October 2017 Volume 16 Issue 10

Alert! Severe hyperglycemia in patientsincorrectly using insulin pens at home

The Institute for Safe Medication Practices (ISMP) National Medication ErrorsReporting Program (MERP) has received several reports of patients who failedto remove the inner cover of a standard insulin pen needle prior to attempting

to administer the insulin. The latest event resulted in a fatality. A recently hospitalizedpatient with type 1 diabetes did not know to remove the standard needle cover fromthe insulin pen needle prior to administration.She was unaware that she was using the penincorrectly and, thus, had not been receivingany of her insulin doses. The patient devel-oped diabetic ketoacidosis and later died.

To protect staff from needlestick injuries andguard against the reuse of needles, many hos-pitals use insulin pen needles that automati-cally re-cover and lock over the pen needleonce the injection has been completed andthe needle has been withdrawn from the skin.Such products include NOVOFINE AUTO-COVER (Novo Nordisk) and BD AUTOSHIELDDUO. These safety needles are also recom-mended for some patients with manual dex-terity limitations or if a caregiver is adminis-tering the injection to a patient.

With the NovoFine Autocover (Figure 1) safetyneedle for example, the user holds the outercover of the needle while it is attached to theinsulin pen and then removes it, exposing aplastic needle shield that covers the needle.During administration, as the device is heldagainst the skin and pressure is applied, theneedle shield slides back to allow the skin tobe punctured by the needle and the insulin tobe injected once the dose button is pressed. Asthe needle is removed from the skin after administration, the shield slides back over theneedle. The needle is hidden throughout the process so the patient will never see it.

Safety Pen NeedleThe Autocover safety needle system is different from standard insulin pen needleswidely used by patients in the home, which do not employ an automatic needle shield.These standard needles are available from brand and generic manufacturers. Becausestandard pen needles and those with an automatic needle shield may look similar, pa-

More on contrived prescriptions to “test”insurance coverage. Once again, we’velearned of a situation where a contrived“test claim” was submitted to a pharmacybenefits manager or insurance companyto determine coverage. Doing so has re-sulted in a patient getting an unintendedmedication that does not match the pa-tient’s actual need. In most cases, it’s beena prescriber trying to learn whether a cer-tain medication will be covered for the pa-tient. In the most recent case, a pharmacytechnician submitted the claim after a pa-tient requested information to determinewhether GENVOYA (cobicistat, elvitegravir,emtricitabine, and tenofovir alafenamide),which was not yet prescribed, would becovered. This patient’s insurance approvedthe medication and a label was printed, re-sulting in the prescription being filled anddispensed to the patient. The patient calledhis physician about the medication, andthe drug was cancelled before the patienttook the medication.

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Figure 1. NovoFine Autocover is an example ofinsulin pen needle with a needle shield thatautomatically retracts upon injection and re-covers and locks over the needle when withdrawnfrom the skin. (BD AutoShield Duo, not picturedhere, is another example of a safety needle usedwith pens.)

Figure 2. BD Ultra-fine III is an example of astandard pen needle. Both the outer cover andinner needle cover must be removed prior to injec-tion.

Outer Cover

Needle Shield

Outer Cover

Needle Cover

Safety Pen Needle

Standard Pen Needle

ISMP self assessment for high-alert medicationsISMP has introduced a new tool to helphospitals, long-term care facilities, andcertain outpatient settings evaluate theirbest practices related to high-alert med-ications. The ISMP Medication Safety SelfAssessment® for High-Alert Medicationsfocuses on 11 high-alert medication cat-egories. Participants who submit their as-sessment findings to ISMP anonymouslyvia an internet portal by the new deadlineof February 28, 2018will be able to obtainweighted scores and compare themselvesto similar organizations. For details, visit:www.ismp.org/selfassessments/SAHAM.

October 2017 Volume 16 Issue 10 Page 2

tients may not be aware of the differences in preparation for administration. Both theautomatic safety needle and standard needle systems have a larger outer protectivecover that, when removed, exposes either a retractable needle shield (Figure 1 onpage 1) or a plain inner needle cover (Figure 2 on page 1). The automatic safetyneedle shield is not intended to be removed prior to injection, but the inner needlecover on the standard needle system must be removed before the injectionto allow the administration of insulin.

