Any medicinal product (including vaccines) may cause side effects; however, all users may not develop such side effects. The State Agency of Medicines assesses the quality, effect, and safety of medicinal products before the medicinal products are marketed. Permission for marketing a medicinal product is only granted if it has been confirmed that the expected benefits from the treatment exceed the risk of any potential side effects. Information about the effect, use, side effects, and composition of a medicinal product can be found in the package leaflet, which helps to use the medicinal product properly.
Initial information about the safety of a medicinal product is obtained from clinical studies. Those patients who will be administered the medicinal product in practice may somewhat differ from the patients who were involved in the clinical studies; they may suffer from several different diseases or simultaneously administer several different medicinal products, which may have an impact on the effect of the medicinal product. It is not always possible to predict all side effects of a medicinal product. Therefore, rare adverse reactions may occur with long-term use during the normal marketing of medicinal products. The effects of concomitant diseases will become clear and side effects caused by interactions between different products appear.
Hence, it is also important to keep gathering information about a medicinal product after conducting the studies, i.e., in the course of regular use. In Estonia, the State Agency of Medicine is responsible for collecting and analysing information about any undesirable effects (side effects) which have been experienced in the course of administering medicinal products and for cooperating with other state agencies of medicines worldwide in this area.
Collecting data on adverse reactions helps to refine the safety profile of the medicinal product and protect the health of patients. If the assessment reveals that the response experienced was caused by a certain medicinal product, the new side effect will be added to the information about the medicinal products and further warnings will be added to the package leaflet, if necessary. If a new side effect associated with a medicinal product is highly hazardous to human health and cannot be predicted and avoided or successfully treated, the balance between the benefits from the medicinal product and potential risks is skewed towards the risks and the medicinal product will be removed from the market completely, or the use of the product will be restricted.
It is important for the patient to tell their doctor about any possible adverse reactions after taking medicinal products. The doctor may change their treatment regimen or prescribe another medicine depending on their condition.
If the doctor considers a serious health problem to be related to a medicinal product, the doctor is required to submit a notification of the adverse reaction to the State Agency of Medicines. The patient could ask their doctor if they will submit a report on the adverse reaction. If the doctor will submit it, the patient does not need to do so. If the doctor will not submit it, the patient has the right to report the adverse reaction, regardless of the assessment of the doctor.
In addition, patients themselves can also submit adverse reaction notices (in Estonian) 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.