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October 2017 Volume 15 Issue 10

ISMP launches the first high-alert medication safety
self assessment for inpatient and outpatient facilities Patients should not swallow AcipHex
Sprinkle capsules! ACIPHEX SPRINKLE
Without a doubt, we consider the series of ISMP Medication (RABEprazole sodium) delayed-release cap-
Safety Self Assessment® tools (www.ismp.org/selfassessments/) sules are used to treat gastroesophageal
to be among the most important activities we’ve undertaken to help reflux disease in children 1 to 11 years for
advance medication error prevention efforts. ISMP is excited to an- up to 12 weeks. Although the product is a
nounce the launch of a groundbreaking new medication safety self capsule, it must NOT be swallowed whole
assessment that will help hospitals, long-term care facilities, and or chewed, nor should the granules be
certain outpatient facilities evaluate their best practices related to high-alert medica- crushed. AcipHex delayed-release tablets
tions, identify opportunities for improvement, and track their experiences over time. for adults should be swallowed whole, not
Many key professional and accrediting organizations have endorsed the new ISMP crushed or chewed. But for the sprinkles,
Medication Safety Self Assessment® for High-Alert Medications (see Table patients or caregivers should open the cap-
1 on page 2). Participation in the new self assessment will help healthcare organiza- sule and sprinkle the granule contents on a
tions analyze how they are meeting requirements for managing high-alert medica- spoonful of soft food or liquid, and take the
tions from regulatory and accrediting agencies, such as the Centers for Medicare & entire mixture within 15 minutes of prepara-
Medicaid Services (CMS) and The Joint Commission. tion. AcipHex Sprinkle is the only capsule
formulation proton pump inhibitor (PPI) that
High-alert medications, a term first coined by ISMP in 1997, are defined as those cannot be swallowed whole. All other PPI
drugs that bear a heightened risk of causing significant patient harm when used in capsules, such as omeprazole, esomepra-
error. Although mistakes may or may not be more common with these drugs, the zole, and lan-
consequences of an error are clearly more devastating to patients. soprazole,
can be swal-
Overview of the New Self Assessment lowed whole,
although pa-
Targeted high-alert medications. The new ISMP Medication Safety Self tients who
Assessment® for High-Alert Medications is being funded through a contract have difficulty
with the US Food and Drug Administration (FDA) Professional Affairs and Stakeholder swallowing
Engagement/Safe Use Initiative, and will focus on best practices for high-alert med- can also open
ications in general, along with eleven specific medication categories: these cap-
Figure 1. Auxiliary labels sules and
Neuromuscular Blocking Agents printed with AcipHex Sprinkles sprinkle the
Concentrated Electrolytes Injection prescription label are confus- pellets over a
Magnesium Sulfate Injection ing. AcipHex Sprinkles should tablespoon of
NOT be swallowed whole.
Moderate Sedation in Adults and Children, Minimal Sedation in Children applesauce.
Insulin, Subcutaneous and Intravenous Other sprinkle capsules, such as topiramate
Lipid-Based Medications and Conventional Counterparts sprinkle capsules, divalproex sodium de-
Methotrexate for Non-Oncologic Use layed-release sprinkle capsules, and KLOR-
Chemotherapy, Oral and Parenteral CON sprinkle capsules (potassium chloride
Anticoagulants extended-release) can be swallowed whole
Neuraxial Opioids and/or Local Anesthetics or opened and sprinkled over soft food.
