Objective: The Relief System for Sufferers from Adverse Drug Reactions was created for the purpose of remedying issues such as medical expenses for people who experience an adverse drug reaction despite the proper use of a medicine.Methods: We used “decision data on adverse drug reaction payments” released by the Pharmaceuticals and Medical Devices Agency to investigate the payment of all medical supplies for adverse drug reactions associated with the HPV vaccine over the 7-year period between 2011 and 2017.Results: The HPV vaccine had a lower rate of supply than all other medical supplies. Medical costs and medical allowance accounted for the majority of supplies for the HPV vaccine. The most common response was “A causal linkage between adverse reactions and the HPV vaccine cannot be confirmed”, followed by “It is not recognized as medical care requiring hospitalization”.Conclusion: Many patients with an adverse drug reaction received no medical supplies, mainly for the reason of “undecidable”. With regard to these patients, it may be necessary to carry out a survey so that they can be judged rather than classifying them as ‘undecidable’.

Objective: “Drug Guide for Patients” (DGP) is a drug information tool designated as one of the routine risk minimization activities in risk management plan (RMP) developed by the Ministry of Health, Labour and Welfare. However, patients and their families hardly recognize DGP. Therefore, we administered a questionnaire on drug consultation service of pharmaceutical companies that provide DGP with an aim to collect their views, elucidate problems when they prepare DGPs and examine effective utilization of DGP in the future.Methods: We sent a questionnaire by letter for 127 drug consultation service of pharmaceutical companies, and received questionnaire results using “Questant” that is web questionnaire making software. The results were examined using Fisher’s exact test or Pearson’s chi-squared test.Results: We obtained responses from 84 (66.1%) companies out of 127. As for the question of the published situation of DGP on their website, the most companies responded “Not published” with 47.6% and subsequently 41.7% for “Published for healthcare professionals”. The combined rate of “Published for Patients (3.6%)” and “Published for both healthcare professionals and patients (7.1%)” was only 10.7%. On the other hand, regarding the burden of companies making DGP, we found that more than 60% of pharmaceutical companies (63.5%) felt burdensome, whereas only 36.5% responded “Not burdensome.” Regarding the question on the role of DGP in RMP, pharmaceutical companies answered that the role is “sufficient” 3.6%, 29.8% “not sufficient”, and 66.6% “unknown”.Conclusion: Our results suggested that it is difficult for patients to get DGP from website of pharmaceutical companies and pharmaceutical companies felt burdensome in making DGP, and they recognized that DGP was not very much utilized by patients. Therefore, it would be necessary to improve the creation criteria of DGP. Furthermore, we felt it necessary to have the DGP known and utilized widely by (consumers and) patients.

Immunization Health Damage Relief Program is a system created with the aim of providing “quick and wide-ranging” relief for health damage caused by routine vaccinations. In this study, we investigated the current status of payments awarded for side effects of the human papilloma virus (HPV) vaccine over the 10-year period from 2013 to 2023. We obtained the data for this study from reports of the subcommittees of the Vaccination Health Damage Relief System, such as the results of deliberations by the Infectious Diseases and Immunization Review Subcommittee. The certification rate under this system was approximately 50%, which is the same as the certification rate of the Adverse Drug Reaction Relief System. The types of diseases and disorders reported in the system were diverse and had multiple symptoms. The number of applications increased in the final year of the study because of the recommendation for reopening the system for applications in 2022.

Objective: The Immunization Health Damage Relief Program was established to provide "prompt and wide-ranging" relief for health damage caused by routine vaccination.Methods: In this study, utilizing the report of the Subcommittee on Infectious Diseases and Immunization, we investigated the relief status of persons who received the new coronavirus vaccine. The study period was three years, from 2021 to 2023, and the number of cases accepted, the number of certifications, the number of denials, and the number of delays were analyzed.Results: Most of the claims were for medical expenses and medical benefits, and the remaining claims were for lump-sum death benefits and funeral expenses. The approval rate was 84.9%, and the denial rate was 14.1%. The scrutiny rate was less than 30% since July 2022, but with the establishment of a new study group on January 2023, the rate rose to approximately 70%. Initially, none of the lump-sum death payments were approved, but later the approval rate increased, and there was a period when almost all the lump-sum death payments were approved.Conclusions: The Ministry of Health, Labor and Welfare (MHLW) is responding as quickly as possible to the increasing number of applications, but the number of health relief applications is unprecedented in the history of vaccines. For the victims and their families, the situation does not appear to be satisfactory.