1.Development of Post Marketing Surveillance Method for Nonprescription Drugs Immediately after Rx-to-OTC Switch
Yuko Fujita ; Rie Nakajima ; Yuka Onodera ; Makoto Shiragami
Japanese Journal of Drug Informatics 2014;16(1):23-27
Introduction: A health assessment sheet was developed to establish a new method for post marketing surveillance (PMS) for nonprescription drugs, the status of which has recently been switched from prescription (Rx) to over-the-counter (OTC) to confirm the efficacy and safety of Rx-to-OTC switched drugs. The assessment sheet was designed to evaluate adverse reactions that may be possibly induced by the drugs and to elicit spontaneous complaints from consumers. An investigation using the assessment sheet had been conducted earlier for famotidine tablets. While the earlier investigation suggested the effectiveness of the assessment method, it also revealed some issues. After making improvements in the assessment sheet, another investigation was conducted for Loxonin®S.
Method: Purchasers of Loxonin®S were asked to tick symptoms that were applicable to them among those listed in the sheet. They were asked to revisit the pharmacy and complete the sheet for the second time after drug administration. The possibility of adverse reactions was considered for the symptoms additionally chosen at the second visit and they were then compared with the adverse reactions described in the package insert of Loxonin®S.
Results: Total 284 people completed the health assessment sheet at their first and second visits. Of them, 44 people (15.5%) reported additional symptoms at the second visit. Commonly reported symptom was “frequent experience of sleepiness,” “persistent headaches” and “fatigability.”
Conclusion: The study suggested that the health assessment sheet can be an effective tool for PMS for nonprescription drugs immediately after the Rx-to-OTC switch and contributes to detecting adverse reactions of the drugs.
2.ANTIOXIDANT SUPPLEMENTATION DECREASES THE AMOUNT OF URINARY 8-OHdG EXCRETION INDUCED BY A SINGLE BOUT OF EXERCISE
SANAE NAKAJIMA ; SEIKA KAMOHARA ; MASARU NAKANO ; MAKOTO OHNO
Japanese Journal of Physical Fitness and Sports Medicine 2006;55(Supplement):S251-S256
The purpose of this study was to investigate the intensity of exercise load which increases urinary 8-hydroxydeoxyguanosine (8-OHdG) excretion and the effect of antioxidant supplementation on urinary 8-OHdG excretion after a single bout of exercise. The subjects included 6 healthy males with the following characteristics : age ; 24.0±1.1 years, height ; 174.0±8.5 cm, weight ; 71.5±15.4 kg, BMI ; 23.2±3.4 kg/m2. The urinary concentration of 8-OHdG was measured by the two-column-switching high-performance liquid chromatography (HPLC) method. After 7 days of supplementation, the time course of the urinary 8-OHdG excretion was observed following treadmill running at 70% VO2max.Significant increases in the urinary 8-OHdG excretion were detected at 2 h (p<0.01) and 4 h (p<0.05) after exercise.After 7 days of supplementation, a significant increase in the urinary 8-OHdG excretion was detected 1 h after exercise (p<0.05); however, it returned to the initial level 2 h after exercise. Therefore, oxidative DNA damage induced by a single bout of exercise was diminished by antioxidant supplementation.
3.Research on Community Resident’s Awareness and Needs for the Services Offered at Primary Care Pharmacies
Rie NAKAJIMA ; Makoto SHIRAGAMI
Japanese Journal of Social Pharmacy 2018;37(1):9-18
When establishing new pharmacy services, they must be in line with the needs of individual community residents. In our research, it was clear that services provided by the newly implemented health support pharmacies and primary care pharmacist system in recent years satisfy the needs of patients as well as the public in general. We collected information via a survey that used a structured questionnaire. In addition to basic information (age/sex), it also covered details of their pharmacy use, their thoughts on pharmacy services, and the actual usability of pharmacy services. Differences in respondent’s opinions and the actual usability of each pharmacy service were compared between age groups and sexes. Female respondents had more favorable opinions about the antismoking, nutrition, and sickness prevention consultation services than male respondents did. The proportion of survey respondents in their 40s and 50s who proactively used pension and welfare consultation services was significantly higher than for other age groups. The younger generation perceived 24-hour pharmacies and the primary care pharmacy system as necessary. There is a large disparity between people’s thoughts and opinions on the actual usability of the services that primary care pharmacies aim to offer, and this differ in people’s ages and sexes. The younger generation tend to expect the pharmacy services. It is important for pharmacies to address the needs of the generation which is skeptical toward the separation of medical and dispensary practice and recognize them the new role of pharmacies.
4.Effect on Undergraduate Medical Students of Exposure to a Summer Camp for Children with Asthma.
