Tag Archives: side effects

Programming Errors Can Impact Patient Safety

By ThinkReliability Staff

Clinical decision support systems (CDSS) aim to improve health care quality, safety and effectiveness by providing alerts to providers based on criteria (such as identifying drug interactions). However, a malfunctioning CDSS can actually reduce patient safety when physicians rely on these alerts.

According to “Analysis of clinical decision support system malfunctions: a case series and survey” by Adam Wright, et al, published March 28, 2016, “CDSS malfunctions are widespread and often persist for long periods. The failure of alerts to fire is particularly difficult to detect. A range of causes, including changes in codes and fields, software upgrades, inadvertent disabling or editing of rules, and malfunctions of external systems commonly contribute to CDSS malfunctions, and current approaches for preventing and detecting such malfunctions are inadequate.”

A survey that was part of the analysis found that 93% of Chief Medical Information Officers who responded had experienced at least one CDSS malfunction and two-thirds experienced at least an annual CDSS malfunction. Four such malfunctions were found within the CDSS system at Brigham and Women’s Hospital and were presented as case studies. We will examine one of these case studies within a Cause Map, or visual form of root cause analysis.

The first step in any root cause analysis method is to identify the problem. The CDSS malfunction in this case study involved a stopped alert for annual thyroid testing in patients prescribed amiodarone. When the issue was noticed and resolved in February 2013, it was determined that the alert had been stopped since November 2009, when the internal code for the drug amiodarone was changed.

An important step in describing the problem is to determine the organizational goals that were impacted. In this case, patient safety is impacted because of the potential for untreated thyroid issues and patient services are impacted because of the potential of missed testing.

The second step is to perform the analysis by developing the cause-and-effect relationships that led to the impacted goals. In this case, patient safety is impacted because of the potential for untreated thyroid issues. Patients may have untreated thyroid issues if they are taking amiodarone to treat arrhythmia. Amiodarone has a known side effect of thyroid issues. If staff is unaware of a patient’s thyroid issues, that patient won’t be treated. Staff would be unaware of thyroid issues in a patient if testing is not performed.

The goal of clinical decision support systems is to identify interventions based on patient needs – in this case, the hospital created an alert to suggest thyroid testing for patients who had been amiodarone and had not had a thyroid test in at least a year. Based on typical alert values from the years prior to 2009, the analysis determined that more than 9,000 alerts suggesting thyroid testing were missed.

Thyroid tests were missed because the CDSS did not identify the need for thyroid testing, and because physicians may rely on the CDSS to recommend a test like this one. The alert was originally set up to identify patients taking amiodarone (then code 40) with a start date at least 365 days ago, and no thyroid test values from within the last 365 days. In November 2009, the internal code for amiodarone changed to 7099, but the logic for the alert was not changed. (The reason for the code change is unclear.) As patient records were updated with the new code for amiodarone, the alert failed to identify them for thyroid testing.

The issue was identified during a demonstration of this particular feature of the CDSS and fixed the next day. While the details aren’t known, this issue identifies an ineffective change management program. When changes are made within systems, change management processes are necessary to ensure there are no unintended consequences. While updating the amiodarone code in the alert logic fixed this particular problem, a robust change management program is necessary to ensure that there are no other unintended consequences that could affect patient safety.

To view a visual root cause analysis of this example, please click on “Download PDF” above.

New Studies Shed Light on Statin Side Effect Concerns

By Kim Smiley

Usage surveys have found that the majority of people prescribed statins in the United States discontinue using them within a year. The number one reason stated by patients for stopping statin use is concern with side effects.

This issue can be analyzed by building a Cause Map, a visual method for performing a root cause analysis.  The first step in the Cause Mapping process is to define the problem by filling an Outline with the basic background information (who, what, when, where, etc.).  Additionally, the Outline is used to capture how the problem impacts the goals so that the magnitude of the problem is well understood.   Once the Outline is complete, the analysis is done by building a Cause Map by asking “why” questions to find the causes that contribute to an issue.

For this example, the fact that patients aren’t taking prescribed statins is an impact to the patient goal.  This occurs because patients were prescribed statins and they are not using them.  Looking at each cause individually, let’s first ask why patients were prescribed statins.  A physician wrote a prescription for statins because the patient was considered at risk for heart disease and statins can reduce the risk of heart disease.  Statins have been shown to reduce cholesterol levels in the blood and high cholesterol can lead to blocked arties that can contribute to heart disease.  Cholesterol is reduced because statins inhibit an enzyme in the liver that controls cholesterol production in the body and the majority of cholesterol is produced by the liver.

So the question that still needs to be answered is why aren’t patients taking their statins if they can reduce their risk of heart disease?  The most significant reason that patients are discontinuing statin use is because they are concerned about side effects and the concerns haven’t been adequately addressed. Patients are concerned about side effects because they believe they have experienced side effects or they are generally worried about potential side effects.

Like most other medications, statins can have serious side effects, such as liver injury, cognitive impairment and potential for muscle damage (especially when combined with certain other medications.  According to the U.S. Food and Drug Administration, the value of statins in preventing heart disease has clearly been established and the benefits outweigh the risks, but one of the reasons that patients are concerned about side effects is that there are very outspoken critics of statins that do not agree with this assessment.  For the purpose of this example, we will assume that the FDA is correct that patients would benefit from taking statins if they are prescribed and that it is in fact a problem if patients discontinue using stating when their physicians have recommended them.

