Essential medicines and health products

Ensuring medicines save lives

Over the past 20 years, new vaccines and medicines have begun to reach people in the world’s poorest and most remote communities. Thanks to dedicated funding for research, there is a healthy pipeline of new products – like the Meningitis A vaccine – that have been created specifically to meet the greatest health needs of people in developing countries.

But creating products and delivering them quickly isn’t enough. The success of new treatments and vaccines hinges on our ability to ensure that they are safe and used responsibly, and that people are actually benefitting from them.

The story of thalidomide shows that drug safety monitoring is central to improving public health. In the early 1960s, pictures of children with horrific birth defects, particularly underdeveloped legs and arms, began to appear in the media. These birth defects were ultimately linked to the drug thalidomide, which had been widely prescribed throughout the world to prevent morning sickness in pregnant women. But it was only after the public reports of birth defects that researchers discovered thalidomide could penetrate the placental barrier between mothers and fetuses, causing serious developmental complications in newborns.

The episode showed that a rigorous system to monitor medical products is essential to patient safety. This final step in introducing new health technologies – monitoring them after they’ve been brought to market – is called pharmacovigilance, and it’s central to increasing access to medicines and improving health.

Pharmacovigilance is our safety net if a rigorously tested new product behaves unexpectedly once it’s introduced on a large scale. In addition to ensuring that innovations deliver their intended impact, it reduces the risk of unintended patient harm, prevents resources from being wasted on unsafe products, expedites the introduction of better ones and safeguards patients’ trust in the health systems they rely on.

In high-income countries, people now take these systems for granted; in most low- and middle-income countries, these safety nets are weak or non-existent. As a result, people’s safety and the quality of their health services are at risk.

So how do we ensure the safety of new products, no matter when or where they’re introduced? At the most basic level, countries need local platforms where patients and doctors can report adverse events and collaboration across affected countries to analyze safety signals and take appropriate action.

For example, distressing symptoms, including severe muscle spasms from a malaria medicine were recently reported and risks minimized in Burkina Faso, thanks to WHO awareness-raising activities and the training of pharmacovigilance professionals. Errors in medicine administration, which could harm or kill patients, are declining in several African countries where WHO works to expand capacity for reporting adverse events by training health workers.

WHO will continue to strengthen this work. On Monday 5 November, to commemorate the 50th anniversary of its pharmacovigilance activities, WHO will launch a toolkit that comprises checklists and clear guidance to countries on how to set up a drug safety monitoring system and the sequence of actions that must be taken to protect patients.

There’s much work to be done to ensure that every country in the world – rich or poor – has access to safe vaccines and medicines. Governments, pharmaceutical manufacturers and the global health community must work together and urgently to ensure that medicines, vaccines and other health products do what they’re supposed to do: save lives.