Shigemi YOSHIHARA ; Toshio ABE ; Yumi YAMADA ; Makoto WATANABE ; Mika ONO ; Mariko OYAMA ; Sanae KANAZAWA ; Michio NUMATA ; Kiyoshi NISHIKURA ; Daisuke NAKAJIMA ; Megumi HOSHI ; Norimasa FUKUDA ; Tamotsu ANDO ; Noriko KANNO ; Osamu ARISAKA ; Mitsuoki EGUCHI
Medical Education 2001;32(1):39-45
We investigated the effects on medical education of early exposure of undergraduate students to a summer camp for children with asthma. An objective evaluation by the editorial staff found final improvements in the following areas (in descending order of frequency): learning of basic medical behavior (91% of students); cooperative attitude of medical staff in general treatment with the patient and the patient's family (88%); understanding of childhood growth and development (80%); knowledge of childhood asthma (69%); and mastery of basic techniques for therapy and examination (41%). The differences in the ratio of improvement (%) before and after visiting the camp, were (in descending order of frequency): cooperative attitude of medical care staff in general medical treatment with the patient and the patient's family (47%); understanding of childhood growth and development (45%); knowledge of childhood asthma (38%); learning of basic medical manner (34%); and mastery of basic techniques for therapy and examination (25%). These findings suggest that a summer camp is useful for exposing undergraduate medical students to children with asthma and is effective for helping them understand patients and family-oriented pediatric medicine.
5.Impact of Stroke Severity and Vascular Risk Factors on Early Versus Late Anticoagulation in Patients With Stroke and Atrial Fibrillation
Masatoshi KOGA ; Mattia BRANCA ; Daniel STRBIAN ; Takeshi YOSHIMOTO ; Kanta TANAKA ; Sohei YOSHIMURA ; Yusuke YAKUSHIJI ; Shigeru FUJIMOTO ; Adhiyaman VEDAMURTHY ; Manju KRISHNAN ; Marjaana TIAINEN ; Jochen VEHOFF ; Gerli SIBOLT ; Kosuke MATSUZONO ; Caterina KULYK ; Silja RÄTY ; Peter SLADE ; Alexander SALERNO ; Dimitri HEMELSOET ; Thomas HORVATH ; Takenobu KUNIEDA ; Makoto NAKAJIMA ; Hisanao AKIYAMA ; Yasuyuki IGUCHI ; Manabu INOUE ; Masafumi IHARA ; Kazunori TOYODA ; David SEIFFGE ; Martina GOELDLIN ; Jesse DAWSON ; Urs FISCHER
Journal of Stroke 2025;27(2):284-288
6.Impact of Stroke Severity and Vascular Risk Factors on Early Versus Late Anticoagulation in Patients With Stroke and Atrial Fibrillation
Masatoshi KOGA ; Mattia BRANCA ; Daniel STRBIAN ; Takeshi YOSHIMOTO ; Kanta TANAKA ; Sohei YOSHIMURA ; Yusuke YAKUSHIJI ; Shigeru FUJIMOTO ; Adhiyaman VEDAMURTHY ; Manju KRISHNAN ; Marjaana TIAINEN ; Jochen VEHOFF ; Gerli SIBOLT ; Kosuke MATSUZONO ; Caterina KULYK ; Silja RÄTY ; Peter SLADE ; Alexander SALERNO ; Dimitri HEMELSOET ; Thomas HORVATH ; Takenobu KUNIEDA ; Makoto NAKAJIMA ; Hisanao AKIYAMA ; Yasuyuki IGUCHI ; Manabu INOUE ; Masafumi IHARA ; Kazunori TOYODA ; David SEIFFGE ; Martina GOELDLIN ; Jesse DAWSON ; Urs FISCHER
Journal of Stroke 2025;27(2):284-288
7.Impact of Stroke Severity and Vascular Risk Factors on Early Versus Late Anticoagulation in Patients With Stroke and Atrial Fibrillation
Masatoshi KOGA ; Mattia BRANCA ; Daniel STRBIAN ; Takeshi YOSHIMOTO ; Kanta TANAKA ; Sohei YOSHIMURA ; Yusuke YAKUSHIJI ; Shigeru FUJIMOTO ; Adhiyaman VEDAMURTHY ; Manju KRISHNAN ; Marjaana TIAINEN ; Jochen VEHOFF ; Gerli SIBOLT ; Kosuke MATSUZONO ; Caterina KULYK ; Silja RÄTY ; Peter SLADE ; Alexander SALERNO ; Dimitri HEMELSOET ; Thomas HORVATH ; Takenobu KUNIEDA ; Makoto NAKAJIMA ; Hisanao AKIYAMA ; Yasuyuki IGUCHI ; Manabu INOUE ; Masafumi IHARA ; Kazunori TOYODA ; David SEIFFGE ; Martina GOELDLIN ; Jesse DAWSON ; Urs FISCHER
Journal of Stroke 2025;27(2):284-288