SOP 01 Filling of ADR forms

NATIONAL COORDINATING CENTRE,

DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

NATIONAL COORDINATING CENTRE,

DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

1.0 Purpose

To describe the procedures for filling the adverse drug reaction forms.

2.0 Applicability:

This procedure is applicable to all the PvPI personnel

3.0 Related SOPs:

3.1 PvPI/NCC/2011/02

3.2 PvPI/NCC/2011/03

3.3 PvPI/NCC/2011/04

4.0 Reference:

4.1 The use of the World Health Organization –Uppsala Monitoring Centre (WHO-

UMC) system for standardised case causality assessment by WHO-UMC

4.2 Glossary of terms used in Pharmacovigilance by WHO-UMC

NATIONAL COORDINATING CENTRE,

DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

5.0 Process/Procedures:

5.1 Fill all the required information in the specified columns.

5.2 Ensure that all the items in the form are filled appropriately and legibly.

5.3 Write the patient’s initials (No: 1), age, gender and weight. This information should

be as complete it is used to identify duplicate reports.

5.4 Mention the date on which the adverse event started (No: 5) and date of recovery

of the event.

5.5 Provide maximum information to describe the nature of the event (No: 7), its

localization, severity and characteristics of the event. Mention, if any treatment

was given for the management of ADR. DO NOT use single word description of

the event.

5.6 Mention the patient’s details including disease condition (i.e., the primary

diagnosis), brief drug history of intake of all medications in the recent past.

5.7 Provide generic as well as brand name of the suspected drug(s) (No: 8) as latter

is essential for entry into Vigiflow.

5.8 Carefully tick in the item no. 9 & 10 (Dechallenge/ Rechallenge).

5.9 Write the details of concomitant medications (No: 11) as this information is

required in causal analysis of the event.

5.10 The outcome of the event must be reported (No: 15).

5.11 Each report should have the name and contact of the reporter (No: 16)

5.12 Mention the causality assessment grade in the ADR form (No. 17) (The causality

assessment will be done by the AMC Coordinator).

5.13 Wherever appropriate, write the case sheet no / hospital numbers/OPD numbers

in the top (left hand side) of the ADR forms. This will help in verification / cross-

checking the report by coordinator as well as the Quality review panel.

NATIONAL COORDINATING CENTRE,

DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

5.14 Check the essentially required items (ERI) no 1, 5, 7, 8, 11, 15, 16 and 18 are

filled appropriately (Failure to fill even one item in ERI will be considered as invalid

report/form).

5.15 All the ADR forms generated at the AMCs should be checked for completeness

and signed by AMC Coordinator before entering into Vigiflow.

5.16 Write the AMC report no. in ascending order based on date of reporting (No: 18)

and worldwide unique no. generated by Vigiflow in the top right corner of ADR

forms in box provided.

Note:

1. All the duly filled ADR Forms should be archived at the AMC.

2. One form should be completed for each patient based on the principle of Individual Case

Safety Report (ICSR).