A crack in our best armor: Wrong patient insulin pen injections alarmingly frequent even with barcode scanning

Transcription

1 October 23, 2014 Volume 19 Issue 21 A crack in our best armor: Wrong patient insulin pen injections alarmingly frequent even with barcode scanning Last month, ISMP learned about some rather alarming data associated with what could be called best practices for proper insulin pen use in a multihospital system. The best practices employed by these hospitals to prevent the sharing of insulin pens between multiple patients included one-onone staff education regarding the safe use of insulin pens, implementation of barcode scanning of both the patient barcode and the patient- and order-specific barcode on the insulin pen, an electronic medication administration record (emar) at the bedside, and an effective monitoring system. Despite these high-level strategies to prevent the sharing of insulin pens, errors still occurred for reasons beyond a knowledge deficit or mistaken belief that changing the needle is sufficient to prevent cross-contamination when sharing pens. Further, the frequency of wrong patient s pen alerts at the bedside that were detected, and administration avoided, with patient- and order-specific barcode scanning gives us great pause when we think about what this means for thousands of US hospitals that are illequipped to implement the same best practices and monitor their effectiveness. Fortunately, the hospitals involved are anxious to share what they have learned with the healthcare community at large. Background: Insulin Pen Safety Insulin pens are designed to be used multiple times for a single patient using a new needle with each injection. Pens should never be used for more than one patient. Regurgitation of blood into the insulin cartridge can occur after injection, creating a risk of pathogen transmission if the pen is used for more than one person, even if a ISMP HIGH-ALERT M E D I C AT I O N new needle is used. Older studies have found squamous, epithelial, and red blood cells; hemoglobin; and macrophages in up to 58% of insulin cartridges in used pens. 1,2 With newer models of insulin pens introduced since then, a 2013 study found 5.6% of contaminated cartridges in used pens. 3 While the level of biologic contamination is believed to occur in quantities enough to transmit bloodborne pathogens, to date, there is no clear evidence of pathogen transmission from pen sharing. 4 Yet, it can t be stated enough that pen sharing could lead to such an adverse outcome. 1-4 In our March 27, 2008 newsletter, 5 we first warned facilities that we had received reports of insulin pen sharing between patients. In one report, a nurse told us that colleagues at her hospital often borrowed a pen from another patient, put on a new needle, and administered a dose to the second patient using the same pen, rather than wait for the patient s pen to be dispensed from the pharmacy. Evidently, the nurses failed to recognize the possibility of biologic contamination of the insulin solution, even if aspiration does not occur prior to injection. Since then, ISMP and others have chronicled large-scale, potential exposures to bloodborne pathogens caused by using insulin pens for multiple patients after changing the needle, including: ,114 patients at a Texas Army medical center in ,345 patients at a Wisconsin clinic in patients at a New York Veterans Affairs medical center in ,915 patients at a New York general hospital in 2013 continued on page 2 Armor > Caution: Per liter content on manufacturers IV bag labels. A pharmacy ran out of 3% sodium chloride and had to prepare the product using an automated IV compounder. The product formula was entered into the compounding software and double checked by the pharmacy manager and the informatics pharmacist. Still, a mathematical error resulted in a 6% product that was labeled as a 3% product; thus, a review of the error was conducted. One thing both pharmacists mentioned was the way electrolyte concentrations are listed on IV bags. Concentrations are listed per 1,000 ml, not per container volume. For example, a 250 ml 0.9% sodium chloride injection container label lists the sodium chloride content as 154 meq/1,000 ml rather than 38.5 meq/250 ml (Figure 1). To make a 500 ml bag of 3% sodium chloride, the pharmacists mistakenly set the proportion up Figure 1. The sodium chloride content in the 250 ml container is listed per liter, not per 250 ml. as 154/0.9 = x/3 and came up with the number of meq needed, 513 meq of sodium chloride. However, they actually needed only meq of sodium chloride for the 500 ml bag. Later, after several bags had been dispensed, a third pharmacist identified the error when checking a finished bag along with the used sodium chloride concentrate continued on page 2 SAFETY briefs >

