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.
Risk management considerations
More than 100,000 reports of medication errors are received each year by the U.S. Food and Drug Administration, with improper medication preparation or administration being a leading cause. In addition, 7,000 to 9,000 people die each year in the United States due to medication error. (1)
In many health care settings, medication errors are often linked to distractions and workflow interruptions. In a busy if not chaotic setting, where physicians are examining patients, answering pages, ordering laboratory and imaging studies, speaking with patients and their families, interacting with insurance companies before ordering a study or procedure, physicians are also writing prescriptions or drug orders and administering medications. In this environment, medication errors can and do occur.
To minimize distraction, consider establishing a policy in your office or practice in which a specific time during the day is established for ordering patient medications. This could also be done when writing daily progress notes. Request that this time be only interrupted in case of an emergency. Also consider establishing a designated area for medication preparation by nurses or other providers that is a “distraction free zone.” (1)
Accurate chart documentation is vital to the medical record keeping process. Keeping timely, detailed encounter notes helps to keep all providers involved in the treatment of a patient up to date and promotes quality continuity of care. Medical records should be routinely reviewed for accuracy and compliance with documentation standards.
Additional policies to consider to minimize medication errors include the following.
- Reconcile patient medications at every patient encounter or transition of care, in which new medications are ordered or administered or existing medication orders are rewritten.
- Eliminate handwritten drug orders and prescriptions by using electronic records to document orders.
- If orders are unclear, encourage nurses or other providers to contact you to verify the order and request clarification.
- Provide your contact information in case there is a question regarding an order or prescription.
- Use metric measures and be careful of how you use the decimal point. “For example, when writing dexamethasone 2.0 mg, if the decimal point is not visualized, the nurse or pharmacist may think it is 20 mg.” A zero should also precede a decimal point, for example document “0.25 mg,” not “.25 mg.” “If the decimal point is not seen, it can easily lead to a tenfold increase in dose.” While the widespread use of electronic records improves legibility issues, it cannot completely prevent transcription or typing errors.
- Specify the duration of treatment, as opposed to just including a total number of doses or pills. By including both the dosage and the duration, the patient and other providers can reconcile that they match and that medications are not being taken too quickly or that there is a correct amount of medication provided in the order.
- Establish a rule for independent double-checking (IDC) when a high-risk medication is administered in your practice. An IDC occurs when a second provider independently (without input from the first provider) verifies that a dosage is correct. The two providers must agree independently (alone and apart from each other) on the dosage before the medication is administered. High-risk medications include, but are not limited to, anticoagulants, opioids, and chemotherapeutic agents. (1, 2)
The use of medication or infusion pumps for medication administration carries additional risks, such as software defects, human error, damaged equipment, and battery failures. In this case, the patient’s medication pump was incorrectly programmed and refilled in the PM physician’s office. The following risk reduction steps may have helped the providers in this case avoid human error when using medication pumps and provide a higher level of care.
- Confirm that the pump is programmed for the right dosage, at the right rate and volume to be infused. In an in-patient setting, this is especially important during a shift change, when any change is made to the infusion pump settings, when a new bag of medication/fluid is hung, or when new infusion tubing is primed.
- Conduct an IDC of infusion pump settings by a second provider when using high-risk medications. The two providers must agree on infusion settings in accordance with the physician’s order.
- Monitor for signs of over- or under-infusion of high-risk medications by using other patient monitoring systems such as cardiac, pulse oximetry, end tidal CO2, and glucose meters, when applicable.
- Participate in educational activities regarding the safe use of infusion/medication pumps.
- Consider a secondary method of checking the expected volume infused, such as a time strip indicator or a buretrol. (3)
It appears that the pain pump manufacturer issued medical device correction notices concerning this pain pump. The corrections were concerning possible over-infusion of the pump and, while they did not recommend removing the pump, there was a recommendation to educate patients, their caregivers, and families on signs and symptoms to look for in the event of a possible overdose, underdose, or withdrawal. Additionally, it was recommended that there be documentation of both the actual and expected reservoir volume at each refill visit.
Patient education should be documented in the medical record to verify the patient was provided pertinent information regarding their care. This would include discussions and any resources given, as they are also important elements of the informed consent process.
Documenting that the patient was given the information needed to make informed decisions and choices can support a physician in the event of a claim. Additionally, it is the physician's responsibility to discuss the risks and benefits of the use of narcotics for the treatment of chronic pain. Further, it is recommended and, in some states required, that this discussion be documented by either a written signed consent or contemporaneous notation in the medical record.
Sources
- Rayhan AT, Vashist R, Sinha A, et. al. Medication Dispensing Errors And Prevention. StatPearls. Updated July 2, 2022. Available at https://www.ncbi.nlm.nih.gov/books/NBK519065/. Accessed September 14, 2022.
- Baldwin K, Walsh V. Independent double-checks for high-alert medications. Nursing 2022. Volume 44, Issue 4. April 2014. Available at https://journals.lww.com/nursing/Fulltext/2014/04000/Independent_double_checks_for_high_alert.16.aspx#:~:text=NURSES%20ARE%20RESPONSIBLE%20for%20ensuring,in%20the%20safest%20manner%20possible. Accessed September 14, 2022.
- Infusion Pump Risk Reduction Strategies for Clinicians. U.S. Food and Drug Administration. February 2, 2018. Available at https://www.fda.gov/medical-devices/infusion-pumps/infusion-pump-risk-reduction-strategies-clinicians. Accessed September 14, 2022.
Laura Hale Brockway can be reached at laura-brockway@tmlt.org.
Jennifer Templin can be reached at jennifer-templin@tmlt.org.
