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U.S. Department of Health and Human Services

Show #79, September 2008

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Show #79, September 2008

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 Preventing Medical Errors

September2008FDA Patient Safety News Homepage
Mixups between Insulin U-100 and U-500 (April 2008) (Video, print, and e-mail functions)
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This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

The Institute for Safe Medication Practices (ISMP) recently described an increase in reports about mixups between insulin U-100 and insulin U-500. These errors could result in dangerous hyperglycemia or hypoglycemia. Mistakes have occurred when prescribers accidentally selected U-500 regular insulin from computer screens instead of U-100.

ISMP has identified several possible reasons for these kinds of errors. For example, sometimes the two dosage forms appear one line apart on the screen, which makes it easy to select the wrong one. Also, depending on the screen size, the prescriber may see only the first few words of the product listing, so the drug concentration may not be visible. And finally, since the use of U-500 insulin is not common at present, prescribers may just assume that the only regular insulin that's available is U-100 and not even look for the concentration on the screen. ISMP suggests that the use of U-500 insulin may be increasing due to the higher prevalence of obesity, the use of insulin pumps, and tight glucose control protocols in hospitalized patients.

ISMP says that the major suppliers of drug information systems have agreed to add the word "concentrated" on their selection screens, immediately following the drug name and preceding "U-500", which should help solve the problem. Until these updates appear in your system, here's what ISMP recommends.

• If U-500 is not commonly used in your facility, consider listing it differently from other insulins, so it does not appear on the same screen as other insulin products.

• Consider adding a hard stop to all orders for U-500. This requires prescribers and pharmacists verify that the patient should be getting the U-500.

• Pharmacies should consider not stocking U-500 if they do not have patients who use it.

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 Recalls and Safety Alerts

September2008FDA Patient Safety News Homepage
Severe Pain with Osteoporosis Drugs (March 2008) (Video, print, and e-mail functions)
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This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases.

This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.

Note that these events are different from the acute phase response some patients experience after the first treatment with IV bisphosphonates, and occasionally after the first dose of oral bisphosphonates.

Although severe musculoskeletal pain is described in the labeling for all bisphosphonates, this association may be overlooked by practitioners because they may assume that the patient's pain can be attributed to osteoporosis itself.

Practitioners should consider whether musculoskeletal pain in patients on bisphosphonates might be caused by the drug, and consider discontinuing it either temporarily or permanently.

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Preventing Meningitis in Children with Cochlear Implants (December 2007) (Video, print, and e-mail functions)
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This story originally aired in December 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

FDA is reminding healthcare practitioners about the importance of vaccinating children with cochlear implants against bacterial meningitis caused by Streptococcus pneumoniae. Two deaths from meningitis have been reported over the past year in children with cochlear implants. Neither of them had completed the recommended vaccinations against pneumococcus.

Many parents of cochlear implant patients are not getting the message about immunizing these children against pneumococcus. A recent survey at Johns Hopkins revealed that despite repeated efforts to educate parents, up to 40 percent did not know their child's vaccination status. This suggests that at least some cochlear implant patients are not getting vital preventive care that can reduce the risk of a potentially life-threatening illness.

To improve this situation, there are several recommendations that healthcare professionals should follow. Here are a few:

• When caring for patients who have or will be getting cochlear implants, review their vaccination records to be sure they are current on all the immunizations recommended by CDC for this special patient population. Note that CDC considers children with cochlear implants as a high-risk group when it comes to invasive pneumococcal infections.

• Teach parents and caregivers to recognize and report the signs of meningitis. It is important to identify and treat this illness promptly in order to avoid permanent neurological damage. Early signs of meningitis may include high fever, headache, stiff neck, nausea or vomiting, photophobia, somnolence, confusion, ear pain and ear infection. Young children with meningitis can be sleepy, cranky and eat less.

• Diagnose and treat middle ear infections promptly. In some of the cases reported to FDA, patients with meningitis had shown signs of otitis media prior to the implant surgery or before the meningitis developed. According to the American Academy of Pediatrics, practitioners treating otitis media in patients with cochlear implants should consider antibiotic therapy more readily than they might for other patients.

• Consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants.

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 Preventing Medical Errors

September2008FDA Patient Safety News Homepage
More Patient Deaths from Luer Misconnections (October 2007) (Video, print, and e-mail functions)
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This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

A recent FDA article in the publication "Safe Practices in Patient Care" highlights the serious errors that continue to occur when different devices that use Luer fittings are mistakenly connected to each other. (NOTE: See link to complete article for FREE Continuing Education (CE) credit for nurses.)

Luer connectors, fittings and locks are widely used because they are inexpensive and easy to use. But the connector design also makes it easy for unrelated delivery systems to be connected to each other, sometimes with disastrous results.

Some of these incidents occurred when 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.

