Author: Miriam Capoulas (Pharmacist) From their development until they are commercialized, all medicines undergo a detailed evaluation that covers multiple area , including their safety. In this case, the objective is to ensure that when a medicine is used within its expiration date, in the expected target population, in the proposed indications, through the appropriate route of administration and in the correct dosage (dose and interval between administrations) it does not cause reactions adverse (or undesirable effects or side effects), i.e. responses that are not supposed or desirable to happen. For most medications side effects are identified in clinical safety trials and yet the medications are marketed. This happens when it comes to minor and infrequent side effects whose occurrence is largely outweighed by the benefits achieved with the medication. In these cases, these known side effects are indicated in the information leaflet that comes with the medicine and which we must read before taking it. Even so, clinical safety trials prior to marketing authorization are always limited, however long and comprehensive they may be, particularly in relation to possible effects that are rarer and/or only manifest in the long term. Therefore, it is also important to compile data on any adverse reactions to a medicine after it is marketed. Their assessment will help to consolidate information about the benefits and risks of using a medicine. Surveillance of medication safety In short, monitoring safety after marketing is the function of pharmacovigilance systems. In Portugal, the Sistema Nacional de Farmacovigilância, which depends on the Autoridade Nacional do Medicamento (INFARMED), is the responsible for monitoring medicines that have marketing authorization on the national market and collects, centralizes, organizes and evaluates information from notifications of adverse drug reactions. How do you report adverse drug reactions The reporting of adverse drug reactions to the Portuguese Sistema Nacional de Farmacovigilância is mainly done by health professionals: doctors, pharmacists, nurses, among others. However, it can also be done directly by all citizens who suspect suffer an adverse reaction in themselves or someone they care for, communicating: Age and sex of the affected person; Description of the adverse reaction; Name of the medicine and batch number; Dose of medicine and names and doses of other medicines the affected person taking. This valuable and often unknown contribution of adverse reaction reporting can be made by: On the Portal de Notificação de Reações Adversas a Medicamentos (adverse drug reactions reporting portal); By email, on paper or by telephone. Reporting adverse reactions, whether directly or through a healthcare professional, is part of our responsibilities. It protects our health and helps improve the safety and efficacy of medicines for everyone. It's simple and helps ensure that medicines are a safe and effective part of healthcare. Please use medicines responsibly Read the medicines information leaflet before taking it or giving it to someone you care for; Do not rule out unusual or unpredictable symptoms after taking a medicine; Document any adverse reactions: describe them by writing, with photos, record the day and time they occurred; Contact a healthcare professional and give all the necessary information to notify the adverse effect, or report it directly through one of the methods provided. Attention The notification of adverse reactions by citizens to the Sistema Nacional de Farmacovigilância does not replace contact with a healthcare professional , with your doctor being the most appropriate person to adjust the dose, replace the medicine or prescribe medicines to treat side effects. The content published in the Health Guide is intended for the general public and is provided for informational and educational purposes only. It does not replace individual medical assessment, diagnosis, or personalized clinical advice from a qualified healthcare professional. The content is produced or reviewed by physicians and other healthcare professionals at Hospital da Luz and is based on the knowledge available at the time of publication or the most recent update, as indicated at the beginning of each item.
