ISMP Quarterly Action
Agenda - july - september 2011
From the October 6, 2011 issue
One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and to use that information to prevent similar problems at your practice site. To promote such a process, the following selected items from the July-September 2011 issues of the ISMP Medication Safety Alert! have been prepared for an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. Each item includes a description of the medication safety problem, recommendations to reduce the risk of errors, and the issue number to locate additional information as desired. Look for our high-alert medication icon under the issue number if the agenda item involves one or more medications on the ISMP’s List of High-Alert Medications (www.ismp.org/Tools/highalertmedications.pdf). The Action Agenda is also available for download in a Word format (www.ismp.org/Newsletters/acutecare/articles/ActionAgenda1104.doc) 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: — ISMP high-alert medication
Epidural analgesic spiked with IV tubing in a labor and delivery unit (15)
Problem: While one nurse was starting a patient’s IV, another nurse scanned the patient’s armband and barcodes on bags of epidural analgesia containing bupivacaine and an IV antibiotic. Then she accidentally spiked the epidural analgesia bag instead of the antibiotic with a secondary IV tubing set and primed the tubing. When the other nurse went to connect the tubing to the patient’s IV access port, she fortunately noticed that the wrong bag had been spiked.
Recommendation: Distinguish epidural solutions from IV solutions by applying boldly colored “Epidural Use Only” warn-ing stickers to both sides of the bag. Have pharmacy spike epidural bags with special epidural (or yellow streaked) tubing prior to dispensing (when possible). Make the set-up of epidural analgesia a separate, dedicated “time-out” process conducted immediately before the infusion is started. Require anesthesia staff to gather or bring to the unit all epidural medications they plan to administer to the patient. Establish a protocol to help recognize and treat bupivacaine toxicity.
Anesthesia Patient Safety Foundation (APSF) recommendations for post-op opioid monitoring (17)
Problem: Clinically significant drug-induced respiratory depression in the post-op period remains a serious patient safety risk leading to significant morbidity and mortality. Intermittent “spot checks” of oxygenation (pulse oximetry) and ventilation (nursing assessment) are inadequate for recognizing drug-induced respiratory depression.
Recommendation: A group convened by APSF recommended continuous electronic monitoring of oxygenation (pulse oximetry, monitored from a central location if possible) and intermittent nurse assessments for all patients receiving post-op IV opioids. Other modalities that measure ventilation and airflow adequacy (capnography) should be employed for patients who need supplemental oxygen to maintain acceptable oxygen saturation.
TAMIFLU (oseltamivir) suspension concentration change (14)
Problem: Errors occurred with Tamiflu last flu season because the commercial concentration of the suspension (12 mg/mL) differed from the concentration of a compounded suspension (15 mg/mL) prepared from capsules according to the manufacturer’s directions in the event of a shortage.
Recommendation: Tamiflu suspension concentration has changed to 6 mg/mL. The oral dosing device that comes with the product is now scaled in mL (not mg), and the label instructs pharmacists to prepare a 6 mg/mL suspension from capsules if needed. Pharmacies need to change the compounding formula so it matches the new labeling.
Misadministration of IV insulin associated with dose measurement and hyperkalemia treatment (16)
Problem: Human error associated with measurement of insulin doses and treatment of hyperkalemia led to numerous events that resulted in significant hypoglycemia. Practitioners did not understand that “U-100” refers to the concentration, the difference between insulin and parenteral syringes, and the role insulin plays in treating hyperkalemia. In one case, 4 mL of regular insulin was administered instead of 4 units. In another case, 50 units of regular insulin was added to an existing IV infusion instead of 5 units. In a third case, a patient with hyperkalemia received only the insulin portion of the treatment (not 50% dextrose injection).
Reccomendation: Educate staff regarding insulin concentration, the differences between insulin and parenteral syringes, and how to measure doses. Restrict insulin preparation and administration to those who have shown competency. Ensure insulin syringes are readily available in all patient care units. Pharmacy should prepare, label, and dispense insulin in minibags for hyperkalemia treatment and in a standard concentration for infusions. An independent double-check should be conducted before dispensing and administering IV insulin. Monitor patient’s response to insulin by obtaining blood glucose levels.
Medication errors with U-500 insulin (17)
Problem: Healthcare providers have picked up and used a U-500 (500 units/mL) vial of insulin to prepare a dose instead of a U-100 (100 units/mL) vial. Dosing confusion has also occurred when U-500 doses were prescribed in units or volume corresponding to a U-100 syringe, or when the dose was administered without recognizing that the markings on the U-100 syringe do not directly correspond to U-500 doses.
Recommendation: U-500 doses should be expressed in actual units of U-500 insulin along with the corresponding markings on the syringe the patient is using (e.g., if using a tuberculin syringe: 200 units [0.4 mL]; if using a U-100 insulin syringe: 200 units [40 units mark on U-100 insulin syringe]). A conversion chart is provided in the package insert for reference (http://pi.lilly.com/us/humu lin-r-u500-pi.pdf). Alert staff to rare instances when U-500 insulin is required for a patient.
Concerns with pharmaceutical gray market during the drug shortage crisis (ISMP survey) (18)
Problem: During critical drug shortages, gray market distributors have been selling inexplicably obtained supplies of these drugs at hugely inflated prices, up to 3,000% mark-ups. Concerns associated with gray market products include: product authenticity (counterfeit products), sale of recalled or stolen products, illegal importation of pharmaceuticals, and questionable chain of custody and storage. While half of pharmacy staff surveyed have made gray market purchases, a third or less require documentation of authenticity, even in states with a pedigree law.
