Objective: The purposes of this study were to verify the actual state and to identify the problems associated with research activities by pharmacists.
Methods: The abstracts presented at the 42nd and the 37th Japan Pharmaceutical Association (JPA) Congress of Pharmacy and Pharmaceutical Science were investigated.  They were categorized into six research types: “Outcome research”; “Intervention research”; “Observational study”; “Status report”; “Case report”; and “Other”.  They were then ranked according to evidence level, with “Outcome research” ranked the highest.  In addition, “Outcome research”, “Intervention research” and “Observational studies” were checked for whether they had structured abstracts, and form scores were awarded.
Results: We found that only 0.8% of abstracts were “Outcome research”.  but the level was higher at the 42nd Congress than the 37th (p=0.03).  Structured abstracts were also more common at the 42nd Congress than at the 37th (p<0.01).  However, the form scores were not significantly different between the 42nd and 37th Congresses.
Conclusions: Our findings suggest that pharmacist research activities are improving, but that there is still room for further development.  The referee system and the guidelines for research design are useful methods to encourage more activity.  The target of this study was community pharmacy, and further studies are necessary for hospital pharmacy.

Objective: Nowadays, patient-centered medical care is essential.  It is very important to use layman’s terms that patients can understand. However, most medical staff tend to use difficult medical terms.  The purpose of this study was to investigate the amount of difficult medical terms in briefing papers given to patients.
Methods: We conducted a questionnaire survey on September 21, 2012 of 246 non-medical professionals in order to identify difficult medical terms used in a manual for handling disorders due to adverse drug reactions.
Result: It was found that there were 387 terms of those in the manual (n=980) that non-medical professionals had never seen or heard before (39.5%).  There were 128 terms for which they could not correctly replace Japanese kana (phonetic) characters with kanji (pictorial) characters (13.1%).
Conclusion: The results indicate that the manual has many terms that are difficult for non-medical professionals to understand.  This may hinder patients’ comprehension.  These difficult medical terms need to be replaced with layman’s terms.

Objective: Recently, use of health foods and supplements, as well as the amount of information available about them, has been steadily increasing.  Therefore, a noticeable increase in adverse drug reactions caused by health foods and supplements has also been seen.  The purpose of this study was to clarify the current status and backgrounds of patients with health food- or supplement-related adverse health effects.
Methods: We selected the cases of health food- or supplement-related adverse health effects from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database, which contains over 57,000 case reports of adverse drug reactions.  We investigated the background, suspected products and adverse events in each case and conducted univariate logistic regression analysis to determine significance.
Results: We obtained a total of 327 cases consisting of 103 causative products.  Women comprised 66% of study subjects and had a significant association with dietary supplements.  Patients with a history of liver disease had a significant association with liver damage caused by “Ukon,” a drink made from turmeric root and sold as an anti-hangover remedy in Japan.
Conclusion: The causative products had several unique features.  This information should be utilized to prevent health food- and supplement-related adverse health effects in the future.

Objective: The present study investigated risk factors and subjective symptoms associated with drug-induced thrombocytopenia.
Methods: We selected 361 patients with drug-induced thrombocytopenia from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database of over 65,000 case reports of adverse drug reactions and assigned these patients to a case group.  We also randomly selected 794 cases of adverse drug reactions not associated with thrombocytopenia as a control group.
Results: Data were compared between the case and control groups, and results were analyzed using logistic regression analysis.  We identified type of infection (non-viral) and renal failure as risk factors for drug-induced thrombocytopenia.  In addition, administration of carbamazepine, methotrexate, interferon alpha, ticlopidine or valproic acid significantly increased the risk of drug-induced thrombocytopenia.  Significant associations were also found between drug-induced thrombocytopenia and purpura, fever, and mucosal bleeding.
Conclusion: These findings provide helpful information for early detection and prevention of thrombocytopenia as a serious adverse drug reaction.

Objective: In recent years, the Ministry of Health, Labor and Welfare has actively promoted the use of generic drugs.  However, implementation of this policy has not progressed smoothly, as information on generic drugs is poorly organized.  As a result, it is difficult for pharmacists to select the appropriate generic drugs.  Therefore, we attempted to develop a code system to organize information on generic drugs.
Methods: We analyzed the guidelines used for the approval of generic drugs.  We then identified the important aspects for comparison of generic drugs and developed a code system.  Next, we tested this code system using temocapril hydrochloride tablets, which is a generic drug.
Results: We were able to develop a code system for selection of generic drugs.  Furthermore, we confirmed the utility of this code system for selecting generic drugs in the case of temocapril hydrochloride tablets.
Conclusion: We believe that this code system with be useful for pharmacists, but further development is necessary for other generic drugs.

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 purpose of this study is to identify the problems in the adverse drug report (ADR) system in early post-marketing vigilance phase (EPM phase) in Japan.
Methods: The incidence of all ADRs and the ratio of serious ADRs were compared between the new drug application phase (ND phase) and the EPM phase.  The target medicines were Moxifloxacin (Avelox®tablets, 400mg), Gatifloxacin (Gatiflo®tablets, 100mg) and Prulifloxacin (Sword®tablets, 100mg).
Results: The average incidence of all ADRs in the ND phase was 100-fold greater than that in the EPM phase.  There were also 2-fold differences in the ratio of serious ADRs of individual medicines.
Conclusion: There are several problems with the ADR system in the EPM phase in Japan.  It is currently possible that the implementation of EPM will vary between in individual medicines and companies.  This suggests that the present data cannot be applied universally.  Thus, there is an urgent need to standardize the implementation of EPM.

Objective: In recent years, the Ministry of Health, Labor and Welfare has actively promoted the use of generic drugs.  However, implementation of this policy has not progressed smoothly, and generic drug companies suggest that this is because medical staff and patients are not properly informed.  We examined pharmacists’ knowledge and opinions concerning generic drugs.
Methods: We conducteda questionnaire survey to determine community pharmacists’ opinions and understanding with regard to generic drugs.
Results: About 90% of pharmacists were apprehensive about the use of generic drugs.  All pharmacists scored low on factual questions, answering an average of 40 % correctly.  The question about the bioequivalence evaluation method in particular was poorly answered.  However, pharmacists’ anxiety about using generic drugs was not related to their knowledge.
Conclusion: Our findings suggest that community pharmacists lack sufficient knowledge about generic drugs.  It is therefore necessary to educate them on the use of generic drugs.  Also, in order to allay pharmacists’ fears, it is important to improve the comprehensiveness of information concerning generic drugs.

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.

Purpose: The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events.  We performed a case series study.
Methods: We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University.  We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.
Result: We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events.  The most frequent offending drug in both groups was ritodrine hydrochloride.  The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride.  The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.
Discussion: We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride.  Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride.  We need to monitor both mothers and fetuses during the drug administration.  It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers.  Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy.  We believe the results could be helpful in the early detection of adverse events in the future.