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
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
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
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.
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
- One or several players in the supply chain is corrupt:
contaminating, substituting or mislabeling products in the supply
- 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
- 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
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
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
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
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
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.
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.
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