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IS ON-DOSE AUTHENTICATION THE ANSWER TO THE COUNTERFEIT DRUG PROBLEM?(Source:Alamy)

Counterfeit medicines are nothing new; over a decade ago the WHO estimated the global cost of illicit drugs at more than $75bn. The COVID-19 pandemic risks turning the issue into a crisis. While some of the current challenges might only be with us in the short-term - such as bogus treatments and tests for COVID – strong demand, misinformation and disrupted supply chains have helped create ideal conditions for counterfeiters.

An arguably more concerning, longer-lasting problem is the shift to digital and the accompanying surge in online drug sales. Thousands of illegal sites have sprung up, which are incredibly difficult for regulators to police.

The risks also differ between geographies. In the US or Europe for example, the most counterfeited medicines are “lifestyle” drugs, a well-known case being Pfizer’s Viagra. In the developing world the issue is more serious – common fake medicines in Africa include anti-malarial or HIV drugs, meaning even if the fake medicine itself is not harmful (which it frequently is) patients are in danger due to not receiving essential treatment.

Checks And Balances

Regulators have gradually been stepping up efforts to tackle counterfeit medicines over the last two decades and have made considerable progress. The most significant change has been the adoption of track and trace systems for drugs, relying on serialization and barcodes. The US FDA issued a report on combatting fake medicines in 2004 which called for wider adoption of tack and trace systems and other product authentication technologies – while noting that there was “no magic bullet.”

The European Union established the legal framework for the falsified medicines directive (FMD) in 2011 to tackle counterfeit drugs through a variety of rules, most notably the addition in February 2019 of the obligation for most prescription and some over-the-counter medicines to have a unique identifier (a two-dimension barcode) and an anti-tampering devise on the packaging.

The UK – with the exception of Northern Ireland – fell out of the FMD and lost access to its database on December 31,2020, at the end of the Brexit transition period and has yet to create a framework to replace it, leaving Great Britain more exposed to counterfeit medicines.

 

Ravina Barret, senior lecturer in pharmacy practice at the University Of Brighton, UK, discussed her research into counterfeit medicines in a recent interview with In Vivo. One key theme she highlighted was the lack of transparency and data around illicit drugs, which by their nature are difficult to record. “The problem with the illegitimate supply chain is that we cannot quantify it,” she said. Furthermore, Barret claims that when seizures of counterfeit drugs are made, the details are often not reported publicly to avoid undermining faith in the health care system.

Barret also discussed the added risks of the current climate, such as the UK no longer being part of the FMD. The pandemic was another theme of the discussion, with Barret stating that “shortages are the fastest way to create incentives [for fraud].” Barret’s research has shown fewer patients collecting their regular prescriptions for conditions such as asthma or arthritis during lockdowns – raising the question of whether they have turned elsewhere in search of medication. Regarding innovations to tackle counterfeit drugs Barret believes “there is scope for technological improvement … there is a demand for it.”

Critics argue that today’s serialization technology is not enough to safeguard against fake medicines. They point to the high cost of implementation, the relative ease with which barcodes can be copied, and the fact that identifiers are often on the secondary rather than the primary packaging of the medicine. Products can also be removed from their original packaging, which can then be reused.

In Vivo recently discussed these challenges with Colorcon’s chief scientific officer, Ali Rajabi-Siahboomi, and product authentication lead, Gary Pond. Colorcon is looking to provide on-dose drug authentication using microtags, which could be scanned to validate drugs throughout the supply chain, including by the consumer via a smartphone.

A Multi-Layered Approach

Colorcon’s on-dose authentication consists of different types of microtags that would sit in the film coating around a tablet, invisible to the naked eye. The company believes these microtags are “impossible to copy.” There are currently two versions of the tags ready for the market.

The first tag is based on DNA, derived from plants. The DNA allows for a great deal of flexibility in creating codes for tablets which can act as barcodes. This technology is aimed at the supply chain rather than the patients, as to scan a DNA-based tag would require a polymerase chain reaction (PCR) test kit.

The second is a silica based microtag. These use small molecules of silicon dioxide, which is already used in the pharmaceutical industry and is treated as an excipient. The silica can be used in small quantities in the film coating and be etched to reflect light in a unique way to each tablet, allowing for multiple different codes. Colorcon is developing a smart phone app that can read these tags, allowing for easy on-dose authentication throughout the entire supply chain, including by the patient.

The goal is not to replace track and trace but to complement it, Siahboomi explained, in order to develop a multi-layered authentication system to tackle counterfeits. This technology will also create large amount of data for manufacturers and patients to make use of.