Recommendation: Purchase supplies only from a manufacturer’s authorized distributor of record (found on company websites). Require any non-authorized distributors to provide a pedigree, and track each transaction back to an authorized distributor. If you notice differences (label, package, contents) between the manufacturer’s product and a gray market vendor’s product, question its authenticity. Report suspect vendors to your pharmacy board, FDA, and the Federal Trade Commission. Utilize the best ways to order drugs in short supply (backordering, direct ordering from the manufacturer).
Mix-ups between DTPA (technetium Tc 99m pentetate) and MDP-Bracco (technetium Tc 99m medronate) (15)
Problem: A radiopharmaceutical vial of DraxImage DTPA was inadvertently placed in a leaded vial shield instead of MDP-Bracco. Both vials have green caps with green and white labels. Unit doses in varying amounts were dispensed from the vial to six hospitals/clinics, which resulted in non-diagnostic images with 12 patients. Barcodes are still not required on radiopharmaceutical vials.
Recommendation: Before activation, the products are not radioactive and should be stored in segregated areas to help prevent mix-ups between the look-alike vials. Special precautions such as pre-activation independent double-checks are needed, particularly since the products’ labels cannot be viewed easily once inside the vial shield. It is undetermined if manufacturers will be required to provide a barcode on radiopharmaceuticals.
Support the second victims of medical errors (14)
Problem: Patient tragedies caused by medical errors can shake involved practitioners to their very core. The impact is felt in their private lives, in interactions with professional colleagues, and in the context of their social life. These second victims of errors suffer a medical emergency equivalent to post-traumatic stress disorder. The instant patient harm occurs, involved practitioners also become patients of the organization—patients who often suffer in silence.
Recommendation: Develop a crisis management plan that includes a formal infrastructure for second victim support before it is needed. Second victims have the right to be treated with respect, to participate in the process of learning from the error, to be held accountable in a just culture, to not be abandon-ed by the organization, and to be supported by their peers and leaders. Details regarding the deployment of a second victim rapid-response team and other resources are in the full article.
How to use stories to improve patient safety (18)
Problem: There is no better way to inspire and sustain patient safety changes than through the simple craft of telling factual stories that move listeners into action. Yet, important stories remain untold in many organizations—particularly if a patient has been harmed. The primary barrier to storytelling is the secrecy that has long accompanied risk and errors, to keep facts hidden from accusatory eyes. But studies have demonstrated that lessons without stories rarely lead to learning and change.
Recommendation: Establish a process for sharing internal and external stories that focus on risk, errors, adverse events, improvements, and acts of caring. Establish a trusting environment in which the stories can be reported and shared without fear of external disclosure or unjust discipline. Describe how storytelling will be used within your quality improvement/peer review processes, the level of confidentiality required, and how to communicate these expectations.
Training pen in EPIPEN (EPINEPHrine) 2-Pak may be mistaken as actual EPIPEN(19)
Problem: EpiPens are now only available in a 2-Pak, which includes two EpiPens plus a nonfunctioning train-ing pen. The training pen looks similar to an actual EpiPen and could be confused with a real EpiPen in an emergency. Such an error could be fatal.
Recommendation: If hospitals store EpiPens on units for use during hypersensitivity reactions, remove the pens from their carton and only store the active pens in unit stock, including in automated dispensing cabinets.
Confusion between PLAVIX (clopidogrel) and PRADAXA (dabigatran etexilate) (18)
Problem: ISMP Canada reported mix-ups between Plavix and Pradax, which is the Canadian brand name for dabigatran etexilate. In the US, dabigatran is Pradaxa. Serious mix-ups between Plavix and Pradaxa are possible, especially since both are available in 75 mg oral dosage forms.
Recommendation: Alert staff to the risk of confusion between these two drugs, and emphasize that they should always verify the product’s indication before dispensing and administering any medication.
IMOGAM RABIES-HT (rabies immune globulin [human]) strength easy to confuse (19)
Problem: A nurse misinterpreted the concentration on an Imogam Rabies-HT carton as 150 international units/2 mL, not the correct strength of 150 international units/mL. On the carton label, “150 IU” is easily viewed, but the corresponding “…/1 mL” is poorly visible. The total volume, 2 mL, in the vial is easily visible below “150 IU,” which led to the error.
Recommendation: Before dispensing the product, add an auxiliary label listing the correct concentration, or circle the actual concentration on the carton/vial label itself to draw attention to it.
Mix-up between TEAspoon and mL (19)
Problem: Dangerous mix-ups between TEAspoon and mL dosages are common and have been happening for many years, particularly in outpatient pharmacies. We recently received a report in which a pharmacist accidentally provided instructions on the prescription label for a child to receive 3.5 TEAspoonfuls of a liquid antibiotic for 10 days instead of 3.5 mL per dose.
Recommendation: ISMP would like to see the complete elimination of TEAspoonful, TABLEspoonful, and other non-metric dosing, as well as elimination of the abbreviations “tsp” and “tbsp,” which are easily confused. Doses expressed using mL are recommended to eliminate the risk of confusion.
Use of two pumps allows bypass of drug library (16)
Problem: A nurse used two smart infusion pumps to deliver propofol IV at an infusion rate of 225 mcg/kg/minute because the pumps’ drug library was set with a hard stop at 130 mcg/kg/minute. Propofol was prescribed for an off-label use (refractory status epilepticus) which required higher than recommended doses. The patient exhibited propofol-related infusion syndrome. Using two infusion pumps to exceed a hard stop has been observed in other inappropriate situations.
Recommendation: Employing a technology workaround like this should prompt an immediate peer review of the conditions that require the workarounds before they are employed. Make staff aware that in most cases the need for this type of workaround could potentially lead to a serious medication error.
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