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Preventing counterfeit drugs with RFID

The medical industry is struggling against counterfeit drugs flourishing not only online, but even in pharmacies and hospitals. Counterfeit drugs cause drug manufacturers reputation and sales losses, but even worse, they endanger our health.

Co-authors: Tanja Könnömäki, Outi Ketola, Mitch de Ruijter, Emiel Bijkerk of Turun Ammattikorkeakoulu, Salo, as part of a school project.

A WORLD-WIDE PROBLEM

Drugs that are not produced by the brand that they are being sold under or drugs that are claimed to be generic to the drugs of a well-known brand, are usually understood as counterfeit drugs. They can be harmless, however, most counterfeit drugs contain wrong ingredients, wrong doses of ingredients, no active ingredients at all, or in worst case, they might contain harmful substances that can lead to illness or even death. Because of the lack of supervision, counterfeit drugs are more likely to have been stored in incorrect conditions and have inadequate, lacking or faulty usage instructions and labeling. 

According to estimations by the National crime prevention council as much as 10% of all pharmaceuticals in the global supply chain might be counterfeit and in some developing countries the percentage might go up as high as 70%. The WHO (World Health Organization), on the other hand, estimates that about 1% of all drugs in the developed countries (USA, Canada, EU, Australia, Japan, New Zealand) are fake and a respective 10% to 30% in the developing countries. The problem is biggest in Africa and Latin America with a fake drug percentage of 30. In the former Soviet Union about 20% of the drugs sold are estimated to be counterfeit.  


The majority of counterfeit drugs are manufactured in countries with little regulation and/or in countries that suffer from legislation loopholes that criminals are quick to exploit. Most counterfeit drugs are sold to developing countries where the drug regulations and enforcements are even weaker and where the local FDAs (Food and Drug Administration) or other equivalents have little control over the situation. Getting real and legal drugs through legitimate channels might be hard and/or expensive for the locals. 

Counterfeiting drugs is a lucrative business. The margins are high and the risks are low. In some countries counterfeiting drugs is not even illegal. "Where there is an opportunity, there will be a thief."

HOW DO COUNTERFEIT DRUGS END UP IN PHARMACIES AND HOSPITALS IN THE FIRST WORLD COUNTRIES?

Most counterfeit drugs and drug ingredients are distributed online, but unfortunately, they have also infiltrated the supply chains to pharmacies and hospitals - even in the most strictly regulated markets in the world. No country goes safe from this problem. This tells us something about how inventive the counterfeit drug distributors are and how prone the supply chains are to corruption. 

counterfeit drugs in hospital -doctor -patient -web

According to the OECD organization, criminals involved in the manufacture and distribution of counterfeit drugs range from medical professionals (such as pharmacists and physicians) to criminal groups like organized crime syndicates, rogue pharmaceutical companies, corrupt local and national officials and terrorist organizations. The problem is extremely hard to tackle, since the criminals can be found basically anywhere in the supply chain.

How do counterfeit drugs enter a legitimate drug supply chain? Here are a few examples:

  • Global complex supply chains make it harder to determine the origin of the drugs or drug ingredients
  • Drugs may travel through many trading companies (none of which check their quality) before they reach their final destinations
  • One or several players in the supply chain is corrupt: contaminating, substituting or mislabeling products in the supply chain
  • The manufacturer might not be aware of that the ingredients came from an uncertified source
  • Ingredient or drug manufacturers pose successfully as legitimate pharmaceutical companies with the help of false paper work
  • The counterfeiters engage themselves in elaborate conspiracies disguising their activities, by e.g. establishing fictitious businesses and front companies
  • Weak border controls that are focusing more efforts on ensuring the free movement of people and products over the borders, than on stopping counterfeit drugs

DAMAGED PHARMACEUTICAL COMPANIES

Clearly, the biggest threat that counterfeit drugs pose on us, is the immediate impact on our health. But they also harm the reputation of the brands that they replicate. When they fail to do as promised, the drug brand gets the blame. Even when the failing drug is exposed as a counterfeit, it drags the brand into the gutter. Patients get scared of using that particular brand, since it might be a counterfeit. 

Counterfeit drugs might also, in some cases, make it harder to measure how efficient a medicine is, since the results might be contaminated by effects of counterfeit drugs. In some regions, it is close to impossible to know what patients actually have been given, thus it can be hard to get reliable statistics. No wonder pharmaceutical companies are looking into RFID. Counterfeit products are decreasing their sales, affecting their stock value and harming their reputation.

