The Corporate Drug Safety Unit, headed by Balazs Toth, is tasked with making sure that our products are as safe as possible. It is a responsibility that requires a detail-oriented approach and compliance with the strict rules and regulations regarding pharmacovigilance.
Regulatory authorities continuously revisit and amend their legislation. The development of drug safety legislation, also known as pharmacovigilance legislation, is based on the observation that adverse drug reactions (ADRs) could cause significant harm to patients.
“Our products have to prove themselves continuously, even after regulatory approval has been granted, as this is the only way to ensure that patients receive the treatment they need and deserve,” says Balazs, who, as well as heading up the Corporate Drug Safety Unit is the European Qualified Person for Pharmacovigilance (EU-QPPV) at Octapharma in Vienna, Austria.
“We work here to ensure patient safety. We have patients in 115 countries who are treated with our products. Monitoring our products and ensuring patient safety is a huge responsibility for the Drug Safety team,” adds Balazs. “We produce medicine that is compliant – nevertheless, we collect data on any reported side effects in a constant process of analysis to ensure our medications are as safe as possible.”
Balazs’ team also keeps relevant regulatory bodies and healthcare professionals up to date. “Our work is to inform health authorities, healthcare professionals and patients on how to administer our products and what can be expected,” Balazs says.
The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem.
The main objective is to reduce patient safety risks by monitoring the risk-benefit ratio of the products based on incoming case reports.
The Drug Safety team closely monitors the side effects of products, taking into consideration reports received from healthcare professionals, articles in scientific journals and information from health authorities. “We enter all information in our drug safety database. We review, assess and, if necessary, further investigate the cases and forward them to health authorities,” explains Balazs. “We have a strong team of around 20 colleagues located in Vienna. However, the team of colleagues engaged in pharmacovigilance is significantly larger. Without the help of our local drug safety officers located in most of the countries where Octapharma products are marketed, we would not be able to fulfil our legal and ethical obligations.”
Besides medical review of cases, Balazs and his team evaluate “safety signals” deriving from case reports. A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. Safety signals, just like reports, can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. As Balazs explains, the evaluation process can lead to a follow-up or it can be decided that no further action other than updating the product information is required.
“The pharmaceutical industry is a truly significant one – we produce life-saving medicines. I always say to myself: when someone from my family takes medication, I want them and all other patients to get the best medicines and to be fully informed about what they are taking. That is my motivation! We have to do the right thing for our patients. We owe it to them and we owe it to our company,” concludes Balazs.