Big changes ahead for pharmaceutical packaging

In 2019, new legislation will take effect in Europe that will significantly transform pharmaceutical packaging as we know it. As a result of the European IVD and Medical Device Delegated Act, every package of pharmaceuticals sold in the European Union (EU) will require a unique serial number and tamper evidence device. Pharmaceutical suppliers must also establish a data processing system to track the packs along with a larger database that will oversee the entire industry. Despite being a few years off, these changes are already having a large impact, spurring a revolution in the way pharmaceuticals are sold, packaged and tracked worldwide.

Amid recent scandals involving breast implants and metal-on-metal hip implants, the European Commission adopted this act to deter the entrance of falsified medicines into the EU. These medicines appear legitimate, but are actually counterfeits that may contain incorrect doses or poor-quality ingredients that are hazardous to human health. The new security protocols limit the possibility of falsified medicines entering the European market, since pharmaceutical packs must now be tracked throughout the entire production process.

Previously, packs of pharmaceuticals needed only expiration dates and batch numbers, not individual serial numbers in order to satisfy EU regulation. Now, manufacturers and distributors of pharmaceuticals will face a massive logistical challenge to install the additional security measures within three years. This will have four main steps:

  1. They must upgrade outdated coding equipment – no easy task since the changes are expected to render 70 percent of equipment installed by 2011 obsolete.1
  2. Manufacturers must then design new packs that each contains a unique serial number to allow easy tracking of pharmaceuticals at every stage of production.
  3. They must also equip every pack with a tamper evidence device, which will show whether a package has been tampered with at any point during the production process.2
  4. New inks must be created that will last for the product’s entire life cycle and provide a stark contrast with the rest of the packaging’s label.

Similar action has been taken in the US, where lawmakers passed the Drug Quality and Security Bill in response to a 2012 meningitis outbreak that left 64 Americans dead. This law established a national standard to ensure drug supply chain security and protect Americans from counterfeit drugs.3 Like in the EU, pharmaceutical suppliers must now assign a unique product bar code on certain prescription drugs. Moreover, drug manufacturers, repackagers and dispensers need to document and track the transaction history of prescription drugs through the entire pharmaceutical supply chain.4

Europe and the United States are not alone in their decisions to more tightly regulate packaging for pharmaceuticals. Brazil, Argentina, South Korea and China have all taken similar actions to protect consumers from falsified medicines. Furthermore, these reforms may have broad implications for sectors other than pharmaceuticals. If they successfully deter counterfeiting, such measures could be implemented to regulate luxury goods and food.5


Footnotes

1“Fresher Food and Safer Medicine – Packaging Steps Up Its Game”, The Future of Packaging 2015 (Raconteur) http://raconteur.net/business/thinking-outside-the-box-to-innovate

2“The EU-FMD ‘Safety Features’ Delegated Act: 10 Things Pharma Manufacturers Need to Consider”, PackagingEurope, http://www.packagingeurope.com/Packaging-Europe-News/64806/The-EUFMD-Safety-Features-Delegated-Act-10-Things-Pharma-Manufacturers-Need-to-Consider.html

3“House Passes Upton Bill to Prevent Repeat of Deadly Meningitis Outbreak, Strengthen Prescription Drug Supply Chain” http://upton.house.gov/news/documentsingle.aspx?DocumentID=351658

4“Drug Supply Chain Security Act”, FDA, http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChain Security/DrugSupplyChainSecurityAct/

5“Fresher Food and Safer Medicine – Packaging Steps Up Its Game”, The Future of Packaging 2015 (Raconteur)