For millions seeking relief from conditions like diabetes or obesity, a new prescription can feel like a lifeline. But in the shadows of this booming market, criminals are turning that hope into a weapon. This has given rise to a dangerous black market of "falsified" and "illicitly compounded" drugs that look legitimate but pose a grave threat to public health.

Navigating this landscape can be daunting, but knowledge can be a big help.

Read on to uncover five of the most critical facts you need to understand about the secret world of falsified medicines.

The trade in falsified medicines isn't a niche issue affecting a small number of people; it is a global public health crisis of immense proportions. 

According to the World Health Organization (WHO), falsified medical products impact millions of people across the globe. The problem is especially acute in developing nations, where an estimated 1 in 10 medicines in low- and middle-income countries are substandard or falsified.

The digital marketplace has only amplified the threat, with approximately 40,000 websites operating illegally to offer prescription-only drugs directly to consumers.

A common misconception is that a "fake" medicine is simply a harmless placebo that just doesn't work. The reality is far more dangerous.

These products may contain no active ingredient at all, leaving a serious condition untreated. Worse, they might contain the wrong active ingredient, an incorrect dose of the right one, or even actively harmful and toxic substances. 

While some criminals create outright fakes, others exploit a legal gray area with even more deceptive results: illicit compounding.

A legitimate compounded medicine is one prepared by a licensed professional for an individual patient's specific needs. Critically, these custom-made drugs are not approved by regulatory bodies like the FDA or TGA. This means they have not undergone the rigorous testing required to verify their safety, quality, dosage accuracy, and effectiveness, leaving the patient completely unprotected.

Illicitly compounded products, often made without adherence to Good Manufacturing Practice (GMP) standards, can contain the wrong dose or different active ingredients altogether. Unregulated production can also introduce new impurities or higher levels of impurities than those present in the approved medicine, potentially leading to serious adverse reactions.

While the problem is global, your personal vigilance is a powerful first line of defense. By pausing and asking a few critical questions before buying or taking any medicine, you can spot the red flags that often accompany falsified products.

Here are six questions to ask to help ensure you are getting authentic medicine:

  • Is this a medicine that is hard to get a prescription for? Criminals often exploit drug shortages and high demand for certain medicines to sell falsified versions.
  • Does the packaging and medicine appear as you expect? Check for differences in the packaging (e.g., colour, font), evidence of tampering, and poor-quality printing or spelling errors.
  • Does the price align to what you would expect to pay from the original medicine? If the price is significantly cheaper than what you would normally pay from a trusted source, this is a major red flag.
  • Am I purchasing from a trusted source? Always purchase your medicine from a licensed brick-and-mortar pharmacy or a known and trusted online pharmacy.
  • Have I been prescribed this medicine by my doctor or healthcare professional? For your own safety, you should never self-diagnose and should not purchase medicines that have not been prescribed to you by a healthcare professional.
  • Is this medicine only available on prescription? If the answer is yes, it should not be available to you without a prescription. Be wary of online questionnaires that result in a prescription being issued without a physical examination or a direct conversation with a healthcare professional.

Treating these simple checks as a routine part of managing your health can serve as a vital personal safety tool in an increasingly complex marketplace.

While consumer awareness is key, a massive and sophisticated effort is underway behind the scenes to protect the global medicine supply chain. This is a constant, high-tech war fought in digital marketplaces and on the ground. Investigators conduct surveillance to unearth illicit networks, and pharmaceutical companies partner with global health organizations to fight back.

For example, we have adopted a comprehensive, cross-functional approach built on a "Prevent, Detect, and Respond" strategy. In collaboration with global, regional, and local organisations, including the Pharmaceutical Security Institute (PSI), we conduct field and online surveillance to identify illegal products.

We systematically report incidents to health authorities and law enforcement and pursue legal action to "detect, disrupt and deter" these illicit activities. This global fight highlights the seriousness of the threat and the complex, coordinated response required to keep patients safe.

In a world of complex international supply chains and the instant accessibility of online shopping, patient vigilance is more critical than ever.

The dangers of falsified and illicitly compounded medicines are real and growing, but understanding the risks is the first step toward avoiding them.

 

1. Pathak R, Gaur V, Sankrityayan H, et al. Tackling Counterfeit Drugs: The Challenges and Possibilities. Pharmaceut Med. 2023;37:281-290.