2 October 23, 2014 Volume 19 Issue 21 Page 2 > Armor continued from page 1 3,149 patients at a Connecticut hospital in 2014 In 2009, in response to reports of improper use of insulin pens in hospitals, the US Food and Drug Administration (FDA) issued an alert for healthcare professionals to remind them that insulin pens are meant for single patient use only and are not to be shared between patients. 11 FDA worked with ISMP to produce a Patient Safety News video that discussed how contamination could occur. 12 FDA also began working with the Centers for Disease Control and Prevention (CDC) and other professional organizations to address infection control issues with insulin pens. In our October 21, 2010 newsletter, we again mentioned the ongoing safety issue with insulin pens, noting that special precautions are required before implementation in hospitals. 13 In our January 12, 2012 newsletter, we published a Hazard Alert about continuing events related to sharing insulin pens. 14 At that time, we urged hospitals to dispense insulin pens assigned to individual patients only and to label the pens accordingly. We also reemphasized that safety could only be assured through timely education and ongoing monitoring. If education and continuous monitoring could not be accomplished, we suggested that hospitals may need to examine their practices to determine if patients would be safer by dispensing insulin vials or prefilled syringes. We also called for manufacturers to prominently label pens with a statement such as, Warning! For Single Patient Use ONLY. Many manufacturers have yet to implement this important strategy despite the seriousness and scope of this ongoing problem. In our May 31, 2012 newsletter, we reported that the Centers for Medicare & Medicaid Services (CMS) was citing hospitals if surveyors identified the sharing of insulin pens between patients. 15 That year, CDC issued a Clinical Reminder stressing that insulin pens must never be used for more than one person, 16 and the Safe Injection Practices Coalition (SIPC) began a campaign to ISMP HIGH-ALERT M E D I C AT I O N promote, Be Aware, Don t Share. One Insulin Pen, Only One Person. 17 Also in 2012, an expert panel convened by the American Society of Health-System Pharmacists (ASHP) Research and Education Foundation concluded that pens could be used safely in hospitals if proper procedures, policies, and staff education are in place. 18 In our February 7, 2013 newsletter, 19 ISMP again warned healthcare providers about ongoing issues with the reuse of insulin pens for multiple patients. This time, we suggested that the risk associated with pen reuse is best mitigated by removing insulin pens from use in inpatient settings. Also in 2013, the 2012 ASHP Foundation consensus recommendations were published along with a call for rigorous evaluations to assess the impact of these recommendations. 18 It is with this objective in mind that the aforementioned multihospital system has agreed to share their findings with others in confidence. Multihospital Insulin Pen Use In 2008, several hospitals within a multihospital system began using pens for various types of insulin. In 2013, when ISMP suggested that hospitals consider transitioning away from insulin pens, the multihospital system convened an interdisciplinary team to evaluate the issue. The team conducted a detailed failure mode and effects analysis (FMEA) associated with using one patient s pen for another patient. In the areas of greatest risk, the system identified safety measures and best practices that, once implemented, the system believed would allow for proper use of insulin pens. Thus, the team recommended continued use of the pens once the best practices were in place. These best practices included: Standardized use. A decision was made to use insulin pens for just one insulin type (rapid-acting) to reduce the risk of pharmacy application of a barcode to the wrong pen an error that would not be picked up by the barcode system if the barcode was scanned. Other types of insulin were dispensed from the pharmacy in vials (e.g., FDA proprietary drug name draft guidance. ISMP has submitted comments regarding the US Food and Drug Administration (FDA) Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs ( =423). ISMP is in support of FDA s guidance to manufacturers for protecting patient safety during development of proprietary names for drug products. Our letter ( specifically calls attention to the issue of over the counter (OTC) drugs and umbrella names (brand name extensions), where a well known, successful, OTC brand name is recycled for a new product that contains an active ingredient or ingredients that differ from those in the original product. For example, CLARITIN EYE (Schering) does not contain loratadine, and ZYRTEC ITCHY EYE DROPS (McNeil) does not contain cetirizine. Instead, they each contain another antihis- continued on page 3 Armor > continued on page 3 SAFETY briefs > cont d from page 1 container. Several patients were potentially exposed to the error. All providers were notified, and the sodium level was monitored for patients at risk. The patients, who were being treated for hyponatremia or increased intracranial pressure, were not harmed. The pharmacy is now determined to avoid adding standard formulas to the automated IV compounder on the fly. Instead, prior to becoming an emergent/urgent need, they plan to preprogram formulas when solutions are at risk for drug shortages. They also plan to increase communication with their supplier to make every effort to keep commercial products available. In truth, the way the concentration is listed on IV bags has tripped up many pharmacists and nurses over the years. It s time for the US Food and Drug Administration (FDA) and the US Pharmacopeial Convention (USP) to rethink this with large volume parenterals (LVPs). For single- and multiple-dose injectables, USP requires strength per total volume as the primary, prominent display on the label, followed in close proximity by strength per ml enclosed in parentheses. We think this should apply to LVPs as well. Register for four ISMP Symposia at the 2014 ASHP Midyear Clinical Meeting:

