According to the International Policy Network, more than 700,000 people die each year due to counterfeit malaria and tuberculosis drugs. In emerging markets, counterfeiters exploit vulnerabilities in the supply chain to re-label, repackage, counterfeit and dilute a variety of pharmaceutical products. While it's more difficult to infiltrate the drug supply chain in developed markets, counterfeiters work around security roadblocks by selling their product directly to consumers over the internet.
Pharmaceutical manufacturers are fighting the problem head-on. One large pharmaceutical company has found talcum powder, boric acid, brick dust, highway paint, and even floor wax in counterfeit versions of its medicines. To prevent spurious drugs from threatening patient safety and affecting the bottom line, the company hired former law enforcement officials and customs agents to investigate counterfeit drug manufacturers and distributors worldwide. The company's global security department has been extremely successful at uncovering criminal activity and involving the appropriate authorities to bring the responsible parties to justice.
With consumer brand loyalty integral in a competitive marketplace, pharmaceutical manufacturers need to understand not just the different types of supply chain threats they face, but also the tools and technologies available to prevent them. Whether the issue is a substandard or counterfeit raw material from China entering the legitimate supply chain or counterfeit drugs being sold over the internet, these companies must be prepared to protect their brand, product and customers.
Harnessing Proven Technologies
Technology can help pharmaceutical manufacturers, distributors, wholesalers and others involved in the supply chain differentiate between genuine products and materials and fakes. Whether trying to ensure the integrity of a product or enforcing intellectual property rights, there are technologies that can assist.
One of the newest technologies available to combat drug counterfeiting is SMS, or text messaging. SMS solutions work by affixing a unique code to drug packaging. Once a consumer purchases the drug, he or she reveals the code by scratching it with a coin. The consumer then text messages the unique code to a "Mobile Authentication Service" and receives an immediate response that identifies the drug as legitimate or suspect. Pilot studies have shown this technique to be effective, though it requires that manufacturers alter the drug's packaging to accept the unique code.
An electronic pedigree is an electronic document that tracks basic data elements of a drug as it travels through the supply chain. Information such as lot number, potency, expiration, manufacturer and other data elements are tracked on an RFID tag from the time a drug is manufactured to final dispensation.
The e-pedigree secures the chain of custody, preventing phony transactions and products from getting into or remaining in the legitimate supply chain. Electronic pedigree systems can detect counterfeit and diverted products by analyzing transaction details and suspicious patterns.
The downside is that RFID is costly and, like any packaging technology, it does not secure the product itself, making it largely irrelevant in markets where the product is sold without its original packaging.
Spectroscopy is less well-known, but has been a game-changer in the industry since becoming available in a portable, handheld instrument. This technology can be used in the supply chain to accurately identify chemicals without direct contact with the substance, through sealed glass, plastic bottles, bags and blister packs at ports of inspection, loading docks, points of sale and manufacturing plants. It has been used by a majority of the largest pharmaceutical manufacturers, as well as regulatory bodies around the world.
Government in Action
Governments around the world are also utilizing new technologies, including those highlighted above, to prevent counterfeit and substandard drugs. Nigeria has been a pioneer in the fight against counterfeit drugs, recently bringing counterfeit pharmaceutical levels down from 42 percent to 16 percent thanks to an aggressive policy of intercepting shipments and pursuing counterfeiters. This success can be attributed in part to the use of two of the technologies outlined above, which have allowed the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) to raise the quality and inspection standards in Nigeria while giving it a greater ability to identify and remove counterfeit drugs from the supply chain.
NAFDAC currently uses spectroscopy, having successfully field-deployed several handheld instruments for the rapid identification of counterfeit and substandard drugs. This technology has aided authorities in several seizures, and has acted as a deterrent for counterfeiters trying to infiltrate the supply chain and sell spurious drugs to the general public.
NAFDAC is also leveraging SMS, working with pharmaceutical manufacturers to affix packaging with special codes that can be used to identify genuine pharmaceuticals. Once a drug is purchased, the consumer uncovers a special code and text messages it to a central hotline. The service responds instantly with an "OK," notifying the customer that the drug is real, or sends a messaging saying that the product is not registered and the customer should recheck the code.
Threats in the pharmaceutical supply chain aren't new, nor are they going to disappear anytime soon, but there are steps that companies can take to mitigate risk and ensure patient safety. New technology has moved the battle against counterfeit and substandard drugs from the laboratory into the field, enabling pharmaceutical companies, government entities and patients to take control of drug quality.
Source: Thermo Scientific
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