The objective of this study is to assess the impact of APV (active pharmacovigilance) and PPV (passive pharmacovigilance) by detection of ADEs (adverse drug events), through PIs (pharmaceutical interventions)....The objective of this study is to assess the impact of APV (active pharmacovigilance) and PPV (passive pharmacovigilance) by detection of ADEs (adverse drug events), through PIs (pharmaceutical interventions). Authors have used observational pre-post intervention study. Dader methodology was used in 123 patients with data obtained from medical records and pharmaceutical interview. Detection of ADE was made by direct observation and laboratory tests, with statistical significance 0.05. In PPV, 47 ADEs were detected: nausea, vomiting, skin rash and skin redness. In APV, 100 ADEs are presented, similar to those described in the PPV, in which Dipyrone produced 26.2%. The causes of DRPs (drug related problems) were: probability of adverse events 36%, personal characteristics 30%, and dose regimen and/or inadequate duration 22%. Out of 127 PIs performed, 91.34% were accepted and resolved. The patient satisfaction rate was 82.7% for APV and doctor satisfaction 90.4% with high impact, surpassing the 80%. The impact of APV was 93.6% and 53% in PPV for PIs and ADEs. PIs were performed to the ADEs with a high percentage of accepted and solved ones. Evaluation of satisfaction of patients and doctors in APV had a high impact. The assessment of APV generated a high impact on compliance and PPV a low one.展开更多
Because the research paper of Alzheimer's disease(AD)new drug(GV-971)was suspected to be fraudulent,the author filed a lawsuit for infringement of reputation.A court in Shanghai rejected the lawsuit.Legal document...Because the research paper of Alzheimer's disease(AD)new drug(GV-971)was suspected to be fraudulent,the author filed a lawsuit for infringement of reputation.A court in Shanghai rejected the lawsuit.Legal documents openly support academic disputes and criticism.The FDA's approval of the listing of a new AD drug(aducanumab)is also full of controversy,and some scholars suspect that there are problems with clinical data(of course there are scholars who support the listing).Falsification of scientific research and papers is not uncommon in China.In 2021,more than 400 people were publicly investigated for falsification of papers(these papers published in SCI journals).The reason for the prevalence of falsification was related to the promotion policy,evaluation system and economic interests.Academic fraud was a serious waste of funds and corrupted the academic atmosphere.And hinder the development of science and technology.In the past two years,the government has successively promulgated a series of scientific research and academic integrity norms,prohibiting the use of scientific research funds in international predatory journals,advocating the purification of the academic environment,and conducive to genuine innovative research.The court respects science,administration does not interfere with academics,and advocates peer review.The first-instance judgment may be a landmark event for China.展开更多
文摘The objective of this study is to assess the impact of APV (active pharmacovigilance) and PPV (passive pharmacovigilance) by detection of ADEs (adverse drug events), through PIs (pharmaceutical interventions). Authors have used observational pre-post intervention study. Dader methodology was used in 123 patients with data obtained from medical records and pharmaceutical interview. Detection of ADE was made by direct observation and laboratory tests, with statistical significance 0.05. In PPV, 47 ADEs were detected: nausea, vomiting, skin rash and skin redness. In APV, 100 ADEs are presented, similar to those described in the PPV, in which Dipyrone produced 26.2%. The causes of DRPs (drug related problems) were: probability of adverse events 36%, personal characteristics 30%, and dose regimen and/or inadequate duration 22%. Out of 127 PIs performed, 91.34% were accepted and resolved. The patient satisfaction rate was 82.7% for APV and doctor satisfaction 90.4% with high impact, surpassing the 80%. The impact of APV was 93.6% and 53% in PPV for PIs and ADEs. PIs were performed to the ADEs with a high percentage of accepted and solved ones. Evaluation of satisfaction of patients and doctors in APV had a high impact. The assessment of APV generated a high impact on compliance and PPV a low one.
文摘Because the research paper of Alzheimer's disease(AD)new drug(GV-971)was suspected to be fraudulent,the author filed a lawsuit for infringement of reputation.A court in Shanghai rejected the lawsuit.Legal documents openly support academic disputes and criticism.The FDA's approval of the listing of a new AD drug(aducanumab)is also full of controversy,and some scholars suspect that there are problems with clinical data(of course there are scholars who support the listing).Falsification of scientific research and papers is not uncommon in China.In 2021,more than 400 people were publicly investigated for falsification of papers(these papers published in SCI journals).The reason for the prevalence of falsification was related to the promotion policy,evaluation system and economic interests.Academic fraud was a serious waste of funds and corrupted the academic atmosphere.And hinder the development of science and technology.In the past two years,the government has successively promulgated a series of scientific research and academic integrity norms,prohibiting the use of scientific research funds in international predatory journals,advocating the purification of the academic environment,and conducive to genuine innovative research.The court respects science,administration does not interfere with academics,and advocates peer review.The first-instance judgment may be a landmark event for China.