3 October 23, 2014 Volume 19 Issue 21 Page 3 > Armor continued from page 2 intermediate-acting insulins) or pharmacyprepared, patient-specific syringes (e.g., basal insulins). Tamper-evident tape on each pen. Tamper-evident tape was applied perpendicular to the pen cap/barrel junction to help prevent accidental reuse if a pen was returned to the pharmacy for credit. Order-specific, barcoded label. A computer-generated, order-specific, barcoded label was applied to the barrel like a flag on each pen. The label included the patient s name and tied the specific insulin pen to the specific patient. The label covered the manufacturer s barcode to prevent accidental scanning but left uncovered the name of the insulin and the manufacturer s lot number and expiration date. Labeling of pen only. The labeled pens were dispensed to patient-specific medication bins in automated dispensing cabinets (ADCs) in unlabeled baggies. This prevented the risk of placing the pen for one patient into a baggie labeled for another patient. Barcode system alerts. If a nurse scanned the label of an incorrect patientspecific insulin pen, a highly visible alert notified the nurse that the drug was not a valid order for the patient. This was a hard stop that did not allow the nurse to document administration of the dose on the emar unless the correct pen was obtained and scanned or if the barcode scanning workflow was abandoned to manually document administration of the insulin. Procedure just a click away.the emar (and order entry) screens included an insulin pen safety hyperlink that users could click if they had questions, along with a reminder to use insulin pens for one patient. Initial and ongoing education. Insulin pen procedures and the problems associated with sharing pens were included in an initial wave of education for nurses, and the topic appeared in system-wide newsletters, staff in-services, online educational ISMP HIGH-ALERT M E D I C AT I O N modules, and departmental meetings. Ongoing monitoring. The multihospital system began monitoring immediately after implementing the best practices. Daily, weekly, and monthly barcode medication administration reports were monitored to evaluate overall nurse compliance with scanning the patient and insulin pen, to identify close calls where the wrong pen was at the bedside but not used to administer an injection, and to identify wrong pen injections where the nurse received a wrong pen alert but proceeded with administration and manual emar documentation without scanning the correct pen. Monitoring Best Practices Month 1. Monitoring during the first month showed several instances in which a pen was reused for another patient. In one event, the nurse scanned the pen and received a warning that it was not a valid order for the patient. She mentally confirmed the insulin order but could not find a pen labeled for that patient. So she withdrew a dose from the cartridge of another patient s pen using an insulin syringe, administered the dose, and manually documented it. The nurse knew she could not use the same pen for more than one patient. But she mistakenly believed it was acceptable to administer a dose taken from the cartridge of another patient s pen, believing it could be used like a multiple-dose insulin vial. In another event, after scanning the pen and receiving an alert that the drug was not a valid order, the nurse mentally confirmed that the pen contained rapid-acting insulin as listed on the emar. Not understanding the alert, she administered a dose of the insulin to the patient using the scanned pen and then manually documented administration. The nurse had been carrying two insulin pens in her pocket and inadvertently used the wrong patient s pen to deliver the dose. Unfortunately, the patient whose pen was used in error tested positive for active hepatitis C. To date, seroconversion has not been de- continued on page 4 Armor > cont d from page 2 tamine, ketotifen fumarate. Umbrella names have been associated with patient and practitioner confusion regarding the product s actual ingredients, strength, and concentration. This has led to errors in which the wrong product or dose was taken or the product was used when contraindicated. Product names that are misleading can also cause confusion when treating side effects or accidental ingestion of these products. Although full ingredients are listed in a product s Drug Facts panel, this information is sometimes overlooked by the consumer due to confirmation bias. Insulin pen error. Improper injection technique with an insulin pen led to elevated blood sugars in two patients (Shah A, Sullivan MM, Rushakoff RJ. A new twist on insulin pen administration errors. Endocr Pract. 2014;20(6):617 viewarticle/827765). In both cases, patients injecting insulin dialed to the prescribed amount of insulin units using the LANTUS SOLOSTAR (insulin glargine) insulin pen. The patients then properly completed the next step and inserted the needle into the skin. However, instead of pushing the purple Figure 1. The correct way to administer a dose using the Lantus SoloStar pen is to dial the correct dose (top) and then push the purple button once the needle is below the skin (bottom). button at the end of the pen to inject the insulin, they twisted the dial back down to zero (Figure 1). By dialing back down to the zero, the patients thought the twisting continued on page 4 SAFETY briefs > Register for four ISMP Symposia at the 2014 ASHP Midyear Clinical Meeting:

