INOPP Forum
Switzerland - Drug exposure during pregnancy and Parent-Child reports
Quote from VigiServe Admin on December 19, 2020, 8:26 AMIn case a drug exposure during pregnancy is suspected, but:
- no complication during pregnancy occurred, and
- no harmful effect of the foetus/child at the time of the report is suspected,
The Individual Case Safety Report (ICSR) should be reported as «nonserious» (within 60 days) or «serious/medically important» (within 15 days), «standard» (no parent/child) case
Only the mother should be recorded as «patient»
Coding options (MedDRA_LLTs) e.g.:
‘Drug exposure during pregnancy’
‘Vaccine exposure during pregnancy’
‘Exposure during pregnancy’
‘Maternal exposure during pregnancy’
‘Maternal exposure during pregnancy, the first trimester’
‘Maternal exposure during pregnancy, the second trimester’
‘Maternal exposure during pregnancy, the third trimester’
In following situations, pregnancy cases from Switzerland (ICSR) are to be reported to Swissmedic expedited (not later than 15 calendar days from receipt):
- if a serious or medically important complication/harmful effect during pregnancy concerning the mother is suspected in association with a drug
- if a serious or medically important complication/harmful effect during pregnancy concerning the foetus (e.g. foetal death, abortion, malformation) is suspected in association with a drug – medically important/serious case – to be submitted as «Parent-Child report»
Coding options (MedDRA_LLTs) e.g.:
‘Foetal exposure during pregnancy’
‘Foetal exposure during pregnancy, first trimester’
‘Foetal exposure during pregnancy, second trimester’
‘Foetal exposure during pregnancy, third trimester’
- when a harmful effect for the neonate is suspected to be drug related–medically
important/serious case – to be submitted as «Parent-Child report»
- for any drug exposure during pregnancy (even without suspected ADR or
complication) with a substance known to be noxious, i.e. a substance which
is contraindicated and should be avoided during pregnancy due to potential risk
of adverse reactions for the foetus/child – «standard» case report, serious
(medically important).
Follow-up reports:
- New data/information to a case-report concerning the mother only should be
submitted as follow-up report of the existing standard (no Parent-Child)
case.
- For new data/information concerning the foetus/neonate in relation to a previous standard (mother) case, a new «Parent-Child report» should be created and submitted. This new «Parent-Child report» will be linked to the pre-existing standard case concerning the mother.
New safety signals concerning exposure during pregnancy (not in form of ICSR but
as a concise, critical evaluation of the issue) identified on the Swiss or international level:
- Not later than 15 calendar days for a new potential risk on Swiss or international level in relation with drug exposure during pregnancy (e.g. signal of possible teratogenic effect, new drug risk, drug use or prescribing problem, increase of abnormal outcomes frequency). This should be considered as a newly identified safety signal for which an evaluation report including available data, risk assessment and planned measures must be submitted.
In case a drug exposure during pregnancy is suspected, but:
- no complication during pregnancy occurred, and
- no harmful effect of the foetus/child at the time of the report is suspected,
The Individual Case Safety Report (ICSR) should be reported as «nonserious» (within 60 days) or «serious/medically important» (within 15 days), «standard» (no parent/child) case
Only the mother should be recorded as «patient»
Coding options (MedDRA_LLTs) e.g.:
‘Drug exposure during pregnancy’
‘Vaccine exposure during pregnancy’
‘Exposure during pregnancy’
‘Maternal exposure during pregnancy’
‘Maternal exposure during pregnancy, the first trimester’
‘Maternal exposure during pregnancy, the second trimester’
‘Maternal exposure during pregnancy, the third trimester’
In following situations, pregnancy cases from Switzerland (ICSR) are to be reported to Swissmedic expedited (not later than 15 calendar days from receipt):
- if a serious or medically important complication/harmful effect during pregnancy concerning the mother is suspected in association with a drug
- if a serious or medically important complication/harmful effect during pregnancy concerning the foetus (e.g. foetal death, abortion, malformation) is suspected in association with a drug – medically important/serious case – to be submitted as «Parent-Child report»
Coding options (MedDRA_LLTs) e.g.:
‘Foetal exposure during pregnancy’
‘Foetal exposure during pregnancy, first trimester’
‘Foetal exposure during pregnancy, second trimester’
‘Foetal exposure during pregnancy, third trimester’
- when a harmful effect for the neonate is suspected to be drug related–medically
important/serious case – to be submitted as «Parent-Child report»
- for any drug exposure during pregnancy (even without suspected ADR or
complication) with a substance known to be noxious, i.e. a substance which
is contraindicated and should be avoided during pregnancy due to potential risk
of adverse reactions for the foetus/child – «standard» case report, serious
(medically important).
Follow-up reports:
- New data/information to a case-report concerning the mother only should be
submitted as follow-up report of the existing standard (no Parent-Child)
case.
- For new data/information concerning the foetus/neonate in relation to a previous standard (mother) case, a new «Parent-Child report» should be created and submitted. This new «Parent-Child report» will be linked to the pre-existing standard case concerning the mother.
New safety signals concerning exposure during pregnancy (not in form of ICSR but
as a concise, critical evaluation of the issue) identified on the Swiss or international level:
- Not later than 15 calendar days for a new potential risk on Swiss or international level in relation with drug exposure during pregnancy (e.g. signal of possible teratogenic effect, new drug risk, drug use or prescribing problem, increase of abnormal outcomes frequency). This should be considered as a newly identified safety signal for which an evaluation report including available data, risk assessment and planned measures must be submitted.