Objective: The purpose of this study is to investigate incidents of erroneously dispensed drugs on the assumption that the incidents stem from the similar names of the drugs.  The investigation was also conducted to prevent such dispensing incidents in the future, i.e. to search for factors that can prevent future incidents, and finally to propose a prevention plan which takes each of these factors into account.
Methods: We extracted incident cases related to generic drugs reported by pharmacies in Japan and from those cases examined those that were categorized as cases of erroneously dispensed medicine.  We used this data to categorize the difference in relationship between the drugs which were supposed to be prescribed and those which were erroneously dispensed, and to analyze the association between the “Flowchart for Avoiding Confusion Errors between Similarly Named Drugs” and the name similarity index based on this flowchart.
Results: The types of incident cases due to name similarities of generic drugs were categorized into specification mistakes and brand mistakes.  The edit of the name similarity index were especially important factors for dispensing incidents between generic drugs.
Conclusion: This study focusing on generic drugs revealed the factors that result in dispensing incidents due to name similarity.  Further empirical studies investigating the usefulness of interventions that alter the name similarity index is required.

Objective: The present study aimed to investigate the identification codes of tablets used in clinical practice, and to clarify the influence of these codes on the differentiation of drugs brought in by patients, and those that have been dispensed as one-dose packages at Tottori University Hospital.
Methods: We obtained the identification codes of tablets, which were released on the market before December 2013, based on their package inserts.  Concerning drugs without identification codes, we conducted a questionnaire survey involving companies releasing these drugs in order to clarify the reasons for the absence of these codes.  Among the drugs brought to the Hospital by patients who were hospitalized in 2013, we investigated the identification codes of tablets dispensed as one-dose packages, and the accuracy of the differentiation of these tablets.
Results: We investigated a total of 5,797 tablets. Among the tablets in which the identification codes imprinted on one side of these tablets were the same, the other side did not have codes for 65 tablets (28 pairs), and had different codes for 1,836 tablets (198 pairs).  A total of 244 tablets did not have identification codes.  The most common reason for releasing drugs without such codes was the cost.  Investigation of the drugs brought in by patients hospitalized revealed that some pharmacists mistook Grinolart®50 mg for Glucobay®50 mg due to them having the same code.
Conclusion: To prevent the misidentification of drugs brought in by patients, hospital pharmacists need to cooperate with other hospitals and health insurance pharmacies, and dispense drugs while regarding their distinguishability as of major importance.  In addition, to increase the distinguishability, identification codes need to be imprinted on both sides of tablets, and there is a need to avoid manufacturing drugs whose identification codes are the same.

Introduction: The purpose of this study is to elucidate the influence of drugs on infants and to provide information about safe drug treatments during breastfeeding using the FDA’s Adverse Event Reporting System (FAERS).
Study Design: Case series based on FAERS data.
Methods: We used the cleaned FAERS data in JAPIC AERS, extracted cases of adverse events from the category “neonatal exposure through breastfeeding (2000189)” in Standardized MedDRA Queries, and collected “the cases of breast-feeding infants” by system organ class, the type of adverse event, therapeutic category of first suspected drugs, and the generic name of the drugs.  We aggregated the data of the most reported cases of suspected drugs from first to fifth by the name of the adverse event.  Additionally, we investigated the properties and disposition of each suspected drug and verified the transitivity of breast milk as well.
Results: Only 551 cases of breast-feeding infants (0.01%) were extracted from the data of JAPIC AERS.  The aggregated data of adverse events in terms of system organ class showed high numbers of gastrointestinal disease (such as diarrhea and vomiting) and impairment of the nervous system (such as drowsiness), and drugs which acted on the nervous system were the most suspected drugs.  There were 26 cases of adverse events associated with lamotrigine, which was the most frequently reported.
Discussion: We could observe the characteristics of adverse events and suspected drugs that were shown as the influence of drugs taken during breastfeeding which were exposed to infants.  Our study showed 2 conclusions: 1) the drugs that have had adverse events frequently reported have the characteristic of facilitating the drug’s migration into breast milk, and 2) the most frequently reported cases were those in which nursing mothers or medical experts could recognize the correlation between breast milk and the adverse event(s) immediately after breast milk was given to the infant.