4 October 23, 2014 Volume 19 Issue 21 Page 4 > Armor continued from page 3 cont d from page 3 tected in the patient who received the dose. for the prior patient. Although no potential cross-contamination occurred, the wrong patients pens were used despite issuance of an alert that the wrong pen was in hand, and before the correct pen could be dispensed for the newly admitted patients. Another error involved a new nurse who received an alert when scanning an insulin pen. The nurse had found two pens in the patient s medication supplies. She asked another nurse about the alert. Looking at both pens, the nurses saw that they were identical products and noticed that both listed the correct location (unit, room #) of the patient. Neither nurse noticed that a different patient s name was on the pen that was scanned, likely due to confirmation bias. The pen used to administer the insulin dose had been dispensed for the prior patient in the room and had not been removed from the patient s locked storage drawer in the room after discharge. It is important to note that, particularly with the latter two errors, the events did not happen because nurses thought it was acceptable to use another patient s pen after just changing the needle. Instead, the nurses thought they had the correct patient s pen and then mistakenly used it to administer a dose. After these errors, the pharmacy began enlarging the patient s name and highlighting it in yellow on the pen label. Additional barcodes were added to the flag so they were visible on both sides of the folded label, and the manufacturer s barcode was blacked out and covered by the patientspecific labeling to be sure only the pharmacy label was scanned. Managers were asked to individually coach each clinician who may administer insulin about the correct use of insulin pens, and a flyer was created as a loose script for the coaching sessions. Within a few weeks, 99% of all nurses had received the one-on-one coaching about safe insulin pen use. Month 2. During the second month, several more errors happened. Two events again happened when a previous patient s insulin pen was left in the locked storage drawer in the room after discharge. In these cases, the tamper-resistant tape was still intact because the pen had not been used ISMP HIGH-ALERT M E D I C AT I O N Month 3. In the third month, errors continued despite all efforts to prevent them. During dispensing, pens were accidentally placed in the wrong patient s medication bin in the ADC. During administration, pens were accidentally obtained from a roommate s proximal medication bin in the ADC or returned to the wrong bin after use. Analysis of the events detected by the barcode monitoring system alone during the first 3 months showed that the contributing factors were not related to a knowledge deficit about the dangers of sharing pens. Instead, they were almost exclusively caused by system issues, at-risk behaviors, and human error associated with inadvertently administering an insulin dose to one patient from another patient s pen. Mixing up pens carried in pockets; keeping pens in locked drawers in patients rooms where they may not be removed in a timely fashion upon discontinuation; untimely removal of pens from units upon discharge or transfer; accidentally retrieving the wrong patient s pen from a proximal medication bin; dispensing the pen to the wrong patient bin; putting the pen back into the wrong patient bin after use; alert fatigue; and other system and behavioral issues were resulting in inadvertent use of the wrong patient s pen. Tipping point. Looking at the data collected over a 3-month period, the multihospital system found that the aggregate data alone could lead to overconfidence in barcode scanning to detect errors because the overall percentages of correct use were high. For example: The overall frequency of scanning the patient, the pen, or both was well over 99% for close to 80,000 insulin pen doses administered. While these continued on page 5 Armor > mechanism was injecting the insulin. Both patients received no insulin. The Lantus SoloStar insulin pen (and others) is designed to be twisted up or down until the user has turned to the correct amount of insulin to inject. But the button must be pushed to inject the insulin. Healthcare providers who teach patients about pen use must adequately explain how the insulin dose is delivered and have the patient demonstrate how they ll be using the pen to confirm proper administration technique. Possible dosing dilemma for infants. Last March, the US Food and Drug Administration (FDA) clarified an earlier warning ( about using RE- VATIO(sildenafil) for treatment of pulmonary arterial hypertension (PAH) in children, now recognizing there may be situations in which the benefit-risk profile of the drug may be acceptable in certain children. Now, Pfizer has introduced a commercial oral liquid formulation of Revatio 10 mg/ml (once reconstituted). This is a welcome addition for pediatric patients who suffer from PAH since, previously, the suspension had to be compounded from tablets. The recommended oral dose of Revatio is 5 mg or 20 mg three times a day, administered 4 6 hours apart. However, some patients may need doses other than 5 mg or 20 mg. For example, Pediatric and Neonatal Lexi-Drugs provides dosing information for neonatal and infant patients with PAH based on a mg/kg/dose that may not equate exactly to 5 mg or 20 mg. Unfortunately, the product comes with a 2 ml oral syringe with only 0.5 ml (5 mg) and 2 ml (20 mg) dose markings. Thus, pharmacies will need to provide 1 ml oral syringes to correctly administer doses that don t conform to the provided oral syringe scale. Pharmacists must be aware of the current packaging shortcoming and determine a process for when doses for a child are not exactly 5 mg or 20 mg. Since the product labeling includes only the 5 mg and 20 mg dose, it is unlikely Pfizer will change the dosing device. Register for four ISMP Symposia at the 2014 ASHP Midyear Clinical Meeting:

