Mod 3 Discussion Peer Responses

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Health Medical

Maricopa Community Colleges - Rio Salado Community College


Please respond to all of the 3 peers discussions post. These need to be in APA format with references and be at least 400 words in length

Original Question 

Discuss the probable use of MedWatch by health care providers, and the likelihood that providers and the general public will use the system. What do you think are the barriers to its use? What are the risks that adverse effects will be missed? Try it out yourselves and comment on your experience with it. What worked and didn't work? 


MedWatch is the Food and Drug Administration's "Safety Information and Adverse Event Reporting Program." It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this voluntary reporting system allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals. MedWatch also distributes information on medical recalls and other clinical safety communications via its platforms (Kessler, 1993). Reporting can be conducted online, by phone, or by submitting the MedWatch 3500 form by mail or fax. In 2013, MedWatch introduced Form 3500B, which is designed to facilitate reporting by healthcare consumers. The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts, or order product recalls, withdrawals or labeling changes to protect the public health. Important safety information is disseminated to the medical community and the general public via the MedWatch website. and the MedWatch E-list.

According to former FDA commissioner David Kessler, who implemented the system, "MedWatch is about preventing illness and death (Worthington, 2002). Along with other healthcare professional associations, the American Nurses Association is a "MedWatch Partner." The partner organizations had considerable input into program development and are committed to encouraging their members to file reports. According to the FDA, nurses have emerged as very active reporters of the MedWatch system, submitting about 25% of the 5,000 voluntary reports received by the FDA each year (Worthington, 2002). In addition to these voluntary reports, mandatory reporting of serious device-related events to the FDA or the manufacturer is required of hospitals, outpatient treatment, diagnostic and surgical centers, and long-term care facilities. These healthcare facilities should have a transparent reporting system in place, and health care workers should be educated on the process. The Joint Commission on Accreditation of Healthcare Organizations reviews compliance with mandatory reporting during its site visits (Worthington, 2002).

It was early reporting to the FDA by nurses and other healthcare workers that led to the identification of latex products as the cause of anaphylaxis among patients receiving barium enemas via latex-containing catheters. Nurses also submitted reports of adverse worker reactions to latex gloves, prompting the FDA to require more stringent labeling of gloves and promoting extensive research into the problem. Other ways that MedWatch data are used to promote safety include: product recalls and withdrawals, publication of FDA public health advisories and safety alerts, and box warnings and labeling changes placed on product packaging (Worthington, 2002).

Any patient who undergoes treatment may experience a negative outcome as a result of that treatment. Adverse events that occur with medical treatment can include medication side effects, injury, psychological harm or trauma, or death. Adverse events can be either preventable or unpreventable and are often associated with medication errors (Gambhir et al., 2020). Adverse events can occur with any provision of care or treatment and have a wide range of severity. There are many methodologies in which an adverse event can occur. The adverse event may be a result of treatment such as surgery or medication. In these instances, the cause may be due to human error or a substance within a medication. Other causes, such as equipment or device failure, can contribute to the occurrence of an adverse event. An adverse event may occur unintended or as a side effect during treatment. However, the treatment's benefit may often be greater than the temporary harm. Many medications can cause an adverse event, and patients are often on multiple medications. In the United States, over 250,000 patients who receive medical care each year will experience an adverse event (Anderson & Abrahamson 2017). Even worse, over 100,000 patients will die from the care that they received (Stewart et al., 2016). Many vulnerable patients are more at risk for adverse events. Globally, it is estimated that approximately ten percent of patients have been affected by at least one adverse event (Schwendimann et al., 2018). Countries with less income report higher rates of adverse events.[16] Age disparities exist in the occurrence of adverse events, with children and elderly patients affected at higher rates. Racial disparities occur in the populations of patients affected by adverse events, with black patients being affected at significantly higher rates. Socioeconomic factors such as lack of education have been associated with a higher burden of many chronic diseases (Dalstra et al., 2005)

It is essential for all AE to be reported as soon as possible. Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public.

Actions may include an update to the label, a batch withdrawal, or even a drug withdrawal. I have never used the MedWatch system before, but now I tested it and found it user-friendly. I saw that there could be reported not only AEs but PQCs as well. Everyone can use MEDWatch since reports can be submitted online, via phone, or by fax. However, I believe elderly patients prefer to report it through their HCP or telephone and won't use the electronic version of the system. Since multiple options are available, I do not see that as a barrier.

My current job is related to patients' safety. Our sponsor uses a Salesforce-based system where medical information specialist reports all Adverse Events on behalf of patients or HCPs. All these reports are auto-uploaded to the Argus database, where several workloads process each case, and finally, they are transmitted to the regulatory authorities. We receive such information from a similar to MedWatch channels: live chats&calls, emails, and callbacks after receiving a request via email through a web form or when the requester leaves us a VM.


Anderson, J. G., & Abrahamson, K. (2017). Your Health Care May Kill You: Medical Errors. Studies in health technology and informatics, 234, 13–17.

Dalstra, J., Kunst, A., Borrell, C., Breeze, E., Cambois, E., Costa, G., Geurts, J., Lahelma, E., Van Oyen, H., Rasmussen, N., Regidor, E., Spadea, T., & Mackenbach, J. (2005). Socioeconomic differences in the prevalence of common chronic diseases: an overview of eight European countries. International Journal of Epidemiology, 34(2), 316–326.

Gambhir, R., Kuriakose, R., Aggarwal, A., Sohi, R., Goel, R., & Rashmi, N. (2020). Patient safety in primary and outpatient health care. Journal of Family Medicine and Primary Care, 9(1), 7.

Kessler, D. A. (1993). Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA: The Journal of the American Medical Association, 269(21), 2765–2768.

