Serious Side Effects From Low Dose Aspirin

By Kim Smiley

A recent study determined that the risks associated with regular use of low dose aspirin may outweigh the benefits for many patients. The researchers determined that regular aspirin users were 10 percent less likely to have a heart event and 20 percent less likely to have a nonfatal heart attack.  These statistics sound good except that regular aspirin users are also around 30 percent more likely to have serious gastrointestinal (GI) bleeding.  The overall risk of death was the same for both patients who regularly used aspirin and those who did not.

This study looked at nine randomized studies of aspirin use and included more than 100,000 patients.  The study only included patients who had not had a heart attack or stroke and involved giving participants either an aspirin or a placebo to see the benefits of regular doses of aspirin.

These findings have the potential to affect many people since nearly a third of middle-age Americans take a low dose aspirin regularly.  Benefits from aspirin seem to outweigh the risks for people who have a history of heart attacks, but this study calls into question the benefits for patients who are hoping to prevent their first heart attack or stroke.

This issue can be analyzed by building a Cause Map, an intuitive, visual form of root cause analysis.  In this example, the safety goal is the main goal that would be considered because of the higher risk of GI bleeding.  The higher risk of bleeding is caused by the fact that patients are taking aspirin regularly and that GI bleeding is a known side effect of aspirin.  People take aspirin because it has been shown to reduce the likelihood of blood clots.  Reducing blood clots will in turn reduce the risk of heart attacks and stroke since blood clots have the potential to block flow to the brain or heart.

The conclusion that the study draws is that there is no one size fits all solution to the question of whether patients should regularly take low dose aspirin.  The risks and potential benefits need to be determined on a case by case basis by the patient’s physician.  For an individual with a strong family history of heart disease, the benefits may very well outweigh the risk of GI bleeding, but for others the use of aspirin may not be worth the risk.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Study Finds Only 1 in 7 medical errors reported

By ThinkReliability Staff

A study by the Office of the Inspector General (OIG) of the Department of Health and Human Services found that hospital employees are only reporting fourteen percent of all medical errors.  Additionally, the study determined that processes are rarely changed to help prevent similar errors in the future.

The study was conducted by reviewing the medical records of Medicare patients. As a condition of participating in the Medicare program, hospitals are required by federal regulations to track medical errors that harm patients and to implement solutions to protect patients from similar mistakes in the future.  All hospitals involved in the study had a method to collect information on medical errors, but all adverse events were not being efficiently captured by the systems in place.

The study found that out of 293 cases reviewed, only 40 were reported, 28 led to investigations and only five resulted in changes in the hospital’s processes.  Additionally, the inspector general estimated that more than 130,000 Medicare beneficiaries experience at least one adverse event in a hospital in one month so there is a plenty of room for improvement in patient care.

The study found a number of reasons that adverse events and medical errors were not being reported.  Confusion over requirements was one cause of the under reporting because hospital employees did not always recognize that a particular event harmed a patient and was required to be reported.  Also, there were cases where employees assumed someone else would report the incident or they considered the incident to be so common that it didn’t need to be reported.  There was also a tendency to not report things that were considered to be isolated events that were unlikely to recur.

To help combat these causes, the OIG report recommends the development of a standard list of medical errors that should be tracked and reported.  The OIG also recommends that guidance be developed and provided for the accreditors of hospitals since they do not typically investigate adverse event collection methods.  Additionally, some consumer groups are pushing for public reporting of medical errors to help pressure hospitals to improve their policies and practices.

Click on “Download PDF” above to view a high level Cause Map of this event which is an intuitive, visual root cause analysis of this issue.

Concerns over Faulty Implants

By Kim Smiley

Thousands of women received faulty breast implants between 2001 and 2010.  These implants contain substandard silicone, not approved for medical use, and are also rupturing at a usually high rate.  It isn’t clear at this time what the long term health risks associated with these implants might be.  The faulty implants were manufactured in France, but eighty percent were exported so the wide spread nature of the problem also complicates the implementation of any possible solutions. (These implants were not sold in the US.)

