PharmoRx: taking on the drug diverters

Five years ago, US psychiatrist David Bear observed at first hand how the pharmaceutical supply chain can be compromised and people put at risk by the actions of a few unscrupulous individuals.

Realising that many of his psychiatric patients were becoming dependent on opioid painkillers, he started to look into the factors behind the phenomenon and uncovered a thriving trade in black market painkillers driven by diversion of legitimate product obtained by prescription.

For individuals on state Medicaid support, these powerful drugs could be obtained simply by complaining to their physicians of ailments, such as lower back pain. For a prescription fee of $1.50, they could get hold of a 60-count pack of the opioid, with a street value of several thousand dollars.

Patients who had developed an opioid addiction could keep 30 tablets, sell 30 for two or three thousand dollars, and later in the same day do the same thing at another public clinic, according to Bear, who believes this practice is defrauding the US healthcare system and leading to surge in addiction to prescription painkillers.

But despite identifying the problem back in the early years of the decade, Bear was unable to find any off-the-shelf technology that could provide a reliable system to counter this type of diversion. So in 2004, with the help of a technologist friend Yogendra Jain, he formed a company called PharmoRx to plug the gap.

Based in Massachusetts, PharmoRx has just put the finishing touches on a suite of technologies - called AuthentiTrack – that can help drugmakers not only authenticate their products but also provide serialisation and track-and-trace capabilities.

Its first success came in 2006 when it developed a system in which unique, serialised codes could be added to unit doses of Purdue Pharma’s opioid painkiller OxyContin (oxycodone HCl), one of the products at high risk of diversion.

In a recent interview, PharmoRx’ chief executive Steve Wood explained that from this first foray into coding, the company moved swiftly on to develop an imaging-based authentication technology known as ISTARx (Image Storage Tracking and Recognition, which now lies at the heart of the AuthentiTrack system.

ISTARx is an imaging technology that takes a small part of the tablet or a capsule and images it at a very high magnification.  The system looks for regions of interest – like a fingerprint – that can be used to match a tablet to a database generated during the brand owner’s manufacturing run. Algorithms allow ISTARx to compensate the usual wear and tear of tablets on handling.

“We have not yet found a tablet that could not be uniquely identified using this technology,” said Wood.

This served the purpose of allowing authentication of a product in the field, but PharmoRx quickly saw the value of expanding this system with a track-and-trace solution.

The initial idea was to partner with a company offering an established technology. But after meeting a number of firms, “we were horrified at how expensive they were, how difficult they were to work with, and  how inflexible their software was,” said Wood.

“We figured that we were already providing serialisation at the unit dose level, so why not work on trace-and-trace ourselves?”

As a result PharmoRx developed CypheRx, a system which generates the unique codes, prints them onto doses or packaging. It can also provide a link between each blister or unit dose with the outer packaging, another link for each pack into a shipping container, and each container to a pallet.

Wood is convinced that serialisation to the unit-dose level is important in many cases of product diversion.

“In many cases, when product is diverted it is in the unit dose form, so solutions such as radiofrequency identification (RFID) tags and on-pack barcodes don’t do you much good,” he told SecuringPharma.com, though he added that RFID and barcodes clearly have an important role to play at the pack, container and pallet level.

By identifying product down to the unit dose, which in the opioid painkiller case described above was how diverted product was being found, law enforcement are given a tool to see if the product is real or counterfeit, and also gain some insight into the supply routes it has followed.

“In the USA, counterfeiting is still not a big problem. But diversion is a terrible problem and is growing rapidly,” he said.

The company joined with the US National Association of Drug Diversion Investigators (NADDI) recently to co-sponsor a symposium to discuss possible legislation at the state and federal level that could help deter drug diversion. This heard that prescription drug abuse has been increasing at an alarming rate, with reported incidents tripling in the USA in the last four years.

At the symposium PharmoRx discussed the feasibility of integrating software at retail pharmacies that would register people picking up controlled substances and recording the purchase transaction in a database that could be used to assist law enforcement in localising sources of drug diversion and abuse.

PharmoRx also offers customers a security management console which allows them to oversee the location of pallets, shipping containers, packages and doses.

Counterfeits lacking the correct serialisation code can be picked up quickly, according to Wood. Moreover, if legitimate product appears in unexpected locations the brand owner can use the system to identify potential diversion and grey market transactions.

Wood cited one case in which a pharmaceutical company claims to be losing a huge sum – upwards of 50 million dollars a year – because they are unwittingly accepting counterfeit product in a scheme which allows returns of unused medicines for credit.

Among its current client portfolio, PharmoRx is working with an opioid drug manufacturer (not Purdue Pharma) on a new painkiller product, and also with a medical device company whose products are becoming increasingly prone to diversion. The firm is also using its serialisation technology for a clinical trial project, to identify exactly what product goes to which patient and help improve data integrity.

Meanwhile, PharmoRx is continuing to build its capabilities in supply chain security, and a few weeks ago forged an alliance with Northern Ireland company MSO, which makes labels and cartons and has also developed a range of security features, such as taggants and invisible inks, that can be placed on drug packaging.

The two companies are exploring ways to print barcodes in invisible inks which - if they can be read reliably - could provide a covert track-and-trace technology.

“Some pharmaceutical companies just don’t want to display any more barcodes than they do already,” commented Wood.

Another new partnership should come to fruition soon, this time with a company specialising in data mining software called The Knowledge Agency, that can scan the Internet for pharmaceutical counterfeiting and diversion activity.