ISMP Quarterly Action Agenda: April - June, 1999

From the July 14, 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 April and June, 1999. Each item includes a description of the problem, recommendations for safe medication practices and the issue number (in parenthesis) to locate additional information. The American Society of Health Care Risk Management (ASHRM) provides the quarterly ISMP Action Agenda to all its members.

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

• ACTIQ (oral transmucosal fentanyl citrate) flavored sugar lozenge with an attached handle (7)
  Problem: Actiq, used to manage breakthrough pain in opiate tolerant patients, resembles a "lollipop." The product could be fatal if children mistake it for candy or if used by adults who are not already taking opioid narcotics.
  Recommendation: Pharmacists and home care/hospice nurses should educate patients and family members to avoid referring to the drug as a "lollipop" or "candy" and to eliminate possible access by anyone other than the patient.
• Alcohol, formalin, and methadone confused with distilled or tap water (7), (11)
  Problem: Several cases have been reported where amoxicillin was reconstituted with 50% alcohol solution, methadone, or formalin instead of water. In all cases, the chemicals and methadone were stored near look-alike containers of water.
  Recommendation: Discard chemicals that have not been used in years. Store those that must remain away from drugs and drug supplies. Place warning labels on those that look like other products. Label and bottle methadone distinctly and segregate it from other drugs. Pharmacies should not be distributing chemicals to laboratories.
• CELEBREX (celecoxib), CEREBYX (fosphenytoin), and CELEXA (citalopram) (1), (3), (4), (7), (8), (9)
  Problem: Over 100 errors have been reported with Celebrex, due primarily to confusion with Cerebyx and Celexa.
  Recommendation: Encourage physicians to include the drug's indication when prescribing these products. Restrict verbal orders to emergency situations with Cerebyx. When used, spell the drug name back to prescribers. Build alerts in the pharmacy computer system. Remove Cerebyx from floor stock and have pharmacists dispense it when prescribed. Educate patients to understand the name and purpose of these products and to carefully check that prescriptions are filled accurately. Consider using an alternate product instead. ISMP continues to urge FDA and Celebrex's manufacturer to change the current brand name.
• Chlorpromazine and chlorpropamide (10)
  Problem: One patient died and another developed serious symptoms after receiving 750 mg of chlorpropamide instead of 75 mg of chlorpromazine daily. The prescriptions were filled with chlorpropamide, 250 mg, with directions to take three tablets daily.
  Recommendation: Place warnings on drug containers and storage bins. Build alerts in the computer system and design mnemonics to prevent the names from appearing simultaneously on the screen. Assure that drug indication matches patient needs.
• BENTYL(dicyclomine) (9)
  Problem: Practitioners are likely to believe that Bentyl ampuls (Merrell Pharmaceuticals) contain a total of 10 mg instead of 20 mg, as the ampuls are labeled 10 mg/mL but the 2 mL total volume is not listed.
  Recommendation: Until the manufacturer changes the label, add warnings to alert practitioners to the total ampul contents.
• Infants' TYLENOL (acetaminophen) concentrated drops and children's acetaminophen elixir (12)
  Problem: A nurse administered 10 mL (1,000 mg) of Infants' Tylenol concentrated drops (100 mg/mL) instead of children's acetaminophen elixir (160 mg/5 mL).
  Recommendation: Use McNeil Consumer Healthcare's new SAFE-TY-LOCK container for Infants' Tylenol concentrated drops. Its design allows the dropper to be inserted, but its one way valves make it difficult to pour teaspoon doses.
• CIPRO (ciprofloxacin), TAXOTERE (docetaxel), and ROTASHIELD (rotavirus vaccine, live, oral) (11)
  Problem: Each of these products contains diluent vials that emphasize the name of the active drug - not the fact that it is only the diluent. As a result, product diluent has been dispensed accidentally instead of the final reconstituted drug.
  Recommendation: ISMP has asked FDA and the companies to de-emphasize the drug name and prominently label the vial as diluent. Until then, add auxiliary reminder labels to shelf cartons.
• Jury verdict finds hospital grossly negligent for stocking concentrated sodium chloride in NICU(13)
  Problem: An infant suffered permanent hand scarring after he was mistakenly injected with concentrated sodium chloride. The jury awarded the infant and parents $85,000, citing that concentrated sodium chloride should not have been available in NICU.
  Recommendation: Remove all forms of concentrated sodium chloride from patient care areas and have pharmacy dispense these solutions as ordered.
• Repeated errors with penicillin G benzathine (13)
  Problem: Another child received penicillin G benzathine IV. Widespread knowledge deficits about using the drug "IM only" and remote placement of the manufacturer's warning contribute to errors.
  Recommendation: Provide ongoing education about this error-prone drug to all practitioners involved in medication use. Apply bold warning labels on syringe barrels before stocking/dispensing the drug.

