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ISMP: Updating Your High-Alert Medication List

Apr 8, 2013

Because insulin is at the top of the “High-Alert Medication List,” we are presenting this updated article from our partner at ISMP (Institute for Safe Medication Practices).

Your high-alert medication list — Relatively useless without associated risk-reduction strategies

Problem: Have you ever watched the 1993 movie, Groundhog Day? Bill Murray plays Phil Conners, a television news reporter who finds himself reliving the same day over and over again — a much-hated assignment covering an annual Groundhog Day event in Punxsutawney, PA. Well, at times it feels like “Groundhog Day” when we hear about the same types of errors happening over and over again. Another patient with diabetes receives a 5-fold overdose of U-500 insulin after a nurse draws the dose into a U-100 syringe, and a double-check by another nurse fails to detect the error. Another hospitalized oncology patient receives an overdose of intravenous (IV) Hydromorphone after a physician prescribes the IV dose in the same oral dose the patient had been taking at home, and neither the pharmacist nor nurse capture the error. Another woman receives a rapid infusion of magnesium sulfate postpartum instead of oxytocin, despite staff awareness of prior mix-ups. Another patient with a deep vein thrombosis suffers a bleeding event after receiving low-molecular weight heparin in the emergency department (ED) and unfractionated heparin shortly thereafter on an inpatient unit, despite a recent memo to ED staff to verbally communicate all medications administered in the ED during patient transfer to an inpatient unit….

In many cases, events like these and others continue to happen in hospitals with medications that are purportedly on the hospital’s list of high-alert medications. High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error with these medications are clearly more devastating to patients. This is repeatedly borne out in the literature1-5 and by reports submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP). High-alert medications still top the list of drugs involved in moderate to severe patient outcomes when an error happens.1-2

The Joint Commission has a standard (MM.01.01.03) that requires hospitals to develop their own list of high-alert medications; to have a process for managing high-alert medications; and to implement that process. While meeting the minimum requirements for The Joint Commission (i.e., any list, any process), we have noticed that some hospitals have neither a well-reasoned list of high-alert medications nor a robust set of processes for managing the high-alert medications on their list. Instead, they have a hastily devised list of high-alert medications, which often are not well known to all clinicians, and they are relying on low-leverage risk-reduction strategies to prevent errors, such as staff education, manual double-checks, and high-alert medication stickers to keep patients safe. Or, the hospital may send memos to staff to increase their awareness of the risks, or establish strategies that impact only one aspect of the medication use process — usually drug storage. In some cases, there are no safety nets in place at all, and hospitals are relying on staff vigilance and care to keep patients who require high-alert medications safe. In addition, some hospitals have not updated their list of high-alert medications since it was first mandated by The Joint Commission more than 10 years ago. A list of high-alert medications is relatively useless unless it is up-to-date, known by clinical staff, and accompanied by robust risk-reduction strategies more effective than awareness, manual double-checks, staff education, and exhortations to be careful.

So, what does it mean if a drug is on your hospital’s high-alert medication list? Does the list serve only to increase awareness of the risk of harm with these medications, or has a robust plan been implemented for each drug or drug class to reduce the risk of errors? Hospitals need a well-thought-out list of hospital-specific high alert medications and effective (vs. easy) high-leverage processes to mitigate the risk of errors with these medications.

Safe Practice Recommendations: We encourage hospitals to take the time to reassess their current list of high-alert medications and any plans that have been enacted to reduce the risk of errors and harm with these drugs. To guide this process, please consider the following:

Develop/Update a Hospital-Specific List

Hospitals need a list of targeted high-alert medications that is comprehensive enough to address the most potentially harmful errors while not being so inclusive that the list is overwhelming. Many hospitals select medications from ISMP’s List of High-Alert Medications (www.ismp.org/Tools/institutionalhighAlert.asp), which is updated every year or two based on error reports submitted to the ISMP National Medication Errors Reporting Program, reports of harmful errors in the literature, and input from practitioners and safety experts.4 Based on national reports of harm to patients, we believe every hospital’s list should include (when used): potassium chloride for injection concentrate, neuromuscular blocking agents, opioids (all, not just patient-controlled analgesia), anticoagulants, insulin, epidural or intrathecal medications, and cancer chemotherapy. Other drugs from the ISMP list should be added if use is prevalent or misuse is a concern.