The FDA article describes still other kinds of misconnections. For example, during a lithotripsy procedure, an ultrasonic lithotripter suction hose was incorrectly inserted into the roller pump. Instead of debris from the fractured stone being suctioned from the kidney, air was pumped into it. The hose was reconnected after the mistake was discovered, but the patient went into cardiac arrest and died shortly afterwards. And in yet another example, a patient misconnected her Foley catheter to her nasogastric (NG) tube. She was found with the Foley catheter disconnected from the drainage bag but with one end still in her bladder. The other end was connected to her NG tube, and urine was going into her stomach.

All these examples show that these misconnections can occur with a wide variety of devices, and in any clinical setting. In 2006, The Joint Commission (TJC) responded to these kinds of events by issuing a Sentinel Event Alert. TJC's alert lists a number of recommendations to help prevent these kinds of mistakes. Here are some of them:

• Do not purchase non-IV equipment with connectors that can physically mate with a female IV Luer connector.

• Always trace a tube or catheter before connecting any new device or infusion.

• When a patient arrives in a new setting or service, as part of the hand-off process, recheck connections and trace all patient tubes and catheters to their sources.

• Inform non-clinical staff, patients, and their families that they must get help from clinical staff whenever their devices or infusions need to be connected or disconnected.

• Never use a standard Luer syringe for oral medications or enteric feedings.

• Be sure to emphasize the risk of tubing misconnections in orientation and training curricula.

Additional Information:

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Preventing Patient Deaths from Fentanyl Patches (September 2007) (Video, print, and e-mail functions)
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This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

A recent report from the Institute for Safe Medication Practices (ISMP) warns about the dangers of misprescribing fentanyl transdermal patches, such as Duragesic. ISMP reminds practitioners that these patches are intended only for patients who are opioid-tolerant, and should not be used for acute pain.

ISMP also pointed out other prescribing errors. In some cases, deaths occurred in patients who were prescribed multiple fentanyl patches, resulting in overdose. In other cases the fentanyl was prescribed in addition to other pain medications, such as oxycodone, or it was prescribed for patients with pre-existing respiratory compromise. ISMP points out that sometimes pharmacists have dispensed these prescriptions without questioning them, and nurses have applied the patches without recognizing the prescribing error.

Here are some of ISMP's recommendations to help avoid these tragic and preventable errors:

• Prescribe fentanyl patches only for patients who are opioid tolerant, and who have chronic pain that is not well-controlled with shorter-acting analgesics. These patches should not be used for postoperative pain, or for pain that's short-term or intermittent. Pharmacists should ensure that the patient is opioid-tolerant and suffering from chronic pain before dispensing the drug, and should question the prescriber if this is not the case.

• Set dosing limits. For example, pharmacy computer systems could be set to flash an alert if more than 25 mcg per hour has been prescribed as a first-time dose. Also, in evaluating whether the dose is appropriate, take into account other opiates or analgesics that may have been prescribed.

• Educate practitioners and patients to know the signs of overdose, which include respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and fainting.

• Prescribing errors are not the only cause of deaths and injuries from fentanyl patches. They also occur when patients mis-use the patches. Sometimes patients and family members do not understand that heat can increase absorption of the drug to dangerous levels. So patients should be told to avoid heating pads, electric blankets or hot baths while the patch is in place, and let their doctors know if they develop a temperature above 102 degrees.

• There have also been cases where children found used patches in the trash and applied them to their own bodies, and died as a result. And so patients should be warned to dispose of the patches by folding them in half and flushing them down the toilet.

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What to Do about Unretrieved Device Fragments (January 2008) (Video, print, and e-mail functions)
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This story originally aired in January 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

A recent FDA article in the journal Nursing2007 alerts healthcare personnel about the potential dangers posed by fragments of medical devices that are left in a patient's body. FDA receives more than a thousand reports each year of device fragments breaking off during invasive procedures or from devices already implanted in the body. The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place.

Many of these reports involve fragments of catheters and guidewires that are left in the patient's body, and some have caused death. In one case, a patient died from cardiac tamponade after a fractured guide wire lodged in a coronary artery and could not be removed.

The article also points out that metallic fragments in the patient's body can move or become heated during MRI exams, and if the fragment is near a vital organ or blood vessel, this can cause injury.

Several dangerous techniques can increase the likelihood of device breakage, such as using too much force during insertion or withdrawal, bending a device to conform to the patient's anatomy, and using old or worn devices.

The article lists several steps healthcare personnel can take to minimize the risks associated with unretrieved device fragments. Here are some of them:

• Make sure that the presence of the fragments is noted in the patient's record.

• Let patients know about any device fragments they may have, and instruct them to report this to other caregivers in order to avoid future complications during testing or treatment.

• When treating a patient, ask about a history of unretrieved device fragments.

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