How to Track Post-Marketing Studies for Drug Safety

• by Melinda Hawthorne
• 0 Comments

Tracking post-marketing studies for drug safety isn’t just paperwork-it’s a lifeline. Every year, millions of people take medications that were approved based on trials involving a few thousand patients. But real-world use? That’s different. Older adults, pregnant women, people with multiple chronic conditions-they weren’t fully represented in those early studies. That’s where post-marketing surveillance comes in. It’s the ongoing watch after a drug hits the shelves. And if you’re responsible for tracking these studies, whether you’re in pharma, regulatory affairs, or hospital safety teams, you need to know how to do it right.

Understand the Core Systems Behind Drug Safety Monitoring

The backbone of drug safety tracking in the U.S. is the FAERS database-FDA Adverse Event Reporting System. It’s not a perfect tool, but it’s the largest. As of 2023, it held over 30 million reports of side effects submitted by doctors, pharmacists, patients, and drug makers. These aren’t confirmed causes, but red flags. A sudden spike in reports of liver damage linked to a new diabetes drug? That’s a signal. And signals trigger investigations.

But FAERS alone isn’t enough. That’s where the Sentinel System steps in. Unlike FAERS, which relies on voluntary reports, Sentinel actively mines real-world data from insurance claims and electronic health records of over 300 million Americans. It doesn’t just see that someone had a heart attack-it can see what medications they were on, what other conditions they had, and whether they were taking the drug at the time. This reduces guesswork. In 2023, Sentinel added data from 24 million more people through linked EHR and insurance records, giving it far more clinical depth than before.

Internationally, the UK’s Yellow Card scheme and Canada’s Canada Vigilance Program do similar work. In 2022, the UK received over 76,000 reports-up 12% from the year before. These aren’t just numbers. They’re clues that, when combined, reveal patterns invisible in clinical trials.

Know the Five-Step Signal Management Process

Tracking isn’t just collecting data-it’s turning noise into action. The FDA uses a five-phase process to handle safety signals:

1. Identification: A spike in reports, a new study, or a literature review flags a potential issue.
2. Triage: Teams assess how urgent it is. Is this a rare side effect in a life-saving cancer drug? Or a mild rash in an acne cream? Priorities shift accordingly.
3. Evaluation: Experts dig into FAERS, Sentinel, published papers, and even patient forums. They look for consistency across sources.
4. Action: If the signal holds, regulators decide: update the drug label? Issue a warning letter to doctors? Restrict use? Withdraw the drug? Between 2018 and 2022, 87% of safety actions were label changes. Only 1% led to removal.
5. Communication: The FDA publishes Drug Safety Communications, posts updates quarterly, and alerts healthcare providers through direct letters. Transparency matters.

If you’re managing post-marketing studies, you need to know how your data feeds into this pipeline. Are your reports timely? Are they detailed enough? A report saying “patient had dizziness” isn’t useful. A report saying “72-year-old woman, on drug X for 3 months, developed dizziness within 48 hours of increasing dose, no other meds changed, resolved after discontinuation”-that’s actionable.

Track Mandatory Post-Approval Studies Like a Project

The FDA doesn’t just wait for problems. It often requires drug companies to run specific post-marketing studies before approving a new drug-especially for high-risk areas like oncology, neurology, or immunology. Since the 21st Century Cures Act in 2016, these required studies have jumped 37%. And they’re not optional.

Here’s the problem: most of them run late. Between 2015 and 2022, 72% of mandated studies missed their 3-year deadline. The average completion time? Over five years. Why? Poor planning, fragmented data systems, and difficulty recruiting patients.

To fix this, treat each study like a clinical trial. Assign a dedicated pharmacovigilance lead-ideally one for every $500 million in annual sales. Set up automated alerts for missed enrollment targets or delayed data submissions. Use a centralized tracking system that links study protocols, timelines, and regulatory deadlines. The industry calls this the Post-Marketing Study Timeliness Index (PMSTI). Measure it. Report it. Improve it.

