A key tenet of highly reliable organizations is the recognition that errors and near misses typically result from system and process breakdowns, rather than individuals. Medication management processes are among the highest risk components of care delivery in the inpatient setting. In fact, the US Department of Health and Human Services estimates that approximately 13.5% of hospitalized Medicare patients experienced permanent harm from a medical error, and 37% of these were attributed to medications.1 By nature of their invasive method of administration and immediate pharmacologic impact, injectable medications present a particularly high risk for potential error and patient harm.
Providing injectable medications in the inpatient setting in the most ready-to-administer (RTA) form decreases the risk of potential errors (See SIDEBAR). However, there are many challenges and barriers to consistently providing injectable medications in RTA form. To address this, we developed the RTA MedSafety tracer tool to assist hospitals in identifying their unique challenges and opportunities for improvement.
Identify Barriers to RTA Use
To help understand the challenges and barriers that clinicians face with using injectable medications, we developed surveys to elucidate current practices in the hospital setting. The following clinical disciplines were identified as having direct roles with providing, preparing, and administering injectable medications:
Survey questions were tailored for each target audience with a focus on identifying the perceptions and workflow challenges each discipline faces with regard to RTA injectable medications.
An independent quantitative market research firm administered the survey and aggregated the data to identify trends and patterns within each group as well as across all groups. A sample size of 250 (50 respondents per each of the five survey groups) was achieved. Some of the identified barriers to RTA use included the increased cost of purchasing RTA products, lack of commercially available products, limitations of available space to store RTA dosage units in automated dispensing cabinets, and product shortages.
Developing the Tracer Tool
With a better understanding of current practices and perceptions relating to injectable medication dispensing, our next step was to develop a means for hospitals to self-identify issues relating to medication preparation at the bedside while being mindful of the goal to provide medications in as RTA form as possible.
Because tracer methodology allows for an assessment of actual delivery of care by observing and interviewing health care team members and patients, and reviewing documentation, this method was chosen as the process for discovering true practices and perceptions relating to the handling of injectable medications. Based on findings identified through tracer activity, organizations can identify opportunities to reduce injectable medication preparation at the point of care.
We designed the MedSafety RTA tracer tool to assess how injectable medications are provided at various points of care and identify the factors that lead to the provision of medications in a RTA form, or that prevent such dispensing. It is important to note that injectable RTA medications can be sourced in a number of ways including purchasing manufacturer prepared RTA dosage forms such as prefilled syringes, premixed IV piggybacks and infusions; purchasing RTA dosage forms from 503B compounding facilities; or providing hospital pharmacy-prepared RTA injectable dosage forms. The tracer tool includes all options of providing RTA injectable dosage forms and does not distinguish or prioritize between any of these modes.
The RTA tracer tool helps hospitals quantify actual practices at the bedside and identify barriers specific to their settings that confound the hospital’s priority to reduce medication preparation at the bedside (see the FIGURE). With an understanding of these barriers, pharmacists and other stakeholders can then develop corrective action plans to increase RTA dispensing and thus improve medication safety. The tool has four sections that can be completed individually or together (see the TABLE):
With input from a variety of clinicians, the tracer results deliver a clear picture of injectable medication practices while also identifying area-specific issues as well as overall practice trends that may require adjusting.
After the tracer tool was developed, the content underwent a rigorous review process conducted by internal and external subject matter experts in pharmacy, nursing, and anesthesia. Modifications were made based on the feedback provided by these professionals to ensure the content was clear and comprehensive.
Once the content of the tracer tool was finalized, we conducted pilot validation tests at a community hospital and a large academic medical center. Multiple pharmacy, nursing, and anesthesia staff members were engaged in the tracers on several nursing units, operating rooms, and procedural areas.
Pharmacy leadership at both hospitals provided feedback on the pilot experience. In both cases, they lauded the value of the tool in identifying barriers, understanding practices and positioning pharmacy departments to better support bedside clinicians through the provision of injectable medication doses that are RTA and require minimal to no manipulation.
Adopting RTA medications impacts the workflows of a cross section of clinicians. Given pharmacy’s role in procuring and dispensing injectable medications, we strongly advocate that pharmacy leadership (ie, directors, managers, and medication safety professionals) oversee and actively participate in each part of the RTA tracer activity. Because different clinicians and professionals have unique perspectives on injectable medications, it also recommended that nursing leadership, accreditation professionals, quality management/performance improvement professionals, safety officers, and others also participate in the tracer activity.
