Pharmacy pharmacists play important roles in the community comprehensive care system that supports seamless medical care throughout the community by collaborating with hospital pharmacists and other medical professionals. Sharing information such as patients’ medication status at the time of admission and discharge is one of the important aspects of collaboration, and may reduce the burden of medical professionals and an improvement in the quality of medical care involved as team medicine. The purpose of this study was to examine whether the provision of information by pharmacy pharmacists on the medication status of patients prior to hospitalization would help reduce the burden on hospital pharmacists and facilitate their work. A questionnaire survey was conducted on hospital pharmacists regarding the current status of management of hospitalized patients’ dowry medicines and the usefulness of information provided by pharmacy pharmacists, and the results were subjected to CS analysis. Providing patient information of pharmacy pharmacists at the time of admission and discharge contributes to reducing the burden on hospital pharmacists. On the other hands, documents provided by pharmacy pharmacists were used only 20% by hospital pharmacists and thought less reliable than the medication handbook. To solve this problem, it is necessary to promote “family pharmacists/pharmacies” that monitor patients’ medication information in a centralized and continuous grasp and to establish a system that enables the smooth sharing of this information between pharmacy pharmacists and hospital pharmacists.

In order to ensure smooth collaboration between R & D-based pharmaceutical companies and medical institutions, it is essential to secure high transparency and gain the trust and confidence of society by disclosing information. The Japan Pharmaceutical Manufacturers Association (JPMA) and The Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry have presented how scholarship donations should be, and the guidelines for the relationship with medical institutions. Each member company of the JPMA complies with these guidelines and gives “donation” on their own responsibility to support “research” independently conducted by healthcare professionals or researchers and “academic meetings/lecture meetings” conducted by academic societies. However, many issues remain to be resolved. On the other hand, Pfizer supports independent initiatives to improve patient’s outcomes, which are conducted by healthcare professionals or researchers, by giving “grants” based on grant agreements. In the framework of this grant program, Pfizer evaluates expected outcomes in advance, then conclude the grant agreement, and supports the initiatives by providing funds, drugs, or compounds. The grantees are required to report on how the outcomes of patients are improved as a result of the support. This grant program covers not only research fields but also medical education and training required in the medical field as well as initiatives to promote changes in behavior of healthcare professionals and the system (structure). This paper raises the issues of support from pharmaceutical companies in Japan, especially support through scholarship donations, introduces the Pfizer’s grant program called Independent Medical Grants, and makes recommendations on how support from pharmaceutical companies should be provided.

Based on Japan-GCP (Good Clinical Practice), study sponsors disseminate safety information for subject protection to principal investigators and medical institution heads (PIs). The Japan Pharmaceutical Manufacturers Association (JPMA) published the guidance of safety communication with PIs in 2009. More than 10 years passed since this proposal, during which time the environment surrounding clinical trials in Japan have changed, such as an increase in multi-regional clinical trials. In 2019 to 2020, the surveys on communication of safety information in clinical trials were carried out to medical institutions and study sponsors (companies) by JPMA. The results showed the urgent and significant safety information were disseminated more rapidly than other non-urgent or non-significant. It was also confirmed that the JPMA-recommended listing format was commonly used to disseminate safety information. On the other hand, the amount of safety information communicated to PIs has significantly increased in the last decade, with a considerable proportion of foreign post-marketing information caused by Japanese specific requirements. This had been the issue that could not be solved due to the regulation. A partial revision to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was enacted in 2019. The new regulation allows to exempt a part of foreign post-marketing cases from reporting to the regulatory authority and dissemination to PIs. Meanwhile, under the new regulation, sponsors are obliged to disseminate safety information not only the investigational product, but also other product defined in the protocol such as concomitant products (called as “products used in the study”) to the PIs. As the result, the amount of safety information to be disseminated is expected to increase further, so well-balanced dissemination method is required. In response to the changes caused by the new regulations, it is important that sponsors deal with new issues on dissemination of safety information for ensuring subject protection in clinical trials.

With the development of cancer medicine and reproductive medicine in recent years, childhood and AYA (adolescent and young adults) cancer patients who can preserve fertility before the start of cancer treatment has increased in number. Oncologists give accurate information to patients about the potential for gonad dysfunction due to treatment as soon as possible. In close cooperation with reproductive endocrinologists, the time for facilitating decision-making regarding fertility preservation should be provided to patients as soon as possible because there is no time to start cancer treatment. In principle, cancer treatment is given priority above all. On the other hands, a cancer patient who wishes to have a baby may try to become pregnant early after the end of cancer treatment depending on the condition of the disease. Consequently, the question arises how soon after cancer treatment completion can gestation be tried, with the effects of chemotherapy and radiotherapy on gametes has been eliminated. To avoid the effects of drug use on gametes in patients, FDA and EMA published guidelines in this field in 2019 and 2020, respectively. However, in Japan, there was no guideline corresponding to the guidance in this area. Therefore, the AMED’s JP20mk0101139 “Research Group on Proper Use of Drugs for People with Fertility” gathered the opinions of experts familiar with reproductive medicine, toxicology, and drug safety measures, and prepared the “Guidance on the Need for Contraception Related to Use of Pharmaceuticals” in March 2021.

Thalidomide caused a great drug disaster and was recovered from this world. This incident has greatly advanced regulations and guidelines on drug safety. Dangerous drugs can be predicted in advance. However, thalidomide was approved again in 2008. For the indication of refractory multiple myeloma, strict management by appropriate guidelines is required. As for safety in drug development, the ICH guidelines specify the type and timing of studies. Based on the results of non-clinical safety studies conducted in accordance with the ICH guidelines, clinical trials are conducted, and then appropriate dosage and administration can be determined. The study cannot be conducted in pregnant women or women of childbearing potential except under special circumstances. Most of the descriptions in the package insert are “No experience in pregnant women or women of childbearing potential”. Drugs that are particularly genotoxic are contraindicated. This paper considers the risk of women treated for cancer in the AYA generation based on the revised ICH S5 (R3).