Standard Pen NeedlePatients using insulin pens with automatic needle retraction devices while hospitalized,but who will be using standard pen needles at home, must be made aware that thestandard needle is different. It is imperative that removal of BOTH covers is explainedto patients during diabetes education as depicted in this video: www.myclickfine.com/clickfine-overview.html. Prior to injection, the pen should be “primed” using 2 to3 units of insulin to make certain that the needle is correctly attached and to remove anyair bubbles or pockets in the insulin cartridge. This is known as an ‘air shot’ or safetyshot, and the patient should see about 2 drops of insulin come out of the needle. If noinsulin appears after two or three attempts, the needle should be tightened or changeduntil a drop of insulin appears. If a patient still does not see any drops, they may havefailed to remove the inner needle cover and will likely bypass this step prior to injection.

Healthcare organizations, practitioners, and patients using these products should takesteps to safeguard against the incorrect use of pen needles. Consider the following:

Hospital, physician practice, community pharmacy, and clinic staff should teachall patients receiving an insulin pen how to use it properly, and require a returndemonstration to verify understanding. Hospital, physician practice, and clinic staff should verify which pen needle thepatient will be using at home, and tailor the initial training to that needle. Onehospital that reported an event to ISMP has changed their practice and nowuses standard non-safety needles when training patients prior to discharge tomake sure patients know how to administer insulin with the same pen andneedle they will use at home.Community pharmacies should establish a system to ensure that patients receivecounseling when picking up new prescriptions and refills for insulin pen andpen needle products (e.g., electronic stop in the sales register that requires in-tervention and acknowledgement by a pharmacist, bag marked with a flag toalert clerical staff that counseling is required).Patient education, including review of injection technique, for insulin pens shouldbe mandatory and scripted to promote consistent discussions. Prescribers canreinforce the need for patient education at the point of dispensing by entering inthe notes section of an electronic prescription or including on handwritten pre-scriptions a request for pharmacist-driven education.The pharmacist should use a teach-back method to verify that the patient under-stands the appropriate administration technique whenever pens and insulinneedles are dispensed. Require the pharmacist to also review the prescribeddosing and prescription label with the patient or caregiver.All practitioners should encourage patients to question the pharmacist if the penneedle is different than what they expect or what they have been taught to use.To determine whether it is due to a problem with the injection technique or if adose adjustment is needed, remind patients to consult a member of their health-

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© 2017 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.

In response to a report submitted to ISMPin 2016 about the risks associated withsending “test” prescriptions to a patient’spharmacy to determine insurance cover-age, Surescripts, the company that routesprescriptions electronically to pharmacies,sent a Customer Bulletin to pharmacy andelectronic health record (EHR) vendors,warning them about errors. In these in-stances, prescribers did not intend for thepharmacy to dispense the “test” medica-tions. To improve patient safety and supportadherence to correct electronic prescrib-ing practices, Surescripts has asked thatEHR vendors and their end-users (practi-tioners) ensure that no “test” prescriptionsare sent in the live environment. Pre-scribers should only transmit electronicprescriptions that are intended to be dis-pensed to the patient. The patient, pre-scriber, or an office-assigned individualshould instead call the insurance companyor pharmacy benefits manager (PBM) toinquire about coverage, submit prior au-thorizations (ideally electronically), or checkplan formularies. Any questions about theissue should be directed to Surescripts at:http://surescripts.com/contact-us.

Severe underdosing of insulin withU-500 pen. An emergency department (ED)pharmacist was speaking with a patientabout his U-500 insulin dose. The patient,who had been using a U-500 insulin pen,told the pharmacist that his dose was75 units but proceeded to demonstrate howhe turned the dose knob on the pen to “15”to deliver each dose. The patient thoughthis physician had told him to dial to “15” todeliver 75 units. Prior to using the U-500pen, the patient used a U-100 syringe tomeasure each dose from a vial of U-500insulin. Before U-500 syringes or pens wereavailable, patients using U-500 insulin werecommonly taught to use a U-100 insulin sy-ringe and to measure their dose in “syringeunits,” meaning the U-100 scale was usedfor dose measurement, but the actual dosewas 5 times more than the measured dose.Thus, the patient had been drawing up the

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October 2017 Volume 16 Issue 10 Page 3

care team if blood glucose levels are elevated after insulin injection. Review theinjection technique with the patient, especially if faulty technique is suspecteddue to poorly controlled blood glucose levels.Manufacturers of standard pen needles should include clear warnings about re-moving both covers in the instructions for use as well as on outer cartons.

