Why the FDA and EMA Insist You Can’t Ignore Literature Monitoring


How do pharmacovigilance specialists typically describe one of their routine tasks, literature monitoring? They often say it’s tedious but unnecessary. But is this truly the case? Would reputable regulatory bodies like the EMA, FDA, and others insist on literature monitoring in pharmacovigilance, complete with well-defined deadlines, if it weren’t an essential task?

In reality, literature monitoring is a fundamental component of pharmacovigilance. It involves systematically scanning medical journals, case reports, clinical trials, and other sources of scientific information to identify new ADRs or updates to known safety profiles.

Challenging preconceptions: The ongoing vigilance in drug safety

The thalidomide tragedy, known to many as the catalyst for stringent pharmacovigilance measures, may be familiar to all. However, only some know that it all began with the publication of adverse reactions to this drug in a medical journal. This pivotal moment has marked the beginning of a new era in drug safety. On the surface, new problems and safety concerns only accompany the introducing of new drugs. Nevertheless, this assumption is fundamentally flawed. Consider an old and extensively researched medication like acetylsalicylic acid. It’s one of the most thoroughly studied drugs with a well-established safety record. However, a recent article on the DrugCard platform blog discusses newly emerging safety signals for acetylsalicylic acid that were published in medical literature. This highlights that even well-known drugs can reveal unexpected safety issues.

A hesitation to report: academic researchers and safety signals

It’s essential to note that the medical community prioritizes academic pursuits. Consequently, certain safety issues have a limited likelihood of being identified through spontaneous reports. Healthcare professionals are often more inclined to publish such reactions rather than report them spontaneously to health authorities (HA) or marketing authorization holders (MAH). For instance, consider the study by Klose et al., who established a link between floppy iris syndrome and tamsulosin. The authors observed that 13 cases were documented in the medical literature during the same timeframe, but none had been reported through spontaneous channels.

Regulatory compliance and the imperative of literature monitoring

When discussing any aspect of the pharmaceutical industry, it’s essential to consider the rigorous regulation of all procedures. This also holds true for pharmacovigilance, with literature monitoring subject to well-defined timeframes. In the contemporary landscape of drug safety regulations, MAHs are mandated to oversee the safety data of their products continuously. Consequently, regulatory authorities expect MAHs to establish a robust literature monitoring system tailored to their specific markets. Timing-wise, conducting literature monitoring weekly for each drug is of utmost importance.

Dispelling stereotypes: The evolution of literature monitoring

Despite its immense importance, literature monitoring has often been viewed as a tedious, time-consuming process that offers little value. Literature monitoring can lead to an overwhelming workload for pharmacovigilance professionals. This perception can lead to underinvestment in pharmacovigilance activities. However, it’s essential to challenge this stereotype and recognize the tremendous value that literature monitoring brings to the table. The perception that literature monitoring is a monotonous and dispensable task arose long before solutions that streamlined this process became available. Advanced technologies like natural language processing (NLP) and machine learning have been employed to address the challenges associated with literature monitoring. These tools can quickly sift through vast scientific literature, flagging potential ADRs and providing valuable insights. This makes the process more efficient and enables more comprehensive monitoring.

A call to action: Investing in medical literature monitoring

Literature monitoring in pharmacovigilance is not a fruitless exercise but a cornerstone of patient safety and public health. By challenging the stereotype that it is time-consuming and lacking value, we can better appreciate its crucial role in identifying adverse drug reactions, updating safety profiles, and ensuring the well-being of those who rely on medications to manage their health. In a rapidly evolving pharmaceutical landscape, literature monitoring is not a choice but a necessity to protect patients and advance the field of pharmacovigilance.

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