Landscape of DILI-related adverse drug reaction in China Mainland

Drug-induced liver injury(DILI)is a type of bizarre adverse drug reaction(ADR)damaging liver(L-ADR)which may lead to substantial hospitalizations and mortality.Due to the general low incidence,detection of L-ADR remains an unsolved public health challenge.Therefore,we used the data of 6.673 million of ADR reports from January 1st,2012 to December 31st,2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation.Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from the original heterogeneous system.By cleaning and standardizing the data fields by the dictionary of synonyms and English translation,we resulted 94,593 ADR records reported to liver injury and then created a new database ready for computer mining.The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years.The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men.The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population,despite known underreporting situation in spontaneous ADR reporting system.The percentage of herbal and traditional medicines(H/TM)L-ADR reports in the whole number was 4.5%,while 80.60%of the H/TM reports were new findings.There was great geographical disparity of reported agents,i.e.more cardiovascular and antineoplastic agents were reported in higher socio-demographic index(SDI)regions and more antimicrobials,especially antitubercular agents,were reported in lower SDI regions.In conclusion,this study presented a large-scale,unbiased,unified,and computer-minable L-ADR database for further investigation.Age-,sex-and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.

Progress of Active Surveillance for Vaccine Safety in China

Vaccination is one of the most cost-effective interventions for saving lives and promoting public health.The coronavirus disease 2019(COVID-19)pandemic is providing a stark reminder of the importance and power of vaccines(1).However,vaccines can cause harm,and their rare safety concerns have increased in relative visibility as successful control and prevention of vaccine preventable diseases has diminished awareness of these diseases.

Active Vaccine Safety Surveillance: Global Trends and Challenges in China

Importance.The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns.This has caused vaccine hesitancy to be the top 10 in threats to global health.The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance.It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials.Highlights.In the present study,the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns.Then,the global progress of active surveillance systems was reviewed,mainly focusing on population-based or hospital-based active surveillance.With these successful paradigms,the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases,methodology challenges,policy supports,and ethical considerations.Conclusion.In the inevitable trend of the global vaccine safety ecosystem,the establishment of an active surveillance system for vaccine safety in China is urgent and feasible.This process can be accelerated with the consensus and cooperation of regulatory departments,research institutions,and data owners.