The properties of novel medicines are subject to a long period of research, generally over 10 years, before there is enough information on their efficacy and safety.
The purpose of the medicine is to cure and prevent diseases and alleviate symptoms. The medicinal product must be of high quality and correctly manufactured. It must be efficient and safe in use. The absolute starting point is guaranteed medicines safety and so-called pharmacovigilance.
A medicine created through scientific research and clinical trials has a long way to go before it reaches the consumer.
Safety is not compromised even when the authorities find that expediting development would be
a smaller risk than leaving the patient without therapy. This is the case, for example, when the population faces the threat of an infectious disease or other illness with no known cure.
In fact, a medicine can impact our system in various ways – especially now that medicine is increasingly individualised and customised. When a medicine is efficient, it can also cause adverse reactions which can also vary in different individuals. There is no such thing as a medicine totally free from any adverse reactions in everybody.
Safety is followed through medicine life cycle
Pharmaceutical companies are responsible for their products and follow the safety of their medicines throughout their life. Pharmacovigilance within the pharmaceutical companies includes the gathering of information on the adverse reactions of medicines.
Clinical trials always involve a limited number of people, and the rarest adverse reactions do not necessarily come up in the samples. Adverse reactions may emerge even decades after the introduction of the medicine. If necessary, the summary of product characteristics of medicinal products will be complemented with warnings or restrictions of use.
Medicine users carry a significant responsibility for the accumulation of adverse reaction data. Any observed, unexpected adverse reactions caused by a medicine must be reported to the Finnish Medicines Agency Fimea or to the pharmaceutical company who has the marketing authorisation of the medicine in question.
Pharmacovigilance life cycle
Adverse Event Reporting Video on YouTube