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ISMP Medication Safety Alert
ISMP Action Agenda: April - June, 1998


From the July 15, 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. Unclear or unsafe order communication

  • Prempro® (conjugated estrogens/medroxyprogesterone acetate)
    Problem: drug frequently ordered without specifying dose (drug now marketed in two strengths - 0.625 mg/2.5 mg and 0.625 mg/5 mg strength)
    Recommendation: accept only complete orders that specify the strength; add auxiliary labeling to highlight differences between these two products to prevent mix-ups by staff
  • Errors related to decimal points and communication of large doses
    Problem: deaths reported due to ten-fold overdoses of cisplatin (204 mg given instead of 20.4 mg) and penicillin G benzathine (1,500,000 units given instead of 150,000 units)
    Recommendation: round cancer drug orders over 10 mg to a whole number to eliminate the use of decimal points (i.e., use 20 mg not 20.4 mg); write large doses of drugs using alpha notation (i.e., one hundred thousand or 1.2 million)
  • Ineffective or absent procedure for resolving medication use conflicts
    Problem: staff concerns remain unresolved when the policy for handling conflicts about the safety of drug orders is ineffective or absent
    Recommendation: develop and follow a clear process for handling drug therapy concerns
II. Look-alike drug names and ambiguous labeling and packaging
  • Norvasc® (amlodipine) and Navane® (thiothixene), Prilosec® (omeprazole) and Prozac® (fluoxetine)
    Problem: these drug name pairs are the most frequently cited in medication mix-ups; both pairs are oral solid dosage forms and have similar strengths and dosing frequencies
    Recommendation: program warnings in the computer; add auxiliary warning labels on drug containers/bins; confirm the drug’s purpose matches patient’s condition
  • Testoderm® (testosterone transdermal patch), Testoderm® with Adhesive, and Testoderm TTS®
    Problem: potential for confusing new TTS product formulation (to release 5 mg/day when applied on the arm, back or upper buttocks) with the other two formulations (to release 4 mg or 6 mg/day when applied to the scrotum, which is 5 times more permeable than other sites)
    Recommendation: note the site of application on the order and educate the patient; add auxiliary labeling to highlight the differences between these products to prevent mix-ups by staff
  • Cerebyx® (fosphenytoin) labeling
    Problem: a child died from an overdose caused by confusing labeling (volume and concentration are listed in different locations, dose was not expressed in terms of phenytoin) and the pharmacy dispensing system was bypassed
    Recommendation: do not store this drug outside the pharmacy; if the drug must remain as floor stock, place auxiliary labeling that lists total vial contents; promote dosing in terms of “PE”; consider restrictions on prescribing privileges
  • Ketalar® (ketamine) injection
    Problem: three serious dosing errors caused by confusing labeling (volume and concentration listed in different locations; appearance of drug name and concentration presented in color rendering total volume, in black print, less visible)
    Recommendation: restrict availability; place auxiliary labeling that lists total vial contents; dispense the weakest concentration and smallest volume whenever possible
  • Inocor® (amrinone) and Cordarone® (amiodarone)
    Problem: two more patients died after receiving amrinone instead of amiodarone
    Recommendation: remove amrinone from the formulary and replace with milrinone (Primacor®); confirm the patient’s diagnosis before dispensing/administering these drugs; eliminate stock on units/automated dispensing cabinets
  • Lamictal® (lamotrigine) and Lamisil® (terbinafine)
    Problem: mix-ups due to difficulty distinguishing Lamictal, an antiepileptic, and Lamisil, an antifungal, on handwritten prescriptions
    Recommendation: verify the drug’s purpose matches patient condition; place “name alert” stickers on containers; program computers to flash warnings; spell out the drug name with oral orders
  • Fosamax® (alendronate) and Flomax® (tamsulosin)
    Problem: inadvertent mix-up resulting from similar names, especially when no dose is specified
    Recommendation: specify the dose on all orders; verify the patient’s sex and diagnosis before dispensing/administering the drug; clarify any ambiguous orders; add computer warnings
  • Invirase® (saquinavir mesylate) and Fortovase® (saquinavir free base)
    Problem: confusion between the two different formulations of saquinavir
    Recommendation: add auxiliary labels to remind staff of the two drug forms; use both the brand and generic name when ordering these drugs; consider removing Invirase from the formulary
III. Insufficient knowledge of appropriate and safe route of administration
  • Navelbine® (vinorelbine)
    Problem: potential for inadvertent intrathecal administration with likely fatal outcome
    Recommendation: treat extemporaneously prepared syringes of this drug like the other vinca alkaloids with label warnings “FATAL if given intrathecally. FOR IV USE ONLY”
  • Administering oral/enteral medications through IV catheters
    Problem: Viokase® (pancrelipase) powder was placed in water and mistakenly used to unclog a peripherally inserted central IV catheter (PICC) line
    Recommendation: train practitioners, patients and caregivers to identify what can and cannot be given through each type of line; develop protocols for drugs that are used in an unusual way
  • penicillin G benzathine and penicillin G procaine
    Problem: administering these medications IV has resulted in yet another serious error
    Recommendation: educate staff about the critical nature of giving these medications IM only - never IV!
IV. Device related errors
  • IV pump set free-flow
    Problem: another tragic death from uncontrolled free-flow of IV fluids and drugs (in this case nitroprusside sodium)
    Recommendation: starting immediately with critical care areas and oncology, actively and systematically phase out all unprotected equipment
  • Line mix-ups
    Problem: inadvertent administration of lipid emulsion through an epidural catheter instead of a triple lumen IV catheter.
    Recommendation: label epidural lines at distal connection site; label IV catheters in similar manner when patient has epidural line; use color-tinted epidural tubing
  • hydromorphone (Dilaudid®) and fentanyl
    Problem: withdrawing the wrong drug from pharmacy narcotic automated dispensing module led to the incorrect preparation of epidural PCA and subsequent narcotic overdose
    Recommendation: develop a procedure in the pharmacy to individually document PCA ingredients and their lot numbers on a running list; institute a system of independent checks of PCA preparation by at least two staff members
V. Unsafe storage and labeling of drugs or chemicals
  • Unsafe storage and labeling of drugs or chemicals
    Problem: patient suffered severe tissue damage from injecting liquefied phenol IV instead of guanethidine when they were placed next to each other in identical, improperly labeled cups
    Recommendation: review and monitor the practices related to labeling, handling and storage of potentially toxic substances throughout the institution; label all basins on the sterile field
VI. For discussion
  • Should disciplinary action be taken against those who make multiple or catastrophic errors?
    • the goal of patient safety is best served with a non-punitive environment that places more value on reporting problems so they can be remedied, rather than pursuing the largely unprofitable path of disciplining employees for errors
    • apply a non-punitive approach to errors consistently through high level management support and commitment
  • Tips to prevent misreading labels
    • read the name of the drug on the label, then reread it backwards
    • read the label ALOUD while holding the container in one hand, then read it ALOUD again while in the other hand
  • Weaknesses in hospital medication systems noted by ISMP
    • lack of critical patient information available to pharmacy and nursing staff
    • pharmacists are not readily available face-to-face in patient care areas
    • environmental stressors (noise/interruptions)
    • no independent check system for verifying dose and rate settings on PCA pumps
    • limited staff awareness of well known error prone situations
    • lack of safety procedures for use of automated dispensing equipment
    • lack of pharmacy involvement in direct patient education
    • attempting to compare error rates without understanding the processes and systems behind the numbers
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