よむ、つかう、まなぶ。

MC plus(エムシープラス)は、診療報酬・介護報酬改定関連のニュース、

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 (2 ページ)

公開元URL https://www.mhlw.go.jp/stf/newpage_25755.html
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》
低解像度画像をダウンロード

資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。

4

目次

5

1.背景 ··························································································

1

6

2.目的 ··························································································

1

7

3.用語の定義 ·················································································

2

8

4.関連組織 ····················································································

3

9

4.1.医療機関 ··············································································

3

10

4.2.特約店 ·················································································

3

11

4.3.TERMS 委員会 ·····································································

3

12

4.4.第三者評価機関 ·····································································

3

13

4.5.組織図 ·················································································

4

14

5.情報提供及び教育 ········································································

4

15

5.1.対象者 ·················································································

4

16

5.2.実施方法 ··············································································

4

17

6.登録 ··························································································

8

18

6.1.登録対象者 ···········································································

8

19

6.2.登録要件 ··············································································

8

20

6.3.登録手順 ·············································································· 10

21

6.3.1.登録申請 ········································································ 10

22

6.3.2.登録通知 ········································································ 10

23

6.4.登録情報 ·············································································· 11

24

6.4.1.藤本製薬株式会社登録情報 ················································ 11

25

6.4.2.医療機関登録情報 ···························································· 11

26

6.5.登録申請内容の確認 ······························································· 11

27

6.6.登録情報の変更 ····································································· 12

28

7.流通、処方及び調剤 ····································································· 13

29

7.1.流通 ···················································································· 13

30

7.2.処方 ···················································································· 13

31

7.3.調剤 ···················································································· 14

32

7.4.遵守状況の定期確認 ······························································· 14

33

7.5.処方及び調剤終了までの流れ ··················································· 15

34

7.6.本手順の運用状況の確認 ························································· 16

35

8.薬剤管理及び妊娠回避の徹底等 ······················································ 17

36

8.1.薬剤管理 ·············································································· 17

37

8.1.1.保管場所 ········································································ 17

38

8.1.2.数量管理 ········································································ 17

39

8.1.2.1.医療機関及び特約店の数量管理 ····································· 17

40

8.1.2.2.患者の数量管理 ·························································· 17
目次 1

- 2-