Pharmacovigilance and Translation: An Overview of an Essential Relationship in Pharmacology

Ensuring the safety of pharmaceutical products is an ongoing commitment. Even the safety of well-known medicines, like acetaminophen, must be continuously monitored. That monitoring process is called pharmacovigilance and, of course, takes place in every language imaginable.
 
I’d like to explain why translation has an essential role in that process. The WHO offers a very precise definition that can help us better understand the concept. “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine-related problem.” (https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance)
 
After a drug is made available to the general public, it embarks on a journey outside of the controlled environments of clinical trials. In the real-world setting, a diverse array of patients, each with unique health profiles, are exposed to the medication. This transition from controlled studies to widespread use introduces the potential for uncovering nuances in the drug's safety profile that may not have been apparent during the initial testing phases. That’s where pharmacovigilance comes in. 
 
Regulatory bodies, such as the FDA and EMA establish reporting obligations for pharmaceutical companies to ensure they respect pharmacovigilance guidelines. These agencies require them to submit periodic safety reports detailing any new information about the safety profile of their marketed drugs. These reports undergo rigorous scrutiny, contributing to a collaborative effort to maintain the highest standards of drug safety.
 
Now, this is where translation comes in!

I’ll illustrate this with an example. Imagine a scenario where a 6-year-old French patient experiences an unexpected reaction to acetaminophen manufactured by the ABC Pharmaceutical Company. The patient’s physician prepares an adverse event report in French to be sent to ABC. Next, the report and any associated documentation needs to be accurately translated into English and other languages to ensure that regulatory agencies, other manufacturers, and researchers worldwide can comprehend the details of the incident. This ensures that the global pharmacovigilance community can analyze and understand the specifics of the adverse reaction, contributing to the identification of potential risks associated with acetaminophen.
 
The process of pharmacovigilance post-market is dynamic and ongoing. Continuous evaluation of safety data prompts regulatory decisions, such as label updates, contraindications, or, in extreme cases, withdrawal of a drug from the market. These decisions are made with the paramount goal of safeguarding public health while ensuring that effective therapeutic options remain available. Throughout that process, all of the documentation is translated to and from a variety of languages. As you can see, translation and pharmacovigilance have an essential relationship, allowing crucial information to traverse borders seamlessly and facilitating a collaborative effort to enhance drug safety on an international scale.

If you enjoyed learning about the role of translation in this part of pharmacology, please also read my post about translation and early access programs in French healthcare, another important relationship. Or if you have any question, please contact me using this email link or using the button at the bottom of the page.