The pharmaceutical supply chain is complex, with a myriad of distributors and dispensing types and an array of international players that include manufacturers, governments, and consumers. Therefore, regulations like the European Union’s FMD and the United States’ DSCSA aim to improve patient safety by securing the supply chain.
In a prior post, How ERP Helps Pharma Companies Achieve Serialization, we focused on implementing serialization in pharmaceutical production and inventory management. This post describes the five stakeholders affected by pharma serialization and how they’ll need to be connected to remain compliant with European Union (EU) and US regulations around serial number authentication and traceability.
As noted in another post, manufacturers must assign serial numbers to individual items, packets, boxes, etc. in various ways across the functional areas of inventory management, production, quality control, and sales. In addition, the EU’s requirement for 2D barcodes on all labels will affect packaging processes.
Manufacturers will need to generate serial numbers and associated labels as well as store, capture, and transmit millions of serial numbers for many different supply chains. Manufacturers selling into the EU must also transmit serial numbers to the European Medicines Verification System.
Like manufacturers, wholesalers and distributors are obligated under US and EU regulations to ensure the security of their pharmaceuticals and supply chains and verify suspicion of false medicines. However, the burden of proof is much more taxing on secondary wholesalers than primary wholesalers.
Primary wholesalers purchase their medicines directly from OEMs and/or marketing authorization holders. These supply sources are already verified when the primary supplier receives the product, so no risk-based verification is imposed on the wholesaler. Secondary wholesalers often purchase products off the main market or from other wholesalers, increasing their risk of taking possession of falsified medicines.
Wholesalers that sell out of the market (e.g., to research institutions and universities), must decommission the serial numbers of products destined for those locations. They must also perform thorough and well-documented risk-based verification for returned items they plan to resell, regardless of the supply source.
There are several varieties of pharmacies, and the way each operates makes regulating their product usage more challenging. Regardless of pharmacy type, however, they must all arrange for their own connection to the medicine verification database.
Hospital pharmacies deliver medicines via several methods, and whether they verify medicines specific to each method isn’t clear. They indirectly deliver medicines to patients via hospital departments and doctors, and much of that product is from hospital stock. In the cases of emergency departments and intensive care units, spending too much time identifying which medicine packs should be dispensed to patients versus clinical areas could be the difference between life and death. For many hospitals, scanning products both upon receipt and just before dispensing is unrealistic.
Community pharmacies must scan the package barcode to verify products before dispensing them to consumers/patients. This is the optimal real-time method for alerting pharmacists of products falling out of date or being recalled/removed from the supply chain.
Online pharmacies have, unfortunately, provoked a massive trade in counterfeit medicines. They’re not all bad, but many online pharmacies market fake medicines in packages virtually identical to the original product. By complying with the EU directive for a common logo, online pharmacies can assure consumers that their website and their products are authentic.
Patients who want to ensure they’re taking authentic medicines have several choices. Recently, government agencies, nonprofit organizations, and for-profit app providers offer means for verifying medicines and medicine packages/packets. For example, Malaysia’s Health Ministry provides access to the Meditag Checker app. The app is highly reliable because all pharmaceutical products sold in Malaysia must be registered with the Drug Control Authority, assigned a unique registration number, and labeled with the Meditag security label, which is produced solely by Mediharta Sdn Bhd.
Nations with major pharmaceutical production, such as the United States, Brazil, China, India, Russia, and South Korea, are continuously implementing mass serialization programs and improvements – it’s in their national interests to do so. Recognizing that fending off counterfeit drugs works best through international cooperation, EU countries and others are making the Gs1 2d barcode format as widely accepted as possible.
At Sapphire, our in-depth knowledge and experience in the international pharmaceutical industry make us the ideal business and technology partner to help your organization navigate the system complexities involved in adopting new compliance measures. Contact us today to discuss your product serialization and compliance goals.
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