Additional medications to consider for the list may include new drugs added to the formulary, potentially harmful drugs used temporarily during a shortage (which can be removed once the shortage is over), and medications involved in potentially harmful errors based on the hospital’s internal reporting process, even if the drug is not on the ISMP list. For example, after fatal wrong route errors were identified as a potential threat with the new drug EXPAREL (bupivacaine [liposomal] used for local infiltration at wound sites) due to its similar appearance to propofol6, hospitals that added this drug to their formulary should have considered it for addition to their high-alert medication list. Addressing drugs given by a certain route of administration (e.g., intrathecal, epidural), or in special populations (e.g. pediatrics) as high-alert can be effective as well. The high-alert medication list should be updated as needed and reviewed at least every 2 years.

Implement Risk-Reduction Strategies

The purpose of identifying high-alert medications is to establish safeguards to reduce the risk of errors with these drugs. To be effective, all of these interdisciplinary components are needed:

Understand the causes of errors. Effective strategies must address the underlying causes of errors with each type of high-alert medication or class of medications. To learn the causes of errors, review internal medication error-reporting data and the results of any applicable root cause analyses. Equally important, a search of the external literature should be completed to uncover reports of errors with high-alert medications that have occurred elsewhere. A failure mode and effects analysis or self-assessment tool also might help identify underlying risks associated with each high-alert medication/class of medications. This important first step should not be skipped — if you can’t describe the ways that errors have happened or could happen with the drug, your strategies may not lessen the risk of an error at all.

Be sure actions are comprehensive. A single risk-reduction strategy for each high-alert medication is rarely enough to prevent harmful errors. The keys to success are as follows:

1)    Numerous risk-reduction strategies must be layered together to address the targeted risk.

2)    Risk-reduction strategies should impact as many steps of the medication-use process as feasible given the underlying causes (e.g., procuring, storing, pre-scribing, transcribing, preparing, dispensing, and administering the medication; monitoring the patient; preparedness for treating [or recovery from] an adverse event if it occurs).

3)    Low-leverage risk-reduction strategies such as staff education, passive information, and the use of reminders should be bundled together with high-leverage risk-reduction strategies such as forcing functions and fail safes, maximizing access to information, limiting access or use, constraints and barriers, standardization, and simplification. Table 1 provides a description of key risk-reduction strategies listed roughly in descending order of effectiveness based on human factors. We highly encourage hospitals to reference this table whenever risk-reduction plans are being developed.

4)    To help inform the planning process, the literature should be searched to identify risk-reduction strategies that have been proven effective, recommended by experts, or implemented successfully elsewhere.

Assess the effectiveness of strategies

Measures should be established and data should be collected routinely to determine the effectiveness of risk-reduction strategies for high-alert medications. The results should be shared regularly in meetings with pharmacy leadership, a medication safety committee, the pharmacy and therapeutics committee, and other appropriate venue. Reviewing the effectiveness of safeguards and keeping up with drugs and processes related to high-alert medications are important to ongoing success.

Table 1. Key Safety Strategies for Safeguarding High-Alert Medications

Key Strategies
Self Assessments
Proactively identify the ways that a process or medication-related equipment can fail, why it might fail, how it might affect patients, and how it can be made safer; assess current systems and practices against best practices
  • Perform an FMEAa on a new high-alert medication before use
  • Perform an FMEAa on a new infusion pump being considered for purchase
  • Perform an FMEAa on a high-risk process associated with medication use
Forcing Functions & Fail Safes
Employ procedures or equipment design features that will:

