Pharmacy Purchasing & Products: The Institute for Safe Medication Practices (ISMP) recently released its 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Should hospital pharmacies seek to implement the 2014-2015 practices first?

Darryl Rich: The new 2016-2017 document contains all of the same practices from the 2014-2015 version, which are listed as Best Practices 1 through 6. Those are purposely repeated in the new version because they remain important and we believe hospitals should concentrate on addressing those issues first. That said, there were revisions to two of the practices (numbers 2 and 3), as these were found to have the fewest implementations. The current version is available at: www.ismp.org/tools/bestpractices/TMSBP-for-hospitals.pdf

PP&P: How have Best Practices 2 and 3 been revised in the latest version?

Rich: In the previous version, Best Practice 2 (which aims to prevent errors involving inadvertent daily dosing of oral methotrexate in both inpatient settings and post-discharge) combined two processes into its sub-point A: Use of a weekly dosage regimen default for oral methotrexate, and requiring a hard stop verification of an appropriate oncologic indication if overrode to daily. We found that many practitioners did not have problems with the weekly dosage regimen, but several were unable to accommodate the second part because their electronic order entry systems did not allow for this functionality. To address this, we split sub-point A into two separate items in the 2016-2017 document (now sub-points A and B (see SIDEBAR 1) so that when ISMP conducts surveys in the future, we can measure these points separately. Furthermore, ISMP provided more detail to indicate that if a facility is using a manual system or an order entry system that does not allow hard stops, all daily orders for methotrexate should be clarified if the patient does not have a documented oncologic diagnosis.

The original sub-point B from the 2014-2015 version is now sub-point C in the new version. The original version required the facility to provide patient education by a pharmacist for all weekly oral methotrexate discharge orders, which many felt was an issue. As a multidisciplinary organization ourselves, ISMP saw the error of this requirement and have now expanded it to any health care professional. Lastly, in the new sub-point C, we emphasized the need to absolutely confirm that the discharge list is accurate and confirm with the patient that he or she understands the instructions as well as the potential ramifications if the regimen is not followed precisely.

For Best Practice 3 (which aims to ensure that when possible, the patient’s actual weight is obtained upon each admission or appropriate encounter), the primary challenge was that facilities were not taking a true patient weight, but were relying on a stated weight from the patient, or even an estimate or historical weight. Now, we are more specific in stating that patient weight should be taken as soon as possible on each encounter using metric units exclusively. In the 2016-2017 version, we have reiterated that we do not expect facilities to immediately replace existing scales (such as bed-scales) to conform to the metric system, but to do so whenever those scales are replaced in the future. Likewise, we encourage facilities to have conversion charts to enable clinicians to provide weights in pounds to patients or caregivers, but to use the metric system in their internal files.

PP&P: There are five new best practices in the 2016-2017 version; can you explain the reasoning behind these additions?

Rich: The new additions to the 2016-2017 list were largely based on an analysis of our internal inspection data indicating practices that were found to be in poor compliance overall. In the case of new Best Practice 8, which recommends the administration of high-alert IV medication infusions via a programmable infusion pump utilizing dose error-reduction software, we found that while this technology is now somewhat ubiquitous, the pumps are not always used properly throughout a hospital or health system, and in some cases the dose error-reduction software is disabled.

In the case of new Best Practice 7, which seeks to segregate, sequester, and differentiate all neuromuscular blocking agents (NMBs) from other medications, wherever they are stored in the organization, we found a lack of facility-wide standardization. Many hospitals were in compliance in patient care areas, but less so in the pharmacy. Similarly, new Best Practice 9 tasks the facility with ensuring all appropriate antidotes, reversal agents, and rescue agents are readily available, with directions for proper use of these agents. Orders for these agents should be available in advance. Many facilities have strong protocols in certain areas of the hospital, but lack universal compliance. For example, we have received reports of deaths because the nurse had to wait for an order for EPINEPHrine, when a patient had an allergic reaction.

PP&P: Have you received feedback indicating challenges with any of the new best practices?

Rich: We have received some comments on the new Best Practice 10: Eliminate all 1,000 mL (1 liter) bags of sterile water (labeled for injection, irrigation, or inhalation) from all areas outside of the pharmacy. The intent of this practice is to avoid accidentally administering an IV infusion of sterile water to a patient, given the similarities of such 1-liter bags to those of dextrose 5% or 0.9% sodium chloride solutions. This has posed some problems in that facilities may have devices that require 1-liter bags, such as certain ventilator humidification systems, or for facilities that hang the bag using a circuit arm, which is not specifically designed for this and does not support the extra weight of, say, a 2-liter bag. (ISMP recommends using an add-on IV pole that can support the weight of a 2-liter bag.) Among the problematic scenarios would be a respiratory therapist hanging a 1-liter bag of sterile water intended for humidifying a ventilator, and a following nurse mistaking it for a bag of saline for infusion.

