MedWatch Coursework: How It Fits Within the FDA Mission

MedWatch
Name
Institutional affiliation
MedWatch
Purpose of The Program
MedWatch is a program that offers the public and health professionals to voluntarily provide information on severe reactions and issues with medical products such as drugs and medical tools. MedWatch works on improving patient care by ensuring that critical safety information is passed on to the doctors on time.
The Requirements of The Program
The information collected through MedWatch is preserved in the Adverse Event Reporting System (AERS) database. Companies that manufacture prescription drugs are legally obliged to provide information on adverse events to the FDA. Also, they are required to file information concerning errors and accidents involved in the making of the products or provide reports on drug quality. The information is crucial in cases where the current manufacturing practices do not occur.
How It Fits Within the FDA Mission
MedWatch provides a framework for the FDA to gather information from the manufacturers. The MedWatch website provides the necessary information on reporting adverse events for the public and medical product manufacturers (FDA, 2014).
The Information That Was Provided
FDA (2016) provides an article addressing patients, OBGYN, and professionals working in the oncology sector about the dangers linked with tests being advertised as ovarian cancer screening tests. The issues are an evidence-based approach that shows studies have found that there is a large number of erroneous results when using screening tests for ovarian cancer. Consequently, there is a risk of delayed preventive care for women who undergo these tests and show no symptoms. Additionally, the result might mislead patients and medical practitioners leading to making inappropriate medical decisions. The agency also notes that the use of ovarian cancer screening test increases the risk of developing ovarian cancer for women who become confident of the preliminary results making them not to take the necessary action in reducing the chances of future risk (FDA, 2016).
What I Think About the Information
The information offered by the FDA is appropriate for the audience. According to the American Cancer Society (2016), it is true that there are various tests which can be conducted when a patient goes to check up on ovarian cancer. Fundamentally, both the FDA and the American Cancer Society show that the treatment history of a patient is critical ...