2.Analysis of Actual Pharmacist Research Activity at Japan Pharmaceutical Association (JPA) Congress of Pharmacy and Pharmaceutical Science
Takamasa Sakai ; Fumiko Ohtsu ; Nobuyuki Goto
Japanese Journal of Drug Informatics 2012;13(4):183-188
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.
3.Analysis of Erroneously Dispensed Named Generic Drugs
Takato Kunito ; Kouichi Tanabe ; Takamasa Sakai ; Fumiko Ohtsu ; Nobuyuki Goto
Japanese Journal of Drug Informatics 2016;18(2):131-140
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.
4.A Case Report of Fatal Cerebellar and Brainstem Infarction Accompanying Clamping of the Left Subclavian Artery during Operation for Thoracic Aortic Aneurysm.
Hajime OTANI ; Yoshiya SAKURAI ; Kazuho TANAKA ; Michio FUKUNAKA ; Hiroji IMAMURA ; Nobuyuki SAKAI
Japanese Journal of Cardiovascular Surgery 1993;22(6):510-513
The authors experienced a case of fatal cerebellar, and brainstem infarction accompanying clamping of the left subclavian artery during operation for thoracic aortic aneurysm. Autopsy of this case revealed that right vertebral artery became markedly hypoplastic distal to the posteroinferior cere bellar artery, and left vertebral and basilar arteries were occluded by thrombus formation. These findings indicate that clamping of the dominant left subclavian artery is responsible for severe vertebrobasilar ischemia producing the fatal brain infarction. Since the occurrence of this devastating complication, we have performed pancerebral angiography and balloon occlusion test of the left subclavian artery in patients who might undergo proximal clamping of the aortic arch between the left carotid artery and the left subclavian artery during operations for thoracic aortic aneurysm. Selective perfusion of the left subclavian artery is then planned for those with abnormal vertebrobasilar communications producing neurological signs.
5.The Influence of Drugs Taken during Breastfeeding on Infants: Report and Analysis of Adverse Events Using FAERS
Maki Sakakibara ; Takamasa Sakai ; Chiyo Mori ; Yasushi Hinomura ; Nobuyuki Goto ; Fumiko Ohtsu
Japanese Journal of Drug Informatics 2016;18(2):114-122
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.
6.Characteristics of Adverse Events in Pregnant Women
Chiyo Mori ; Takamasa Sakai ; Reiko Yano ; Kouichi Tanabe ; Nobuyuki Goto ; Fumiko Ohtsu
Japanese Journal of Drug Informatics 2017;18(4):261-269
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.
7.Clinical and Epidemiological Studies of Ixodiasis and Infectious Diseases Sequental to Ixodes Tick Bites in Rural Areas: Report II
Nobuyuki HORIUCHI ; Yosio NISHIGAKI ; Sinji OGUCHI ; Kuninori SHIWAKU ; Takeshi MATSUNAGA ; Hiroyuki SAKAI ; Eiji SATOU ; Nagao SUZUKI ; Kimito UCHIKAWA ; Kouichi MURAMATSU ; Nobuki YAJIMA
Journal of the Japanese Association of Rural Medicine 2005;54(1):50-64
This is the second report of the findings of the clinical and epidemiological studies on pathogen-carrying madani tick bites (ixodiasis) and the vector-borne diseases conducted by a study group of researchers specially organized by the Japanese Association of Rural Medicine. The report covers the period from January 1 through December 31, 2004.The same questionnaires that had been prepared in the previous survey were sentto 80 JARM-affiliated medical facilities and 11 non-member medical institutions to collect information about tick bites and resultant infections.It was found that during 2004 there were 134 cases (67 for men and 67 for women) of skin lesions caused by ixodid tick bites, 14 cases of Lyme disease (7 for men and the same for women), and none for Japanese spotted fever. These ixodiasis cases did not show any speciffic difference from those reported previously. All the Lyme disease patients developed erythema migrans which characterize stage 1 infection.As there is still plenty of catching up to do in terms of coping with the tick bite problems in Japan, we referred to some literature on the control of ixodid ticks, serologic testing techniques for Lyme disease, administration of prophylactic antibiotics and therapeutic methods.
Ticks
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Clinical
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Lyme Disease
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seconds
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Japanese language
8.Is repeated high-dose medroxyprogesterone acetate (MPA) therapy permissible for patients with early stage endometrial cancer or atypical endometrial hyperplasia who desire preserving fertility?.
