The Food and Drug Administration (FDA) is a U.S. government agency within the Department of Health and Human Services. Its primary role is to protect public health, by ensuring safety and effectiveness of drugs, vaccines, medical devices and food products. There are rigorous steps that may take years, and all these steps must be completed before a drug can be approved. The FDA has made some lifesaving investigational drug therapies available sooner than usual by offering an expedited drug approval process, known as “Fast Track”.
1. Discuss the process and regulations of Fast Track.
2. Identify which medical conditions warrant the use of “Fast Track” drugs.
Use at least 2 peer reviewed references Within 5 Years of Publication. You must use APA 6th ed.
Shelly is a 4-year-old preschooler who lives with her parents and younger brother. She and her brother attend a local daycare center during the week while their parents are at work. In the evenings she and her brother take a bath and then their parents read to them before bedtime at 8 PM. Shelly’s daycare class includes many children her age and she enjoys playing outside with them. Although snack times are planned, Shelly would rather play and does not always finish her beverages. Shelly’s mother calls the clinic and tells the nurse practitioner that Shelly has been “running a fever of 101 F for the past 2 days” and although her temperature decreases to 37.2 C (99 F) with Tylenol, it returns to 38.4 C (101 F) within 4 hours of each dose. Further, her mother says that Shelly complains that “it hurts when I pee-pee”. Shelly’s mother also has noticed that her daughter seems to be in the bathroom “every hour”. She makes an appointment to see the nurse practitioner this afternoon.
The potential diagnosis is UTI.
1. What other assessment data would be helpful for the nurse practitioner to have?
2. What are the organisms most likely to cause an UTI?
3. What is the pharmacological treatment for Shelly? Keep in mind safe dosing.
4. What are the teaching priorities for Shelly and her mother prior to her discharge from the clinic?
Please keep it concise. Using peer-reviewed references published within 5 years.