Blog 6- FDA & Questions are the Answers

FDA to Post Quarterly Report of Potential Safety Issues

We have all used medications at one time or another, in hopes of getting better. Most of us don’t think we could have adverse effects from our medications that could potentially harm our well-being. Yes, all medications have known side effects, but some drugs can be life altering.

Patients depend on the people at the U.S. Food and Drug Administration (FDA) to monitor the effectiveness of medications, and to investigate them if they have the potential to harm them. Recently, on September 5, 2008, the FDA posted their first quarterly report listing medications that are being evaluated for potential safety issues. The drugs listed in this report have been identified based on a review of reports in FDA’s Adverse Event Reporting System (AERS).

The FDA is required to issue these reports based on the provisions of the FDA Amendments Act that was signed into law on September 27, 2007. This law requires them to inform the public each quarter of new safety information or potential signals of serious risk.

One might think that if a drug appears on this list that is poses a risk, but it is on the list because FDA has identified a potential safety issue that they are investigating. The list of drugs is generated by the FDA’s AERS, which is a database of millions of adverse events submitted by drug manufacturers, health care professionals & patients. In the previous sentence, you might have notice “millions of adverse events”. Frankly, I think that is unacceptable-- especially with the technology of automated dispensing systems and MARs.

With all of the drugs on the market today, you would think that there would be more than 20 medications on the list. The FDA will continue to post these reports online every three months. In healthcare today, it is comforting to know that the FDA and federal government are taking the safety of medications more seriously. As a future HIM professional, I feel it is not only my responsibility to improve patient safety, but also those responsible for the medications prescribed in our country.

A few of the drugs on the list that were surprising were Nitroglycerin, Insulin U-500, and Heparin. For these medications, the potential adverse events were caused by dosing or labeling errors. If you are interested in seeing the other medications listed, please visit

http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm.

http://www.psqh.com/enews/0908b.html

Questions Are the Answers: Reducing Medical Mistakes

The quality tool I selected this week discussed the importance of managing your own healthcare. We should be very familiar with this concept since our profession advocates the use of PRHs. The title of this tool really caught my attention because no question is stupid question. Some patients might feel intimidated by their physicians. This could be caused from a lack of knowledge, or as Tammi mentioned Tuesday, due to their low literacy rate. Despite these concerns of patients, they should ask questions because the answers they get could help them make better decisions, receive a higher level of care, reduce medical mistakes, and feel better about their health care. The tool provided a list of 10 questions to ask your physician. The two questions most people don’t ask that they should are:

How many times have you done this?

Which hospital is best for my needs?

I think that we should all be more open with our healthcare providers, and take charge of our lives.

http://www.ahrq.gov/questionsaretheanswer/level3col_1.asp?nav=3colNav01&content=01_0_reduce

Classmate Pick of the Week- Tammi

This week I read Tammi’s blog concerning the legibility of medical information in patient’s charts. I agree with Tammi 100% on this issue. Today, physicians are always in a hurry to get and get out. They are so concerned with making more money that they often deprive their patient’s of needed time to discuss their medical conditions. In addition, they tend to write notes in the chart that are illegible. To them this might not seem like an issue, but we all know too well that it is. Illegibility could have a spiral effect in a patient’s care. What if the patient came to the ER with chest pain, but the nurse couldn’t make out the physicians notes and the patient died. I don’t know about you, but I wouldn’t want that hanging over me for the rest of my life.