Objective: In our previous study, we revealed that articles on "dangerous drugs" in weekly magazines are inadequate and incomplete with respect to scientific validity, and that there may be many aspects that need to be improved. Next, the extent to which medical professionals, including doctors, pharmacists, and nurses, received consultations by patients owing to such media reports and what countermeasures are implemented requires clarification. In the present study, as a first step, we performed a questionnaire survey of community pharmacists to clarify the occurrence of such consultations.

Methods: A questionnaire survey was conducted among 698 community pharmacists. The survey was conducted over 10 days from December 8 to 17, 2021.

Results: Out of the 698 community pharmacists, 545 responded (response rate: 78.1%). Of these, 323 (59.3%) had experienced consultations from patients owing to media reports on the dangers of drugs. Of the 323 respondents, 215 (66.6%) had experienced these consultations less than five times. In contrast, 83 respondents (25.7%) reported more than 10 such consultations. Of the 545 respondents, 190 (34.9%) responded that they routinely perform measures to deal with media reports on the dangers of drugs. The most common routine measure was the "regular checking of various media sources (including preparation of responses when receiving consultation requests)."

Conclusion: Our results indicated that more than half of the community pharmacists had experienced receiving consultations from patients, although only approximately 30% were adopting routine measures. This suggests that community pharmacists have been affected to some extent by these media reports, and that further countermeasures need to be implemented.

Objective: Drugs that are excreted by the kidneys may require dose adjustments, depending on the patient’s renal function. The pharmacist must ask the prescribing physician about the prescription if a dose is deemed inappropriate. In the current study, we investigated the economic effects of prescription questions associated with renal function and the antibiotics treatment completion rate.

Methods: The current study included inpatient prescription inquiries by pharmacists at our institution between January and December 2018. For all cases that were inquired prescription, the economic effects were estimated as follows; the drug costs were calculated based on drug prices at April 2018 edition, and the reduced medical care costs associated with avoiding adverse reactions due to prescription questions were calculated based on the number of benefits and the total cost of benefits in the Relief System for Sufferers from Adverse Drug Reactions. The antibiotics treatment completion rates were calculated based on the number of cases in which drug and dose maintained after prescription questions.

Results: The study included 279 cases, 266 of which involved inappropriate doses due to deteriorated renal function. Most prescriptions were for antibiotics. The drug costs were reduced due to the prescription question in 213 cases; the total reduced cost was 699,483 Japanese yen. The economic effects associated with avoiding adverse reactions due to prescription questions were worth approximately 11,481,056 Japanese yen. The completion rate of antibiotic treatment in cases where doses were reduced due to prescription questions was 63.0% (treatment of 75 cases completed/all cases were 119), compared with 63.6% (7 cases/11 cases) in cases in which doses were not changed. Thus, dose reduction due to questions regarding the prescription did not lead to reduced completion rates of antibiotics treatment (p=0.621).

Conclusion: Dose adjustments due to prescription questions about drugs excreted by the kidneys led to reduced drug costs and adverse reactions, and did not result in negative effects during infectious disease therapy.

Objective: In clinical settings, new drugs are frequently administered to patients who have been excluded in the clinical trials. However, health professionals seldom recognize this. Focusing on monoclonal antibody drugs, we conducted a questionnaire survey of pharmaceutical companies and accumulated cases in which risk management differed between clinical trials and post-marketing.

Methods: We obtained information on exclusion criteria for clinical trials of monoclonal antibody preparations from pharmaceutical companies. We compared these exclusion criteria with the contraindicated items in the package insert.

Results: The most common exclusion criteria were “reproductive-related events”, “cancer-related events”, “HBV/HCV infection”,and “history of allergy/hypersensitivity”. The most common contraindications in the package insert were “history of allergy/hypersensitivity”, “other infectious diseases”, and “tuberculosis infection”. The average number of exclusion criteria for safety measures at the time of clinical trial was 10.1per drug, while that of contraindications was 2.1per drug; the difference was statistically significant. In addition, there were significant differences in one clinical trial exclusion criterion ( “upper age limit” ) and two contraindications ( “tuberculosis infection” and “other infectious diseases” ) between antineoplastic agents compared to therapeutic agents for autoimmune-related diseases. In half the products, serious adverse drug reactions related to the exclusion criteria that were not contraindicated were reported after marketing.

Conclusion: Because the contraindications at the time of marketing are drastically fewer compared to the exclusion criteria at the time of clinical trials, pharmacists should inform doctors of it and carefully monitor the outcomes of new drugs that have not been used with patients with complications.

Objective: Our previous study reported many technical alarms in the dispensing inspection support system due to setting or operation errors, but not due to dispensing errors, and that countermeasures reduce technical alarms. In this study, we investigated the long-term effects of the countermeasures.

Methods: The log data of the inspection results were extracted from the dispensing inspection support system and divided into image inspection and weight inspection data. The details and frequency of technical alarms before (April-June 2019), after (April-June 2020), and one year after (April-June 2021) the countermeasures were compared by chi-square test.

