Managing Drug Safety Issues
In any given week, half of U.S. adults will use prescription medicines and 10 percent will take at least 5 different ones, according to a survey conducted by the Slone Epidemiology Center at Boston University. Over-the-counter drugs are also used frequently in American households.
Under the law, FDA must make sure that drug treatments are safe and that for most people the drugs will not cause harm. But almost all drugs can cause harm to some people. FDA deems a drug “safe” when its benefits outweigh its risks for the people the drug is intended to treat and for its intended use.’
On Jan. 30, 2007, FDA announced 41 initiatives it is undertaking in its ongoing commitment to drug safety, as well as the safety of medical devices and biologics such as vaccines, blood products, and gene therapies.
We read and hear a lot of scary stories about bad drug interactions and/or side effects. But we don’t always get the “other side” — the issues faced and addressed but the FDA.
The Food and Drug Administration (FDA) is aggressively improving the management of important drug safety issues. Safety has been, and continues to be, a central focus of their regulatory work.
FDA came up with its drug safety initiatives, organized around three key themes:
- Strengthening the science that supports FDA’s medical product safety system
- Improving communication so that health care providers and patients can get the information needed to make informed decisions about treatments
- Improving FDA’s operations and management supporting drug safety.
Now you can also read an interesting Q and A with Paul Seligman, M.D., M.P.H. that informs you as to what process the FDA goes through when approving drugs.
Read the Q & A Managing Drug Safety Issues.
