This Malpractice Case Study presents a closed claim involving a family practice physician who failed to consult FDA approved dosage recommendations on the morphine sulfate label. The subsequent over-prescribing of morphine is alleged for the death of a 41 YOM with spinal stenosis and lower back pain.
Allegation
The physician negligently introduced morphine and subsequently doubled the prescription one day prior to the patient’s death.
Case Details
A 41 YOM with a history of chronic back pain presented to establish care with a family practice physician. The physician and nurse practitioner managed his ongoing chronic low back pain, asthma, type 2 diabetes, lower extremity pain, depression, and anxiety. The patient had a history of gastritis and heart disease.
During a follow-up visit the physician increased the patient’s acetaminophen/oxycodone to 325 mg/5 oral tablet, one tablet 1-2 times daily, a total of thirty tablets were prescribed with no refills. Other medications included celecoxib 200mg 60 tablets with 11 refills and sertraline 100mg, 1½ tablets once daily. The patient agreed to participate in physical therapy.
Two weeks later the patient was seen in the clinic for left side back pain and described his pain as 15 on scale of 1-10. The patient indicated that the celecoxib was not working. The patient was experiencing urgent and frequent urination, had chills without fever, and was unable to sleep. His ADLs were significantly affected and limited by pain radiating down his left leg to his foot. The physician’s review of systems noted frequent urination, nocturia, difficultly starting and stopping stream, and incontinence.
The physician ordered an EMG and prepared an order for the MS Contin brand* of morphine sulfate 60 mg extended release one tablet three times daily. The quantity was 90 tablets with no refills. The patient was scheduled for a two-week follow-up. Two days later, the patient called to request an appointment that day due to increased back pain the preceding night continuing into the morning. The physician increased the prescription for morphine sulfate to two pills 3 times daily and told the patient to call the office in a few days. The patient was found unresponsive by his wife the next morning and expired.
Three days later the county medical examiner’s office issued an autopsy report noting the patient’s time of death was one day after the last increase in the patient’s morphine sulfate dosage. Morphine, diphenhydramine, sertraline, bupropion, amitriptyline, and nortriptyline were detected in the post-mortem blood specimens. The autopsy reported pulmonary edema, cerebral edema mild, and a full urinary bladder. The coroner confirmed the pill count was correct per medication instructions.
At the time of this case, the FDA-approved dosage recommendations on the MS Contin label stated: “MS CONTIN 100 mg and 200 mg capsules, a single dose greater than 60 mg, or a total daily dose greater than 120mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established.” It defines opioid-tolerate patients as “those taking, for one week or longer, at least 60 mg of morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg of oral oxycodone per day, 8 mg of oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.” In the month before he was prescribed 180 mg of morphine sulfate, the patient was instructed to take 5-10 mg of oral oxycodone per day.
Expert Testimony and Resolution
Defense counsel consulted with forensic toxicologists who would not support the prescribing standard of care. The most significant and proximate change preceding the patient’s death was the introduction of morphine and the resulting doubling of the dose of morphine the day before the patient’s death.
The physician and the family agreed to settle the case.
Risk Reduction Strategies
When treating patients with chronic pain, especially those who require the management of opioid polypharmacy, consider the following strategies:
- Perform a comprehensive medical history and physician examination, create and monitor a comprehensive treatment plan to ensure pre-determined goals are met throughout the clinical course.
- Maintain access to all current and ongoing FDA updates regarding extended-release, long-acting opioids, and the risks of higher dosages.
- Follow FDA black box and individual drug label warnings prior to prescribing.
- Educate the patient on how to properly take the medication and the risks involved if they’re not taken properly.
- Monitor the patient closely especially when increasing dosages.
- Document all clinical data supporting legitimate medical purpose, diagnostic and therapeutic rationale, referrals to subsequent treaters, and patient education.
Conclusion
Unsatisfactory review of dosage recommendations can adversely impact patient care, result in death, and may damage the ability to obtain expert testimony on the standard of care.
---
If you have questions on this topic, please contact us at RiskAdvisor@ProAssurance.com or 844-223-9648.
