Medicines safety

The properties of new 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 also safe in use. The highest priority is to ensure patient safety.

A medicine created through pre-clinical research and clinical trials has a long way to go before it can be used by larger number of patients.

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 body in various ways. Although a medicine would be efficient, it can also cause adverse reactions. Adverse reactions can vary in different individuals, for example depending on the patient’s age, other diseases or concomitant medications. There is no such thing as a medicine totally free from any adverse reactions in everybody.

Safety is followed through the whole medicine life cycle

Pharmaceutical companies are responsible for their products and follow the safety of their medicines throughout their life together with health authorities. Pharmacovigilance aims at detecting, assessing, understanding and preventing adverse drug reactions and other challenges which may appear in connection with the use of medicines.

Clinical trials involve only a limited number of people, and the rarest adverse reactions do not necessarily come up during the trials performed before the marketing authorization. Adverse reactions may emerge even decades after the introduction of the medicine to the market. If necessary, the summary of product characteristics of medicinal products will be updated with warnings or restrictions of use.

Also patients carry a significant responsibility for the collection of adverse reaction data. Any serious or unexpected adverse reaction observed in connection with the use of 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