よむ、つかう、まなぶ。

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資料、研修などをパッケージした総合メディアです。


参考資料4 TERMS 第7版 (3 ページ)

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出典情報 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会安全対策調査会(令和4年度第4回 5/24)《厚生労働省》
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41

8.1.2.3.入院中の数量管理 ······················································· 17

42

8.1.3.カプセルシート ······························································· 17

43

8.1.4.薬剤の返却 ····································································· 18

44

8.1.5.薬剤の廃棄 ····································································· 18

45

8.1.6.薬剤紛失時の対応 ···························································· 18

46

8.1.6.1.医療機関又は特約店における紛失 ·································· 18

47

8.1.6.2.患者による紛失 ·························································· 18

48

8.2.妊娠回避の徹底 ····································································· 19

49

8.2.1.対象者 ··········································································· 19

50

8.2.2.妊娠回避の期間 ······························································· 19

51

8.2.3.妊娠回避の方法 ······························································· 19

52

8.3.妊娠検査 ·············································································· 20

53

8.4.禁止事項 ·············································································· 20

54

8.4.1.禁止項目及び禁止期間 ······················································ 20

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8.4.2.禁止項目の遵守状況確認 ··················································· 21

56

8.5.逸脱時の対応 ········································································ 21

57

9.評価及び改善 ·············································································· 22

58

9.1.評価 ···················································································· 22

59

9.1.1.TERMS 委員会による評価 ················································ 22

60

9.1.2.第三者評価機関による評価 ···········································

23

61

9.2.改善 ···················································································· 23

62

10.その他 ······················································································ 24

63

10.1.情報の公開 ········································································· 24

64

10.1.1.本手順の公開 ································································· 24

65

10.1.2.遵守状況等の公開··························································· 24

66

10.2.行政への報告 ······································································ 24

67

10.2.1.定期報告 ······································································· 24

68

10.2.2.緊急報告 ······································································· 25

69

10.2.3.追跡調査報告 ································································· 25

70

10.3.記録の保存 ········································································· 25

71

10.4.情報の管理及び個人情報の保護 ·············································· 25

72

10.4.1.情報の管理 ···································································· 25

73

10.4.2.個人情報の保護 ······························································ 26

74

10.5.適応外使用 ········································································· 26

75

10.6.主な様式 ············································································ 26

目次 2

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