Monthly Archives: October 2011

Root Cause Analysis

Unbalanced Antidepressant Use

By Kim Smiley

A recent Centers for Disease Control and Prevention report provided results of a study of Americans taking antidepressants from 2005 to 2008.  The study came to two interesting conclusions that have a potential impact on patient safety.  We can outline the potential impacts of the results of this study in a problem outline, then provide a graphic analysis of the causes within a Cause Map, or visual root cause analysis.

First, the study determined that antidepressant use has increased 400% since 1988.  Eleven percent of Americans over the age of 12 are now taking antidepressants.  Any drug has risks, and more people taking a drug means that the total risk for side effects is higher.  Additionally, traces of certain kinds of antidepressants have been found in  the water supply, likely caused partially by improper disposal of these drugs.  (Don’t flush them down the toilet!)  The cost of anti-depressants is an additional issue raised with the high usage of these drugs.

Even though talk therapy is a very useful tool for treating depression, less than 1/3 of patients who are taking antidepressants have met with a mental health professional in the last year.  Patients reportedly prefer drugs to talk therapy, potentially because reimbursement for prescriptions is generally much simpler and cheaper than reimbursement for mental health therapy, which can be capped or may not be covered at all.

Because most antidepressants are obtained with a prescription, the higher usage of antidepressants indicates a higher rate of diagnosis of depression.  While the faltering economy can take some of the blame, hormonal changes (as middle aged women are the most frequent users of antidepressants), a decreased stigma against depression, and increased awareness of the drugs, thanks to pharmaceutical marketing, have also been listed as potential causes for the increase.

Many agree that the decreased stigma towards depression is a positive step; however, the other side of the study found that only one third of people with severe depression symptoms are taking antidepressants.  While many with mild depression symptoms may find relief with talk therapy or other options, American Psychiatric Association guidelines recommend medication for moderate to severe depression symptoms.  This indicates that patients with severe depression may be under medicated and increases the risk for mental health problems and/or suicide.  There are many possibilities for why individuals with severe depression are not getting – or seeking – the help they need.  The high out of pocket cost for anti-depressants may be a barrier to some, as is the ability to receive screening for depression.  Although there are certainly other roadblocks along the way, making screening easier to receive may increase the treatment rate for sufferers.  The Centers for Medicare and Medicaid Services recently announced it would be covering annual screening for depression.  Hopefully this first step will result in more people getting the help they need.

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

Root Cause Analysis

A Stealth Contact Lens Recall?

By Kim Smiley

Avaira Toric contact lenses, manufactured by CooperVision Inc, were voluntary recalled on August 19, 2011.  The recall occurred after dozens of consumers complained about eye problems including impaired vision, eye pain and torn corneas.  According to a company statement, a manufacturing error resulted in a silicone oil residue on some contacts.  More than 8 million lenses were affected worldwide by the recall, but only about 780,000 of these contact lenses were distributed in the USA.

The company has received a large amount of negative media attention following the recall.  News articles and blogs  have claimed that CooperVision was purposely downplaying the recall, resulting in many consumers being unaware that their lenses had been recalled. Unaware of the potential danger, consumers continued to wear their lenses and continued to have eye problems as a result. The FDA publicly threatened to independently inform consumers of the risk associated with these contact lenses if the manufacturer didn’t better publicize the recall.

Following the media attention , the company has increased efforts to notify consumers about the recall.  The FDA has also posted a notice on their website of this recall, identifying it as a Class I recall, the most serious class of recall. The FDA has said that the company’s actions are now consistent with what would be expected with a Class I recall.

This example is a good illustration that the execution of a recall is a very important thing.  If consumers view a recall as slow to happen or badly executed, they will probably be less likely to trust a company in the future.  Ideally, a recall should be executed so that consumers are left with the feeling that a company did the right thing as quickly as possible.

If you are concerned that you might have recalled lenses, you can visit this website  to check.  If your lenses are recall, you are asked to remove them immediately and return them to the point of purchase.