Objective: Medical education was initiated in 2012 as part of health and physical education (HPE) in junior high schools.  This new measure was a result of a revision of school curriculum guidelines.  In this study, we aimed to clarify the implementation status of medical education in schools.
Methods: A questionnaire survey targeting junior high school teachers in Gifu (from 184 junior high schools) was conducted by mail.
Results: 60.9% of schools responded (112/184).  HPE teachers and school pharmacists were found to be in charge of providing medical education in 94.6% and 10.7% of schools, respectively.  The average duration of classes was 50 min and the average frequency was 1.2 times a week.  On average, 0.9% of schools stated that implementing medical education was “under contemplation,” 2.7% held “occasional” classes, and 2.7% only held “drug abuse-related” classes.  It was also found that the most commonly used educational material was the school textbook (91.1% of schools).  Additionally, 87.5% of schools responded “yes” to “lectures are delivered by outside lecturers,” and 69.6% responded “yes” to “we hope to introduce workshop participation.”
Conclusion: The results of the survey indicated that many junior high schools have provided medical education classes and that HPE teachers were in charge of teaching these classes.  However, some schools have not provided these classes.  It is considered necessary to enhance medical education activities in the pharmaceutical field by involving specialists from different areas.

Objective: Tamoxifen is a drug that is frequently administered for 5 years to treat hormone receptor-positive breast cancer in premenopausal women.  Metabolism of tamoxifen by cytochrome P450 enzymes such as CYP3A4 and CYP2D6 is required for drug efficacy.  However, reports suggest that the effect of tamoxifen is attenuated in the presence of CYP2D6 inhibitors.  In this study, I evaluated drug-drug interactions that may attenuate tamoxifen action for improved pharmaceutical management.
Data Source: Potential interactions were evaluated by using the tamoxifen package insert, Kyoto Encyclopedia of Genes and Genomes (KEGG), Pharmaceuticals and Medical Devices Agency (PubMed), and Lexicomp Online.  We have searched the paper using the PubMed and JDream III.
The Choice of Research: The paper about the interaction related CYP2D6 and 3A4 of tamoxifen.
Results and Conclusion: The use of tamoxifen is often long term; however, adverse effects such as hot flashes, can cause poor regimen adherence.  Although selective serotonin reuptake inhibitors (SSRIs) can effectively treat menopausal hot flashes, many SSRIs inhibit CYP2D6.  In particular, paroxetine has been reported to adversely affect tamoxifen metabolism.  There are 31 drugs and 843 compounds that inhibit CYP2D6.  Thus, it is necessary to avoid these combinations.  In addition, there are many CYP2D6 gene polymorphisms that have been identified in Japanese patients, and some reports indicate that they affect tamoxifen efficacy.  Therefore, in order to continue use of these medications without attenuating the effect of tamoxifen, development of medical database which can be updated daily is required to avoid CYP-related interactions.

Objective: In drug treatment for pregnant and lactating women, pharmacists need to contribute to adequate drug treatment by collecting much information from various sources.  However, it takes much time to collect information using plural sources.  In this study, we tried to develop a database system which enables expeditiously collecting the domestic and foreign drug use criteria information in order to streamline collecting information for pregnant and lactating women.  In addition, we assessed the utility of the database by comparing the time to collect information using the database to that using each information source and the usability by questionnaires.
Methods: We developed a database system that integrates drug information from the FDA Pregnancy Category, Australian categories for prescribing medicines in pregnancy, “Drugs in Pregnancy & Lactation,” and Japanese package inserts.  For assessment of the usability of the database, we assessed the time required to collect information and subjective evaluation using the five-method questionnaires.
Results: The database significantly reduced the time needed for collecting criteria information and made it possible to compile the information simultaneously from various sources.  The questionnaire survey showed that over 80% of pharmacists and students were satisfied with the database.
Conclusion: It is suggested that our database system is useful to efficiently collect drug use criteria information for pregnant and lactating women.