Guidance on the need for contraception related to use of pharmaceuticals has been shaped by the Japan agency for medical research and development (AMED) research group, providing information on the proper use of pharmaceuticals in patients with reproductive potential. The guidance provides basic concepts regarding the conditions under which contraception is recommended during or after the last dose of medication and the duration of contraception, in order to minimize the potential risk for embryonic and fetal development from the use of medications in patients of reproductive potential. This article outlines the guidance on male contraception and adds three additional points: “assisted reproductive technology (e. g., sperm cryopreservation)”, “risk of reproductive and developmental toxicity by radiopharmaceuticals, regenerative medicine products, vaccines, etc.”, and “risk of infection to partners from sexual activity with pharmaceuticals that may be infectious.

Many of oncology pharmaceuticals have ovotoxicity and/or genotoxicity. Ovarian reserve, numbers of healthy oocytes in the ovary, gradually decreases in aging, but abruptly decreases when young female cancer patients are exposed to ovotoxic pharmaceuticals. Therefore increasing number of young patients undergo fertility preservation in which oocytes or ovarian tissue are retrieved and cryopreserved before chemotherapy. The deterioration of the quality of oocytes in aging is called “oocyte aging”, and the function of DNA repair in the oocytes are known to be deteriorated in aging. Similar to those from U. S. Food and Drug Administration and European Medicines Agency, labeling guidance in Japan recommends “5×T_1/2+6 months” of contraception period after the cessation of genotoxic pharmaceuticals, based on mouse model experiments which suggested that early fertilization soon after the administration of ovotoxic pharmaceuticals can result in a high rate of pregnancy failure and high malformation rate. However, the teratogenicity of pharmaceuticals has been generally found when administered during the 4th to 10th weeks of pregnancy, and healthy children were born even when they originated from the oocytes or ovarian tissue which had been retrieved immediately after chemotherapy. All healthcare professionals, especially obstetricians and pharmacists, should carefully provide information and counseling to the female patients and their partners who get unexpectedly pregnant during the above-mentioned contraception period.

Regulations on drug package inserts in Japan, Europe, and the United States are controlled by the regulatory authorities of each country. The equivalent of drug package inserts in Japan is treated as SmPC in Europe and Labeling in the United States. Regarding the content of information on contraception in this package insert, it was found that there are differences in the content in Japan, Europe and the United States. It was also found that even if there is a specific description of the contraceptive period in the overseas package insert, there is a poorly specific description of “contraception for a certain period” in the domestic package insert. In the United States, “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry” was issued in May 2019, calling attention to specific contraceptive periods based on the half-life of blood levels for each drug. It is considered necessary to describe the specific period in the description of the contraceptive period in the package insert in Japan.

This report discusses risk communication regarding the need for contraception related to use of pharmaceuticals between health care providers and cancer patients. The results of an online survey targeting 2,000 men and women in their 20 s to their 40 s show that the highest knowledge rate (79.8%) was for “anticancer drug” among the 10 terms included in the survey. However, the knowledge rate was less than 20% for almost half of the survey terms. These results indicate that health care providers require strong communication skills in order to provide information to patients effectively. The “Guidance on the Need for Pharmaceutical Contraception” can help ensure that patients receive accurate information. Scrutinizing that the expressions on the website are clear and providing a glossary of terms may reduce the burden of communication for both health care providers and patients and promote understanding among patient groups.

The purpose of “Draft Guidance on the Need for Contraception Related to Use of Pharmaceuticals” is to minimize the potential risk of developmental toxicity and genotoxicity in the offspring of male and female patients treated with pharmaceuticals and to suggest when and for how long contraception should be recommended during and after treatment. This draft guidance may be useful for pharmaceutical companies in determining the necessity for recommending contraception in the labeling of pharmaceuticals. Such recommendations should be based on safety information from nonclinical studies, clinical studies, and post-marketing phase. Together with this information, this guidance will also be useful for physicians treating patients in clinical practice. This report introduces the summary of the draft guidance and provides actions to be taken by pharmaceutical companies according to the draft guidance.

Recently, various types of Software as a Medical Device (SaMD), including computer-aided diagnosis systems developed using artificial intelligence technology, digital therapeutics prescribed by doctors and installed to the patients’ mobile phone etc, have been developed and put into practical use. They are expected to be new options of therapeutic or diagnostic methods. Since it was clarified that medical software is classified as medical device by the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960) in 2013, the number of the marketing approval of SaMD has been increasing. In addition, it is mentioned in the Basic Policy of Economic and Financial Management and Reform (decided by the Cabinet on June 18, 2021) and the Action Plan of the Growth Strategy (decided by the Cabinet on June 18, 2021) that the government of Japan will accelerate the approval process in order to promote the practical application of SaMD. Based on such background, Ministry of Health, Labour and Welfare of Japan published “DASH for SaMD” (DX (Digital Transformation) Action Strategies in Healthcare for SaMD) on November 24, 2020. This action plan is composed of the following four parts; 1) Early recognition of research seeds and publication of the review guide. 2) Centralization of the consultation contact desk. 3) Review system applicable to unique characteristics of SaMD. 4) Enhancement of structure for early realization. As for 2 and 4, these measures had been taken by April 2021, and as for 1 and 3, these measures are to be taken by the end of FY2021.