1️⃣ Therapeutic safety is an important factor in healthcare since it refers to how far a treatment or intervention can be provided without harming the patient. Assessing and managing the risks associated with a certain medication, including potential side effects, adverse reactions, and combinations with other medications or conditions, is part of ensuring therapeutic safety.

2️⃣ Clinical trials, adverse event monitoring, Pharmacovigilance, medication interactions, individual patient variables, and regulatory control are all important aspects and procedures that contribute to therapeutic safety. It is vital to emphasize that therapeutic safety is a continuous process, with healthcare professionals constantly assessing and monitoring the safety of therapies in order to give the best possible care to patients.

3️⃣ Therapeutic safety monitoring is an independent and separate function that requires a skilled qualified workforce trained in pharmacovigilance and therapeutic monitoring. At the level of the regulatory authorities, a separate department is involved in the therapeutic safety monitoring and maintaining alert systems for reporting of adverse drug reactions from medical professionals, other healthcare workers as well as from patients. Based on the reported frequency and severity of an adverse reaction, the guidelines for using a particular medicine are updated and cautions are added to the prescribing information. For very serious and life-threatening incidents, the medicinal product in question could be withdrawn from the market.