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ISMP Medication Safety Alert


ISMP Quarterly Action Agenda - April and June 2007

From the July 12, 2007 issue

One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and use that information to prevent similar problems at your practice site. To promote such a process, the following selected agenda items have been prepared for your senior leaders and an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. These agenda topics appeared in the ISMP Medication Safety Alert! between April and June 2007. Each item includes a brief description of the medication safety problem, recommendations to reduce the risk of errors, and the issue number in parentheses to locate additional information as desired. Many product-related problems can also be viewed in the ISMP Medication Safety Alert! section of our website. The Action Agenda is also available for download ( in a Word format that allows expansion of the columns in the table designated for organizational documentation of an assessment, actions required, and assignments for each Agenda item.

Key: v  — ISMP high-alert medication

Unintentional acetaminophen overdoses(7)
Problem: Unintentional acetaminophen overdoses are rooted in the failure of consumer education about potential harm from exceeding recommended doses, the variety of products that contain acetaminophen, confusing or incomplete labeling of prescription drugs that contain acetaminophen (e.g., APAP), and unknowing conco-mitant use of acetaminophen-containing products. Advertising campaigns that fail to prominently include “acetaminophen” as an ingredient also foster the risk of an overdose. 
Recommendation: Educate patients about the potential for acetaminophen toxicity as well as how to identify acetaminophen as an ingredient in products. Inpatient medication administration records (MARs) should include the amount of acetaminophen in mg for each acetaminophen-containing drug prescribed. Advertisers should prominently list all active ingredients in products.

Ongoing, preventable fatal events with fentanyl transdermal patches (13)
Problem: Instances of significant patient harm, including death, continue to be reported when fentanyl transdermal patches are prescribed inappropriately to opiate-naïve patients and for acute post-operative pain. Despite changes to package labeling and efforts by the FDA, ISMP, and manufacturers to enhance provider education about safe prescribing, the incidence of harm-causing events remains unacceptably high.
Recommendation: Develop guidelines that address appropriate prescribing of fentanyl patches that are consistent with fentanyl patch package labeling, limit use of the patch to opiate-tolerant individuals with chronic pain, and include equianalgesic conversion tables. Measures to make these objectives operational include: setting pharmacy computer systems to provide hard stops if the initial dose is more than 25 mcg/hr; limiting prescribing privileges or requiring review by a pain management specialist; and scripted counseling to stan-    dardize patient education in outpatient settings.

HUMAPEN MEMOIR and HUMIRA PEN (adalimumab) mix-ups (7)
Problem: Humapen Memoir is a pen device that was recently launched for use with HUMALOG (insulin lispro injection [rDNA origin]). This product may be confused with Humira Pen used to treat immune-related disorders. The brand names look and sound very similar
Recommendation: Be aware of the look- and sound-alike characteristics of these products. Prescribers should include the indication for these products, and practitioners should match the prescribed medication’s indication to the patient’s condition to help prevent errors.

Replacing outdated ACTIVASE (alteplase) and TNKASE (tenecteplase) (7)
Problem: When the expiration date has been reached with Activase and TNKase, Genentech instructs hospitals to open the box, check if it’s the diluent or drug that has expired, and if it’s the diluent, to replace it and re-label the outer package with a new expiration date. An expired drug almost reached a patient after a pharmacist listed the new expiration date for the diluent, when the actual drug had an earlier expiration date.
Recommendation: While Genentech discourages return of the product if only the diluent has expired, ISMP confirmed with the company that they would allow pharmacists to return the entire box for replacement when the outer package expiration date has been reached, as ISMP has recommended.

