February 2016 Volume 15 Issue 2 Government and industry fail to protect the public when they suggest “carefully following instructions” is enough to prevent vaccine errors Take our survey! t’s difficult to say this, but we were truly disappointed in our colleagues at the ISMP is updating its list of Look-Alike Drug Centers for Disease Control and Prevention (CDC) and the US Food and Drug Names with Recommended Tall Man Letters IAdministration (FDA) after reading about a recent analysis that representatives (www.ismp.org/tools/tallmanletters.pdf ). We from these agencies conducted on errors associated with administering just one are asking for your input by taking a 15-minute component of the two-component vaccine, MENVEO (meningococcal groups A/C/Y, survey, a copy of which appears on pages 5- W-135 diphtheria conjugate vaccine). 1 We greatly respect the important work carried 6. Please submit your responses by April 15 out by the CDC and FDA. However, the recommendations in the article seemed to online at: www.ismp.org/sc?id=1670 . Our list take a giant step backwards to an earlier time when healthcare providers tried un - of drug name pairs with tall man letters was successfully to manage and improve patient safety simply by exhorting staff to be first compiled after a survey in 2008 to help careful and to follow the rules. In the report, the central message to those who ad - healthcare organizations employ a standard minister Menveo was that, “By carefully following instructions included with the set of tall man letters to differentiate look- vaccine, administration errors with Menveo and similarly packaged vaccines can alike drug names. Our last update was 5 years be prevented.” 1The article was clearly missing an understanding of why such errors ago. We are considering a few name pairs occur and robust system strategies that would actually prevent ongoing errors with that have been involved in errors to add to Menveo, or PENTACEL (diphtheria and tetanus toxoids, acellular pertussis, po - this list, and we truly value your opinion! liovirus, Haemophilus b conjugate), which was also mentioned in the article. Vaccines with diluents also present similar problems (e.g., diluent given instead of mixing with the vaccine first). ISMP Fellowships ISMP is now accepting applications until Menveo and Errors March 31 for two yearlong Fellowship po - Menveo is a two-component vaccine supplied by GlaxoSmithKline (previously No - sitions starting in July 2016. We will be vartis) in two vials, one containing MenA lyophilized (freeze-dried) powder and the holding a call with potential applicants on other containing MenCYW-135 liquid. The contents of the two vials must be mixed March 2 from 1:00 to 2:00 p.m. ET to discuss prior to intramuscular (IM) administration of the positions and answer questions.Please the resulting solution. However, sometimes send a message to [email protected] if the liquid component of the vaccine has been you would like to participate. For details administered alone, without the lyophilized about applying for the Fellowships, please component—an ongoing error that ISMP first visit: www.ismp.org/sc?id=55 . published in 2014. 2 The vaccine comes in a car - ton containing five doses (10 vials total). A warning, “NEITHER MenCYW-135 NOR MenA COMPONEN T T O BE USED ALONE,” is only Paregoric, not “opium tincture.” Pare - visible on the back panel of the carton, despite goric (anhydrous morphine 2 mg per 5 mL, plenty of “white” space elsewhere. The vial la - alcohol 47%) was first formulated in the bels also contain language noting their proper early 1700s. Even though it had never been Figure 1. Warning, “NOT TO BE USED ALONE,” use, but one’s vision is not immediately drawn approved by the US Food and Drug Admin - does not catch the eye because it is in the same to the warnings to combine these products, istration (FDA), it remained on the US mar - red font as the other label information. because it is presented in the same color font ket for decades. In 2010 and 2011, FDA as the vaccine names ( Figure 1 ). Even though the vials are slightly different sizes began taking action against companies and have different cap colors, similarity in label style and color, and the small font that manufactured, distributed, or mar - size increase the risk of mistaking either vial as the complete vaccine. Also, both keted certain unapproved prescription vials list the root Men —one Men CYW-135 and the other Men A—which could be products. Paregoric was among them, and continued on page 2 —Fail to protect > continued on page 2— SAFETY briefs > February 2016 Volume 15 Issue 2 Page 2 > Fail to protect —continued from page 1 mistaken to simply mean that either vial contains the Men ingitis vaccine by those cont’d from page 1 who do not know it is a two-component vaccine. for a time, it was unavailable in the US. Nevertheless, upon the request of both pa - Several errors reported to ISMP also suggest that practitioners may mistakenly tients and health professionals, at least one believe the “liquid” component of the vaccine is just a standard diluent. 