -year-old middle-aged persons and old persons suffer from the ADReasily. In those reports, the ADR caused by using the one drug is about 90%; the ADR caused bythe anti-infection medicine ranks first due to using it wide in clinical medicine and applyingunreasonably. The intravenous injection easily causes the ADR. Through individual interview andthe seminar, the paper also discusses the establishment of the ADR compensation system and howto raise fund. By analyzing the compensation management, the compensation standards, thecompensation ways, the compensation ranges, the institutions appraising the ADR and identifiedprocedures, the paper proposes the ADR compensation system for our country. (4) The paperdiscusses the ADR fund and management. By comparing the international ways and channels ofraising fund, the paper gives the pattern which is suitable for our country, that is fund pattern, andcarries on the simulation calculation, simultaneously analyzes the ADR compensation fundmanagement and its supervising mechanism. In the above analysis foundation, we put forward thecorresponding policy proposals.Conclusions: 1. Consummate related law and legally establish the ADR compensation system. 2.Consummate related policy and take the system into effect successfully. 3. Design the reasonableand scientific compensation system, define the scopes of the compensation clearly, and formulatestrictly the procedures which can be used to judge the ADR compensation. 4. Make use of thefunds from various channels and establish effective management systems and operation mechanisms. 5. Establish the related policies which encourage the society to donate the fund. 6.Use the experience of other countries for reference and carry out the drugs liability insurancegradually. 7. Give wide publicity and change ideas.Creations and limits: In the paper, we give the modal design of the ADR compensation, putforward its calculating method and formulas and calculate the compensation fund based on thetheoretical analysis and spot investigation.Shortcomings of the study: Since the study has only carried on the investigation in Hubei Province,the statistical data analysis and the rate of the ADR don't have the representation. The paper is forthe purpose of offering a few ordinary remarks so that others may come up with their valuableideas. The system frame proposed in the paper needs to be improved and consummated accordingto the objective reality.