Pharmacovigilance: What is the Significance of It?

Pharmacovigilance What is the Significance of It?

If you’ve ever seen a television advertisement for a new or even long-existing medication for the treatment or prevention of a disease, you’re probably aware of the various warnings that follow the discussion of its benefits. Often the ad may advise the user of a medication to tell their doctor about any negative effects they are experiencing.

Our bodies are all different and even benign medications can occasionally result in adverse reactions or negative side effects in some people, particularly if they suffer from other conditions or take additional medications. For this reason, medicines and vaccines are put through rigorous testing processes including multiple clinical trials that look at safety and efficacy before they can be prescribed by a physician or purchased over the counter.

The clinical trial process, however, is not fool proof. Such trials are often conducted on small groups of individuals and for relatively short periods of time. Adverse conditions from the use of medications may not appear until after they are being used for some time. This is where pharmacovigilance comes into play.

What is Pharmacovigilance?

The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.” This vital discipline looks at adverse effects as they impact individuals over long periods of time.

What is the Significance of Pharmacovigilance?

In short, it’s all about drug safety. The body of knowledge gained from such studies assists physicians in making wiser decisions when prescribing medications so as to improve their efficacy while also preventing or reducing negative side effects.

Post-market drug safety monitoring is, of course, serious business. As one might expect, because medicines and vaccines can have a massive impact on human health, there is a tremendous regulatory system that oversees the collection, processing and reporting of such data, not only in the United States but with other worldwide regulatory agencies. Respected med/science firms such as Memphis, TN-based Med Communications employ distinguished experts with medical, pharmaceutical and academic backgrounds to meet the demanding timelines of these regulatory authorities. Among other things, they help ensure reporting compliance, produce post marketing individual case safety reports, conduct patient support programs and they look at causality for adverse effects such as abuse or misuse of a drug or medication errors.

Important Tips about Pharmacovigilance

Educate Yourself

While it may be disconcerting to read about the serious side effects of medications, it is important to remember it is intended to be educational. When health care providers and patients are aware of potential side effects and can properly identify them if they occur, it helps them make more informed decisions and to create a plan of action if they occur.


If, as a patient, you are experiencing a negative side effect, make sure you inform your doctor immediately. She may need to adjust your dosage, switch you to another medication that might work better for you, or stop prescribing it altogether. In addition, your physician should report your and others experiences to the appropriate regulatory bodies to help build a knowledge base on the medication.

Monitor the Effects

If you take a medication regularly, its efficacy may change over time. It’s important to keep your physician apprised of any changes not only for your general well-being, but also to help assess the medication’s long-term safety profile.

Something Important to Remember

Pharmacovigilance is about more than how your medications affect you. It’s about creating a body of knowledge that can help to create better patient outcomes for everyone. Your participation in the process is important!

Published by: Martin De Juan


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