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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Competency Standards in South Africa

Competency Standards for a Specialist Pharmacist who provides Radiopharmaceutical Services in South Africa

Table 1: Summary of Radiopharmacy Competency Standards

Domain 3: Supply of Radiopharmaceuticals and Medical Devices

 

DOMAIN 3: SUPPLY OF RADIOPHARMACEUTICALS AND MEDICAL DEVICES

 

INTRODUCTION

 

A radiopharmacist plays an important role in the supply of radiopharmaceutical medicines by ensuring that relevant policies, procedures, and legislation are followed in the manufacturing, compounding, and dispensing of radiopharmaceuticals. The competencies required in the domain to supply radiopharmaceuticals and medical devices are as follows:

 

3.1 Radiopharmaceutical production

 

3.2 Radiopharmaceutical compounding.

 

3.3 Supply chain management.

 

3.4 Radiopharmaceutical dispensing.

 

DOMAIN 3: SUPPLY OF RADIOPHARMACEUTICALS AND MEDICAL DEVICES

COMPETENCIES

BEHAVIOURAL STATEMENTS
3.1 Radiopharmaceutical production (Large scale manufacturing)
3.1.1 Demonstrate and understand the manufacturing of radiopharmaceuticals.
3.1.2 Manufacture radiopharmaceuticals in accordance with GMP.
3.1.3 Implement a manufacturing process to ensure the stability of radiopharmaceuticals throughout their shelf-life.
3.1.4 Demonstrate and understand how to manufacture radiopharmaceuticals using synthesis modules.
3.2 Radiopharmaceutical compounding (Small-scale manufacturing in centralised and hospital radiopharmacies)
3.2.1 Implement aseptic preparation of radiopharmaceuticals.
3.2.2 Manage the preparation and labelling of radioactive blood products according to prescribed protocols.
3.2.3 Demonstrate and apply the necessary knowledge to perform generator elution.
3.2.4 Demonstrate an in-depth knowledge of the safe compounding of radiopharmaceuticals from kits and generators.
3.2.5 Demonstrate knowledge of the use of synthesis modules in the compounding of radiopharmaceuticals.
3.2.6 Ensure that the radiopharmaceutical product is sterile.
3.2.7 Understand the IAEA operational levels for hospital radiopharmacies.
3.3 Supply chain management
3.3.1 Design a compounding area suitable for the preparation of radiopharmaceuticals.
3.3.2 Ensure that the sterility and stability of radiopharmaceuticals are maintained throughout the supply chain.
3.3.3 Maintain an inventory of radiopharmaceuticals.
3.3.4 Maintain an inventory of non-radioactive kits, starting materials and reference standards.
3.4 Radiopharmaceutical dispensing
3.4.1 Evaluate orders and prescriptions and ensure that correct calculations are used to dispense the required radiopharmaceutical quantity or dose.
3.4.2 Manage, organise, and prioritise the dispensing of radiopharmaceuticals according to the relevant legislation.
3.4.3 Manage the preparation and distribution of radiopharmaceuticals in bulk form.
3.4.4 Dispense and distribute individualised patient doses in accordance with GMCP.