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Real life is not a clinical trial

All clinical drugs are intended to go through lengthy and thorough trials before reaching a pharmacist’s shelves. These tests are designed in part to catch any adverse effects of the drug on the patients. But these clinical trials are extremely controlled and the test subjects are cherry picked from the patient pool, according to Nick O’Donnell, a recent graduate of Northeastern’s doctor of pharmacy program. The real world looks a lot different than this, he said.

That’s why O’Donnell, in conjunction with John Devlin, an associate professor of pharmacy practice in the Bouvé College of Health Sciences, decided to delve a little deeper into one class of drugs: intravenous sedatives. Because of their systemic action, these drugs have the potential to disrupt processes across the body.

Every time a patient experiences an adverse effect of a drug—be it an increase in heart rate, the development of an infection, a failure in the gastrointestinal track, or anything in between—the attending physician has the option of reporting the event to a central database maintained by the Federal Drug Administration. Because the system is voluntary, O’Donnell said, there are some serious reporter bias problems built in. For instance, if a patient experiences an adverse effect that doesn’t surprise the physician, it’s less likely to be reported.

Still, the database represents the most inclusive collection of wisdom on drug side-effects post-marketing. O’Donnell used this information to perform the most comprehensive examination on the most often used IV sedatives to date. He selected 2,500 anonymous patients from the database, who collectively experienced 6,000 adverse events over an eight-year period from 2004 to 2011.

He looked at the relative incidence of events per organ system, including the neurological, cardiac, respiratory, metabolic, and gastrointestinal systems. He also looked at infection rates.

“No one had looked at which sedatives affect different organ systems the most,” O’Donnell said. Much of what they found was to be expected. But there were a few anomalies that could never have been detected without this kind of search.

For instance, one of the sedatives known to decrease blood pressure and heart rate was also associated with a large incidence of cardiac arrest, something doctors would never have previously been concerned about with this particular drug. Another drug commonly known to affect the GI tract had similarly high rates of respiratory-related events.

O’Donnell presented the work at the Research, Innovation, Scholarship, and Entrepreneurship expo, or RISE, earlier this year and earned an award in the Health Sciences category. “I enjoy this kind of work because I can turn the data I have into something useful for the field,” he said.