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Dispense As Written
Time to get a little nerdy about industrial automation—but you’ll see how this impacts much of the pharma business’ future.
Anyone who has used multiple smartphones has encountered Apple’s IOS, or Google’s Android operating system. They do the same things—sort of—but in different ways; and usually, one is easier off sticking with apps that are compatible with one or the other, than to try to blend or connect the same app with both. This is an example of proprietary industry standards; same as, in an earlier era, Apple’s operating system and Microsoft Windows.
In the industrial automation world—process controllers, robotics and the like, there is an equivalent standardization effort, but in this case, many (not all!) parts of the industry have gravitated to a variety of standards, which are open and which (most of the time) enable Vendor A’s device to communicate with Vendor B’s without additional software coding. The value of this ranges from convenient to essential. On a factory floor, a communication incompatibility could lead to process upsets or outright disasters; automation engineers get very serious about this topic because lives could be at stake. Most of the time, though, the value is in ease of use and substantial cost savings when automation systems are installed.
Now, transfer this line of thought to the massive serialization effort going on in pharma packaging and distribution. As our annual Product Security Report (p. 22) details, the mandates of the US Drug Supply Chain Security Act of 2013 and the Falsified Medicines Directive in the EU (as well as national or regional mandates around the world) are now hitting. Ultimately, each unit package of pharmaceuticals in commercial distribution will have a unique ID number, and that number enables tracking from one trading partner to another—or from the manufacturer to the patient. While many in the industry still look on this as an onerous regulatory burden, others are realizing that this “traceability” could have profound effects on patient outcomes, post-approval clinical studies, biosimilars adoption and other applications. If the ID numbers are there, smart people will find ways to derive value from it.
Although the IT and hardware system for traceability have been in development for years, and although the GS1 organization has been successful in developing a global standard for how the ID information is written, little has been done to standardize the equipment and the IT systems that handle this data. Custom interfaces abound—having those interfaces available is a competitive issue for many vendors.
A handful of vendors are now attempting to develop a standard, tentatively called the Open Serialization Standard working group (Open-SCS).* Some are putting in funds to hire subject matter experts, some are dedicating internal resources to the effort. The current list (which is growing gradually) is these vendors: Advanco, Antares Vision, OCS Checkweighers, Omron, Optel Vision, SAP, Systech and Werum. Serialization customers—pharma companies—include Abbott, Roche, Teva and Pfizer.
According to industry sources, lack of interoperability of the various levels of automation in a serialization project can double its IT costs. Equally important, higher cost is going to slow down the effort in less-developed parts of the world, which happen to be where most of the counterfeit products also show up. The companies that are pushing this effort forward (in the face of conventional vendors’ perspective that a proprietary system is “better”—i.e., more profitable) are to be lauded. Pharma companies making hardware and IT investments in serialization should be asking their vendors about their involvement.
* An existing standards-setting organization, the OPC Foundation, is hosting this work group; more information is available at https://opcfoundation.org/open-scs-working-group/.