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.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.
5.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.
6.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.
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.
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8.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.
9.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.
10.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.