Medication Error Malpractice Claims

Medication Error Malpractice: Overview

The Institute for Safe Medication Practices and the U.S. Food and Drug Administration (FDA) define a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.” Medication errors are estimated to harm at least 1.5 million people in the United States each year and account for thousands of deaths.

Medication errors can occur at any stage of the medication use process: prescribing, transcribing, dispensing, administration, or monitoring. Each stage involves different healthcare professionals and creates different opportunities for error — and for liability.

Categories of Medication Error

• Wrong drug — the patient receives a different drug than the one prescribed (often a sound-alike or look-alike drug)
• Wrong dose — the patient receives a dose higher or lower than that ordered, or an inappropriate dose was ordered
• Wrong route — a medication intended for one route (oral, IV, intramuscular) is administered by another
• Wrong patient — the medication is administered to a patient other than the one for whom it was ordered
• Wrong time — the medication is administered outside the prescribed window
• Omission — a prescribed dose is not administered
• Failure to identify allergies or contraindications — a medication is prescribed or administered despite a documented allergy or contraindication
• Drug interaction — two or more medications are prescribed without recognition of a clinically significant interaction
• Failure to monitor — a patient is started on a medication requiring laboratory or clinical monitoring without that monitoring being arranged

High-Alert Medications

The Institute for Safe Medication Practices (ISMP) maintains a list of High-Alert Medications — drugs that, when used in error, have a significantly heightened risk of causing serious patient harm. These medications are subject to special handling, double-check, and monitoring requirements. Common categories include:

• Anticoagulants — heparin, warfarin, direct oral anticoagulants
• Insulin and other hypoglycemic agents
• Opioids and other controlled substances
• Chemotherapy and other antineoplastic agents
• Concentrated electrolytes — potassium chloride, hypertonic saline
• Neuromuscular blockers
• Sedatives — particularly midazolam, propofol
• Pediatric and neonatal medications

Failure to apply enhanced safety procedures to high-alert medications — including independent double-checks, smart pump dose limits, and standardized order sets — is significant evidence of breach.

Physician Liability for Prescribing Errors

Physicians may be liable for prescribing errors including:

• Prescribing a medication to which the patient has a documented allergy
• Prescribing a contraindicated medication (e.g., NSAID in a patient with renal failure)
• Prescribing a dose inappropriate for the patient's age, weight, or organ function
• Failure to adjust dosing for renal or hepatic impairment
• Failure to recognize a clinically significant drug interaction
• Inappropriate prescribing of opioids leading to overdose, respiratory depression, or addiction
• Failure to communicate medication changes to the patient's other providers

Pharmacist Liability for Dispensing Errors

Pharmacists are licensed healthcare professionals with their own duty of care. Pharmacist liability arises from:

• Dispensing the wrong drug (sound-alike or look-alike substitution)
• Dispensing the wrong strength or quantity
• Failure to identify a prescribing error that should have been obvious to a competent pharmacist
• Failure to identify a clinically significant drug interaction recorded in the pharmacy system
• Failure to provide adequate counseling on a medication's use, risks, and side effects
• Compounding errors — particularly for sterile preparations and chemotherapy

The independent pharmacist's duty creates an additional layer of legal protection for the patient and an additional defendant for the plaintiff. Both retail pharmacy chains and hospital pharmacies have been held liable in dispensing error cases.

Nursing Administration Errors

Nurses are responsible for the actual administration of medications to inpatients. The Five Rights of medication administration — right patient, right drug, right dose, right route, right time — are basic nursing standards. Nursing administration errors can include:

• Administering a medication to the wrong patient
• Failing to verify medication against the medication administration record
• Administering a medication via the wrong route (e.g., IV instead of oral)
• Programming an infusion pump with the wrong rate or concentration
• Failing to monitor for and respond to adverse reactions
• Failing to perform required pre-administration assessments (e.g., blood pressure before antihypertensives)

Most hospital nursing administration errors give rise to vicarious hospital liability. Independent practice nurses and home health nurses may be sued individually.

Failure to Monitor Patients on High-Risk Medications

Many medications require ongoing laboratory or clinical monitoring to detect early signs of toxicity or therapeutic failure. Examples include:

• INR monitoring for warfarin
• Renal function monitoring for nephrotoxic drugs (vancomycin, aminoglycosides)
• Lithium and digoxin levels
• Methotrexate weekly bloodwork
• Liver function monitoring for hepatotoxic agents
• Continuous pulse oximetry and respiratory rate monitoring for IV opioid infusions

Failure to arrange, perform, or act on required monitoring — leading to preventable toxicity, organ failure, or death — is a significant and frequently litigated category of medication error claim.

Drug Interaction and Contraindication Errors

Both prescribing physicians and dispensing pharmacists are responsible for identifying and managing clinically significant drug interactions. Modern electronic prescribing systems and pharmacy systems flag interactions automatically — but alerts are frequently overridden, and so-called “alert fatigue” is a recognized patient safety issue.

The legal standard does not allow the override of clinically significant interaction warnings without affirmative clinical judgment that the benefit outweighs the risk and appropriate monitoring is in place. Routine override of interaction warnings without documented justification is below the standard of care.

Evidence in Medication Error Cases

• The original prescription or order — paper or electronic
• Medication administration record (MAR)
• Pharmacy dispensing records
• Pharmacy system interaction and allergy alerts
• Smart pump logs for IV infusions
• Laboratory monitoring records
• Hospital and pharmacy incident reports
• Manufacturer's prescribing information and FDA-approved labeling

Damages in Medication Error Cases

Damages in medication error cases include the cost of treating the adverse drug event, additional hospitalization, organ damage, lost wages, pain and suffering, and — in fatal cases — wrongful death damages. In overdose and respiratory depression cases involving permanent anoxic brain injury, damages can reach the multimillion dollar range to fund lifetime care. Full damages guide →