February 2018 Volume 16 Issue 2

Unreadable and multiple barcodes on packages can lead to errors Simplist syringe with StabilOx canister SMP has received several reports about scanning difficulties with products may surprise some. A nurse called the that could previously be scanned without problems. One such issue is that the pharmacy with a question about the pack - Ilinear barcode on the FLOVENT HFA (fluticasone) inhaler was recently reposi - aging of the SIMPLIST (Fresenius Kabi) tioned in a horizontal orientation around the circumference of the canister ( Figure brand prefilled morphine syringe that her 1). The same is true with the barcode on Teva’s enoxaparin injection, which is located hospital had recently begun using. She was horizontally around the barrel of the syringe ( Figure 2 ). These horizontally oriented unsure what to do with the “vial” in the barcodes may not be readable if they no longer meet scanner requirements for package. The pharmacist who received the reading barcodes at specific focal distances, angles, or orientations. The bending of call investigated and found that the nurse a barcode around a curved surface affects how light reflects off it, was asking about the STABILOX canister and, if it is distorted in such a way, scanners cannot capture the contained within the unit-dose syringe pack - entire barcode. As reports are received, ISMP alerts product man - aging ( Figure 1). The round canister contains ufacturers and the US Food and Drug Administration (FDA) to iron oxide, which absorbs oxygen and re - urge them to consider barcode readability when Figure 1. Horizontally duces oxidative degradation of morphine to designing and reviewing product labels. placed linear barcode improve stability. It is not part of the syringe (red arrow) on the but is contained within the packaging. It’s Flovent HFA inhaler These and other barcode-related problems makes it unreadable unusual for unit-dose syringe packaging to prompted us to further examine barcodes and by a scanner. The how they are currently being used on drug con - linear barcode was vertically oriented tainers. until a 2D data matrix barcode was added Types of barcodes and scanners to the label. There are various types of barcodes based on the symbologies they use for encoding data that a scanner can decode ( Table 1 ). 1 Figure 1. Simplist syringe with StabilOx canister enclosed in blister package (top, far right) and A linear (1 dimensional [1D]) barcode typically encodes the na - after removal from the package (below). tional drug code (NDC) number. A 2D (2 dimensional) data matrix barcode encodes more information than a linear barcode, and in - contain these canisters, so it’s not surprising cludes the NDC, lot number, and expiration date. Although most that the nurse did not know what to do with scanners can read both linear and 2D data matrix barcodes, some the canister. The pharmacist explained the may require enabling of certain barcode symbology so they can purpose of the canister and instructed the extract 2D data matrix barcode information. nurse to just throw it away upon opening the package. Both morphine and DILAUDID Other barcodes you may see on drug containers include a Quick (HYDROmorphone) Simplist syringe pack - Response (QR) code, which is a type of 2D code used for accessing ages contain these canisters, but the com - product information. However, this barcode is not used for auto - pany will be removing them during a re - mated product identification purposes. Over-the-counter (OTC) prod - design of the packaging. For now, let nurses ucts must contain a (UPC), which is a type know to discard the canister. of linear barcode that scanners and some QR code readers can in - terpret. Two types of scanners are available: light-based readers for Mix-ups between AuroMedics levo- linear barcodes, and image-type readers, which Figure 2. Horizontal FLOXacin and levETIRAcetam. Given the can read both linear and 2D barcodes. orientation of an enox- current scope of product and intravenous aparin syringe linear (IV) fluid shortages, many facilities are using Barcode label requirements barcode stretches commercially available premixed IV products around the barrel (red According to the 2004 Title 21 Code of Federal arrow), making it as much as possible to decrease the number Regulations (CFR), section 201.25, barcode label unreadable by most of IV solutions that must be mixed in the requirements, most prescription medications scanners. pharmacy. Some of these products are being continued on page 2 —Barcodes > continued on page 2— SAFETY wires >

Supported by educational grants from Novartis and Fresenius Kabi February 2018 Volume 16 Issue 2 Page 2