Adapted from the National Alert Network (NAN) alert published October 12, 2017(www.ismp.org/NAN/files/NAN-20171012.pdf).

Alarming survey results from CDC: Unsafe injection practices continue

To safely prepare and administer an injectable medication, practitioners mustfollow aseptic technique, avoid reuse of single-dose or single-use vials, useneedles and syringes just once for only 1 patient, and never reenter a medication

container with a used needle or syringe. However, the results of a recently publishedsurvey1 conducted by the Centers for Disease Control and Prevention (CDC) on injectionpractices in long-term care, outpatient, and acute care settings revealed dangerousknowledge gaps, attitudes, and practices by physicians and nurses; this despite wide-spread media coverage of more than 50 outbreaks associated with unsafe injectionpractices since 2001 and the launch of the national One & Only Campaign(www.oneandonlycampaign.org/) in 2009 by the Safe Injection Practices Coalition.The One & Only Campaign aims to raise awareness among patients and practitionersabout safe injection practices.

Survey respondent profile and questionsThe survey was completed by 370 physicians with a median of 14.5 years of clinicalexperience, and 320 nurses with a median of 21 years of clinical experience. The physi-cians’ specialties included anesthesiology-pain management, dermatology, gastroen-terology, internal medicine, orthopedics, oncology, and radiology. All nurse participantswere registered nurses who were working at least half of the time in a clinical setting.Along with knowledge and attitudes associated with injection practices, nurses wereasked about the frequency of their own injection practices in the workplace, and physi-cians were asked about the frequency of injection practices by all healthcare personnelin their work area, not just their own practices.

Highlights of survey resultsWhile most physician and nurse responses to the survey aligned with CDC recom-mended injection practices, there is a dangerous minority of practitioners who are vi-olating basic infection control practices associated with the use of syringes, needles,single-dose vials, diluent containers, and other unsafe injection practices.

Syringe reuse: Survey responses indicated that 12.4% of physicians and 3.4% ofnurses reuse a syringe for more than 1 patient, despite findings that most physicians(91.6%) and nurses (99.4%) do not agree that this is an acceptable practice. Almost 5%of physicians reported that this unsafe practice usually or always occurs in their workarea. This unsafe practice was most frequently reported by oncologists; 17.9% of on-cologists thought it was an acceptable practice, and 23.9% reported its occurrence inthe workplace (13.5% reported this usually or always occurs). While statistical analysiscomparing nurse practice locations did not occur in this study, little or no differenceswere seen in either attitudes or practices associated with syringe reuse in acute care,long-term care, or outpatient facilities.

U-500 insulin into the U-100 syringe to the“15” units marking. A diabetes educatorworked with the patient to explain the cor-rect dosing by dialing the U-500 insulin pento the patient’s actual dose.

Even with the availability of U-500 insulinpens, patient and provider confusion aboutthe dose may still occur, especially whenpatients previously relied on a U-100 sy-ringe to measure and inject U-500 insulin.It is clear that dangerous underdosing witha U-500 pen is still possible. Despite thisrisk, U-100 syringes are still used with U-500insulin by some patients. For U-500 insulin,ISMP recommends using only a U-500 in-sulin pen or a U-500 insulin syringe. Whenpatients are started on U-500, using eithera vial or insulin pen, prescribers and phar-macists must engage patients, provide ed-ucation, and verify that patients can accu-rately prepare and administer a dose.

Readability of labeling information onblister package. A patient could not readthe directions on a dose package of methyl-PREDNISolone (Greenstone, LLC) that hadbeen dispensed from a community phar-macy. Several factors make the directions(Figure 1) difficult to read: 1) the small, light-

weight fontused for di-rections im-pairs legibil-ity on a foilbackground;2) all upper-case lettersare used,which areless legiblethan wordswritten inmixed-casel e t t e r s ;3 ) g l a r ecaused bylight reflect-

ing on the foil reduces the legibility; a non-reflective, matte material may improvereadability; and 4) the foil backing is dim-

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Figure 1. Wording on foil isalmost impossible to read.

