informal phvwp october 2011 warszawa workshop 3 new definition of adr, including medical errors,...
DESCRIPTION
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 2011TRANSCRIPT
Informal PhVWP October 2011Warszawa
workshop 3
New definition of ADR, including medical errors, abuse, overdoseChallenges of the analysis of data
The new legislation will have impact on the tasks and activities of the Member States
ADR definition broadernon serious ADRsPatient reportsLogisticsCooperation with “others” Signal detectionReports from post authorisation studiesDuplicates
many things will not change
iPhVWP october 2011
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
iPhVWP october 2011
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
iPhVWP october 2011
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 difficultmight impact how you would like to have the outputNon serious will impact calculations, evolution of PRRsDecisions have to be made eg exclude non serious in detection
iPhVWP october 2011
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
Put pieces together!
iPhVWP october 2011