What is an ADR report

A report that contains information

describing a suspected adverse drug
reaction related to the administration
of one or more medicinal products to
an individual patient
 ADR reporters
• ADRs are usually reported voluntarily
– In some countries it is mandatory for healthcare professions
to report
• Reporters include:
– Clinicians
– Nurses
– Pharmacists
– Other health professionals
– Researchers and managers of public health programmes
– Patients (in some countries)
 Why do we need to report?
• To detect adverse drug reactions not detected in
clinical trials
• Rare
• Long-term
• Occur in high risk groups
• To detect programmatic errors- medical incident
that was caused by some errors in transportation,
storage, handling of medicines.
• Medicines are not administered correctly
• Medicines are of poor quality