Objective: The purpose of this study was to assess the opinions of healthcare professional regarding the contributions of the Medical Affairs department. Furthermore, we aimed to identify factors influencing and reasons for the contributions in the new coronavirus disease 2019 (COVID-19) pandemic situation.Design/Methods: A web-based survey was conducted among healthcare professionals (Key Opinion Leader/Key Thought Leader, KOL/KTL) who had multiple contacts with the Medical Affairs department, Japan.Results: The responses of 141 KOL/KTLs in Japan were collected; 77.3% of the respondents indicated that the contributions of the Medical Affairs department exceeded their expectations (achieved the expected level of contribution). The most common responses were “the identification of unmet medical needs” and “the dissemination of medical and scientific information, providing advanced medical and scientific information;” other responses included “promoting sales of the company's drugs.” The requests from KOL/KTLs regarding quality were “knowledge about biological and clinical statistics” and “proposal and quick response ability from the perspective of medical staff and patients,” but these responses were partially different between physicians and pharmacists. COVID-19 has resulted in substantial changes, for example, “face-to-face” interactions have significantly decreased from 91.5 to 50.4% and “Online” interactions have significantly increased from 20.6 to 70.9%. However, the effects of the declaration of emergency state could not be identified. The KOL/KTLs requested to make the meeting times more appropriate, conduct in-depth two-way discussions, provide latest information, and discuss about professional manners and behaviors.Conclusion: In summary, regardless of the changes in the types of activities caused by COVID-19, the Medical Affairs department has made substantial contributions to healthcare professionals, who highly appreciated them. Furthermore, depending on responses of individuals whose expectations could not be met, areas of improvements have been suggested.

Evaluation of the efficacy and safety is most important for introducing the vaccine. But when introducing widely using public resources such as routine vaccination, it is also necessary to consider cost-effectiveness. In this paper, we first introduce the situation of ACIP in the United States and JCVI in the UK as examples of using cost-effectiveness analysis for vaccine policy in other countries. Next, I will outline the situation of efforts at the immunization inoculation group of the Infectious Disease Subcommittee of the Welfare Science Council of Japan and the vaccination/vaccine section of the Health Science Council. Next, we describe the necessity of standardization of research methods and outline the research guidelines on the evaluation of the cost-effectiveness of immunization prepared by the authors so far. With reference to the analysis guidelines for cost-effectiveness evaluation already used in the Chuikyo, this guideline considers vaccinespecific issues such as loss of productivity and Herd effect while trying to unify within a possible range such as discount rate etc. Based on this guideline, the economic evaluation is carried out by a unified method. It will be possible to do scientific discussions on the appropriateness of introducing routine vaccination of each vaccine, the priority order, the subjects of inoculation, the method of inoculation, etc. based on the financial influence and the value from a social point of view.

Guidelines for the usage of psychoactive drugs for behavioral and psychological symptoms of dementia (BPSD) were issued by the Japanese Ministry of Health, Labour and Welfare in July 2013. Using the Anatomical Therapeutic Chemical (ATC) classification with prescription data, we surveyed the usage of psychotropic drugs in patients with dementia. N05C (hypnotics and sedatives) was the most frequently prescribed class of drugs [9,920 (19.7%) individuals]. In addition, there are few prescription ratios of risperidone in comparison with 5.6% and the survey in the UK. Although anti-anxiety drugs should not be used as per BPSD guidelines, etizolam was prescribed in a considerable proportion of patients (6.2%). In addition, with respect to prescription of combinations of antipsychotics in the same month, the highest rate was found for risperidone and tiapride [209 (2.4%) individuals]. In addition, 39 individuals were prescribed antipsychotics that are contraindicated for patients with diabetes. When the number of the clinical departments is as above 2, the ratios to become the contraindicated prescription, careful administration prescription of the antipsychotic increase with significant difference (p<0.01). The increased of the number of the clinical departments tended to increase the ratio of the contraindications and careful administration prescription. Thus, the need for a family doctor to prevent such situations was suggested, which was introduced by the 2014 Medical Treatment Fee Revisions.

