Identifying and Characterising Risks
Monitoring the safety of medicines, which is also known as, pharmacovigilance, includes all activities related to the detection, assessment, understanding and prevention of adverse effects and other possible drug-related problems. This monitoring is carried out in a number of ways, including review and evaluation of suspected adverse reaction reports, published literature, epidemiological studies and additional clinical trial results. The HPRA continually assesses new and emerging safety data as it becomes available and undertakes regulatory action as appropriate.
In Ireland, the HPRA is responsible for monitoring medicine safety, including operation of the national adverse reaction reporting system. Reporting of suspected adverse reactions is just one way of identifying possible new adverse reactions (i.e. a signal), which may also be detected from other sources, such as new clinical trial data, literature reports etc. Once a signal is identified, further evaluation and additional data are necessary to help determine its significance and which includes information between exposed and unexposed patients, to confirm or refute the signal, identify potential risk factors, estimate the incidence etc.
In addition to contributing to the safety profiles of existing drugs, pharmacovigilance activities help to improve the knowledge set and contribute to the breadth of epidemiological data. Pharmacovigilance is, therefore, vital for the advancement of medical understanding, future research, drug development and epidemiological studies. Any improvements in drug safety or understanding will ultimately lead to improvements in patient care.