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U.S. Department of Health and Human Services

Show #55, September 2006

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Show #55, September 2006

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 Preventing Medical Errors

September2006FDA Patient Safety News Homepage
Avoiding Fatal Overdoses with Fentanyl Patches (October 2005) (Video, print, and e-mail functions)
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This story originally aired in October 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA has issued a public health advisory about deaths and serious injuries that have occurred when pain-relieving transdermal patches containing fentanyl, such as Duragesic, were misused. This has caused fatal overdoses of the drug.

The Institute for Safe Medication Practices describes an incident where a patient's caregiver placed the fentanyl patch on the patient's buttock, which was the site of her pain. When the patient went to bed, she also used a heating pad at the same place. The patient was discovered dead two days later. According to ISMP, neither the prescribing physician nor the pharmacist had counseled her on how to use the patch properly, and they hadn't told her to avoid applying heat over the patch.

There have also been cases where children have gotten hold of the patches, with tragic results. In one case, a mother found her 4-year old son dead next to an overturned trash can that held torn wrappers and used patches. The boy had applied a patch to his body, either a discarded one from the trash, or one he opened from a box of new patches. ISMP also describes a case where a child was accidentally exposed to a patch that fell off a family member, and another one where a child removed his grandmother's patch and applied it to himself.

It's important to instruct patients how to safely store and dispose of the patches. Used patches, or those that are no longer needed, should be folded in half so that the sticky side of the patch sticks to itself, then flushed down the toilet. And of course, warn patients to keep the patches out of the reach of children.

Absorption of the drug can also be increased by exposing the patch to heat sources such as heating pads, electric blankets or long, hot baths. A high fever can also increase absorption. In addition, using other CNS depressants, including alcohol, can have an additive effect on a patient using fentanyl.

The advisory says to counsel patients and their caregivers to recognize the signs of fentanyl overdose. These include trouble breathing, extreme sleepiness, or the inability to think, talk or walk normally. If these signs occur, patients or their caregivers should get medical help right away.

It’s important to recognize that the indications for these patches are somewhat limited. The advisory reminds practitioners that these patches should only be used by patients who have chronic pain that's not well controlled with shorter-acting painkillers, and who are tolerant to opiates. Fentanyl patches should NOT be used to treat short-term, intermittent, or post-operative pain. And they should always be prescribed at the lowest dose needed for pain relief.

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September2006FDA Patient Safety News Homepage
Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars (February 2006) (Video, print, and e-mail functions)
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This story originally aired in February 2006. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA issued a reminder about the potential for falsely elevated glucose readings in patients who are also receiving products that contain other sugars. These products include oral xylose, parenterals that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin.

Several patients have died because of this problem. Their glucose readings were very high, so they were given aggressive insulin treatment. The glucose readings were falsely high, however, and too much insulin was administered. The patients suffered hypoglycemic shock or irreversible brain damage and died.

In these cases, the glucose meter was reading the patient’s actual blood glucose level, plus the maltose that was contained in the IV immune globulin he was receiving. The readings were falsely elevated because the glucose monitoring device couldn't distinguish between glucose and other sugars.

All glucose meters don't suffer from this problem. There are several kinds of enzymatic glucose monitoring methods that are used, and only one of those has this problem. This problem occurs only with the monitoring method that uses an enzyme called GDH-PQQ. This method is employed in some glucose monitoring devices used by diabetics at home and in point-of-care settings.

The other methods currently used in glucose monitoring systems are called GDH-NAD, GDH-FAD, glucose oxidase, and glucose hexokinase, and they are capable of distinguishing between glucose and other sugars.

The test method used in glucose meters is identified in the package insert that comes with the glucose test strips. The package insert is also available from the manufacturer. The most important thing to remember is not to use the GDH-PQQ method if the patient recently received other sugars. That includes oral xylose for a D-Xylose absorption test, or an IV solution containing maltose or galactose, or a peritoneal dialysis solution containing icodextrin.

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September2006FDA Patient Safety News Homepage
Possible Connection between Menactra Meningococcal Vaccine and Guillain-Barre Syndrome (December 2005) (Video, print, and e-mail functions)
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Update: CDC MMWR October 20, 2006. "Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. "This report summarizes nine additional GBS cases reported to VAERS during March--September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.

... original story...
This story originally aired in December 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA and CDC are alerting health care providers and consumers about six reports of Guillain-Barre Syndrome following administration of Menactra, a Meningococcal vaccine manufactured by Sanofi Pasteur.

At this point, it isn't known whether these cases of GBS were caused by the vaccine, or were just coincidental. At the present time, there are no changes in the recommendations for vaccination against meningitis.

