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ISMP Medication Safety Alert
ISMP Action Agenda: July - September, 1998

From the January 27, 1998 issue

One of the most important methods for preventing adverse drug events is for organizations to seek and use knowledge from other organizations that have already experienced problems. Since ISMP believes that it will make a significant impact on error prevention efforts, we ask that an interdisciplinary committee at each practice site review the following agenda to prompt discussion, and then take the necessary action to prevent these adverse drug events. Please be sure to share this agenda with administration. The American Society of Healthcare Risk Management (ASHRM) will also be enclosing this agenda with their bimonthly newsletter which is sent to all members. The following selected items appeared in the ISMP Medication Safety Alert! between July and September, 1998. Each item is followed by a description of the problem and our recommendations to promote safe medication practices. The issue number is also included in parenthesis next to each item.

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

  • Lipid-based amphotericin B products, lipid-based doxorubicin, and daunorubicin hydrochloride (15, 16, 17, 19; Special Alert, Aug. 19 )
    Problem: with dosing recommendations vastly different, additional dangerous overdoses have been reported when staff confuse lipid-based products with their conventional counterparts. Amphotec, sometimes referred to in texts and drug databases as “amphotericin B colloidal
    dispersion,” may be confused with conventional amphotericin B, also thought of as a “colloidal dispersion” since it forms a “colloidal suspension” after reconstitution
    Recommendation: educate staff when introducing lipid-based products; avoid storing these products next to each other; use warning labels and add computer warnings; use brand names only when prescribing lipid-based products; dispense from pharmacy and restrict nursing access to
    pharmacy after hours; assure proper nomenclature is used in computer systems
  • KETALAR (ketamine) and CEREBYX (fosphenytoin) labeling (17)
    Problem: additional reports received about errors caused by confusing labeling (total volume and concentration are listed in different locations) and bypassing the pharmacy dispensing system
    Recommendation: whenever possible, avoid using these drugs until the labeling problem is remedied; store the drugs in the pharmacy only; if the drug must remain as floor stock, provide vials with the smallest amount of drug possible; add auxiliary labels that list total vial contents
  • OXYCONTIN (oxycodone HCl controlled-release) and oxycodone HCl immediate release tablets (17)
    Problem: mix-ups occur when staff confuse the brand name, OxyContin, with oxycodone, or the prescriber uses the generic name to order the controlled release formulation without specifying “controlled release”
    Recommendation: do not store immediate release and controlled release products together; if possible, have the pharmacy dispense oral oxycodone products for individual patients; use brand names when prescribing these drugs; educate staff about the potential for confusion
  • INTEGRILIN (eptifibatide) (19)
    Problem: with the vial labeled “20 mg/10 mL bolus vial,” staff may believe that an entire vial is a single bolus dose; with the 2 mg/mL concentration prominently listed in an enclosed border, but separated from the total vial contents, staff may misunderstand the strength as the total vial contents; dosing requires calculation from mcg/kg to mg/kg
    Recommendation: store the product only in the pharmacy and have them prepare “stat” loading doses; develop and post dosing charts to avoid calculations; use the term “loading dose,” not “bolus dose” when prescribing the drug
II. Dosing errors
  • Use of dosage equations (14)
    Problem: medication errors occur frequently when physicians use dosage equations, especially when calculating pediatric drug orders (Lesar TS. Errors in the use of medication dosage regimens. Arch Ped Adol Med; 1998;152:340-4)
    Recommendation: use pre-established dose ranges or tables, computer order entry which calculates doses, or require both the calculated dose and dosage equation on orders to facilitate independent double checks
  • Excessive dosing of nortriptyline (17)
    Problem: with dosing recommendations for treatment of neuropathic pain syndrome significantly different from conventional antidepressant dosing, two patients receiving nortriptyline for neuropathic pain received excessive doses
    Recommendation: include the drug’s indication with prescriptions; program maximum dose warnings into the computer for each indication; educate staff about dosing for neuropathic pain syndrome; teach patients the names, doses and purposes of all their medications
  • Lack of unit dose system in NICU (18)
    Problem: an infant died after receiving 7.4 mL (185 mg) of aminophylline instead of 7.4 mg when the drug was removed from floor stock, prepared, and given without being independently double checked
