Every time you take a pill, get a vaccine, or use a new medicine, there’s a quiet global system working behind the scenes to make sure it’s safe. This isn’t science fiction-it’s pharmacovigilance, the science of tracking drug side effects across borders. And it’s more critical today than ever.
How the World Tracks Dangerous Drugs
The global drug safety system started in 1968, after the World Health Organization realized that drug side effects don’t wait for national borders. A medicine that causes liver damage in Brazil might also harm someone in India or Sweden-but without shared data, no one would know. So they built VigiBase, a central database managed by the Uppsala Monitoring Centre in Sweden. Today, it holds over 35 million reports of adverse reactions from more than 170 countries.
These reports aren’t random. They come from doctors, pharmacists, patients, and hospitals. Each one is an Individual Case Safety Report (ICSR), filled out with details like the drug name, the reaction (like a rash, heart issue, or liver failure), and when it happened. To make sense of millions of reports, everyone uses the same language: MedDRA, a medical dictionary with over 78,000 terms for symptoms. And drugs are labeled using WHODrug Global, which includes more than 300,000 medicine names across 60+ categories.
This system doesn’t just store data-it finds patterns. If ten people in different countries report the same rare reaction to a new diabetes drug, the system flags it as a potential safety signal. That’s how they caught the link between Dengvaxia and severe dengue in people who’d never had the virus before-first spotted in the Philippines, then confirmed globally.
Who’s Running the System?
The WHO Programme for International Drug Monitoring (PIDM) is the backbone. But it’s not a top-down agency. It’s a network. Each country has its own national pharmacovigilance center. Some, like the U.S. FDA, the European Medicines Agency (EMA), and Australia’s TGA, run advanced systems. Others, especially in low-income countries, struggle with basic tools.
There are 34 countries classified as “Full Members” that actively send data to VigiBase. The rest either send occasional reports or don’t send any at all. That creates a big gap. Just 16% of the world’s population lives in high-income countries-but they submit 85% of all reports. Sweden reports 1,200 adverse events per 100,000 people each year. Nigeria? Just 2.3 per 100,000. That doesn’t mean Nigerians don’t have side effects. It means they can’t report them.
Meanwhile, the EU runs EudraVigilance, a legally binding system. Companies must report side effects within 15 days. The FDA’s FAERS gets about 2 million reports a year but doesn’t automatically feed into VigiBase-though it does contribute manually. The WHO system is voluntary. It doesn’t force anyone to report. It just makes it easier to connect the dots when they do.
Why Some Systems Work Better Than Others
Not all countries have the same tools. In the UK, healthcare workers use a mobile app to report side effects in under 48 hours. In Ethiopia, before they adopted the PViMS system in 2020, it took 90 days just to get a report from a rural clinic to the capital. After PViMS, that dropped to 14 days. But even now, only 35% of health facilities in Ethiopia report regularly-because of poor internet, lack of training, or no electricity.
Training is another issue. WHO says pharmacovigilance officers need 40 hours of specialized training. In Southeast Asia, 68% have had less than 15. That means reports are incomplete, unclear, or never filed at all.
Europe’s advantage? Active surveillance. Instead of waiting for reports, they mine electronic health records from 150 million patients. That’s how they found a 37% increase in signal detection speed. The U.S. and EU can catch problems faster because they’re looking for them, not just waiting for someone to call in.
The Money and the Market
Pharmacovigilance isn’t cheap. The global market was worth $5.38 billion in 2022 and is expected to hit $13.17 billion by 2030. Why? Because regulators demand it. The top 50 pharmaceutical companies now have pharmacovigilance teams averaging 250 people each-up from 150 in 2018. If a drug causes harm and the company didn’t report it properly, they face fines, lawsuits, or even a global recall.
But money doesn’t reach everywhere. In 50 African countries studied, the average pharmacovigilance budget was just $0.02 per person. In high-income countries, it’s $1.20. That’s a 60-fold difference. Some low-income systems rely entirely on donor funding. When that funding ends, the system shuts down.
That’s why the WHO’s Global Benchmarking Tool shows only 28% of countries have a formal system at all. The rest? They’re flying blind.
How Technology Is Changing the Game
Artificial intelligence is now helping sift through millions of reports. UMC’s AI system cuts false alarms by 28%. Instead of human reviewers spending weeks on noise, they focus on real signals. That’s huge.
Another big change? Public access. Since 2015, anyone can use VigiAccess to search anonymized data from VigiBase. Doctors, researchers, even patients can look up what’s been reported about a drug. Over 12 million people have used it.
By 2025, the world will adopt ISO IDMP standards-100+ data elements that uniquely identify every medicine. Right now, “ibuprofen” might be listed as “Ibuprofen 200mg tablet,” “Ibu 200,” or “Advil” depending on the country. With IDMP, every version will be linked to one exact code. That means matching side effects across borders will be 40% more accurate.
What’s Still Broken
Even with all this tech and data, big problems remain. One is causality. When someone gets a headache after taking a new drug, was it the drug? Stress? Something else? The EU and U.S. agree on whether a case is drug-related only 63% of the time. That’s not good enough.
Another issue: reporting bias. If a drug is widely used in rich countries, side effects show up fast. But what about drugs used mostly in low-income countries? Like certain antimalarials or tuberculosis treatments? They’re often ignored until it’s too late.
And then there’s the political gap. When a drug is pulled in Europe but still sold in Africa, who decides? The WHO can recommend action-but it can’t force a country to act. That’s why experts like Dr. Maria P. G. Kaisermayer say we need an independent global review body for high-stakes safety issues.
What You Can Do
You don’t need to be a doctor to help. If you notice a strange side effect-rash, dizziness, nausea, unusual fatigue-report it. In many countries, you can file a report online or through an app. Even if you’re not sure, report it. One report might seem small. But 100 similar reports? That’s a signal.
And if you’re a patient in a low-income country, ask your pharmacist or clinic: “Do you report side effects?” If they don’t, push for it. Global safety starts with local action.
The Big Picture
International drug safety monitoring isn’t perfect. It’s uneven, underfunded, and slow in places. But it’s also the only reason we know about risks like Vioxx, thalidomide, or the Dengvaxia issue before millions more are harmed.
It’s the reason new drugs are safer today than ever before. It’s why you can trust that your flu shot won’t cause a rare nerve disorder. And it’s why, even with all the gaps, the world is slowly getting better at protecting you-from one report at a time.
