April – June 2008

ISMP QuarterlyActionAgenda

No. / Problem / Recommendation / Organization Assessment / Action Required/ Assignment / Date Completed /
Medication errors associated with CEREBYX (fosphenytoin)
(7) / In 1999, label changes were made to highlight the total amount of drug available in Cerebyx vials after fatalities resulted from confusing the per mL concentration as the total dose in the vial. Despite label changes, FDA has identified seven more fatalities of children who received 10-fold overdoses of Cerebyx. In four cases, the drug was obtained from an automated dispensing cabinet (ADC). In two cases, the per mL concentration (50 mg PE/mL) was listed on the ADC screen, not the total drug in the vial (500 mg PE/10 mL). / ADC screens, shelf labels, and printed requisitions should display the total drug content per container instead of the concentration per mL. Ensure all written information is consistent with the manufacturer’s label (100 mg PE/ 2 mL, or 500 mg PE/10 mL). Pediatric facilities should consider stocking only 100 mg PE/2 mL vials of Cerebyx in the emergency department. The need to retrieve many vials in order to prepare a single dose (i.e., ten 2 mL vials would be needed to prepare a 1,000 mg PE dose versus just two 10 mL vials) may serve to alert practitioners to a possible dosing error.
Recall of heparin leads to use of unfamiliar concentrations
(10) / The current situation with heparin products and back-orders means that hospitals may be receiving heparin in quantities, strengths, and packaging that are unfamiliar to staff. The possibility of significant dosing errors increases when unfamiliar products are stocked. / Barcode scanning is the best defense against mix-ups arising from unfamiliar products. Use auxiliary labels to call attention to unusual strengths—even circling the concentration on vial labels with a pen. Vials of heparin flush solutions should be separated from vials containing therapeutic concentrations.
Mix-ups with propylthiouracil and PURINETHOL (mercaptopurine)
(10)
(12) / A fatal error occurred when a pregnant woman was given a prescription for propylthiouracil, abbreviated as “PTU,” early in her pregnancy but received Purinethol when the prescription was filled. A second patient experienced liver toxicity when a prescription for propylthiouracil, also written as “PTU,” was dispensed as Purinethol. / The dangerous abbreviation “PTU” should not be used. Physicians should be encouraged to list brand and generic names on orders for Purinethol, and to include the purpose when prescribing either drug. Computer order entry system warnings should be installed for both drugs. Do not store Purinethol and propylthiouracil near each other. Consider placing warning labels on product containers.
Caution regarding color-coded eye meds
(8) / The American Academy of Ophthalmology has long endorsed a voluntary color-code scheme for ophthalmic products based on therapeutic class. But the color schemes are too similar to differentiate between classes of eye medications, and numerous product mix-ups, both between and within each class, have been reported. / Color-coding ophthalmic products according to therapeutic class does not decrease medication mix-ups in hospitals, as it might in a patient’s home. To prevent look-alike problems, pharmacy purchasers should avoid awarding contracts to one vendor for an entire product line and should consider purchasing drugs within a class from different manufacturers.
Strength misread as total dose on mannitol IV bags (B. Braun)
(8) / The labeling on 250 mL bags of IV mannitol 20% states, “Each 100 mL contains: Mannitol USP 20 g in Water for Injection USP.” A physician prescribed three bags for a patient, believing each one delivered just 20 g. Each 250 mL bag actually contains 50 g. / Consider affixing alert stickers to mannitol to inform staff about the total amount of drug in each bag. Review other medication labels for potential errors, and affix warning stickers or other visual cues to communicate the total content of medication in each container.
Safety issues with insulin pens used in hospitals
(9) / Errors arising from the adoption of insulin pen devices in healthcare organizations are emerging: needlestick injuries to healthcare workers; sharing pens among different patients; withdrawing medication from pens, which results in air pockets that can interfere with dosing accuracy; inadvertent product mix-ups; and erroneous dosing due to improper drug administration techniques. / Although insulin pens offer many advantages over insulin vials, safe use requires anticipating and reducing potential risks before implementation and close monitoring during the first few months of implementation when unanticipated failures and workarounds are most likely to occur. Conducting a failure mode and effects analysis before use, limiting the variety of pens in use, educating staff before use, and establishing written guidelines for reference are important risk reduction strategies.
Avoid confusion with TORISEL (temsirolimus) dose preparation
(9) / Torisel injection is distributed in a kit that contains a vial of active drug along with a vial of diluent. Following dilution, the pre-printed strength on the vial is no longer accurate. A 20% overfill (that is not explicitly stated on the label) adds complexity and increases the potential for dosing errors. / Pharmacists should keep the package insert, with full instructions for dilution, with both the active drug and diluent vials. Use pharmacy computer alerts during order entry and/or warning stickers on packaging to notify staff about the change in concentration when preparing the final dilution. For more information, visit: www.ismp.org/sc?k=pbm.
