To ensure safe and effective use of medicines, manufacturers of medicines have to monitor, record, and inform the public about possible side effects of medicines. This pharmaceutical subdivision that studies side effects of medicines is called pharmacovigilance. Let us introduce Marija Briede, Head of Pharmacovigilance.
Marija Briede emphasizes the importance of pharmacovigilance, as its essence is to weigh the risks and consequences of taking the certain medicine and find out the possible side effects that may occur.
What is pharmacovigilance?
Pharmacovigilance is a relatively new sub-sector of pharmaceutical science, which started in the 50s-60s of the last century, when thalidomide, new medicine in those times, was authorized in Europe.
“Before that, there was essentially no pharmacovigilance. Of course, some research was done, but not in the sense it is today. The new medication thalidomide was prescribed to pregnant women to reduce morning sickness and was also used to treat headaches, insomnia, and colds. For several years, the product was commercially available in several European countries and proved to have serious side effects when used by pregnant women,” says Marija Briede about the origins of pharmacovigilance, “children with severe anomalies were born – often with underdeveloped arms and legs. Aware of the scale of the tragedy, the World Health Organization called on each country to set up its own system to monitor the safety of medicines more closely, including the establishment of pharmacovigilance units in pharmaceutical companies.”
Strict monitoring of medicine side effects
Since the tragedy of thalidomide in Europe and many other parts of the world, there have been much stricter rules for the production of pharmaceutical products, with more detailed research of medicines and their effects on the health of patients. Of course, this also applies to the Grindeks Group.
“It must be said that this is a very important area because even for many years, new side effects have been recorded for medicines that have been in circulation. Such very strict monitoring of medicines and monitoring of side effects significantly increases the safety of medicines,” points out Marija Briede.
She also reveals that pharmacovigilance departments are not only involved in the study of side effects, but also in providing additional information to distributors, doctors, and patients about additional conditions for the use of certain medicines, which is a matter of patient safety when using medicines.
What are the side effects of medications?
“Traditionally, an adverse reaction caused by the use of a medicine is considered to be a side effect of the medicine. Side effects can vary. They are also often seen in population groups when the medicine is not used as prescribed, for example, medicine is given to children. Even then, side effects are recorded,” explains Marija Briede.
“However, side effects cannot always be negative – there are situations when the side effect does not affect the quality of life in any way,” says Marija Briede.
Why is it important to report side effects?
Today, in the manufacture of medicines, a big part of side effects are identified in the tests, before the medicine is placed on the market. But the number of study participants is limited, from a few dozen in the initial research phase to a few thousand in the final phase.
“However, this is in no way comparable to the possibility of identifying side effects when a new or even existing medicine is in circulation. When medicine is used by tens of thousands or even millions of people, then we can record much more precisely – what are the side effects, how often, under what conditions they appear,” reveals Marija Briede, “by obtaining more information, we can inform people more accurately what side effects medication may have and with what probability they will appear.”
Therefore, Marija Briede calls on everyone to report if any additional side effects are observed. “This way we can improve the information about medicines and accordingly guarantee their safe use,” explains Marija Briede.