II. Misinterpretation or miscommunication of drug orders

• Numbering orders (7)
  Problem: Numbered medical orders may be misinterpreted as the number of tablets/doses to be administered.
  Recommendation: Circle numbers used for listing orders or avoid numbering orders at all, even on preprinted ordered forms.
• Lack of space between drug name and dose (9)
  Problem: A handwritten order for "cisplatinol (sic) 75 mg/m2" was subsequently typed as "cisplatinol75 mg/m2." The last letter (l) was misread as part of the dose. The patient received 175 mg/m2 and suffered hearing loss and acute renal failure.
  Recommendation: Review all preprinted orders, drug protocols, computer-generated MARs and label formats to assure spaces are appropriately placed between drug names and doses. Use only approved generic names (cisplatin, not cisplatinol).
• Misplaced decimal point (9)
  Problem: A patient received 5 mL of fentanyl (0.25 mg or 250 mcg) instead of 0.5 mL (25 mcg) after a nurse mentally misplaced the decimal point when converting the milligram dose expressed on the label with the ordered dose in micrograms.
  Recommendation: Consider using morphine as the preferred opiate for intermittent pain control. If fentanyl must be used, design dosing charts. Have pharmacy prepare PCA doses and develop protocols to guide safe dosing and administration.
• Ordering by volume, not weight (9)
  Problem: An order for ferrous sulfate "1 dropperful 3 times daily" led to confusion about the intended dose, especially since practitioners or consumers may vary in their interpretation of a "dropperful" and droppers supplied with various ferrous sulfate products have differing measurement scales.
  Recommendation: Prescribe drugs by weight, not volume. Express both mg weight and volume on prescriptions and MARs since measurement devices may include only volume calibration marks. Use the measurement device included in the package.
• Transcription error on discharge summary (10)
  Problem: Reliance on a mistranscribed discharge summary led to an order for SYNTHROID (levothyroxine), 0.5 mg, when the patient was actually taking 0.05 mg.
  Recommendation: Encourage prescribers who are unfamiliar with patients to contact family physicians, internists and community pharmacies for accurate drug therapy information. When transcribing discharge summaries, use current MARs and clearly enunciate and spell all drug names. Promote timely and careful physician review of all discharge summaries.
• Unclear communication of orders using a felt tip pen (13)
  Problem: A COUMADIN (warfarin) dose duration of 2 days was misinterpreted as 7 days when the prescriber used a felt tip pen and the bottom of the numeral 2 failed to carry through to the carbon copy.
  Recommendation: Remind prescribers to use a ball point pen to write orders on multiple copy forms.
• Misinterpretation of apothecary measurements (13)
  Problem: A patient received phenobarbital 0.5 grams (500 mg, obtained from 4 x 130 mg unit dose syringes) IV daily for three days instead of 0.5 grains after the prescriber misread the apothecary dose listed on the patient's prescription bottle.
  Recommendation: Only the metric system should be used when prescribing and labeling drugs. Educate practitioners that needing more than 2 or 3 dosage units could signal an error.
• Misread checkmarks used to order drugs on preprinted order forms (13)
  Problem: A pharmacist misread a checkmark on a preprinted prescription form that listed twelve different eye products. TOBRADEX (tobramycin and dexamethasone) was dispensed instead of TOBREX (tobramycin) (listed on the line above) and the child suffered steroid-induced glaucoma. Recommendation: If using preprinted order forms that allow prescribers to check a box to order the drug and/or fill in a dose, assure that look-alike drug names do not appear near each other.

III. Medication delivery device problems

• Check valves on IVAC administration sets may be difficult to prime (12)
  Problem: Some check valves used for piggybacking with IVAC administration sets may be difficult to prime. Problems may also be encountered with other IV sets, as the same check valve vendor provides materials for other brands.
  Recommendation: Until Alaris (markets IVAC devices) makes corrections, squeeze the IV bag or firmly tap the check valve against a hard surface to open it. Otherwise, attach an empty sterile syringe to the injection port below the valve, clamp the tubing, and aspirate using the syringe. Place directions for opening the valve with administration sets
• Amber oral syringes pose potential risks (11)
  Problem: Using amber oral syringes heightens the potential for error as the volume contained in the syringe is difficult to see and the solution's color is not visible. Empty amber syringes have been labeled and dispensed as if there were medication inside.
  Recommendation: Encourage the use of clear oral syringes (not hypodermic syringes) for oral liquid drugs. Light sensitive preparations should be placed in USP compliant, ultraviolet light protecting sleeves. Label both the sleeve and syringe.
• Multiple infusion lines, dual chamber pumps and look-alike IV solutions (13)
  Problem: Magnesium sulfate overdoses occurred when multiple infusion lines on a dual chamber pump were mixed up (magnesium sulfate restarted instead of oxytocin) and when IV solutions were misidentified (magnesium sulfate hung instead of Ringer's lactate).
  Recommendation: Use single chamber pumps for high alert drugs such as magnesium sulfate, label IV tubing near its juncture with the pump, physically trace the tubing from the IV bag to the pump, and establish a system of independent double checks when adjusting rates or hanging solutions. Provide magnesium sulfate in containers that differ in size from other common labor and delivery solutions.

