The HPRA greatly appreciates the contribution of busy healthcare professionals in reporting suspected adverse reactions which aids in facilitating the continued surveillance of the safety of medicines. While the time-consuming nature of form-filling and the provision of follow-up is recognised and acknowledged; the collection and evaluation of comprehensive reports is essential to ensure that appropriately detailed case information is available for the continuous surveillance of the safety of medicines. Such reports are essential for the HPRA to ensure that regulatory action/proposals take account of all available data. There are several options in place for reporting suspected adverse reactions to the HPRA. These are as follows:
- By following the links (‘Report an Issue’ tab) to the online reporting options accessible from the HPRA website homepage (www.hpra.ie);
- Using the downloadable report form also accessible for the HPRA website, which may be completed manually and submitted to the HPRA via ‘freepost’;
- Using the traditional ‘yellow card’ report, which also utilises a freepost system. ‘Yellow cards’ are available from the HPRA Pharmacovigilance department on request.
- By telephone to the HPRA Pharmacovigilance section (01-6764971).
Since July 2012, when new legislation came into force, patients and consumers across the EU were enabled to directly report any suspected adverse reactions they may have experienced to their national reporting system. Information on this option is available from the HPRA website and the package leaflet that accompanies medicines and has also been highlighted via patient organisations. It is HPRA practice to routinely check all reports received for possible duplicates of cases received from other sources and to collate all relevant information related to case reports, as far as possible.
The revised legislation also introduced the concept of additional monitoring, previously highlighted in the DSN (editions 50 and 53), to support prompt identification of any new safety hazards. Healthcare professionals and patients are particularly encouraged and reminded to report all adverse reactions associated with the use of these medicines, identifiable by an inverted black triangle on the product information. An explanatory statement is included both in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL):
▼ This medicinal product is subject to additional monitoring
The European Medicines Agency (EMA) first published the list of medicines subject to additional monitoring in April 2013 (which is accessible from the HPRA and EMA websites), with an increased focus on reporting of suspected adverse reactions associated with the products concerned. This list is reviewed and updated as necessary, following consideration by the Pharmacovigilance Risk Assessment Committee (PRAC) at its monthly meetings. Medicines remain on the additional monitoring list for a five year period, or until PRAC decide to remove it from the list.
Key message
- All products subject to additional monitoring are identifiable by a black inverted triangle accompanied by an explanatory statement in the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)).
- Reports of suspected adverse reactions to these medicines are particularly valuable for regulatory monitoring purposes.