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ISMP Quarterly Action Agenda: July - September, 1999


From the October 6, 1999 issue

One of the most important methods for preventing adverse drug events is for organizations to be proactive by seeking and using knowledge from other organizations that have already experienced problems. To make a significant impact on error prevention efforts, administrative staff and an interdisciplinary committee at each practice site should review the following agenda to prompt discussion, and then take the necessary action to minimize adverse drug events in your facility. The following selected items appeared in the ISMP Medication Safety Alert! between July and September, 1999. Each item includes a description of the problem, recommendations for safe medication practices, and the issue number (in parentheses) to locate additional information. The American Society of Health Care Risk Management (ASHRM) provides the ISMP Quarterly Action Agenda to all its members. A list of agenda items is also posted on our web site (www.ismp.org), and, in many cases, product-related problems can be visualized in the ISMP Medication Safety Alert! section of our web site.

I. Look-alike/sound-alike drug names, ambiguous or look-alike labeling and packaging

  • Handwritten AVANDIA orders confused with COUMADIN and PRANDIN (15, 18
    Problem:Poorly handwritten orders for the new oral antidiabetic agent for Type II diabetes, AVANDIA (rosiglitazone), have been confused with the oral anticoagulant COUMADIN (warfarin) and PRANDIN (repaglinide), also a drug for Type II diabetes. Avandia and Coumadin are both available in a 4 mg oral dosage form. Prandin is available in a 2 mg tablet but the dose ranges up to 4 mg. These dose similarities increase the risk of confusion.
    Recommendation:Educate staff about the error potential between these products, even if any of these drugs are not on the formulary. Build alert flags into pharmacy computer systems and use reminder labels on drug containers. Physicians should provide written indications for medications with each prescription and educate patients so they are aware of the product name and know what to expect at the pharmacy.
  • Ferrous sulfate confusion (16)
    Problem:The front label panel on each carton of Hi-Tech Pharmacal Company's liquid ferrous sulfate product indicates the contents as "ferrous sulfate solution" and "iron supplement drops." In the U.S., ferrous sulfate "solution" is not standard nomenclature. Liquid preparations here include a syrup (18 mg elemental iron per 5 mL), an elixir (44 mg elemental iron per 5 mL), and drops (15 mg of elemental iron per 0.6 mL). Since the drops have about three times as much iron as the elixir and about seven times as much as the syrup, labeling the drops as "solution" could lead to confusion with the syrup or elixir and a dangerous overdose. One case of iron overdose was reported.
    Recommendation:: Inspect all drug storage areas to determine if this product is in stock and replace with another manufacturer's ferrous sulfate drops. FDA and the company are aware of the problem. Label changes are underway.
  • Confusion reported between XELODA and XENICAL (18
    Problem:Roche Laboratories, manufacturer of both XELODA (capecitabine), an antineoplastic agent, and XENICAL (orlistat), an antiobesity agent, has notified health professionals about the potential for name confusion with these products. Although the dosing is significantly different, both drugs begin with the letters XE, have similar packaging, and are oral agents.
    These drugs should be stored separately. Computer mnemonics should be based on the generic name. Since the dose and directions for taking these products differ greatly, educating patients and printing the drug's name, strength, daily dose, and the medication's purpose on the prescription can help to prevent mix-ups.
  • HESPAN and heparin mix-ups (18)
    Problem:A fatal error occurred when a nurse mistakenly selected and administered two heparin 25,000 unit per 500 mL premixed bags instead of HESPAN (hetastarch) for a patient who was actively bleeding. Such mix-ups have been reported on several occasions to USP, ISMP and FDA. Although this is primarily a nomenclature issue (both names include the characters h-e-p-a and n in the same sequence), the drugs are also found in similar IV bags with blue and red labeling. Since Hespan may be used in patients who are actively bleeding, the danger of inadvertent heparin administration is obvious.
    Recommendation:Since hetastarch is now manufactured generically by other companies, consider using an alternate to Hespan and refer to hetastarch products by generic name. If Hespan remains in stock, do not store alphabetically next to premixed heparin products. Label products, storage bins, and automated dispensing machine pockets with a reminder about error potential. ISMP has communicated with FDA and the manufacturer about this serious problem.

