RFID: Getting The Real Thing

Drug counterfeiting is a widespread and serious problem that directly affects patient safety. The problem is prevalent due to weak drug regulation and enforcement, scarcity and/or erratic supply of basic medicines, unregulated markets and unaffordable prices.

The World Health Organization (WHO) estimates counterfeit drugs make up more than 10% of the global medicines market. The Centre for Medicines in the Public Interest (CMPI) in the US predicts that counterfeit drug sales will reach US$75 billion globally in 2010, an increase of more than 90% from 2005.

The WHO labels counterfeit medicine as a product which is deliberately and fraudulently mislabelled with respect to identity, composition and/ or source. This extends counterfeit drugs to include fake drugs (absence of any active ingredient, a placebo), as well as sub-standard drugs (reduction in amount of active ingredients), and those which have been tampered with in order to misrepresent the contents.

It is imperative that governments, drug companies, hospitals and the healthcare industry acknowledge this problem now and work towards curbing it using legislation, education and readily available technology.

The Extent of the Problem
The problem of counterfeit drugs is mounting in both developing and developed countries. According to the WHO, an estimated 25% of the medicines consumed in developing countries are believed to be counterfeit. In some countries, the figure is thought to be as high as 50%.

Even wealthier, developed countries have fallen prey to the counterfeit trade. The high rate of Internet penetration in these countries has led to a bustling online trade of counterfeit drugs. With this new marketplace transcending national borders, Internet sales can account for as much as 50% of medicine sales.

While there are legitimate Internet pharmacies that require prescriptions and deliver medicines from government-licensed facilities, some operate illegally without prescriptions and peddle counterfeit products for unlawful gains. This threatens the health of those who seek cheaper, stigmatized or unauthorized treatments.

Another troubling aspect of this problem is that patients who consume sub-standard drugs will start to build immunity towards them. These drugs in "sub-therapeutic doses" may kill off some causal agents but leave the stronger strains to mutate and build resistance towards the active ingredient in future treatments.

At the same time, patients are fooled into thinking that the treatment is working because they see short-term improvement. Sadly, this is a common scenario in the treatment of some of the world's most deadly diseases such as tuberculosis, HIV and malaria.

How the Counterfeit Industry Works
Contributing to the growth of counterfeit trade has been the increasing sophistication of organised crime groups with distribution networks mirroring the old heroin networks.

Counterfeiting is an extremely lucrative trade with constant demand, huge profits and the absence of deterrent legislation. Given its high demand, the counterfeit industry has grown from backyard manufacturing to an industrial-scale business.

Global trade agreements that facilitate the flow of goods across transnational borders have also indirectly facilitated the movements of counterfeit drugs into global networks.

As a result, these groups are able to slip their "look-alike" fakes into the legitimate drug supply chain around the world, affecting suppliers and consumers alike.

Not only do pharmaceutical companies unwittingly lose revenue to the unethical profiteers, their corporate reputation may also suffer grave repercussions. Businesses, hospitals and charitable organisations that form part of the pharmaceutical and drug supply chain may also unsuspectingly purchase the counterfeit medicines.

Using Technology to Combat Counterfeits
On the legislative front, the drug wholesaler industry is required to fulfil the pedigree requirement of the Prescription Drug Marketing Act of 1987 (PDMA). This implies that many smaller wholesalers without formal manufacturer contracts need to obtain detailed product information, and pass this down step-by-step as each component moves from the manufacturing site through the supply chain. This information is finally provided as part of the drug's final packaging.

With recent advances in Radio Frequency Identification (RFID) technology, the United States Food and Drug Administration (FDA) recommended the creation of an electronic pedigree (e-pedigree) to facilitate information flow, secure the pharmaceutical supply chain and ultimately improve patient safety.

E-pedigree is achieved by item-level RFID tagging, and the industry as a whole has been pushing in order to achieve standardization. NXP, for example, recently launched the latest product in its range of ICODE high-frequency RFID chips, the ICODE UID-OTP, which can run pharmaceutical tracking programs tailored to end-to-end security for high-value prescription drugs.

Drugs delivered to wholesalers and pharmacies can be authenticated easily by scanning their RFID tags, which carry a Unique Identifier (UID) guaranteeing each tag is unique. Pharmacies can then run a query via a secure internet connection to check tag data and authenticate the drug.

According to Frost & Sullivan, RFID sales revenue within the healthcare and pharmaceutical industry will rise almost six fold, from a total of US$370 million in 2004 to US$2.3 billion in 2011.

The healthcare market is likely to see swift uptake of RFID technology due to easily demonstrable benefits beyond traditional return on investment - for example, cutting the risk of drugs being misplaced or administered to patients incorrectly.

Other benefits include optimized counterfeit protection, increased inventory control, shelf-driven replenishment, reduced labour costs, and overall improved manufacturing and supply chain efficiency.

Companies like Purdue Pharma and Pfizer have already begun using RFID technology to track their respective drugs, OxyContin and Viagra. Together with their technological partners they are committed to laying the groundwork to ensure that the pharmaceutical industry is equipped with the latest in RFID technology and best practices in their anti-counterfeiting implementations - from the production line to the pharmacy.

RFID is proving to be an important tool in the fight against counterfeit drugs. We will see more and more pharmaceutical companies starting to implement RFID in their supply chains to protect consumers from non-genuine drugs, avoiding revenue losses caused by illegal copies, managing corporate and brand reputation, and for securing the overall supply chain. Most importantly, with RFID technology, public health can be better protected.PA