Logistics Minded

Serialisation: the new challenge of medicines traceability

The pharmaceutical industry must face a new threat: counterfeit medicines

Counterfeit medicines exist everywhere in the world: although countries are impacted in various degrees, the overall trade in fake medicines has been expanding faster and faster over the last few years.

Why is that? The trade in counterfeit medicines is 25 times as profitable as drug dealing and the sentences much lighter.

According to the World Health Organisation (WHO), counterfeit medicines are thought to represent 10% of the global medicines trade, killing each year 800,000 people either directly or indirectly.

  • Developed countries: 1% of medicines are counterfeit
  • Emerging countries: 10-15% of medicines are counterfeit
  • Developing countries: up to 30% of medicines are counterfeit

Source: www.rfi.fr

 

Source: www.docteurclic.com

 

As the WHO announces, “A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging.”

Is this threat also present in France? French patients are quite well protected against counterfeit medicines thanks to the pharmacy network and to the quality and safety of the distribution channels (wholesalers, logistics and distribution companies) – which are highly controlled and regulated.

According to the French Pharmacy Association, counterfeit medicines have not been detected in pharmacies in France.

France is more of a “transit area” for counterfeit medicines: from the port of Le Havre to other European countries and via internet (by post mainly due to a lack of control).

In 2013, custom officials of Le Havre seized 1.2 million doses of fake aspirin (without active ingredients, from China).

The European directive 2011/62/EU to fight against falsified medical products:

It includes:

  • safety features: identification of individual packs (unique identifier = serialisation), authenticity and integrity (anti-tampering device);
  • verification of safety features by all actors in the supply chain;
  • the nature of the safety features and the detailed rules for verifications that are to be added (in the delegated acts).

 

Source: gabi-journal.net

 

Serialisation: recording system for unique identifiers, including controls at the distribution location

Principle: recording of units in a country-based system.

The unique numbers are recorded and “activated” in a centralized “repository” at European level.

Wholesalers will be able to check these unique identifiers if necessary, or if they have any doubt regarding the provenance of the products, the returned merchandise from a customer, or in case of parallel imports for example.

Upon dispense to patients (hospitals, pharmacies or other dispensers) or for exports outside of Europe, this number, written in a barcode (like Data Matrix barcodes) is then disabled from the centralized repository.

Source: www.emvo-medicines.eu

 

Impacts for the pharmaceutical supply chain

A unique identifier (up to 20 numbers in addition to the batch number) is given to each box by the manufacturer thanks to a randomised algorithm, so that it is unpredictable. This barcode shall be affixed onto each box.

Source: www.csp-epl.com

Each actor in the pharmaceutical supply chain, depending on their prerogatives, ensures the traceability of this unique identifier for all of their operations. They are also in charge of activating or disabling these unique identifiers.

This is a real challenge in terms of data management and computer interfacing for all the actors in the pharmaceutical supply chain.

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