ISMP Medication Safety Alert



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|(14, 19)|After years of errors when using U-100 or tuberculin (TB)|Make sure patients who will be using U-500 insulin vials | | | |

| |syringes to measure and administer U-500 insulin, a U-500|upon discharge are also prescribed U-500 syringes, and that| | | |

|[pic] |insulin syringe should be on the market beginning in |prescribers order the dose in actual units and not in | | | |

| |November 2016. Updated prescribing information for |“U-100” units or by volume. For hospitals that will not | | | |

| |HumuLIN R U-500 no longer provides a conversion table for|stock the U-500 insulin syringe because it does not contain| | | |

| |using U-100 or TB syringes and states that patients using|a safety needle, the HumuLIN R U-500 KWIKPEN is available | | | |

| |vials must be prescribed the U-500 syringe to avoid |as an alternative. Unless dispensing a U-500 pen, U-500 | | | |

| |errors. However, the U-500 syringes will not have a |insulin doses should be prepared in and dispensed from the | | | |

| |safety needle, which may preclude its use in hospitals. |pharmacy. | | | |

|NeoMed and Medtronic low dose tip ENFit syringes get US Food and Drug Administration (FDA) clearance |

|(16) |The new low dose ENFit syringes, along with regular ENFit|Consider using a DoseMate add-on device with the NeoMed low| | | |

| |syringes, allow the industry to adopt the ENFit system to|dose tip syringes to cover the flanges when administering | | | |

| |prevent misconnections between enteral and parenteral |oral medications to neonates until other efforts to resolve| | | |

| |systems. However, mouth injuries are a concern with |concerns with the flanges are completed. Recommend the use | | | |

| |neonates when using the NeoMed low dose tip syringe for |of an ENFit dosage straw in conjunction with a | | | |

| |oral administration due to flanges near the syringe tip |child-resistant bottle closure for home use until | | | |

| |that prevent connection to a tracheostomy tube opening. |child-resistant caps compatible with ENFit syringes are | | | |

| |Also, screw-on transfer lids and plug-in stepped stoppers|available. | | | |

| |used to transfer drugs from bottles to syringes are not | | | | |

| |child-resistant. | | | | |

|Cisatracurium is available in two concentrations |

|(17) |Cisatracurium is available in 2 mg/mL and 10 mg/mL |In the pharmacy, stock the two concentrations in separate | | | |

|[pic] |concentrations. The 2 mg/mL concentration is used during |locations. Store the 200 mg/20 mL vials intended for | | | |

| |intubation. The 10 mg/mL concentration is used to |compounding with IV room supplies, and include a warning | | | |

| |compound continuous infusions. Anesthesia administered a |label, “NOTE-HIGH CONCENTRATION. For pharmacy compounding | | | |

| |5-fold overdose after the pharmacy accidentally dispensed|use only.” When possible, use barcode scanning to verify | | | |

| |a 200 mg/20 mL (10 mg/mL) vial to the operating room. |that the correct concentration is used during compounding | | | |

| |Anesthesia was not aware the drug was available in a 10 |or is dispensed. | | | |

| |mg/mL concentration. | | | | |

|Recent patient-controlled analgesia (PCA) by proxy event suggests reassessment of practices may be necessary |

|(19) |A hospital employed “safety companion” activated PCA |Healthcare facilities should reassess their policies and | | | |

|[pic] |doses for an elderly postoperative patient who was |practices regarding proper patient selection to make sure | | | |

| |agitated and hallucinating. The safety companion was |patients have the mental alertness and cognitive, physical,| | | |

| |unaware that the PCA doses should be delivered by only |and psychological ability to manage their own pain. Make | | | |

| |the patient. Analysis of the event uncovered several |sure policies and practices related to patient monitoring | | | |

| |causative factors: patient selection criteria for PCA was|are clear about how to identify and act when a patient has | | | |

| |not enforced, policies did not specify who could/could |respiratory insufficiency due to opioid toxicity. Educate | | | |

| |not activate a dose, a warning no longer appeared on the |patients, family, and staff, and place warning signs on PCA| | | |

| |PCA cord to warn that only patients could press the |cords that only the patient can press the button. | | | |

| |button, and staff had limited awareness about the dangers| | | | |

| |of PCA by proxy. | | | | |

|National Alert Network (NAN) alert about syringe leakage |

|(19) |We have received multiple reports about various |Look for fluid leakage during the syringe-filling process, | | | |

| |BD syringe sizes in which the drug has leaked beyond the |and discard any syringes that contain fluid that has leaked| | | |

| |syringe plunger onto surfaces exposed to air. This |past the black stopper on the plunger. The syringe lot | | | |