Results: The frequency of technical alarms in image inspection was 13.7, 11.3, and 9.1% in 2019, 2020, and 2021, respectively (p< 0.01). However, the frequency of technical alarms in weight inspection was 3.0, 3.0, and 1.6% in 2019, 2020, and 2021,respectively (p< 0.01). The ratio of technical alarms to all alarms was 98.2% for image inspections and 91.2% for weight inspections in 2021.

Conclusion: The frequency of technical alarms was reduced by the countermeasures. However, the ratio of technical alarms to all alarms is still high, and further improvements are needed to prevent the loss of reliability due to technical alarms.

Objective: The provision of drug information from medical representatives (MRs) of pharmaceutical departments was changed to non-face-to-face on the principle of preventing further spread of the Coronavirus disease 2019 (COVID-19). However, there have been no reports investigating the impact of operational changes under such circumstances on the drug information response service and drug information provision activities of MRs. In this study, we investigated the influence of such changes.

Methods: We investigated the number of requests for drug information from MRs, the number of visits by MRs, and the response rate for information issued by companies. In addition, a questionnaire survey was conducted with MRs who provided information to drug departments to investigate their workload, work efficiency, and sense of anxiety about the provision of information.

Results: The MRs’ average number of requests per operating day was 16.0±6.4 (cases/day). The median number of visits to the pharmacy department per operating day was 11 before the operational change, compared to 1 after the change, revealing a significant decrease (p < 0.001). The response rate for information provided by companies was 64.9% (161/248) after the operational change,compared to 64.6% (93/170) after the change, showing no significant difference (p=1.00). As for the influence on information provision activities, less than half of the MRs perceived a negative influence in terms of workload and efficiency; however, more than half of the MRs perceived a negative influence in terms of anxiety about information provision.

Conclusion: We clarified the impact of operational changes during the COVID-19 pandemic on our work. We believe that the results of this study can be one of the most useful sources of information for continuing information provision activities based on the principle of non-face-to-face communication.

Objective: In this study, we conducted a questionnaire survey of hospital pharmacists throughout Japan with the aim of identifying the most-requested in-hospital preparations and off-label use drugs, and exploring the possibility of commercializing them.

Methods: The Commercialization Study Group of the Japanese Society of Hospital Pharmacists conducted a questionnaire survey on the Japanese Society of Hospital Pharmacists website targeting hospital pharmacists who are members of the Japanese Society of Hospital Pharmacists. The period of the survey was from February 1, 2019 until January 21, 2020. In the questionnaire, the respondents wrote specific product names (generic names), specifications, and dosage forms that they would like to see improved and made commercially available in a free-text format. In addition, respondents chose their reasons for wanting the product to be improved or made commercially available from a list.

Results: A total of 1,627 drugs were requested to be made commercially available. After duplicates and insufficient descriptions were excluded, the total was 553. The drugs that were most frequently requested were Levothyroxine suppositories, followed by Mohs’ ointment and Ulinastatin vaginal suppositories.

Discussion: This survey identified certain drugs that pharmacists want to be commercialized and the specific reasons why. In-hospital preparations not only benefit patients whose diseases are becoming more complex and difficult to treat with existing prescription drugs, but also enable pharmacists to demonstrate their abilities. We believe that the commercialization of these important in-hospital preparations and off-label drugs will help avoid various risks associated with dispensing them and enhance the pharmacy profession. For this reason, pharmaceutical drug companies should conduct further surveys on the actual use of and literature research on the efficacy and safety of the drugs that were ranked high on the questionnaire and start considering their commercialization.

Objective: There is little information on the effectiveness and safety of health foods for pregnant women. The purpose of this study was to analyze the risk of health food to pregnant women and fetuses from pharmaceutical interventions and clarify the problems for standardization of pharmaceutical management and guidance.

Methods: Among 243 pregnant inpatients who received consultations from our pharmacists, 61 subjects were taking health food products were recruited from May 2015 to April 2017. We developed novel guidelines for the use of health food products for pregnant women, and used the guidelines to provide pharmaceutical interventions. Results of these interventions were reviewed retrospectively to identify issues associated with pharmaceutical management of the use of health food products.

Results: Among 61 subjects, 10 (16%) received a total of 11 interventions for the use of health food products. Suggestions to discontinue the use of health food products were accepted by 9 subjects (82%). The majority of interventions (n=7, 64%) were related to therapeutic disadvantages of health food products, such as “bleeding complications during childbirth” and “interaction with other medicines”. Information on the number of weeks of pregnancy, drug history, and treatment status were used to trigger and determine appropriate pharmaceutical interventions.

Conclusion: From the intervention cases, the potential disadvantages associated with the use of health foods were confirmed, and the risk status of pregnant women and fetuses associated with the use of health foods was clarified. It is necessary to intervene before embarking on using health foods, to make judgements based on risk assessment considering the number of weeks of pregnancy and patient background, and to provide accurate information to pregnant women. We anticipate that future studies will provide additional insights into the effects of health food intake on pregnant women, and that support systems for pregnant women will be established by medical professionals.