Key concepts to be considered in expedited reports : Pharmacovigilance Practice

The following list of items are to be included in CIOMS form and submitted to regulatory bodies :

1. Patient details (vitals)
2. Suspected medical product( brand name,batch number, dosage form and strength,dosage regimen, route of administration, international non propiatory name, starting date and time , stopping date and name )
3. Details of the adverse drug reaction (starting date, onset of reaction , stopping date and time and duration of reaction )
4. Details of reporter (name, address, telephone number , profession)
5. Details of the sponsor (source of report, country in which event occurred ,name and address of sponsor , sponsor identification number ).

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.