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Medication Safety Alert!

A federally certified

Patient Safety Organization

Educating the healthcare community about safe medication practices

NurseAdvise-ERR
May 2011

Volume 9 Issue 5

Final Acute Care Guidelines for Timely Administration of Scheduled Medications posted on ISMP website
SMP extends its sincere thanks to the 150 groups and individuals who provided comments on our draft Guidelines for Timely Medication Administration, which were published in our January 13, 2011 newsletter (www.ismp.org/Newslet ters/acutecare/articles/20110113.asp). Approximately 30% of the 150 submissions represented opinions from entire hospital safety teams that met and discussed the guidelines together, or from large professional organizations, including but not limited to: The Joint Commission American Nurses Association Intravenous Nurses Society South Carolina Organization of Nurse Leaders New York State Board of Nursing Ohio Department of Mental Health American Pharmacists Association American Society of HealthSystem Pharmacists American Association of Respiratory Care. The remaining responses were from individual staff nurses, nurse executives, staff pharmacists, directors of pharmacy, and patient safety staff. With input from an interdisciplinary advisory group, ISMP developed the draft guidelines after conducting a survey in late-2010 regarding the requirement in the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation Interpretive Guidelines to administer medications within 30 minutes before or after the scheduled time. Almost 18,000 nurses who responded to our survey made it clear that changes to drug delivery methods and gradual increases in the complexity of care, number of prescribed medications per patient, and number of patients assigned to each nurse have made the long-standing CMS 30-minute rule error prone. Many nurses reported feeling great pressure to take shortcuts to comply with the rule, which have led to errors, some harmful. While delaying the administration of certain timesensitive medications can also result in harm, a one-size-fits-all, inflexible requirement to administer all scheduled medications within 30 minutes of the scheduled time is a precarious mandate given that relatively few medications truly require exact timing of doses. The vast majority (97%) of those who submitted comments to ISMP, including all of the professional organizations and agencies listed above, were very supportive of the draft guidelines and believed they allowed organizations the flexibility to establish more realistic and safer goals associated with timely medication administration while still allowing nurses to utilize their critical thinking skills to manage their time wisely and prioritize patient needs. Among those who supported the guidelines, about a quarter expressed concern regarding a specific componentmost notably the complexity of the goal associated with timely administration of medications prescribed more frequently than every 4 hours (i.e., administer within 25% of the dosing interval). Only four respondents (3%) expressed a general lack of support for the guidelines, either believing the proposed guidelines were wholly unnecessary or not evidence-based. Nevertheless, numerous frontline nurses who provided comments disclosed that the proposed guidelines represent exactly what they feel most nurses follow
G continued on page 2Guidelines

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Patient confused by insulin pen design. An error reported to us involving the LANTUS (insulin glargine rDNA origin) SOLOSTAR pen from sanofi-aventis has important implications for those who dispense this product or similar insulin pen devices from Novo Nordisk. A Lantus Solostar pen was prescribed for a patient who had prior experience administering Lantus from vials using insulin syringes. When the patient picked up the pen at the pharmacy, he was not counseled. Each pen contains 300 units of Lantus. The dose is set in the pen's dosing window by turning a dosage knob. The dose is then released by pressing an injection button, which sets a plunger in motion within the pen's insulin reservoir. The physician told the patient to inject 75 units of insulin every morning. Unfortunately, the patient took 225 units of Lantus instead of the prescribed amount, resulting in an emergency department (ED) visit. The pen looks like it functions as a syringe or other pen devices, where the plunger moves all the way to the hub of the needle as it releases a dose. However, the plunger of the Solostar pen is not designed to deliver the entire amount of insulin in the reservoir; thus, the plunger only moves partially, resting on a reservoir scale that shows the remaining quantity of Lantus in the pen. The patient, who expected the plunger to move like a typical syringe, didn't notice the subtle movement and repeated the injection three times, delivering 75 units each time. Patients should receive instructions about use of the device from the prescriber and/or a diabetes educator as well as the dispensing pharmacist. Fortunately, the patient was monitored and discharged from the ED without permanent harm and now knows how to use the device. If using this device, refer patients to view an instructional video at: www.ismp.org/sc?k=lantus. continued on page 2 wires

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Supported by educational grants from Baxter Healthcare and McKesson

