How Do Fake Medicines Reach Patients?
How Do Fake Medicines Reach Patients?
The journey of falsified and substandard (SF) cancer medicines often begins long before they reach hospitals or pharmacies. Weak oversight, fragmented supply chains, and cost pressures create openings for poor manufacturing practices, illegal production, and other vulnerabilities. From the earliest stages of drug formulation to distribution and repackaging, each link in the chain presents opportunities for substandard or falsified medicines to enter legitimate markets.
Production of active pharmaceutical ingredients or finished products in facilities that do not follow GMPs (Good Manufacturing Practices)
Falsified drugs are often produced in substandard facilities lacking proper equipment and adherence to GMPs, leading to contamination and errors. This is especially a problem in countries where regulation and legal oversight to enforce GMPs is weak.
Compounding pharmacies
Compounding pharmacies are not directly implicated in SF cancer medicines, but they are an important consideration for other SF medicines. Unregulated compounding pharmacies can proliferate substandard and falsified drugs due to dosing errors, contamination, or improper ingredients. In some countries like the U.S., compounding pharmacies are regulated and can be an important source of legitimate medicines in certain contexts.
Example: In the U.S., the 2012 New England Compounding Center fungal meningitis outbreak illustrates one of the worst case scenarios of unregulated compounding. Sixty-four people died after receiving contaminated steroid injections from the compounding center, which was in violation of its state license.
Repackaging
Repackaging is often needed when drugs are shipped across borders (e.g., changing patient leaflets into local languages, relabeling per regulatory requirements). Risks introduced by this process include removal of original anti-counterfeiting features, mistakes or fraud when serial numbers and expiry dates are reprinted, or re-use of authentic discarded packaging by counterfeiters. This is mainly a problem in the EU and other countries engaging in parallel trade. As the U.S. supply chain is closed to importation and parallel trade, repackaging is less of an issue.
Example: In 2007, the UK Medicines and Healthcare Products Regulatory Agency identified counterfeit versions of several cancer medications, including Casodex, that had entered the legitimate supply chain via parallel importation. These products were repackaged at multiple points, as they were made in China, shipped to Singapore, sold to wholesalers in Belgium, and finally sold to UK parallel importers. At some point, counterfeit drugs slipped through and were found due to packaging errors in English. Approximately 40,000 packs were seized, and around 10,000 more were recalled.
Cold chain lapses
Cancer medications contain active ingredients which require storage in temperature-controlled conditions during transportation. Unregulated producers or counterfeiters may disrupt sensitive temperature conditions at any point due to lack of resources or malicious intent, resulting in an ineffective or dangerous product.
Example: An individual illegally shipped foreign cold chain cancer chemotherapy drugs to U.S. doctors, who received the medicines in a “gooey mess” due to cold chain lapses. The individual did not have the temperature-controlled shipping to ship Rituxan, Herceptin, and Neupogen.
Diversion or use of repurposed drugs
A medicine designed for a specific market or function is re-marketed in violation of the producer’s instructions. According to the United States Department of Justice, “Most pharmaceuticals abused in the United States are diverted by doctor shopping, forged prescriptions, theft and, increasingly, via the Internet.”
Parallel trade and gray markets
The practice of purchasing items in one country at a lower price and importing them into a country in which they are available at a higher price. While there are regulations around parallel trade in some regions (such as Europe), the system is still subject to risks since parallel traders don’t need to verify the origin of products they buy, creating a “gray market” of pharmaceuticals. They can undergo 20-30 intermediary transactions, introducing the potential for counterfeiting. Key regions where parallel importation is legal and regulated include the EU, Australia, Japan, and some parts of Africa and Southeast Asia.
Example: A common misconception is that medicines imported from countries like Canada and the UK are under strict regulatory oversight and are safe. With parallel trade, a medicine sold in one of those countries may actually originate from a country notorious for ineffective or lethal SF medicines. Additionally, regulations in Canada do not always apply for exported drugs. Exporters may operate out of Canada, but if the drugs are primarily for export, Canadian safety regulations do not apply.
Free trade zones
Low regulatory oversight makes free trade zones attractive for criminals falsifying medicines.
Example: In a 2006 case, UK customs seized several pharmaceutical products in transit from Dubai to the Bahamas free trade zone. The seizure uncovered that the drugs were destined for the U.S. and marketed as originating from a Canadian online pharmacy.
Foreign labeled drugs without verified pedigree
Medicines imported from another country that carry foreign packaging or labeling but lack a documented supply chain tracing them from the original manufacturer to the distributor. The FDA requires all drugs to contain a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the dates of those transactions and the names and addresses of all parties to them.
Street vendors and informal markets
In some developing countries, street markets are often used to sell medicines, but this process is not regulated.
Example: In Ghana, drug inspectors found tablets purporting to be antimalarial medicines in a rural dispensary. The tablets contained less than 2% of the expected active ingredients.
Online pharmacies
Most online pharmacies operate illegally and without a license. Ninety-five percent of sites selling prescription drugs operate unlawfully, and 50-90% of medicines sold online are SF. Frequently, in the U.S., pills purchased online have been found to contain fentanyl. They target vulnerable patients directly through search ads, social media, and no-prescription offers, luring people with low prices and convenience.
Example: According to the IQVIA Institute for Human Data Science, oncology medicines are the #1 product sold in illegal online pharmacies in the U.S. A 2023 Alliance for Safe Online Pharmacies report revealed that 24% of Americans who have previously used an online pharmacy have been exposed to counterfeit or substandard medication from an online pharmacy, a 7% increase from 2021. In one incident, online pharmacies disguised deadly synthetic opioids as common prescription drugs such as Adderall and Xanax and sold them to customers across the U.S, Germany, Slovenia, and Puerto Rico, resulting in the death of nine people.
Medical tourism
Medical tourism is often driven by lower costs, faster access, or treatments unavailable at home, but it carries significant risks. Patients may encounter weaker regulation, gray-market supply chains, and language barriers, making it easier for substandard or falsified medicines to slip into care. These drugs may contain the wrong ingredients, be stored improperly, or be entirely fake, leaving patients vulnerable to treatment failure or harm.