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.

Pregnant Patient Dies After Wrong Organ is Removed

By ThinkReliability Staff

A series of errors resulted of the death of a young mother in Romford of the United Kingdom on November 11, 2011.  Details of the patient’s condition and care provided by a  local hospital during a bout of appendicitis were recently released.  We can look at the causes that led to her death – and the death of her unborn baby – in a Cause Map, or visual root cause analysis.

With a complex issue taking place over several days like this one, it can be helpful to develop a timeline to aid in understanding.  In October, 2011, the 5-months pregnant patient entered the hospital and was diagnosed with appendicitis.  Surgery to remove her appendix occurred on October 23rd.  On the 29th, the patient was discharged from the hospital.  The pathology results became available on October 31st. These tests indicated that it was not the appendix that had been removed, but an ovary.  However, the results were not read by any hospital staff at this time.

The patient returned to the hospital on November 7, still in pain.  On the 9th, she suffered a miscarriage, at which point the pathology tests were read.  The patient underwent surgery to remove septic fluid from the diseased appendix, which had not been removed.  Two days later, on the 11th, the patient underwent a second surgery to remove her appendix, and died during the operation.

Before beginning an analysis it’s important to determine which organizational goals were impacted as a result of any issue being analyzed.  In this case, the patient death and miscarriage are both impacts to the patient safety goal.  (Both the mom and baby can be considered patients.)  As a result of the issues related to the patient’s death, eight hospital staff are being investigated, an impact on the hospital’s employees.  The death of a patient related to the wrong procedure being performed – in this case, the wrong organ was removed during her appendectomy – is a “Never event”, which is an impact to the compliance goal.  The Hospital Trust has accepted liability for her death, an impact to the organization.  The wrong organ being removed is an impact to the patient services goal. Additional required surgeries are an impact to the labor goal.

To perform our root cause analysis, we begin with an impacted goal and ask “Why” questions.  In this case, the patient death was due to multiple organ failure.  The multiple organ failure occurred because the patient had sepsis, and the sepsis was not immediately recognized.  (Although it appears that nothing was done to deal with sepsis until two days after the patient returned to the hospital, details on what was done have not been released.)  The sepsis resulted from the patient having appendicitis, and the appendix not being removed for 19 days.  Why was the appendix not removed for 19 days?  Instead of removing the appendix during surgery, the patient’s ovary was removed.  The results of the pathology report (which would have identified that the organ sent was not an appendix) was not read when available.  It is also not clear what the process was for reading these reports at the hospital, and how that process is being fixed.  It is known that the pathologist did not do any special reporting of the adverse results.

Now we get to the question, why was the wrong organ removed in the first place?  The surgeons were attempting to remove the appendix, which was inflamed as the patient was suffering from appendicitis.  Because they were performing open surgery, rather than laparoscopic, and the uterus was in the way of the appendix (due to the pregnancy), the surgery was being performed by feel, rather than sight.  (As you can imagine, this makes the surgery more difficult.)  During the surgery by feel, the ovary was mistaken for the appendix.  The ovary was possibly inflamed, due to the pregnancy, but another important issue is that the surgery was performed with overall inadequate expertise – specifically by trainees with no senior medical staff present.  (Senior medical staff were not required to be present, but due to the admitted difficulty of this type of surgery, that may have been a good move.)

As with many medical mishaps, any number of staff members could have improved the patient’s outcome.  Specifically, though the pathologist was only tangentially involved in the patient’s case, had she or he called the patient’s team immediately upon noticing that what was labeled an appendix was actually an ovary, the patient’s (and baby’s) life would likely have been saved.  Patient safety depends on everyone.

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

Promising New Cancer Drugs Use the Immune System

By Kim Smiley

A promising and potentially powerful new type of cancer treatment uses the immune system to fight tumors.   The drugs are still in early testing, but reports are that they shrunk tumors significantly in 15 to 50 percent of patients.  Patients with different types of cancer have also responded, which is an encouraging sign that the new treatment may have wide spread applications.

