Objective:Medical device malfunctions can significantly impact pharmacotherapy. With advances in digital technology, smartphone applications for the treatment of nicotine addiction have recently been released in Japan. However, it cannot be denied that the malfunction of medical devices related to such programs may affect drug treatment. Therefore, we investigated malfunctioning medical devices related to the program.Methods: We investigated reports on malfunctions from FY 2006 to 2021, using the Pharmaceuticals and Medical Devices Agency database.Results: A total of 94 cases of program-related medical device failures were reported in Japan. The malfunction of medical devices (such as infusion pumps and dialysis machines) associated with drug treatment were confirmed. The events included a rapid infusion of the drug and an inability to ascertain the total dose, both of which were caused by bugs in the program. Although the specifics are unknown, there was a malfunction in the contrast medium injection device as well.Conclusion: When issues arise with the dosage setting of medical devices, it is necessary to consider both human errors by medical staff as well as program bugs. Additionally, to provide safe drug therapy to patients, pharmacists must inspect the medical devices used in drug therapy when visiting hospital wards and patients' homes.

Objective: Crimes related to falsified medicines for medical use are of international concern and becoming increasingly sophisticated. Therefore, in this study, we investigated information on education and training/enlightenment activities on falsified medicines worldwide that are open to the public on the Internet to contribute to medical/pharmaceutical professionals’ and consumers’ education regarding falsified medicines in Japan.Methods: In April 2023, we searched the information written in English and Japanese on education and training/enlightenment activities on falsified medicines using the Internet.Results: We surveyed several countries and obtained important findings. In particular, the World Medical Association (WMA), the International Pharmaceutical Federation (FIP), and the World Health Professions Alliance (WHPA) released programs for healthcare professionals. The US news programs, the US Department of Justice, and the Council of Europe released consumer warning videos. Japan issued the “Guidelines for Good Distribution Practice (GDP)” to the pharmaceutical distribution industry in 2018. Additionally, US and UK medicine regulators and the International Criminal Police Organization (ICPO) offered programs for professionals such as police and customs officers, and public prosecutors.Conclusion: These programs contain useful information not only for medical/pharmaceutical professionals in Japan but also for consumers. However, many are provided by foreign governments or international organizations, while few are from Japan. Therefore, to prevent the distribution of falsified medicine in Japan, educational institutions must further strengthen education and training/enlightenment activities and develop and publish educational tools for falsified medicines.

Objective: Pharmacists deliver medicines that require refrigeration directly to patients’ homes for home medical care or due to supply shortages. However, there are no investigations into the delivery of medicines under appropriate temperature control. Therefore, we conducted a questionnaire survey regarding the delivery of cold-stored pharmaceuticals and considered packaging methods for medicines that would enable appropriate temperature control based on the results. Methods: A questionnaire survey was conducted at 86 pharmacies between January 25 and March 31, 2019. Subsequently, we measured the surface temperature of the medicine (InnoLet® 30R Injection) using a cold bag and ice pack. Results: We received responses from 79 pharmacies. The questionnaire survey revealed that 44% (35 pharmacies) delivered medicines needing refrigeration directly to patients’ homes, and of those, 43% (15 pharmacies) expressing concerns about temperature control during delivery. Additionally, based on a reproduction experiment using the packaging method confirmed in the questionnaire survey (using a cold bag, 0 to 4 ice packs, and an outside temperature of 28℃), the lowest storage temperature (mean±SD) of InnoLet® was 18.8±0.3℃ for zero ice packs, 18.0±0.3℃ for one ice pack, 12.7±0.1℃ for two ice packs, and −0.2±0.3℃ for four ice packs. Thus, the storage temperature of InnoLet® was outside the range of 2-8℃. Therefore, we improved the packaging method to maintain the proper storage temperature by using bubble wrap and paper wiper (Kim Towels®) in 10-45℃ weather conditions. Conclusion: In this study, we discovered the packaging method of medicines to maintain the proper storage temperature (2-8℃) in 10-45℃ weather conditions. Applying the temperature-based packaging method studied in this paper to actual pharmacy operations will ensure the quality of pharmaceuticals that require refrigeration, contribute to ensuring their efficacy and safety, and help ensure delivery. This is expected to alleviate pharmacists’ concerns regarding temperature control of medicines.

Objective: To keep medical costs down, it is important to promote the use of generic drugs at pharmacies, where prescription volumes are high. However, many parents do not opt for generic drugs. This study examines the effectiveness of pharmacists’ explanations to parents, with the aim of promoting the use of generic drugs among young patients under the age of 20.Method: A questionnaire-based survey was conducted from November 25 to December 1, 2019, at 129 pharmacies.Results: During the survey period, 91 pharmacies received 4,491 prescriptions from young patients. The percentage of generic drugs dispensed per prescription was lower for the young patients than for adult patients (65.4% vs. 70.4%; p < 0.001). Statistically, the percentage of prescriptions dispensed using generic drugs was higher in pharmacies that explained costs, equivalence of quality and efficacy, safety, side effects, and the trial system (divided dispensing), compared to pharmacies that did not use these explanations. Conversely, the percentage of prescriptions dispensed using generic drugs was lower at pharmacies that explained dosage form and ease of swallowing. Many pharmacies explained the equivalence of quality and efficacy (85.7%), with many questions from parents (82.4%). However, only a few pharmacies explained the trial system (divided dispensing) (1.1%), with no questions raised by parents (0.0%).Conclusion: This study found that pharmacists’ explanations are effective in promoting the use generic drugs for young patients. However, there is a lack of awareness among parents about the trial system (divided dispensing), and public institutions and pharmacists are not responding appropriately. To promote generic drug usage among young patients, it is important to develop educational tools regarding the trial system (divided dispensing), create awareness campaigns for parents, and revise medical fee. Furthermore, to ensure safe drug therapy, pharmacists should also provide information on the appearance and taste of generic drugs.

