U.S. CBP officer Boris Sapozhnikov looks at counterfeit drugs seized by the agency on Aug. 15 at its offices at John F. Kennedy Airport in New York. |  Keith Bedford / Reuters

This year at the Healthcare Distribution Alliance (HDA)’s PCSC Educational Seminar in East Hanover, New Jersey, I had the pleasure of meeting Tony Orosz, assistant director of the Pharmaceutical, Health and Chemical Center of Excellence and Expertise with the U.S. Customs and Border Protection (CBP), an agency of U.S. Department of Homeland Security (2). A leader in combating the counterfeit drug market, Tony gave an illuminating speech and spoke with compassion and urgency about the true cost of counterfeit drugs, relaying the fact that the John F. Kennedy Airport alone sees over 78,000 packages a day.

With an ever-increasing volume of shipments from mail order pharmacies among them, the sheer magnitude of inspection necessitates a lengthy process and battery of tests to verify the veracity of the pills, one that is both too time and resource-consuming for us to continue given an ever-escalating number of incidents.  As it’s LSPediA’s core commitment to furthering best practices in pharmaceutical supply chain management and, ultimately patient care, we feel compelled to create this series to dive deeper into the true cost of counterfeit drugs and what we can do to counteract them.


>> The Scope, Scale, and Severity of Counterfeiting:

Rat poison, paint, mold, and more in counterfeit pills kill & cause severe side effects

Tests run by the Customs and Border Protection (CBP) have discovered counterfeit drugs containing various toxic compounds such rat poison, paint, baby powder, floor wax, sawdust, mold, and more, which have caused death and severe side effects in several incidents (3)

1 million

Every year, it is estimated that up to 1 million deaths are attributed to counterfeit drugs globally, 700,000 of which are attributed to fake drugs for malaria and tuberculosis alone. (4)

10,000%

The rise in counterfeiting has grown over 10,000% in the past two decades globally (5)

95%

In a recent study reviewing nearly 11,700 internet pharmacies accessible to the US market, roughly 95% failed to comply with laws and industry standards created to protect patients (6)

90%

9 out of 10 drugs bought on the web come from a country different than the website claims (6)


Adding to the complexity of the issue, the elusive nature of tracking fake pharmaceuticals and their effects make it nearly impossible to obtain hard statistics on the extent of dangerous complications and severe side effects of these illicit drugs. As a result, counterfeit drugs makers often remain under the radar, though their devastating effects on individuals and entire communities alike make tragic headlines around the world. In 2014 and 2015, a suspected meningitis outbreak leading to the hospitalization of more than a thousand people in the Democratic Republic of Congo was linked to a falsified form of diazepam tablets containing haloperidol, an antipsychotic used to treat schizophrenia. (7) Worldwide, every 45 seconds a child dies of malaria, yet up to one-third of all malarial medications are counterfeit. (8,9)

And while the majority of counterfeit and contaminated drug complications occur in developing countries, their occurrence is not isolated. An increasingly alarming rate has been documented in developed countries due to the globalization of drug manufacturing and internet pharmacies. In 2015, 23-year-old father-to-be Joe Patterson died of a massive accidental drug overdose after purchasing counterfeit oxycodone that contained fentanyl. And in 2014, Arizona resident Betty Hunter developed a violent reaction to cancer medication Avastin purchased and administered by her own doctor’s oncology and hematology clinic, eventually resulting in an FDA investigation revealing the medication purchased from Canada actually came from a Turkish supplier and contained only water and mold with no active ingredient whatsoever. (10)

Counterfeit Drug Distribution | Source: (6)

 

What’s in these drugs, and equally as important, what’s not?

