Summary
This case involves a 78-year-old female patient who was admitted to a local medical center after several days of weakness, nausea, vomiting and diarrhea, preceded by a longer period of fever and headaches. Because an infectious condition was suspected, the treatment team initiated a diagnostic workup that included a lumbar puncture.
Early in the admission, the patient also experienced several episodes of rapid heart rate exceeding 150 beats per minute. The episodes were documented as sinus tachycardia or atrial fibrillation and resolved without intervention. A cardiology consultation was requested before the lumbar puncture. The cardiologist cleared the patient to undergo the procedure and diagnosed new-onset atrial fibrillation. The treatment plan included initiating anticoagulant therapy with dabigatran following completion of the lumbar puncture.
The cardiologist entered an order directing that the first dose of dabigatran be administered at 10:00 p.m., approximately 12 hours after the scheduled lumbar puncture. When reviewing the order, the pharmacist noted the atrial fibrillation diagnosis and concluded that anticoagulant therapy should begin promptly. The pharmacist therefore changed the specified medication start time from 10:00 p.m. to immediate administration. The pharmacist did not recognize that the lumbar puncture had been ordered and was underway and did not review the patient’s medical record or contact the prescribing physician before changing the specified start time.
The lumbar puncture was subsequently characterized as traumatic. Following the pharmacist’s change to the prescribed start time, nursing staff administered the first dose of dabigatran less than one hour after the procedure. Additional doses were administered before the medication was discontinued. The nurse who administered the first dose later acknowledged that she had not recognized the bleeding risk associated with administering the medication shortly after a lumbar puncture.
The following day, the patient began experiencing decreased sensation in her lower extremities and was unable to move her toes. Her symptoms progressed, and she became unable to move her legs. An emergency stroke assessment and neurology consultation were initiated. During the evaluation, the neurologist reviewed the patient’s medications and noted that she had received dabigatran. Suspecting a spinal bleed, the neurologist ordered an immediate MRI, discontinuation of dabigatran, reversal of its anticoagulant effect with idarucizumab, and an emergency neurosurgical consultation.
Following the neurosurgical consultation, the patient was transferred to another medical center for emergency surgery. Surgeons confirmed that significant bleeding had compressed the spinal cord. After surgery and intensive care, the patient was transferred to a rehabilitation facility. She remained unable to move her lower extremities. The patient was discharged home with continued outpatient rehabilitation after nearly a month of inpatient care. At the time of settlement, approximately two years after the incident, she had not regained the use of her legs. Her condition was further complicated by multiple pressure ulcers, associated infections and the need for ongoing wound care.
Resolution
A professional liability claim was asserted against multiple healthcare providers, including the pharmacist, members of the nursing staff, and the prescribing cardiologist. The plaintiff alleged that the cardiologist’s diagnosis of atrial fibrillation and decision to initiate anticoagulant therapy were not adequately supported by the patient’s clinical presentation. The cardiologist maintained that the diagnosis and treatment plan were appropriate and resolved the allegations separately.
The primary allegation against the pharmacist was that the pharmacist changed a clinically significant component of the physician’s order without reviewing the medical record, identifying the recent lumbar puncture, or contacting the prescriber. The plaintiff contended that, regardless of whether anticoagulation was otherwise indicated, the pharmacist should not have advanced the specified medication start time without determining why the physician had deliberately scheduled the first dose for later in the day.
Similar allegations were asserted against nursing personnel. The plaintiff alleged that the nurses should have recognized the potential significance of administering an anticoagulant shortly after a lumbar puncture and questioned the changed start time before giving the medication.
The defense considered characterizing the pharmacist’s decision as an effort to begin timely treatment for newly diagnosed atrial fibrillation. However, this position was weakened by the availability of relevant procedural information in the medical record and the pharmacist’s failure to investigate the reason for the prescriber’s specified start time. The defense concluded that a jury might determine that the pharmacist had a duty to review the record and/or contact the prescribing physician before independently changing the order.
The patient sought compensation for pain and suffering, loss of consortium, ongoing medical care, and future expenses related to the spinal injury and its complications. Although she was retired and did not assert lost wages, she reportedly had maintained an active lifestyle before the incident.
The claim involving the insured pharmacist was resolved through settlement. Total incurred costs were approximately $850,000, consisting of an $825,000 indemnity payment and $25,000 in legal and claim expenses.
Risk Management Comments
This case illustrates the professional liability exposure that may arise when a pharmacist independently changes the timing of a medication order without first understanding the clinical reason for the prescriber’s instructions. Although a change in specified start time may appear less consequential than changing the drug or dose, timing can be a critical component of medication safety, particularly when anticoagulants, invasive procedures and other high-risk clinical circumstances are involved.
Pharmacists play a critical role in medication optimization and patient safety. When an order appears delayed, unusual or potentially inconsistent with a diagnosis, the appropriate response generally involves gathering the relevant clinical information, reviewing the patient’s medical record, and communicating with the prescriber.