Opioids
Some of the auxiliary labels that automati-
Several changes have been made to this particular self assessment as compared to cally print with pharmacy labels for AcipHex
our other self assessments to make the tool easier to use. Participants can choose Sprinkle capsules may be interpreted to
one or more of the high-alert medication sections to assess. They can complete the mean that the capsules can be swallowed
tool in phases, responding to just the sections on the high-alert medication categories whole (Figure 1). If applied to the prescription
continued on page 2—Self assessment > continued on page 2—SAFETY wires >

Supported by educational grants from
Novartis and Fresenius Kabi

the labels can cause confusion and each section is completed. In fact.” Weighted scores. and diagnostic testing cen. ISMP will NOT be able to identify individual facilities that have entered and/or submitted information. However. nurses need to targeted high-alert medications. But this was misheard as TENI- the self-assessment items repre- USP VAC(diphtheria and tetanus toxoids). Several minutes later. They can even submit their findings anonymously to ISMP as bottle. if the receiving practitioner is score unless there is full implementation of the item throughout the organization. and the self-assessment items American Hospital Association to print with AcipHex Sprinkle prescriptions are designed for diverse healthcare American Nurses Association to be sure they reflect the correct adminis- settings that use any or all of the American Society for Healthcare Risk Management tration method. which affords an cainamide hydrochloride injection 1. Organizations that will benefit. “10 of vec.000 even higher level of protection when clinicians and organizations choose to submit mg/10 mL prefilled syringes should only be error data and other patient safety work to ISMP. cine commonly given to trauma patients. information is collected as part of the assessment process. American Pharmacists Month (October) and National Health IT Week (October 2-6) . 2017. Lessons learned: don’t abbreviate Most of the self-assessment items are weighted in a way that results in no numerical drug names—not even when communicat- score (zero value) unless there is partial or full implementation of the item. ing drug names verbally—and repeat back some of the self-assessment items are weighted in a way that results in no numerical (or read back. oncology clinics. Unsafe procainamide packaging. and the company could care facilities. such as ambulatory surgery centers. ISMP is a federally certified patient safety organization (PSO). cedure.Assessment® for High-Alert Medications Sprinkle capsule whole. Keep in mind Institute for Healthcare Improvement ing seriously injured in a motor vehicle ac- that ISMP is not a standards set. physically able to transcribe the order im- mediately) all verbal orders. tem enhancements that are not widely implemented in healthcare facilities today.To determine a weight needed for continued paralysis while the for each self-assessment item. but the label continued on page 3—Self assessment > continued on page 3—SAFETY wires > Join us in celebrating. Pro- tion. staff will be able to obtain weighted scores based on their assessment. pamphlet and auxiliary labels programmed ties. We also con- high-alert medications. emergency/urgent information group. National Committee for Quality Assurance cident. and dosing units. Retail pharmacies mographic questions are provided should evaluate the medical information American Association of Colleges of Nursing for inpatient and outpatient facili. Read back or repeat back of the verbal order Their value in reducing errors is grounded in scientific research and/or collaborative either did not occur or was accomplished agreement by the expert Advisory Group regarding items included in the assessment. However. the lyzed with vecuronium for rapid sequence National Patient Safety Foundation self-assessment items do not rep. Healthcare organizations can use this unique tool in their own medication safety efforts. ISMP Association for the Advancement of Medical tacted all major drug information vendors worked with an expert Advisory Instrumentation Foundation so they can make any necessary changes Group to ensure that the systems Association of periOperative Registered Nurses to auxiliary warnings they provide in their and practices most crucial for pa. ISMP used a standard process to independently evaluate trauma team performed an emergency pro- each item to determine its impact on patient safety and its ability to sustain improvement. content for pharmacies. long-term care facilities. As such. intubation.Table 1. treatment centers. The patient had initially been para- ting organization. More details about this process follow. increase the risk of incorrect administration if older children try to swallow the capsules. saying the full Protection of anonymous results submitted to ISMP. some of The Joint Commission curonium). When in the electronic medical record or other developing the assessment for Anesthesia Patient Safety Foundation drug information resources. In addi. endoscopy not comment on the clinical and safety out- centers. a trauma resent a minimum standard of Pediatric Pharmacy Advocacy Group surgeon verbally ordered more vecuronium. Healthcare organizations that can benefit from the new self assessment include hospitals. so they can compare quickly recognized that vecuronium was themselves to demographically similar organizations nationally. only organizations that submit their assessment Although Tenivac was administered (and findings to ISMP anonymously via a secure internet portal by December 15. health systems.. Although demographic drug name. practice and should not be con. October 2017 Volume 15 Issue 10 Page 2 > Self assessment—continued from page 1 continued from page 1 used in their facilities. dental surgery centers. A separate set of general de. would have been ordered anyway). If self-assessment information is used to prepare IV infusions. American Society for Parenteral and Enteral Nutrition be aware of the correct administration either through built-in administration instructions American Society of Health-System Pharmacists Self-assessment items. Organizations endorsing the ISMP Medication Safety Self comes if patients swallow the AcipHex ters. In hospitals. Society of Critical Care Medicine saying she needed “10 of vec” (10 mg of ve- sidered as such. ECRI Institute tient safety were included. A patient achievable in a broad range of Infusion Nurses Society was being treated in a trauma bay after be- healthcare facilities. ISMP contacted the manufacturer’s medical and some outpatient facilities. and that the recommendations were Health Care Improvement Foundation Don’t abbreviate drug names.. dose. using the same abbreviated name and dose that the prescriber voiced. a vac- sent innovative practices and sys.