Fentanyl and midazolam bolus doses programmed in mcg, not mcg/kg (8)
Problem: Several medication errors with a single infant occurred when the dose on the MAR was expressed in mcg while a smart pump prompted for a dose in mcg/kg. A total bolus dose of fentanyl was programmed as 12 mcg, without noticing that the smart Smiths Medical Medfusion 3500 Syringe Pump had prompted for the mcg/kg dose (4 mcg/kg). A soft dose-limit alert that appeared on the pump was overridden. The same type of error occurred when programming a bolus dose of midazolam.
Recommendation: Whenever possible, the dose of a medication should be prescribed and displayed on the MAR in the same way the information will be needed to program the pump. This will require nurses to communicate to prescribers about the format needed, and to ensure that pharmacy knows the way that bolus doses are typically delivered to patients (pump or syringe). Alerts, even soft alerts, from a smart pump should require close scrutiny before bypassing.

RCA of chemotherapy error available (10)
A woman with advanced nasopharyngeal carcinoma died after inadvertently receiving an infusion of fluorouracil over 4 hours instead of   4 days. Investigation showed that similar fatal errors have occurred at least seven times in North America.
Recommendation: published a RCA about this event, performed by ISMP Canada, on its website  ( res/4107CCF0-2608-4E4D-AC75-E4E812F94 FD6/0/Incident_Report_UE.pdf) to promote learning. Review the RCA to evaluate and reduce the risk of this type of error in your facility.

Error-prone drug concentration expression on ZEMURON (rocuronium) carton (8)
A near-miss that could have resulted in a ten-fold overdose of Zemuron was reported, due to the prominent display of a mg/mL concentration (10 mg/mL) on the multiple-vial container, without listing the total amount of drug in each vial (100 mg/10 mL).
Recommendation: Providers should be aware of the labeling issue with Zemuron and exercise caution when dispensing and administering the drug. Pharmacy staff should highlight important information, such as the total dose of medication per vial, on carton labels to draw attention to it, or add auxiliary labels if the information is not available on the label.

HydromorPHONE (DILAUDID) and morphine mix-ups (11)
An advisory was issued about harmful and fatal overdoses associated with hydromorPHONE and morphine, many of which were attributed to lack of practitioner awareness of what constitutes an equianalgesic dose of hydromorPHONE, as compared to morphine; and confusion between the names hydromorPHONE and morphine.
Recommendation: ISMP has formally requested changing the name of hydromorPHONE to clearly differentiate it from morphine. Provide equianalgesic dosing charts in all areas where the drugs are prescribed, dispensed, and administered, and use tall man letters when referring to hydromorPHONE.

Purchasing for safety (4)
To prevent mix-ups between look-alike products manufactured by the same company, hospitals may purchase one of the products from a different manufacturer. This safeguard may be met with resistance in the face of binding contracts with a manufacturer, purchasing group, or hospital purchasing department.
Recommendation: Purchasing decisions must always be made with patient safety in mind and not totally dependent on purchasing agreements. Pharmacy directors should seek the input of staff who will be using the product and gain approval from the Pharm-acy and Therapeutics Committee when making decisions about which brand to purchase. Clauses should appear in purchasing agreements to allow for changes if safety is an issue.

Action needed to prevent dangerous heparin-insulin confusion (9)
Inadvertent mix-ups between heparin and insulin have caused grave patient harm. In one case, insulin was added instead of heparin to TPN for a neonate resulting in serious hypoglycemia. Non-diabetic patients have also received insulin instead of heparin during catheter flushes and as a result of transcription and order entry errors. Mix-ups are generally attributed to similar product packaging and/or mental slips, particularly since both drugs are dosed in units and may share a similar 100 units/mL concentration.
Recommendation: Reduce the risk of mix-ups by: segregating heparin and insulin vials; using prefilled heparin syringes; differentiating heparin from insulin by dispensing insulin in pen devices; retrieving and adding insulin to an IV admixture in the pharmacy, and then returning unused stock to its storage area immediately after use; matching the indication for heparin or insulin to the patient’s diagnosis; and requiring independent double-checks for TPN additives. In cases of unexplained hypoglycemia, always consider the possibility of a medication error.

