Pharmacists Case Study: Overdose and Hospitalization of a Minor Patient from Compounding Error

This case study involved a 15-year-old female diagnosed with Attention-deficit/hyperactivity disorder (ADHD) at the age of ten. The patient had been prescribed clonidine since diagnosis and was tolerating the therapy well. Due to dosing considerations, a compounded oral suspension was prescribed as the best delivery method for the medication, as it was not commercially available in liquid form from a FDA approved manufacturer. The patient’s parents had been getting the compounded medication from a competing pharmacy but decided to switch due to the convenience of a new location opening closer to their home.
 
After depleting the supply of medication from the old pharmacy, the patient’s mother administered the first dose from the prescription compounded by the new pharmacy. Upon administration, the patient complained of a chalky taste which was rationalized by the family to be a result of changing pharmacies. One hour after administration, the father of the patient noticed that she was showing slurred speech and trouble communicating.
 
At this point, the patient was rushed to the emergency department (ED) located within a children’s hospital. Upon arrival, the patient was in extreme discomfort and was experiencing episodes of bradycardia with a heart rate in the 30’s, as well as hypoxia and decreased respirations. When her oxygen saturation fell to 66% the medical team proceeded to intubate the patient. Etomidate and succinylcholine were administered for sedation to facilitate intubation. During the intubation, suctioning was required due to a significant amount of food in the pharynx. This further complicated the hospital treatment, as aspiration was suspected.
 
Antibiotics were given after a chest X-ray showed consolidation in the upper lobes of the lungs. The patient remained intubated for 12 hours, during which she exhibited episodes of bradycardia but did not require pharmaceutical intervention.
 
The patient was extubated and maintained normal oxygen levels through the night. She tolerated a normal diet, and no other effects were noticed. The working diagnosis for the 3-day hospitalization was clonidine poisoning, as the initial symptoms occurred immediately following the first dose from the medication compounded by a new pharmacy. In addition, the clonidine was suspected to have inhibited peristalsis causing food aspiration.

Resolution

After discharge of their daughter from the hospital, the parents immediately contacted an attorney and decided to file a lawsuit. They named the pharmacy that supplied the latest compounded prescription, the pharmacy owners, as well as the pharmacists and technicians involved in compounding and dispensing the medication. In addition to hospitalization costs, the plaintiffs sought compensation for other damages, including post-traumatic stress syndrome and future medical expenses. The plaintiffs also alleged that the overdose resulted in loss of the non-narcotic treatment option of clonidine due to hypersensitivity. The initial plaintiff demand was $1.75 million.
 
The pharmacy’s investigation of the medication error did not establish a clear root cause. Compounding instructions were well-documented and followed by a new trainee who had been closely supervised by a pharmacist. The master compounding log and inventory checks for that day seemed to be accurate with the correct number of tablets accounted for. A total of 65 tablets were dispensed on the day of the error, which included two 30-day prescriptions for other patients and five tablets for the compounded product. However, other controls, including the inventory of excipient ingredients, were missing. Upon review, it was noted that the compounded medication bottle included an inaccurate expiration date, resulting in a misbranded product.
 
Since the investigation into the compounding logs and process did not reveal any errors or potential causes, the patient's parents sent the remaining medication for laboratory testing. The results indicated that the compounded product contained approximately 700 times the strength of the active ingredient stated on the label, confirming the hospital’s diagnosis of clonidine overdose. Further complicating the situation, the pharmacy’s website promoted its compounding expertise. Although the technician had obtained certification, no other pharmacy personnel had pursued accreditation, such as that offered by the National Association of Boards of Pharmacy. With the laboratory test results showing unmistakable evidence of a compounding error associated with an adulterated and misbranded product, the defense team strongly recommended settling the case as quickly as possible to avoid further discovery and expense.
 
The initial plaintiff demand of $1.75M exceeded the policy limits. The defense offered $250,000 to adequately reimburse the plaintiffs for hospitalization costs and other damages. This seemed reasonable and fair, given the short hospitalization and the absence of long-term health effects. The plaintiff disagreed with the offer citing that the patient could no longer take clonidine for treatment, claiming this as a long-term effect. However, no evidence of clonidine hypersensitivity was provided, and defense expert witnesses concluded that no long-term injuries were supported. Several rounds of offers and counteroffers eventually led to a final settlement of $450,000.

Risk Management Comments:

The recently-published Pharmacist Professional Liability Claim Report: 3^rd Edition observed that claims associated with compounding tend to be some of the most severe, with an average total incurred of more than $438,000.
 
Without clear insight into how the error occurred, it is difficult to determine a specific corrective action. A visual inspection by the pharmacist or parent before administering the medication was unlikely to lead to meaningful action, as the prescription came from a new pharmacy. The appearance of the medicine can vary depending on the compounding ingredients and methods used. Mis-dosing by the parent is also unlikely, as they had been administering the medication for five years.

Risk Management Considerations for Pharmacy Personnel and Pharmacies:

Risk management for compounding pharmacies is critical to ensure compliance with regulatory standards and, more importantly, to protect patient safety. A robust risk management plan should be in place to enhance product quality and safety.

1. Assess the availability and viability of FDA approved commercially available drug products. Dispense commercially available products whenever possible. If compounding is necessary, use commercially prepared ingredients to the maximum extent possible.
2. Standard Operating Procedures (SOPs)
   1. Develop SOPs for compounding processing, equipment maintenance, and housekeeping/cleaning procedures. Deviations from SOPs should be documented and reviewed.
   2. Master Formulation Record. This document expresses the drug name, base solution, patient-specific dose, preparation calculations, final volume of the preparation, and identifies the appropriate drug dosage form (e.g., suspension concentration and container size) and includes the name or initials of the person(s) who prepared and verified the preparation.
   3. Errors and near misses that occur during compounding that are identified by either the pharmacist or technician prior to dispensing are documented and reported through the organization’s reporting system for analysis.
3. Technology
   1. Use automated systems to reduce errors in measuring, mixing, packaging, and labeling. Automation can also help to ensure that the final product’s appearance and other characteristics remain consistent, although staff members involved may vary.
   2. Consider electronic record keeping to enhance accuracy, workflow, and quality.
   3. Implement barcode scanning and verification of individual compounding components with hard stops if an error occurs.
4. Staff Management
   1. Education - Consider requiring advanced compounding certifications for all compounding personnel.
   2. Training - Implement regularly scheduled training sessions that focus on compounding competency, recent technologies, and medication safety.
   3. Safety - Communicate that all personnel have the authority to “stop the line” (i.e., call a halt to compounding activities) at any time to question or express concerns about a compounded product.
5. Consult additional compounding resources and information toward the goals of improved safety, competency, and compliance. For example:
   1. National Association of Boards of Pharmacy – Verified Pharmacy Program® (NABP – VPP®). Compounding pharmacies may pursue accreditation to USP nonsterile (<795>) and/or sterile (<797>) compounding standards.
   2. American Pharmacists Association compounding resources page.
   3. Board Certified Sterile Compounding Pharmacist (BCSCP) certification.
   4. American Society of Health-System Pharmacists. Compounding Frequently Asked Questions.

Disclaimer
The information, examples and suggestions presented in this material have been developed from sources believed to be reliable, but they should not be construed as legal or other professional advice. CNA 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. “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. Copyright © 2025 CNA. All rights reserved.