Counterfeit Drugs Bought by US Oncology Practices

By Kim Smiley

Counterfeit Avastin, a cancer treatment drug, was purchased by as many as 19 U.S. oncology practices last year.  The counterfeit drug did not contain anything that would harm patients, but there were no active cancer fighting ingredients in it. There have been no reported cases of patients being given the fake drug, but there was a very real risk that this could happen.

How did this happen?  How could so many medical facilities fall for a counterfeit drug?

This example can be analyzed by building a Cause Map, a visual root cause analysis format that intuitively shows the cause-and-effect relationships between the many Causes that contribute to an issue.   In this case, many factors led to the oncology practices purchasing the fake Avastin.  The supplier offered the lowest price for the drug, about $400 less than the manufacturer’s price.  Additionally, the supplier appeared to be legitimate and had a very convincing salesman working for them.  The supplier appeared to have both US phone number and offices in the US.  In reality, the US number phones were being automatically routed to an overseas number, but this process was transparent to the medical practices.  The counterfeit drugs themselves also appeared to be authentic.  As technology improves it is becoming more difficult to spot the fakes.

At this point in the investigation it’s not clear whether the supplier knew the drugs were fakes.  The company claims it had no knowledge that the counterfeit product.  One thing that is clear is why counterfeit drugs appear in the supply.  There is a lot of money to be made. Some prescription drugs are extremely expensive and selling fakes can be very profitable.  The drug in this case, Avastin, sells for more than $2,000 for a 400-milligram vial.  There are also generally less severe punishments for crimes associated with prescription drugs compared with the illegal drug trade.

It is estimated that less than one percent of the drug supply is counterfeit in developed nations, but counterfeit drugs are a huge issue in developing countries.  Even a small amount of counterfeit prescription drugs  has the potential for a large impact on peoples’ health.  There are a number of solutions to this issue that have been suggested.  The US Senate has recently passed a bill that pushes for stronger punishments for counterfeit drug trafficking and calls for a universal system to track prescription drugs, but it’s unclear how this might be adopted into law.

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

New Use for Old Drug May Save Lives

By ThinkReliability Staff

An off-label use for an existing drug, tranexamic acid, has been shown in recent studies to reduce bleeding – and so risk of death – from trauma.  The drug is believed to slow bleeding by slowing the dissolution of blood clots  by  blocking plasmin, which aids in the dissolution of blood clots.  A recent trial shows that 128,000 lives could be saved thanks to the use of tranexamic acid, an existing, cheap generic.  The drug slows bleeding in trauma patients and is being used on the battlefield, in Britain . . . and just about nowhere else.

How does the drug help trauma patients and why isn’t it being used? We can look at both of these issues in a Cause Map, or visual root cause analysis.  We begin the Cause Map with the outline, which captures the basic information about the issue and the impacts to the goals.  Here, we are looking at the use of tranexamic acid to slow bleeding in trauma patients.  Currently, it’s being used primarily on battlefields and in trauma centers, mainly by Britain.  Use of the drug impacts the patient safety goal by potentially reducing the risk of death from trauma, and the patient services goal by slowing bleeding.

We begin with these impacted goals and ask “Why” questions to add detail to the Cause Map.  In this case, the potential for the reduced risk of death  results from having 400,000 people die of trauma in hospitals every year, and  the potential for slowed bleeding.    The potential for slowed bleeding is due to a drug that has been shown to slow bleeding, and the fact that that drug is not commonly used for trauma.  The drug is believed to slow bleeding by  blocking plasmin, which aids in the dissolution of blood clots.  The drug is not commonly used  for trauma, in part because it has not been FDA approved for this use.  (It can still be prescribed “off label” by doctors.)  The leader of the trial showing the potential benefits of the drug in trauma believes that the lack of use is due to inertia.  Because the drug is inexpensive, it doesn’t provide a large profit for drug companies, and so they are less likely to advertise the benefits.  Additionally, since the FDA hasn’t approved it for trauma, the drug companies aren’t allowed to advertise the drug for this use.

It’s unclear if manufacturers are attempting to  obtain FDA approval for trauma use.  However, publication of these studies, and sharing information between healthcare facilities may help increase the use of this drug, potentially saving lives.   It’s been added to the World Health Organization’s essential drugs, and is finding use on battlefields aiding wounded soldiers.  Hopefully in time, it will be used in healthcare facilities as well.

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

Mercury in Cosmetics

By Kim Smiley

The toxic metal mercury has been found in cosmetics in at least 7 states in the US. Some products contain hundreds or thousands of times the allowable level.  Even small amounts of mercury are a concern as it accumulates in the body.

The use of products containing mercury can result in risk of illness or even death due to mercury poisoning.  Mercury accumulates in the body, increasing the risk with each application.  Additionally, family members can also be exposed, even if they aren’t using the product.

The Food and Drug Administration (FDA) does not allow mercury in cosmetics, whether manufactured in or imported into the US.  These mercury containing products are generally manufactured outside the US and are brought in by non-regulated channels, such as personal mail or luggage.   The FDA is constantly adding products found to contain mercury to the seizure list.  If found, the products are taken and the importers or sellers can face legal action.