Remove insulin vials from cartons
(9) / Inadvertently storing one insulin product inside of the external carton of another type of insulin can lead to serious wrong-drug errors. / External cartons for insulin products should be discarded prior to dispensing the vials or at the time of receipt on the nursing unit.
Sumatriptan (IMITREX) confused with sitagliptin (JANUVIA)
(9) / Sumatriptan 25 mg tablets were placed into a matrix drawer intended for sitagliptin 25 mg tablets in an automated dispensing cabinet (ADC). Both medications are manufactured in 25, 50, and 100 mg tablets, and the generic names are similar when read and pronounced. / Be alert for potential mix-ups with this look-alike, sound-alike pair. Use of a bar-coding system when replenishing ADC stock diminishes the risk of inadvertent drug mix-ups. Add a redundancy to manual checking processes by having stocking personnel match both the generic and brand names (if available) when refilling matrix drawers.
Managing visits from pharmaceutical sales representatives
(10) / Hospitals may not manage the process by which pharmaceutical products, devices, and related education are brought into their organizations to maximize safety. Unexpected pharmaceutical products (including samples) and changes in drug storage have given rise to serious, preventable errors. / If you allow onsite visits by pharmaceutical representatives, require them to schedule visits with the pharmacy, wear an identification badge, sign an agreement to abide by hospital rules—including no sample distribution, and be escorted to their destination. For details, visit: www.ismp.org/Newsletters/acutecare/articles/20080522.asp.
Red rules in healthcare
(10)
(12) / In highly reliable industries, “red rules” are limited to just a few rules that must always be followed to prevent serious harm to employees, customers, or the product line. In healthcare, red rules should not be confused with policies or standard operating procedures—even crucial ones like handwashing that call for strict adherence. While compliance with policies and procedures is always expected, there will inevitably be circumstances when practitioners cannot abide by the rules, or circumstances where violating a rule may be the best course of action. / Red rules should be limited to a few, well understood and memorable rules that are possible and desirable for everyone to follow under all circumstances. Anyone who notices that a red rule has been breached should have the authority to stop the process. Examples of red rules in healthcare might include a time out before an invasive procedure and reconciliation of a sponge count before closing a surgical incision. Following the “5 rights” of medication use and full compliance with barcode scanning technology are not appropriate red rules in healthcare, as both rules are often broken for reasons rooted in inadequate system support for following the rule.
Restricted character space and truncated drug listings are a set-up for medication errors
(11) / Truncated information appeared on a medication administration record (MAR) as “NOVOLOG FLEXPEN 70” rather than “NOVOLOG FLEXPEN 70/30.” This led a nurse to administer 70 units of NOVOLOG (insulin aspart) instead of NOVOLOG 70/30 (insulin aspart protamine, insulin aspart). / Review how drug information appears on MARs and pharmacy labels. If problems are found, work with the pharmacy computer system vendor to prevent truncated data from appearing on MARs and labels. Including “Mix” with NOVO-LOG MIX 70/30 (which is the actual brand name) can help differentiate the drug from NovoLog.
Identify home medications
(11) / A patient filled prescriptions for ISENTRESS (raltegravir) 400 mg, one tablet BID, and PREZISTA (darunavir) 300 mg, two tablets twice daily. The labels on the prescription bottles were reversed, so he took incorrect doses for a month. He was admitted to the hospital where the error persisted because his home medications were administered according to the misplaced labels. / The original medication error was a causative factor in the need for inpatient care, and his condition continued to worsen until the error was discovered and rectified. Pharmacists must identify—very early on—any medication brought from home by patients, especially if it’s necessary to use the patient’s home medication supply until the hospital pharmacy can obtain the drug(s).
Prevent dangerous drug-device interaction causing falsely elevated glucose levels
(12) / When patients receive EXTRANEAL (icodextrin) peritoneal dialysis solution, blood glucose values obtained using some point-of-care (POC) glucose meters may be falsely elevated. Deaths have been reported due to severe hypoglycemia after prescribing insulin based on the falsely elevated glucose levels. Maltose-containing IV immunoglobulin (IVIG) products may cause similar falsely elevated glucose values with glucose meters. / Hospitals should consider using only POC blood glucose meters that rely on glucose oxidase, glucose hexokinase, glucose dehydrogenase nicotinamide adenine dinucleotide (GDH-NAD), or flavin adenine dinucleotide glucose dehydrogenase (FAD-GDH), which are accurate even in the presence of interfering products including maltose. If other POC meters are used, screen patients for interfering products and, if they are prescribed, obtain glucose levels using hospital laboratory methods only.
Look-alike glass bottles of sodium chloride and nitroglycerin
(12) / Sodium chloride 0.9% injection was administered instead of IV nitroglycerin when similarly appearing glass bottles were stored beside one another in a busy ED. / Evaluate and correct storage practices that can lead to errors. Determine if at-risk behaviors (such as “grab and go” when selecting products) are occurring on busy units. Practice habits—such as meticulous reading of labels and consistent use of barcode technology—should be operational norms that are periodically monitored.
July 17, 2008 / ISMP MedicationSafetyAlert!Ò
/ QAA 4