NurseAdvise-ERR
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May 2011

Volume 9 Issue 5

Guidelinescontinued from page 1

right now, even if attempts are made to document medication administration more in line with the 30-minute rule. After thorough review of all the submitted comments, ISMP has made several changes to the draft guidelines, as described below. Time-critical scheduled medications The recommendation for hospitals to define their own list of time-critical scheduled medications and to administer these medications at the exact scheduled time when necessary or within 30 minutes of the scheduled time remains unchanged. However, we added several examples of time-critical scheduled medications that should be on all hospitals lists, including scheduled (not prn) opioids used for chronic pain or palliative care (fluctuations in the dosing interval may result in unnecessary break-through pain), and medications that must be administered apart from other medications (e.g., antacids and fluoroquinolones). Medications administered more frequently than every 4 hours were also moved to this category of time-critical scheduled medications (see next section). We also emphasized that medications administered around mealtimes require nursing judgment regarding the actual time of administration, which may fluctuate based on meal delivery time, actual consumption of the meal, and the patients condition. Non-time-critical medications Among those that generally supported the draft guidelines, some expressed concern that having three categories of non-time-critical medication types would make the goals of timely administration too complex to remember, enforce, and monitor. To reduce complexity, the final guidelines now suggest that medications prescribed more frequently than every 4 hours should be considered time-critical scheduled medications. The number of medications that would fall into this category is small, and the type of medications that are dosed this frequently often require

administration at the exact time, or at least within 30 minutes of the scheduled time, which is the goal for timecritical scheduled medications. This change means there are now only two categories of non-time-critical scheduled medications and proposed goals: Daily, weekly, monthly medications: to be administered within 2 hours before or after the scheduled time Medications prescribed more frequently than daily, but no more frequently than every 4 hours: to be administered within 1 hour before or after the scheduled time
Operational guidelines The draft guidelines included a table of Supporting Operational Guidelines for Timely Administration of Scheduled Medications that provides brief guidance for appropriate allocation of human resources, the content of policies and procedures related to timely drug administration, and evaluation associated with event reporting and data analysis. Changes were made to the event reporting description to streamline the process and remove what was felt to be an unrealistic tracking mechanism based on end-of-shift reports. Other enhancements The final guidelines include additional language to promote understanding that these guidelines are just that guidelines, not standards. An interdisciplinary team with nursing representation must translate the guidelines into facility-specific policies and procedures. The guidelines also recommend flexibility of goals for timely administration, as appropriate, to accommodate the additional time needed to learn to operate new medication-related technologies.

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We also received numerous comments from practitioners who wanted to remind us that limitations in current information technology associated with medication use would make it difficult to: accommodate more than a single time interval to trigger an alert
continued on page 3Guidelines

Injury from dislodged wallmounted IV pole. A tragic accident last month left an ICU patient in critical condition when a wall-mounted IV pole (Figure 1) became dislodged as the bed was being raised. The top of the headboard lifted the pole from its housing, and an infusion pump that was clamped to it fell onto the patients head, causing an intracranial bleed. Unfortunately, the patient died from the injury a few days later. The hospital has now removed all wall-mounted IV poles and is using only floor-based IV poles. An electric bed capable of lifting patients that weigh 100 kg or more has the power to easily shear off wall-mounted equipment if the headboard catches onto it as the bed rises. ISMP nurses have recounted similar incidents in which an IV pole on a bedframe dislodged a light fixture on the wall when the bed was raised, nearly falling on the patient. In fact, almost any piece of equipment attached high on a pole (e.g., a monitor) could potentially harm a patient if it falls. Standing IV poles can also tip easily if Figure 1. Pump was on they hold a wall-mounted IV pole. more devices than recommended by the pole manufacturer or heavy fluid bags (e.g., 3 liter parenteral nutrition bags). These heavy objects, when raised high on IV poles, may shift the center of gravity, making it more likely to tip. Standing IV poles also risk tipping if the wheels are close together or if a wheel does not spin freely, sometimes due to debris (e.g., tape) that collects on the wheels. In light of the above tragedy, please examine the possibility of a similar accident, even if you dont have wall- or bed-mounted units. Lawyers weigh in on consistent use of smart pump libraries. As noted in our April 19, 2007 article, Smart pumps are not smart on their continued on page 3 wires

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Nurses Day/Week: We hope you all had a wonderful Nurses Day and wish to extend our gratitude for all the work you do!