WHAT IS BEING DONE TO STOP COUNTERFEIT DRUGS?

A few countries, e.g. Ghana, Nigeria, Kenya and Rwanda, are testing a system that enables an authenticity check of a drug by sending its hidden serial number as a SMS. This system is helpful in detecting counterfeit drugs that have reached their destination, right before handing them to a patient, but it demands a lot of manual labor and is easy to surpass. The system could be further improved by adding RFID tags to the drug packages, since this would make product recalls more effective. 

There are ways of testing whether a drug is what it claims to be. E.g. Raman Spectroscopy and energy-dispersive X-Ray are techniques that are used for analyzing the chemical composition of a drug. They can even be used for identifying drugs in unopened plastic cans. 

Despite the availability of the above mentioned methods, U.S. FDA is encouraging the use of RFID for fighting counterfeit drugs. The technology identifies all individual drug packages with the help of RFID readers and RFID tags containing information about the drug's origin, a so called ePedigree (electronic pedigree), which is hard to manipulate. 

RFID ENSURES A SAFE SUPPLY CHAIN

Drug packages only equipped with barcodes are not unique for each product and they are easy to copy. RFID tags, on the other hand, are unique for all items and significantly harder to copy or tamper with. By RFID tagging as well as tracking and identifying the drugs on an individual basis, the likelihood of a counterfeit drug to travel all the way to its final destination is reduced significantly. Here is how:

Authorized drug ingredient manufacturers tag all their ingredients with RFID tags before distribution to the pharmaceutical companies. As the drugs are manufactured, the tags of the ingredients are scanned and reported. Information about medicament ingredients as well as a serial number and other essential product information are added to an RFID tag that is attached on the package of the drug. Now the drug package tag contains information not only about its own origin, but also about the ingredients and the amount of each ingredient in the drug. The information on the tag can be converted into a so called ePedigree (electronic pedigree), which will be filled with more and more information about the events on the drug's journey through the supply chain - all the way from the factory to the pharmacy or hospital.

Scanning the tag and analyzing the ePedigree allows the wholesalers and pharmacists to determine the identity and composition (and dosage) of ingredients in the drug as well as its route in the supply chain. Specific information like color, size, weight and shape of the pills can be helpful in detecting counterfeits. Information on the tag about manufacturing date and expiration date makes it hard to re-label products with a later expiration date. The RFID reader will give an alert if the drug has expired. Last but not least, if a suspected counterfeit drug is detected and reported, the product recall can be conducted in an efficient manner thanks to the RFID tracking system. Tagging drugs with RFID will make the supply chains safer and ensure that patients get the right treatment. And, as a bonus, RFID will also be an effective weapon against theft and shrinkage both in the supply chain and at the end destination. 

MEDICAL HOUSES ARE ALREADY TAGGING THEIR DRUGS

It has taken RFID a while to gain foot in the pharmaceutical business, but now it's spreading all the faster and many big houses are already piloting and/or implementing RFID tracking of their products. Pfizer is tagging all their Viagra packages intended for sale in the U.S. with RFID. GlaxoSmithKline, Purdue Pharma and Johnson & Johnson are also participating in pilots and the creation of standards, as well as tagging products deemed susceptible to counterfeiting. 

RFID adoption has been slow in the pharmaceutical area as medicaments often travel in global open-looped systems with many players, who all need to conform to the same or, at least, a compatible system. A proof-of-concept for ROI (return on investments) as well as common standards across the supply chain has been missing. But as major pharmaceutical companies are starting to implement RFID, standards are being created and more reliable KPIs (key performance indicators) are being presented. This, in its turn, increases the confidence in the technology throughout the industry.

TAGGING DRUGS EFFICIENTLY

Drugs are often delivered in packages consisting of plastic cans. In this case the tags can preferably be placed under the product label on the side of the can or on the lid. RFID readers work very well with plastic materials and as long as the cans aren't extremely small (causing tags to get packed too tight together) reading performance should be close to 100%. The problem arises when the drug package contains metal particles (like blister packs or tubes) or when the drug itself is a liquid. But don't throw in the towel yet, there are ways to overcome these obstacles. 

Bottles containing liquid medicines should preferably be tagged on the lids so that as much space as possible is left between the tag and the liquid. Avoid packing many bottles on top of each other in the same sealed cardboard box. 

