Episode #110 - Protecting you from substandard and falsified medicines

VGS You may have heard about contaminated syrup harming children and even causing death in some cases. There have been reports about falsified diabetes and weight loss treatments.

We're going to talk about substandard and falsified medical products today. How can you protect yourself and how does WHO keep you safe from these products?

Here to talk about it is Pernette Bourdillon Esteve. Welcome Pernette. Pernette, talk to us about falsified and substandard medical products. What do we mean by these terms?

PBE Thank you, Vismita. So a substandard product is one that has basically lost its attributes of quality. Perhaps through degradation. It's become out of specification. A falsified product is one that deliberately misrepresents its composition, identity or source. There is an intent to deceive. And both substandard and falsified medical products may contain the wrong active ingredients. They might have been manufactured in unsanitary conditions. They will most likely not treat you for the condition for which they were intended, and sometimes they can even be toxic, as in the case of the contaminated syrups that you've just mentioned. Both substandard and falsified medical products harm patients, and there's a wide range of socioeconomic and public health impact attached to these.

VGS So Pernette, explain to us how are these medical products allowed to exist and circulate, and how do they actually reach people? And how can people protect themselves?

PBE So they're not supposed to be allowed to exist. Falsified medical products are by definition very difficult to detect. They can be almost similar or identical to the original or the genuine product. And a substandard product, often requires laboratory analysis to be identified as such.

There are three major forces that drive the existence of substandard and falsified medical products. The first is constrained access. This means: is the product available? For example, shortages. Acceptability: can you accept this product? And affordability: can you afford to pay for it? The other driving forces are technical capacity. Is there the capacity to detect the product?

VGS So you're talking about capacity of a country.

PBE This is about being able to do the laboratory testing to identify these products. And once you have identified it, you have got to be able to report it to share the information. And that requires quite a lot of technical capacity. And the third major driving force is poor governance. This includes corruption, unethical practices and weak administrative structures.

So you don't need all three driving forces to converge for substandard and falsified medical products to exist. A single one is enough, but populations where these forces converge are the most vulnerable.

VGS So how can we all protect ourselves?

PBE Well, people need to have access to safe and quality medical products, and that's why WHO works closely with national regulatory authorities, those very institutions who are the best placed to safeguard the public from these substandard and falsified medical products.

VGS So Pernette, once WHO receives an alert about a falsified or substandard medicine or medical product, what happens next?

PBE So as soon as we receive a report in the WHO Global Surveillance and Monitoring System, the first thing that we do is to validate the information. Then we identify and assess the risks. And that allows us to determine  what are the immediate actions that are needed to protect public health. 

We work with a wide network of public authorities and experts to understand the nature and the scope of the danger. We provide technical assistance to countries who are dealing with the incident and, when necessary, we communicate about the risk.

For example, with the WHO Global Medical Product Alerts that you have seen. This is really a very global issue. Our network reports to us all sorts of medicines, antibiotics, cancer medicines,  hormones, vaccines.

Every single therapeutic category in every single form is affected by this. In the past year, we've spent a lot of time working on the examples that you mentioned earlier, which are the liquid medicines contaminated with antifreeze and also the falsified weight loss diabetes type 2 products. It's very important to report early because a timely report from one country can save lives in another country.

Good quality information is what will guarantee effective interventions. So if you or someone that you know suspects to have been exposed to a substandard or a falsified medical product, or if the medicine has not worked as you expected, or if there was an unexpected adverse reaction, please talk to your health care professional about it as soon as possible. Your doctor, your pharmacist, your community health care professional. We all have a role to play when it comes to preventing, detecting, and responding to substandard and falsified medical products.

VGS Thank you, Pernette. That was Science in 5 today. Until next time, then stay safe. stay healthy and stick with science.