Mercury is added to cosmetic products in an attempt to aid in skin lightening, anti-aging or blemish control.  However, it seems unlikely that any effectiveness the product may have is worth the possible side effects of mercury poisoning, which include damage to the kidneys and nervous system, tremors, depression, memory problems, and even death.  It can also interfere with the development of the brain in the unborn and very young.  Because mercury is sometimes listed under different names on the ingredient list (or imported products contain no ingredient list or the ingredient list is in a different language), it’s likely that users of these products are unaware they contain mercury.

The FDA recommends that you check the labels of any products advertised as face-lightening, anti-aging or blemish treatments.  If the label contains mercury, mercurous chloride, calomel, mercuric or mercurio, stop use immediately.  Additionally, if there is no ingredient label or the label is not in English, stop use immediately.  Store in a sealed bag and contact Poison Control or your healthcare provider.

We can investigate the issue of mercury in cosmetics in a Cause Map, or visual root cause analysis, in order to show the cause-and-effect relationships that lead to the potential for health effects.  To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Technique Increases Availability of Donor Kidneys

By ThinkReliability Staff

Transplanted donor kidneys save lives, but availability does not meet demand.  Contributing to the problem is that some people who are willing to be donors have organs that are considered unsuitable for transplant.  A new procedure has been successful in making some of these previously rejected kidneys usable again.

The procedure involves flushing donated kidneys, which would previously have been rejected as unsuitable for transplant, with oxygenated blood (normothermic perfusion).  This can allow use of some damaged kidneys, such as those from the elderly or those with high blood pressure or diabetes.  It decreases the risk of a marginal organ being rejected.  It is believed that this could increase the availability of organs by about 500 a year in the United Kingdom, reducing the number of people on transplant waiting lists by about 10%.   (There are more than 6,400 kidney patients waiting for a transplant in the UK.)

So far, 17 organs that have been through the procedure have been successfully transplanted, between November 2010 and November 2011.  They are all functioning well.  The success of this procedure can be examined in a Cause Map, or visual root cause analysis.   Positive impacts to the goals can be examined in the same way that negative impacts are – by identifying the impacts and asking “why” questions to identify the causes.  Due to this procedure, the patient safety goal has been impacted by reducing the risk of rejected transplanted organs.  The patient services and material goal has been impacted by increasing the availability of donor kidneys.  And, the “labor” goal has been impacted by reducing the amount of time people wait for donor kidneys.

Beginning with these impacts and asking “why” questions, we can identify that the procedure is allowing the use of previously marginal organs by allowing treatment outside the recipient body and  reducing the risk of rejection.  This increases the number of organs that can be used, and since there are still more organs needed than available, this reduces the amount of time on the waiting list.

Although this procedure should increase the number of organs available and reduce time on the waiting list, it still will not provide enough organs for everyone who needs one.  Donor outreach to increase donors and family understanding of the life-saving organ donation process is still needed.

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

Potential Dangers of Unpasteurized Dairy Products

By Kim Smiley

A new study by the Centers for Disease Control and Prevention (CDC) found that unpasteurized milk is 150 times more likely to cause food-borne illness outbreaks than pasteurized dairy.  The CDC found that there were 73 disease outbreaks, two deaths and many permanent disabilities caused by the consumption of unpasteurized dairy products from 1993 to 2006.  Pasteurized dairy products aren’t perfect either.  According to the same report there were 48 disease outbreaks from contaminated pasteurized milk and cheese resulting in thousands of illnesses and one death during the same time period.  But the CDC determined that unpasteurized milk is a far greater risk since more illnesses were caused by it and it is estimated that only about one percent of the population consumed unpasteurized dairy products.

This issue can be analyzed by building a Cause Map, an intuitive, visual format for performing a root cause analysis.  In this example, the safety goal was obviously impacted since hundreds got sick from consuming unpasteurized milk.  The Cause Map is built by asking “why” questions and adding the information onto the Cause Map in order to show the cause and effect relationships between all the factors that contributed to the issue.  In this example, people got sick because they were exposed to harmful microorganisms.  This occurred because unpasteurized milk is more likely to be contaminated with harmful microorganisms and consumers drank unpasteurized milk.

Unpasteurized milk is more likely to be contaminated because by definition it isn’t heated to kill microorganisms.  During the pasteurization process, milk is heated to 161 degrees and held there for about 20 seconds to kill anything harmful that might be in the milk.  There is the potential for all milk to get contaminated because cow manure is a potential source of contamination and it’s a constant in the environment where milk is produced.

People drink unpasteurized milk because they prefer it and it’s legal to buy in many states.  Some consumers prefer unpasteurized milk for a number of reasons.  Unpasteurized milk has a distinct taste some people like.  There is also a general trend of people moving towards less processed foods.  The pasteurization processes decreases the amount of a few nutrients in milk so some people think that unpasteurized milk is healthier for them.  There are also a number of people who believe that unpasteurized milk has healing properties.  There are testimonies that unpasteurized dairy products have reversed a number of health issues, including allergies, asthma, digestive disorders, arthritis and behavior problems in children.

There are some who believe the sale of all unpasteurized diary should be banned because of the risk of contamination and the resulting illnesses, but unpasteurized dairy has very active, vocal advocates that believe strongly that its sale and consumption should be legal.  Both the CDC and the Food and Drug Administration urge consumers to avoid unpasteurized dairy products because of the potential health risks.