> Barcodes —continued from page 1 continued from page 1 marketed in the US must contain a linear barcode that encodes the appropriate NDC used for the first time. Two examples include number on the product label. Exempted are certain drugs such as low-density poly - levo FLOXacin (antibiotic) and lev ETIRA- ethylene ampuls (e.g., albuterol, isoproterenol, and others). cetam (anticonvulsant). Several of these Table 1. Types of barcodes products may only be available from one manufacturer through the organization’s 2D Quick Criteria 1D Linear 2D Data Matrix UPC Code usual purchasing group or wholesalers. Response (QR) AuroMedics Pharma provides levo- Visual FLOXacin in 250 mg/50 mL, 500 mg/100 mL, Appearance and 750 mg/150 mL bags, as well as lev- ETIRAcetam in 500 mg/100 mL, 1,000 mg/ Reduce medication Identify and trace Provide informa - Keep track of 100 mL, and 1,500 mg/100 mL bags. Some errors certain prescrip - tion (website, sales and inven - hospitals that started using these products tion drugs as they nutrition informa - tory of retail Primary have reported that, once the overwrap is Purpose are distributed in tion, etc.) about products sold the US the product to within the US removed, the bags look very much alike. which it is affixed and Canada One hospital alone reported “numerous NDC NDC, serial num - Not applicable 12-digit number mix-ups” between the two products. Both Contains ber, lot number, that identifies the drug names start with L-E-V, and there is a (Minimum and expiration specific product shared 500 mg/100 mL strength. Additionally, Requirement) date the font size used on the label is very small Linear barcode 2D data matrix Not required by Required for OTC and difficult to read (particularly in compar - required on nearly required on the FDA on product items Requirement ison to other manufacturers’ products). The all drug products smallest saleable labels and label - strength for each product is printed within in the US package ing a black background, which is also hard to On some product labels, you may also find a 2D data matrix barcode pursuant to the read. A mix-up was even reported between Drug Supply Chain Security Act (DSCSA). The DSCSA, enacted in 2013, requires a 2D a 250 mg/50 mL bag of levo FLOXacin and a data matrix barcode on the smallest container intended for individual sale to a dis - 1,500 mg/100 mL bag of lev ETIRAcetam penser, and manufacturers had until November 27, 2017, to comply ( www.ismp.org/ (Figure 1). sc?id=3030 ). However, a linear barcode is still required. Although the smallest saleable container is not usually a unit-dose package, some unit-dose products used at the bedside are being encoded with both linear and 2D data matrix barcodes. Barcode repositioning and two barcodes on labels causing scanning difficulties The horizontal repositioning of linear barcodes, as mentioned earlier with the Flovent HFA inhaler, are likely due to the addition of a 2D data matrix barcode to some product labels. The presence of two barcodes can lead to confusion regarding which barcode should be scanned. 2 The hospital that reported scanning difficulty with the Figure 1. Once the overwrap is removed, the bags of levo FLOX acin (left) and lev ETIRA cetam (right) Flovent HFA inhaler also noted that nurses were forced to scan the 2D data matrix look very much alike. barcode on the inhaler ( Figure 1 ), because the horizontal linear barcode was un - readable. However, the 2D data matrix barcode was not associated with the product ISMP contacted the manufacturer and in their database, and scanning the 2D barcode resulted in various incorrect product suggested redesigning the labels using a matches. larger font size and tall man letters. Printing the strength within a black background Conclusions should also be eliminated, as it acts to draw The presence of two barcodes on product labels may cause confusion, so alert all one’s eyes away from the drug name. To practitioners to the new DSCSA requirement to include a 2D data matrix barcode on improve the likelihood that an error will be certain product labels (as of November 27, 2017), in addition to the linear barcode to recognized, we recommend placing any which all are accustomed. Be sure practitioners understand which barcode to scan pharmacy-applied label just below the drug for verification during the drug preparation, dispensing, and administration processes. name and strength on premixed bags, Also, organizations should have a process in place to program new medication bar - rather than on the reverse side, unless codes into information technology databases and ensure that they are linked to the there is insufficient room on the front of correct product and operational before use. Report any barcode scanning problems the bag. This way, both the base solution to ISMP so we can alert the manufacturer and FDA. and/or drug name, as listed by the manu - facturer, and on the pharmacy label, can For a more in-depth understanding of barcodes and scanning equipment, and the be easily scrutinized to make sure they cor - challenges associated with planning and implementation of a barcode verification relate. continued on page 3 —Barcodes > continued on page 3— SAFETY wires >

© 2018 ISMP. Reproduction of the newsletter or its content for use outside your facility, including republication of articles/excerpts or posting on a public-access website, is prohibited without written permission from ISMP. February 2018 Volume 16 Issue 2 Page 3

> Barcodes —continued from page 2 continued from page 2 system for medications, the American Society of Health-System Pharmacists Foun - In the reports we received, nurses have also dation published a tool kit in 2016 that serves as an excellent resource on the prevented mix-ups by scanning the manu - topic. 3 facturer’s barcode; in some cases, the phar - macy has left the barcode off the label to References direct nurses to the manufacturer’s label. 1) Cummings J, Ratko T, Matuszewski K. Barcoding to enhance patient safety. Patient Safety & Quality Healthcare. September/October 2005. www.psqh.com/sepoct05/barcodingrfid1.html Scanning a pharmacy label barcode would 2) Koppel R, Wetterneck T, Telles JL, Karsh BT. Workarounds to barcode medication administration not detect the wrong drug if the label was systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc. affixed to the wrong bag. We recommend 2008;15(4):408-23. 3) ASHP Foundation. Pharmacist’s tool kit for implementing barcode medication administration. placing the pharmacy label in such a way 2016. www.bcmaresources.com/ as to not cover the manufacturer’s barcode. However, this is quite a challenge with the AuroMedics products.

