1. Informal PhVWP October 2011 Warszawa workshop 3 New definition of ADR, including medical errors, abuse, overdose Challenges of the analysis of data

2. The new legislation will have impact on the tasks and activities of the Member States ADR definition broader non serious ADRs Patient reports Logistics Cooperation with “others” Signal detection Reports from post authorisation studies Duplicates many things will not change iPhVWP october 2011

3. Definition ADR As detailed in Article 1 of Directive 2001/83/EC, this is a response to a medicinal product which is noxious and unintended and which arises –From use of a medicinal product within the terms of the marketing authorisation, –From use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, –From occupational exposure iPhVWP october 2011

5. Medication error etc Challenging information exchange at national level Identify medication errors: –Coding with Meddra terminology? –Separate flag? Abuse/misuse: MAHs must report HP/Patients encouraged iPhVWP october 2011

7. What changes Content EV: ADRs occurring Serious and non serious HCP, MAH and patients On label use Off label use/use outside the MA Medication errors Will impact on what will be flagged Off label use is already difficult might impact how you would like to have the output Non serious will impact calculations, evolution of PRRs Decisions have to be made eg exclude non serious in detection iPhVWP october 2011

8. Wishlist Data quality should be optimised (art 57, IDMP, duplicate Summaries, history, different values over time of PRR We whould like to be able to search/question the data base as needed The current pdf output is not doable, eg tracking is impossible as is documenting results eRMR might be of value filter(s) to flag important things would like to have a “dashboard” (point 1) as a system, drill down to individual cases ( at a click, easy tool to go back to EV and narratives once there is an issue. Helpful output to facilitate tracking eg notes of the assessor (audit trail) Output integrated with RMP, PSUR, SPC Tools for automated signal detection ( eg EU ADR) Periodicity can only be decided after we know what will be provided iPhVWP october 2011

9. Put pieces together! iPhVWP october 2011