A Cause Map, or visual root cause analysis, can help illustrate how these new drugs work and explain why researchers and the companies developing them are so excited about them.  It may seem strange to use a root cause analysis technique on something positive, but it can be just as beneficial to understand why things are going well as it is investigate when problems crop up.  If you understand why a success occurred, the information may be used to reproduce it.   Building a “success” Cause Map is the same as any other Cause Map.  You start by identifying the impacted goals and then ask “why” questions.

In this example, the safety goal was impacted because the new type of cancer treatment shows promise, and the economic goal was impacted because the stock for the companies developing the new cancer drugs rose.   The new cancer treatment being developed shows promise because patients are responding to it and it is completely different from anything being used today.  The new immunotherapy treatments use the body’s own defenses, the immune system, to fight cancer.

You may wonder why drugs are needed at all if the immune system has the ability to fight cancer.  The answer lies in a  cancer tumor’s ability to hide from the T cells, the part of the immune system that detects bacteria and other “invaders”.  Tumors produce a protein on their surface that prevents T cells from detecting them so the immune system never even knows they are there.  A very simplified explanation is that the new drugs block the protein that hides tumors and allow T cells to detect them.   Once detected, the immune system will attack the cancer.

If immunotherapy is successfully developed, it would give doctors more options in treating cancer, especially those that don’t respond to the conventional treatments.  So far the side effects have also been minimal, far less than what is generally seen with chemotherapy and radiation treatments.

Much more research is needed before this type of drug is widely available, but the findings so far are positive enough to increase stock prices and excite experts in the field.   I have my fingers crossed that the end result is everything researchers are dreaming it will be.

Lack of Care After Overdose Led to Patient Death

by ThinkReliability Staff

An inquest into the death of a patient in a Milton Keynes hospital was completed on May 17, 2013 by the local coroner.  The coroner found that the staff failed to take and report appropriate observations and render effective treatment.  Diagramming the cause-and-effect relationships identified in the inquest in a visual root cause analysis, or Cause Map, allows identification of lessons learned and possible solutions to reduce the risk of this type of incident happening again.

We begin with the impacts to the goals.  In this case, the patient safety goal is impacted due to the patient death.   It was suggested that nursing shortages may have been related to the issues that occurred.  If this is the case, the shortages would impact employees.  The inquest that resulted due to the patient death can be considered an impact to the compliance and organization goals.  Last but not least, the insufficient patient treatment is an impact to the patient services goal.

Beginning with these impacted goals, we can ask Why questions to determine the cause-and-effect relationships that resulted in the patient death.  In this case, the patient death was due to respiratory arrest caused by an obstructed airway.  The patient being placed on her back while unconscious (though sources differ on whether the patient was placed on her back or her side) due to a drug overdose.   The patient overdose was due to a self-administered overdose and not being administered the antidote for the drugs on which she had overdosed.

The patient was not given an antidote for the drugs on which she overdosed.  The family of the patient, who had a history of mental illness and frequented the hospital, believes that the staff believed she was faking her symptoms.

Through the patient’s eleven hours within the hospital’s Accident & Emergency (A&E) Department, only 2 formal observations were recorded.  One set of observations was recorded on a glove, which was later lost.  Abnormal results from these observations were not passed along from the healthcare aid who was responsible for the patient, likely due to nursing shortages.

Once all of the causes related to the incident have been recorded within the Cause Map, solutions can be brainstormed and recommended for implementation.  The coroner involved in the case has requested the Secretary of State for Health implement changes that would require seriously ill patients to be observed by nurses rather than healthcare assistants. The hospital has stated that they “have conducted an investigation to ensure lessons are learned” and “will be continuing to improve our service in regard to emergency patients”.  The hospital has commissioned training for their healthcare assistances to improve their skills.

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