Single Case Processing- Pharmacovigilance

Single Case Processing- Pharmacovigilance

The various sources from where we may get information :
a) Spontaneous reports
b) Clinical trial reports, including SAE case narrative writing
c) Special reports (legal, literature)

Following established guidelines, source documents sent to Drug Safety Unit are entered (MedDRA coding) on to a Drug Safety/Pharmacovigilance database, after a duplicate search, on behalf of those clients. This may involve an initial triage and a subsequent medical review/assessment of the report by physicians.

a) Spontaneous reports :These can be serious or non-serious event reports from the following sources, originating after a product has been marketed by the Marketing Authorization Holder (MAH):

Government agencies, Industry, Hospitals, Academia, Medical and Pharmaceutical Associations, Poisons and Medicines Information Centers, Health Professionals, Patients,Consumers,Media

b) Clinical trial reports :These are adverse event reports originating from clinical trials involving investigational products. Only serious events and non-serious events of special interest are reportable to the health authorities. Such events may be considered related or unrelated to the investigational product by the investigator/client.

c) Special reports :
i)Legal reports : These are case reports originating from filed lawsuits. These cases are forwarded to Drug safety typically by the MAH's legal department and contain a list of damages (events that are the subject of the legal action). The source documents includes plaintiff fact sheets, medical records, e-mail communications, jury trial demand notifications, deficiency letters and summons etc.
ii)Literature reports : These are all case reports where an adverse event associated with a marketed or investigational product has been generated from a systematic search of commercial scientific databases of published peer-reviewed journal articles. In these, only a generic name of the marketed or investigational product may have been reported, and quite often the manufacturer cannot be determined.

Source: ICH Guidelines