This issue can be investigated by building a Cause Map, an intuitive, visual root cause analysis.  A Cause Map is built by asking “why” questions to determine what causes contributed to an issue.  In this example, women are facing health risks because they received faulty breast implants.  The implants are considered faulty because they are filled with substandard, non-medical grade silicone and they are rupturing at twice the industrial average.

The implants were filled with industrial grade silicone, instead of medical grade, because industrial grade silicon is far less expensive and the company was trying to cut costs.  Hundreds of thousands of these implants were manufactured before any quality issues were raised so inadequate oversight should also be considered as a potential cause.  It isn’t clear why the implants are rupturing at an unusually high rate at this time, but that information can be added to the Cause Map once it is available.

The long term health consequences of this issue also aren’t clear yet.  The substandard silicone used may have impurities in it that could pose a health risk in addition to any health effects that result from the ruptured implants in general.  There are concerns that the implants are increasing the risk of breast cancer, but there isn’t any hard evidence that this is the case at this point.  All the countries involved are struggling to weigh the known risks of removing the implants with the unknown risks of leaving them in place.  There is also the question of costs and who will pay for removal or replacement of the faulty implants. Ongoing monitoring for signs of leakage and ruptures are recommended for any woman who chooses to keep the implants.

Drug Used to Treat Diabetes May Increase Risk of Heart Disease

By ThinkReliability Staff

Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did not have success with front line treatments in 1999, studies have shown that this drug (included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart disease in users.  This is of particular concern because most Type 2 diabetics die from heart disease.  It is estimated that 60,000 to 200,000 people have suffered from heart disease due to these drugs.

A black box warning was placed on these drugs, but not until November 2007.  The European Medicines Agency recommended that the drug be suspended from European markets in 2010, and the drug was withdrawn from New Zealand markets in 2011.  What took so long?

We can attempt to add some clarity to this issue by viewing it in a Cause Map, or visual root cause analysis.  To begin this analysis, we look at the impact to the goals from the point of view of the manufacturer.  The patient safety goal is impacted because of the increased occurrence of stroke, heart attack, and death. The compliance goal is  impacted because – according the Senate Finance Committee – trial results that would have indicated the increased risk for cardiovascular disease were not publicly released in a timely manner.  Reduced sales as a result of the risk are estimated to be more than $2 billion (an impact to the organizational goal) and lawsuits (an impact to the patient services goal) are projected to cost more than $1 billion.

Although the actual mechanism that is causing the increased risk of cardiovascular disease is unknown, the cause of the increased occurrence of heart attack, stroke and death is due to use of the drug rosiglitazone.  Although rosiglitazone has been found to be an effective second-line treatment for Type 2 diabetes, it is unlikely that doctors would have prescribed it as readily had they known about the increased risk of heart disease.  Instead, they were likely swayed by a multi-million dollar advertising campaign, while test results that showed increased cardiovascular risk were allegedly covered up.

Unfortunately, it’s not the first (or last) time this has happened.  In early 2012, the British Medical Journal raised concern about research misconduct – including cases where poor results from clinical trials are not released to the public.  In the US, it was found that less than half of studies – including those funded by the government – are publicly released in a timely manner.  Although there are regulations that require publication of studies, they aren’t always (or even usually) followed.  Some consideration of what can be done to ensure that these regulations are effective is ongoing.

Meanwhile, rosiglitazone has been removed from Europe and New Zealand markets.  In the US, new regulations went into effect making the drug extremely difficult to come by.  A different drug – Actos – is said to have similar effects on controlling blood sugar without the increased cardiovascular risk.  However, patients should consult with their doctors.

To view the Outline, Cause Map, Solutions and Timeline, please click “Download PDF” above.  Or click here to read more.