Edward Napke

Pioneers in the field of pharmacovigilance

Edward Napke, MD, DPH, is considered one of the pioneers of pharmacovigilance. Back in 1965, he set up Canada’s first system for reporting adverse drug reactions, which was later integrated with the National Poison Control Program and other reporting systems. He also played a key role in drafting the “No Smoking in Public” law in Canada in 1976, along with other regulations related to environmental issues. Since 1990, he’s been a volunteer consultant for the WHO’s Uppsala Monitoring Centre, where he helps review data from official monitoring systems on adverse drug reactions (ADRs), organized by System Organ Classes.

My dedication

Life has a way of surprising us. Sometimes in beautiful ways, sometimes not. That’s just how it is, part of everyday life. But when life decides to be generous, it can be incredibly so. That’s what happened to me in 2008, when it placed in my path a wise, open-minded man, rich in qualities.

To my professor, my friend, the person who encouraged and guided me, the man of science, the example of humanity—thank you from the bottom of my heart.

My work today, and the work I will do in the future, are dedicated to you.

Thank you, Ed.

I met Edward Napke in 2008 at the annual conference of the WHO Programme for International Drug Monitoring.

Perhaps partly because of our shared origins—he too was born in Lebanon, and in Uppsala he was genuinely happy to see his country represented at this convention for the first time—Dr. Napke took a close look at my projects, “Pharmacovigilance in Middle Eastern Countries” and “Pharmacovigilance in the Pediatric Population.” He advised me to focus on the pediatric issue, to help fill a gap that exists worldwide, largely because children and pregnant women are excluded from clinical trials.

It’s worth noting that drug safety is even more critical in pediatrics, since more than half of the medications used to treat children are prescribed “off-label,” meaning they haven’t been adequately tested, formulated, or officially approved for pediatric use. Differences in age and stages of development can lead children to experience adverse drug reactions that differ in nature, type, and intensity from those seen in adults.

We stayed in touch over the years, and Dr. Napke continued to advise me on various aspects of my work—until I ventured into the field of addiction, which he considered one of the most serious adverse reactions. In other words, addiction is the downside that follows the pleasure a person experiences from using a substance—or even a non-substance.