The EU Falsified Medicine Directive (EUFMD), which requires serialisation and bar codes on the smallest saleable units of drugs, is “expected to come on line in the first half of 2018,” Brian Daleiden, VP, TraceLink, told in-Pharmatechnologist.com.
“That sounds pretty far away, over three years. But we’ve been working with companies on serialisation and track-and-trace for a decade in regions like China that already have regulations in force. We’ve seen how long it takes to actually serialise the product, capture the information required, and provide it to the partners you work with.
“We tell companies you need to work back from 2018 and get really specific – what products do you have, how are they produced, and with which partners or internally owned facilities?
“We would say in 2015, 75% of the top pharma companies are already feeling behind at meeting the 2018 deadline when they take a harder look.
“I may have a company with 20 products in my portfolio. In order to do those products, I may have 4 or 5 internal facilities with 10 packaging lines and 20 external partners, with another 25 packaging lines.
“Now suddenly I have 40 to 50 facilities and packaging lines that I have to enhance with hardware and serialisation software, and I have to orchestrate all of these while I’m producing product today. It’s not like a pharma company can shut down for a year and retrofit.”
How to prepare
Daleiden advised pharmaceutical firms to “build a buffer” of time into their serialisation plans, bearing in mind all the other companies involved in their networks.
“The natural tendency for companies when they look at track-and-trace is to say ‘I need to put a bar code on a bottle or box,’ and myopically focus on just doing that, and worry about everything else later.
“Companies will delay because they don’t want to invest ahead of when they need to. But when they just focus on their own business they risk the issue of resource contention.
“A contract packager may work with 20 other companies like you. That company is making its own prioritisations based on the needs of all its customers. They may not be ready when you want them to be ready.”
“For the EU we’re talking about thousands of contract manufacturer and packagers, just on the supply side that are all going to have to work together in the next 3 years to meet the 2018 deadline and priorities are not always going to align.”
EU vs US – what are the track-and-trace requirements?
The EUFMS concentrates on serialisation and verification. Manufacturers will supply a central European hub with data on their products, which will then be passed to national hubs. Pharmacists dispensing drugs can scan packaging barcodes to verify the product in their hands against the database, to check for recalls and counterfeiting.
The US Drug Supply Chain Secutiry Act (DSCSA), currently being phased in, has a greater emphasis on traceability at every stage in the supply chain, and tracks when products change hands on their way to pharmacies.
EU Falsified Medicines Directive
The EUFMD will require a unique serialisation number and bar code on every saleable unit of drug product intended for dispensation to a patient. A batch of 48 boxes of blister pack pills will need 48 different identifiers, not just one for the lot level.
The US Drug Supply Chain Security Act (DSCSA)
The DSCSA’s serialisation rules are being applied in three phases.
Phase 1: Lot traceability and verification. This phase came into force on January 1, 2015. The DSCSA requires a transaction history, like a title to a house or car, which tracks when a batch of drugs is divided or changes ownership. The transaction history will show that 20 units have been sold from one lot, but if does not identify individual units.
Phase 2: Unique serialisation. In 2017 manufacturers will be required to give unique serialisation numbers and bar codes to the smallest saleable unit of pharmaceutical product, and to every homogenous case of those drugs.
Phase 3: Combination. By 2023, the DSCSA will require the transaction history or every product to contain drug units’ unique serial numbers.