Click on “Download PDF” above to view an outline and initial Cause Map of this example.

Root Cause Analysis

Increased Risk of HIV Transmission with Injectable Contraceptives

By Kim Smiley

A recent study has brought to light some disturbing news for women using injectable contraceptives.  The study, published October 4, 2011, has discovered that the transmission rate of HIV is nearly doubled for both women who use injectable hormones for contraception and their partners.  Specifically, the rate of HIV transmission for women is 6.61 per 100 people per year when using injectable contraceptives, compared to 3.78 for those who do not.  For men whose partners use injectable contraceptives, the rate is 2.61, compared to 1.51 whose partners do not use injectable contraception.

This study may have profound implications.  More than 12 million women in eastern and southern Africa use injectable contraceptives.  Their popularity is likely due to the cost and convenience of the once-quarterly shots, used to prevent unintended pregnancies, long an issue for maternal health in the developing world.  Although the injectable contraception is not meant to prevent transmission of HIV and other sexually transmitted diseases, the hormones (namely progestin) in the injectables appear to cause a biological change that actually increases the rate of HIV infection ABOVE that of using no contraception at all.  Previous studies have also suggested this is the case, and have found that pregnancy also increases the rate of HIV.  Birth control pills (taken once daily) may also increase the risk, though so far the increase is statistically insignificant, possibly because daily pills involve   much smaller amounts of hormone.  (Although the increased transmission risk is true for all who use injectable contraception, the focus is on sub-Saharan Africa because of the high rate of HIV.)

The World Health Organization (WHO) will be reconsidering its contraception recommendations as a result of this study.  Woman using contraceptives are unlikely to use additional means of preventing HIV infection so wide spread use of a birth control method that doubles the risk of HIV infection creates a very real, global health risk.  However, the risk of death or serious health issues from unintended pregnancy have still not decreased, leading health officials unsure what the best path forward will be.  Removing an effective pregnancy control without other equally attractive options could leave more women at risk.  Officials at WHO will be working through this issue to see if both health risks from unintended pregnancy and HIV transmission can be minimized together.  It will be a tough job, but the lives of millions are at stake.

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

Root Cause Analysis

Contaminated Cantaloupes Cause Deaths

By Kim Smiley

The number of food recalls in the news lately is enough to make you lose your appetite.

Let’s start by focusing on just one of the recent recalls.  Listeria from contaminated cantaloupe has caused at least 15 deaths and has sickened more than 80 across the USA.  Tests have traced the listeria back to a single farm in Colorado, but the source has not yet been identified.

Listeria is a common, but potentially deadly bacteria that can be found in soil, water, decaying plant matter and manure so the potential sources are numerous.  Another important piece of information is that Listeria can be difficult to eliminate once it has spread to distribution and processing facilities because it grows well at low temperatures, unlike most bacteria.  Listeria can continue to grow in refrigerated areas where fruit maybe stored or processed.

Finding the source of a listeria outbreak can also be difficult because it can take up to two months for an individual to become sick.  Adding to the complexity of identifying what food is causing an outbreak of listeria is the wide variety of foods that can become contaminated.  Listeria can be found in meat, dairy, fruits and vegetables.

Even once the source of contamination has been identified, it can be difficult to effectively remove the item from the food supply.  In this example, the sheer number of cantaloupes involved as well as a long supply chain made it difficult to remove all contaminated melons.  The farm recalled their entire 2011 cantaloupe crop which was more than 300,000 cases distributed from the end of July to mid-September.  The cantaloupes were shipped to 25 states and sold through many different retailers.

A recent article by CBS stated that the average cantaloupe makes four or five stops on the way to the super market shelves.  Typical cantaloupes will go to a packing house for cleaning and packing, a distributors, a retail distribution center and finally a grocery store before they make it to the consumer.   This makes it very difficult to identify where a food might have been contaminated.

Click on “Download PDF’ above to view a high level Cause Map of this issue.  A Cause Map is an intuitive form of root cause analysis that visually lays out the causes that contribute to an issue.