よむ、つかう、まなぶ。
資料２－２ TERMS 改訂案 第8版 (2 ページ)
出典
| 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》 |
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目次
4
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 ·················································································
4
11
4.3.TERMS 委員会 ·····································································
4
12
4.4.第三者評価機関 ·····································································
4
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 ··············································································
5
17
6．登録 ··························································································
9
18
6.1.登録対象者 ···········································································
9
19
6.2.登録要件 ··············································································
9
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 ········································································ 11
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 ···························································· 12
26
6.5.登録申請内容の確認 ······························································· 12
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-
4
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 ·················································································
4
11
4.3.TERMS 委員会 ·····································································
4
12
4.4.第三者評価機関 ·····································································
4
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 ··············································································
5
17
6．登録 ··························································································
9
18
6.1.登録対象者 ···········································································
9
19
6.2.登録要件 ··············································································
9
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 ········································································ 11
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 ···························································· 12
26
6.5.登録申請内容の確認 ······························································· 12
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-