The World Health Organization (WHO) estimates that the global counterfeit drug market is worth $432 billion USD, with one in ten medical products in developing countries being substandard or fake.
But the counterfeit drug business does not discriminate, and even though the United States and Europe have strict drug distribution systems in place to prevent counterfeit drugs from entering their markets, these systems aren’t foolproof. According to the Pharmaceutical Security Institute (PSI), there were 2,121 recorded counterfeit drug incidents in the US in 2022 – a 17% increase from the year prior.
“Dangerous forms of pharmaceuticals are illicitly sold by criminal elements and illegal transnational organizations creating patient safety and public health dangers that undermine public and private investments in health care,” write the authors of the article “Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment" published in the American Journal of Tropical Medicine and Hygiene. “The scope of this illegal international trade is broad and complex, includes products spanning a host of therapeutic classes and lifesaving treatments, involves multiple actors and enabling stakeholders, and impacts global populations from the poorest to wealthiest.”
Government agencies, pharmaceutical companies, manufacturers and healthcare providers are doubling down on safety measures to authenticate medicine and protect patients. In cooperation with supply-side tactics and law enforcement, public health experts recommend the continued prioritization of quality assurance anti-counterfeit technologies and consumer-facing communication campaigns in the global fight against the growing counterfeit medicine crisis.
Counterfeit Drugs: A Global Public Health Threat
Counterfeit medicine is any falsified drug that is designed to mimic real medicine. It poses a significant risk to patients and to the companies whose drugs are being illicitly imitated. Counterfeit medicines may contain low quality, fake or poisonous ingredients in addition to fraudulently labeled packaging. These drugs do not pass through the standard evaluation of quality, safety and efficacy that is required by the US FDA (Food and Drug Administration) and EMA (European Medicines Agency) authorization procedures.
“At best, such medications do not treat the ailments they purport to treat. At worst, they contain toxic ingredients that outright kill patients,” writes Sylvester Senyo Ofori-Parku in his article Fighting the global counterfeit medicines challenge: A consumer-facing communication strategy in the US is an imperative published in the Journal of Global Health. “In both cases, counterfeit medications not only present brand safety and economic challenges for pharmaceutical companies, but they also present serious global public health and safety consequences.”
Up until recently, the most frequently falsified medicines in wealthier countries were expensive 'lifestyle' medicines, such as hormones, steroids and antihistamines, according to the European Medicines Agency.
Now, expensive and high-demand medicines, from anticancer to antiviral to contraceptives, are being falsified. In the US, common counterfeit medicines are made to look like prescription opioids such as oxycodone (Oxycontin®, Percocet®), hydrocodone (Vicodin®), and alprazolam (Xanax®). Stimulants like amphetamines (Adderall®) are also being counterfeited.
Protective Measures Against Counterfeit Medicine
Effective drug safety enforcement is essential to prevent counterfeit medicines from entering the legal supply chain and reaching patients. Western countries have a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale via the internet.
Safety features such as anti-tampering devices on packaging with unique barcodes offer an end-to-end authenticity verification from the GMP (good manufacturing practice) sites to subsequent hospitals, pharmacies, and patients.
Despite strides in drug safety enforcement over the past decade, counterfeit and falsified drugs are still reaching the public, and these numbers only continue to grow1. In 2023, Ozempic manufacturer Novo Nordisk had to alert consumers of a counterfeit Ozempic purchased in a retail pharmacy in the United States. This follows a counterfeit Ozempic incident from two months prior in the UK.
Laxxon’s SPID®-Technology Leads Anti-Counterfeit Drug Efforts
The public health sector continues to develop and explore anticounterfeit technologies and methods for mass-implementation in the pharmaceutical industry.
Laxxon Medical is pioneering a new generation of advanced pharmaceuticals with SPID®, a novel 3D screen printing platform technology. SPID®-Technology allows for the mass customization of pharmaceuticals down to the single-level tablet.
In the scientific article “3D Screen Printing Enables Application of Integrated QR Codes on Pharmaceutical Dosage Forms in Mass Production – A Game Changer” published in the Biomedical Journal of Scientific & Technical Research, the Laxxon Medical R&D team members explores the integration and possibilities of in-drug labeling of pharmaceuticals with unique identifying information, such as QR codes, to reduce medication errors, improve patient safety, and provide a viable mechanism for remote patient monitoring and identifying counterfeit drugs.
Quick Response (QR) codes have shown enormous potential to improve the flow of information from industry to providers and patients, by enabling access to supplemental safety data, and potential drug interactions, among numerous other use cases in real-time.
The integration of in-drug labeling of pharmaceuticals with unique identifying information in QR codes have been shown to reduce medication errors, improve patient safety, and provide a viable mechanism for remote patient monitoring and identifying counterfeit drugs. QR codes can be printed post-process on existing tablets or in a singular manufacturing process with 3D screen printing.
Patient Safety Through Irreplicable Additive Manufacturing Techniques
SPID®-Technology presents a unique solution to combat counterfeit drugs by 3D screen printing intricately designed dosage forms that cannot be replicated with traditional manufacturing technologies.
Unlike traditional manufacturing methods, Laxxon’s patented 3D screen printing technology allows for the precise composition of pharmaceutical ingredients layer by layer, resulting in highly customized medication structures. This level of customization not only enhances product efficacy but also serves as a unique security feature.