Wataru YAMAGAMI ; Nobuyuki SUSUMU ; Takeshi MAKABE ; Kensuke SAKAI ; Hiroyuki NOMURA ; Fumio KATAOKA ; Akira HIRASAWA ; Kouji BANNO ; Daisuke AOKI
Journal of Gynecologic Oncology 2018;29(2):e21-
OBJECTIVE: Reports on the repeated administration of medroxyprogesterone acetate (MPA) for intrauterine recurrence after fertility-preserving therapy for atypical endometrial hyperplasia (AEH) and early grade 1 endometrioid carcinoma (G1) are lacking. We aimed to clarify the outcomes of repeated MPA therapy in cases of intrauterine recurrence after fertility-preserving therapy with MPA against AEH/early G1. METHODS: Patients with AEH or stage IA well-differentiated endometrioid carcinoma without myometrial invasion who underwent first-line MPA therapy for primary lesions or intrauterine recurrence were divided into initial treatment and repeated treatment groups (162 and 82 patients, respectively). Oral MPA administration (400−600 mg/day) was continued until pathological tumor disappearance. Data regarding clinicopathological factors, adverse events, and outcomes following the initial and repeated hormonal treatments were extracted from medical records and analyzed. RESULTS: Complete response rates in the initial and repeated treatment groups were 98.5% and 96.4%, respectively, among patients with AEH, and were 90.7% and 98.1%, respectively, among patients with G1. In the initial treatment group, 5-year recurrence-free survival (RFS) rates were 53.7% and 33.2% among patients with AEH and G1, respectively. In the repeated treatment group, RFS rates were 14.0% and 11.2% among patients with AEH and G1, respectively. Among patients with AEH, the pregnancy rate tended to be lower in the repeated treatment group than in the initial treatment group (11.1% vs. 29.2%; p=0.107), while no significant group difference was observed among patients with G1 (20.8% vs. 22.7%). CONCLUSION: Repeated treatment is sufficiently effective for intrauterine recurrence after hormonal therapy for AEH/early G1.
Carcinoma, Endometrioid
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Endometrial Hyperplasia*
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Endometrial Neoplasms*
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Female
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Fertility Preservation
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Fertility*
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Hormone Replacement Therapy
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Humans
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Medical Records
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Medroxyprogesterone Acetate*
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Medroxyprogesterone*
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Pregnancy Rate
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Recurrence
9.Creating a Checklist and a Survey on Research That Used the Japanese Adverse Drug Event Report Database
Takamasa SAKAI ; Yukito WADA ; Akira KOKAN ; Kouichi TANABE ; Nobuyuki GOTO ; Fumiko OHTSU
Japanese Journal of Drug Informatics 2020;22(1):7-16
Objective: The purpose of this study was to create a checklist that summarizes checkpoints that should be noted when using the Japanese Adverse Drug Event Report database (JADER). After we created the checklist, we then used it to survey published academic papers that used JADER.Method: First, we created a draft checklist for research that uses JADER by citing the report of CIOMS working group VIII “Practical Aspects of Signal Detection in Pharmacovigilance”. Then, we conducted a pilot test and revised the draft checklist. Finally, the checklist was completed after the review by a pharmacoepidemiology expert. The checklist was applied to published academic papers that used JADER, and the fulfill rate of each checkpoints was calculated.Results: A “checklist of important points to be noted during research that uses the data mining method in JADER (mainly signal detection by disproportionality analysis)” was created. We also revealed problems with published academic papers that used JADER. For example, some researchers were thought to be inappropriately using JADER as a source of their research while others used an inappropriate version of MedDRA.Conclusion: The checklist created in this study summarizes key points that could be noted in research that uses JADER and is thought to contribute to an improvement in quality of research that uses JADER. Additionally, in our investigation of published academic papers that used JADER, we found the possibility that both the role of signal detection and the impact on analysis of JADER using the updated MedDRA version are not well understood.
10.Japanese Medical Academic Organizations Surveyed on the Current Situation of Medical Information Providedto the Public on the Internet
Nobuyuki GOTO ; Hitoshi TSUKAMOTO ; Takaaki KODAWARA ; Toshiaki IGARASHI ; Kyohei WATANABE ; Ryoichi YANO ; Takamasa SAKAI ; Fumiko OHTSU
Japanese Journal of Drug Informatics 2021;22(4):193-201
Objective: The internet isflooded with drug information; however, some of it isinappropriate and thisinadequate information could expose the public to health hazards. Therefore, we conducted research on the idea of transmitting drug information to the public via the internet and the current state of the information currently provided by each academic society relevant to the field of Medical Informatics.Methods: A questionnaire was mailed to the website managers for the website of 129 specialist medical societies, all members of the Japanese Association of Medical Sciences. We conducted our research between October to November 2018. We investigated each website administrator’s opinion about offering drug information for consumers via the internet and what information each academic society is currently providing.Results: The effective response rate was 43.4% (56/129 groups). Most respondents thought that drug information overflowed in the current Internet society. Moreover, more than half of the respondents thought that the quality of drug information transmitted to the public wasinadequate. Currently, 30 of the academic groupssurveyed are providing information to the public. When providing information, they did not refer to the “Drug Guide for Patients” much. More than 80% of respondents said they would cooperate with linking to the information provided to the public. However, each academic society felt there would be many problems with doing so such as the need for a system to check the contents of the information provided and a system to perform maintenance.Conclusion: The results showed that the website administrators recognized that there is a need to improve the quality of and system for providing drug information to the public. We believe that an integrated information system can be constructed by aggregating the drug information held by each academic society. However, this cannot be realized without first solving many problems.