Safety of Medicines
Monitoring the safety of medicines, which is also known as pharmacovigilance 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 Irish Medicines Board continually assesses new and emerging safety data as it becomes available and undertakes regulatory action as appropriate.
Reporting of suspected adverse reactions is just one way of identifying a possible new adverse reaction (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 include information between exposed and unexposed patients, to confirm or refute the signal, identify potential risk factors, estimate the incidence etc.
Healthcare professionals and patients/consumers are encouraged to report suspected adverse reactions associated with the use of medicines to the IMB. Further information on reporting suspect product problems is available on this site.
Defects in Medicines
The Market Compliance Section of the Compliance Department receives and investigates complaints and reports of actual or suspected defects in medicines. Product defects, also known as Quality Defects, may be described as unplanned attributes of a medicinal product, which may affect the quality, safety and/or efficacy of the product, and/or which are not in line with the approved registered file on that product.