The pharmacological and pharmaceutical sectors have been trying to improve patient safety for some time. However, the task is a difficult one, mainly because it involves different areas of expertise and the collaboration between many parties. Patient safety has often been considered as an additional layer on top of the established drug development process. Even though it is true that safety considerations are part of the regulatory requirements for registration, patient safety analysis should be an integral part of pharmacovigilance and drug development. It has to become a way of thinking, and not just something done at the end after all clinical studies have been completed.
Patient safety is the ultimate goal of pharmacovigilance
A comprehensive pharmacovigilance system with direct links to the drug development process has to be in place from the start. It will establish a culture where patient safety can be managed and integrated seamlessly into pharmacovigilance activities as well as clinical trials, marketing authorizations and post-marketing studies.
The best way to achieve this goal is through a complete understanding of why patient safety is so important , and through the application of a more effective approach to pharmacovigilance activities - one that is centered on patient safety.