Schwendimann, R., Blatter, C., Dhaini, S., Simon, M., & Ausserhofer, D. (2018). The occurrence, types, consequences and preventability of in-hospital adverse events – a scoping review. BMC Health Services Research, 18(1).

Stewart, K., Choudry, M. I., & Buckingham, R. (2016). Learning from hospital mortality. Clinical Medicine, 16(6), 530–534.

Worthington, K. A. (2002). MedWatch. AJN, American Journal of Nursing, 102(11), 112.


In 1993, "many health professionals did not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacture" the reason being was because, it was viewed that, "reports from health professionals of adverse events or product quality problems are essential to ensure the safety of drugs, biologicals, medical devices, and other products regulated by the FDA once they are introduced into the US market" "MEDWatch: The FDA Medical Products Reporting Program- this new system encourages health care professionals to regard reporting as a fundamental professional and public health responsibility. It was developed with the enthusiastic support of the medical community, and its success will depend on close cooperation among the FDA, the medical community, and industry to identify and report adverse events and problems with medications and devices" (medwatch, 1993). To report such events, "under the MEDWatch program, the separate forms previously used to report adverse drug reactions, drug quality product problems, device quality product problems, and adverse reactions to medical devices have been consolidated into a single, one-page reporting form for health professionals. This form can also be used to report problems with other FDA-regulated products, such as dietary supplements, cosmetics, medical foods, and infant formulas" (medwatch, 1993). In a separate article, Dr. Kessler shared his views on this new approach and stated, "If there is one message I need to convey to you today, it is how critically important it is for health professionals to report any serious adverse events to the FDA. This is not just another FDA initiative. It's about someone in your family or mine. If you are a physician, pharmacist, nurse, or dentist, it's about your patient. It's about the person whose illness, suffering, and even death can be prevented because someone took the time to report a serious adverse event. and it's about the person whose illness, suffering and death was not prevented because someone failed to report a serious adverse event" (Couig et al., 1993). 

After reading these two articles, it is clear that there were speculations and concerns in using this form. Although they were both written in 1993, I believe that barriers that could have arisen were the misunderstanding of how to correctly fill out the form or lack of willingness to do so. This program was intended to bring light to such adverse events and the risks of missing such adverse events goes back to not filling out paperwork correctly or even at all. I am unsure if there is a newer version or program that is less of a "hassle" for some but, in my opinion, when you take on a responsibility relating to clinical research, there is this duty of reporting and documenting all observations. Yes, this may be an extra step but, as Dr. Kessler shared, I believe we can all resonate and agree that by reporting such events, it can help you or me or a family member in the present or future. 


Couig, M. P., & Merkatz, R. B. (1993). From FDA Nurses: MedWatch: The new medical products reporting program. The American Journal of Nursing, 93(8), 65-68.

MEDWatch, I. (1993). Introducing MEDWatch. JAMA, 269(21).


FDA has launched a program called MedWatch, which makes it easier for doctors and patients to report adverse events related to drugs. Before I enrolled in this course, I had no idea about this program. As a consumer, I have multiple medications that I take to manage my health. It is unclear how patients are supposed to be informed that they have the right to report adverse effects related to their medication to the FDA if they have not been informed about the program.

I assume that most people are not aware of the MedWatch system's existence or purpose. Also, most of them are not aware of the importance of reporting adverse events. According to 21CFR 201.57, the labels should inform patients that they have the right to notify the FDA if they suspect that their medication has an effect (FDA, 2006). Initially, I thought that the underreporting of drug-related adverse events was because people were not aware of how to report them. This is not the case. The lack of knowledge about how to do so is not the reason for the underreporting.

The failure to report adverse events could prevent the labels of products from listing all the information about the side effects of medication. This is because the law requires manufacturers to provide the necessary information to consumers. Being able to report adverse events is very important to improve the quality of medication. It can also help prevent the spread of disease. This is because the information collected from the past can be used to monitor the potential emergence of a new disease. Being able to report adverse events can also be a cost-effective way to implement a preventive plan. It can also help keep track of the quality of the medicine.

The lack of access to the complaints system can prevent the timely reporting of adverse effects, which can threaten the safety of patients. It can also delay the effects of the drug on the person. This is because the skilled and experienced health professionals handling these issues might not be able to resolve them. The establishment of a data transmission system and a conducive environment would help the public and health professionals raise their concerns about the safety of drugs.

When it comes to reporting drug-related adverse effects, the presence of reactive substances in the body is one of the most crucial factors that health professionals and the public should consider. For instance, a person who took aliskiran for high blood pressure may have experienced respiratory symptoms after just a couple of days. According to Kumar, data collected through the drug program's public dashboard can help improve the agency's decision-making process.


Abelson, M. B., & Lafond, A. (2011, January). Making the Most Of FDA's Medwatch. Review of Ophthalmology. Retrieved October 31, 2022, from

FDA. (n.d.). World of drug safety module. to an external site.

Berniker, J. S. (2001). Spontaneous reporting systems: Achieving less spontaneity and more reporting. Why medwatch is problematic.

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Response to Martin

Informative post. Indeed, MedWatch can be described as the FDA's "Safety Information
and Adverse Event Reporting Program." Thank you for pointing out that MedWatch is used as a
platform to report a sentinel or an adverse event. I agree with you that through the voluntary
system, information can be shared with the general public or the medical community. MedWatch
indeed includes publicly available and accessible online analysis tools and databases for
professionals. The MedWatch platform also plays another crucial role in distributing information
on medical recalls and other clinical safety communications through its platforms. It is
interesting to know that reporting can be done by phone or online. There is also the option of
submitting the MedWatch 3500 form by fax or mail. Good job explaining what Form 3500B is
and when it was introduced by MedWatch. I concur with you that the MedWat...

Excellent! Definitely coming back for more study materials.


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