WHO releases 2 new reports on substandard and falsified medicines

In November 2017, WHO released 2 important publications on the topic of substandard and falsified medicines:

• a report on the WHO Global Surveillance and Monitoring System for substandard and falsified medical products; and
• a study on the public health and socioeconomic impact of substandard and falsified medical products.

These 2 documents represent the first publications by WHO in almost 10 years on the topic. They include estimations of the observed failure rates of sampled medicines in quality surveys carried out in 2007–2016, involving over 48 000 samples from 88 Member States. The aggregate observed failure rate in low- and middle-income countries is estimated at 10.5%.

The reports also include estimates of spending on substandard and falsified medical products, and specific models on the impact of substandard and falsified antimalarials and antibiotics.

Substandard and falsified medical products may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient. Such medical products can be toxic when they contain fatal levels of the wrong active ingredient or other toxic chemicals. In addition, these products are often produced in poor and unhygienic conditions by unqualified personnel; they can contain unknown impurities and are sometimes contaminated with bacteria.

The presence of substandard and falsified medical products in countries and their use by patients threatens to undermine progress towards meeting the Sustainable Development Goals (SDGs). Such products may be of poor quality, unsafe or ineffective, threatening the health of those that take them.

A growing problem

The problem of substandard and falsified medical products continues to increase as globalized manufacturing and distribution systems grow more complex. This complexity heightens the risk that production errors will occur, and that medicines will degrade between leaving the factory and reaching the consumer.

Increasing demand for medicines, vaccines and other medical products in almost every country, as well as poor supply-chain management and the growth of electronic commerce, also create opportunities for falsified medicines to be introduced into the supply chain.