According to the World Health Organization (WHO), counterfeit drugs and medicines are responsible for more than 700,000 deaths annually with up to an estimated 30 percent of all medication in emerging and developing countries deemed fake.
In the European pharmaceutical industry alone, counterfeit drugs are estimated to represent a $15 billion illegal industry, according to WHO research. This represents 4.4 percent of the sector’s sales in that region.
To fight this global scourge, more than 40 countries are working on track-and-trace laws and standards to thoroughly regulate pharmaceutical products as they pass through the supply chain with strict serialization, aggregation and coding requirements.
Aggregation? What does it have to do with serialization?
Aggregation impacts serialization projects on the packaging lines throughout manufacturers’ operations and the overall supply chain. It provides any company involved in pharmaceutical packaging with the ability to build a serialized relationship between unique identifiers assigned to packaging containers. Not only does this ease the minds of pharmaceutical companies but it meets requirements in the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD).
If you have a case with a serial number and salable units (cartons, bottles) with unique serial numbers within that case, aggregation enables associates the multiple serial numbers of the individual units (child) with their case (parent). Thus establishing a “parent-child” relationship as products move through the packaging stages of the pharmaceutical supply chain.
Aggregation lets you scan the case’s barcode to determine the identity of all the contents within the case. The key end-user benefit of aggregation removes the need to open the case and scan all of the individual saleable units. You can scan one code and understand exactly what is in the whole shipment, every case, bundle, individual carton, etc., making it challenging for counterfeit products to enter the market. This is one of the reasons that aggregation can facilitate the material handling aspects of serialized projects in warehouse environments and create efficiencies across the entire supply chain.
Be prepared. Be reactive.
Keep in mind, in order for reliable aggregation, data needs to be trusted throughout its lifetime. When something changes, like the removal of a case or saleable units, the original relationship needs to be disaggregated and then rebuilt. These changes are now tracked to maintain the “parent-child” relationship.
The legal landscape for drug serialization is always changing which means the challenge of long-term compliance is two-fold. Not only will you have to follow changes in the markets you currently cater for, but you will also have to be prepared to adhere to new legislation that is likely to come into place in markets not yet regulated. Use a scalable serialization solution that can keep up with a changing environment, enabling you to be more reactive when faced with new legislation or when expanding into new markets.
Pineberry Manufacturing Inc. is a member of PMMI and will be showcasing its aggregation solutions in our booth 709 at PACK EXPO East in April.
For more information, visit www.pineberryinc.com.