This vaccine has been given to several million people and the number of reported cases so far is about what would be expected in a patient population of this size, even without the vaccine.

However, the timing of these six events causes some concern. And since vaccine adverse events aren't always reported, there may be additional cases that we don't know about. So, FDA and CDC are asking anyone who knows of GBS occurring after Menactra administration to report this to the Vaccine Adverse Event Reporting System.

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September2006FDA Patient Safety News Homepage
Luer Lock Misconnections can be Deadly (December 2005) (Video, print, and e-mail functions)
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This story originally aired in December 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

Luer fittings, connectors, and locks are small, inexpensive, and convenient. They're commonly used to connect many medical devices, components, and accessories. Unfortunately, because they're so easy to use, health care personnel may mistakenly connect the wrong devices and then deliver a substance through the wrong route. These kinds of errors can cause serious injury or even death.

Previously, we described incidents where tubing from a portable blood pressure monitor was mistakenly connected to the patient's IV line, causing fatal air emboli. In another case, an air supply hose from a pneumatic compression device was inadvertently hooked up to a needleless IV tubing port.

A recent FDA article in the journal Nursing2005 reports on these and other types of misconnections between devices with luer connectors. In one case, while a patient was being repositioned, his I.V. tubing became disconnected. It was inadvertently reconnected to the inflation port of his tracheal cuff. The I.V. fluid infused into the cuff, causing an acute airway obstruction, and the patient suffered respiratory arrest and died.

In another example, a ventilator-dependent patient was receiving enteral nutrition after an aortic aneurysm repair. The enteral nutrition tubing was inadvertently connected to the patient's central line after a diagnostic test was performed. The patient received about 45 ml of enteral feeding solution intravenously.

The FDA article describes some precautions to help prevent these deadly mix-ups.

• First, teach staff to carefully inspect and then follow the proper connector sequence when connecting tubing and device components.

• Read and follow the equipment manufacturers' recommendations and precautions, especially about compatibility with other devices.

• Don't modify I.V. or feeding devices because doing so may compromise the safety features built into their design

• Consider using devices that are specifically designed for safety, to reduce the risk of misconnections.

• And tell patients and family members that they must ask clinical staff for help when they need to disconnect and reconnect equipment because they could easily connect the wrong devices.

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September2006FDA Patient Safety News Homepage
Caution on Accidentally Giving Nimodipine Intravenously (November 2005) (Video, print, and e-mail functions)
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This story originally aired in November 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

In a recent Medication Safety Alert, ISMP warns about inadvertently administering nimodipine, or Nimotop, intravenously. This has resulted in patient deaths and serious injuries. Nimodipine is a calcium channel blocker that's used to prevent vasospasm in patients with subarachnoid hemorrhage.

Nimodipine capsules are given by mouth, but for patients who can't swallow, the contents of an oral capsule can be extracted into a syringe and then injected into the nasogastric tube.

Although putting it into an NG tube is still not the same as giving it IV, once it’s in a parenteral syringe, accidents can happen. ISMP notes that several incidents have occurred when a patient has been injected IV, and then suffered severe hypotension, cardiac arrest, and death.

ISMP recommends that pharmacists warn patient care personnel about the danger of IV administration each time nimodipine is dispensed. ISMP also notes that some pharmacies are trying to prevent this problem by preparing nimodipine in advance for patients who can't swallow, rather than having it prepared in the patient care area. They're packaging the drug in amber oral syringes, and labeling them “for oral (NG) use only.”

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September2006FDA Patient Safety News Homepage
Caution on Power Injection of MRI and CT Contrast Media (October 2005) (Video, print, and e-mail functions)
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This story originally aired in October 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA is reminding radiology personnel about the potential for serious patient injury when vascular access devices that are not designed to withstand high pressures are used for power injection of CT or MRI contrast media.

FDA has received approximately 250 reports over the past few years where vascular access devices have ruptured under high pressure, sometimes causing fragmentation that required surgical intervention. The ruptured devices included central venous catheters, implanted ports, extension tubing and I.V. administration sets. Ruptures occur when the injection pressure is too great for the vascular access device to withstand.

To help prevent these ruptures, FDA recommends that radiology personnel check the labeling of each vascular access device for its maximum pressure and flow rate. If this information isn't available, you should assume that the device is not intended for power injection and don't use it for this purpose.

If you do know the maximum pressure that the vascular access device can withstand, be sure to adjust your power injector so that it doesn't exceed this limit. It's important to understand that if the recommended pressure for a vascular access device is exceeded, the device could be weakened even though no rupture is evident, and the weakened device could fail to operate properly when it is used again.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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