Idarucizumab is a specific reversal agent for dabigatran and is indicated when rapid reversal of its anticoagulant effects is required for emergency surgery or an urgent procedure, or in cases of life-threatening or uncontrolled bleeding. Its use in this case reinforces the severity of the suspected bleeding event but could not assure prevention of permanent injury once spinal cord compression had occurred.
Risk Management Considerations/Recommendations
As human beings, pharmacists and all healthcare providers may make mistakes. Therefore, healthcare organizations should develop systems that help clinicians recognize clinically significant medication timing instructions, identify recent or planned invasive procedures, and resolve questions before a medication is released or administered.
Consider the following proposed risk management actions, among others:
1) Treat changes to medication timing as changes to the order
Changing a specified medication start time or administration schedule may alter its safety and intended clinical effect. Pharmacy policies should identify the circumstances under which a pharmacist may adjust routine administration times and distinguish those adjustments from material changes requiring prescriber authorization. Before advancing or delaying therapy, determine whether the specified timing may relate to a procedure, laboratory result, drug interaction, organ function, bleeding risk or another clinical consideration. When the reason cannot be established from the available information, contact the prescriber and document the clarification.
2) Review the clinical record before modifying high-risk medication orders
Before changing an anticoagulant order, review relevant clinical information, including, as appropriate, recent procedures, active bleeding concerns, laboratory findings, renal function, concurrent medications, and specialty consultation notes. Electronic access to clinical information provides an important opportunity to identify risks that may not be apparent from the medication order alone. Organizations should establish defined expectations regarding the level of review required before pharmacists modify high-risk orders.
3) Strengthen safeguards for anticoagulants and neuraxial procedures
Healthcare organizations should consider using electronic alerts, order sets or other workflow safeguards to identify anticoagulant orders when a patient has undergone or is scheduled for a lumbar puncture or other neuraxial procedure. Alerts should direct clinicians to review procedural timing, hemostasis, renal function, medication-specific guidance and the prescriber’s instructions rather than supplying a single default interval for every patient.
4) Establish a closed-loop clarification process
When a pharmacist questions an order or recommends a change, communicate directly with the prescriber or another authorized clinician. Document the concern, the information reviewed, the individual contacted, the response received, and the final order. If the matter remains unresolved, use the organization’s escalation pathway. A clear, closed-loop process reduces the risk that treatment will proceed based on an assumption or that different members of the healthcare team will rely upon conflicting instructions.
5) Support an independent nursing assessment before administration
Nurses provide an additional safety check at the point of administration. Medication administration policies should encourage nurses to pause and seek clarification when an anticoagulant order appears inconsistent with a recent invasive procedure, a documented bleeding concern, or the patient’s current condition. This review should not depend solely on whether the medication appears on the active medication administration record. A pharmacist’s verification and release of an order do not eliminate the administering clinician’s responsibility to consider whether the medication is appropriate for the patient at that time.
6) Analyze medication-timing overrides and near misses
Organizations should include altered start times, rescheduled doses and other timing-related changes in medication-safety reviews. Audit trails may help identify important details, including whether the change bypassed an established safeguard. Reviewing near misses and override patterns can identify vulnerabilities before patient harm occurs. Lessons should be translated into specific improvements, such as revised policies, more prominent procedural alerts, standardized documentation fields or targeted education for pharmacists and nursing staff.
Conclusion
This case demonstrates that medication timing may be as consequential as drug and dose selection. Pharmacists who identify an apparent need to alter a prescriber’s instructions should pause, review the relevant clinical information, communicate with the prescriber, and document the resulting decision before the medication is released.
Resources
Disclaimer
The information, examples and suggestions presented in this material have been developed from sources believed to be reliable as of the date they are cited, but they should not be construed as legal or other professional advice. CNA, Aon, Affinity Insurance Services, Inc., NSO, or HPSO accepts no responsibility for the accuracy or completeness of this material and recommends the consultation with competent legal counsel and/or other professional advisors before applying this material in any particular factual situations. This material is for illustrative purposes and is not intended to constitute a contract. Please remember that only the relevant insurance policy can provide the actual terms, coverages, amounts, conditions and exclusions for an insured. All products and services may not be available in all states and may be subject to change without notice. Certain coverages may be provided by a surplus lines insurer. Surplus lines insurers do not generally participate in state guaranty funds, and insureds are therefore not protected by such funds. The claims examples are hypothetical situations based on actual matters. Settlement amounts are approximations. Certain facts and identifying characteristics were changed to protect confidentiality and privacy. Any references to non-CNA, non-Aon, AIS, NSO, and HPSO websites are provided solely for convenience, and CNA, Aon, AIS, NSO and HPSO disclaim any responsibility with respect to such websites. “CNA” is a registered trademark of CNA Financial Corporation. Certain CNA Financial Corporation subsidiaries use the “CNA” trademark in connection with insurance underwriting and claims activities. This material is not for further distribution without the express consent of CNA. Copyright © 2026 CNA. All rights reserved.
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Created: 11/2026