October 2017 Volume 16 Issue 10 Page 4

Reentering a vial with a used syringe/needle:While 12.7% of physicians and6.7% of nurses mistakenly believed that reusing a syringe to access a medication vialis an acceptable practice, even more reported its actual occurrence in the workplace:43.2% of physicians and 24.1% of nurses reported reentering multiple-dose vials witha used syringe (7.3% and 5%, respectively, reported this usually or always occurs).Belief that this was a safe practice was highest with oncologists (25.5%) and radiologists(20%), and its practice was reported in the workplace by more than half of all anesthe-sia-pain management physicians (63.4%), radiologists (57.5%), and oncologists (53.7%).Nurses in long-term care facilities (27.3%) and outpatient facilities (21.8%) reportedreentering a vial with a used syringe/needle more often than nurses in acute care fa-cilities (16.1%).

Using single-dose vials for multiple patients:The misperception that using a sin-gle-dose vial for more than 1 patient is an acceptable practice was high with physicians(34%) and nurses (16.9%). The frequency of occurrence in the workplace was reportedby fewer, although still substantial, physicians (25.1%) and nurses (10.9%). This unsafepractice was reported most often by oncologists (34.4% overall, 10.5% reported thisusually or always occurs) and anesthesia-pain management physicians (31.7% overall,9.8% reported this usually or always occurs). Little or no differences were seen inusing single-dose vials for multiple patients by nurses in acute care, long-term care,or outpatient facilities, although more nurses in outpatient facilities believed thepractice was acceptable.

Using source bags or bottles as diluents for multiple patients: Using bags orbottles of IV solutions as a source supply of diluent for more than 1 patient wasreported by 28.9% of physicians and 13.1% of nurses. This unsafe practice was reportedby nurses more often in long-term care and outpatient facilities than acute care hospi-tals, and by oncologists (44.8% overall, 14.9% reported this usually or always occurs).However, orthopedists and dermatologists also reported that this practice occurs fre-quently (7.5% and 7.3%, respectively, reported this usually or always occurs).

ConclusionsA dangerous minority of healthcare practitioners continue to violate best practices as-sociated with safe injections and are placing patients at risk of serious infection. Giventhese lapses in infection control practices, academic institutions and programs, licensingbodies, and healthcare providers must enhance their ongoing surveillance of propertechnique and devote resources to ensure students, staff, and practitioners have theknowledge and skills associated with even the most basic concepts of infection controland injection safety. Education on safe injection practices should be required duringorientation and at ongoing intervals thereafter, and staff competencies should be as-sessed regularly. All staff should understand that any form of syringe and/or needlereuse is dangerous and should be avoided, and that syringes cannot be reusedeven if the needle is changed. Healthcare practitioners should be vigilant in followingthe current CDC guidelines that recommend that syringes and needles be used onlyonce. Single-dose or single-use vials should only be used for 1 dose for 1 patient, andthen discarded after initial entry into the vial. If multiple-dose vials are used, theyshould be limited to single-patient use whenever possible, and both the needle andsyringe used to access the vial must be sterile.

ReferencesKossover-Smith RA, Coutts K, Hatfield KM, et al. One needle, one syringe, only one time? A survey1)of physician and nurse knowledge, attitudes, and practices around injection safety. Am J InfectControl. 2017;45(9):1018-23.

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ismp.org consumermedsafety.org twitter.com/ISMP1 facebook.com/ismp1 medsafetyofficer.org

pled, and directions are printed on the cor-rugated areas.

In our December 2012 issue, we wroteabout this same product and the confusing,serpentine layout of the blister pack anddirections for use. The intention of the de-sign is to guide the patient to the correctdose, at the right time, and on the right day.However, the layout is potentially confusingand differs from other dose packs ofmethylPREDNISolone which have thetablets for a given day arranged in a lineacross the dose pack.

