Medical Evalaution on Medically significant/IME
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Medical Review Convention on Seriousness assessment of adverse event or reaction:
Per my individual observation, medical judgment/evaluation is very subjective (based on individual experience and expertise) hence reproducibility & repeatability (Consistency & replication) is not practically feasible.
From auditor perspective, How to ascertain (objective evidence of evaluation) whether Medical/scientific judgment of 6th criteria (Medically significant/Important Medical Event) is being practiced/exercised or not to decide whether expedited reporting is required or not?
Delayed submission: Adverse event/reaction which is initially assessed as non-serious by triager then later it was identified as serious but by then submission is already delayed because being categorized as non-serious case is not getting prioritized hence leading to regulatory non-compliance.
In order to prevent such delayed submissions or inconsistent medical evalaution I am curious to understand how to Standardized medical review conventions. Please advise.
RQA GPvP Committee
IME or Medical Events of Special Interest are often pre-defined by the company or predefined by the Health Authorities and detailed in the Reference Safety Information /SmPC, PIL, or Risk Management Plans).
The EMA has published updated guidance just this month:
EMA/155528/2018 Inclusion/exclusion criteria for the “Important Medical Events” list, see page 2ff. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/08/WC500212100.pdf
We hope you find this useful.
RQA GPvP Committee
with regard to your 2nd question Delayed submission (upgrade from non-serious to serious) :
The expedited reporting requirements start from the moment the company (or the contractor collecting the safety information locally) has received the particular follow-up information that would upgrade the event to serious or expedited IME.
Whilst the initial report date must not be changed in the database, when your company reports the upgraded ICSR to the HA it must be clear on which date the additional follow-up information was received which upgraded the seriousness. The company's triage and case duplicate checks should be set-up in such a way to identify such information, so that the due dates for expedited reporting can be met (e.g. 15 calendar days in EU/EEA countries).
We hope you found this information useful.
I have question regarding MSE/IME.
1) Should the IME list be followed to upgrade an event, in order to maintain consistency among the Medical reviewers. If yes, shouldn't we be all the events as serious as EU IME list contains 8000 events
2) If there is very limited information available in a case, should it still be upgraded as serious; for example say loss of consciousness: should it be upgraded without any additional information
@Nihal, EMA IME list is always considered as serious unless medical reviewer have a rationale to consider it nonserious. The same should be mentioned in the medical reviewer comment. Few companies/MAH decide not to use EMA IME list since their products have a specified indication. e.g. vaccines/biologicals/medical devices. However, in such scenario they prepare an always serious list and get approval of the same from HA.
If a company has adopted its own IME list, does that company have to get list approved by HA, before adopting it.
If this company list is over and above the IME list published by EMA, then that is fine. However if it is a subset of IME list and rest of IME list is not considered at all, then that's a problem.
In any case, it is not required to contact the authority and get the company's list verified.