2 As such, manufacturer, Hi-Tech Pharmacal, inter - some errors involved administration of only the MenA powder after it was recon - acted with FDA to bring it back on the mar - stituted with a “generic” diluent (e.g., normal saline) or diluent supplied with an - ket, even though it remains an unapproved other vaccine (e.g., varicella; measles, mumps, and rubella). Some reported errors product. also involved accidentally diluting the MenA powder with another liquid vaccine, believing the liquid vaccine was a standard diluent. In addition, some of the errors in which the liquid MenCYW-135 component was given alone were reported as administration of just a “diluent,” without recognition that the “liquid” component is part of the vaccine. All of these errors are serious because they leave people exposed to a potentially deadly disease—meningococcal meningitis, meningococcemia, or a related meningo - coccal disease. Furthermore, if an error goes unrecognized, which is certainly possible with these types of errors, individuals who have not received a proper dose will not know they are unprotected. Although errors can be made by anyone preparing and administering vaccines, it should be noted that, in the US, unlicensed medical assistants who may not have Figure 1. Paregoric is not opium tincture 2%. the training or knowledge to recognize and address these challenges are often ad - ministering vaccines. About 40% of inpatient and outpatient vaccine errors reported Unfortunately, when the product was rein - to the ISMP National Vaccine Errors Reporting Program (VERP) involve unlicensed troduced, for some unknown reason the medical assistants who may be unfamiliar with the vaccine. nomenclature “opium tincture, 2%” was used in addition to “paregoric.” This is a MMWR Article problem for several reasons. First, “pare - Although ISMP has been writing about this type of error since 2014, the CDC-FDA goric” is the official name; next, paregoric analysis of Menveo errors and subsequent publication in the February 19, 2016, is NOT “opium tincture, 2%” and should Morbidity and Mortality Weekly Report (MMWR )1 was prompted by a question never be confused as such. Here’s why: posed to the CDC by a practitioner who wanted to know if it was safe to administer paregoric has 0.4 mg of morphine per mL a properly prepared vaccine dose of Menveo immediately after an error had been (2 mg in 5 mL). A typical adult dose would made by administering just the powder component alone. This led the CDC to be 5-10 mL, 1 to 4 times a day. A child would search the national Vaccine Adverse Event Reporting System (VAERS) database receive 0.25 to 0.5 mL/kg for each dose. But for reports of Menveo errors from March 1, 2010, through September 22, 2015. The opium tincture is an entirely different prod - agency identified 390 reports where only one component of the vaccine was ad - uct. Also known as laudanum, opium tinc - ministered to a total of 407 patients. Most patients (66%) received only the Men - ture contains 10 mg/mL (1%) of anhydrous CYW-135 liquid component, although some (34%) received only the MenA morphine. A typical adult dose is 0.6 mL, 4 lyophilized component, reconstituted with sterile water, saline, a different liquid times daily; a child would receive just 0.005 vaccine (e.g., hepatitis B vaccine), or an unspecified diluent. The data also identified to 0.02 mL/kg for each dose. A 10 kg child disproportional reporting of errors associated with Menveo, two times more often might get 5 mL of paregoric (anhydrous when compared to other vaccines. morphine 2 mg), but using opium tincture in error would result in the administration To their credit, the authors note that some errors with Menveo were detected by of an equivalent of 50 mg of morphine. routine processes as part of quality assurance, and they refer readers to other strate - gies available from the CDC to prevent vaccine administration errors. 3 Yet, it is dis - Confusion between paregoric and opium appointing that these strategies address all vaccines together and do not speak to tincture has been a longstanding problem the particular problem of two-component vaccines. While there is clearly good in - because paregoric was previously known formation about vaccine safety in this CDC reference, 3 it is also frustrating that the as “camphorated tincture of opium,” strategies begin with a recommendation to basically adhere to the five rights of which is easily confused with opium tinc - continued on page 3 —Fail to protect > continued on page 3— SAFETY briefs > © 2016 ISMP.