The CHRU pharmacy is a research pharmacy designed according to world class specifications and run by an experienced team of pharmacists who manage and dispense study drugs. The sophisticated temperature control systems in the pharmacy ensure drug storage temperatures remain within the required ranges that are specified for each study. This includes remote monitoring.
Procurement and importation of study drugs are coordinated by the pharmacy team who ensure there are sufficient supplies at all times. This also applies to Section 21 applications to the South African Health Products Regulatory Authority (SAHPRA) for permission to use and import unregistered drugs into SA.
For drugs that need special preparation, eg chemotherapy, the CHRU pharmacy has specialised facilities. These include:
- A Class II Type A2 biological safety cabinet for reconstituting chemotherapeutic agents
- An ISO Class 5 reconstitution room which houses the biosafety cabinet
- An ISO Class 7 whites’ room in which the pharmacists gown up before entering the reconstitution room.
The pharmacy also has the following well-designed Standard Operating Procedures (SOPs) which are regularly updated and strictly followed:
- Study product ordering and importation
- Study product receipt
- Study product storage
- Study product dispensing, including accountability and counselling
- Study product destruction
- Pharmacy quality management
- Pharmacy communications and
- Pharmacy roles and responsibilities.
The five research pharmacists and four fully qualified pharmacist assistants are proficient with research protocols and SOPs.
CHRU’s pharmacy expertise and infrastructure supports the integrity and validity of all studies.