The term pharmacovigilance is not widely understood by the public and remains unfamiliar even within some areas of healthcare. However, recent discussions surrounding access to medicines, intellectual property, regulatory authority and the growing use of compounded medicines have created an important opportunity to raise public awareness about the role of robust safety surveillance systems.

Before a medicine is registered by the South African Health Products Regulatory Authority (SAHPRA), it undergoes years of clinical development and testing to demonstrate its safety, effectiveness and quality. However, these studies are conducted in carefully controlled environments and cannot fully predict how a medicine will affect every individual once it is used by a much larger and more diverse population. Pharmacovigilance is therefore an essential part of SAHPRA’s broader responsibility to protect public health.

Manufacturers of registered medicines are required to maintain formal pharmacovigilance systems and report relevant safety information to SAHPRA. Healthcare professionals are encouraged to report suspected adverse drug reactions, while patients also have an important role to play by reporting their own experiences with medicines.

Compounding medicines to meet individual patient needs can provide an important alternative in specific circumstances, including when suitable commercially available medicines are unavailable. However, the fact that a medicine is compounded does not remove the need for appropriate documentation, quality assurance and safety monitoring. In fact, the nature of compounded medicines can make pharmacovigilance more complex, particularly when preparations are made in different settings or distributed more widely.

When a suspected adverse reaction is reported, it is essential to identify the medicine involved and collect relevant information. For compounded medicines, this may include the formulation, strength, batch or preparation number, date of preparation, expiry date and the pharmacy or facility where it was prepared.  As compounded medicines become more widely used and distributed, consistent documentation and traceability will become increasingly important to ensure that patients receive an appropriate level of protection. Robust safety surveillance systems must be able to identify potential problems, trace medicines back to their source and support timely action when concerns arise.

The ongoing discussion surrounding compounded medicines has demonstrated why strong systems for documentation, traceability and pharmacovigilance are more important than ever.