Comparison of drug safety data obtained from the monitoring system, literature, and social media: An empirical proof from a Chinese patent medicine

Abstract

ObjectivesTo investigate the consistency of adverse events (AEs) and adverse drug reactions (ADRs) reported in the literature, monitoring and social media data.MethodsUsing one Chinese patent medicine-Cordyceps sinensis extracts (CSE) as an example, we obtained safety data from the national monitoring system (July 2002 to February 2016), literature (up to November 2016) and social media (May 2019). For literature data, we searched the Chinese National Knowledge Infrastructure Database (CNKI), WanFang database, Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Embase and the Cochrane Library. Social media data was from the Baidu post bar and Sina micro-blog. Two authors independently screened the literature and extracted data by PRISMA Harms checklist was followed. AEs and ADRs were coded using the World Health Organization Adverse Reaction Terminology (WHO-ART). AEs and ADRs were grouped into thirty-one organ-system classes for comparisons. Frequencies, relative frequencies and rank were used as metrics. Radar chart was used to manifest the features of the distributions and proportions.Results610 AEs reported in CFDA monitoring data were associated with CSE, of which 537 (88.03%) were suspected ADRs (10.49% certain). 5568 AEs were identified from 172 papers (63% RCTs, 37% other types of studies including case series, case reports, ADR monitoring reports and reviews), in which 86 (1.54%) were ADRs (1.54% certain). 15 AEs (0 certain ADR) were identified from social media. AEs, ADRs and their affected system-organ classes, looked largely similar, but different in every aspect when looking at details. Data from RCTs demonstrated the most disparity.ConclusionsIn our study, the most prevalent AEs and ADRs, mainly gastro-intestinal system disorders including nausea, diarrhea and vomiting, in monitoring system were largely similar with those in literature and social media. But data from different sources varied if looked at details. Multiple data sources (the monitoring system, literature and social media) should be integrated to collect safety information of interventions. The distributions of AEs and ADRs from RCTs were least similar with the data from other sources. Our empirical proof is consistent with other similar studies.

Analysis of Influencing Factors of Acute Medication Poisoning in Adults in Emergency Department of Our Hospital from 2016 to 2019 and Observation of Curative Effect of Optimizing Emergency Procedures

“…Especially in Chinese patent medicine, because of the composition of raw materials conflicts or improper decocting method during production, the drug toxicity increases. In addition, in our country, with the widespread use of Chinese herbal medicine, compared with Western medicine and other synthetic drugs, its side effects are less severe and the safety is high, but more people will mistakenly believe that it is harmless or completely nontoxic; therefore, accidental ingestion or unverified consumption of various medicinal plants and large amounts of medicinal plants has also become one of the important reasons for acute drug poisoning and other adverse drug events [18][19][20]. ere is a certain probability of adverse drug reactions after each drug Only a small part of the patient's body has an antagonistic reaction with the drug and cannot be absorbed and utilized, and when the concentration of the drug in the blood reaches a certain amount, poisoning occurs [21].…”

How is Social Media Used in the Context of Complementary and Alternative Medicine? A Scoping Review

“…Theme 1: To Share User/Practitioner Beliefs, Attitudes, and Experiences about CAM Several studies provided insight into the beliefs, attitudes, and experiences of CAM users and practitioners [35,36,38,40,41,43,45,48,49,53,55]. Three subthemes developed among the studies: negative beliefs and attitudes about CAM use, positive beliefs and attitudes about CAM use, and experiences of using CAM.…”

“…The rst of the three subthemes found among the studies was negative beliefs and attitudes about CAM use. Numerous studies identi ed negative beliefs and attitudes about CAM treatments that were posted on social media [38,40,49,53]. One study conducted in Spain analyzed the discourse of skeptics of complementary therapies on Twitter [38].…”

“…Studies with a narrow search criterion within a subset of CAM did not necessarily have a small sample size, therefore having a narrow search criterion was not viewed as a challenge with social media research in the context of CAM. Subtheme 3.1: Sampling Biases are Inherent More than a third of studies reported that a challenge with social media research in the context of CAM was that sampling biases are inherent and surveying a representative sample is di cult [31,34,36,40,45,47,48,50,55,57]. Studies that analyzed activity on Facebook or Twitter mentioned that they may have missed potential participants that were not Facebook/Twitter users, had private accounts, or did not have access to the internet [31,34,36,48].…”

“…The common themes among the tweets were "anti-science", " ghting against harmful, for-pro t practices", and protecting "the most vulnerable [who have] little knowledge of science". Another study investigated social media as a platform to share information about the safety of Chinese patent medicine [40]. The authors found that there were a signi cant number of posts to online blogging platforms about individuals experiencing adverse effects while undergoing Chinese patent medicine.…”