A Hard Look at Hard Stops and Workarounds in the Acute Care Setting
Problem: A medication order with a soft stop provides a warning to the practitioner, communicating information about a potential drug safety or efficacy problem. The soft stop may offer alternative suggestions to consider. To proceed, the practitioner may be required to acknowledge the warning with minimal action or no action. The practitioner might choose to ignore the warning, or, due to alert fatigue, may not read the warning at all. This desensitization may lead practitioners to disregard valuable information meant to safeguard patients from harm.
On the other hand, a hard stop is used to completely halt the progression of prescribing, dispensing, or administering a medication that would likely cause harm to a patient. The intent is to block further execution of the order. Consider how a hard stop may have helped prevent patient harm in the following scenario. Had a hard stop been in place, chances are a potential adverse event would have been identified and prevented before reaching the patient.
A patient was admitted with deep vein thrombosis that required surgery to remove the blood clot. The prescriber started the patient on apixaban, a direct oral anticoagulant. The patient had been on phenytoin at home for a seizure disorder. When processing admission orders for the phenytoin, the pharmacist received a severe drug-drug interaction alert—phenytoin reduces the effectiveness of apixaban and increases the risk of clot formation. Even though the combination of these medications should be avoided, the alert was not a hard stop. Unfortunately, the pharmacist failed to read or consider the alert and verified the order without further investigation or documentation as to why the order was approved. The patient was discharged on both medications, which were dispensed by an outpatient pharmacy after a pharmacist overrode a similar soft stop. Fortunately, the error was identified a few days later during a nurse discharge call and the therapy was adjusted.
Unfortunately, practitioners are sometimes confronted with situations they must troubleshoot to work around a barrier to provide patient care. Practitioners may become creative and think of ways to circumvent unexpected barriers and even hard stops within their practice setting. This is usually because the rationale for the hard stop is unclear, or they do not recognize the problem the hard stop is attempting to prevent. Consider why the practitioner used a workaround in the following scenario:
A prescriber ordered propofol 220 mcg/kg/minute for a patient with refractory status epilepticus. Since this indication was an off-label use, the organization had no clinical decision support (CDS) in the electronic health record (EHR) or a protocol for this indication. The pharmacist verified the order, knowing that the dose was higher than usual but thinking it was an appropriate dose for the patient. The organization’s smart infusion pump dose error-reduction system (DERS) was set with a soft limit of 50 mcg/kg/min and a hard limit of 130 mcg/kg/min for propofol. The hard limit was based on external literature and internal data analyses. When the patient’s nurse attempted to program the dose using the DERS, the hard limit prevented it. To administer the ordered dose, the nurse used two vials of propofol and programmed two infusion pumps each with a rate of 110 mcg/kg/min. The patient’s condition deteriorated, and symptoms resembling propofol-related infusion syndrome were exhibited (e.g., metabolic acidosis, acute renal failure, hyperkalemia). The prescriber was notified, the propofol order was discontinued, and the patient’s condition improved.
Safe Practice Recommendations: Organizations should determine the circumstances in which hard stops should be implemented. Consider the following recommendations:
Determine oversight. Assemble an interdisciplinary team (e.g., clinical informatics specialist, medication safety officer, prescriber, pharmacist, nurse) to review current hard stops in the organization’s various technologies (e.g., EHR, intravenous workflow management system [IVWMS], automated compounder software, smart infusion pumps, automated dispensing cabinets [ADCs]). This team should be tasked with assessing the need for modifying and/or adding additional hard stops on a regular basis. Designate approval committees (e.g., Pharmacy and Therapeutics Committee, Medication Safety Committee, Smart Pump Committee, Medical Executive Committee) to approve hard stop changes and additions and consult with specialty departments (e.g., oncology, neonatology/pediatrics, cardiology) when considering modifying or adding a hard stop.
Evaluate EHR systems. EHR systems often have pre-set severity levels for alerts that have intervention requirements that vary. Lower level alerts may not require practitioners to enter reasons for bypassing the alert, whereas higher level alerts may require the practitioner to select or enter a free text acknowledgment of the alert and justification for bypassing it. Work with your EHR vendor to determine if alert levels can be adjusted if deemed appropriate by your oversight committee. Also, determine which practitioner types are presented with these warnings. EHR systems often allow for alerts to be turned on or off at the prescribing, verification, and administration steps. Include these considerations in discussions with the interdisciplinary oversight team.
