During this session we will explore:
Pharmacovigilance through pharmacy.
In 2014, GuildLink was the first company to provide an integrated link to the Therapeutic Goods Administration (TGA)’s adverse event reporting web service. Through the GuildCare software, community pharmacists are now able to automatically transmit adverse event reports directly to the TGA. The software facilitates recording and reporting of adverse drug reactions, problems with medical devices, and soon to launch will be medicine deficiencies and defects. One year on – the results so far and the lessons learned.
Risk management Plans – a TGA Update:
This session aims to present TGA perspectives about the evaluation and implementation of risk management plans. The key topics and outcomes of the TGA/ARCS RMP Workshop in March 2015 will be presented including the revised RMP guidelines and common pitfalls. This will also be an opportunity for follow-up discussion from the workshop.
An EU perspective on adverse event reports of off-label use.
In order to prioritise patient safety for a medicine intended for marketing in the European Union it must undergo an exacting and significant approval process. This includes an assessment of quality, safety and efficacy of the medicine for the intended population in question, and ongoing assessment of benefit – risk ratio. If the medicine is judged to be safe and effective for the given indication, a marketing authorisation (MA) is granted by the competent regulatory authority. Deviations from the conditions set forth in the label are defined as off- label use. Off – label prescribing is a common medical practice that is neither restricted to particular clinical situations nor single countries. Although accepted in certain circumstances, the use of medicines for indications for which they have not been comprehensively assessed may expose patients to an unfavourable benefit – risk ratio. Therefore there is a high need for regulation in this medical field. Using drugs outside the scope of the MA have to be identified, monitored and controlled in order to ensure patient safety.That said, this is an area that is causing the industry significant policy and ethical scrutiny due to recent drug scandals in France and ongoing challenges in Ophthalmology. David will discuss the subject of off-label prescribing; some of the issues around it, and the way that the 2012 EU legislation is requiring sponsors monitor it.
Chairperson: Josie Gabites, CPharm