You Took the Drug—Now What?

The System That Forgets to Watch What Happens Next

In one of the most technologically advanced nations on Earth, it’s hard to accept that medical error and adverse drug reactions remain among the top causes of death. According to a 2016 BMJ study, medical errors account for more than 250,000 deaths a year in the United States—making it the third leading cause of death, behind only heart disease and cancer. Meanwhile, the CDC estimates that 1.3 million Americans visit emergency rooms each year due to adverse drug events, with roughly 350,000 requiring hospitalization.

These tragedies are often preventable—not through more prescriptions or procedures, but through better information, more transparency, and systems built with people, not profit, at the center.

A Caregiver’s Perspective: Why This Matters Deeply to Me

As a caregiver to both my son and daughter living with cystic fibrosis, and someone who has faced complex health challenges myself, I’ve lived at the intersection of medical hope and heartbreak. I’ve celebrated breakthroughs. I’ve watched miracles unfold. But I’ve also seen firsthand how a lack of clear post-market tracking of medications can put families like mine in danger.

So many of our complications weren’t just from the disease—they came from unexpected side effects, interactions between medications, and decisions made without full data. Some of these side effects led to life-threatening situations, landing my children in the ICU, fighting to stay alive. We are not the exception—there are countless families like ours caught in the aftermath of treatments that were never fully understood beyond approval. We were often navigating uncharted waters because the post-approval surveillance systems simply weren’t built to catch what happens in real life

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What I learned early on was that effective care requires ongoing collaboration—between patient, caregiver or advocate, pharmacy, and provider. But what happens when the system itself fails to close the loop?

The Broken Feedback Loop

Once a drug, device, or vaccine is approved by the FDA, the tracking basically stops. The agency and the public rely on voluntary self-reporting systems like:

• VAERS (Vaccine Adverse Event Reporting System)

• FAERS (FDA Adverse Event Reporting System)

• MedWatch (for all consumer-facing medical products)

These systems were designed to catch side effects, complications, and unexpected outcomes after products hit the market. But in practice, they fall dangerously short.

How often has your healthcare provider asked for an updated medication list—and truly taken the time to ask why you stopped taking something? And when you do report a side effect or concern, are you confident it’s being formally tracked, flagged, or followed up on? And if that information is being entered into a system, where is it actually going? Is it being reported to a national database? Is anyone analyzing it? Or is it simply disappearing into an electronic record, never to be seen again?

It’s estimated that fewer than 1% of adverse drug reactions are ever reported to these systems. Most people don’t even know they exist. Doctors don’t have time. Patients are overwhelmed. Caregivers—often already in survival mode—don’t know how, or even that, they can report.

As a result, we lose vital data that could save lives, improve care, and expose dangerous drug interactions before they become national tragedies. We all have a role to play in improving the safety of our healthcare system. When adverse reactions occur, it’s not just a personal experience—it’s data that could protect others. Reporting these events isn’t just helpful, it’s a civic responsibility that can lead to better oversight, better treatments, and lives saved

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The Truth About the FDA—and What Most People Don’t Know

There is a widespread misconception that once the FDA approves a treatment, it has been thoroughly vetted on all populations, including children, pregnant women, and those with complex chronic illness.

But that’s not the case.

Most clinical trials are done on healthy adult volunteers or a narrow subset of patients. Children and pregnant women are often excluded entirely—leaving them vulnerable to treatments that may not have been tested for their unique physiology.

Even more concerning: The FDA does not conduct its own trials. It does not independently test medications. It relies entirely on data submitted by pharmaceutical companies and affiliated research institutions.

The FDA’s job is to analyze that data—not to produce it. That means we’re placing enormous trust in the integrity and thoroughness of those submitting the information. Meanwhile, post-approval data is often inadequate or non-existent. This is not a sustainable system for public safety—or public trust.

We Need a New Model

We need to build a system where real-world outcomes matter as much as pre-market studies, where patient experiences are data, and where reporting problems is as easy as refilling a prescription.

Imagine a system where every treatment, prescription, or procedure is digitally tracked in real time, from the ER to your local pharmacy to your home. A system where patients, caregivers, and providers all have access to a shared platform—where they can report issues, track effectiveness, and flag potential side effects as they happen.

We need to shift from a reactive system to a proactive one.

The Real-Time Healthcare Intelligence System (RTHI)

To build a smarter, safer, and more responsive healthcare system—and perhaps even a new federal agency—we must adopt a model that treats every patient interaction not as an endpoint, but as part of a continuous story. A Real-Time Healthcare Intelligence system, or RTHI, would fundamentally transform how we gather, analyze, and respond to health data. It would center the lived experiences of patients and caregivers, making those experiences visible, measurable, and meaningful—turning every data point into an opportunity to improve care.

RTHI would integrate digital tracking of medications and treatments across EMS, hospitals, clinics, and pharmacies. It would provide patients and caregivers with a user-friendly app or dashboard to log outcomes, report side effects, and access their full treatment history. AI-powered analytics would detect patterns, clusters of harm, and early warning signs, while transparent public dashboards would keep consumers, providers, and regulators informed in real time.

To ensure trust, privacy, and security, RTHI would be built on blockchain technology—creating a tamper-proof, decentralized ledger where health events are time-stamped and verified across systems. Patients would own and control their health data, deciding how and with whom it’s shared, while anonymized data could be safely used for research and public health decision-making. Smart contracts could automate incentives for patients and providers who actively participate in data sharing and follow-up reporting, encouraging a culture of responsibility and collaboration.

