Crisis Management and Response

Context: A major European generics manufacturer detected suspicious medicines in its wholesaler and distributor network. Consequently, a number of international regulators insisted the manufacturer remove the product from the market with immediate effect, and enact a recall of products already in the supply chain.

Solution: IPAV rapidly deployed a team to sites where suspicious medicines had been detected to analyse their composition and provenance, working alongside a trusted supplier of medicine verification solutions to implement enhanced supply chain security to facilitate controlled product reintroductions.

Outcome: The suspicious medicine was identified to contain the bona fide medicinal product and thus did not pose an immediate threat to patient safety. However, a repackager facilitating parallel importing between multiple European countries had inserted an out-dated patient information leaflet (PIL), triggering concern amongst pharmacists. IPAV assisted the client in designing and distributing training to repackagers to prevent recurrence and is currently supporting a number of European branded and generic clients implement similar programmes.