5 October 23, 2014 Volume 19 Issue 21 Page 5 > Armor continued from page 4 percentages seem laudable, even the high rate of compliance meant that barcode scanning did not occur during 800 patient encounters in which insulin administration via a pen occurred over 3 months. Thus, mistakes for up to 800 patients could not be confirmed or ruled out. The rate of close calls that were averted at the bedside due to barcode scanning was less than 1% for close to 80,000 insulin pen administrations during the 3 months. But, again, more than 400 times in 3 months, nurses had picked up the wrong patient s insulin pen and, without the barcode scanning system, might have used it to administer a dose. These results shed light on the frequency of wrong pen injections that may be occurring in hospitals that have not implemented barcode scanning. While some may view these data as proof of how robust the barcode scanning system is, we believe it is no less alarming than if the hospitals had detected 400 cases of potential wrong site/wrong patient surgery during time outs over 3 months! The rate of using the wrong patient s insulin pen when administering a dose to another patient was less than 0.1%. However, this still meant that 7 patients received an insulin dose using another patient s insulin pen over 3 months. Conclusion Despite laudable compliance with the best armor available to prevent wrong patient ISMP HIGH-ALERT M E D I C AT I O N pen use, this multihospital system decided, after 3 months of data, to dispense 3 ml vials of rapid-acting insulin instead of insulin pens. For now, the hospital system is not convinced that the benefits of using insulin pens in hospitals (e.g., accurate dosing) outweigh the risks even if every nurse knows that pens should not be shared, and best practices are implemented, including order-specific barcode scanning with compliance rates above 99% and a hard stop if the wrong pen is scanned. For ISMP, this multihospital system s experiences have pulled back the curtain to view a crack in the armor of patient- and order-specific barcode scanning and its ability to ensure correct pen use. Even with this and other strategies considered best practices, hospitals are still vulnerable to pen sharing. While we can t call for an allout moratorium on using insulin pens in hospitals, we still lean toward their use only under special circumstances, such as the use of pens that may become available for concentrated U-200, U-300, and U-500 insulin. We urge hospitals to consider the findings from the multihospital system when determining the safest way to dispense and administer insulin to inpatients. Of course, there are also risks associated with using insulin vials that can lead to errors, 20 and we can t ignore the current reality that other bloodborne diseases may bring new meaning to risks associated with reuse of pens or misuse of vials. Thus, we know decisions regarding pen vs. vial use may not be clear-cut for all hospitals. ISMP will continue to bring information to readers as it becomes available to help hospitals make the most informed decisions possible. References 1) Le Floch JP, Herbreteau C, Lange F, Perlemuter L. Biologic material in needles and cartridges after insulin injection with a pen in diabetic patients. Diabetes Care. 1998;21(9): ) Sonoki K, Yoshinari M, Iwase M, et al. Regurgitation of blood into insulin cartridges in the penlike injectors. Diabetes Care. 2001;24(3): ) Herdman ML, Larck C, Schliesser SH, Jelic TM. Biological contamination of insulin pens in a hospital setting. Am J Health Syst Pharm. 2013;70(14): ) Hakre S, Upshaw-Combs DR, Sanders-Buell EE, et al. An investigation of bloodborne pathogen transmission due to multipatient sharing of insulin pens. Mil Med. 2012;177(8): ) ISMP. Cross contamination with insulin pens. ISMP Medication Safety Alert! 2008;13(6):1-2. 6) ISMP. Reuse of insulin pen for multiple patients risks transmission of bloodborne disease. ISMP Medication Safety Alert! 2009;14(3):1-2. 7) Conley M. Wis. clinic warns patients of possible bloodborne disease exposure. ABC News. Aug. 30, ) Associated Press. Possible HIV exposure at Buffalo VA hospital. USA Today. Jan. 14, ) Olean General Hospital. Olean General alerts patients to possible insulin pen re-use. Jan. 24, ) Buffa D. 3,100 Griffin Hospital patients at risk of disease after misuse of insulin pens. Hartford Courant. May 16, ) FDA. Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens. March 19, ) FDA. Don t share insulin pens between patients. Patient Safety News video. May 4, ) ISMP. Is ISMP endorsing use of insulin pens in hospitals? ISMP Medication Safety Alert! 2010;15(21):2. 14) ISMP. Do not use an insulin pen for multiple patients! Hazard Alert. ISMP Medication Safety Alert! 2012;17(1):1,4. 15) ISMP. CMS citing reuse of insulin pens. ISMP Medication Safety Alert! 2012;17(11):2. 16) CDC. CDC clinical reminder: insulin pens must never be used for more than one person. Jan. 5, ) CDC and SIPC. Be aware, don t share. One insulin pen, only one person. One and Only Campaign ) Cobaugh DJ, Maynard G, Cooper L, et al. Enhancing insulin-use safety in hospitals: practical recommendations from an ASHP Foundation expert consensus panel. Am J Health Syst Pharm. 