The World of Diabetes Unreported Adverse Events

These types of articles scare the dickens out of me. Yes, there are a lot of unreported adverse events that happen with diabetes medications. Not only this, but many in the medical profession do this intentionally because there are no clear rules or even guidelines for reporting adverse events. Plus there are no penalties for misreporting or not reporting.

This prevents an accurate accounting of what many of our diabetes medications are doing to patients and especially which ones cause a disproportionate number of deaths. There are also under reported cases of hospitalization caused by diabetes medications. I thought this statement was especially appropriate, “Diabetes drugs have been linked to thousands of deaths and hospitalizations over the last decade, a MedPage Today/Milwaukee Journal Sentinel investigation found -- but there is little ability to measure the true risk of the drugs.:

Not all of this can be blamed on the Food and Drug Administration (FDA), but this statement is still true, “Theres gotta be something better than approving drugs based on a lab test and then losing track of them.” This is only part of the reason we can honestly say that we have a broken medical system. Each year the FDA approves new drugs, but only provides a partial listing of potentially dangerous side effects. Diabetes drugs seem to bear the brunt of this because the endpoints, such as reducing heart attacks, strokes, blindness, or amputations are not tested before the release.

The following is important enough to quote.

“A MedPage Today/Milwaukee Journal Sentinel analysis of the case reports from 2004 through March 2014 found about 3,300 deaths and 20,000 hospitalizations in which diabetes drugs were considered the primary suspect.

The three drugs with the most reported problems were:

• Sitagliptin (Januvia), a once-daily pill that helps boost insulin production in the pancreas and lower the amount of sugar made in the liver, approved in 2006: 964 deaths and 4,425 hospitalizations.
• Exenatide (Byetta), an injectable that enhances the body's ability to release insulin, approved in 2005: 880 deaths and 7,115 hospitalizations.
• Liraglutide (Victoza), another injectable product, approved in 2010: 319 deaths and 2,827 hospitalizations.

The three drugs made up less than 7% of the 180 million diabetes prescriptions dispensed in 2013, according to data supplied by IMS Health, a drug market research firm. But they accounted for more than half of deaths and reported hospitalizations last year.

The FDA has called the database a "critical element" in ensuring the safety of drugs once they are on the market, but experts say the system misses the vast majority of cases.

That is due in large part to the system being voluntary for healthcare professionals. That means professionals fill out lengthy case reports without incentive or reimbursement -- or even any guarantee they will trigger an FDA response.” Unquote

I think that this is a topic that needs exposure and I would urge everyone to read the full article.

Most Adverse Events in Hospitals Go Unreported

I am not sure how to react to this report. Yes, I believe the study and I am surprised it is not more of a horror story. Having experienced a few incidents first hand which I doubt were reported, anything is possible. Some hospitals are indeed better than others are, but I believe this comes from the top down. If the head of the hospital is conscientious and concerned, generally he will employ physicians and nursing staff that are concerned. Anyone can hire a bad apple, but it is the hospital administrator that sets the tone. In some cases, it is the hospital board of directors that establishes the standards.

The study reports that about 86 percent of patient mishaps in hospitals go unreported and are not entered into any incident database. Whether better reporting will improve the quality of care or patient safety remains to be seen. A big surprise in a way is that 62 percent of adverse and “temporary harm” events that were not reported were believed not reportable by hospital staff.

The Office of Inspector General (OIG) in the US Department of Health and Human Services (HHS) recommends that the Centers for Medicare and Medicaid Services (CMS) collaborate with the federal Agency for Healthcare Research and Quality and develop a master list of potentially reportable events. Then hospitals and other healthcare providers could use this list to eliminate any confusion. Presently, the three organizations that accredit hospitals - the Joint Commission, the American Osteopathic Association, and Det Norske Veritas Healthcare — do not have standardized lists of reportable patient incidents.

I seriously wonder if there will be any changes made, as you have to think that hospitals will continue on the present path. If nothing more than to minimize lawsuits, they will resist reporting adverse events. With hospitals now employing many doctors, they will continue to be profit motivated to a fault and to avoid legal problems. Nurses will continue to be dismissed when they do their job and counsel patients to the detriment of potential profits.

You may read the study here and the situation about the nurse here.