This post is the first of a five part series on Inception of Fake and Falsified Medicine. In this post I describe the well studied methods by which counterfeits and falsified drugs enter in to the official pharmaceutical chain.  I’ll describe the complex supply chain and it’s it’s vulnerabilities and exploitations by bad actors.

Snake oil was profoundly promoted as a cure-all, a miracle medicine that cures all illnesses. It was supposedly produced by boiling rattle snakes and skimming off the oil that rose to the surface. It sales turned profitable quickly. But government investigation revealed that the constituents were petroleum based oil and beef fat, capsicum, turpentine and camphor.

 “Hucksters, in an attempt to make more money found it cheaper and easier to create faked it, substituting with other oils” - pharmaceutical-journal.com

Trade in illicit and falsified medicines have surpassed 250 Billion dollars even surpassing the trade in Narcotics. Counterfeits continue to cause missed opportuity for legitimate pharmaceuticals. A void that need to be filled identified by fraudsters and here comes a wave from the ocean of counterfeits rising to fill it. Herein, is how counterfeits emerge.

One of the issues with fake drugs is that it remains a poorly identified problem. As a result, a large number of cases of harm caused by fake drugs go unreported. Adverse health problems such as injury, disability, paralysis, complications and treatment failure are prevalent aftermaths. So what is the difference between counterfeit drugs, falsified drugs, fake or substandards.

Counterfeit drugs are medical products that deliberately/fraudulently misrepresent their identity, composition or source. It is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. Fraudsters constantly refine their methods and are apprise on new vulnerabilities. Reports have shown that many Medicines used to treat the most common causes of child death are compromised in developing countries.

What about Fake..?

Fake drugs are medicines that infringe trademarks. These products go beyond faking their labels by mislabelling. These may contain non-active ingredients. Contents may be toxic or non-toxic and others may contain active ingredients but are unlicensed and unauthorised in the local market.

Substandard Drugs

Substandard drugs are packaged medicines that are authorised medical products that fail to meet either their quality standards or specifications, or both. These products are “out of specification”, and using them poses imminent danger.Many of these Medical products may not have undergone evaluation and/or approval by the national or regional regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.

How they emerge

Fraudsters employ advance techniques of social engineering. A practice they did not invent but may have perfected. Social engineers know how to be something they are not, persuade others to believe something that is not true and of course who better to sell snake Oil.

Stolen and diverted pharmaceuticals

Counterfeits need reference products. Stolen products eventually end up in the market unfortunately through unlicensed supply chain actors. Casually demonstrating market need for more stolen or complete diversion of products from the supply chain. And in no time a black market is created. Many reports on quantitative analysis includes stolen and diverted pharmaceuticals. Importantly, stolen and diverted goods enter the market without the consent of IP right owners, and in many instances they also deceive final consumers.

In the event that theft and diversion of product suddenly becomes impossible, due to reactive changes made by the manufacturer, the black market faces shortage in supply and again the void is created. With growing black market demand right there and then a counterfeiter is born. Culprit graduates from diverting to making counterfeits or outright fake.

Rising cost may also indirectly increase the demand for substandard medicines. Most times patients have delayed, rationed, or even skipped doses due to shortages or rising cost of medicines. Dispensers conscentiously ask supply chain partners for alternatives.

Out-of-Specification Ingredient

A tragedy unfolded on a larger scale several years ago in Panama when a chemical manufacturer sold diethylene glycol, the active ingredient in antifreeze, as pharmaceutical-grade glycerin to a European company (Bogdanich and Hooker, 2007).

The poison caused acute kidney failure in the people who ingested it, often as the solvent in cough syrup (Bogdanich and Hooker, 2007; CDC, 2009). The Panamanian government counted 219 deaths from kidney failure brought on by diethylene glycol poisoning (Núñez, 2011).

Developing new medicine is cost intensive. A 2010 estimate put the cost of developing a single drug at $1.3 billion (Kaitin, 2010), and a 2003 study showed that the cost of drug development grew 7.4 percent faster than inflation (DiMasi et al., 2003).

There are ongoing global efforts championed by the United Nations and partner organisations to ensure access to safe supply of drugs. On National and regional levels different instruments are engaged to increase access to safe drugs backed by political will and commitment a progress in the right direction are starting to occur.

Standard operating procedures and regulatory systems often fail to capture substandard especially when they are products of sabotage, process errors, quality assurance failures or operational defects by licensed stakeholders.

Manufacturers must not lose their reputation as the impact of this will only fuel more counterfeiters. Also widespread consumer panicky would lead to complete distrust in the health ecosystem which would be uncontrollable. This is why fighting counterfeits and substandard drugs requires careful strategy including appropriate communication tactics.

Manufacturers employ unique ways to distinguish their products and brands. Manufacturers also employ an ecosystem of certified partners. New Innovative solutions are needed to transform pharmaceutical supply chain to ensure consistent access to safe products

Stakeholders and relevant providers are collaborating on national and regional levels to implement comprehensive systems to address the growing problem of fake drugs. Introducing several frameworks with measurable in-process indicators will also be advantageous.

Counterfeiters apprise closely to find vulnerability as new frameworks are introduced. Exploiting them to blend in with market demand, the obvious void and the pressure for On-shelf availability (OSA) combined with intermittent shortages and acting with a twisted conscientious motive altogether are among the many ways fake products emerge.