  • Prevent something from happening until certain conditions are met (forcing function)
  • Prevent malfunctioning or unintentional operation by reverting back to a predetermined safe state if a failure occurs (fail safe)
  • Use of oral syringes that cannot be connected to IV tubing ports
  • Use of epidural tubing without ports
  • Use of infusion pumps with an automatic clamping mechanism to prevent free-flow if the tubing is removed from the pump
  • Use of PCAb pumps with default settings or zero, or the highest possible concentration for the opioids used
  • Engineering features that stop a process from moving forward or require the entry of key information (e.g., allergies) before proceeding
Maximize Access to Information
Use active, not passive, means of providing staff and patients with necessary information at the exact time when needed while performing critical tasks
  • Use of smart infusion pumps with dose checking software enabled
  • Use of concurrent data monitoring software that notifies practitioners with critical monitoring information (e.g., labs)
  • Deploy clinical pharmacists in patient care units for immediate consultation when needed
  • Use of electronic prescribing systems with decision support, thus providing immediate warnings if unsafe orders are entered
Constraints &
Use of special equipment or environmental conditions to prevent a hazard from touching a target
  • Use of personal protective equipment to reduce employee exposure to hazards
  • Use of a compounding aseptic isolator or compounding aseptic containment isolator to prepare chemotherapy
  • Use of a needleless system to administer medications and fluids, or for other procedures involving a potential risk of exposure from contaminated sharps
Create clinically sound, uniform models of care or products to reduce variation and complexity
  • Employ evidence-based, standard order sets (1 for each care process)
  • Standardize concentrations, container sizes, drugs used to treat specific conditions
  • Use scales that only weigh patients in kg, and document weight only in kg
Reduce the number of steps, handoffs, and options without eliminating crucial redundancies
  • Use commercially available products instead of preparing solutions
  • Dispense oral and parenteral medications in the most ready-to-use form
  • Use electronic prescribing to eliminate transcriptions
  • Consult dosing charts instead of manually calculating infusion rates
Steps in process*
Error probability
*If each step is 99% reliable
Externalize or Centralize Error-Prone Processes
Transfer error-prone tasks to an external site or centralized area to help ensure they are completed in a distraction-free environment by those with expertise, with appropriate quality control checks in place
  • Use commercially available products
  • Have a centralized pharmacy IV admixture service prepare all IV solutions under sterile conditions as specified in USP <797>
  • Use a specialized external service (outsourcer) to prepare complicated solutions such as PNc or cardioplegic solutions
Limit Access or Use
Use constraints to restrict access to certain medications or error-prone processes; require special education or conditions for prescribing, dispensing, or administering a particular drug; require special authorization for participation in certain tasks
  • Sequester neuromuscular blocking agents in separate container to limit access
  • Require special education/credentialing for the use of certain high-alert medications (e.g., chemotherapy)
  • Carefully select the drugs, concentrations, and quantities of medications in floor stock/automated dispensing cabinets (e.g., restrict stock of liquid concentrated oral opioids to certain units)
  • Establish parameters to change IV therapy to oral therapy as soon as possible to limit IV access
Differentiate Items
Modify the packages and labels of medications to help distinguish them from other medications with look-alike packaging or look- and sound-alike names
  • Affix auxiliary labels to call attention to important information
  • Use color or a pen/marker to draw out or circle important information (e.g., strength, epidural) on labels or MARsd
  • Purchase look-alike medications from different manufacturers to maximize label differences
  • Use tall man lettering on labels, MARsd, and computer screen drug listings to call out differences in look-alike drug names
Implement multiple pathways so if the first pathway fails, a second pathway may detect the error and be successful
  • Employ automated check systems such as barcode scanning or smart pumps to warn when conditions are unsafe or selections are erroneous
  • Require a time-out process to verify the patient, treatment plan, and drugs prior to a procedure
  • Require a manual independent double-check to verify a crucial aspect of prescribing, dispensing, or administering a high-alert medication (limited use)
  • Require the verification of two unique patient identifiers to verify patient identity before medications or procedures
  • Require both mg/kg dose and calculated dose for pediatric or chemotherapy drug orders to facilitate a double check on calculations
Checklists & Reminders
Provide a list of items for comparison, verification, or to assist with remembering important steps or information; provide additional alerts or warnings to make important information highly visible (overuse of reminders can lead to desensitization and alert fatigue)
  • Label IV and other access lines and tubing
  • Use checklists for complex tasks (e.g., surgical checklist, checklist for setting up automated IV compounders in the pharmacy)
  • Build reminders for special monitoring into order sets or protocols
  • Set visual and audible alarms on monitoring equipment
  • Apply an auxiliary label on epidural medications stating, “Epidural Use Only.”
Use of Affordances
Human-centered quality of an object that takes advantage of generally held knowledge about how things work, thereby suggesting how to interface with the object
  • Numerical keys of infusion pumps arranged in the same pattern as computer and calculator key pads
  • Medication administration records that list the name of the medication followed by the patient’s dose (e.g., 2 mg), not the available dosage strength from which the dose will be provided (e.g., 1 mg).
Situational Awareness & Critical Thinking
To enhance an accurate understanding of the environment in order to understand how information, events, and one’s own actions will impact patient safety and other goals, both immediately and in the near future; a strategy used to reduce drifting into unsafe practice habits
  • Use simulations to expose staff to common risk and to teach them to identify and manage the risks
  • Coach staff to recognize the specific risks associated with their behavioral choices that were not seen or misread as being insignificant or justified
  • Teach and encourage self-briefings before critical tasks to reinforce memory cues and knowledge, and to seek answers to questions
  • Implement team huddles with a specific focus to communicate and share information concurrently with a care team
Positive Performance Shaping Factors
An aspect of the human’s individual characteristics, environment, task, or organization that specifically improves human performance, thus decreasing the likelihood of human error (e.g., available job aids, work environment, workflow, workload, time urgency)
  • Limit distractions in the environment when staff are carrying out critical and/or complex tasks; no multi-tasking
  • Provide hands-on experiences and/or simulation training to rehearse and reinforce new skills and knowledge
  • Establish realistic workloads; avoid global productivity quotas
  • Establish staffing patterns and workflow that guard against fatigue
  • Promote a Just Culture to foster reporting and learning
Education & Competency Validation
A baseline strategy intended to impart upon staff and patients specific knowledge (what they know) and skills (the ability to apply the knowledge) about medications and their safe use, and verifying their knowledge and skills
  • Provide patients discharged on a high-alert medication with written information regarding the types of errors that have happened with the drug and how to avoid them
  • Educate staff about each high-alert medication/class of medications on the hospital’s high-alert medication list, how errors happen, the steps the hospital is taking to avoid errors, and the staffs’ role in error-reduction
Recognizes that, despite efforts, an error might occur, and thus enhances the ability to detect the initiating event and correct it before significant patient harm can occur
  • Monitor the patient’s level of sedation, vital signs, respiratory quality, and pulse oximetry/capnography when receiving opioids
  • Monitor drug levels and dose-dependent lab values (e.g., INR) regularly
  • Establish a well-rehearsed resuscitation protocol with lipid emulsion to treat the effects of bupivacaine toxicity

