There are three ways that drug companies can ensure patient safety. First, of all, they can look at the adverse event reports which they are receiving or that they get from the Food and Drug Administration. The Food and Drug Administration makes available to anyone, you, me or the drug manufacturer, the adverse events that are in their database, which they get from other manufacturers, from patients directly, from pharmacists and so forth. So the drug company can get the information and look at its’ own adverse events, and, of course, look at what is in the FDA database. Secondly, they look to surveys of who is using the drug. In other words, if– if you say that the top dose of this drug is 20 milligrams and the drug company find suddenly that people are writing prescriptions for 40 milligrams or 60 milligrams, then that alerts them that they need to do something to change that behavior. And the third thing, of course, is they look at the medical literature, even though that may be delayed by sometimes as much as a year, but that’s another very valuable source of information. These activities are referred to in the industry as “pharmacovigilance.” This means that all scientific and data-gathering activities relating to the detection, assessment and understanding of adverse events, are monitored to ensure patient safety. The goal of pharmacovigilance is to minimize risk associated with prescription drugs. So, if the drug company isn’t reading the literature, as many drug companies don’t, then who is minding the store to ensure patient safety?
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