- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
Squeezing ROI from your serialisation initiative
8 March 2017 • Author(s): Mark Davison, CEO, Blue Sphere Health Ltd
At last, there is a global shift towards serialised (coded) and traceable prescription medicines.
The European Union’s Falsified Medicines Directive (FMD), the Drug Supply Chain Security Act (DSCSA) in the United States, and similar laws elsewhere, have been well discussed and I won’t go over the legal details here. This modernisation requires significant investment but long after the cost has been forgotten the benefits will remain. Mandatory serialisation is an opportunity to add value to patients and to the bottom line.
Isn’t it just a different shaped code?
Most traceability systems use space-efficient DataMatrix codes rather than the older linear barcodes – but implementing serialisation is about much more than that. It is a major corporate change programme.
Although the titles of the FMD and DSCSA are ostensibly about anti-counterfeiting, these new laws also drive down the pixel size in the supply chain from “batch” to “pack”. By insisting on unit-level coding, they boost resolution by orders of magnitude. It’s the difference between knowing that a large crowd went to a football match and having a list of their names and which seats they were in.
Committing to the new reality
If you make prescription medicines, then you need to understand the challenge (and corporate risk) that all new data brings – a homemade Excel solution isn’t going to work. The data need to be generated, assigned, reconciled, stored and reported with 100% accuracy or you won’t be able to sell your product. You can’t just buy and install a commercial, off-the-shelf (COTS) solution either.
First, you’ll need to figure out a User Requirement Specification so that vendors can tailor their systems to your exact situation. To do that properly, you’ll need a cross-department, fully empowered project team. If you’re just starting now, I recommend getting an outside consultant, too, to save time.
Strategies for ROI discovery in serialisation
Assuming you’ve been running an FMD/DSCSA compliance project for a while, you’ve probably started to look beyond the must-do basics to see how your business can benefit. It’s easy to get lost in the industrial and mechanical challenges of serialisation but there is an upside, too.
We use specific methodologies for ROI discovery, but the most common themes are Safety, Efficiency and Convenience. Thinking deeply about how you can improve these three areas will pay dividends.
Current Good Distribution Practice guidelines treat the global supply chain as a storage area, with an implied onus on stakeholders to keep the place tidy.
Serialisation provides stakeholders with more visibility of how product flows from factory to patient. Partial-batch recalls may also be possible, if a minor event has affected some, but not all, of the batch, since the serial numbers affected will be known and can be flagged before or during dispensing.
Arguably, serialisation is a pre-enabler for wider supply chain improvements such as a move from batch to continuous processing. Having every pack identified makes batch numbers redundant.
Serialisation is also relevant to Good Pharmacovigilance Practice (GPvP). Having identifiable packs in the market should boost the clarity of the “signal” for safety-related events. The European Medicines Agency (EMA) encourages market authorisation holders (MAHs) to consider data from all appropriate sources. In future, a code scan of the pack could be part of an adverse event report.
Incidentally, FMD and DSCSA also make demands for very fast reporting of suspected falsification incidents. Some of our customers are installing additional software and systems to manage anti-counterfeiting including the collation and reporting process.
In our experience, individual lines lose a small amount of efficiency but there is often a corporate net gain as a by-product of well-planned serialisation programmes. This comes from asking strategic questions before tactical ones. Rather than equip five below-capacity lines, why not amalgamate production onto three or four? Instead of coding as you pack, could you serialise finished goods offline, or at another site? What about “make versus buy” considerations – do you even need to do serialisation in-house?
There are competent service providers who can serialise for you, either as part of a packing process or on finished goods. You should only procure new equipment and software once you’ve optimised your needs.
Serialisation and point-of-dispense verification shows where every pack is dispensed. If even a pixelated view was shared with MAHs, this would allow greater supply chain efficiency and lower costs for everyone. FMD doesn’t allow it but common sense suggests that a solution could be found.
On a smaller scale, serialisation should help you to make your in-house hub operations and external logistics more efficient. You may want to think deeply about aggregation (building data hierarchies to allow inferred verification of unit products inside a larger container). Many experts view this as a non-mandatory but business-driven necessity.
Some companies are devising ways of making serialisation (with consumer verification) a service enhancement by embracing the opportunity to interact with patients. Think about how you could add convenience to your product by encouraging the patient to scan the code to initiate a dialogue.
Information, adherence support, adverse event reporting, and patient forums can all make it easier for patients to keep taking your product. Fewer drop-outs mean higher sales. Of course, there are commercial, ethical and compliance issues to solve, but that’s why you set up a cross-departmental team.
Serialisation is expensive and tricky to implement. That shouldn’t blind us to the benefits. Experience in India and elsewhere has shown that simple but powerful interventions with coded products can lead to better adherence, improved clinical outcomes and easier reporting of adverse events.
In a few years, the prescription drug will be a part of a much bigger patient experience. Pharmaceutical business models will evolve radically. The mechanics of serialisation will change – printed DataMatrix codes will be superseded by Near-Field Communication (NFC) labels or some future technology.
But identifying every pack uniquely is a key part of the fundamental shift to personalised medicine.
Mark Davison is a leading global expert on serialisation and the author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. He is CEO of consultancy Blue Sphere Health Ltd and has held senior roles in the pharmaceutical industry and with system vendors.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics