Pharmaceutical serialization is the application of a unique serial number to each saleable unit of a pharmaceutical product. Serialization allows government agencies, as well as pharmaceutical manufacturers, distributors, and dispensers, to track medications from their place of origin to their place of administration. The ability to track medicines makes it possible to identify counterfeit products, alert companies when a product may be stolen or diverted, and initiate more effective recalls in cases where quality may be compromised.
In addition to supply chain security and patient safety, pharma serialization promises to help make pharmaceutical supply chain management more efficient. The granular information that is generated by logging each stop in a drug's path to market provides a huge trove of data that can be mined for insights by logistics specialists and used to improve supply chain operations.
Preparing for final FDA approval of your next product? Download the eBook: Serialization—Where to Begin: A Guide for Clinical Stage Manufacturers
The critical importance of pharmaceutical products to global health
Stunning advances in pharmaceutical research and development have made pharmaceutical therapies critically important to a fast-growing range of medical conditions and treatments. Today, it's impossible to imagine effective medicine without the myriad substances that have become essential tools for medical practitioners. The World Health Organization's list of essential medicines—which includes all the substances considered to be the minimum requirements for an effective medical system—comprises hundreds of vital pharmaceutical products.
Legitimate pharmaceuticals are produced and tested with exacting standards in tightly controlled conditions. For example, when a vaccine is first produced and tested at scale, some patients may exhibit a strong response to the vaccine, leading to increased immunity to the targeted pathogen. Others may show little to no resistance. At this point, further research is required to determine if differences in immune responses were due to production differences, with which methods might yield better results in patients.
These standards of pharmaceutical quality control are necessarily high: The consequences of lax or inadequate production methods can range from reduced efficacy to serious harm. Serialization represents an important tool in maintaining quality control at every step in the supply chain assuring healthcare providers that medicines are legitimate and effective.
Addressing the problem of a reliable drug supply through serialization
Prior to serialization, a medical practitioner administering a vaccine or medicine had few resources to determine whether the medicine is effective, or even genuine. A doctor or nurse inoculating a class of school children against a dangerous childhood illness won't have the wherewithal or time to perform laboratory analyses on every dose. In emergency medical situations, more than dozen medications may be administered in order to treat a patient. If any of those drugs are ineffective or out of date, it could end up costing a patient their life.
Tracking expiration dates and batch numbers can only go so far in identifying issues with a pharma supply chain. A more insidious problem is counterfeit medicines: It has been estimated that around 10% of pharmaceuticals for sale may be counterfeit. While pharmaceutical companies are entrusted with making sure the medicines they produce are safe, the growing demand for medicines has made counterfeiting increasingly common—and a primary motivation for government-mandated serialization. Without a reliable way to verify a product via serialization, the risk of administering a counterfeit pharmaceutical product to an unsuspecting patient becomes more likely every day.
A solution to fight illegitimate products
Serialization is a common and proven practice in other industries, where unique identifying strings of numbers and letters are placed on products. These serial numbers give manufacturers an easy way to identify goods after they are sold. Instead of having to reconstruct the chain of sales between the factory and the consumer, a company can simply check a serial number against records of production to determine when and where that item was produced.
Prior to unit-level serialization, large volumes of a medication were usually shipped using a single serialized shipping container code (SSCC) or identified by a single manufacturing lot number, and would end up being divided into multiple courses of treatment for multiple patients. This meant that a healthcare provider administering medications would not have a fast, reliable way of verifying the authenticity of the medication when treating a patient without spending valuable time to track down the original SSCC or lot number.
Stolen and counterfeit medications can enter the pharmaceutical supply chain at multiple points, which means that just checking the SSCC on a pallet of medications may be insufficient. With a traceable serial number on every saleable unit, bad actors are prevented from using legitimate SSCCs and lot numbers on large shipments to move significant quantities of fake pharmaceuticals.
As more and more governments are pushing for every saleable unit of a medication to carry a unique serial number, modern pharmaceutical serialization requirements are giving healthcare providers greater confidence that the medication has traveled through legitimate channels—while giving them the ability to check whether every medication is genuine at the point of administration.
Regulating and implementing pharma serialization in the United States
Pharma serialization uses a system where standard alphanumerical identifiers are attached to units of sale at the time of production and packaging. In addition, the packaging uses tamper-resistant methods so that any effort to alter the package's contents will be apparent to the end user. At every point in the pharmaceutical supply chain, the serial numbers can be captured and recorded in a local or shared database so that a given medicine's journey can be reconstructed, or "traced," back to its point of origin.
Under the 2013 Drug Supply Chain Security Act, (DSCSA), the united States Food and Drug Administration (FDA) has stipulated that companies and organizations involved in the pharmaceutical supply chain in the United States must implement an all-digital pharmaceutical serialization track and trace program by 2023. This will track the movement and sale of pharmaceuticals within the United States by tracking saleable unit serial numbers.
FAQs: How do companies comply with serialization requirements?
How do companies comply with serialization requirements?
Companies comply by implementing systems and software for generating, labeling, storing, retrieving, and tracking every saleable unit of any medicine that is covered under a specific mandate. In addition, companies may have government reporting requirements or requirements for providing an audit trail of a suspect product.
What countries have pharmaceutical serialization requirements?
The European Union, United States of America, Russia, China, Brazil, and a growing number of other countries have pharmaceutical serialization laws.
What percentage of the international pharmaceutical market requires pharma serialization?
It's estimated that more than 70% of the world's drug supply will eventually be subject to some form of serialization requirement. The actual percentage varies if you include or exclude over-the-counter medications.
Are all medical supplies subject to serialization requirements?
Some jurisdictions require tracking of medical devices and supplies as well.