2013;70(16): ) ISMP. Ongoing concern about insulin pen reuse shows hospitals need to consider transitioning away from them. ISMP Medication Safety Alert! 2013;18(3): ) ISMP. A clinical reminder about the safe use of insulin vials. ISMP Medication Safety Alert! 2013;18(4):1-4. If you would like to subscribe to this newsletter, visit: ISMP Medication Safety Alert! Acute Care (ISSN ) 2014 Institute for Safe Medication Practices (ISMP). Permission is granted to subscribers to reproduce material for internal communications. Other reproduction is prohibited without permission. Report medication errors to the ISMP National Medication Errors Reporting Program (ISMP MERP) at FAIL-SAF(E) or online at Unless noted, published errors were received through the ISMP MERP. ISMP guarantees confidentiality of information received and respects the reporters' wishes as to the level of detail included in publications. Editors: Judy Smetzer, RN, BSN, FISMP; Michael R. Cohen, RPh, MS, ScD; Russell Jenkins, MD. ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA ismpinfo@ismp.org; Tel: ; Fax: This is a peer reviewed publication

6 October 23, 2014 Volume 19 Issue 21 Page 6 ISMP Activities at the ASHP Midyear Meeting There will be a wide variety of opportunities to meet and learn from ISMP staff at the 2014 American Society of Health-System Pharmacists Midyear Clinical Meeting in December. For more information, visit: or call ISMP Medication Safety Intensive Friday and Saturday, December 5 & 6 7:30 a.m. 4:00 p.m. (Day 1) 7:30 a.m. 3:30 p.m. (Day 2) Business Expo Center, 1960 S. Anaheim Way Register online at: Exhibit Monday to Wednesday, December 8 10 ISMP will be at booth 682 in the Anaheim Convention Center exhibit hall Symposia Register for ISMP symposia online at: Monday, December 8 Improving Medication Safety in the Radiology Setting Breakfast 6:15 a.m. 6:45 a.m. Symposium 6:45 a.m. 8:45 a.m. Hilton Anaheim, Pacific Ballroom D Addressing a Trifecta of Overlooked IV Medication Risks 11:30 a.m. 1:00 p.m. Doors open at 10:45 a.m. Hilton Anaheim, Pacific Ballroom D This symposium will be simulcast as a concurrent webinar; register at the same link given above. Tuesday, December 9 Recognizing and Responding to Serious Safety Concerns with Subcutaneous Insulin 11:30 a.m. 1:00 p.m. Doors open at 10:45 a.m. Hilton Anaheim, California Ballroom D Wednesday, December 10 Improving Medication Safety in the Perioperative Setting 11:30 a.m. 1:00 p.m. Doors open at 10:45 a.m. Hilton Anaheim, Pacific Ballroom D Cheers Awards Tuesday, December 9 6:00 p.m. 9:30 p.m. 17th Annual ISMP Cheers Awards Dinner Astor Classics Event Center Automotive & Communication Museum. Register online at: ASHP Education Session Wednesday, December 10 Improving Medication Safety: A National Perspective from ISMP Presentation by ISMP staff 8:00 a.m. 9:45 a.m. Hilton Anaheim, Ballroom A

7 July - September 2014 ISMP QuarterlyActionAgenda 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 2014 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 brief description of the medication safety problem, a few 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 List of High-Alert Medications ( The Action Agenda is also available for download in a Microsoft 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. Many product-related problems can also be viewed in the ISMP Medication Safety Alert! section of our website at: Continuing education credit is available for nurses at: Key: ISMP high-alert medication 2014 ISMP Issue No. Problem Recommendation Organization Assessment Action Required/Assignment (14) A patient with brain cancer was prescribed a single 150 mg dose of lomustine, followed by reassessment in 6 weeks to evaluate the benefit of additional doses. A mail-order pharmacy dispensed a 3-cycle supply of the drug (3 doses). Expecting a single dose, the patient took all of the capsules totaling 450 mg. The overdose led to a slow and painful death 6 weeks later. Similar errors with dispensing this drug have been published previously with fatal results. (16, 20) Early in 2015, manufacturers will distribute administration sets with the new enteral-only connector, called ENFit, at the end that connects to the feeding tube. The new feeding tubes will not be available until later in Thus, a temporary transition adapter will be attached to the administration set. Once new enteral feeding tubes are in place, ENFit syringes will be required to flush or administer enteral liquid medications via a feeding tube. An oral or Luer syringe will not connect to the port. (19) In the past, vaccine diluents have been mixed up with neuromuscular blockers primarily due to lookalike vials and ampules, as happened recently in Syria, leading to the death of 15 children vaccinated against measles. Similar errors have happened around the world and in the US where several patients received doses of pancuronium instead of influenza vaccine because the similar vials were stored in the refrigerator next to each other. Error with lomustine caused by dispensing more than a single course of therapy Order entry systems should not allow more than a single dose to be entered and should limit the quantity dispensed. Pharmacists should provide patient counseling, supply leaflets, and enhance labels (e.g., CAUTION: TAKE A SINGLE DOSE ONLY ONCE EVERY 6 WEEKS). Nurses should reinforce education prior to discharge, and insurers should pay only for a single dose