Adverse Drug Reactions Individual Reporting System Structure And The Related Mechanism Research

Objective: Rules and regulations in our country people discover new or serious adverse drug reactions, can report to the attending doctor, can also be to the drug manufacturer and distributor or local adverse drug reaction monitoring agencies report. But in the absence of relevant laws and regulations define individual reports of adverse drug reactions contents, standards and specifications, individual report adverse drug reactions cannot get the attention they deserve. We hope that through this study to increase the government’s emphasis on the work, to urge their perfect relevant mechanism as soon as possible and the corresponding measures to encourage individuals involved in the adverse drug reactions report,and build the atmosphere actively involved in adverse drug reaction monitoring for the whole society. Adverse drug reaction monitoring is not only the responsibility of the drug manufacturer and distributor and medical organizations, more in need of the public’s supervision and actively participated in. This study included in Guangdong adverse drug reaction basic concept of the public cognition and public awareness of the adverse drug reactions monitoring system and corresponding laws and regulations、 public tend to how to report adverse drug reactions, and combining with the investigation result of pharmaceutical production enterprise, and adverse reaction monitoring center of Guangdong province present situation, To discuss how to establish a reasonable scientific and feasible individual adverse drug reaction reporting system.Methods:In January 2014, this study through interview to the director of the adverse drug reaction monitoring center of Guangdong province, director,understand the current government monitoring department’s attitudes towards personal reports and recommendations. The author had an internship the adverse drug reaction monitoringcenter of Guangdong province in February 2014 to June. during the internship, through the field research method to research on the current status quo of adverse drug reaction monitoring work. In May 2014 to June and August 2014 to December, we use the self-made questionnaire, for the pharmaceutical production enterprise of Guangdong province and the public the relevant investigation, respectively. After recycling questionnaire, to carefully check questionnaire, eliminate invalid questionnaire. Using Excel 2010 input data and make a preliminary treatment, using SPSS 19.0 statistical analysis.Results:We’ve learned through the key figures interviews: our national quality is the important reason for restricting our personal report activities, our country current implements is mandatory reporting system for adverse reactions, but the existence the penalty enforcement problems. Government level demands for personal report adverse drug reactions, especially the over-the-counter(OTC) medicines. Adverse reaction centers encourage the public to report to the doctor preference, second also can consult adverse reaction monitoring center, but the current province adverse drug reaction monitoring center does not have enough administrative resources to deal with all the personal report. Due to the adverse reaction is very special, too many uncertain factors, so the adverse reaction monitoring center is difficult to give a definite reply after receiving reports, this is a factor restricting the public reported.enterprise parts: Survey contact the 90 drug manufacturer in Guangdong province, including 7 didn’t give reply, a total of 83 questionnaires, recycling of 65, the recovery rate of 78.3%, are all effective questionnaire, finally get effective questionnaire 65, total effective rate was 78.3%.Only 4.6% of the enterprises submitted more than 20 reports of annual adverse drug reactions. 38.5% of the enterprises were not equipped with specialists to answer inquiries, 10.8% of the enterprises did not set up strict internal rules and regulations and report time limit of adverse drug reactions, 58.5% of the enterprises had no provisions of the drug safety obligation with business partners, 27.7% of the enterprises failed to do comprehensive literature search on a regular basis, 60% of the enterprises had no internal 24 hours reporting system, 46.2%of the enterprises failed to provide drug safety training when recruiting staff.Public part: altogether 1500 questionnaires, in Guangdong province recycling questionnaire 1450, screening of recycling questionnaire, it is concluded that effective questionnaire 1379, recovery rate was 78.4%, the recovery and effective rate was 91.9%.The public’s awareness of the concept of adverse drug reactions in the province is 67.5%, correct analysis of the concept of ADR along with the increase of degree, and is associated with age(P < 0.05). Once the adverse drug reaction the 62.2% public more inclined to report the hospital,95.7% of the public would like to submit the adverse drug reactions to the government, 31.0% of the public wants to login website system directly report, 29.0% of the public want to go to the hospital, community health service centers, or retail pharmacies in the related personnel assistance report adverse reactions.Conclusion: Government department has a need for personal reported adverse reactions. Concept of Guangdong province public ADR recognition rate is not high. but the public have higher willingness to report. The government should strengthen the propaganda of the public understanding of ADR, encourage and guide the public to actively participate in ADR reports, and widen the channel of the ADR personal report. Drug manufacturer in our province of adverse drug reactions monitoring work situation is not optimistic, the enterprise internal monitoring system is imperfect, collecting channel is not smooth, the lack of enough effective methods of analysis and evaluation. According to the results of the study and combined with the public in the process of research, enterprise staff 、 government supervision department and management of pharmaceutical affairs related experts to build the individual reporting system of adverse drug reactions, and for our country to carry out the individual report ADR work provide relevant reference.