WHO study estimates 1 out of 10 medical products in low- and middle-income countries is substandard or falsified

Author: Zoïe Alexiou

by Zoie Alexiou

The World Health Organisation (WHO) has recently published an advocacy document in attempt to quantify the cost and socio-economic impact of falsified and substandard medicines in low- and middle-income countries (link). The report provides a first estimate of the magnitude of the problem, and shows compelling outcomes regarding the dangers of poor-quality medicines. Below you find the key considerations related to detection, impact and prevention. 

Estimating prevalence and socioeconomic impact

The literature review focuses on economic impact and aggregates data from 100 papers reporting on 48,218 medicine samples, tested in 88 countries. Of those samples, two out of three were commonly prescribed antibiotics and antimalarials, drugs that reach vulnerable populations in vast quantities through public and private supply chains. The aggregated observed failure rate for the samples tested is approximately 10.5%. This percentage represents an estimated US$30.5 billion expenditure on substandard and falsified medical products by developing countries. The authors state that: ‘Obtaining accurate estimates on failure rates from the available literature is hindered by large variations in sample size, sampling strategies and analytical techniques’. Data collected in this study shows that advanced tests (i.e. HPLC), generate on average higher observed failure rates than field tests. However, when financial and technical resources are limited, in-field methods such as packaging analysis or suitcase labs are still useful for pass/fail screening.

How do the observed failure rates impact public health?

To translate the observed failure rates into public health considerations, the WHO requested development of two impact models. The University of Edinburgh modelled the impact of treatment with falsified or substandard antibiotics on mortality in childhood pneumonia. Pneumonia is one of the main causes of under-five child mortality globally. They estimate the number of excess deaths in the WHO African Region associated with a 1% increase in substandard medicine prevalence to be 1,997. This number increases to 5,527 excess deaths when medicines are present that have no active component at all. These distressing numbers are avoidable child deaths, that can be halted by strengthening control systems in high risk regions.

The London School of Hygiene and Tropical Medicine modeled the number of excess deaths, disability-adjusted life years and additional treatment costs due to substandard antimalarial treatments in sub-Saharan Africa. With an estimated 216 million cases of malaria yearly, of which 90% occurred in the sub-Saharan Africa region, the burden on the public health system is enormous. Their model, that benchmarks the effectiveness of treatment with substandard antimalarials against treatment with antimalarials containing sufficient API levels, attributes 2.1 – 4.9 % of the total malaria deaths in the region to substandard or falsified antimalarial products. Both models are likely to under-represent the true health impact of these products, as complex factors like antimicrobial resistance, adverse drug events and loss of trust in health care systems are not taken into account.

What global response is needed?

Given the degree of uncertainty, results presented above should be considered tentative and illustrative only. To give a more accurate picture, the WHO emphasizes the need for better reporting systems and information sharing; systematic collection of disaggregated data by product type, geographical location and level of active ingredient; and the need for analytical technologies that enable high volume testing in low resource settings. Falsified and substandard medicines are an unacceptable threat to our public health systems, hitting the weakest communities the hardest and causing a cycle of poor health and poverty. The recent growth of e-commerce creates additional opportunities for falsified medicines to be introduced into our global supply chains. This report is a call for action to mobilize governments, the pharmaceutical industry, scientist and all other stakeholders to develop systems to secure access to safe medicines.


WHO: A study on the public health and socioeconomic impact of substandard and falsified medical products, http://www.who.int/medicines/regulation/ssffc/publications/se-study-sf/en/, 2017

WHO: World Malaria Report 2016: http://www.who.int/malaria/publications/world-malaria-report-2016/report/en/, 2016