FDA Patient Safety News: Show #15, May 2003

Warning on I.V. Infusions of "Free Water"

The Institute for Safe Medication Practices recently issued an alert that warned physicians, nurses and pharmacists about the danger of giving patients intravenous infusions of "free water"--- that is, water that doesn't contain any dissolved ions.

The case they cited was an elderly diabetic patient who was admitted to the ICU with pneumonia, congestive heart failure, respiratory failure, and severe hypernatremia. Because of the patient's hypernatremia, the physician didn't want him to receive any more sodium. And because of the patient's diabetes, the physician didn't want to infuse dextrose solution. So he ordered that sterile water for injection be administered by I.V. infusion. This was presumably intended to alleviate water loss in the patient and thus correct the hypernatremia. The patient experienced a hemolytic reaction and acute renal failure, and died.

ISMP's basic safety message is that "free water," such as sterile water for injection, should never be administered through I.V. infusion, because hypotonic solutions can result in hemolysis.

Sterile water for injection is not generally available as an I.V. solution. It's used in the pharmacy to prepare various I.V. solutions, and it's not intended to be used alone as an I.V. infusion. In this case, the physician ordered a large bag from the pharmacy. They complied, and the nurse administered the I.V. infusion.

There's usually a warning on the bags of sterile water for injection saying that it shouldn't be used for I.V. infusion, but sometimes this doesn't stand out. In fact, in this particular case, the warning label was on the opposite side of the bag.

Here's some of what ISMP is recommending to prevent this kind of problem. First, they're saying that practitioners should understand the danger of infusing sterile water without any additives. They should be aware that in severe hypernatremia, sodium levels should be brought down slowly with infusions that contain some sodium. "Sterile water for injection" should never appear in order entry systems for prescribers. If an order for sterile water is received, this should trigger an immediate call to the physician.

In the pharmacy, they're recommending that pharmacists never allow the ingredients used to compound IV solutions to leave the sterile compounding area, and of course that would include "sterile water for injection." And they’re saying that warning labels should be placed on the front of bags containing "sterile water for injection."

Additional Information:

ISMP Medication Safety Alert – January 23, 2003.
http://www.ismp.org/MSAarticles/water.htm


Antibiotic Resistance Information on Drug Labels

All of us know by this time about the over-prescribing of antibiotics, and how this promotes the development of drug-resistant bacterial strains. And yet the problem persists. According to CDC, about half of the 100 million antibiotic prescriptions written each year in physicians' offices in the U.S. are unnecessary, because they’re prescribed for the common cold and other viral infections. Unnecessary use of antibiotics in hospitals is also common.

In an effort to reduce this problem, FDA is going to require changes in the labeling for all systemic antibiotics. By early next year, health care providers will see new statements in the labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria.

But there’s also a role for the patient. When patients fail to complete the full course of treatment, that also promotes drug resistance. And so part of the labeling will encourage physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed --- to complete the full course of therapy and not to skip doses, even they feel better.

Additional Information:

FDA Publishes Final Rule to Require Labeling about Antibiotic Resistance.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm092810.htm


New Test to Rule Out Heart Attack

FDA has recently cleared for marketing a new laboratory blood test that will increase the ability to rule out a possible heart attack in patients complaining of chest pain. The test is called the Albumin Cobalt Binding or ACB Test, and it’s manufactured by Ischemia Technologies, Inc. This is the first new blood test to evaluate heart attacks since 1994 when the blood test for troponin was introduced.

It relies on the fact that serum albumin normally is able to easily bind to metals such as cobalt. Before an MI, there are structural changes in the albumin that make it less able to bind metals. During the test, cobalt is added to a blood sample and the free cobalt---the amount that isn’t bound to the albumin---is measured. If the test is negative---that is, it shows that the patient does not have a high level of free cobalt---this may indicate that the patient has not had an MI.

This is not a stand-alone test. It has to be used in conjunction with other tests to rule out an MI in a patient with chest pain. The ACB test can be viewed as the third component in a trio of tests for MI, the other two being the ECG and the troponin test.

Only about a quarter of patients who present in the emergency room with heart attack symptoms actually are having an MI. In a study conducted by the manufacturer, physicians using the ECG and the troponin test together were about 50 percent accurate in ruling out an MI. When they added the ACB test, their accuracy rose to about 65 percent.

Additional Information:

FDA Clears New Lab Test to Help Rule Out Heart Attack.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=612


Update on Counterfeit Procrit

In a previous broadcast, we told you about the counterfeiting of the drug Procrit, which is marketed by Ortho Biotech Products, L.P. Procrit is used to stimulate the production of red blood cells in patients with severe anemia.

In a significant new development, Ortho Biotech and FDA have now alerted healthcare providers and consumers that 3 more lots of counterfeit Procrit have been identified. They’re labeled as 40,000 units/mL.

There's also a new hazard this time. Our concern with the prior lots of counterfeit Procrit was focused on the active ingredient. That is, whether the strength of the counterfeit product might have been lower than what was stated on the label. This time, counterfeit Procrit was found to be contaminated with bacteria, and that could pose a significant hazard to patients. FDA testing has also shown that some of the counterfeit product contains no active ingredient.

