Tag Archives: prescription drugs

Root Cause

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.

 

 

Root Cause Analysis

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.