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From Wikipedia, the free encyclopedia

MedWatch logo

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 system of voluntary reporting 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.

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  • MedWatch Safety Information Resources for Busy Physicians
  • MedWatch for Nurses: Clinically Important Reporting and Safety Resources for Practice

Transcription

"As the medical Director of Patient Safety here, I want to know about medication alerts, safety concerns, as early as anybody else in the hospital." "Health professionals are really swamped with information that's coming in different ways. They need to have the best information at the right time to manage their patients." As physicians, you are bombarded with information. Knowing your time is valuable and limited, the FDA provides MedWatch Safety Alerts. These free alerts cover drugs, medical devices, biologics and dietary supplements and will provide you with new safety information on these products. The alerts will be sent right to your smart phone or computer via text message, email or RSS feed. The choice is yours to receive the alert where and when it is best for your practice style. "These are actionable drug, medical device and other human medical product safety information delivered to you at the point of care from the FDA so you know that they are accurate, non-biased and science-based using the best available evidence" These alerts include time sensitive information on: Important labeling changes such as boxed warnings and contraindications like a new drug/drug interaction; Class One recalls of drugs and devices; "Dear Healthcare Professional" letters from manufacturers about important safety changes; And early communications about FDA reviews of safety signals received during post-market surveillance for drugs and devices; "Whether you practice in a hospital, private office or clinic, extended care facility, or any other medical setting, our FDA MedWatch safety alerts allow you to stay current with the new information available on drugs, biologics or medical devices that you use during your busy practice day." Having the most current safety information at the point of care allows you to better educate and inform patients as you jointly decide on the medical treatment or diagnostic test that's best for the individual patient. "The thing I liked about it too is that a patient then sees you checking their information and insuring them that the information that you're delivering to them is accurate and as much up to date as possible." The MedWatch safety alerts can be sent right to your smart phone. They can also be incorporated into a hospital's or medical association's web site, whether it's the public Internet or a hospital's intranet site that serves as a practice or reference resource for the busy doctor. "I utilize the Med Watch system in two different ways. One is I've signed up for the email alerts that are provided by the FDA. And then I also get that information via my hand held" "I would like to have as much clinical information available to me on a handheld as possible." "We are changing the way we disseminate information. And I think that health care professionals and the public has seen a much greater flow of information directly from the FDA in the last few years." The MedWatch Safety Alerts play a big part in increasing patient safety and can link you directly to more detailed information on the FDA MedWatch website, your gateway to safety information on all human medical products used by busy doctors. For example, a visit to the MedWatch website allows busy doctors to quickly learn about drug labeling changes, including new boxed warnings, contraindications, and precautions that can inform your prescribing decisions and minimize risk of harm. This information is provided in a quick view table format that is "clickable" to take the user directly to a detailed view of the information and to the current label. The speed of medical practice these days is fast-paced and busier than ever. The FDA recognizes that you want to find new drug and device safety information rapidly, to take advantage of the FDA's Safety Information Resources. We now provide many options, so you may tailor the type of alert or information to help you avoid information overload and better serve your patients. It is very easy to sign up for our FDA MedWatch safety alerts and I know that you will find that receiving this timely and actionable safety information from the FDA will be an enormous return on a small time investment. For more information on MedWatch, go to fda.gov/medwatch.

History

MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports.[1]

Operations

Voluntary reporting by healthcare professionals, consumers, and patients is conducted on a single, one-page reporting form (Form FDA 3500[2]). Reporting can be conducted online,[3] 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.[4] 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 web site.[5] and the MedWatch E-list.[6]

Raw data from the MedWatch system, together with adverse drug reaction reports from manufacturers as required by regulation, are part of a public database.[7] Online tools (such as those from eHealthMe) that analyze the database are available for both health care consumers and professionals.[8][9][10][11] The database was used by journalists to investigate FDA's drug approval practice.[12][13]

References

  1. ^ McKee, Jennie. "Using the FDA's MedWatch program". American Academy of Orthopaedic Surgeons. Archived from the original on January 16, 2014. Retrieved January 15, 2014.
  2. ^ "Archived copy" (PDF). Food and Drug Administration. Archived from the original (PDF) on 2013-02-22. Retrieved 2019-12-16.{{cite web}}: CS1 maint: archived copy as title (link)
  3. ^ "MedWatch Voluntary Reporting Form". www.accessdata.fda.gov.
  4. ^ "FDA's MedWatch program turns 20: What's new?". American Pharmacists Association. October 1, 2013. Archived from the original on January 16, 2014. Retrieved January 15, 2014.
  5. ^ "MedWatch Home Page". Food and Drug Administration.
  6. ^ "MedWatch - Join the MedWatch E-list". Food and Drug Administration.
  7. ^ "Adverse Event Reporting System (AERS) Database". Food and Drug Administration.
  8. ^ "eHealthMe - Personalized drug monitoring". www.ehealthme.com.
  9. ^ "FDAble: Search FDA MedWatch FAERS / AERS Database". www.fdable.com.
  10. ^ "OpenVigil". SourceForge.
  11. ^ "OpenVigil free scientific AERS analysis tool (online search engine hosted at Kiel university)".
  12. ^ "CBS News - Dangerous Drugs". Archived from the original on 2008-11-01. Retrieved 2008-07-04.
  13. ^ "Resource Center || Dangerous Drugs". Archived from the original on 2008-11-01. Retrieved 2008-07-04.

External links

This page was last edited on 16 March 2023, at 08:03
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