With recent reports addressing the vulnerability of the pharmaceutical industry to counterfeiting, the security of the pharmaceutical supply chain is a matter of growing concern. The practice of counterfeiting can place significant burdens on the economy. For instance, the government is challenged with increased economic pressures such as loss of foreign investments, increased law enforcement costs, and an increased possibility of unseemly public health incidents.
Many counterfeit drugs include wrong ingredients, little or none of the active ingredient, and potential toxins that may lead to additional ailment and even fatalities. According to Newton P.N. (Counterfeit anti-infective medicines; Lancet Inf. Dis. 2006;602–613) counterfeit drugs were responsible for the deaths of more than 500 children after consuming paracetamol containing a renal toxin. This is one among the many cases over the last 190 years which have seen counterfeit products leading to death. In fact, developing countries are particularly vulnerable to the practice of counterfeiting.
Identification and Traceability of Pharmaceutical Products
With an increasing number of counterfeit products entering the supply chain and reduced transparency of the supply chain, several regulatory bodies introduced additional requirements to monitor the identification and traceability of pharmaceutical products. According to the European Medicines Agency, measures from its 2011 directive on falsified medicines will be implemented by EU member states from January 2013 onwards. The aim of this directive is to make it more difficult for counterfeits to introduce fake medicines into the market by monitoring manufacturing activities, employing improved safety features on prescription drugs, and clamping down on internet sales.
Pharmaceutical Coding of Medicines
One major issue behind this counterfeiting problem is that there is no standardised system for detecting and coding of pharmaceutical products in Europe. Pharmaceutical coding was first used for managing trade flows, but now many national authorities have implemented coding systems for public health reasons. Also, many EU countries are recommending and developing separate coding systems, but these differ in terms of the physical placement of the code and contents of the code. This fragmented coding further compounds the problem.
Importance of Serialization
While industry guidelines specify the need for more rigorous measures to combat imitation drugs, increasing number of pharmaceutical companies are using track and trace processes within their products. Although a centralized and regulated database for serialization is still not established, the pharmaceutical industry is completely aware that serialized products are important to ensure the safety of the supply chain. Implementation of serialization will not only ensure patient safety, but will also provide numerous benefits to both business and the economy.
PCI Serialization System
In order to overcome industry challenges, Packaging Coordinators, Inc. (PCI) has developed a serialization system that provides a complete, point-of-dispense identification solution. The system employs an exclusive identification code on each pack, created and applied by the packer. It operates directly between PCI and the client by way of a unique-to-client server.
A 2D data matrix bar code is fixed to the packet that includes a special serial number, along with the material code, GTIN number supplied by client, lot number and expiry date. Then, the product verification process compares the information held within the data matrix code with a product record on a database to validate that the product record exists and goes with the data held on the product itself. The design of PCI’s serialization system meets the requirements for strong data management throughout the process.
When completing any serialization project, it is important that both client and supplier establish a complementary partnership. It is imperative that a supplier is selected who has the right equipment to facilitate its partners’ requirements throughout a project.
The complexity of the EU supply chain is one of the main factors of counterfeiting issue. In addition to placing pressures on the economy, the practice of counterfeiting also puts lives at risk. Moreover, fragmentation has reduced transparency in the supply chain and presented more difficulties in detecting and tracing medicines, thus leading to considerable threat from counterfeiting. It is therefore important that the supply chain remains safe and free of counterfeits. One major obstacle is that there is no unified global database where scanned bar codes on drug packaging can be checked at point of dispense. In future, the regulatory bodies, pharmaceutical sector, retailers and clinicians will need to work together to overcome this counterfeiting pandemic.
Produced from articles authored by Dr. Sue Miles, UK Site Director, PCI
About Packaging Coordinators, Inc.
Packaging Coordinators, Inc. (PCI) specializes in providing packaging solutions to the global healthcare industries that need to increase their products’ speed to market for commercial success. PCI brings the proven experience that comes with over 50 successful product launches a year and more than 40 years in the healthcare business. Continued investment and leading technology allows PCI to meet global packaging needs throughout the product life cycle - from Phase I clinical trials through commercialization and ongoing supply. PCI’s clients view the company as an extension of their business and a collaborative partner, with the common goal of improving patients’ lives.
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