. we have the best data upon which to base our decisions regarding the most valuable page 4): aciclovir (International Nonpropri- use of our collective resources. to gain access to all sections. If stored in emergency supplies. valaciclovir (INN) As explained in the workbook. valGAN- continued on page 4—Name > can be submitted to ISMP using the online form after creating a free account at: ciclovir. identify and prioritize opportunities to reduce patient merases. procainamide bolus doses as well as infu- duced if it is completed by a single person or a single discipline. other sections can be used to evaluate systems and practices associated with specific high-alert medications. 2017. No contract with ISMP is required for this legal protection.” may be missed (Figure 1).The new assessment tool is now available bolus loading doses. ISMP recommends that healthcare organizations establish in. practices often differ. We have notified FDA and the manu- facturer. This will help create a baseline of national efforts to enhance viral DNA synthesis by inhibiting DNA poly- safety with high-alert medications. “FOR THE PREPARATION OF I. They continued on page 4—Self assessment > Newsletter also partially supported by an educational grant from . the information is granted protection from INFUSIONS ONLY. the tool requires information that can only be provided by practitioners who work in the facility. ISMP Please note: Because medication use is a complex.1 All antiviral Submitting findings to ISMP.ismp. For an accurate assessment. The tool (workbook) dose of procainamide could lead to toxicity is available for download. information technology (IT) staff. and risk management/quality improvement professionals. ISMP strongly encourages all facilities to complete the assessment for every high-alert medication category used in their facility.V. Again. discovery in connection with federal. or local civil. given that the prefilled syringe has a Luer connector. etary Name [INN]) or acyclovir (United States Adopted Name [USAN]). findings from any or all of the assessment sections or valACYclovir (USAN). state. Each fa- cility will truly benefit from completing the assessment individually and obtaining its The “-ciclovir” drug name stem own individual set of scores to focus on vulnerabilities that may vary from facility to fa- cility. and information entered can be saved and revisited for later completion. penciclovir. se. Your participation in this study is crucial to ensure tiviral agents available in the US (Table 1. the general demographics sec. and famciclovir. interdisciplinary recommends using 1 g vials for preparing process. The online form can be used to record ties). off the market. Not all the targeted high- alert medications included in the assessment may be used in every inpatient or out- patient facility. Although standardization across a health system is desirable. infusions. There are six “-ciclovir” an- can help improve medication safety. of our concerns. and submitting information to ISMP online. which include facility leaders. Safety Choosing the medications for assessment. During the 1980s and 1990s. physicians. Figure 1. 1 g and 2 g syringes. staff mize Medication Errors (www. agents have the stem “vir” in their drug pleting any section of the assessment to submit their results to ISMP anonymously by names.The further dilution prior to administration should assessment workbook contains instructions for establishing and convening teams. Assessing as a team. October 2017 Volume 15 Issue 10 Page 3 > Self assessment—continued from page 2 continued from page 2 collected within the organization’s patient safety evaluation system and submitted statement. administrative. not be packaged in containers that could lecting high-alert medications for analysis. allow direct administration (e.ismp. organizations need to complete the first section of the assessment covering general high-alert medications. Amphastar. However.g.org/ nurses. and help ISMP create tools associated with identified areas of vulnerability that antiviral agents. sions. resulting in more than submitted to ISMP in order to gain access to all other sections of the assessment. a different mechanism from other harm. Medications that have the suffix “-ciclovir” are considered antiviral agents. An accidental 1 g bolus on the ISMP website at: www. Those with the suffix “-ciclovir” stop December 15. We strongly encourage all healthcare facilities com. or disciplinary The risk of accidental bolus injection is high proceedings. 50 deaths before the syringes were taken The online form is also used to submit your results to ISMP anonymously. medication safety sc?id=2975). lidocaine responses.org/selfassessments/saham. Considerations for Product Design to Mini- terdisciplinary teams to work on the assessment. to ISMP as patient safety work product. Then. and directions for creating a free account to use the online (the drug has known proarrhythmic proper- self-assessment form are available at this site. so each facility can choose one or more of these high-alert medications upon which to focus. a syringe is typically used for direct administration). notes that products that require or patient safety officers. Label statement to use for the preparation of IV infusions is easy to miss. and pharmacists. were accidentally used for bolus tion and the general high-alert medications section will need to be completed and dosing of lidocaine. It is also important for each facility in a health system to complete the assessment indi- vidually and submit its information separately. Corporate-level assessment invalidates the tool’s effectiveness and usefulness. also meant for preparing If using the online form to complete the assessment. A draft guidance from the US Food and Drug Administration (FDA). ganciclovir. the value and accuracy of the self assessment is significantly re. Details on Participation this product might be selected instead of a vial of procainamide and used for preparing Obtaining the free assessment tool.