Errors could also be detected if these prod - ucts were scanned before being dispensed The “-triptan” drug name stem from the pharmacy for individual patients, or scanned upon placement and removal The suffix “-triptan” is a drug name stem used for serotonin (5-HT) receptor from an automated dispensing cabinet agonists that are SUMA triptan derivatives. 1 Medications with names that end (ADC). Even keeping the two drugs far apart in “-triptan” are used for the acute treatment of migraine headaches (with or from one another, rather than stored in bins without aura) and in some instances to treat cluster headaches. 2 As a medication close by, would help. used to treat an acute condition, triptans work best when administered early in an attack. Triptans do not prevent migraine or cluster headache attacks and Leaving the AuroMedics bags in their over - should only be used for patients at the first sign of an attack if they have a clear wraps until the time of use can also prevent diagnosis of migraine or cluster headaches. 2,3,4 mix-ups, as the overwraps use various col - ors for the different strengths. The pharmacy There are seven 5-HT receptor agonists available by prescription in the US, as label can be attached to the product via well as a fixed-dose combination product containing SUMA triptan plus rubber band or tape so it can be affixed to naproxen 4 (Table 1 ). Triptans are available as oral tablets, oral disintegrating the bag immediately before use. However, tablets, nasal sprays/powders, or subcutaneous injections. 4,5 even that would not help with AuroMedics lev ETIRAcetam 1,500 mg and levo FLOXacin Triptans should only be taken as prescribed; but most of the time, if the 750 mg, each of which share the same headache has not resolved in 2 hours (4 hours for Amerge) or has returned orange c olor on the overwrap ( Figure 2). after transient improvement, the dose may be repeated once. Patients should not take more than 2 doses within a 24-hour period. 5,6

Triptans are generally well tolerated, but due to their vasoconstrictive properties, they should not be used for patients with cardiovascular disease (CVD) and continued on page 4 —what’s in a Name ? >

Table 1. List of current 5-HT receptor agonists in the US using the “-triptan” drug name stem

Generic Names Examples of Brand Name Formulations Figure 2. Despite the different strengths, the Products 1,500 mg bag of lev ETIRA cetam (left) was mixed almotriptan Axert Tablet up with the 750 mg bag of levo FLOX acin (right). eletriptan Relpax Tablet frovatriptan Frova Tablet Don’t “hold” onto that patch! We recently received a report about a nurse who began naratriptan Amerge Tablet feeling weak, lethargic, and dizzy while at rizatriptan Maxalt, Maxalt-MLT Tablet, Oral Disintegrating work. She also had other vague symptoms Tablet that led her coworkers to believe she was SUMA triptan Imitrex, ONZETRA Xsail, Tablet, Nasal Solution or having a stroke! They rushed her to the Imitrex STATdose system, Powder, Subcutaneous Injection Sumavel DosePro, Zembrace emergency department (ED) to be evaluated SymTouch so she could be treated quickly if, in fact, she was having a stroke. While assessing SUMA triptan plus naproxen Treximet Tablet her, the ED staff discovered that during her ZOLM itriptan Zomig, Zomig ZMT Tablet, Oral Disintegrating shift, she had removed a transdermal scopo - Tablet, Nasal Solution continued on page 4— SAFETY wires >

Newsletter also partially supported by an educational grant from February 2018 Volume 16 Issue 2 Page 4