While pushback on this topic is understandable, our intention is to challenge facilities to seek best practices. History does not have to imply perpetuity; just because something has been done a certain way over time does not mean it should be done that way forever. Rarely is questioning this idea more appropriate than in health care.

PP&P: Are any of the new best practices likely to have a significant financial impact on hospital pharmacy?

Rich: Some of the practices may necessitate the addition of automation and technology to the pharmacy and the hospital in general. For example, the implementation of smart pumps in all areas, including the OR, radiology (ie, an MRI-safe smart pump), and outpatient infusion settings could be a challenge for many facilities. That said, many hospitals do have widespread smart pump use, and simply need to begin utilizing the pumps’ advanced capabilities in all areas.

We feel strongly about the technology components involved in new Best Practice 11: When compounding sterile preparations, perform an independent verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container. Some practitioners say it is impossible not to use the syringe pullback method, or some proxy method, unless they station a pharmacist in the compounding room or purchase IV workflow verification technology. The fact of the matter is: Modern medication compounding in the hospital necessitates technology in order to maintain strict patient safety measures. A typical situation may involve using IV workflow technology only for high-alert medications. But in a 2014 case, a patient intended to receive IV fosphenytoin (non-high alert) for seizure control was instead administered a dose of the neuromuscular blocking agent rocuronium (high alert), despite the bag being labeled as fosphenytoin.¹ Had IV workflow technology (or even bar code scanning of ingredients) been used, this death could have been adverted. Given a non-high-alert drug was the intended therapy, hospitals that only use IV workflow technology when compounding high-alert drugs could have made the same catastrophic error.

The good news is, more hospitals and health systems are utilizing improved information systems that include bar code scanning technology during compounding processes. While this may not cover the entire workflow as stand-alone products do, this approach can provide improved assurance that the correct product has been selected and gravimetrics can be used to determine proper amounts. As with any change, we realize the adoption of robust IV compounding management technology can take time and money, but there is little doubt of its efficacy and, frankly, of its necessity when working with today’s incredibly potent medication compounds. As is always the case, we are challenging health care facilities to continually seek best practices, and technology often offers a solution.

PP&P: What other areas is ISMP focusing on in 2016-2017?

Rich: We are planning to issue new guidelines on insulin use this year, as there are a plethora of new insulin products and strengths now on the market. One relatively recent announcement is a new U-500 syringe and a U-500 pen, which could eliminate many of the errors associated with that product. We have received numerous reports of dosing errors when using a U-100 syringe, mostly due to improper communication of “U-100 equivalents” as the dose. These new products will eliminate the need for any conversions for dosing.

Another obvious concern is opioid use. Although this is a broad topic with many aspects, we are particularly concerned about the risk of medication errors, as we continue to see errors involving opioids. Often it is the older drugs that continue to cause serious problems.

Despite the added interest in insulin and opioids in this coming year, we are maintaining a focus on neuromuscular blockers, as these agents have caused a number of publicized fatalities in 2014, and we find this one best practice can reduce errors involving these agents (see SIDEBAR 2).

PP&P: How can hospital pharmacies leverage ISMP site visits to improve their medication safety practices?

Rich: We encourage hospitals to reach out to us and request a site visit. ISMP representatives will come and tour the facility, evaluate medication safety practices, and provide an improvement report (if necessary) based on our guidelines. The site visits are performed by a multidisciplinary group, consisting of a nurse, a physician, and a pharmacist, at minimum. We tailor the visit to the request of the facility, so we might target sterile compounding only, or expand to broader institutional medication safety practices and advise on gaining compliance with regulatory bodies.

The Centers for Medicare and Medicaid Services (CMS) recently revised its interpretative guidelines for the Medicare Conditions of Participation for Hospitals so that hospitals “must be consistent with accepted standards of practice based on guidelines or recommendations issued by nationally recognized organizations with expertise in medication preparation and administration,” and ISMP is one of the organizations listed.2 Even so, most facilities that take part in this process are eager to continually improve their operations. For information about site visits, please contact Michelle Mandrack at mmandrack@ismp.org, or visit www.ismp.org

Reference

1. Institute for Safe Medication Practices. Tragic error with neuromuscular blocker should prompt risk assessment by all hospitals. ISMP Medication Safety Alert. December 18, 2014. Accessed: 9/1/16
   www.ismp.org/newsletters/acutecare/showarticle.aspx?id=97
2. Centers for Medicare and Medicaid Services. Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications. S&C memo: 16-01-Hospital. October 30, 2015. Accessed: 9/1/16 https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-01.pdf

Darryl S. Rich, PharmD, MBA, FASHP, is a medication safety specialist for ISMP, and is responsible for ISMP’s Targeted Medication Safety Best Practices initiative. He also is a lead surveyor for ASHP’s residency accreditation program. Previously, he worked at the Joint Commission for almost 20 years as an associate director for surveyor management and development and then as a surveyor. Prior to that, he was director of pharmacy for Boston Medical Center. Darryl received his PharmD from the University of California at San Francisco and his MBA in Health Care Management from Bryant University in Rhode Island.