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Pharmacists Case Study: Compounding Error Leads to Overdose and Hospitalization for a Minor Patient

Pharmacists Medical Malpractice Case Study with Risk Management Strategies
Presented by HPSO and CNA


Note: This case study involves an insured pharmacy technician and other defendants for alleged liability associated with a drug compounding error. The patient was a 4-year-old female with a history of premature birth, De Morsier syndrome with panhypopituitarism, and type 1 diabetes mellitus. Due to the patient’s medical conditions and associated symptoms, the patient was under the care of an endocrinologist, a pediatric neurologist, as well as speech and physical therapists. At the time of the incident, the patient had an existing jejunostomy tube (J-tube). The patient also suffered from central hyperthermia, for which she received a compounded suspension of baclofen 5 mg/5 mL, three times daily. Notwithstanding the patient’s multiple health issues, physical and speech therapy had a positive impact, resulting in significant mobility and verbal improvement in the months before the medication incident.


The patient’s mother presented a new baclofen prescription to the defendant pharmacy for compounding to replace an expired order. The pharmacy technician who compounded the preparation in this instance had not done so previously, because the technician who had prepared the medication several times in the past was on vacation at the time. After compounding and review by the pharmacist-in-charge (PIC), the medication was delivered to the patient’s home for use.

On the day of the incident, the father prepared the patient for her scheduled physical therapy appointment at the local outpatient/hospital medical complex. He was about to administer the patient’s morning baclofen dose via the patient’s J-tube when he noticed that the liquid looked milky white, which he thought was different than in the past. His spouse confirmed that this was a new prescription, but the dose and directions for use had not changed. The father contacted the pharmacy to confirm the medication order was correct. He was assured by the compounding technician that the medication was correct and appropriate to administer.

Initially, on the way to the appointment, the patient seemed fine, but she fell asleep in the car before they arrived. The father could not arouse his daughter after they arrived. He raised his voice and gently shook the patient, but she was unresponsive. He placed the patient in her wheelchair and sought assistance from the outpatient center personnel. Staff immediately contacted emergency services, and the patient was transported to the nearby hospital emergency department (ED). After admission and examination, the ED physician ordered imaging to rule out a stroke. The physician also followed up with the pharmacy regarding the medication administered at home approximately two hours earlier. The pharmacy soon responded to report that an error had, in fact, occurred. The strength of the dispensed drug product appeared to be 250 mg/5 mL instead of the prescribed 5 mg/5 mL.

Shortly after this discovery, the patient began vomiting and was in respiratory distress. She suffered bradycardia and periodic apnea, with her oxygen saturation dropping into the 80s. After admission to the intensive care unit (ICU), the patient was intubated and the staff worked to stabilize her condition. The patient remained somnolent for the next two days. On day three, the patient was able to be weaned off of the ventilator. Although she developed hypernatremia and aspiration pneumonia, her condition stabilized and improved with ongoing treatment. The patient was discharged to home three weeks after admission.


Approximately 10 months later, the patient’s parents filed suit against the pharmacy, the PIC and the pharmacy technician who compounded the medication. The plaintiffs asserted that the patient suffered harm as a direct result of the defendants’ negligence. The complaint alleged that the patient suffered permanent injury, the loss of enjoyment of life and other pain and suffering. The plaintiffs demanded compensation for these injuries and for incident-related and future medical expenses in the amount of $1.25 million.  

Medical follow up in the months following the alleged compounding error and overdose indicated that the patient had suffered significant regression in her health condition. In the opinion of her treating physicians and the plaintiff experts, the incident would have a lasting negative impact on the patient’s progress and overall health.

When contacted by the ED physician about the compounded medication, the pharmacist on duty reviewed the master formula and related prescription records. She quickly understood the source of the error. The master formula called for a specific number of commercially available tablets to supply the active ingredient for the suspension. However, instead of using the correct number of baclofen tablets comminuted into a powder, the compounding technician used the number of tablets in grams of bulk powder to supply the active ingredient, resulting in a concentration 50 times that of the prescribed 5 mg/5 mL. Although the insured technician compounded the prescription, the PIC was primarily responsible for ensuring the safety of the dispensed medication. Significant liability also may be attributed to the pharmacy, whose procedures and controls were inadequate to prevent the error. Given the facts of the case and following evaluation of the medical records and other discovery by the defendants’ experts and defense counsel, seeking early settlement was strongly recommended and pursued. The defense team effectively negotiated a settlement amount substantially below the original demand.    ­

Total Incurred: $258,000


Risk Management Comments

The recently published Pharmacist Professional Liability Claim Report: 3rd Edition  observed that claims associated with compounding tend to be among the most severe, with an average total incurred of more than $438,000. Although the payment for the insured technician was well below that average, the total damages and global settlement significantly exceeded the average.