at a time. URGENT! Health systems need to plan for changes in enteral connectors Convene an interdisciplinary team to assess the existing systems and processes that may need to change during and after transition to the new enteral connectors. The team should specifically focus on how the change will be communicated, how the enteral medications will be dispensed, how the connectors and sets will be stored, and how to transition to the new connectors. To stay updated, visit this website frequently: Mix-ups between vaccine diluents and neuromuscular blockers ISMP has called upon regulators and manufacturers to improve vaccine packaging, including the use of dual-chamber containers and redesigned vials that allow larger labels. Until then, when possible, stock prefilled vaccine syringes to decrease reconstitution in patient care units. Limit or eliminate the storage of neuromuscular blockers on patient care units and sequester remaining storage. Educate staff about vaccine and diluent errors. Date Completed October 23, 2014 ISMP MedicationSafetyAlert! Ò QAA 1

8 July - September 2014 ISMP QuarterlyActionAgenda 2014 ISMP Issue No. October 23, 2014 Problem Recommendation Organization Assessment Action Required/Assignment (16) Two children sustained leg lacerations while receiving EpiPen injections when they moved while the needle was still under the skin. The directions for use say that the EpiPen must be held in place for 10 seconds. The needle does not retract until the pen is removed. The needle can cut through the subcutaneous tissue and cause a laceration if the child moves during administration. (13,16) Glass vials of Naropin, intended for epidural use, have been repeatedly confused with glass vials of Ofirmev, intended for IV use. Either product can be administered without further dilution. Although, the labels are dissimilar, the drugs may be the only two available in similar glass vials in some patient care areas. The risk of error is highest if they are stored near one another, such as in the same automated dispensing cabinet (ADC) drawer. (13) With the new labeling on Baxter s DOBUTamine IV bags, the concentration appears on the overwrap but there s no longer reverse print used for the 250 mg/250 ml bag to differentiate it from the 500 mg/250 ml bag. A mix-up happened when 500 mg/250 ml bags were accidentally used in place of the lower concentration to restock an automated dispensing cabinet (ADC). (13) To prepare an 850 mg dose of Alimta, a total of 34 ml were needed using one 500 mg vial and four 100 mg vials after being reconstituted to obtain a final concentration of 25 mg/ml. But pharmacy staff were able to obtain 34 ml of Alimta without using the last 100 mg vial of drug. When contacted, Lilly confirmed that the vials contain overfill. In this instance, one vial was wasted, but the patient could have received a larger dose than prescribed. Leg lacerations following EPIPEN (EPINEPHrine) autoinjector use Providers using EPINEPHrine autoinjectors for children should pay close attention to patient restraint prior to injection, as the child may move if the needle remains in the thigh for 10 seconds. If the needle is dislodged, reinsertion should never be attempted. If it was in place for at least 3 seconds, the EPINEPHrine was likely delivered. Repeat doses only if clinically necessary. Confusion between NAROPIN (ropivacaine) and OFIRMEV (acetaminophen injection) Consider adding auxiliary labels ( For nerve block and epidural use only ) to the Naropin containers before dispensing the product from the pharmacy. Store the products in different drawers or, when possible, limit ADC storage to only one of the drugs. Use barcode scanning for stocking and removal of the products from ADCs. Baxter DOBUTamine overwrap label change contributes to error Standardize to a single concentration when possible and use barcode scanning when restocking or removing the product from ADCs. In hospitals where more than one concentration must remain, consider storing only one concentration in the ADC, and dispense the less common strength from the pharmacy. Add bold auxiliary labels to draw attention to the concentration differences. ALIMTA (PEMEtrexed) vials contain overfill Overfill is mentioned in the package insert, but the details aren t specified. Be sure staff are aware of vial overages with this drug, especially when a small difference could be clinically important. Date Completed ISMP MedicationSafetyAlert! Ò QAA 2

9 July - September 2014 ISMP QuarterlyActionAgenda 2014 ISMP Issue No. Problem Recommendation Organization Assessment Action Required/Assignment (16, 17) Isovue is now packaged in an imaging bulk package (IBP) approved for use with multiple patients in the CT suite in conjunction with an automated contrast injection system or syringebased injection system. Use of the Isovue Multipack PBP (pharmacy bulk package), renamed Isovue PBP, is limited to the preparation of syringes in an ISO Class 5 environment in the pharmacy. (15) When 4,500 units of Kcentra were ordered, pharmacy staff noted the 500 U in the upper right corner of the carton and vial label and assumed each vial contained 500 units. Each vial actually contains a range ( units) of factor IX, which is listed on the back panel or the carton and vial label. Nine vials were used to prepare an infusion labeled 4,500 units in 180 ml, but the bag contained 5,026 units given the actual units in each vial. (19) The Docefrez brand of DOCEtaxel is available as a lyophilized powder that reconstitutes to a concentration