The system would directly integrate with the FDA, helping to modernize and eventually replace outdated tools like VAERS and FAERS. It would expand post-market surveillance to include not just drugs, but medical devices, supplements, cosmetics, and food products—recognizing that true public health oversight must extend across the entire healthcare and consumer landscape.

By turning fragmented data into a coordinated, real-time intelligence system—secured through blockchain—RTHI would close the dangerous gaps in today’s healthcare model and deliver a future where safety, transparency, and trust are built into every stage of care.

But for this system to thrive, it must be mutually beneficial. That means recognizing the value of the people who contribute to it.

Imagine a reward system that acknowledges the patients and providers who model ideal collaboration. When patients consistently engage with their care—updating medication logs, reporting issues, or participating in follow-ups—they could earn incentives such as reduced co-pays, health savings credits, or priority access to new wellness programs. Providers who consistently demonstrate high-quality, data-informed, patient-centered care could earn public recognition, practice bonuses, or even national certification as “RTHI Collaborative Sites.”

These types of programs would not only improve participation—they would instill a sense of shared responsibility between the system and the individuals it serves. We all want better care, but better care is a two-way relationship. Empowering patients to take part in their health story—and giving providers tools and feedback to improve theirs—creates a system built not just on innovation, but on trust.

Together, we can build a healthcare model that doesn’t just track illness—but cultivates wellness, accountability, and collective advancement. And it starts by inviting everyone to the table. The economic model could be supported through a blend of public investment, private innovation, and value-based incentives. Health systems could subscribe to premium analytics; pharmaceutical companies would be required to participate in data-sharing; and patients could be compensated for their feedback as contributors to public health.

As a family, we’ve always felt a deep responsibility to pay it forward—to participate in clinical trials and studies not just for our own benefit, but to help others living with similar conditions. Living with rare diseases has given us a strong sense of duty to contribute wherever we can. But what if everyone took part, even when the condition isn’t rare? This mindset—a culture of shared responsibility and contribution—has become part of our everyday life. It’s a transactionally holistic approach to care: what we give comes back around, not just to us, but to the whole system.

Who Can Make This Happen?

Change won’t come from one place—it must come from all directions, working together with a shared sense of urgency and responsibility.

Congress holds the power to fund robust, modern surveillance systems and to legislate transparency requirements that ensure data about post-market drug and treatment performance is not only collected but made publicly accessible. They can also push for broader, more inclusive clinical testing—particularly for vulnerable populations that have historically been excluded from trials.

Photo by Andy Feliciotti on Unsplash

Federal agencies like the FDA and NIH must take the lead in modernizing the outdated systems that currently exist. With the right vision and resources, they can streamline adverse event reporting, invest in technologies that allow real-time feedback from patients and providers, and improve public awareness around how to participate in post-market monitoring.

The President and the Department of Health and Human Services (HHS) can direct these agencies to break down silos and coordinate national efforts, ensuring that reforms don’t just sit on paper, but are implemented effectively and with the public good at the forefront.

State governments also have a vital role to play. They can serve as innovation hubs, piloting local models that improve reporting, mandate data sharing among hospitals and pharmacies, and bring health systems and communities into closer collaboration.

Healthcare professionals—doctors, nurses, and pharmacists— are on the front lines. They can be powerful advocates for smarter systems and can educate patients about the importance of reporting side effects and medication changes. Their voices are trusted, and their leadership is essential.

And finally, patients and caregivers—the real experts in lived experience— must be empowered to speak up, organize, and share their stories. They know firsthand what’s working and what’s not. Their insights should not just be welcomed, but built into the foundation of how our healthcare system learns and evolves.

The Bottom Line

This isn’t a partisan issue. It’s not political. It’s personal. We’ve all assumed someone else is keeping us safe. But the truth is, the system we rely on to monitor treatments after they reach the public is failing us. We can’t fix what we don’t track. We can’t protect what we don’t understand. And we can’t heal if we’re not willing to face the truth—and change it. Flying blind will only lead to collapse.

The power to create a safer, smarter healthcare system is in our hands. But we must demand it—from Congress, from federal agencies, from our providers, and from ourselves. Pharmaceutical innovation and medical advancement can thrive—but not at the expense of human safety and care. Profit and progress must go hand in hand with accountability, transparency, and the well-being of the people they are meant to serve.

A truly participatory health system—one that engages consumers, providers, producers, and regulators—is a patriotic commitment to our nation’s well-being. It’s not about giving up personal freedoms, but about e

mbracing the freedom to contribute, to be informed, and to take part in shaping a system that serves us all. When participation is voluntary, transparent, and empowering, it becomes a shared act of care—one that strengthens both individual health and our collective resilience as a nation.

It’s time to make American healthcare human.
And it starts with one simple truth:
We grow what we measure

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By Jacqueline Capriotti
Jacqueline is a mother, caregiver, and the Founder and CEO of Health Revolution USA, a public relations and strategy firm focused on advancing health, agriculture, and community-based solutions. She also leads the Victory Garden Alliance, an initiative of Health Revolution USA and a modern revival of the original Victory Gardens—the most successful public awareness campaign in U.S. history. At the height of World War II, over 20 million Victory Gardens were planted, producing 40% of America’s vegetables and fruits—grown largely by women, children, clergy, teachers, small farms, and seniors. Inspired by that legacy, Jacqueline’s work bridges wellness, policy, and grassroots action, with one clear goal: to make American healthcare—and our communities—human again. She resides in Monmouth County, New Jersey, where she raised her family and continues to advocate for change from the ground up.