One in Ten Medical Supplies Sourced From Developing Countries Is Substandard or Falsified

The World Health Organization recently released a bombshell report that should concern anyone who relies on discount medical supplies to fortify health or treat chronic conditions. Unfortunately, the report largely flew under the radar. Many Americans remain unaware of the potentially fatal risks they take when buying cut-rate products from abroad.

The 2017 study, titled "1 in 10 medical products in developing countries is substandard or falsified," summarizes the findings of a systematic survey of popular medical supplies that Americans sometimes purchase from developing nations that often host a bustling yet unregulated pharmaceutical production infrastructure.

In the medical community, industry analysts utilize the term "substandard and falsified or SF medicines" to categorize the types of adulterated or ineffectual drugs of concern. For the purposes of the study, the WHO defines the categories thusly:

  • Falsified medicines: drugs that are deliberately and fraudulently mislabeled with respect to identity and/or source.
  • Substandard medicines: genuine medicines produced by manufacturers authorized by the NMRA [national medicines regulatory authority] which do not meet quality specifications set for them by national standards.

As it turns out, the discounts offered by unscrupulous foreign producers on SF medicines can come with a heavy toll on patients' well-being.

On the global health threat that SF drugs pose, WHO Director General Dr. Tedros Adhanom Ghebreyesus said, "These products do nothing but prolong sickness, waste money and erode hope. At worst, they kill, cause serious harm, and fan the flames of drug resistance."

Nightmare scenarios for parents and caregivers such as this, while rare, constitute a serious public health crisis that calls for rapid and decisive intervention from government regulators at the FDA and other agencies as well as personal vigilance from patients.

What's Really in Your Medicine?

Unsettling reports of substandard and falsified drugs include formulations purported to be children's cough syrup that contain unlabeled narcotics and false birth control pills, among other examples. Obviously, such deceptions can cause serious and irrevocable damage to patients who fall for them.

Until the issue of subpar, dangerous medical supplies sourced from abroad is corrected at the system-wide level, the burden to protect yourself as a patient falls on your shoulders.

Here is the meat-and-potatoes of the WHO study's findings. Later on, we'll explore the implications of the results and how you can take charge to safeguard your own health and that of your loved ones in terms of safely procuring necessary medicine that works as intended.

The Epidemic of Substandard and Falsified Medicines in the Developing World

Prior to the landmark study of SF drugs by the WHO, public health experts had warned for years of the dangers of Third World medical products to no avail – the data didn't exist at the time to support the urgency of their warnings.

Now, though, we understand the extent to which Third World medical products threaten the welfare of potentially millions of Americans who remain woefully uninformed about the risks they take when purchasing drugs from abroad.

SF Drug Prevalence by Region

The chart below documents the prevalence of substandard and falsified drugs across the developing world.

Source: JAMA Network

The data indicates that medicines originating from Africa are of the highest concern. A disturbing 18.7% of all drugs emanating from Africa, nearly 1 out of 5, are substandard or falsified.

Asia, while still a hotbed of illegitimate medicines, has improved its monitoring and interdiction efforts in recent years in terms of combating SF drugs, dropping the figure for that region to 13%. However, it is still a region to be cautious of while considering where to purchase medicine.

The all-encompassing "other regions category" (that includes Latin America, Eastern Europe/Mediterranean, and the Pacific island region) registered at 14.4%.

SF Prevalence by Drug Type

In addition to where SF drugs come from, we also now have data regarding what types of medicines are most often found to be substandard of falsified. The information is broken down in the following chart.

Source: JAMA Network

As the chart above indicates, almost 20% of antimalarial drugs do not meet respective national standards. 12.4% of antibiotics from developing regions are SF. Taken altogether, 13.6% of drugs produced in developing countries were found to be substandard or falsified.

SF Reporting by Region

The WHO and affiliated global monitoring groups rely largely on reports "from the field" to coordinate their mitigation efforts with relevant national authorities and to direct global strategy to remedy the major public health issues posed by substandard and falsified drugs.

The chart below breaks down the percentage of reports of SF drugs to the WHO by region.

Source:  World Health Organization

As the authors of the WHO study noted, the variability in reporting by region likely indicates that the SF numbers are skewed due to limited data.

For example, while estimates indicate that 13% of Asian-produced drugs are substandard or falsified, the Southeast Asia WHO Region – a huge sector of the global economy encompassing roughly ¼ of the entire world population - only accounted for a miniscule 2% of SF drug reports to the WHO.

This means that the rates of SF drugs introduced to market are almost certainly substantially higher than the numbers currently documented by the WHO and other groups.

The Fake Drug Trade Is Big Business

All of this hard data on fake drugs begs the question:  Why?

The answer, as is often the case, boils down to money. The fake drug industry is booming. The illicit industry generates windfall profits for traffickers of falsified and substandard medicines, often with little need for startup investment – making it an attractive sector of the economy for dishonest actors hoping to make a quick buck.

The figures shock the conscience. According to one report, SF drugs generate in excess of $30 billion annually – more than the entire GDP of some countries.

Substandard and Falsified Medical Supplies Are a Symptom of a Globalized Economy and Skyrocketing Healthcare Costs

Globalization, the process of ever-increasing economic and social connectivity across borders, has fundamentally and dramatically altered how humans access healthcare.

While greater interconnectivity between nations offers a unique set of economic benefits (especially for developing nations), it also comes with potentially heavy costs, as the WHO study explored.

The web has facilitated the global drug trade. While the technology opens up the door for increased healthy competition among legitimate pharmaceutical firms to attract business, it also opens the possibility of widespread counterfeiting.

The burden of skyrocketing healthcare costs for US patients likely fuels demand for cut-rate medical supplies from abroad. The chart below shows the year-by-year increase in healthcare spending as a percentage of US gross domestic product (GDP).

Source:  Organization for Economic Co-operation and Development

Medical costs to American families have steadily climbed for decades due to a complex set of economic and political factors. Accordingly, many Americans find themselves increasingly unable to afford basic medical necessities.

According to respondents to a 2018 GoodRX Survey, a whopping 42% of Americans say they struggle to finance their medications.

It comes as no surprise, then, that desperate US residents are often willing to jeopardize their health with SF drugs from questionable sources.

Protecting Yourself and Your Family From the Threat of Falsified and Substandard Drugs

The issue of SF drug prevalence in the US and abroad is complex and requires the coordinated efforts of a host of international non-government organizations (NGOs), national public health agencies, and global health leaders to solve.

Until the much-needed reforms materialize, though, as a patient you must take the proper precautions to avoid purchasing or taking SF drugs unknowingly.

Without the ability to perform oversight over the manufacturing process for pharmaceutical drugs yourself, the safest strategy that you can employ in your own life is to insist only on drugs produced in the West or other modern nations – i.e., Western Europe, the US, Canada, Australia, New Zealand, Japan, etc.

These highly-developed nations, while they have their own issues with drug inspection, nonetheless have far more stringent labeling and quality testing requirements than those of the developing regions studied in the WHO report referenced earlier.

As the old saying goes, "you get what you pay for." This bit of conventional wisdom holds as true for the international drug market as for any other; if the advertised price of a medicine seems too good to be true, then it likely is. Don't trade your health or even your life for a discount on drugs that may be substandard or falsified.

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