Counterfeit Cures and Poisoned Promises: The Growing Burden of Substandard and Falsified Medicines

BY LILIA POTTER-SCHWARTZ

Envision a child who has contracted pneumonia and is prescribed amoxicillin. After the child finishes their treatment, the ‘antibiotic’ is discovered to contain limited active amoxicillin, preventing full recovery while potentially increasing community rates of amoxicillin-resistant bacteria. Instances such as these represent a growing public health burden affecting individuals in every country: the use of substandard and falsified medicines.¹ While substandard medicines do not meet quality standards, falsified medical products are intentionally misrepresented in their composition to deceive consumers for financial gain.¹

The World Health Organization estimates that nearly two billion people do not have access to necessary medicines, vaccines, and medical devices.¹ Too often, this void is filled by substandard and falsified medicines.¹ Insufficient regulatory oversight, a lack of affordable medicines, and a dearth of education around the risk of these medicines has caused continued spread.¹ Beyond the blatant public health obstacles these medicines cause, there is a prominent economic burden.¹ Countries spend upward of $30 billion each year on these products, not including the money lost due to ineffective treatments, increased antibiotic resistance, and loss of life.¹ Nonetheless, fake medicine trafficking remains one of the most profitable sectors within global trade markets of counterfeit goods.²

An estimated 10% of medications worldwide are substandard and falsified, with some regions experiencing rates upward of 50%.¹ Conflict and political instability can pose particular challenges that exacerbate the use of substandard and falsified medicine.³ During times of political instability, inadequate quality control, attacks on health infrastructure, and a mistrust in government can create avenues for “bad actors” to distribute fake medicine.³ For instance, ongoing war in Sudan has worsened the prevalence of counterfeit medicine, known in-country as “Koko.”⁴ Local pharmacists describe the market as being overwhelmed with “completely fake drugs alongside expired ones,” which can imbue mistrust within the healthcare system.⁴ The repercussions of substandard and falsified medicine use, especially in conflict-ridden regions, are far-reaching.³

One such repercussion is the exacerbation of bacterial antimicrobial resistance, which is already understood to cause five million deaths per year.²^,⁵ If an individual is infected with an antibiotic that does not contain the standard amount of active ingredient, the bacteria may be able to gain a competitive advantage, increasing the density of resistant microbes and leading to increased onward transmission.⁵ Treatment failure can also cause chronic infections and accelerate community transmission.⁵

Given the complexities surrounding substandard and falsified medicine, ongoing research has extended across disciplines. Mathematical modellers assess the prevalence of these medicines. Pharmacologists and chemists have developed detection devices. Legal scholars continue to consider the medical regulatory paths. And implementation scientists examine the efficacy of public awareness campaigns.^6–11

Of particular note, leading researchers have developed portable, nondestructive screening devices that are able to detect substandard and falsified medicines.⁷ Many of these devices use vibrational and near infrared spectroscopy, which can quantify the content of active pharmaceutical agents.⁷ For falsified vaccines, a proof-in-principal study found that rapid diagnostic tests could be used to screen for falsified vaccines in supply chains.⁸ However, tracing the origin of detected falsified medicines remains a challenge.¹²

Beyond detection devices, public education interventions can be critical to inform communities of the risk of substandard and falsified medicines.¹⁰ However, previous research on such interventions for fake medicines found that some campaigns may exacerbate health inequities among disadvantaged groups.¹⁰ Therefore, public health campaigns must carefully consider impacts on equity and ensure that interventions to improve quality medicine access precede such subsequent awareness-raising efforts.¹⁰ Organizations and campaigns such as Fight the Fakes Alliance and Medicines We Can Trust are aimed at ensuring high quality medicine control and preventing counterfeit production.¹³

Access to medicine is a fundamental element of the human right to health.¹⁴ The public and global health spheres face many complexities today. With climate change and humanitarian crises, inequities in health are worsening, further compromising human rights. Without action, substandard and falsified medicines will continue to undermine our healthcare system, causing a severe human toll and community health repercussions. Further research, advocacy, and intervention must continue to address this growing human rights issue.