Safety of medicinal products and notification of adverse reactions

All medicinal products cause adverse reactions. Naturally, not all users will have them, but a medicinal product is approved for sale only in case it is certain that the benefit from taking the medicinal product is greater than the risk of adverse reactions. State Agency of Medicines evaluates the efficacy and safety of medicinal products before these are released on the market, and approves patient information leaflets based on the submitted data. These help doctors prescribe and patients use the medicinal products correctly.

At the same time, not all effects of a medicinal product can be foreseen at all times, because patients often suffer from several illnesses and they use several medicinal products simultaneously. In practice, long-term use will result in the emergence of rare adverse reactions, the impact of underlying diseases, and adverse reactions caused by drug-drug interactions.

Therefore, it is important to collect data on a medicinal product after its release on the market as well. In Estonia, the State Agency of Medicines collects and analyses notices of undesirable effects (adverse reactions) caused by using medicinal products, cooperating in this regard with other agencies of medicines around the world.

If it becomes evident, as a result of analysing the adverse reaction notices, that the benefit-risk ratio of a medicinal product has become negative, i.e., risks related to taking a medicinal product outweigh the potential benefit of taking it, either marketing of the medicinal product is terminated in full, or its use is limited and warnings are added in its product information.

Doctors that receive information from their patients most often submit notices concerning adverse reactions, which is why it is important to discuss undesirable health effects with your doctor. Depending on the adverse reaction, the doctor may either change the treatment plan, or prescribe another medicinal product.

In addition, patients themselves can also submit adverse reaction notices by using the template in the Notifications section on the website of the State Agency of Medicines. If you need assistance with sending a notice, you can also consult a pharmacist.

Last amended: 09-10-2015 00:00 | Compiled by: State Agency of Medicines