[How Should Pharmacists Use the Evidence in the Community-based Integrated Care System?]

Regarding the Separation of Dispensing and Prescribing (SDP) in Japan, there are some negative opinions that the value of separating these services has not been commensurate with the cost. On the other hand, there is substantial data showing the current state of SDP and its merits, which has been collected and published in academic journals. In 2019, the Japan Pharmaceutical Association searched for articles on this subject in domestic academic journals published over the past five years, and found that there were more than 300 articles that evaluated efforts to contribute to therapeutic efficacy and safety at pharmacies. Among these, some addressed the roles required of pharmacies in a community-based integrated care system, such as efforts toward coordinated medicine management of patients who visit multiple medical institutions, follow-up with patients receiving drug therapy, utilization of patient test values at pharmacies, and home medical care. These research results can be utilized in healthcare policy making. However, even with this volume of existing research, it is hard to determine whether such research is sufficient to connect these findings to measures that would improve policy issues. Therefore, it is necessary to identify for researchers the types of evidence that would help guide and formulate effective new SDP policies.

New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies.

In Japan, a recent issue that required an urgent response was the streamlining of regulations concerning clinical trials of medical devices. On July 31, 2017, the Ministry of Health, Labour and Welfare enacted a new regulatory framework called the fast-break scheme for innovative medical devices aiming to expedite patient access while reducing the premarket regulatory burden of clinical trials and enhancing postmarketing commitments. The new framework is expected to provide greater benefits to patients who require access to new medical devices and to companies via improved transparency and predictability, as well as to reduce the social and medical cost incurred for medical innovation.

Response to Nature's editorial regarding the Japanese legal system for regenerative medicines.

Nature's editorial, dated 10 December 2015, made several criticisms of the new Japanese conditional and time-limited marketing authorization system for regenerative medical products. We believe these comments were based on a misunderstanding of the purpose of the regulations, which are patient-oriented, offering patients access to promising regenerative medicines in a timely manner at reasonable expense while also ensuring the efficacy and safety of the medicines. The new regulatory system represents an attempt by Japan to accommodate unmet medical needs, particularly for life-threatening diseases, and is in line with current global regulatory trends to enable early patient access to new therapies.

[Social change and Pharmaceutical Affairs Law (PAL)].

Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943. This is also regarded as the origin of the current PAL (LawNo.145 in 1960). Through this analysis, we tried to clarify the relationship between the social change and the role of PAL in society. During the War, the bill was discussed, aiming at the improvement of both human resources who treated drugs, and the quality of drug materials. Diet members discussed three main points, namely, "the duty of pharmacists", "the mission of the Japan Pharmaceutical Association" and "the quality control of pharmaceutical products". Notably, the bill pharmacists are required not only to dispense drugs, a role they had previously, but also to manage drug and food hygiene through the quality control of pharmaceutical products and the inspection of food and drink, in order to improve the public health in Japan. Originally, the law was passed to deal with the extraordinary circumstances during the War, but through our analysis, we found that they proactively improved the role of the law to comply with various drug issues raised during the War, the rapid change of the pharmaceutical hygiene concept and the social transformation.

[The law of patent medicine and the separation of drug dispensaries from medical practice].

On March 30, 1914, the law of patent medicine was enacted in Japanese, though it took three years for this to be accomplished. One reason why it took such a long time for enactment is because the doctors and drugstore owners raised strong objections to the law. They feared that pharmacists might try to take over all rights to sell drugs. The pharmacists, however, believed this law to be very important, making it possible for them not only to expand the business rights and the establishment of their status, but also to hold exclusive rights to the sales of drugs. On the other hand, doctors were very cautious about this law. They considered it to be a preliminary stage toward the enactment of the separation of drug dispensing by the medical practice. On March 19, 1914, Dr. Miyake former dean of the School of Medicine, University of Tokyo, and a member of the House of Lords, delivered his opinion on the "needlessness of pharmacists" by quoting European cases in the House of Lords, to members of the Special Committee of the Drug Trade Bill. He stated that a separation of the dispensary from the medical practice was a turning point in the field of medicine that should be reconsidered, and he tried to suppress the pharmacists' movements to pursue this issue. Probably Dr. Miyake was afraid that someone might submit a bill calling for dispensary separation. The proceedings of the Imperial Diet revealed a close relation between the law and the separation of dispensaries.

[Dispensing drugs without prescriptions and the separation of drug dispensaries from the medical practice].

Many cases of dispensing drugs without doctors' prescriptions were reported throughout Japan during 1914-16. Some cases were brought to the courts. Pharmacists had been selling prescription drugs to their customers without prescriptions. This dispensing act was admitted by the Ministry of Internal Affairs after 1913. However, doctors claimed that the act of dispensing drugs without a prescription infringed on Law No. 10, and the Japan Pharmacists Association hired a notable lawyer and fought a lawsuit against eight pharmacists who dispensed prescription drugs without prescription in Shiba Ward, in Tokyo. This case occurred because at that time no practice existed that allowed drugs to be dispensed separately from medical practice.

[A case of a mispreparation of medicine on Yokohama and the separation of drug dispensaries from the medical practice].

On June 10, 1921, a fatal drug administration case occurred in Yokohama. A nontitled dispenser of drugs with little knowledge about drugs working in a hospital dispensary gave a patient a capsule of strychnine nitrate instead of one containing strychnine hydrochloride. This patient died 20 minutes later. A pharmacist revealed the case to the public. Pharmacists insisted that this unfortunate event occurred because of a current hospital system handling both medicine and drug dispensation. Therefore they argued that the responsibilities of doctors and of drug dispensaries must immediately be separated out of respect for the lives of patients. Pharmacists publicized the importance of separating drug dispensaries from the medical practice through newspapers, magazines, and public lectures. We are quite doubtful about this appeal to the public being effective. We question how many people could understand what the pharmacists were saying under such the era when people were not much educated. It became a great fear to doctors that pharmacists appealed the necessity of the separation of drug dispensaries from medical practice directly to the public.