What is Next After Serialisation?

Ever the last few years, the pharmaceutical industry has invested a lot to achieve compliance with track & trace/authentication regulations from across the world. These range from the European Falsified Medicines Directive, to the Drug Supply Chain Security Act in the USA, diverse traceability regulations in the Middle East region, as well as in Argentina and Brazil. And we also see more and more developing serialisation requirements in the Asia Pacific regions. For all of these, packaging lines needed to be upgraded to deliver serialised drug packs. Significant money and effort has gone into these changes, increased when aggregation was also implemented. The data exchanges with stakeholder owned databases or those held by regulatory bodies have had implications for supplier software systems.

A recent survey in the US has shown that more than 70 percent of all products carry a barcode with the four data elements and a barcode format on which the world seems to harmonise: the product identification number (GTIN=GS1 Global Trade Item Number), lot number, expiry date, and serial number in a Data Matrix barcode. And, although in Europe, there are still a number of small manufacturers not yet connected to the European HUB—the large majority of products are compliant.

So, what is next? What is needed regarding pharmaceutical product labelling?

For many years, a very strong request has come from hospitals to enable bedside scanning by providing a barcode on the single unit packaging level: the blister, the vial, the syringe. This call for support from industry, to prevent medication errors, has become louder over the last few years. For some time, the industry was too busy with serialisation to look at this level of packaging, but now seems to be a good time to consider this as the next step. It has been proven by many studies that the introduction of Closed Loop Electronic Medication Management systems to minimise manual selection, inputs and transcription, prevents serious errors in the administration of medicines; a reduction of 50 to 70 percent has been experienced! This means that many patient lives could be saved, or the quality of their treatment significantly improved. It is known that at least a third of the medication errors reported occur when administering medication to patients. Barcoded medicinal products, which can be scanned at the point of care, will enable staff in hospitals to be sure that they give the right drug to the right patient at the right time in the right way—and ensure that patients benefit from an ‘additional check’ via systems that are always alert, even when our hard working clinicians and nurses may be tired or distracted. Medical errors are costly—even if we cannot give a monetary value to the life of a human, additional treatments alone are causing significant financial burden for our healthcare systems. In Australia, for example, medication errors contribute to 250,000 hospital admissions each year.

Beyond that, wider implementations, for example, in the UK with Scan4safety, have shown significant financial benefits through access to accurate patient costing information, which can be stored safely and automatically in electronic patient records. At the same time, the accuracy of inventory management, due to access to real-time consumption information, has improved.

Up until today, to enable scanning at the point-of-care, most hospitals outside of the US have had to repack and re-label their drugs themselves—often manually—or have had to invest in robots that do so automatically. This is a time and cost intensive process, which would better take place at the source of manufacturing. Simply put, the best place to produce safe, secure, and correctly identified medicines is at the manufacturer, where the right equipment, expertise, and quality controls exist, not at the hospital!

Some forward-thinking manufacturers have started projects to move barcoding and identification across their products to the level of primary packaging. These are not serialized—that is at the moment technically not possible, but with a GTIN as product identifier and sometimes also with expiry date and lot number. These organisations are taking their responsibility toward patient safety very seriously, and at the same time, are creating a competitive advantage for their organisations.

Applying static product identification on the single-unit package greatly helps to ensure that the right medication is provided! Of course, the expiry date is extremely useful to avoid expired drugs being given to a patient and the lot number helps with targeted inventory control and recalls. Of course, the regulatory requirements regarding text size used on the packages need to be re-evaluated.

As the implementation of traceability means hospitals are more used to barcode scanning, their requests towards manufacturers will increase. Amgros in Denmark was the first hospital group to make primary packaging identification and barcoding a criteria in of their tenders. Others will follow as they act to improve the quality of care and give their staff more security and support when treating their patients.

One medication error leading to serious harm is one too many—for the patient and their family, but also for the caregiver. And safer, more efficient care starts with a simple scan, meaning the availability of a barcode on the level of packaging that is applied to the patient is essential. Full implementation will take time, but the time to start is now!