Why patient safety doesn't end at approval
Regulatory authority approval is one of the most important milestones in drug development. For those who designed, synthesised, and trialled the drug, regulatory approval means a wider reach for patients seeking a cure, delayed disease progression, and symptom relief. For some professionals, approval fulfills their purposes and ambitions; for others, it marks the beginning of a post-market journey.
Once a treatment becomes available to the public, protecting patient safety remains a priority throughout its time on the market; patient safety is the highest priority of regulatory authorities and marketing authorisation holders (MAHs). Is the treatment effective for a broader patient population? Is the treatment causing other effects not previously reported? Are there any interactions with other products? And is the treatment misused unknowingly or intentionally?
Unfortunately, these answers don’t directly flow to regulatory authorities or MAHs. For most patients, their treatment journeys unfold through day-to-day interactions with healthcare professionals (HCPs), caregivers, family, and friends. So, MAHs must harness this information through as many channels as possible, including field representatives, contact centres, social media, and broader online forums. And when they collect enough of what may have looked like simple comments could signal noteworthy warnings to investigate.
Why post-approval interactions surface signals that clinical trials structurally can't capture
Clinical trials are designed to assess the efficacy and safety of a treatment across multiple phases. In the meantime, they are limited to specific populations and protocols to generate evidence for regulatory approval. Because of their controlled size, duration, and environment, clinical trials often fail to capture real-world wild-card patients and long-term treatment effects.
As the treatment is used by the general public over the years, post-market surveillance functions, such as Medical Affairs (MA) and Pharmacovigilance (PV), have observed, collected, and reported data that, in some cases, strengthens the trial evidence and, in others, constitutes a whole new profile of the treatment. And often, these functions also capture off-label use or misuse based on word of mouth, rather than evidence-based studies that would never have been captured in clinical trials.
Small, routine-looking signals are often the first indicator of a larger issue
Whether information comes from the field representative or contact centre interaction, an individual report may not initially sound alarming. One report of a nosebleed could have several possible causes, including dry air, scraping of tissues, nasal irritation, diet, or an underlying health condition. But if nosebleeds are reported repeatedly in connection with a particular product, the MAH and regulatory authorities may need to evaluate the evidence, potentially alerting the public and updating the warning for those prone to bleeding or impaired blood clotting.
A nurse accidentally breaking a vial in a clinic could be an ordinary mishap. But if incidents of vial breakage are detected across multiple clinics or regions, that’s a red flag for an investigation into product integrity. And if this leads to a recall and a shortage, it disrupts or alters patients’ therapies and ultimately risks their safety. Therefore, collecting and recognising the connections between signals is imperative for identifying issues that require action before they become greater risks to patients.
Integrating cross-functional information to identify and address patient safety concerns
Several functions capture safety signals, including Pharmacovigilance (PV), quality, Medical Information (MI), and commercial, which input data from contact centre activities into online monitoring. No single function has the entire picture of the patient’s journey, and functions collaborate with one another to ensure that safety information is submitted to authorities with as many details as possible to connect the dots and act on any concerns. For example, MI ensures any adverse event (AE) or product quality complaints (PQC) intakes from the contact centre, social media monitoring, and commercial transfers are delivered to PV or quality within one business day or earlier so that they are processed, reported, and addressed by regulatory authorities and MAHs. Periodic reconciliation processes are also in place to detect any missed AEs or PQCs.
Why continuous vigilance throughout the product lifecycle protects patients
Clinical trials evaluate a treatment’s efficacy and safety within defined patient populations and under strict protocols overseen by institutional review boards and regulatory authorities. How the product is administered and how the participants are monitored differ markedly from the typical outpatient treatment journey. In real-world situations, the variability of people's behaviours or treatment outcomes is almost unlimited. That’s why, when the product enters routine clinical practice, the true pattern of its profile emerges. Ultimately, ongoing surveillance, detection, and action, as early as possible, before it becomes a more widespread or serious issue, ensures patient safety if the product is available to the public.
Ongoing surveillance allows organisations to detect and address concerns before they become more widespread or serious. This continuous vigilance is essential to protecting patients throughout the product’s time on the market.
About the author
Rajul Jain is president of medical information (MI) at ProPharma, has more than 20 years of global experience in MI, pharmacovigilance, technology, and programme management. With an MBA, an engineering background, PMP certification, and additional certifications, including AI from Harvard and the Accreditation Council for Medical Affairs, Jain brings extensive knowledge to her role leading global contact centre operations. She is passionate about operational excellence, innovation, and delivering long-term value to clients across the healthcare and pharmaceutical industries.