Health economics evaluations are affected by uncertainty when estimating their parameters. Therefore, it is important that we use a sensitivity analysis to determine the robustness of these evaluations. Most countries' guidelines recommend using a probabilistic sensitivity analysis (PSA), which enables us to evaluate the uncertainty of multiple parameters at the same time, based on a joint probability distribution. In this article, we first introduce the Monte Carlo simulation and Bootstrap method as PSA methods. Then, we review how various guidelines incorporate the PSA. Finally, we review Japanese health economics studies to determine the level of PSA use in Japan. Guidelines published before 2008 recommend conducting a sensitivity analysis, but do not specify a method. In contrast, both the French, American and English guidelines, which were published after 2011, specifically recommend using a PSA. In Japan, the “Guideline for economic evaluation of healthcare technologies in Japan” recommends conducting a PSA, “if possible”. However, PSA methods are not widely used in Japan. Of 49 Japanese health economics studies based on quality-adjusted life years, only six conducted a PSA (12.2%), although 35 (71.4%) did conduct other types of sensitivity analyses. If PSA methods are accepted as a good way to determine the robustness of an evaluation, then we need to foster their use. This, in turn, means we need specific guidelines on how best to use these methods.

A number of pharmaceutical colleges have adopted a training program for the vital signs in their 6 year-education curriculum. However, few hospitals or pharmacies carry out vital signs monitoring or physical assessment at present, and graduate pharmacists cannot utilize the techniques that they are skilled in fully. In this study, in order to clarify the situation for implementing vital sign monitoring by pharmacist and what is necessary for pharmacy education, we carried out a web survey for two months, from October 4th to December 3rd, 2012, targeting 1026 pharmacists who attended the vital signs training program hosted by The Japanese Association of Home Care Pharmacies. The Survey item were; (1) basic information of a respondent; (2) situation of homecare conducted by pharmacists; (3) seminar attendance status; (4) vital signs monitoring status after the seminar; (5) hope for future pharmacy education. From the result of the survey, it became clear that over 40% of pharmacists had a chance to perform vital sign monitoring, leading to proper use of medicines. In total, 183 responses to the questions concerning future pharmacy education were obtained from 135 pharmacists and were classified into 11 categories. A request for “a purpose and the significance” was the most common. In the education of pharmacy schools, it is thought that having lectures from on-site pharmacists with an abundance of experience in cases will be effective.

Acetaminophen is commonly used as the global standard of analgesics. For example, the WHO lists acetaminophen as an essential drug and various clinical guidelines in many countries include acetaminophen as a first-line drug for pain relief because of it's efficacy and safety profile. In particular, there is not significant risk of such as gastrointestinal disorders, renal dysfunctions, bleeding, or cardiovascular events, and it is considered to be a safer option than non-steroidal anti-inflammatory drugs(NSAIDs). In Japan, however, NSAIDs are widely used to treat pain while the use of acetaminophen for pain relief is quite limited. This difference could be attributed to the low approved dose of acetaminophen in Japan, which is less than half of that used elsewhere. This lower approved dose causes difficulty in obtaining analgesic effect with acetaminophen. In January 2011, however, the approved dose of acetaminophen in Japan was increased to the world standard dose, making it easier to obtain an analgesic effect. In the near future, an increase in the use of acetaminophen for pain relief can be expected in Japan. NSAIDs are common drugs for pain in Japan, but often require co-prescription of a gastric mucosal protective agents, H₂- blockers, or proton pump inhibitors(PPI) to prevent gastrointestinal disorders. On the other hand, acetaminophen has much less risk of such adverse reactions and there is no need for co-prescription of digestive medicines. Thus, increased use of acetaminophen could decrease the cost for pain relief in Japan. (Jpn J Pharmacoepidemiol 2012; 17(2): 75-86)

Objective: To explore the data sources used in economic evaluations performed on new drugs, and to propose an improved data infrastructure in Japan.
Design: A systematic review.
Methods: We systematically reviewed economic evaluation studies of the new drugs which were launched in Japan between April 2006 and March 2011, and have been priced by the cost calculation method. The “Ichushi” and Pubmed databases were used to find the published articles.
Results: 198 drugs were priced under cost calculation methods in the last 5 years in Japan. 14 published articles (9 drugs) were found: 5 CUAs and 10 CEAs (including one that was both CUA and CEA). In all studies, several data from different sources were incorporated. Cost data were estimated by using standard treatment protocols and national price lists for drugs and medical services, or obtained from limited number of claims data. Efficacy data were obtained from RCTs or clinical trial data mostly conducted in Japan. In 4 out of the 5 CUAs, utility data were used from other studies conducted on non-Japanese samples. Other data, such as epidemiological data, were adopted from overseas as well as Japanese studies.
Conclusion: In order to increase quality and efficiency to conduct economic evaluations in Japan, three steps need to be taken in the data environment: increased accessibility to large cost databases such as the national claims database; establish an epidemiological database; and collect and accumulate utility data in Japanese samples.