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What’s Next for Pharmaceutical Serialisation?

Supply chains for pharmaceutical products are exceptionally complex, with medicines and ingredients often crossing the borders of many countries before reaching the end consumer.  To protect patient health and safety, serialisation and track and trace requirements have become standard for pharmaceutical products worldwide. Legislations include the EU’s Falsified Medicine Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA), which both necessitate serialisation and government reporting for prescription pharmaceutical products.

Spotlight on Safety

With increasing focus on consumer health and safety, the over-the-counter (OTC) market could likely be next for review. Counterfeit OTC medications can cause significant harm to consumers and arguably need the same protection as prescription-only ones. The possibility of purchasing OTC medicines from entities other than legitimate pharmacies, including online sellers, increases the potential for criminal activity.

New serialisation requirements in Russia, which came into effect in July 2020, cover all prescription and OTC medicines and set a clear precedent. While serialisation of OTC medicines is unlikely to be implemented in the immediate future, it is highly conceivable that EU and US legislation will be extended to OTC medicines in the coming years.

That said, when it comes to pharmaceutical products, serialisation can extend far beyond protection against counterfeit products, opening doors to increased patient health and safety in pharmacies, hospitals, and healthcare facilities. With more sophisticated serialisation of pharmaceuticals, healthcare staff can ensure that a medicine is not counterfeit and that the right patient gets the right dose, of the right medication, at the right time.

Individual Dose Identification

Hospitals, pharmacies, and healthcare providers are realising the benefit of data in helping to protect patient safety and are placing pressure on pharmaceutical manufacturers to provide a greater level of more granular information on pharmaceutical products than dictated by current pharmaceutical legislation.

Including a 2D code – containing information on the product, dose, batch code, and expiry date – on individual strips or blister packs, or even going so far as coding each pocket containing a tablet, can help to reduce the number of cases where patients unintendedly receive the wrong dose of the right medicine, the wrong medicine, or, in some cases, no medicine at all.

In some countries, pharmacists have a legal requirement to open medicine packs to take out and only sell the exact number of tablets that a patient needs. In these cases, all forms of verification and authentication may disappear if machine-readable codes are only present on the carton pack from which their strips or blister packs have been separated.

Adding more granular data to strips and blister packs of medicines can allow for inventory control within hospitals, care homes, and other healthcare facilities to improve medicine distribution. Scanning 2D codes can allow for automatic electronic validation of medicines to ensure that patients are given the correct medicine. This level of detail decreases dispensing errors and can improve inventory management and stock control by allowing medications to be tracked down to the individual dose level.