Use hard stops judiciously. Hard stops should be limited to preventing absolute contraindications or catastrophic errors. They should not prevent practitioners from prescribing, dispensing, or administering a clinically appropriate, but perhaps unusual dose. Rather, hard stops should be in place to at least force a time-out and protect against massive overdoses or contraindications. Previously, ISMP has published concerns related to soft stops that were unheeded for amphotericin B, methotrexate, and fentaNYL. While organizations need to address practitioners’ concerns with hard stops and make every effort to minimize any unintended effects, we recommend using hard stops judiciously for catastrophic drug doses. In addition, the rationale for hard stops should be clearly displayed for practitioners to help identify the problem.
Consider the need for hard stops when medications are assessed for formulary addition. When a medication is considered for formulary addition or when conducting an annual formulary review, think through the entire medication-use process to consider if hard stops are necessary and, if so, where they might be incorporated. To cite a few examples that ISMP has previously recommended, please refer to the following:
For intravenous (IV) infusions, use DERS (upper and lower, soft and hard limits) for medication doses, concentrations, infusion rates, intermittent infusion time duration, bolus and loading dose infusions (e.g., dose, duration, rate, bolus interval), and patient weights (ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps).
Require a hard stop verification of an appropriate oncologic indication for any daily oral methotrexate orders (ISMP Targeted Medication Safety Best Practices for Hospitals, Best Practice #2).
Require a patient’s opioid status (naïve versus tolerant) and type of pain (acute versus chronic) to be documented before prescribing and dispensing extended-release and long-acting opioids (ISMP Targeted Medication Safety Best Practices for Hospitals, Best Practice #15 .
For vinca alkaloids (e.g., vinCRIStine, vinBLAStine), default orders to the IV route and do not allow prescribers to modify it since this can be fatal if administered by other routes (ISMP Targeted Medication Safety Best Practices for Hospitals, Best Practice #1).
Restrict prescribers from being able to order medications/formulations that are contraindicated for enteral feeding tube administration.
When possible, institute a hard maximum dose limit for conventional amphotericin B in order-entry software (prescriber and pharmacy) and infusion pumps. A single daily dose of the conventional amphotericin B should never exceed 1.5 mg/kg.
Develop an escalation process to address hard stop workarounds. During orientation and annual competency assessments, educate practitioners about what they should do if they receive a hard stop (e.g., do not assume the system is wrong). If a prescriber orders a dose above the organization's approved protocol, a reference to support this dose should be available to ensure the dosing is appropriate and not an error. If a practitioner programming an infusion using the smart pump DERS receives a hard stop because it exceeds the maximum dose, they should know the appropriate individual(s) to contact to reconcile this before bypassing the system. While bypassing a hard stop should be rare, there may be times when it is clinically necessary. Organizations should have an escalation process that outlines required actions or notifications to designated individuals for assessment prior to hard stops being circumvented (e.g., independent double-check, approval by a supervisor). The need and frequency of bypassing a hard stop should be monitored and the hard stop design should be re-evaluated to determine if modifications are needed.
Use objective measures to determine alert appropriateness and utility. Use technology to evaluate practitioners’ response to an alert.1 Did the practitioner make an alert-indicated change? Was the response appropriate? Technology should also be used to aggregate instances of workarounds. If a hard stop or system is bypassed frequently then it should be reviewed for appropriateness. Metrics within technologies that should be evaluated include:
EHR (e.g., hard stops generated through CDS, orders changed to free-text order entries)
Automated compounder software that is used for parenteral nutrition (PN) (e.g., hard maximum dose override attempts, compounds programmed outside of PN library templates)
IVWMS (e.g., doses made in which scanning was bypassed, direct observation of proxy scans [scanning the barcode not affixed to what is actually being used])
ADCs (e.g., ADC overrides, clinical alerts and subsequent actions taken)
Bedside barcode scanning (e.g., scanning compliance by medication and user, review events where barcode scanning was bypassed or occurred after administration)
Perform functional testing. Test hard stop functionality to ensure it will capture the errors that it is intended to prevent, including 10-fold under- and overdose errors or other dosing errors for medications with narrow therapeutic windows. Look for any unintended consequences that the hard stop could create. Offer end users the chance to participate in hard stop evaluation and planning.
Gather feedback. Encourage practitioners to provide feedback on the hard stop design with a focus on unintended consequences that may lead to error-prone scenarios or unsafe choices. Elicit ways in which the hard stop may be or has been bypassed. Use this information to adjust hard stops as needed.
Collaborate with vendors. Work with technology vendors to discuss software capability for hard limits and provide feedback for upcoming enhancements to prevent patient harm.
- McCoy AB, Waitman LR, Lewis JB, et al. A framework for evaluating the appropriateness of clinical decision support alerts and responses. J Am Med Inform Assoc. 2012;19(3):346-52.
Institute for Safe Medication Practices (ISMP). A hard look at hard stops and workarounds in the acute care setting. ISMP Medication Safety Alert! Acute Care. 2023;28(13):1-4.