NurseAdvise-ERR
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May 2011

Volume 9 Issue 5

Guidelinescontinued from page 2

for delayed and early doses with barcoding technology; change the appearance of a medication entry for delayed doses in electronic medication administration records (eMARs); and set different time limits for the removal of scheduled medications from automated dispensing cabinets. Challenges also exist with highlighting time-critical medications on eMARs and differentiating between first doses and subsequent scheduled doses when using these technologies. We are aware of these limitations and will be encouraging vendors to address them in updated versions of their technology. Next steps ISMP has posted the final Acute Care Guidelines for Timely Administration of Scheduled Medications on our website at: www.ismp.org/tools/guidelines/acute care/tasm.pdf. We encourage hospitals to evaluate their goals for timely medication administration using these guidelines, which have been thoroughly vetted by many medication and patient safety experts; hospital safety teams; professional nursing, pharmacy, and respiratory therapy organizations; The Joint Commission; pharmacists; and frontline nurses who bear the ultimate responsibility for administering medications in a timely manner. Using a modified failure mode and effects analysis process, ISMP has
Special Announcements

taken steps to anticipate any unintended consequences of changing the goals for timely medication administration. For example, we recognize that dose omissions may be a risk with wider dose intervals but have determined that this risk is lower than the many more serious risks associated with workarounds, shortcuts, and rushed drug administrationthe unintended consequences of the 30minute rule. However, any change carries the risk of introducing new, unrecognized sources of errors. Thus, we are asking acute care facilities that make changes to their policies based on these guidelines to report any associated concerns, hazards, errors, or adverse events to ISMP via the ISMP Medication Errors Reporting Program (www.ismp.org/merp). CMS staff has requested a copy of the final guidelines, and based on our recent conversations with them, we are optimistic that positive changes will be made to the current 30minute rule. For now, hospitals will still be held accountable for the 30minute rule in the CMS Interpretive Guidelines. But given the wide support for these more reasonable and clinically appropriate guidelines, we hope CMS surveyors will allow hospitals to justify their carefully considered policies and procedures regarding timely medication administration using these guidelines to anchor the process.

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own (www.ismp.org/Newsletters/acute care/articles/20070419.asp), clinicians should not view the dose-checking feature of smart pumps as an option that can be turned on or off. Nor should the alerts that arise from the system be bypassed without serious consideration. Unfortunately, we still hear about serious medication errors in which users bypassed pump libraries, resulting in patient injuries. An article about legal considerations with the use of smart pumps (Harding AD, Connolly MW, Wilkerson TO. Nurses risk without using smart pumps. JONAs Healthcare Law Ethics and Regulation. 2011;13(1):17-20) points out that, when this technology is available but not utilized, litigation could be successful in finding fault with nurses and others if a patient is harmed. Therefore, available smart pump technology should be fully maximized and employed consistently, and alerts issued by the technology should be addressed before administering parenteral therapy.
Confusing Sandoz packaging. Weve asked FDA to look into a packaging issue with Sandoz itraconazole 100 mg capsules. A strip pack labeled 100 mg (Figure 1) actually contains two 100 mg capsules. Staff may believe that the two capsules together equal 100 mg. This might result in the administration of two strip packs (4 capsules) containing 400 mg instead of the prescribed 200 mg dose. This package should be labeled 200 mg (2 x 100 mg). Hopefully, the manufacturer will respond with proper labeling for the product. Until then, if the pharmacy purchases itraconaFigure 1. Itraconazole strip zole pack labeled 100 mg from actually contains two 100 Sandoz, mg capsules or a total dose ask of 200 mg. pharmacy staff to relabel the product to assure nurses understand the total amount contained in each package.

ISMP Webinar: On June 29, ISMP will present a webinar, The Pharmacist Perspective: The Expected and Unexpected Results of Computerized Prescriber Order Entry (CPOE) Implementation. Follow the journey of one hospital as it navigates through transformed relationships and altered workflow and efficiency associated with CPOE implementation. Speakers will highlight challenges to anticipate after CPOE go live date and will share ideas on how to maximize medication safety benefits through the use of CPOE. For details and to register, visit: www.ismp.org/educational/webinars.asp.
ISMP Medication Safety Alert! Nurse Advise-ERR (ISSN 1550-6304) 2011 Institute for Safe Medication Practices (ISMP). Permission is granted to subscribers to reproduce material for internal newsletters or communications. Other reproduction is prohibited without written permission. Unless noted, published errors were received through the ISMP Medication Errors Reporting Program. Editors: Judy Smetzer, RN, BSN, FISMP; Ann Shastay, RN, MSN, AOCN; Michael R. Cohen, RPh, MS, ScD; Russell Jenkins, MD. ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044-2321. Tel.: 215-947-7797; Fax: 215-914-1492; EMAIL: nursing@ismp.org.

Report medication errors to ISMP by going to www.ismp.org/MERP.

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