WHO: 1 in 10 Drugs Is Falsified or Substandard

A recent report by the World Health Organization (WHO) showed that nearly 1 in every 10 drugs is falsified or substandard, and estimates the net worth of the industry for such drugs at nearly $30 billion.

The presence of substandard and falsified medical products (and their subsequent use by patients) threatens the health and safety in hundreds of thousands of individuals. Such products may be of poor quality, unsafe, or ineffective. Increasing demand for medicines, vaccines, and other medical products in almost every country, combined with poor supply-chain management and the growth of e-commerce, has resulted in opportunities for falsified medicines to be introduced into the supply chain.

In order to quantify the magnitude of this problem, the World Health Organization (WHO) sought to first define the terms being used in the field of substandard and falsified medical products. In May 2017, the World Health Assembly endorsed the following definitions:

• Substandard medical products: also described as “out of specification,” these are authorized medical products that fail to meet either their quality standards or their specifications, or both.
• Unregistered/unlicensed medical products: these products have not undergone evaluation and/or approval in the markets in which they are sold or used, and are subject to permitted conditions under national or regional regulations.
• Falsified medical products: these are medical products that deliberately or fraudulently misrepresent their identity, composition, or source.

An expert group, comprising specialists in public health, medicines regulation, and health economics, was convened to review existing data sources to determine the public health and socioeconomic impact of the products. A literature search identified 100 papers that reported on testing of 48,218 samples of medicines collected from 88 countries. Eighty-five percent of samples came from survey sizes of over 500.

The observed failure rates of drugs were classified by country income level. The study tested 11,156 samples from low-income countries and found 1166 failures, resulting in a percentage failure rate of 10.5% (95% confidence interval [CI]; range, 9.9% to 11.0%). Additionally, 36,884 samples from middle-income countries found 3906 failed samples. Analysis resulted in a 10.6% (95% CI; range, 10.3% to 10.9%) failure rate. In a pharmaceutical market worth $300 billion, the failure rate suggests that the falsified or substandard drug industry’s worth is approximately $30 billion. Given these results, it is also important to note the study’s limitations: the study was restricted to information in the public domain, and to studies in the English language.

To provide examples of the impact of standardized and falsified products, the WHO demonstrated 2 different models focusing on childhood pneumonia and malaria, respectively.

Findings were estimated at prevalence levels of substandard and falsified antimicrobials of 1%, 5%, and 10%, when assuming that the use of substandard and falsified medicines would result in a “most likely” scenario of a 2-fold increase in case fatality rate (CFR) if there is reduced antibiotic activity. For substandard or falsified antimicrobials:

• 1% prevalence of substandard and falsified products would result in 8688 excess deaths
• 5% prevalence would result in 37,018 excess deaths
• 10% prevalence would result in 72,430 excess deaths

The case of malaria, too, highlights the potential impact of substandard and falsified drugs. The World Malaria Report (WMR) estimates that 31,000 unnecessary deaths, and the Clinton Health Access Initiative (CHAI) estimates that 116,000 unnecessary deaths, are tied to substandard or falsified antimalarial drugs each year. The total annual economic impact of such poor-quality antimalarials is about $10 million, says WMR, or $40 million, according to CHAI.

The public health impact of substandard and falsified products as found by this study could lead to a loss of confidence in medication and health systems, and could result in patients avoiding particular health facilities, refusing to vaccinate their children, or failing to take treatment as prescribed.

The most direct socioeconomic impact is on individual and household costs, as money is spent on medical products that cause harm or do not work at all. Furthermore, toxicity, treatment failure, or infection resulting from failed prophylaxis may also lead to extra spending on health services and new medical products. About 84% of the world’s population, largely in developing nations as well as low-income areas, is affected by the risk of out-of-pocket spending on these drugs.

The products not paid for from household budgets usually represent the costs to health systems, including payers. Additional testing, treatment, and care absorbs money, staff, and infrastructure across the health system, further straining resources that are often already overstretched.