| |happens most frequently when the plunger and barrel are |number should be identified, and such instances should be | | | |

| |not vertically aligned while filling the syringe. If |reported to the FDA MedWatch program (sc?id | | | |

| |fluid has leaked past the black stopper on the plunger, |=1660), ISMP (MERP), and the syringe | | | |

| |the contents may be contaminated, or healthcare workers |manufacturer. | | | |

| |could be exposed if the drug is hazardous. | | | | |

|EPINEPHrine and infant 4.2% sodium bicarbonate injection mix-up during neonatal code |

|(14) |A nurse inadvertently prepared a prefilled syringe of |Hold mock codes to identify potential problems like this | | | |

|[pic] |infant 4.2% sodium bicarbonate injection instead of the |and to familiarize practitioners with items in the code | | | |

| |EPINEPHrine requested by a physician during a neonatal |cart. Train staff to immediately remove packing slips at | | | |

| |code. Three doses of the wrong medication were given. The|the beginning of a code so they won’t obscure visibility. | | | |

| |error may have been partly due to the crash cart tray |Have different practitioners prepare and administer drugs | | | |

| |packing slip covering the EPINEPHrine carton labels. |during codes to provide an opportunity for a verbal and | | | |

| |Also, the sodium bicarbonate syringe labels may have been|visual confirmation by a second practitioner. Include | | | |

| |oriented upside down from the nurse’s point of view. |pharmacists on code teams to help prepare necessary | | | |

| | |medications. | | | |

|FDA allows bleomycin injection to be imported during shortage |

|(15) |During a shortage, imported bleomycin sulfate powder for |Make sure staff are aware of the label differences and the | | | |

|[pic] |injection 15,000 international units will be available |difference between units and international units for this | | | |

| |(equal to 15 units of bleomycin injection, USP). The |product. Have pharmacy apply barcodes to these imported | | | |

| |label refers to the drug as BLEO 15K, does not have a |bleomycin vials. | | | |

| |barcode, and expresses the dosage in international units | | | | |

| |instead of units. | | | | |

| Cost of EPINEPHrine auto-injectors leads to error-prone use of ampuls/vials and unprepared consumers |

|(16)(18)|The excessive cost of EPINEPHrine auto-injectors has led |If your organization has replaced, or plans to replace, | | | |

| |consumers to do without the medication, use a single |EPINEPHrine auto-injectors with ampuls/vials, provide | | | |

| |device for multiple family members, or rely on expired |patient care areas (not patients) with an anaphylaxis kit | | | |

| |products. As an alternative, the media has publicized |containing a 1 mL vial or ampul of EPINEPHrine (1 mg/mL), a| | | |

| |ways for consumers to construct an EPINEPHrine |syringe, and other needed supplies, along with directions | | | |

| |anaphylaxis treatment kit using a 1 mg vial of |for measurement of the dose and administration by the | | | |

| |EPINEPHrine, syringe, and needle. However, this may lead |correct route. Conduct simulation training using the kit so| | | |

| |to administration of the entire 1 mg vial of the drug. |practitioners are comfortable with preparing and | | | |

| |High costs have also spurred organizations to replace the|administering EPINEPHrine from a vial or ampul. Due to the | | | |

| |auto-injectors with ampuls and/or vials. ISMP recently |possibility of overdose, the use of vials by consumers is | | | |

| |received reports involving the administration of |not a viable alternative to the EPINEPHrine auto-injectors.| | | |

| |EPINEPHrine 1 mg IV instead of 0.3 mg IM, after switching| | | | |

| |from auto-injectors to vials. | | | | |

|Correct use of inhalers: Help patients breathe easier |

|(14) |Most patients with asthma and chronic obstructive |If patients are not responding as expected, ask to observe | | | |

| |pulmonary disease use their inhalers incorrectly leading |their inhalation technique. Remind patients to discard an | | | |

| |to diminished drug delivery, omitted doses, overdoses, |inhaler when the dose count is zero, even if the device | | | |

| |and exacerbation of the underlying disease and |continues to spray. Demonstrate proper use during patient | | | |

| |respiratory symptoms. Depending on the inhaler type, |education and counseling and request patient return | | | |

| |examples of common errors include inhaling at the wrong |demonstration. Provide patients with access to videos on | | | |

| |time (not in sync with pressing the inhaler), using an |the proper use of inhalers. Educate practitioners regarding| | | |

| |empty inhaler, and swallowing the capsule containing the |common error types. See the newsletter article for a 2-page| | | |

| |inhalation medication. Design enhancements of the newer |chart of safety tips for patients using the newer inhaler | | | |

| |inhalers have improved correct use but errors still |types. Post this chart for staff reference. | | | |

