Why serialization is vital for pharmaceutical product integrity in the cold chain

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

What is serialization?

Serialization enables product authentication and product quality monitoring, by assigning a unique traceable number to each individual package or container.  This unique number, as it is tracked through the supply chain, allows key stakeholders do several things:

  • enable verification of the legitimacy of the drug product identifier down to package level
  • enhance detection and notification of illegitimate products in the drug supply chain
  • facilitate more efficient recalls of drug products

Essentially this facilitates the prevention of and identification of counterfeit, diverted, sub-standard or adulterated drugs in the market, and provides accountability for the movement of drugs by participants in the supply chain.

Why it is needed

Serialization and security technologies are a vital part of addressing counterfeiting and theft of drugs – according to some estimates global drug counterfeiting is a $200 billion market.  Counterfeit drugs can result in financial loss, but for patients it could mean the difference between life and death, especially if the fake medicines are manufactured with sub-standard materials or have diluted dosages.

According to this article, ‘How technology can protect consumers and pharma companies from fake drugs’, Interpol estimates that 10 percent to 30 percent of all pharmaceutical drugs in circulation in the world are counterfeit and that up to one million people will die annually from counterfeit pharmaceuticals.

How serialization helps – providing absolute traceability

Serialization provides absolute traceability, sometimes down to individual packs; by providing this level of detail for the entire supply chain, it makes companies accountable, and enables them to act with confidence and speed should a recall be required. It also ensures that a pharmacy or distribution point can be identified and informed quickly and effectively if any problems occur, reducing the level of risk in the supply chain.

The USA introduced the Drug Supply Chain Security Act at the end of 2013, which by 2023 is expected to have in place, in different phases, the following requirements for drug traceability and accountability on the part of the supply chain involving manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies):

  • Product identification: manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: all stakeholders in the drug supply chain to provide information about a drug and who handled it each time it is sold in the US market.
  • Product verification: all stakeholders to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: all stakeholders to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: all stakeholders to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

Other countries are also in different phases of discussion about introduction of regulations requiring serialization, to ensure accountability and traceability – for example China, India, Mexico, Saudi Arabia, Brazil and Europe. This was discussed at the recent Pharmaceutical Traceability Forum, which looked at topics such as global compliance architecture, forthcoming regulatory deadlines, visibility between manufacturers, wholesalers and retailers, and the technology aspects – such as data standards and interoperability for product IDs.

From the technology platform perspective, Dyzle has for a while been providing a solution helping customers go some way towards tracking and documenting a drug product’s journey. Its real time monitoring solution transmits temperature and other critical cold chain data from a package or container to the web via mobile and wireless networks, and its traffic light system provides instant alerts of any digression.

From a serialization point of view, it also enables key stakeholders to get instant access at any time to the data via the web about the product and its journey, with its ability to identify the location as well as its temperature profile.

With the implementation of serialization, the process is also required to be automated within 10 years, and not paper based. Technology will be an important element in ensuring this automated assurance, providing the accountability and the traceability that various regulations around the world will require over coming years. Without proper integration, this could end up requiring significant investment.

In the next article, we will demonstrate how serialization can actually be implemented cost-effectively in the cold chain, so that full visibility of the entire journey of a product is available. As outlined in this article, it will help the industry demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

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