Abstract: Background: The Pharmacovigilance Program of India recently initiated a process
for direct patient reporting of Adverse Drug Reactions (ADRs) with a designated form.
Patients and Methods: A survey of 200 patients reporting ADRs filling the form. Forms were analysed
for patient data, the suspected medication(s), ADRs and possible causality.
Results: 54.3% of respondents provided their contact information; the implicated medicine was
mentioned in 60% and the description of ADRs in 80% although 46.2% were not interpretable. The
severity of ADRs was mentioned in 73.5%. No responder filled the expiry date component of the
implicated modification and a causality assessment from most forms was unclassifiable (57%) or
unclassified (26%). Details of concomitant drugs were missing.
Conclusion: Missing information was a deterrent in analysing the consumer ADR reports for signal
detection. It is recommended that the following fields are highlighted in the form: consumer’s initials,
address, date suspected reaction started, description of event, name, dose, and the reason for the use the
medication as well as its expiry date. These should be mandatory in the existing form and new fields
added for weight and height, batch number for vaccines and biological products, de challenge and rechallenge
results to the suspected medicine and concomitantly used medicines. To improve the quality of
information in the consumer reporting form an awareness campaign is also suggested.