Also, use distributed data networks. In 2018, starting a post-marketing study took 14 months. By 2023, that dropped to under 9 months because companies now share data across health systems instead of building each study from scratch.

Use Technology to Cut Through the Noise

Manual review of millions of reports? Impossible. That’s why machine learning and AI are now part of the standard toolkit. The FDA’s Sentinel Innovation Center now uses Bayesian statistics and AI models to reduce false alarms. In 2018, 34% of signals turned out to be noise. By 2023, that dropped to 19%.

Even more promising? Large Language Models (LLMs) trained on unstructured EHR notes. A 2023 pilot with Lifebit AI showed a 42% improvement in detecting real safety signals by reading doctor’s notes, discharge summaries, and lab comments-things traditional databases miss. But there’s a catch: these models still generate 23% more false positives than traditional methods. And they can inherit biases from the data they’re trained on.

If you’re adopting AI tools, don’t replace humans-augment them. Use AI to flag potential signals, then have pharmacovigilance experts verify them. Never rely on an algorithm alone.

Prepare for Global Changes Coming in 2025 and Beyond

The future of drug safety tracking is connected. The EU is launching its EudraVigilance AI system in 2025, which will automatically compare adverse event patterns across 30+ countries. The WHO is building a global data-sharing network aiming to include 100 countries by 2027. And the FDA’s Sentinel Common Data Model Plus will start integrating genomic data with clinical records for 50 million patients by 2026.

What does this mean for you? Your tracking systems need to be interoperable. If you’re using a local database that can’t export data in standard formats, you’ll fall behind. Start planning now. Adopt common data standards. Train your team on how to interpret global signals. A side effect that’s rare in the U.S. might be common in Japan due to genetic differences. You need to see the whole picture.

What Happens When You Don’t Track Properly?

Bad tracking has consequences. In 2021, a widely prescribed painkiller was linked to rare but fatal heart rhythm issues. It took over two years to confirm because reports were scattered across different hospital systems and not standardized. By then, thousands had been exposed. The drug’s label was finally updated-but lives were lost.

Or consider elderly patients. In pre-approval trials, only 15% of participants were over 65. But in real life, they make up 43% of users. That’s why 28% of serious side effects found in post-marketing studies would’ve been missed in clinical trials. If your tracking system doesn’t filter for age, comorbidities, or polypharmacy, you’re flying blind.

Don’t wait for a crisis to fix your system. Build it now.

Best Practices for Reliable Tracking

• Use both spontaneous reporting (FAERS, Yellow Card) and active surveillance (Sentinel) together-they complement each other.
• Standardize your adverse event reports. Always include: patient age, sex, comorbidities, concomitant medications, timing of reaction, and outcome.
• Assign ownership. Someone must be accountable for each post-marketing study’s timeline and data quality.
• Review your data quarterly. Don’t wait for annual reports. Look for trends monthly.
• Train your team on signal detection basics. Even non-experts should know what a red flag looks like.
• Engage with regulators early. If you’re struggling with a study, ask for help before you miss a deadline.

Drug safety isn’t a one-time task. It’s a continuous conversation between patients, doctors, data, and regulators. The more you track, the safer the drugs become.

Next Steps: Build Your Tracking System Today

If you’re responsible for drug safety tracking, start here:

1. Map out all your active post-marketing studies. List deadlines, owners, and data sources.
2. Ensure your adverse event reports follow a standard template-age, sex, meds, timing, outcome.
3. Connect your internal system to FAERS and your regional reporting system (like Yellow Card).
4. Assign one person to monitor safety signals weekly.
5. Review your technology. Are you still using spreadsheets? It’s time to upgrade to a dedicated pharmacovigilance platform.

Drug safety isn’t about avoiding blame. It’s about saving lives. The data is out there. The tools exist. The question is: are you ready to use them?