The RTA tracer activity includes targeted questions and observations for practices in the hospital pharmacy, nursing units, emergency department, operating rooms, and procedural areas supported by anesthesia providers (eg, interventional radiology, gastroenterology procedures areas, cardiac catheterization procedure areas, ambulatory surgery, obstetrical operating rooms, etc). To ensure a thorough assessment, tracers should be conducted on multiple nursing units, operating rooms, and procedural areas to help identify patterns and trends, as well as variations in practice.
Each set of observations and questions asked of clinicians should take approximately 20 to 30 minutes. Many injectable medication practices change over time for varying reasons, including medication shortages. Therefore, the RTA tracer tool can be used periodically to reassess injectable medication processes. The tool is a free resource that is available online ( www.rtamedsafety.com/download). The tool can be completed electronically, or PDF documents can be printed and completed manually.
The information captured from the RTA tracer should be reviewed by pharmacy, nursing, and anesthesia leadership to identify potential opportunities for system and process improvements. With a thorough understanding of the workflows and challenges that nurses and anesthesia providers have with injectable medications, hospital pharmacy leadership can determine the best ways to provide RTA injectable medication dosage forms. After using the tool, hospitals have shared that the tracer process led to a better understanding of the challenges from dispensing medications in forms requiring preparation by frontline nurses and providers. In addition, the tool highlighted various performance improvement opportunities directed at purchasing, order verification, automated dispensing cabinet stocking, and preparation (in clinical areas and in the pharmacy) of ordered medication doses.
With the RTA tracer tool, hospitals can gain a solid understanding of the human factor issues that impact the RTA workflows in their organizations. The tracer tool results will clarify the challenges, barriers, and any misconceptions that pharmacists, nurses, and anesthesia providers have with injectable medications. With this knowledge, pharmacy leadership can self-identify system and process opportunities to provide these high-risk dosage forms in a safer way, and thus further the organization’s journey toward high reliability and Zero Harm.
The development of the tracer tool was sponsored in part by Fresenius-Kabi but all content was created by Joint Commission Resources, Inc. (JCR). JCR, by policy, does not endorse Fresenius-Kabi or its products.
Amanda Ryan, RPh, PharmD, CJCP, is the intermittent quality and pharmacy consultant at Joint Commission Resources, Oak Brook, Illinois.
Jeannell Mansur, RPh, PharmD, FASHP, FSMSO, CJCP, is the principal consultant of medication management and safety at Joint Commission Resources, Oak Brook, Illinois.
Best Practices for IV Medication Distribution
Evidence-based guidance on best practices for providing injectable medications in the safest manner possible are available from nationally recognized medication safety authorities. The American Society of Health-System Pharmacists (ASHP) cites numerous studies on drug distribution systems which indicate that providing unit dose systems, requiring little to no manipulation by the nurse, are safer for patients, are more efficient and economical, and are a more effective method of utilizing professional resources.2 In addition, ASHP’s minimum standards for safe medication dispensing state that whenever possible, medications (including injectable medications) should be available in single-unit packages and in a ready-to-administer form (RTA), with manipulation before administration by clinicians minimized. Examples of manipulation include withdrawing doses from containers, reconstitution of lypholized drug products, and diluting injectable medication doses.3
The Institute for Safe Medication Practices (ISMP) Safe Practice Guidelines for Adult IV Push Medications state that errors associated with the administration of the wrong dose and/or wrong concentration of injectable medications are more prevalent when non-pharmacist clinicians are provided with a parenteral product that requires additional manipulation before administration to the patient. In order to minimize the risk of errors, the safer approach is to provide injectable medication doses in the most RTA form without the need for additional manipulation by the clinician administering the medication to patients.4,5
Likewise, The Joint Commission (TJC), a nationally recognized independent, not-for-profit organization with deeming authority by the Center for Medicare and Medicaid Services (CMS), includes accreditation requirements in the Medication Management chapter related to the preparation and dispensing of injectable medications (see BOXES 1 and 2).6
MM.05.01.07 The hospital safely prepares medications.
Element of Performance 1: A pharmacist, or pharmacy staff under the supervision of a pharmacist, compounds or admixes all compounded sterile preparations except in urgent situations in which a delay could harm the patient or when the product’s stability is short.
MM.05.01.11 The hospital safely dispenses medications.
Element of Performance 4: Medications are dispensed in the most RTA forms commercially available and, if feasible, in unit doses that have been repackaged by the pharmacy or licensed repackager.
Standard MM.05.01.11 applies to all medication dosage forms dispensed by hospitals, including injectable medications.