The distribution systems of certain European countries have been breached by falsified medical products. These countries have adopted “good distribution practices” to prevent a major threat.
Four risk zones have been identified and good practices have been defined for each to limit risks.
- Purchase and supply:
Reinforced procedures to control authorizations for suppliers have been defined, along with products, certifications and audits, to prevent falsified medical products from entering the first link in the distribution chain.
With the discovery of falsified medical products in the distribution chain, a strict separation is now required between falsified and authentic medication.
Furthermore, distributors are required to implement an information and awareness program for their staff concerning the risks of falsified medical products. The goal is constant vigilance.
- Return products:
Products must be stored under conditions dictated by the Autorisation de Mise sur le Marché (AMM – Market Authorization), notably in terms of exposure to temperatures.
Guarantees of a product’s integrity (products may not be opened, mixed, or manipulated) must be provided. Furthermore, it is necessary to verify that the return product is the same as the one that was delivered.
This is a weak link in that it allows products whose quality is not guaranteed to re-enter the market. It can also be the moment when falsified medication enters into the chain.
Wholesale distributors must “protect medication against damage, adulteration, and theft. They must also guarantee that temperatures be maintained within acceptable limits.”
These transporters are a serious weak point in the distribution channel. They do not have the status of “pharmaceutical establishment” and therefore are not subject to similarly stringent norms.
To limit risks, specifications have been strictly defined, risk analyses and audits have been carried out, and delivery can only be carried out in specific places (no substitute locations).
Brokers, from the Anglo-Saxon system, are alternative transporters.
Brokers first appeared in France when the European Community harmonized its commercial practices.
Traceability is weak at their level. They are not subject to authorizations and are allowed to furnish simple declarations. They are also not inspected. The security of the distribution channel at this level does not seem to be guaranteed.
For more information, read Guidelines on good distribution practices.