The final step in the Cause Mapping process is to come up with solutions that can be implemented to help reduce the risk of a problem occurring in the future. So how can the risk that patients will discontinue statins be reduced?  One possible solution would be to give patients reliable information that shows that statins are relatively safe and are effective at reducing the risk heart disease.  If patients believe that the benefits of statins outweigh the risks, they will be significantly more likely to take them.  More information is becoming available as researchers continue to study the benefits of statins and the frequency and severity of side effects.  For example, a recent study that used 83,000 patients and randomized statin therapy and a placebo found that “only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo”.  With more data about the effectiveness of statins and the accurate information the risks associated with them patients can make decisions based on real data and better determine if they should keep taking the statins.

To view the Outline and Cause Map, please click “Download PDF” above.

Common Birth Control Pills Have Increased Risk of Blood Clots

By Kim Smiley

Deaths of 24 Canadian women associated with the use of Yaz and Yasmin birth control pills have been making headlines in recent weeks.  South of the border in the US, more than $1 billion has already been paid out to settle thousands of lawsuits over alleged side effects.  Yaz and Yasmin are drospirenone-based birth control pills that are the most widely prescribed birth control pills worldwide so any concerns with the safety of the medication are alarming.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map lays out the many causes that contribute to an issue in an intuitive way that illustrates the cause-and-effect relationships.  The first step in the Cause Mapping process is to fill in an Outline with basic background information and to determine how the problem is affecting the overall goals of the organization.  In this example, side effects from the pills have been reported to have caused deaths and injuries.    Lawsuits associated with the side effects, specifically blood clots, have cost the drug manufacturer huge amounts of money as well as generated significant negative publicity, neither of which are outcomes a company is hoping for.

The complaints about severe and potentially deadly side effects have been focused on blood clots.  Blood clots are a known potential side effect of using any birth control pills.  It is believed that the estrogen used in birth control pills increases the clotting factors in blood making blood clots more likely.  The reason these specific pills are making headlines is that researchers have found that drospirenone-based birth control pills have a higher risk of blood clots than other birth control pills.  Researchers have estimated that the risk of blood cloths is 1.5 to 3 times higher with drospirenone-containing pills than with some other birth control pills.

For perspective, the FDA has stated that if 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot and for women using birth control pills the range is 3 to 9.  But, and in my opinion this is a pretty big but, it’s worth knowing that the risk of blood clots during pregnancy is estimated to be 5 to 20 out of 10,000 and it’s even higher during first 12 weeks postpartum; estimated to be 40 to 65.

Please talk to your doctor if you have any concerns about blood clots or questions about whether a particular birth control pill is safe for you, especially if you think you may have other risk factors for blood clots.  If you’re curious about the symptoms of a blood clot or about other risk factors you can get more information here.

Please click on “Download PDF” above to see a high level Cause Map of this issue.

FDA Recommends Lower Doses of Sleep Aids

By Kim Smiley

On January 10, 2013, the Federal Drug Administration (FDA) announced a new requirement to dramatically decrease the normally prescribed doses of sleep aids containing zolpidem, which includes Ambien, Edluar and Zolpimist.    Products containing zolpidem are the most commonly prescribed sleep aids with about 40 million dispensed in 2011.

A Cause Map, or visual root cause analysis, can be used to help understand this issue.  The first step in the Cause Mapping process is to fill in an outline with the background information for a problem, such as the date and location.  The bottom half of an outline is filled in with the impacts to an organization’s goals.  In this example, the safety goal is impacted because there is a risk of car accidents after patients used prescriptions containing zolpidem and drove a car.  There have been about 700 reports of car accidents after people used products contain zolpidem. The customer service goal is also impacted because this issue has generated some bad publicity for the companies that manufacture these drugs.

After the outline is completed, the next step is to use the impacts to the goals to ask “why” questions and add the answers to the Cause Map to show the cause-and-effect relationships.  Why is there a risk of car accidents? People may be driving while impaired because zolpidem makes you drowsy and they may have zolpidem in their systems.  Zolpidem is a sedative; it’s the active ingredient in a number of sleep aids.  People may still have zolpidem in their systems because millions of people take prescription sleep aids containing it and it stays in the body longer than was known.    Originally it was believed that it was safe to drive 8 hours after taking zolpidem, but the FDA determined that enough of the drug may be present to impair driving after 8 hours.  Women are especially at risk of impaired driving because they metabolize the drug slower.

The final step in the Cause Mapping process is to determine possible solutions that would prevent a problem from reoccurring.  In this example, the FDA determined that taking a lower dose of sleeping aids containing zolpidem would help reduce the risk of impaired driving and the potential for car accidents.  The new FDA requirements would lower the dose for women from 10 milligrams to 5 milligrams for immediate-release products and from 12.5 milligrams to 6.25 milligrams for the extended-release product. The safest option is always to take the lowest dose of any sleep aid that is effective.

If you use a sleep aid containing 10 mg or 12.5 mg dose zolpidem, the FDA recommends that you continue taking your medication as prescribed until you can contact your healthcare professional.

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



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.