While in the past, the core focus of counterfeit drugs was on fraudulent versions of “lifestyle” drugs like baldness and erectile dysfunction remedies, there has recently been a more ominous shift towards more life-saving and urgent treatment therapies for active infections and life-threatening conditions such as malaria, tuberculosis, HIV/AIDS, and cancer (4). In addition to harming the patient by denying them essential active ingredients, tests run by the Customs and Border Protection (CBP) revealed many counterfeit drugs contain toxic compounds such as sawdust, rat poison, paint, baby powder, etc. (3) Oftentimes, it’s these toxins that kill and poison patients outright.  Other times it’s the lack of active ingredients in what should be an essential therapy that may contribute to death. By taking counterfeit drugs, not only are patients put directly in harm’s way from poisoning and toxicity, they may also lose the potentially life-saving treatment they desperately need and deserve. Due to ever expanding access to drugs anytime, from anywhere, the presence of counterfeit drugs now affects both communities continents away as well as the neighbor next door.

Where are they from?

Many mail order counterfeit pharmaceuticals are actually manufactured in South East Asia or developing countries but routed through countries such as Canada to engender credibility and gain the trust of potential buyers, which include not only individuals but also physicians and hospital groups. The source of these counterfeit drugs come primarily from internet pharmacies, in which there were 50,000 in operation as of 2016. Within these 50,000 internet pharmacies, it’s estimated 95% are noncompliant with the laws and industry standards created to protect patients (a full list of internet pharmacies that meet NABP standards can be found here). (6) What’s worse, over the years, illicit internet pharmacies have become more adept at making it harder to distinguish between legitimate and illegitimate internet pharmacies, with organized call centers and marketing campaigns that allow them to target physicians and sell their illegal counterfeit or diverted prescription drugs.

Global Counterfeiting Market by Sector | Image data source: 4

 

What is the financial cost of counterfeit drugs?

In addition to the enormous amount of deaths caused by the counterfeit drug pandemic, fake pharmaceuticals have also created widespread financial consequences. These fraudulent drugs have caused $200 billion in annual sale loss, in addition to all the money going towards marginally effective counterfeiting methods. Aside from the quantifiable cost, the counterfeit issue strikes a reputational cost as well. Illegal versions of a company’s manufactured pill can cause severe damage to the company’s brand, since the patient will most likely remember the name on the bottle after taking a pill that hurts or fails to help them. (4) With the high price tag of combating fraudulent medications and doing reputational damage control, it is reasonable to assume some of the costs are being pushed onto consumers, further driving up already high drug prices.

Solutions

Given the enormity and immeasurable life and death consequences of this issue, it is imperative we find solutions to combat counterfeiting immediately with urgency and empathy. New technologies, like LSPediA, now hold promises for enhancing manufacturing efficiency and even boosting sales as customers discover that they can buy drugs safely on the Internet. With both the severity and scope of the issue increasing every day, we are proud that LSPediA offers a proactive solution which protects the safety and peace of mind of patients everywhere.

 

Stay tuned this month for helpful tips from the U.S. Customs and Border Protection (CBP) and National Intellectual Property Rights Coordination Center on how to protect your company from the growing threat of counterfeiting and piracy.

 

Sources:

  1. https://www.nbcnews.com/health/health-news/drug-ingredients-made-china-entering-market-little-oversight-flna968328
  2. https://www.hda.org/events/2018-hda-pcsc-educational-seminar
  3. http://www.businessinsider.com/fake-viagra-its-one-of-those-things-you-dont-want-to-mess-with-even-if-its-half-the-cost-2011-12
  4. https://www.strategyand.pwc.com/reports/counterfeit-pharmaceuticals
  5. https://www.ibanet.org/Article/NewDetail.aspx?ArticleUid=02fb8505-e9c4-4f23-b271-c5bf64a8326d
  6. https://www.netnames.com/assets/shared/whitepaper/pdf/The-Online-Counterfeit-Economy-web-FINAL.pdf
  7. https://www.iddo.org/news/news-articles/fake-diazepam
  8. https://www.un.org/press/en/2012/sgsm14247.doc.htm
  9. http://www.bbc.com/news/health-18147085
  10. https://www.safemedicines.org/victim-tragedies

 

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