different than most commercially available DOCEtaxel products. Instead of a 10 mg/ml or 20 mg/ml concentration, reconstitution results in 24 mg/ml (80 mg vial) or 25 mg/ml (20 mg vial) concentrations. Overdoses have occurred, as the concentration is not clearly visible on the label. (15) A renal transplant patient who had been taking oral tacrolimus 3 mg every 12 hours was converted to a once-daily product, Astagraf, and instructed to take 6 mg. Despite application of a pharmacy label, the manufacturer s label was visible, which prominently displays ONCE-DAILY below the drug name and 1 mg strength. The patient took just 1 mg once daily. New ISOVUE (iopamidol) imaging bulk package (IBP) for use with power injectors The Isovue PBP and Isovue IBP products must be used exactly as described in the package insert to ensure sterility. Misleading KCENTRA (prothrombin complex concentrate [human]) label leads to dosage errors Use an auxiliary label or computer reminder to alert staff to verify the actual number of units in each vial listed on the back label panel on the carton and vial. We asked the company to modify the label so the range is better communicated. We also suggested that additional information is needed where 500 U appears on the front label panel perhaps specifying 500 Units Range as a midpoint of dosages in each vial. Unfamiliar concentration of DOCEFREZ (DOCEtaxel) increases risk of error List Docefrez along with the concentration after reconstitution in order entry systems. Have a process in place to review new products (particularly for replacement products on backorder or during drug shortages) so that staff are aware of the differences, and make adjustments to the IT system (including strengths and concentrations) as needed for safe use. Once-Daily designation on label of long-acting ASTAGRAF (tacrolimus) leads to error Properly label containers dispensed to patients and provide education to them about how to take the medicine. ISMP reported this risk to FDA for consideration of label modifications. Date Completed October 23, 2014 ISMP MedicationSafetyAlert! Ò QAA 3

10 July - September 2014 ISMP QuarterlyActionAgenda 2014 ISMP Issue No. October 23, 2014 Problem Recommendation Organization Assessment Action Required/Assignment (17) Dantrolene, used to treat malignant hyperthermia (MH), is often available in kits containing 20 mg vials of the drug and a liter bag of sterile water to dilute each vial with 60 ml. Preparation during an emergency takes time because multiple 20 mg vials are often needed. Accidental IV administration of the liter bag of sterile water as also occurred with catastrophic results. (17) A child was to receive 125 units of Varizig IM. A nurse used the entire 8.5 ml of the supplied diluent to reconstitute the drug instead of 1.25 ml as stated in the package insert. To administer this volume, the nurse needed to give the child three IM injections. Subtherapeutic doses are also possible if the entire diluent is used and staff believes this provides the labeled 100 units per ml concentration (the concentration when 1.25 ml of diluent is used). (17) A pregnant patient with asymptomatic uterine contractions was given a Prostin E2 vaginal suppository instead of a progesterone vaginal suppository. Both suppositories were available in the labor and delivery area. Prostin E2 suppositories are used for evacuation of uterine contents for missed abortion or intrauterine fetal death (IUFD). The patient developed contractions and delivered a 1.1 kg baby. (17) Baxter labels nitroglycerin with the mg per total volume (100 mg/250 ml) listed first, and the mcg/ml concentration (400 mcg/ml) below in parentheses, while Hospira labels nitroglycerin with the mcg/ml (100 mcg/ml) listed first, and the total mg/volume below it in parentheses. In a recent report, a nurse set an infusion pump for 200 mg/250 ml after misreading 200 mcg per ml on a container label. New dantrolene (RYANODEX) product can improve safety A new formulation of dantrolene, Ryanodex, is available in a 250 mg per 20 ml vial, which requires further dilution with 5 ml of sterile water for injection. One vial provides a loading dose as opposed to 12 or more vials of traditional dantrolene, allowing quicker treatment of MH. The new formulation also eliminates the need to stock liter bags of sterile water. VARIZIG (varicella zoster immune globulin [human]) dilution issues reported Consider adding an auxiliary label that reminds practitioners to reconstitute the drug with the correct volume (1.25 ml per 125 unit vial, which provides 100 units per ml) and then to discard the remaining diluent. A new liquid form of the product is under development that will not require reconstitution. Dinoprostone (PROSTIN E2) suppository confused with progesterone Remove the Prostin E2 suppository from stock in patient care areas and add a warning on the screens of pharmacy and electronic prescribing systems that Prostin E2 is indicated for IUFD, uterine evacuation, and termination of pregnancy only. Barcode scanning verification at the point-of-care should be used when available. Nitroglycerin injection labeling issues during shortages During shortages, draw attention to the nitroglycerin label information that matches the way staff are used to it appearing on nitroglycerin labels, and reprogram infusion pump libraries as necessary. Meanwhile, FDA is examining the differences in the labels, and ISMP is conducting a survey regarding nurses preferences. Date Completed ISMP MedicationSafetyAlert! Ò QAA 4