| |persist. | | | | |

|Automation bias and complacency affect decision making when using technology |

|(18) |When typing “dil” for DILANTIN (phenytoin) into a |Improve the reliability of the technology itself and | | | |

| |pharmacy system, dilTIAZem was selected in error from the|support clinicians to more accurately assess the | | | |

| |drop-down menu and dispensed. The nurse obtained the drug|reliability of technology so appropriate monitoring and | | | |

| |from an automated dispensing cabinet (ADC). She noticed |verification strategies can be employed. Limit the amount | | | |

| |the handwritten “Dilantin” on the medication |of human input needed to use the technology, and design it | | | |

| |administration record but accepted the information on the|in a manner that reduces over-reliance. For example, if an | | | |

| |ADC screen as correct because it was automated. This is |order entry system provides choices after entering the | | | |

| |an example of automation bias, when users favor the |first 3 letters of the drug name, then consider forcing it | | | |

| |output of technology over a manual source of information.|to require 4 or 5 letters of a drug name and the product | | | |

| |A similar bias, automation complacency, occurs when users|strength before it will suggest choices. Train staff about | | | |

| |fail to monitor technology output, believing it to be |technology limitations and opportunities for error. | | | |

| |accurate. | | | | |

|Don’t abbreviate drug names in computerized prescriber order entry (CPOE) systems |

|(17) |Space limitations in CPOE drug name fields can be |For these and other combination products, display both the | | | |

| |problematic for combination products. In one hospital, |brand and generic names of the drug when possible and do | | | |

| |GENVOYA (elvitegravir, cobicistat, emtricitabine, |not abbreviate the drug names. | | | |

| |tenofovir alafenamide) was abbreviated as | | | | |

| |“Elviteg-Cobic-Emtricit-TenofAF” in the CPOE system, | | | | |

| |which led to mix-ups with STRIBILD (elvitegravir, | | | | |

| |cobicistat, emtricitabine, tenofovir disoproxil | | | | |

| |fumarate). The two drugs are not interchangeable. | | | | |

|Vaccine errors associated with age-related factors |

|(15) |Analysis of 4 years of vaccine error reports submitted to|Purchase age-specific formulations from different | | | |

| |ISMP found that age-related contributing factors were |manufacturers so they look dissimilar. Separate pediatric | | | |

| |linked to more than 1 in every 3 reports. Causes include |and adult vaccines and those with similar labels, names, or| | | |

| |confusion between numerous age-dependent vaccines that |overlapping components. Use auxiliary warning labels to | | | |

| |target the same diseases (especially influenza virus |draw attention to vaccines which come in multiple age | | | |

| |vaccines, Haemophilus influenzae type b vaccines, |formulations. Label the specific locations where vaccines | | | |

| |hepatitis A and B vaccines, combination vaccines that |are stored to facilitate correct, age-specific selection. | | | |

| |target diphtheria, tetanus, and pertussis); unfamiliarity|Post immunization schedules in clinical areas. Ask patients| | | |

| |with the vaccine-specific recommended age; not verifying |or parents to help verify age by reading the Vaccine | | | |

| |the patient’s age prior to administration; and similar |Information Statement (VIS) and checking the specific age | | | |

| |vaccine abbreviations, packaging, and labeling. |range for the vaccine. | | | |

|Storage and reconstitution differ for CUBICIN and CUBICIN RF by Merck |

|(19) |A pharmacist ordered Cubicin from a wholesaler but |The original Cubicin product will be phased out, but it is | | | |

| |received Cubicin RF instead, a newer form of DAPTOmycin. |important to be aware of the differences between the new | | | |

| |Cubicin RF should be stored at room temperature and |and old formulation and any generics that may become | | | |

| |reconstituted with bacteriostatic or sterile water for |available on the market. | | | |

| |injection. Cubicin must be refrigerated and reconstituted| | | | |

| |with normal saline. | | | | |

|American Academy of Pediatrics, Textbook of Neonatal Resuscitation, uses volumetric dosing |

|(19) |The 7th edition of this textbook refers to the dose of |We recommend against the use of volumetric dosing and have | | | |

| |EPINEPHrine in terms of mL/kg (page 189). But, there are |notified the textbook publishers of our concerns. Dosing | | | |

| |two commercially available concentrations of EPINEPHrine:|tables should be used during codes, which automatically | | | |

| |1 mg/mL and 0.1 mg/mL. It may be unclear that the |calculate the dose and volume based on the patient’s weight| | | |

| |volumetric dosing refers only to the 0.1 mg/mL solution. |and drug concentration. | | | |

| |Another problem is that mL/kg dosing is uncommon and may | | | | |

| |be misread as mg/kg. | | | | |

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