IV. Miscellaneous errors and adverse drug reactions

• Stress from making an error may contribute to other immediate errors (8)
  Problem: After administering VERSED (midazolam) to the wrong patient, an anxious practitioner, intending to administer ROMAZICON (flumazenil), accidentally administered ZOFRAN (ondansetron) to the patient.
  Recommendation: Take into account the amount of stress that practitioners undergo upon realizing their involvement in a serious error and, whenever possible, have another practitioner provide additional treatment, as indicated.
• Incorrect dose calculation and lack of double checking (8)
  Problem: A prescriber incorrectly calculated a dose of methylprednisolone, but included the mg/kg dose in the written order. Failure to double-check the physician's calculated dose led to a patient receiving a massive overdose.
  Recommendation: Encourage prescribers to include the mg/kg or mg/m2 dose with the calculated dose and require nurses and pharmacists to mathematically double-check the physician's calculated dose and initial the order form. Pharmacy computer systems should be effectively designed to alert practitioners to subtherapeutic or excessive doses.
• "Rule of 6" not optimal for patient safety (11)
  Problem: Calculation errors, nursing IV admixture errors, inconsistent use of the rule, and fluid overload are a few examples of problems that have occurred when nurses rely on the "rule of 6" to calculate pediatric critical care drugs dosed in mcg/kg/min.
  Recommendation: Standardize concentrations for pediatric critical care drugs and use commercially available premixed solutions or pharmacy prepared products. Provide nurses with mcg/kg/min dosing charts and make them available on preprinted solution labels.
• Incorrect label instructions (9)
  Problem: Accidentally touching the letter "f" instead of "g" resulted in a drug label which read "five ¼ teaspoonful" instead of "give ¼ teaspoonful." Also, adding an unnecessary verb to directions for a coal tar bath ("take four capfuls in bath") led to a patient swallowing the product meant for dilution in bath water.
  Recommendation: To detect order entry errors, keep the original prescription and typed label together during the dispensing process and review directions out loud with the patient. Use verbs in directions only when necessary for correct interpretation.

V. Discussion Items

• Potential error analysis by Pharmacy & Therapeutics (P&T) Committee (8)
  Problem: When adding new formulary drugs, P&T Committees may consider cost, efficacy, and serious adverse drug reactions (ADRs). Yet, the drug's potential for error may not be fully anticipated and considered.
  Recommendation: Include error potential as a standing discussion item for all new drugs considered for formulary inclusion. Establish guidelines or restrictions for those with heightened error/harm potential and educate staff before using the drugs. Search the literature for at least six months to identify errors or ADRs that may have been reported since product launch.
• The "five rights" of medication use (right patient, drug, dose, route, time) (7)
  Problem: The "five rights" are goals of safe medication use, not procedural guidelines for practitioners. They focus on individual performance and fail to acknowledge the significant contribution of human factors (e.g., confirmation bias) when errors are made.
  Recommendation: Avoid simply admonishing practitioners who make an error for not following the "five rights." Instead, help practitioners achieve these goals by establishing strong support systems and processes that encourage safe medication use.
• Proactive root cause analysis (8)
  Problem: Many hospitals wait until a sentinel event to perform their first root cause analysis.
  Recommendation: Test your root cause analysis process now so that you can function well in an actual emergency. As an added benefit, performing such analyses on "near misses" will provide you with considerable opportunities to improve drug safety.
• Rapid expansion of clinical services may outpace adequate planning for safe medication practices (9)
  Problem: Pharmacy supplied a newly established pediatric emergency department with 5 mL vials of Ketamine, 100 mg/mL (500 mg), instead of the 5 mL, 10 mg/mL vials the newly hired emergency staff used at another ER. A physician administered the total vial contents (500 mg), instead of 50 mg, when sedating a child.
  Recommendation: When establishing new hospital services, devote adequate time to identify and remedy potential areas of weakness. Ensure proper staff training and appropriate staffing levels in proportion to the new workload for all involved disciplines.
• Current public-policy discussions explore various types of national reporting programs (10)
  Problem: While a mandatory reporting program may yield larger numbers of actual errors, hazardous situations that have the potential to cause harm may not be reported. Further, a mandatory program is unlikely to yield much new information beyond what can be learned from the current, streamlined voluntary reporting program, the USP Medication Error Reporting Program (MERP). Rather than more data, effective action must be taken on problems that have already been identified and will continue to be identified through the current voluntary program. Prior experience with state-mandated reporting programs has identified numerous problems, including a punitive focus (to identify dangerous practitioners and punish those who fail to report), which discourages reporting and in-depth evaluation of system-based causes of errors.
  Recommendation: Non-punitive and confidential voluntary reporting programs tend to provide more useful information about errors, system-based causes of errors, and effective remedies. Resources should be directed toward expanded use of the current non-punitive, voluntary USP MERP and authoritative oversight of system-based safe practice recommendations by JC, state, and federal healthcare agencies.
• Medication error prevention "toolbox" (11)
  Problem: Selecting the best error prevention strategy is not easy. Often, the most effective action is not clear. Recommendation: Select high-leverage error prevention strategies that fix the system (forcing functions, constraints, automation, etc.). Place less reliance on those that attempt to fix people (rules, policies, staff education, etc.).