FDA Basics Webinar: Managing Medication Risks
All medicines approved by the Food and Drug Administration (FDA) have both benefits and risks. Part of how FDA determines the safety of a drug or biologic (such as a vaccine) is to assess whether its benefits outweigh its risks. In some cases, FDA requires the manufacturer to implement a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of the drug or biologic.
FDA may require the REMS as part of a new product's approval process, or for an already approved product when new safety information arises.
"Essentially, a REMS is a safety strategy to manage a known or potential serious risk of a medicine and to enable patients to have continued access to these medicines by managing their safe use," says Theresa Toigo, RPh, associate director for Drug Safety Operations at FDA.
Some of those strategies involve specific steps the patient's physician must take, such as a special training program before being able to prescribe a medicine. Some strategies may require a pharmacy to meet certain requirements and be certified before being able to dispense a medicine.
Most REMS programs involve extra patient education about the risks and benefits of a drug or biologic, as well as including information about how to take the product safely, Toigo says. This information is provided in a printed Medication Guide or other patient education materials.
This presentation will discuss the role of REMS and how they help you, your physician and your pharmacist manage medication risks safely.
When: Tuesday; November 20, 2012; 1:00 PM EST
Length: 30 minutes
Where: To join the Webinar, see the instructions at http://www.fda.gov/AboutFDA/Transparency/Basics/ucm325201.htm (or copy and paste the URL into your Internet browser).
Host: FDA’s Center for Drug Evaluation and Research
Featured Speaker: Theresa Toigo RPh, Associate Director for Drug Safety Operations
This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand how the agency protects the health of the American public.
Posted November 19, 2012