Objective: The subjects of this study were consumers with cold-like symptoms who visited drugstores to purchase OTC drugs.  The purpose was to elucidate the factors that influence the intention of these consumers to consult pharmacists or sellers.
Design: Analytic observational study
Method: We conducted a survey of consumers who visited pharmacies or drugstores for cold-like symptoms.  Pharmacists and registered sellers (hereafter “pharmacists or sellers”) utilized tools to serve them, entering details in customer records.  We handed postcards to these consumers asking them to respond to questions about the prognosis and the degree of satisfaction about the service they had received.  We then used the customer records and follow-up results to perform linear regression analysis with “I would like to consult the pharmacist or seller again” (hereafter “desire for consultation”) as the dependent variable, and the usefulness of the advice and degree of satisfaction about the explanation and service as the independent variables.
Results: We analyzed the data of 81 consumers for whom we were able to match the customer records and postcards.  The linear regression analysis indicated that “the usefulness of the advice (coefficient of standardization: 0.73)” affected the desire for consultation most, followed by “the degree of satisfaction about the service (coefficient of standardization: 0.24).
Conclusion: We verified that, in self-medication assistance, advice that lets consumers feel the consultation was actually “helpful” by focusing on individual needs, and good customer service were necessary to increase the desire for consultation with pharmacists or sellers, and to encourage actual consultation.

Objectives: First steps to promote the proper use of medicines in remote islands and rural areas are as follows: (1) recognition of the profession of “pharmacist” from secondary-remote-island residents who do not have a pharmacy or drugstore or the opportunity for pharmacist contact and (2) an understanding by remote-island residents of the advantages of having a “family pharmacist.”
Methods: Repeated “medicine information and consultation sessions” for secondary-remote-island residents of Japan’s Nagasaki Prefecture were held.  Residents were then surveyed for changes in awareness of or demand for pharmacists and the nature of such changes.
Results: Before the information sessions, 29.7% of residents did not recognize the profession of pharmacy, but the extent of their recognition increased after information sessions were concluded.  They were asked “Who explains medicines in a way that is easy to understand ?”; more than half responded “doctors” before the information session, but after information sessions were concluded, those who said “pharmacists” increased.
Conclusion: Conducting “medicine information and consultation sessions” for residents of secondary-remote islands and rural areas enabled them to understand the profession of pharmacy.  The initiatives in the present study are first steps toward promoting proper use of medicines by residents of remote islands and rural areas who use “family pharmacies/pharmacists.”

Objective: Distigmine can cause cholinergic crisis as the side effect.  In 2010, the safety information of distigmine was announced and its dosage was changed up to 5 mg per day.  However, the malpractice that a pharmacist dispensed over dose of distigmine caused severe health damages in a community pharmacy.  Therefore, we made the protocol with the urologists for the appropriate use of distigmine, including contents of monitoring the side effects.  The purpose of this study was to measure using the protocol was useful for the propulsion of proper use of distigmine.
Methods: The protocol was introduced in 10 community pharmacies and 1 hospital pharmacy from December 2013 to April 2014, and the patients and pharmacists were filled out the answer to the questions that we have made.  The protocol consisted of five main checks; the dosage, lower urinary tract symptom, presence of renal disease, combined drugs, and signs of the side effects.  Each patient was filled out the checklist given by the pharmacist to monitor the signs of the side effects for 2 weeks.
Results: The 3 prescriptions of distigmine (18.8%) were more than 10 mg per day.  Although 2 patients were confirmed diarrhea and sweating etc., they were mild.  The pharmacists significantly more (p<0.05) answered that the protocol made their motivation to do the pharmaceutical interventions.  All of the patients answered that the pharmaceutical interventions made them relieved.
Conclusion: The use of protocol that we made supported pharmacists to do the pharmaceutical interventions and patients welcome them.

Objective: The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.
Design: Document analysis.
Methods: We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.
Results: Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.
Conclusion: About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.