Yesterday, on July 1, 2015, the Drug Supply
Chain Security Act (or Drug Quality
and Security Act) became effective in the United States.The law is designed to secure the supply chain of
medicines and restrict counterfeit drugs, an industry estimated to be bigger
than Pfizer and GSK combined.
Laws against counterfeit drugs have also led to the arrest of Toyota’s highest-ranking female employee for alleged smuggling banned painkillers from the U.S. to Japan… What exactly are counterfeit drugs? An
estimated market of $75 billion, by the World Health Organization’s own admission, “counterfeit
drug is defined differently in different countries”. What the FDA calls “fake medicine”, WHO calls any medicine, “which is deliberately and fraudulently mislabeled with respect to identity and/or source”. For this reason, Toyota executive Julie Hamp’s efforts to “disguise illegal drug tablets” of painkiller oxycodone, legal with a prescription in the U.S., while a narcotic in Japan, would also fall under the same, loose classification. Why is it such a big issue? Counterfeit
drugs present a big challenge for users of medicines since there is no easy way
for patients to know whether or not the medicines they consume are safe.The WHO believes
that between 1% and 10% of drugs sold around the world are counterfeits and
this number could be as high as 50% in some countries. The primary distribution channel for such products are
illegal pharmacies operating over the internet. However, it is when fake drugs get
mixed with the normal medicine supply chain that countless horror stories get
reported. We have decided to cover some headlines made in recent times. Recent impact of counterfeit drugs- 365 children died in Panama due to a “toxic cough syrup” in which pharmaceutical manufacturers used toxic brake fluid component, diethylene glycol instead of glycerine. - FDA
discovered
that foreign distributors had supplied unapproved, counterfeit versions of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication unapproved in the United States but approved in Turkey. Lab tests found
that the injections contained no active ingredient. - Counterfeit
versions of orlistat (Alli), GlaxoSmithKline’s over-the-counter weight-loss medication, were distributed over the internet, which did not contain the active ingredient. The fake product had been made with varying amounts of a controlled substance called sibutramine instead (anorexiant, removed from the US market due to concerns about heart attack and stroke). - A
brand of Viagra in
India, Kamagra, could not be sold outside India due to patent laws. So while Kamagra
was not a counterfeit drug in India, the success of Kamagra made it available
in other countries at prices much lower than Viagra. - In early 2008, ‘fake’ heparin based medicines caused deaths in the U.S. and other parts of the world. Chinese producers, trying to realize cost saving opportunities, had added a potentially toxic substance called ‘over-sulphated chondroitin sulphate’ to pharmaceutical grade heparin. The counterfeit product was cheaper to make, did not offer the intended therapeutic effect and was difficult to differentiate with existing test methods. - FDA discovered counterfeit versions of Roche’s cancer drug Avastin had entered the U.S. supply chain. Two Turkish nationals were arrested for shipping the drugs to the United States with false customs declarations.
- A physician, supplied with a research version of onabotulinumtoxinA (Botox), which was much more concentrated than the actual dosage, and not intended for human use. The research version resulted in respiratory paralysis and near death for several patients, including the physician who was using it himself. A very profitable businessAn expert estimates that counterfeit drugs are significantly more profitable than selling illegal drugs like heroin or cocaine. A
$1000 investment in counterfeit prescription drugs can result in a $30,000
return, which is 10 times the profit rate of trafficking heroin. Another source reported that selling counterfeit Viagra (sildenafil) “can be as much as 2000 times more profitable” than selling cocaine.Finally, the criminal penalties for the sale of
counterfeit medications are far less than the penalties for selling illegal
narcotics. Given the variation in global prices of the same drug, supply of medicines with incorrect documentation
through internet based models is common practice. An international effort, Operation Pangea VIII, earlier in June, shut down 2,800 websites across, 115
countries and seized medicines worth $81 million. Bring it on! In addition to restricting the entry of
counterfeit products at different ports, FDA scientists have developed a counterfeit detection device, CD-3. A battery-operated, hand-held and
inexpensive tool, using CD-3 costs a
fraction of the price of existing laboratory-based and field-deployable
technologies. Africa, where the counterfeit drug problem
is the most prevalent, has also initiated trials of the CD-3 device. While detection is only part of the
solution, laws designed to implement product
serialization, a comprehensive system to track and trace prescription drugs
through the entire supply chain, have been drafted. ChallengesThe intent of track and
trace systems is to enable comprehensive product traceability (down to lot
number details) from the manufacturer to the patient. Europe, India, Nigeria, Brazil, China have all announced
measures to combat the counterfeit drug problem. However, there are differences in each country’s approach towards the implementation of product serialization. The lack of harmonization, to achieve compliance in
different countries, will impact production and packaging processes of many
pharmaceutical manufacturers with global operations. Given the scale of this
endeavor, the U.S. planned implementation timeframes for the Drug Supply Chain
Security Act are stretched across a 10-year period. Digital
solutions?In the meantime, some
pharmaceutical companies are already moving ahead of the curve. EMD Serono,
part of Merck
KGaA, launched a mobile application called Check My Meds TM for product verification and is already
available for download for U.S. patients.As some medicines and such apps are not available yet all over the world, where ever you are, it’s important to be careful, since problems with counterfeits can occur everywhere on
the planet.
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