Pharmacovigilance of herbal drugs and their derivatives: the beginning of necessary action for patient safety in the context of rational use of drugs

Abstract

In antiquity, the treatment of diseases affecting humans was usually performed medicinal plants. Since the industrial revolution in the nineteenth century, this alternative treatment method has fallen into disuse. In recent decades, however, it has been used again because of factors such as lack of access to doctors and pharmacists and the high cost of synthetic drugs services. Consequently, the number of reports of adverse events related to plant drugs has increased. Its use is common in primary care, and most users believe that it is a safe treatment method. The toxicity of medicines or drugs that contain plants is a matter of public health because they can trigger adverse reactions such as severe poisoning and can interact with conventional drugs. There are few data on the safety of herbal drugs, and most of them have not been subjected to clinical phase studies. Monitoring of unwanted effects through the implementation of a pharmacovigilance system that includes the medicinal plant species is required. However, in Brazil, the safety assessment of herbal drugs and their derivatives is only beginning. It is therefore necessary to take actions to ensure that an effective and robust system is structured.