Safety Considerations for Product Designto Minimize Medication Errors, releasedby the US Food and Drug Administration(FDA) in April 2016, states that if containerclosures serve as the container labels,they should not have illegible lettering ormake information difficult to read. Manu-facturers should avoid container closuresthat provide poor visual contrast betweenthe container closure material and labelinformation, such as foil. ISMP again con-tacted the manufacturer regarding thelegibility issue on the blister package. Weencourage all organizations (e.g., healthsystems, community pharmacies, insur-ers, pharmacy benefit managers [PBMs])to consider labeling legibility when makingformulary and purchasing decisions.

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ISMP MedicationSafety Alert! Commu-nity/Ambulatory Care(ISSN 1550-6290) © 2017

Institute for Safe Medication Practices (ISMP). Subscribersare granted permission to redistribute the newsletter or re-produce its contents within their practice site or facilityonly. Other reproduction, including posting on a public-ac-cess website, is prohibited without written permissionfrom ISMP. This is a peer reviewed publication.

Report medication and vaccine errors to ISMP:Call 1-800-FAIL-SAF(E), or visit www.ismp.org/ MERP orwww.ismp.org/VERP. ISMP guarantees the confidentialityof information received and respects the reporters’ wishesregarding the level of detail included in publications.

To subscribe: www.ismp.org/sc?id=386

Editors: Michael J. Gaunt, PharmD; Michael Cohen, RPh,MS, ScD (hon), DPS (hon); Judy Smetzer, BSN, RN,FISMP; Ann Shastay, MSN, RN, AOCN. ISMP, 200 Lake-side Drive, Suite 200, Horsham, PA 19044. Email:ismpinfo@ismp.org; Tel: 215-947-7797; Fax: 215-914-1492.

Support the AwardsYour donation or attendance helps ensure the future of the Cheers Awards and allows ISMP to continue its lifesavingwork in preventing medication errors. As this is an important anniversary year, all Cheers supporters will receive specialrecognition in ISMP’s many communication avenues, including publications and social media. To make a tax deductibledonation or to register for the awards dinner, please visit: www.ismp.org/Cheers/support.aspx.

Lifetime Achievement AwardBona Benjamin, BS PharmBona Benjamin is a safety leader who has had a significant impacton clinical practice, accreditation issues, and regulatory standards.She has managed crucial national-levelprojects to help reduce drug shortagesand improve the safety of sterile com-pounding. In 2011, ISMP honored her,along with two of her colleagues, witha Cheers Award for her advocacy inaddressing drug shortages and helpingto bring together a group of stakeholderorganizations to examine the problemand recommend solutions. Ms. Ben-jamin also has served on several of theInstitute’s advisory boards, and pro-vided input into the development of the ISMP Targeted MedicationSafety Best Practices. Before her recent retirement, she was Direc-tor of Medication Use Quality Improvement for American Societyof Health-System Pharmacists.

Join ISMP on Tuesday evening, December 5, 2017, at6:00 p.m. for the 20th Annual Cheers Awards at B.B.King’s Blues Club in Orlando, FL. The special anniver-sary gala will commemorate two decades of advancingmedication safety by honoring an outstanding group of

healthcare leaders and showcasing their innovative pro-grams. You can demonstrate that your heart and soulheart and soulare dedicated to medication safety as well by making adonation and/or attending the awards dinner(www.ismp.org/Cheers/support.aspx).

Keynote Speaker Michael R. Cohen, RPh, MS, ScD (hon), DPS (hon)Michael Cohen is the President and co-founder of the Institutefor Safe Medication Practices (ISMP) and has dedicated his ca-

reer to advocating for medication errorprevention. During the 20th anniversaryof the Cheers Awards celebration,Mike will provide a unique perspectiveon the amazing journey toward safermedication practices—a journey thatmany have joined. A nationally and in-ternationally known speaker on thetopic of medication safety, Mike willchronicle our achievements and dis-appointments as a nation, and pavethe way for the next 10 years of the

journey. Mike has received numerous awards and honors, in-cluding being recognized as a MacArthur Fellow by the JohnD. and Catherine T. MacArthur Foundation.

Celebrating the Heart & Soulof Medication Safety

20th Anniversary of the ISMP Cheers Awards