    Recommendation: examine medication practices in your NICU units and require pharmacy to dispense medications (to NICU and all other units) in the most ready-to-use form possible
III. Ambiguity or errors in drug references or advertisements
  • Handbook on Injectable Medications, 8th Ed .( 16)
    Problem: another patient died from improper dilution of albumin when staff relied on an outdated text that implies safe use of sterile water as a diluent regardless of volume
    Recommendation: discard outdated editions of this text and purchase the 10th edition; educate staff to use sodium chloride 0.9% or 5% dextrose in water to dilute albumin regardless of volume; prepare guidelines for albumin dilution
IV. Miscellaneous
  • Ineffective patient education (16)
    Problem: after a physician demonstrated use of an inhaler by releasing two puffs into the air, the patient used his inhaler by releasing puffs into the air (while sitting in his car to minimize space) and breathing deeply
    Recommendation: be clear and complete when providing instructions for medication use; provide thorough instructions and always include the obvious; ask patient to repeat instructions
  • IV medications administered intrathecally (19)
    Problem: one patient died after intrathecal injection of vincristine, instead of cytarabine; another patient developed hemiparesis and currently requires mechanical ventilation after intrathecal injection of rifampin, along with vancomycin
    Recommendation: separate the location and delivery times for intrathecal medications so that IV drugs are never present with intrathecal medications; have two practitioners independently verify the accuracy of intrathecal medications before administration; apply warnings “FATAL if given intrathecally. FOR IV USE ONLY” on all vinca alkaloid products
V. Adverse drug reactions, side effects and product impurities
  • VISTIDE (cidofovir injection) (17)
    Problem: cases of acute renal failure resulting in dialysis and/or contributing to death were reported after as few as one or two doses of the drug
    Recommendation: Gilead Sciences has distributed a letter to reinforce the importance of adhering to specific treatment guidelines when prescribing and administering the drug
  • Albumin or plasma protein fraction (PPF) use with seriously ill patients (research cited in British Medical Journal) (15)
    Problem: recent research revealed excess mortality in patients with hypovolemia, burns or hypoproteinemia who received albumin instead of or in addition to crystalloid solutions
    Recommendations: FDA urges physicians to exercise discretion using albumin/PPF; consider development of treatment guidelines for use of albumin, nonprotein colloid and crystalloid solutions
  • Impurities in some 5-hydroxy-L-tryptophan (5-HTP) products (18)
    Problem: FDA has confirmed the presence of impurities, including “peak X,” in some 5-HTP products; “peak X” has been associated with past epidemics of eosinophilia-myalgia syndrome (EMS)
    Recommendation: although the significance of finding “peak X” in these products is unknown, past experience suggests vigilance is warranted
  • Use of high dose epinephrine during cardiopulmonary resuscitation (CPR) (research cited in Annals of Internal Medicine) (19)
    Problem: a study noted that, while restoration of circulation is possible, patients revived with high-dose epinephrine (>6 mg) often left the hospital with severe neurological impairment
    Recommendation: emergency care providers should be wary of using repeated doses of epinephrine that result in excessively high doses
VI. For discussion
  • Benchmarking medication error rates - when is it dangerous? (18)
    Problem: benchmarking error rates is effective only if a system of objective measurement, more reliable than spontaneous error reporting, is used to identify best practices, and if it is combined with a system to determine the processes that enable safe medication use
    Recommendation: encourage error reporting to identify and remedy problems, not to provide statistics for comparison
  • Florida State Board of Pharmacy the first to require continuous quality improvement (CQI) (14)
    A non-punitive approach to errors is promoted by requiring a multidisciplinary committee to meet bimonthly to discuss errors and suggest system improvements while considering, at a minimum, the effects of staffing levels, work flow and technological support
  • Herbal medicines (17, 19)
    Problem: herbal products are not free of risks; no standards exist for manufacturing, labeling or pre-marketing approval to demonstrate safety and efficacy; there is limited human research or practitioner reporting about adverse drug events
    Recommendation: learn about herbal products and keep reliable references on hand; ask patients about their use of alternative therapies and monitor them carefully for unusual/adverse events; report adverse events (see list of reporting mechanisms in newsletter)
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