The three affected lot numbers are P007645 (expiration date 10/2004), P004677 (expiration date 2/2004), and P004839 (expiration date 2/2004). It's important to note that authentic Procrit was also distributed under these lot numbers.

In a March 2003 letter to health care professionals, Ortho Biotech points out that there are several differences between the features of this counterfeit product and authentic Procrit. For example, one difference is with the carton closure seal. The seal on authentic Procrit leaves a visible mark on the package when it’s removed. And, the authentic seal has the letters "OBPLP VOID" printed in a random sequence on its underside, which you can see when the seal is removed. When counterfeit product seals are removed, they leave no visible mark and they have no printing on the underside of the seal. Ortho Biotech's web site also points out other differences to look for.

FDA is urging health care providers and patients to check the packaging and vials very carefully before using this product. If you receive any product that you suspect is counterfeit, don't use it. Store it properly and promptly contact the FDA and Ortho Biotech. And if you know of patients who could have the counterfeit product, contact them and provide them with this information.

Additional Information:

Ortho Biotech Letter - March 2003 - Updated Information on Counterfeiting of Procrit.
http://www.procrit.com/counterfeit/letter.html


Drug Errors Caused by Abbreviations

Although abbreviations and acronyms can save time, they can also cause medication errors. Abbreviations aren't always read the same way, and they can be interpreted differently by different practitioners. That's why the National Coordinating Council for Medication Error Reporting and Prevention is encouraging practitioners to avoid using abbreviations when prescribing medications.

Medication errors often happen when the reader misinterprets a poorly written abbreviation or acronym. For example, tenfold insulin overdoses have occurred when the abbreviation "U" (for "units") is read as a zero. That's likely to happen when the "U" is written too closely after the number. A patient died when "20 U" of insulin was misinterpreted as "200 U." Likewise, if they're not written clearly, the abbreviations for microgram (µg) and milligram (mg) can easily be mistaken, causing a 1000-fold error.

But even when abbreviations are typed, mistakes still occur because people sometimes use them improperly. For example, in one case a practitioner intended that a 13-day old infant receive Diluted Tincture of Opium, and so "DTO" was specified on the order. But DTO actually stands for Deodorized Tincture of Opium, which contains 25 times more opium. Had the nurse administered the more concentrated preparation, the result could have been fatal. Luckily, the error was caught in time.

Mistakes also occur when people misinterpret an abbreviation's meaning. For example, HCT, which stands for hydrocortisone, has been misinterpreted to mean hydrochlorothiazide. And conversely, HCTZ, which stands for hydrochlorothiazide has been misinterpreted to mean hydrocortisone.

Latin abbreviations can cause trouble either because they’re written poorly and thus misinterpreted, or because people don’t understand their meaning. The term "q.i.d." has sometimes been interpreted as "q.d.," and vice-versa, leading to a fourfold dose error. In one case, a patient died when a prescription for furosemide 40 mg. “q.d.” was misinterpreted as "q.i.d."

And sometimes mistakes occur because two abbreviations sound alike. For example, an investigational drug to treat cystic fibrosis called CPX sounds similar to CTX, which is the abbreviation for the chemotherapy drug Cytoxin.

Additional Information:

Drug Topics: July 1, 2002. FDA Safety Page: Stemming Drug Errors from Abbreviations.
http://www.fda.gov/downloads/Drugs/DrugSafety/MedicationErrors/ucm080862.pdf


FDA Proposes Bar Codes on Drugs, Blood, Vaccines

Everyone's seen the barcodes found on food and other consumer goods. Now, FDA has issued a proposal to require bar coding on almost all drugs and blood products. Under this proposal, barcoding would be required on all prescription drug products, except for physician samples, on most OTC drugs that are commonly used in hospitals, and on vaccines.

The bar code would contain, at a minimum, the drug's NDC or National Drug Code number. This number identifies each drug, its manufacturer, dosage form, strength and package size. Blood and blood components for transfusion are also included in the proposal. Under the proposal, these products must have machine-readable information, which could be a bar code, that includes blood and Rh type, the facility that prepared the unit, and codes that can trace back to the donor, if necessary.

In hospitals with bar code scanners and computerized patient information systems, the bar coding of drugs and blood products can prevent many medication errors, such as giving a patient the wrong drug or unit of blood, the wrong dose, or the right drug and dose at the wrong time.

When the drug's bar code is scanned, a computer would compare the scanned information against the patient's drug regimen before the drug is given to the patient. So for example, barcoding could prevent a child from receiving an adult dosage of a drug, or keep a patient from receiving a duplicate dose of a drug he’s already been given. A bar code system could also allow the computer to record the time the patient receives a drug, ensuring more accurate medical records.

FDA estimates that when this bar code rule is implemented, 50 percent more medical errors could be caught before the drugs are dispensed or administered. That translates to 413,000 fewer adverse events over the next 20 years. And there’s evidence from some hospitals that already have bar code systems in place that they can reduce even more errors.

Additional Information:

FDA Proposes Bar Codes for Drugs, Blood, Vaccines.
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/BarCodeLabelRequirements/ucm133136.htm



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