With an increase in the consumption of health foods, the associated adverse events have been increasing. Nevertheless, the relevant information is insufficient, and there is a lack of a standardized reporting system in Japan. In this study, we attempted to develop a standardized reporting format for the adverse events associated with health food consumption and investigated its usability in combination with a previously developed causal-relation estimation algorithm, using virtual cases, by medical staff.
We extracted the necessary information from nine reported formats, searched from PubMed, and domestic and international websites, including the websites of pharmaceutical regulatory authorities. Using the developed format, the match rates of format items estimated by 77 medical staff（56 pharmacists, 13 physicians and 8 registered sellers）and those of the causal-relation algorithm items estimated by specialists and medical staff were determined.
The match rates of most items in the reporting format were over 65％, but some items showed lower match rates. Furthermore, the match rates of items in the causal-relation algorithm showed a different tendency in each case.
In conclusion, for its application in clinical practice, the standardized reporting format of adverse events associated with health food has to be improved further.
The impact of COVID‒19 on our society is significant. To continue to offer new treatment options to society during and after the pandemic, experiences and ideas gained during this period should be utilized to transform drug development. Collaboration within the industry and with health authorities across the world is required, and now is the time to start the dialogue. To promote transformation, deploying methodologies based on high ethical standards and scientific rigor, prioritizing the safety of study participants, and securing transparency and the quality of deliverables are essential. In addition, broad acceptance of patient and public involvement is needed to promote understanding of drug development and to enable proactive participation of patients and family members. Utilization of digital tools and improving their reliability, the application of model informed drug development and real world data, improvement of regulatory procedures, continuous regulatory harmonization, and collaboration among companies and health authorities are required to continue to deliver breakthroughs that have a positive impact on society.
In recent years, many excellent drugs with few side effects have been introduced into treatment and contribute to improving prognosis, but elderly people often have multiple diseases and take many drugs in combination. As a result, the existence of drug interactions has become more important as a risk factor for the occurrence of adverse drug reactions（ADRs）. In Japan as well, the importance of drug interactions has been recognized since the Sorivudine incident in 1993, in which sorivudine, a therapeutic drug for herpes zoster, caused death due to serious myelosuppressive side effects when used in combination with 5-FU anticancer drugs, and cautions have been issued such as the revision of the description procedure in the package insert. In addition, efforts are being made by various parties concerned in the drug development process. In 2018, the Ministry of Health, Labor and Welfare issued the “Guideline on drug interaction for drug development and appropriate provision of information” regarding the method of examining drug interactions and the provision of information.
On the other hand, looking at the medical field, although some side effects of individual drugs and interactions between the two drugs are described in the package insert, it is impossible to grasp all of them. In addition, even if the drug therapy is recommended in the treatment guidelines for a certain disease, if the drug is complicated with another disease, the drug interaction with the recommended drug for those diseases may become a problem. A meta-analysis of prospective studies on the incidence of drug-induced ADRs in inpatients published by the United States in 1998 estimated that 106,000 people die annually from ADRs. Healthcare professionals are required to work harder than ever to prevent ADRs. Even now, medications are checked by pharmacists, but it is hard to say that they are fully prepared for drug interactions.
In this session, I would like to describe what can be done and what kind of knowledge should be learned to prevent serious drug interactions. Based on that, I would like to think about what points should be emphasized and dealt with in the actual medical field.