aFMEA: failure mode and effects analysis bPCA: patient-controlled analgesia cPN: parenteral nutrition dMAR: medication administration record

Click here for ISMP’s List of High Alert Medications.

  1. Rickrode GA, Williams-Lowe ME, Rippe JL, et al. Internal reporting system to improve a pharmacy’s medication distribution process. Am J Health-Syst Pharm. 2007;64:1197-1202.
  2. Sakowski J, Newman JM, Dozier K. Severity of medication administration errors detected by bar-code medication administration system. Am J Health-Syst Pharm. 2008;65:1661-6.
  3. Monroe PS, Heck WD, Lavsa SM. Changes to medication use processes after overdose of U-500 regular insulin.Am J Health-Syst Pharm. 2012;69:2089-93.
  4. ISMP’s List of High-Alert Medications. 2012. Accessed at: www.ismp.org/tools/institutionalhighAlert.asp.
  5. National Alert Network. Potential for wrong route errors with Exparel. NAN Alert. March 20, 2012.
  6. Cohen MR, Smetzer JL, Tuohy NR, et al. High-alert medications: safeguarding against errors. In: Medication Errors. Cohen MR ed.; Washington, DC: The American Pharmacist Association. 2007;317-412.


Report Medication Errors to ISMP:

Diabetes in Control is partnered with the Institute for Safe Medication Practices (ISMP) to help ensure errors and near-miss events get reported and shared with millions of health care practitioners. The ISMP is a Patient Safety Organization obligated by law to maintain the anonymity of anyone involved, as well as omitting or changing contextual details for that purpose. Help save lives and protect patients and colleagues by confidentially reporting errors to the ISMP.