When it comes to metal drug blister packs (also called bubble packs), the tags are best placed on the individual cardboard box surrounding the blister pack. As the drugs are usually packed in bigger transportation boxes, it's recommended to place the individual packages in the transportation bigger box in a way, so that the tags are as close to the wall as possible. This places the tags as close to the RFID reader as possible. But most important, once the transportation box is sealed, tag it as well with an own RFID tag containing information about all the individual medicaments inside the package. This lowers the risk of having to open the box repeatedly across the supply chain if the reading of the item tags isn't completely accurate. 

drug blister pack

Metal tube drug containers, for e.g. of vitamin pills that dissolve in water, can be dealt with the same way as blister packs, as long as the metal tubes containing the pills are packed in individual cardboard boxes. Sometimes, though, they are standing on a plastic display plate inside the cardboard box. In this case, the tags should be placed on the lid, which usually is made of plastic, as far away from the metal surface as possible.  

Metal is a tough nut to crack for RFID, but there are hard tags available on the market that are suitable for placement on metal surfaces. These hard tags are more expensive than label tags, but they can preferably be used as long as label tags aren't a requirement. The price of the tag will pay itself back time and time again, at least when placed on more expensive drugs. The hard tag's diameter is about 6 mm and it's about 3 mm thick, so the size should not create any problems.  

In the future it's recommendable to take RFID requirements into consideration already in the product package planning stage or, if the package already exists, consider improving the package in order to make it more RFID-friendly. It can prove a much smaller cost than repeatedly experiencing inaccurate readings.

RELATED ARTICLES:

RFID: The medical miracle

SOURCES AND RECOMMENDED READING:

FDA:
http://www.fda.gov/Drugs/DrugSafety/ucm169918.htm

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htm

Science Daily:
http://www.sciencedaily.com/releases/2010/03/100331152648.htm

Pharmacy About:
http://pharmacy.about.com/od/Technology/a/Radio-Frequency-Identification-Rfid.htm

The Body:
http://www.thebody.com/content/art31582.html

NCPC:
http://www.ncpc.org/topics/intellectual-property-theft/counterfeit-drugs-1

RFID Journal:
http://www.rfidjournal.net/PDF_download/Global_Data_RFID_Report.pdf

BBC:
http://news.bbc.co.uk/2/hi/health/6314287.stm

Outsourcing Pharma:
http://www.outsourcing-pharma.com/Contract-Manufacturing/New-counterfeit-report-highlights-worrying-trends

WHO:
http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/

5 comments on “Preventing counterfeit drugs with RFID”

  1. Posted 28 August 2013 at 05:27:25

    While the article is well written, there are many more effective ways to combat counterfeit activity in the pharma industry, none of which are mentioned here. That's probably because the site is call RFID Arena, right?

  2. Gravatar of Hanna ÖstmanHanna Östman
    Posted 30 August 2013 at 11:52:52

    Thanks for your comment, Ollie. As you guessed, we focus on RFID solutions, since that is our area of expertise. But I do see it as a good thing that there are alternative solutions out there. This way we have a better chance at overcoming the problem with counterfeit drugs.

  3. Posted 05 November 2014 at 19:53:53

    Hello Hanna,
    A terrifically written and brilliantly outlined summary, you write very well Hanna and have hit ever fissure that needed to be not just uncovered but totally revealed - great job in many respects. Your theme was of considerable interest because we at cStar have finally developed a truly intrinsic and non-clonable process using our unique ‘Stealth Tag [pRFID] within a system called ‘Global Brand Protection’; being a closed loop pathway. We identify and track pilfering/counterfeiting/piracy/substitution downstream/upstream for pharmaceutical and other blockbuster products and devices through the ‘cloud’. See 'Global Brand Protection' web-page.

  4. Gravatar of Suvi DalénSuvi Dalén
    Posted 06 November 2014 at 08:29:10

    Hello Mike,
    thanks for your nice comment!

  5. Posted 07 January 2015 at 11:39:51

    Great article. Thanks much for this Hanna. You focus on the supply chain which is one part of the problem. Why not also offering a solution for endusers as well for example with a device that enables the customer at home to verify the drugs they purchased whereever. There will also be a sales channels that is completely out of the control of the brand owner (the internet) At no stage from the production of the ctf medicine via the online reseller until the customer is a chance to implement some sort of detection tools. A not too expensive device at home for everybody could be helpful to tell the user of the medicine if he is about to use fake drugs (of course only makes sense if there are legit ways of online distribution on the genuine drug version)

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