The import of medicines for personal use by physicians for aesthetic-related medical treatments in Japan is limited to cases such as a medical emergency and when substitutes are unavailable in the country. However, the real reasons why doctors import these products and their safety have not been investigated. Therefore, to contribute to future countermeasures, we investigated the circumstances for personal import of these medicines. We found that 60 of 177 (33.9%) physicians in the cosmetic surgery, plastic surgery, and dermatology departments had experience of importing medicines. Although only medically urgent medicines can be imported, 11.7% of physicians who imported medicines cited price differences between Japan and other countries as the reason for importing. Botulinum toxin injections (25.0%) were the most commonly imported medicines. Furthermore, 11 physicians (18.3%) responded that there was some defect in the products. This proportion was significantly higher among physicians who experienced a product efficacy or safety issue (68.8%) than among those who had never experienced it (0.0%) (P<0.001). This survey revealed that the import of aesthetic-related medicines that are not suitable for personal import is rampant. In addition, there could be an association between the defects of these products and their efficacy/safety. Therefore, to prevent health damage caused by these medicines, it is important to strengthen the regulatory system for collecting and providing information to ensure thorough confirmation (regarding specifications and package insert) at the time of delivery and use in patients and to tighten administrative checks about reasons for import.

Objective: The proportion of young patients in Japan in whom generic drugs are used is lower than that of other age groups. To promote the use of generic drugs in young patients, we need to change the parents’ attitude toward generic drugs. Therefore, we aimed to contribute to the maintenance and reform of the Japanese social security system by investigating the effects of parent’s sex, patient’s age, and use of the children’s medical expense subsidy system on the selection of generic drugs. Method: We surveyed parents of young patients (<20 years) whose prescriptions were filed at pharmacies from November 25 to December 1, 2019. Results: Of the 712 valid questionnaires retrieved, 74.3% of parents reported using generic drugs for young patients. Approximately 92.2% of the parents reported using the children’s medical expense subsidy system. The highest (51.4%) reason for switching to generics was “recommendation from a pharmacist, etc.” Cognitive methods using online content were higher among male parents than among female parents (28.0% vs. 11.5% ; P<0.001). Regarding catchphrases that make them want to hear, female parents were more likely to hear about generic drugs than male parents were if the catchphrases quality and safety were used (38.1% vs. 23.8% ; P＝0.007). Compared to parents of 7-19-year old children (6.8%), parents of 0-6-year old children (13.1%) reportedly switched to generic drugs because they were easier to ingest (P＝0.022). Conclusion: Recommendations from medical professionals such as pharmacists are effective in convincing parents of young patients to switch to generic drug use. To promote the use of generic drugs in young patients, in addition to explaining and publicizing its financial benefits, pharmacists need to explain the added value of generic drugs such as the ingenuity of its dosage form. In addition, it is essential to adopt a multifaceted approach that considers the parents’ background including (1) publicity using the internet for male parents, (2) reaching out to female parents with preschool children, (3) increasing publicity using tickets for children’s medical expenses subsidy system, and (4) drug education that matches the growth of children.

Owing to the fear of worsening their relationship with physicians, several pharmacists hesitate to contact physicians regarding prescription-related questions. We investigated the personal factors of pharmacists contributing to their hesitation to contact physicians regarding prescription-related questions. We analyzed the responses of 213 pharmacy pharmacists. A comparison of the degree of hesitation to contact physicians regarding prescription-related questions revealed that the most hesitant questions were pertaining to “the same prescription content from before”; insurance questions (3.37) were higher than medical questions (3.20) (P＝0.006). The multiple regression analysis results revealed that “pharmacy work is busy and there is no time” was influenced by regular employees (medical (β＝−0.181, P＝0.030) and insurance (β＝−0.257, P＝0.002)). “A co-pharmacist said no questions needed” was influenced by the sex of pharmacists (medical (β＝0.194, P＝0.011) and insurance (β＝0.177, P＝0.020)). Overall, type of questions (medical or insurance) and individual backgrounds (prescription issuing medical institution, pharmacy scale, location, age, sex, employment type, years of service, current management pharmacist, and hospital work experience) have a complex effect on the pharmacists’ psychology. To facilitate pharmacists to contact physicians regarding prescription-related questions, physicians and pharmacists should share information and communicate on a daily basis, such as actively participate in joint training programs. It is also important to create an environment where regular employees and female pharmacists can work comfortably. The smooth resolution of prescription-related questions by relieving the psychological pressure of pharmacists will improve patient safety.