Food and Drug Administration, Coursework Example

Introduction

The Food and Drug Administration (FDA) is a comprehensive organization that is responsible for ensuring that all drugs that are tested and sold to market are safe for all patients and consumers within the United States. The organization adheres to the following steps regarding adverse events or other problems associated with drugs for which it is responsible for oversight: 1) reporting the problem; 2) providing safety information; and 3) obtaining information regarding the problem and possible solutions (FDA, 2015). Adverse events should be reported regarding medicines and other products via MedWatch, and the organization provides the general public with safety information and warnings regarding specific drugs and other products on a regular basis (FDA, 2015).  Also, the organization offers safety alerts via email subscription and social media in order to provide the public with important information regarding product safety (FDA, 2015).

Analysis

The FDA Adverse Event Reporting System (FAERS) records all adverse events that are reported to the organization and enables them to evaluate safety concerns and other issues that may impact the consumer population (FDA, 2015). Reports may be made by medical professionals and consumers and provides a basis for supporting the safety of all medications and other products that are used by the general public for medical purposes (FDA, 2015). Therefore, this alternative enables individuals and medical professionals to offer important insights regarding the safety of the general public with respect to medical products. It is important to identify any potential adverse events and to share this information with the FDA as quickly as possible in order to prevent any possible complications for other consumers who might not have had direct experience with these products, but might be exposed to them in the future.  The data that is recorded with the FAERS system is also available to the public, and this supports the development of a new framework that encourage public disclosure of the events that have been instrumental in supporting the lives of those who use medical products throughout the United States (FDA, 2015). The risks associated with these products must be shared with the public because they may pose a threat to their health and wellbeing; therefore, this process must be aligned with the needs of the general population in order to prevent lasting or long-term complications (FDA, 2015).

There are a number of tools and resources available to residents of the United States with respect to medication safety and the information that is provided by the FDA for the consumer and medication professional populations. It is important to provide as much information as possible regarding medication safety in order to prevent further complications and to be effective in addressing the risks associated with some medical products. The Institute for Safe Medication Practices is responsible for reporting much of the information that is provided by the FDA in order to enable consumers to be protected as best as possible from medication and product-related risks that may impact their health (2015). The data that is generated by the FDA, therefore, is analyzed and reported upon so that patients are able to receive the best possible and most updated information regarding medication safety practices in the United States (Institute for Safe Medication Practices, 2015).

Reporting adverse events requires a high level understanding of the different risks associated with medication administration and medical products in order to prevent future events of this nature (Marks, 2009). Under these conditions, it is important to identify the resources that are available to support consumers and to recognize the impact of accurate and timely safety information in protecting patients from unnecessary risk or harm (Marks, 2009). This practice will demonstrate the value of full disclosure and communication regarding adverse event reporting and medication safety risks in order to prevent further complications for other patients (Marks, 2009). These factors play a critical role in the development of new ideas and approaches to support patients and in developing new ideas to ensure that patient care outcomes are achieved at the desired level (Marks, 2009). Through a network of reporting opportunities, it is possible for patients to receive updated and accurate information regarding the risks associated with medication safety and product development so that patients and medical professionals are able to make wise decisions regarding the types of treatments that are available and that will support effective patient care outcomes throughout all age and population groups who are impacted (Marks, 2009).

Conclusion

The role of the Food and Drug Administration in adverse event reporting and medical safety is of critical importance in order to ensure that patients receive the best possible opportunities to achieve the safest possible circumstances. This is an important reminder of the FDA’s role in shaping the direction of medical product development and safety throughout the United States. In addition, it reflects the importance of understanding the needs of its population and in supporting a safe and effective environment in which to achieve greater quality of life. In spite of the advantages of the current system, it nonetheless could be improved with a number of tools and resources that involved enhanced communication for consumers so that they are able to better understand the risks of medication and other products that impact patient care. In addition, FDA-based resources must be easy to understand and reflect the critical priorities of the organization and its responsibility in protecting consumers throughout the United States.

References

Food and Drug Administration (2015). FDA Adverse Event Reporting System (FAERS). Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/Food and Drug Administration (2015). MedWatch. Retrieved from http://www.fda.gov/Safety/MedWatch/default.htm

Institute for Safe Medication Practices (2015). A critique of a key drug safety reporting system. Retrieved from http://www.ismp.org/quarterwatch/

Marks, N.S. (2009). MedWatch: safety information and adverse event reporting. Retrieved from http://www.medscape.org/viewarticle/588757