Module 1-Case Study (B)

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School

San Jose State University *

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Course

186

Subject

Health Science

Date

Feb 20, 2024

Type

odt

Pages

1

Uploaded by rockybueno

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Module 1: Case Study Scenario #B This activity contains 3 questions. 1.How would you counsel Gertrude about the safety of OTC drugs? I would educate Gertrude on the safety of over-the-counter medications and how it may not be too effective. I would tell her that when taking OTC medications, there are risks involved and may not be safe. Taking OTC medications is available to everyone and doesn’t need to be prescribed by a doctor. The danger to that is it may not be the correct treatment and it could potentially worsen the complications. Lastly, OTC and supplements are not FDA approved and may not be safe and effective. 2.What are the advantages and disadvantages of OTC medications? - Some advantages is that it doesn’t need a prescription or an authorization from a health care provider. Anyone has access to them so people don’t feel restricted of not being able to buy it. People are also able to treat themselves. - Some disadvantages in taking OTC medications is the different risks involved such as not choosing the proper medications, interacting with other food or medications, and may be harmful. It also isn’t FDA approved which ensures that the drug is safe and effective. 3.How can Gertrude be certain that OTC medications are safe for her? - Taking OTC medications can be safely taken if Gertrude asks for assistance from a health care provider. They can also make an appointment with their doctor about their issues so they can suggest proper OTC medications to take. This activity contains 2 questions. 1.What is the role of the FDA and what role does it play in regulating herbal and dietary supplements? - The U.S. Food and Drug Administration is responsible for making sure that drugs and medical devices are safe and effective for people to use. They have been around for a long time and have seven different branches under them. Before a drug is approved, it goes through extensive laboratory testing which goes through three different phases. The FDA doesn’t test supplements for safety and doesn’t have the same regulatory process that drugs go through. One of the seven centers from the Food and Drug Administration oversees and is responsible for cosmetics, herbal, and dietary supplements which is called the Center for Food Safety and Applied Nutrition (CFSAN). 2.How quickly can a new drug be approved by the FDA? - The FDA approval process can take up to several years because it has to go through extensive laboratory testing. Then is it passed on to the New Drug Application for review if it looks promising. The last stage it goes through is the post marketing surveillance which observes the population for harmful drug effects. This whole process can take up to 20 to 30 years to get a new drug approved. Currently, there has been changes that were made for the drug approval process such as speeding up the process for drug review and getting accelerated approval for priority drugs.
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