| 1.7.1 |
Designation of the Medicine Room |
In a premises where the services are provided by a licensed dispenser in the consulting rooms of a health establishment there must be a suitable room designated as a medicine room for use as a storage area for medicine. In such a facility the following standards must be observed:
| (a) |
the dispensing must be done in the consulting room(s) and not in the medicine room; |
| (b) |
no medicine may be stored in the consulting room(s) except in situations where there is air-conditioner installed and the temperature is controlled; |
| (c) |
where medicine is stored only in the medicine room, medicines or scheduled substances must be transported to the consulting room(s) on a daily basis in for example, a lockable medicine trolley or tray. |
| 1.7.2 |
Condition of the medicine room |
| (a) |
The walls, floors, windows, ceiling, woodwork and all other parts of the medicine room must: |
| (ii) |
be kept in such good order, repair and condition as to enable them to be effectively cleaned and to prevent, as far as is reasonably practicable, any risk of infestation by insects, birds or rodents. |
| (b) |
Countertops, shelves and walls must be finished in a smooth, washable and impermeable material which is easy to maintain in a hygienic condition. |
| (c) |
Light conditions, temperature and humidity within the medicine room must comply with the requirements for the storage of medicine, other pharmaceutical products, and packaging materials. |
| (d) |
The temperature in the medicine room must be below 25°C. |
| (e) |
The medicine room must have the following fixtures/fittings: |
| (i) |
an air-conditioner in good working order; |
| (ii) |
a refrigerator in good working order (see below). |
| 1.7.3 |
Storage areas in the medicine room |
| (a) |
Storage areas must have sufficient shelving constructed from smooth, washable and impermeable material, which is easy to maintain in a hygienic condition. |
| (b) |
No medicines may be stored on the floor. |
| (c) |
Storage areas for medicines must be self-contained and secure. |
| (d) |
Storage areas must be large enough to allow for orderly arrangement of stock and proper stock rotation. |
| 1.7.4 |
Equipment in the medicine room or premises |
There must be adequate, suitable dispensing equipment in the medicine room. Each item must be clean, in good repair and of suitable material. The list below provides a standard for equipment, which must be available:
| (a) |
A suitable means of counting tablets and capsules. This equipment must be cleaned regularly so that cross-contamination between products is avoided. |
| (b) |
A range of graduated, stamped glass or plastic measures suitable for the medicines dispensed in the facility. |
| (c) |
A refrigerator equipped with a suitable thermometer capable of storing products at temperatures between 2°C and 8°C. The refrigerator must be cleaned, defrosted and checked periodically to ensure efficient running. This refrigerator must be used only for storing pharmaceutical products. Where applicable, a freezer for the storage ice packs must be available. |
| (d) |
A suitable range of dispensing containers for medicinal products. The use of child-resistant closures is encouraged. |
| (e) |
Dispensing labels. Additional warning labels must be available, unless those warnings are printed on the dispensing labels. Where computer software is relied on for warnings/interactions, this must be the latest version available. |
| (f) |
Suitable refuse receptacles. |
| 1.7.5 |
Reference sources in the medicine room or premises |
In addition to any reference sources required by the statutory council of the licensed dispenser, the following must be available on the premises of the licensed dispenser, namely—
| (a) |
the latest edition of MIMS; |
| (b) |
the latest edition of Daily Drug Use (Tincture Press Publications) or another drug interactions reference source; |
| (c) |
the latest edition of either Mims Desk Reference or South African Medicines Formulary; |
| (d) |
a comprehensive textbook on Pharmacology; |
| (e) |
a medical dictionary; |
| (f) |
a Good Pharmacy Practice Manual; |
| (g) |
the latest copy of the Medicines and Related Substances Act 101 of 1965 as amended; |
| (h) |
a textbook on complementary medicines (where applicable). |
| 1.7.6 |
Control of access to the medicine room |
| (a) |
The licensed dispenser must ensure that every key, key card or other device, or the combination of any device, which allows access to a medicine room when it is locked, is kept only on his/her person. |
| (b) |
Control of access to the medicine room and/or consulting room(s) (as applicable) must be of such a nature that only the licensed dispenser(s) has direct access to medicine. |
| (c) |
A procedure must be in place to ensure access to the medicine room and/or consulting room(s) (as applicable) in an emergency situation in compliance with the Occupational Health and Safety Act, 1993. |
Consumer Affairs (Unfair Business Practices) Act, 1988 (Act No.