“The additional information we can give to the patient, that's really exciting. As well as “bringing the physical world of the pharmacy and drugs to the digital world - bridging them together and providing the best solution to the health care system, both to the patient as well as to the providers,” said the CSO.

Pond, though, highlighted the cost effectiveness of the technology as a major benefit. “With serialization these companies are used to having to spend millions, and they're going to continue to spend millions to support that. What we're looking at, there's no investment needed on the production line,” he said. The microtags make use of existing technology for manufacturers; at most they would have to purchase a PCR reader – but equally they could simply use smartphones.

Pond and Siahboomi believe technology like Colorcon’s is essential considering the situation with counterfeit drugs. Pond states that counterfeiting has risen 70% in the last five years, mostly through online channels. “I would say [counterfeit drugs are] one of the biggest challenges at the moment in the marketplace, mainly because people are becoming digital, they're going online … it opens the doors and windows for potential fake medicine and is putting patients in danger,” Siahboomi said.

The affect is twofold; companies lose revenue and risk damage to their brands and reputation; while patients are also being put in danger. The latter very much depends on the type of counterfeit drug. As Siahboomi explains, the fake medicine a patient receives may have no API at all, it may be the wrong drug, or it could be the wrong dosage form. On the other hand, patients may receive the correct medication, but the drugs may have been illegally diverted from the supply chain.

“At the end of the day the accountability goes to the pharmaceutical industry, how do we protect ourselves, how do we take the lead, to make sure that we don't lose our brand, we don't lose the trust in the eyes of the patient,” Siahboomi said.

A significant element of the on-dose microtag approach centers around patient education. While the legitimate supply chain will benefit from cheap on-dose authentication, it does little to protect patients who have unwittingly ordered counterfeit drugs from an illegal website. That is, unless patients know to scan their medication as a matter of habit.

 

Pond explains that the company’s customers see it as their responsibility to educate patients if and when they choose to put a microtag on a given product which can then be scanned. He points to similar trends in other areas of consumer goods, with tags being added to products from baby formula to designer handbags to validate authenticity.

“We're anticipating over the years that it is going to become much more of a standard or expectation - if I'm getting something that is very expensive, or that I'm concerned about for safety and health reasons, then there should be something that I can scan to authenticate it.,” Pond said.

The FDA View

Turning to regulatory adherence, the FDA appears to be looking favorably towards this technology. The US regulator issued guidance in 2011 on physical chemical identifiers (PCIDs) for solid oral dose drugs to combat counterfeiting, with examples including “inks, pigments, flavors, and molecular taggants” and expects that many of the ingredients which “will ultimately be employed as PCIDs are already used as food additives, colorants, or excipients with established safety profiles.” The guidance report recommends companies use food substances that are generally recognized as safe (GRAS) or “those ingredients listed in the FDA Inactive Ingredient Guide that have been used in solid oral drugs.”

Ingredients that have not previously been used in a solid oral dosage form or as a direct food additive “could present a toxicological risk” and therefore Colorcon is seeking to avoid such ingredients, says Siahboomi. The silicon dioxide used for the company’s silica tags is already in use and therefore manufacturers would simply have to report the change. The two regulatory aspects that Colorcon is focused on, is firstly to comply with the regulations for the material used as micro tags, then secondly to make on-dose authentication a regulatory requirement.

 

Regarding uptake among pharma companies, Pond noted, “This is a new technology we're introducing to pharma and they're traditionally conservative when it comes to putting something on your product. They're working with us or looking at the data we've created … We're working with clients right now demonstrating that stability, making them as confident as we are that the product is ready to go.”

Clinical Trial Adherence

An advantage of patients having an app to authenticate drugs, is that a touchpoint is created which can be expanded to dual functionality. Colorcon is looking to develop an app that can both validate drugs and monitor patients to ensure they are taking their medication correctly, which could prove particularly useful for improving clinical trial accuracy. Patients could record the time that they take a treatment and even provide photo or video evidence of proper dosage. This data would pair well with decentralized clinical trials, argues Siahboomi, reducing the need for patients to attend a clinic.

“I think one of the important elements here is behind this authentication technology is a secure database that operates in real time. What we're working on with the smartphone is the ability to integrate an app to provide these other values to the patient,” said Pond. “That can happen in real time as well, so that companies can actually see what's going on from a safety perspective, from a compliance perspective, and the types of tools that are being used by the by the patients.”

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