Central and Clinical Research Site (CRS) pharmacies support UZ-CTRC’s overall scientific agenda by ensuring uninterrupted provision of study products (investigational drugs and devices) and primary care drugs to all NIAID Division of AIDS (DAIDS)-funded and other non-DAIDS funded clinical trials. The Central Pharmacy is a central distribution, storage and administrative hub for the department, and is responsible for the efficient distribution, use, and destruction of primary care drugs. All the pharmacies in the programme have DAIDS-approved pharmacy establishment plans and are Medicines Control Authority of Zimbabwe (MCAZ) certified.
Centralized Pharmacy Structure and Capacity
The UZ-CTRC Pharmacy Department is composed of a Central Pharmacy and CRS pharmacies, co-located at each of the distinct geographic locations of our CRS’s.
The centralized structure enables CRS pharmacy staff to dedicate their activities primarily to protocol-specific activities at their respective CRS location. Our cross-trained staff dispenses investigational study products and primary care drugs to an average of 20-25 participants per day at each CRS. Primary care drugs ordered by the Central Pharmacy include agents for the treatment of respiratory infections, co-trimoxazole prophylaxis, sexually transmitted infections (STIs), contraception, and antiretroviral drugs used in the treatment and prevention of HIV, TB and COVID-19. All primary care drugs are procured and stored at the Central Pharmacy where the supply chain management is efficiently executed. Inventory of study product and primary care drugs is monitored centrally through the use of ProPharm® computerized dispensing software.
Capacity for Specialized Preparations
The 7 CRS Pharmacies are involved in daily management of study product and dispensing of study products to participants. Six of the CRS Pharmacies (all except Seke North) have functional sterile products preparation rooms (clean rooms), equipped with internationally commissioned and certified Biosafety Cabinets for preparation of injectable study products. This well-developed infrastructure supports complex protocols evaluating combination bNAbs, long-acting injectables, implants, MPTs for HIV prevention, and treatment. is installed in each of the preparation areas. This cabinet is a vertical laminar airflow bench with about 70% laminar flow re-circulated air and 30% extracted air with prior High Efficiency Particulate Air (HEPA) filtering. The Aseptic Rooms are designed based on the Pressure Differential concept (high pressure differential, high airflow) to meet *ISO Class 8 and U.S. Pharmacopeia 29 standards for the Anteroom and Preparation area.
Standards and Certification
Protocol implementation for NIH Research Networks involves compliance with the DAIDS Pharmaceutical Affairs Branch (PAB) and MCAZ. DAIDS-appointed monitors conduct quarterly pharmacy-specific investigational drug audits, and investigational pharmacy inventory and storage assessments. The local regulatory authorities conduct a general pharmacy assessment. We are also subject to FDA monitoring on a spot basis.
We follow sponsor guidelines, Good Clinical Practice (GCP), and MCAZ clinical trials regulations through the expertise of our Pharmacists of Record (PoR), led by the Pharmacy Director. Our PoRs keep complete written accountability records of all investigational drugs that are received from the NIAID Clinical Research Products Management Center and of all medications dispensed to participants. They maintain the stock of study products/investigational drugs, ensuring that they are maintained under appropriate conditions (temperature, humidity, security) at all times. In addition, to dispensing products to study participants, PoRs conduct adherence counseling sessions, and review participant charts for compliance with good prescribing practice of primary care medications.
For inquiries to the UZ-CTRC Central Pharmacy and the services it provides, please contact the Central Pharmacist, Gift Chareka, R. Ph, MSc (Clinical Trials), ACRP-CP