Failure to properly administer pain medication

by Laura Hale Brockway, ELS, Vice President, Marketing, and 
Jennifer Templin, Risk Management Representative

Presentation

A 57-year-old woman was being treated for chronic pain related to failed back syndrome. For the last several years, her pain management (PM) physician was treating her with a spinal cord stimulator and a subarachnoid narcotic infusion system. The PM physician initially dispensed morphine via the pump, but the patient developed itching secondary to the morphine. Her medication was changed to hydromorphone. 

In July 2018, the patient came to her PM physician to have the pump refilled with 20 ml of hydromorphone. The pump was refilled, but the medical assistant programmed the pump for 40 ml. This did not affect the dose or rate of administration, but did cause the pump to be depleted of medication in October, ahead of the January 2019 refill. The patient went two months without hydromorphone infusion. 

At the planned January 2019 refill appointment, the patient had no opiate or narcotic in her system and was a narcotic naïve patient. If the PM physician had been aware of this, he would have started her on a lower dose of hydromorphone. The pump was refilled with 20 ml, but the medical assistant again programmed the pump for 40 ml. The pump was again empty in April 2019, ahead of the July 3 refill appointment. 

On June 21, the patient returned to the PM physician reporting breakthrough pain. She was on a continuous infusion with the option for a limited patient-controlled bolus and oral pain medications as needed. The continuous infusion rate was 1.94 mg/day of hydromorphone. The patient also reported constipation secondary to hydromorphone, which required enemas every two-to-three days. 

The PM physician refilled the pump reservoir with hydromorphone and changed the infusion rate to 2.174 mg/day. The PM physician did not recognize that the pump had been empty for two months due to incorrect programming in January. Because the pump had been empty, the patient was again a naïve opiate/narcotic patient.

On June 23, the patient went to the ED with abdominal pain, inability to urinate, nausea, and vomiting. She was discharged with a prescription for prochlorperazine. It was not clear if she filled the prescription for prochlorperazine, but she did receive a 10 mg dose by IV before discharge from the ED. (Prochlorperazine can intensify and prolong the effects of central nervous system depressants including opiates.)

The patient returned to the ED on June 25 with signs of narcotic overdose. She was noted to have altered mental status and a possible stroke, nausea and vomiting, fatty liver, renal failure, an elevated troponin level, and had retained a liter of urine in her bladder. The hydromorphone was stopped and then adjusted to a subtherapeutic dosage (0.064 mg/day). The patient quickly regained consciousness after the hydromorphone was stopped. She left the hospital against medical advice on July 1. 

On July 18, the patient came to her PM physician to have the pump re-programmed. She reported short-term memory loss and weakness. The pump was re-programmed to an infusion rate of 0.50 mg/day. She came back to the clinic on July 19 and reported nausea and drowsiness. The PM physician adjusted the infusion rate to 0.48 mg/day.

Several weeks passed. The PM physician received a letter from the manufacturer of the pain pump dated September 25. The letter detailed allegations the patient was making against the pump manufacturer related to her hydromorphone overdose, which she claimed was responsible for her stroke and memory loss.  

At her subsequent appointments with the PM physician, the patient was started on pregabalin and exchange of the pump was discussed. The patient’s speech was noted to be improving. 

Her last visit with the PM physician was October 31, 2019. She was reportedly doing well on low-dose infusion and pregabalin. She was to return to the clinic in February 2020 for evaluation before a pump refill in March 2020. She never returned. 

Allegations

A lawsuit was filed against the PM physician, alleging negligent administration of hydromorphone leading to over-infusion, overdose, and stroke. The manufacturer of the pain pump was also sued. 

Legal implications

This case presented several challenges to the defense. The PM physician had been treating the patient for chronic back pain for several years. On two occasions, his staff improperly programmed the pain pump leading to early emptying of the reservoir. As a result, the patient went weeks without her pain medication and became narcotic naïve. The PM physician failed to determine that these programming errors had occurred. It was also noted that the documentation of the patient’s refill visits was “sloppy.” 

Regarding causation, the plaintiff’s expert attributed the patient’s stroke to an overdose of hydromorphone. Defense experts disputed this, arguing that imaging patterns reflected an embolic/thromboembolic event rather that a global hypoxic ischemic cause. According to these experts, the patient’s stroke was unrelated to the refill or the use of hydromorphone. 

Disposition

This case was settled on behalf of the PM physician. The outcome of the case against the manufacturer of the pain pump is unknown. 

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