II. Misinterpretation or miscommunication of drug orders

  • Safe dispensing process needed for patients who can't swallow NIMOTOP capsules (17)
    Problem:NIMOTOP (nimodipine), indicated for improvement of neurological deficits due to cerebral artery spasm following subarachnoid hemorrhage, must often be given via feeding tube to patients who cannot swallow. Although the manufacturer recommends extracting the Nimotop capsule's liquid contents into a syringe to facilitate tube administration, a parenteral syringe is often used and this allows the drug to be given accidentally by the IV route instead of the feeding tube if the lines are confused by staff. Several fatalities have occurred.
    Recommendation:Nurses should notify pharmacy when patients can't swallow. Liquid capsule contents must be placed into an oral syringe that is prominently labeled with the route of administration. It is critical for pharmacists to communicate with nurses about error potential whenever the drug is dispensed. Computer reminders can be used to trigger this response and to assure that appropriate warnings appear on computer-generated medication administration records.
  • Hypertonic solutions of sodium chloride injection repeatedly confused with isotonic products (17)
    Problem:Orders for "sodium chloride 0.3% injection" have been confused with sodium chloride injection 3%.
    Recommendation:Use of hypotonic sodium chloride 0.3% injection by itself could lead to patient harm. The concentration exists commercially only in combination with dextrose injection. Prescribers should avoid using items not on the hospital formulary. Hypertonic sodium chloride injection 3% is available in most hospitals and has been given in error when 0.3% is ordered. Hypertonic 3% solutions should be stored only in the pharmacy to limit access and reduce the potential for this dangerous mix-up. To assure patient safety, a pharmacist should review each patient's clinical situation before dispensing either concentration.
  • Clinical personnel must understand physiologic concept behind peritoneal dialysis (19)
    Problem:A child suffered fatal hypernatremia after receiving specially prepared peritoneal dialysis solutions. The pharmacist who prepared the dialysate started with a base solution that already contained a physiologic amount of sodium. He thought he was adding more sodium to treat an electrolyte deficiency, as one would by increasing the amount of sodium in an IV solution. The ordered solution should have used sterile water for injection (SWFI) as the base.
    Recommendation:Practitioners who treat dialysis patients, including personnel who prepare solutions, must clearly understand the physiology underlying peritoneal dialysis. The patient's serum sodium level tends to equilibrate with the dialysate's electrolyte concentration during each cycle of dialysis. Adding sodium ions, while failing to take into account the physiologic amount of sodium already present in the commercially available base solution, will lead to hypernatremia. A clear order to use SWFI as the base solution also would have prevented this error.

III. Medication delivery device problems

  • Proper label placement on syringes can reduce errors with "IV push" medications (15)
    Problem:: Many serious medication errors occur when the wrong patient receives an "IV push" medication or when the wrong drug or dose reaches a patient.
    Recommendation:Error potential can be reduced by a labeling technique that places the patient's name, location, drug, and dose uppermost on the syringe label. When the label is affixed, flush with the syringe scale, which must be viewed during injection, important information is easily visible to the person administering the drug. This provides additional opportunity to recognize any errors.
  • Lack of focus on human factors allows error prone devices (15 )
    Problem:Practitioners and patients are often blamed for serious errors that are rooted in poorly designed IV infusion pumps, patient-controlled analgesia devices, drug delivery and packaging systems, drug administration tubes and catheters, etc. Manufacturers and regulatory authorities often fail to adequately consider user needs and human factors.
    Recommendation:Make error potential a factor in device purchasing decisions. Manufacturers and purchasers must take into account the possibility of device-related errors so that error-prone devices may be avoided where possible. Establish an independent double check system before administration to detect possible programming errors. Consult with independent organizations that evaluate medical equipment and review reports of device-related errors published in the ISMP Medication Safety Alert! and elsewhere.

V. Discussion Items

  • Error rates from practitioner reporting are a meaningless and potentially dangerous way of measuring medication safety (16)
    Problem:Hospitals and health systems often rely on incident reports to "benchmark" or measure their medication error rates as an indication of the safety of their system. Yet, by itself, data from hospital incident reports provides an inaccurate and meaningless way to measure effectiveness of error prevention strategies. Many actual and potential errors are either undetected or unreported.
    Recommendation:Rates that appear high may actually reflect a nonpunitive environment that encourages reporting and facilitates open discussion to improve systems. Criticizing high error reporting rates instead of rewarding them is punitive and will suppress the gathering of essential information. More useful measurement strategies are listed in the ISMP Medication Safety Alert!.
  • Four-pronged error analysis (19)
    Problem:Excluding analysis of near misses and medication errors that have happened at other facilities prevents proactive error reduction strategies. Most often, proactive efforts are not given high priority. As a result, organizations may be busy "fighting fires" rather than preventing them.
    Recommendation: In addition to examining internal errors that cause patient harm and analyzing aggregate data, include a systems review of internal and external errors that have the potential to cause harm. This fosters less defensive posturing since the errors have not happened at your facility. Also, as improvements are made, enthusiasm builds for identifying, reporting, and analyzing errors that are actually occurring within the organization. In the end, discussion about external errors leads to more effective analysis of internal errors.
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