Substandard, Falsified Medicines Most Prevalent, Costly in Africa and Asia

Sachiko Ozawa, PhD, MHS

A combined systematic review and meta-analysis involving nearly 500,00 drug samples concluded that substandard and falsified medicines are 13.6% prevalent in low- and middle-income countries—costing them anywhere from $10 billion to $200 billion annually.

In a global assessment of 265 drug-based studies that estimated the prevalence of substandard and falsified (SF) medicines of essential need in low- and middle-income countries (LMIC), investigators from the University of North Carolina Chapel Hill (UNC) were able to specify the monetary impact of certain types of drugs in certain regions of the world.

According to the World Health Organization (WHO), about 10.5% of all medicines worldwide are SF—with a large burden of the medicines falling on the lesser-resourced LMIC population.

Investigators, led by Sachiko Ozawa, PhD, MHS, of the UNC Eshelman School of Pharmacy, wrote that reductions of global morbidity and mortality rely on increased access to efficacious, essential medicines in these regions.

Circulation of SF medicines with little clinical effectiveness also places entire communities at risk of drug resistance, posing a threat to global treatment effectiveness, as well as undermining people’s overall trust in the health system and its legitimate health care professionals,” investigators wrote. “Over time, diminished trust in licensed health care professionals may further encourage informal care-seeking and self-medication.”

Additionally, the burden of SF medicine costs may be two-fold—not only in the actual expense of care, but the economic burden of a sicker population.

Investigators noted that “decreased economic productivity resulting from prolonged illness, reduced sales and tax revenue, and costs of anti-counterfeiting initiatives, are borne by governments, companies, the pharmaceutical industry, donors, and society as a whole.”

To better articulate the prevalence and burden of SF in LMICs, investigators identified and assessed 265 studies that estimated its prevalence. They included 96 of such studies—all of which tested 50 drug samples or more (n= 67,839)—in a meta-analysis that assessed for overall prevalence of SF drugs in LMICs, divided by regions. Investigators also categorized for antimalarials and antibiotics among the SF drugs.

Compiled data came from studies primarily focused in Africa (n= 133; 50.2%), Asia (90; 34.0%), and South America (8; 3.0%). Just 3 studies (1.1%) featured samples from each of Europe, North America, and Oceania, and 25 (9.4%) tested samples from multiple continents.

A majority (157; 59.2%) were published in this decade, 63 (23.8%) of which were published in the past 3 years. Antimalarials (117; 44.2%) and antibiotics (104; 39.2%) comprised a majority of the drugs studied; in 35 instances (13.2%), they were both investigated.

In the meta-analysis, overall SF medicine prevalence was reported in 13.6% (95% CI; 11.0-16.3) of LMICs, with an 18.7% regional prevalence in Africa, and 13.7% prevalence in Asia. Studies across multiple continent reported a pooled prevalence of 11.6%.

SF medicine prevalence was 19.1% for studies involving antimalarials, and 12.4% for antibiotics. In assessing for study details, SF medicines were most prevalent in studies published prior to 2000 (20.4%), in patient sample sizes ranging from 50-99 (34.4%), and with combination drug sampling methods (47.4%).

In assessing 65 unique records with differing estimates on the economic effect of SF medicines, investigators compiled 8 qualified economic estimates, ranging from $10 billion to $200 billion annually (median, $31.25 billion).

Though this study and prior discussions surrounding SF medicines have centered on LMICs, investigators reiterated that they are prevalent worldwide.

“The global nature of the medicine supply chain implies that weaknesses in any country in the supply chain affect all the countries downstream,” investigators wrote.

Efforts such as the WHO Global Surveillance and Monitoring System, launched in 2013, have sought to improve the strength and quality of global drug regulation capacity, investigators noted. But additional steps must be taken by lawmakers and agencies with the capability to share global drug data.

“Without such concerted global effort, the global supply chain, and thereby every country within it, remains vulnerable to SF medicines,” investigators wrote.

The study, "Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries," was published online in JAMA on Friday.