Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. The aim of the PV is to receive the information, documentation of the work and knowledge online while giving priority to the new and important safety issues. Non-serious events have less priority than serious events but important in comparing the changes in health, although they are also screened routinely.
At Pharmasia, products are manufactured, distributed and marketed as per quality standards before a medicine is authorized for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine’s authorization, it has been tested in a relatively small number of selected patients for a limited length of time. After authorization the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances. The challenge of maximizing drug safety and maintaining public confidence has become increasingly complex.Pharmasia must not only monitor, but also proactively estimate and manage drug risk throughout a product’s lifecycle, from development to post-market.