DHHS 19044.org/high_alert/. with comparative reports of the safety practices in US facilities based on the data submitted. BSN. Report medication and vaccine errors to ISMP: Call 1-800-FAIL-SAF(E).org .org) to obtain a group code that can be used to aggregate the online submission results of their par. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings.ismp.S. Cincinnati. ISMP Nurse AdviseERR (ISSN 1550-6304) © 2017 Institute for Safe Med.org/self function (except for topical penciclovir). participants can generate a report Table 1.86(10):1009-26. October 2017 Volume 15 Issue 10 Page 4 continued from page 3 > Self assessment—continued from page 3 https://ismpassessments. 200 Lakeside Drive. visit: www. Litman.ismp. After a self-assessment section for a high-alert and hepatitis. Centers for Editors: Ann Shastay. ISMP will use the aggregate findings to plan addi. active against other viruses such as hu- man immunodeficiency virus. shin- participating facilities that can be used for comparison to like facilities. AOCN. O’ Callaghan JP. ISMP will prepare and publish a preliminary aggregate results workbook for the general Topical high-alert medications and each of the targeted high-alert medications. References 1) World Health Organization. ISMP guarantees the confidentiality of information received and respects the reporters’ DB. including posting on a public-access website. DO. Judy Smetzer.2 medication category has been submitted to ISMP. visit: www. Fax: 215-914-1492. and CMV disease. RN. Suite 200. Antiviral drugs for viruses other the newsletter or reproduce its contents within their practice site or facility than human immunodeficiency virus. DeBord DG. Organizations that submit results to ISMP are used to treat or prevent viral infections must complete general demographic questions and the general high-alert medica. which will allow a collaborative effort to develop an action plan based on the group’s self-assessment results. (NIOSH) Publication Number 2016-161 (Super- sedes 2014-138). Injectable.ismp. RN. 2016. Viewing a report of your results. Tel: 215-947-7797.org/sc?id=3023 ication Practices (ISMP). ment of Health and Human Services. This is a peer reviewed pub- lication. RPh. MD. tools. and their dosages should be ad- representative of US hospitals. VALTREX Oral that submit information to ISMP will be able to access these aggregate comparative clovir reports by logging into the account that was used to enter and submit their self-assess. Horsham. Large health systems or organiza- ciclovir tions with large participating groups can contact ISMP (selfassess@ismp. and to ensure gles. Injectable. 2011. OH: U. VALCYTE Oral Aggregating results for collaborative efforts. Trout or www.2 assessments/saham.org/VERP. Ronald S. email selfassess@ismp. and resources to help healthcare practitioners enhance marrow suppression and are on the Na- safety when using high-alert medications. 3) NIOSH [2016]. is Proc. valACYclovir.org/MERP By Connor TH. The report can then be used to identify Generic Common Formula- and prioritize opportunities for improvement as part of the organization’s medication Name(s) Brand tions safety action plan. caused by herpes simplex virus. ment information. For more information. Other reproduction. prohibited without written permission from ISMP.2 Ganciclovir medication safety self assessments.ismp. An analysis of the aggregate results also will be submitted Settings. They are NOT a representative sample of US healthcare facilities participates in our study. Examples of US “-ciclovir” antivirals showing their weighted scores in that section. dling these two medications. and other countries and Health (NIOSH) List of Antineoplastic have adopted the assessment tool to gather information and to set goals for their own and Other Hazardous Drugs in Healthcare medication safety efforts. penci. Depart- wishes regarding the level of detail included in publications.com/ismp1 medsafetyofficer. ismp. acyclovir ZOVIRAX Oral.org. famci. varicella tions assessment items before navigating to any of the targeted high-alert medication zoster virus. ganci.com/ISMP1 facebook. Email: ismpinfo@ismp. Russell Jenkins. ISMP. FAMVIR Oral ticipants submit data to ISMP. Mayo Clin only. National Institute DPS (hon). clovir ZIRGAN Ophthalmic valGAN. The use of stems in If you would like to subscribe to this newsletter. genital herpes. Subscribers are granted permission to redistribute 2) Razonable RR. Michael Cohen. categories. Several national medication safety initiatives tional Institute for Occupational Safety have been based on data from ISMP’s previous self assessments. PA for Occupational Safety and Health. MacKenzie BA. DENAVIR Topical clovir ticipating facilities. This information is necessary to provide aggregate information back to such as cold sores. long-term care facilities.org twitter. clovir Value to the Healthcare Community Acyclovir.org/sc?id=382 the selection of International Nonproprietary Names (INN) for pharmaceutical substances. or call 215-947-7797.org. CYTOVENE. Facilities valACY. MSN.3 Please check your organiza- for publication in a professional journal to detail national baseline efforts to reduce the tion’s hazardous drug policy when han- risk of errors and prevent patient harm associated with high-alert medications. and cytomegalovirus (CMV). www. MS. and famciclovir are generally well-tolerated with occa- As with the data submitted by thousands of organizations in response to prior ISMP sional headache and nausea. All “-ci- clovir” antiviral agents are excreted Please help ISMP make this assessment tool a valuable medication safety resource renally.The code should be obtained before par. Disease Control and Prevention.ismp. After the data collection period ends. and valGANciclovir both can cause bone tional educational curricula. Name(s) Comparing your results to like facilities. influenza. FISMP. and outpatient facilities by justed in patients with impaired renal participating in this important effort.org consumermedsafety. 2013. ScD (hon). or visit www.