Ideally, this incident should have been averted when the father observed that something seemed different about the medication and contacted the pharmacy. The pharmacy technician who compounded the medication spoke with and advised the father without consulting the PIC or another pharmacist. In retrospect, consultation with the PIC or another pharmacist not involved with preparing or approving the compounded prescription may have resulted in identifying the error and thus averting patient harm. Nevertheless, error prevention during compounding is preferred to catching a near miss after dispensing.  

Risk Management Recommendations for Pharmacy Personnel and Pharmacies

As for all medication services, drug compounding requires implementation of multiple error prevention approaches and safety processes to mitigate risk and ensure safe practice. Consider the following risk management recommendations:
  • Assess the availability of ready-made product formulations as an option to compounded prescriptions and consult with the prescriber, when appropriate.
  • Implement standard operating procedures (SOPs) for compounding and for checking the compounded drug product. These procedures should be sufficiently detailed to prevent process variation among staff.
  • Implement automated identification systems, such as barcode scanning, to reduce the risk of selection errors.
  • Use a preparation label, worksheet, or Master Formulation Record to guide all drug compounding. This document should express the drug name, base solution, patient-specific dose, preparation calculations, final volume of the preparation, the drug dosage form to be used, as well as the name or initials of the individual(s) who prepared and verified the preparation.
  • Follow the sequence of steps for compounding drugs and processes specified in the formulas and SOPs. Adhere to procedures in all cases, unless a deviation is justified for the case at hand. Deviations must be documented and must not represent routine practice. If a change is necessary, recommend, test and validate procedure changes prior to implementation.
  • Designate a compounding area that is separate from other pharmacy activities. Minimize distractions and interruptions in the compounding area.
  • Verify that active pharmaceutical ingredients and bulk chemicals, including dilutions used in the pharmacy for compounding, are clearly labeled with their contents, the date the product was first opened, and the manufacturer’s expiration date. If an expiration date is unavailable, consult appropriate formulation/stability guidelines, official pharmacy compendia and/or other professional resources to help determine shelf life. Consider serial batch analysis to establish the expiration.
  • Incorporate an independent double check by a second practitioner to verify selection of the correct compounding formula, active ingredient calculations and other critical tasks. Additional checks may be appropriate for narrow therapeutic index active ingredients.  
  • All staff members involved in preparing compounded drugs or supervising the preparation of compounded drugs should participate in a comprehensive orientation and training program, as well as ongoing competency assessments.
  • Pharmacists and pharmacy technicians who perform drug compounding, should participate in compounding certificate program(s), where applicable and when possible.
  • Seek additional information on compounding regulations, compliance, accreditation and certification. The APhA’s Frequently Asked Questions About Pharmaceutical Compounding provides useful information and hyperlinks on these topics.
Implementation of, and compliance with, drug compounding safety procedures and processes — and those that apply to other medication services — will help pharmacists meet individual patient needs and adhere to the standard of care.


These are illustrations of actual claims that were managed by the CNA insurance companies.  However, every claim arises out of its own unique set of facts which must be considered within the context of applicable state and federal laws and regulations, as well as the specific terms, conditions and exclusions of each insurance policy, their forms, and optional coverages. The information contained herein is not intended to establish any standard of care, serve as professional advice or address the circumstances of any specific entity. These statements do not constitute a risk management directive from CNA. No organization or individual should act upon this information without appropriate professional advice, including advice of legal counsel, given after a thorough examination of the individual situation, encompassing a review of relevant facts, laws and regulations. CNA assumes no responsibility for the consequences of the use or nonuse of this information.
This publication is intended to inform Affinity Insurance Services, Inc., customers of potential liability in their practice. This information is provided for general informational purposes only and is not intended to provide individualized guidance. All descriptions, summaries or highlights of coverage are for general informational purposes only and do not amend, alter or modify the actual terms or conditions of any insurance policy. Coverage is governed only by the terms and conditions of the relevant policy. Any references to non-Aon, AIS, NSO, HPSO websites are provided solely for convenience, and Aon, AIS, NSO and HPSO disclaims any responsibility with respect to such websites. This information is not intended to offer legal advice or to establish appropriate or acceptable standards of professional conduct. Readers should consult with a lawyer if they have specific concerns. Neither Affinity Insurance Services, Inc., HPSO, nor CNA assumes any liability for how this information is applied in practice or for the accuracy of this information.

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