By printing either a QR code onto each pill or a colored marking within the pill, SPID® can establish visual identities that are impossible to recreate without the patented additive manufacturing technology. Moreover, the flexibility of technology enables the incorporation of multiple active ingredients into a single dosage form, reducing the risk of medication errors and enhancing patient safety.
End-to-end Product Traceability Through QR Coded Tablets
In addition to patient benefits and drug optimizations made possible through 3D screen printing, the integration of QR code technology further strengthens pharmaceutical security by providing authentication and traceability capabilities. QR codes contain a wealth of information, including product details, manufacturing data, and supply chain history.
By labeling each pill with a QR code, rather than just the container of pills, healthcare providers and patients can verify the authenticity of their medicine through a simple scan using a smartphone or QR code reader. This real-time authentication process helps consumers avoid counterfeit drugs and fosters trust and transparency within the pharmaceutical supply chain.
Market Opportunities: The Potential of Pharmaceutical Safety Solutions
The counterfeit medication public health threat presents a market opportunity for those interested in driving public health safety and healthcare innovation.
As reported by McKinsey & Company, MedTech revenue growth is projected to stabilize at a higher rate compared to pre-pandemic levels as new innovative technologies are used to address unmet needs in the industry. In 2023, the US Food and Drug Administration (FDA) approved more novel medical technologies than it has in any single year ever before.
With billions worth of counterfeit pharmaceuticals coming to the market yearly, the demand for innovative safety solutions is at an all-time high. This demand not only emphasizes the need for widespread pharmaceutical security measures, but also points to where the industry's greatest efforts – and dollars – need to be driven.
With a powerful approach to overcoming counterfeit medication issues and a commitment to pushing the boundaries to increase global pharmaceutical safety, Laxxon Medical presents a compelling investment opportunity for those looking to capitalize on a combination of both technology and healthcare.
The Future of Global Drug Safety
In the complex worlds of healthcare and pharmaceuticals, innovative medical technologies like Laxxon’s SPID® offer promising avenues for safeguarding patients against counterfeit medication, revolutionizing pharmaceutical manufacturing and product validity on a pill-by-pill basis.
There is already a powerful effort being taken to put an end to counterfeit drugs. Through innovation and collaboration, we are working towards a new era of pharmaceutical safety, guaranteeing drug safety globally.
To explore investment or partnership opportunities with Laxxon and to join the mission against counterfeit medicine, contact our team. To stay informed on our initiatives, subscribe to our newsletter for updates.
References:
Brewer, C. Fraud in a bottle: How big pharma takes on criminals who make millions off counterfeit drugs. CNBC. https://www.cnbc.com/2023/12/11/fraud-in-a-bottle-big-pharma-takes-on-counterfeit-drugs.html
European Medicines Agency. (n.d.). Falsified medicines overview. Retrieved from https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/falsified-medicines-overview#:~:text=Until%20recently%2C%20the%20most%20frequently,%2C%20tuberculosis%20and%20HIV%20%2F%20AIDS
Drug Enforcement Administration. (2021, September). Counterfeit pills: What you need to know. Retrieved from https://www.dea.gov/sites/default/files/2021-09/DEA_Fact_Sheet-Counterfeit_Pills.pdf
World Health Organization. (2017, November 28). 1 in 10 medical products in developing countries is substandard or falsified. Retrieved from https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified
Laxxon Medical. (n.d.). 3D screen printing enables QR codes on pharmaceutical dosage forms in mass production. Retrieved from https://www.laxxonmedical.com/post/3d-screen-printing-enables-qr-codes-on-pharmaceutical-dosage-forms-in-mass-production
Laxxon Medical. (n.d.). Laxxon Medical granted U.S. patent for the sequential release of multiple drugs within pharmaceuticals. Retrieved from https://www.laxxonmedical.com/post/laxxon-medical-granted-u-s-patent-for-the-sequential-release-of-multiple-drugs-within-pharmaceutica
Laxxon Medical. (n.d.). Advantages of QR codes in the pharmaceutical industry. Retrieved from https://www.laxxonmedical.com/post/advantages-of-qr-codes-in-the-pharmaceutical-industry
McKinsey & Company. (n.d.). What to expect from MedTech in 2024. Retrieved from https://www.mckinsey.com/industries/life-sciences/our-insights/what-to-expect-from-medtech-in-2024
Mackey, T. K., Liang, B. A., York, P., & Kubic, T. (2015). Counterfeit drug penetration into global legitimate medicine supply chains: A global assessment. American Journal of Tropical Medicine and Hygiene, 92(6 Suppl), 59-67. doi:10.4269/ajtmh.14-0389
McElhaney, L. US: Crackdown on $230 million counterfeit medication scheme unveils global drug fraud crisis - Naddi - National Association of Drug Diversion Investigators. NADDI. https://www.naddi.org/us-crackdown-on-230-million-counterfeit-medication-scheme-unveils-global-drug-fraud-crisis/
Ofori-Parku SS. Fighting the global counterfeit medicines challenge: A consumer-facing communication strategy in the US is an imperative. J Glob Health. 2022 Apr 23;12:03018. doi: 10.7189/jogh.12.03018. PMCID: PMC9031510..
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions that optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process with the individual and the pharmaceutical partner in mind.
To keep up to date with SPID®-Technology and Laxxon Medical news and announcements, follow us on LinkedIn.