§ 10 Medicines and reagents

In detail

What § 10 requires

1. A system of regular checks makes sure only medicines or reagents within their expiry date are used § 10(1).
2. Storage follows the rules and is checked regularly § 10(2).
3. The medicines and reagents needed are kept available, with a system of regular checks for that too § 10(3).
4. You report adverse drug reactions, as required, to the Federal Office for Safety in Health Care (BASG) § 10(4).

The Hygiene Regulation adds: medicines and medical devices are stored as the manufacturer specifies, in dry, dust-free and, where needed, temperature-controlled store rooms Hygiene-V § 8(6); nothing is stored on treatment-room floors Hygiene-V § 10(5).

What works as proof

• a dated checklist: expiry dates checked, stock topped up, who checked;
• a temperature log where medicines are kept refrigerated;
• copies of side-effect reports.