The preparation of the European Pharmacovigilance Congress 2018 gave us the opportunity to listen to interesting speeches on various topics related to pharmacovigilance. One above all that impressed us in particular was that of Calin Lungu, EudraVigilance and XEVMPD Trainer for EMA and CEO of DDCS. During his speech, entitled “EVDAS and Eudravigilance updates”, he gave some valuable practical indications on case management.
Here are 8 useful suggestions to avoid creating duplicates:
- do not send acknowledgements to ICSRs downloaded from EudraVigilance: acknowledgements have to be transmitted only for cases physically received in the company
- do not send back to EudraVigilance NCA cases except if you have received additional relevant information
- do not retransmit to EudraVigilance cases from other MAHs, even if you disagree with their assessment
- do not send back to EudraVigilance MLM reports, unless you have contacted the primary source and you have obtained additional first-hand information from them
- do not transmit nullifications for that ICSRs yet submitted to EudraVigilance by other sender organisations
- do not send back to EudraVigilance downloaded cases where the suspected adverse event was upgraded from “non-serious” to “serious”
- do not retransmit the ICSR downloaded from EudraVigilance, unless the sender organisation has received new information from the primary source qualified for follow-up
- set a download date that includes the three days prior to the last available date, as EudraVigilance will pause after 6 p.m. UK time and the cases containing errors concerning drug names have to undergo a manual recoding that can last even 2-3 days
For Italy it was also pointed out that:
- any additional information collected in the AIFA database will be included in the case narrative and will therefore be available in the future in EudraVigilance too. Therefore, sending follow-up containing this information must be avoided
- during the transmission of cases from AIFA to EudraVigilance there are still certain data elements that currently do not map to the ICH E2B (R2) ICSR format, for example medication errors, place of vaccination, use of other substances as food supplements. This information is made available locally by AIFA for download, so that MAHs can register them.
For France it is useful to know that:
- the ANSM announced that French imputability is no longer mandatory for MAHs, but the French GVP requires it.
In conclusion, during the round table in which the MAHs shared their experiences on how to download and manage duplicates, Calin participated on an issue that still arouses great apprehension and uncertainty among the operators: how to calculate the day zero. The EMA trainer clarified that the day zero is a concept not recognized by EMA. The date from which the counting of the deadlines for data exchange should start is a matter the pharmaceutical companies must define with an internal standard operating procedure (SOP) and carefully agree with the partners (SDEA – Safety Data Exchange Agreement).