Look-alike heparin vials (9)
A pharmacist who was checking medications destined for an automated dispensing cabinet found 10 mL vials of heparin 5,000 units/mL mixed in with 10 mL vials of heparin 1,000 units/mL, both manufactured by Abraxis. The labeling and caps on the vials are similar, and the products may be difficult to differentiate, especially if lighting is low.
Recommendation: Abraxis plans to investigate relabeling these products. Meanwhile, consider purchasing one product from another vendor to reduce similar appearance. In the pharmacy, do not store concentrations of heparin used to prepare IV infusions near those used to maintain vascular catheter patency. Limit floor stock heparin to 5,000 units per vial or prefilled syringe.

Oral solution given IV (11)
Two patients received IV infusions containing oral ondansetron liquid. The automated dispensing cabinet (ADC) from which the drug was removed contained oral and injectable ondansetron, but the screen did not designate “oral” beside the oral preparation. The product’s clear appearance led the nurse to believe she had an injectable drug, so she withdrew the solution from an oral syringe into a parenteral syringe and gave it IV.
Recommendation: Apply auxiliary labels “For oral use only” to preparations in oral syringes. The ADC product selection screen should state “oral” for oral solutions, especially if injectable agents of the same drug are available in the cabinet. Ensure that nurses receive education about the safety design and purpose of oral syringes. The need to remove an agent from one syringe to another should signal a potential error.

Smart pump not used smartly to detect misprogrammed heparin infusion (8)
A nurse programmed a smart pump to infuse heparin 1,000 mL/hour instead of the prescribed 1,000 units/hour. The dose-checking mode had been bypassed, and the smart pump had been programmed in the standard mode. Investigation revealed that the majority of nurses in the facility were using the standard programming mode instead of the dose-checking mode.
Recommendation: Consistently use the dose-checking features built into smart pumps and evaluate all alerts that arise. Measures to promote full utilization of dose-checking technology include: pre-implementation readiness assessment; post-implementation analysis of pump logs to track overrides; adjusting the pump library to minimize unnecessary alerts; and setting up pumps to default to the dose-checking mode.

IV tubing misconnected to tracheostomy collar  (12)
Problem: A patient’s IV tubing was accidentally connected to the Luer connection on his tracheostomy collar. Fluid further inflated the tracheostomy collar balloon, causing an airway obstruction. The patient became cyanotic, but the error was quickly noticed. The IV line was disconnected from the tracheostomy collar, and the fluid was withdrawn from the balloon.
Recommendation: Conduct a failure mode and effects analysis (FMEA) on existing medical tubing and when introducing new tubes, connectors, and cath-eters, to uncover and manage risks of misconnections. Limit tasks that involve disconnecting and reattaching tubes to trained professional staff. Label lines and trace tubing from insertion to source before making connections.

AHRQ releases its first report on hospital safety culture (10)
Problem: The Agency for Healthcare Research and Quality (AHRQ) has released the results of a 2007 Patient Safety Culture Survey ( qual/hospsurveydb/). Findings of concern include widespread perception that mistakes would be held against those involved in the errors. As a result, more than half of respondents failed to report a single error or safety concern to their hospital during the past 12 months.  
Recommendation: Consider administering the AHRQ Patient Safety Culture Survey in your hospital and comparing your results to the first nation-wide database of findings. Use the results to pinpoint cultural issues that need to be remedied to enhance patient safety, particularly error and safety reporting.

NORCURON (vecuronium) prescribed electronically for wrong patient (11,12)
Problem: The Agency for Healthcare Research and Quality (AHRQ) has released the results of a 2007 Patient Safety Culture Survey ( qual/hospsurveydb/). Findings of concern include widespread perception that mistakes would be held against those involved in the errors. As a result, more than half of respondents failed to report a single error or safety concern to their hospital during the past 12 months.  
Recommendation: Investigate how prescribing software may be configured to limit the prescribing of a neuromuscular blocking agent to patients on units where mechanical ventilation occurs. Before dispensing these agents, have pharmacists verify that patients who are not in an ICU or ED are mechanically ventilated. Smart pumps with unit-specific drug libraries would not have these drugs on

Debora Simmons is an approved California CE provider of continuing education and complies with the criteria for quality continuing nursing education programming.

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