Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites

Area of Science:

• Pharmacovigilance
• Drug Safety
• Global Health

Background:

• Substandard medicines pose a significant threat to patient safety.
• Spontaneous adverse drug reaction reporting systems aid in identifying quality defects and lack of efficacy.
• The Uppsala Monitoring Centre developed an algorithm to detect patterns of substandard medicines in VigiBase.

Purpose of the Study:

• To evaluate the effectiveness of an algorithm for identifying potentially substandard medicines.
• To assess the algorithm's performance when evaluated directly by national centers (NCs).

Main Methods:

• The algorithm identifies countries and time periods with disproportionately high reporting of product inadequacy.
• Six national centers (Republic of Korea, Malaysia, Singapore, South Africa, UK, USA) participated.
• Clusters were systematically assessed at NCs using a standardized protocol and compiled centrally.

Main Results:

• Of 147 assessed clusters, 8 were confirmed substandard, 12 potential, and 51 unlikely.
• 19 clusters were confirmed not substandard.
• 57 clusters were classified as indecisive due to retrospective evaluation challenges.

Conclusions:

• The algorithm can identify some substandard medicines but requires national-level prerequisites for practical utility.
• Key factors include rapid report handling, detailed product/distribution information, reporter contact, sample availability, and laboratory capacity.
• Effective implementation necessitates robust national pharmacovigilance infrastructure.