continued from page 3 continued from page 3 lamine patch from one of her patients. How - should be used with caution in patients with cardiovascular risk factors. 7,8 To ever, she did not discard it right away be - prevent a potentially life-threatening drug interaction (serotonin syndrome), cause her patient had other immediate patients should not use triptans while taking monoamine oxidase inhibitors needs. So, she held onto the patch, which (MAOIs) or ergotamines (e.g., dihydroergotamine [ MIGRANAL ], ergotamine got stuck to her skin, causing the scopo - with caffeine [ CAFERGOT , MIGERGOT ]). 8 lamine to absorb into her body. Enough of the drug must have been absorbed to cause When taking triptans, patients may experience these side effects: tightness/pres - these symptoms. The nurse was monitored sure in the chest, throat, neck and/or jaw; nausea; increase in blood pressure; for a few hours until the symptoms resolved. tachycardia; fatigue; burning sensation over the skin; and paresthesia. 5 Mix-up with VoLumen and Voluven. A References patient in obstetrics received oral VOLUMEN 1) World Health Organization. Guidance on the use of International Nonproprietary Names (INNs) for pharmaceutical substances. Switzerland: 2017:42. http://www.who.int/medicines/ (barium sulfate suspension, manufactured services/inn/FINAL_WHO_PHARM_S_NOM_1570_web.pdf?ua=1 by E-Z-EM) instead of IV fluid resuscitation 2) Triptans. In: Lexicomp online. Hudson, OH: Lexi-Comp, Inc. Updated April 24, 2017; accessed with VOLUVEN (tetrastarch, hydroxyethyl December 19, 2017. http://online.lexi.com 3) Triptan. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Updated May starch in sodium chloride, manufactured by 19, 2016; accessed January 12, 2017. http://www.micromedexsolutions.com Hospira). It might seem next to impossible to 4) Helfand M, Peterson K. Drug Class Review: Triptans. Drug Cl Rev Triptans Final Rep Updat make this error given the different routes of 4. 2009;(June). http://www.ncbi.nlm.nih.gov/pubmed/21089254 5) Rothrock JF. Oral triptan therapy. Headache . 2006;46(6):1038. administration, the typical dose of oral barium 6) Amerge [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2016. sulfate, and the fact that imaging of the gas - 7) Alwhaibi M, Pan X, Sambamoorthi U. Triptan use for migraine headache among adults trointestinal (GI) tract had not been ordered. with cardiovascular risk. Value Health . 2014;17(3):A57-58. 8) Gilmore B, Michael M. Treatment of acute migraine headache. Am Fam Physician. However, here’s how the error happened. 2011;83(3):271-80. While deciding what to order for fluid re - suscitation, the patient’s obstetrician con - sulted with a certified registered nurse anes - Don’t forget to take the ISMP Survey on thetist (CRNA) who recommended Voluven. Smart Infusion Pumps The obstetrician then typed “V-O-L-U” in FOR FRONTLINE NURSES ONLY the computer order entry system, and VoL - In May 2018, ISMP will be holding a national summit on smart infusion pumps to update umen popped up. Subsequently, 500 mL of and establish best practices. While several frontline nurses will be attending the summit VoLumen was ordered instead of the in - as representatives who have first-hand knowledge of infusion pump use, we are inviting tended Voluven. A pharmacist called the pre - all nurses who use smart infusion pumps to contribute to the summit. If you have not scriber to confirm the odd request, but the done so, please complete the short survey and submit your anonymous responses to prescriber insisted the drug was what the ISMP at www.ismp.org/sc?id=3085 by March 9, 2018. Your participation in this survey CRNA told him to order. The pharmacist then truly matters! Frontline nurses are the primary users of smart infusion pumps, and we called the CRNA on call, but due to a lan - clearly need your input to help shape national best practices. Furthermore, we sincerely guage barrier and unfamiliarity with VoLu - welcome an opportunity to explore any challenges that you face when using smart men, the CRNA thought the pharmacist was infusion pumps—just let us know what they are! asking about Voluven and stated that it was fine to use. The patient received the entire 500 mL of oral barium (orally) and suffered Congratulations, nurses! The Gallup organization released the 2017 results of its poll no adverse effects other than a delay in care. of the most HONEST and ETHICAL professions, and NURSES were at the top for the 16th year, outpacing 21 other professions! For details, visit: www.ismp.org/sc?id=3087. When clarifying orders, encourage practi - tioners to use a standard format that helps to ensure clarity of communication (e.g., If you would like to subscribe to this newsletter, visit: www.ismp.org/sc?id=384 SBAR). In this case, asking if the patient was scheduled for GI imaging might have clari - ISMP Nurse Advise ERR (ISSN 1550-6304) © 2018 Institute for Safe Medica - tion Practices (ISMP). Subscribers are granted permission to redistribute the fied the issue. The hospital added these newsletter or reproduce its contents within their practice site or facility only. medications to its look-alike, sound-alike Other reproduction, including posting on a public-access website, is prohibited without written permission from ISMP. This is a peer reviewed publication. drug name list and made modifications in Report medication and vaccine errors to ISMP: Call 1-800-FAIL-SAF(E), or visit www.ismp.org/MERP the electronic prescribing system to alert or www.ismp.org/VERP . ISMP guarantees the confidentiality of information received and respects the re - providers when one or the other is ordered. porters’ wishes regarding the level of detail included in publications. ISMP has contacted each manufacturer as Editors: Ann Shastay, MSN, RN, AOCN; Judy Smetzer, BSN, RN, FISMP; Michael Cohen, RPh, MS, ScD (hon), well as the US Food and Drug Administration DPS (hon); Russell Jenkins, MD; Ronald S. Litman, DO. ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA (FDA) to consider the need for a name 19044. Email: [email protected]; Tel: 215-947-7797; Fax: 215-914-1492. change for one of these products.

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