A serialized guide to serialization #1
At the beginning of the serialization timeline
The Drug Supply Chain Security Act
Patient care does not merely begin in primary healthcare centres, but in the research and development phase of pharmaceutical products. This position is the basis for the Drug Supply Chain Security Act, introduced in 2013, the Falsified Medicines Directive, and the reason behind the ever-growing awareness of drug security.
You may be interested in our guide to temperature controlled logistics.
A knowledgeable pharmaceutical firm or partner should strive to understand a medicine’s entire journey though the supply chain – and one of the most critical tools in enabling this is serialization. Not only can large shipments be tracked and traced, but individual dosages can be accounted for and located.
An upcoming serialization timeline
With 2017 heralding a new age in compliance deadlines, new regulations are being rolled out in 2019, with a large number of organizations known to be lagging behind schedule.
With hundreds of firms anticipating difficulties with the impending US/EU schemes for serialization of individual packets next year, it remains to be seen how effective the changes will be when implemented. Will large contractors be prosecuted if legally uncompliant? Will the balance of the marketplace shift when major players are unable to utilize their supply chains? Both the FMD and the DSCSA are likely to change the pharmaceutical industry in two of the world’s major markets.
See also: how the US system is not ready for 2019.
Going back to the beginning of serialization
So, what's the big deal? Tracking shipments is hardly something groundbreaking enough to threaten some of the world’s largest firms, but the level of precision required is responsible for catching much of the industry unawares. By allocating each package a unique number, the legitimacy of the pharmaceuticals can be verified extremely precisely, and any products that have been tampered with are far more likely to be recalled successfully.
With hundreds of billions of dollars’ worth of drugs adulterated each year, the issue is expensive for drug companies, dangerous for consumers, and global in its reach. Pfizer reported discovering 26 counterfeited versions of its own range between 2004 and 2016 - and the ability to not only identify adulterated products, but also the point along the supply line at which the tampering occurred allows companies like Pfizer to protect themselves if consumers or other business claim products to be substandard, and to inform those at the point of retail about dangerous materials.
Serialization timeline or ticking time-bomb?
In a recent interview with European Pharmaceutical Manufacturer magazine, the director of corporate projects at multi-billion-dollar Swedish firm Recipharm spoke of the difficulties many smaller firms would have with the change, describing the prohibitive nature of such a price tag for remaining compliant in the EU, and how his firm had to undergo
a large-scale change to our operations… costing around €40 million.
Whilst touted as a revolutionary move that will improve patient safety across the globe, these changes may result in a failure to coordinate in larger multinationals – and complete barriers to compliance for smaller CMOs. The FDA has been known to offer grace periods to smaller firms, but these typically only extend for one year, and do not lower or assist with the base costs of implementing the new serialization timeline.
Because serialization itself tends to be inextricably linked to the packaging of pharmaceutical products, many CMOs may outsource their packaging functions entirely. Product authentication and the monitoring of quality may become the sole realm of the CPO – leaving the manufacturers to focus on brand consistency and reputation.