by Wayne Wenske, Senior Marketing Strategist, and
Emma Louise, MS, CCC-SLP, Risk Management Representative
Presentation
A 43-year-old man came to the emergency department (ED) on August 21 with sudden epigastric pain radiating to his back with severe nausea and vomiting. The pain was described as sharp and stabbing.
His lipase (30) and creatinine (0.81) levels were within normal limits. The patient was given morphine, and his pain subsided. He was instructed to follow up with his primary care physician (PCP).
On August 24, the patient went to his PCP who performed an ultrasound of his gallbladder and found multiple small stones and sludge. The patient was sent back to the ED.
Physician action
The patient was seen in the ED by General Surgeon A, who took the patient to surgery that day. Upon admission, the patient’s bilirubin (2.2) and liver function enzymes were elevated. His lipase was still within normal range. General Surgeon A prescribed a five-day round of ketorolac for the patient’s pain.
A laparoscopic cholecystectomy with intraoperative cholangiogram was performed, and a common bile duct stone was identified.
General Surgeon B performed an endoscopic retrograde cholangiopancreatography (ERCP) concurrently, while the patient was still under anesthesia. An extraction of the identified common bile duct stone was completed.
Over the next two days in the hospital, the patient continued to experience epigastric abdominal pain, nausea, and vomiting, and was placed on a clear diet. His urine output dropped to 400cc.
General Surgeon A noted that the patient was experiencing post ERCP pancreatitis with lipase levels over 4000 and amylase levels over 1000. The patient was given intravenous fluids, antiemetics, and pain medication including large and frequent doses of morphine. He was also continued on ketorolac.
On the patient’s fifth day in the hospital, the patient’s pain, nausea, and vomiting were still present, and he reported that the ketorolac was not providing any relief. He also reported “spots” in his vision. His urine output was 1150cc.
The hospital pharmacy’s automated unit dose distribution system cancelled General Surgeon A’s ketorolac prescription at the fifth 24-hour period. The surgeon ordered another round of the medication without blood work. On this day, the patient had zero urine output, visible swelling, and had gained more than 20 pounds from his admission weight.
On August 31, the patient’s bloodwork showed elevated creatinine (12.25) and anuria. General Surgeon A stopped the patient’s ketorolac and consulted with Nephrologist A. Nephrologist A noted that the patient had acute kidney injury likely due to the nephrotoxic effects of ketorolac.
On September 3, the patient was transferred to another hospital for hemodialysis. He received hemodialysis for seven days. Upon discharge from the second hospital, the patient’s creatinine level was 3.97, lipase was 231, and bilirubin was 0.6. By the end of October, he had complete recovery of renal function and his visual disturbances were resolved.
Allegations
A lawsuit was filed against General Surgeon A for prescribing ketorolac beyond the five-day safe dosage limit, causing kidney damage and impaired vision.
Legal implications
General surgeons who reviewed this case for the defense were critical of General Surgeon A for not following the patient’s electrolyte panel daily. They expressed that had this blood work been done, the elevated creatinine would have been noticed and the ketorolac stopped earlier, preventing acute renal failure and the need for hemodialysis.
General Surgeon A did not document his reasoning for continuing the medication past the five-day recommended dosage and did not monitor its effects on the patient’s condition. The reviewing surgeons agreed that it was a deviation from the standard of care to not monitor the patient via lab work. It is well known that long-term use of ketorolac can cause kidney damage or bleeding.
No documentation exists of an appeal from the hospital’s pharmacy regarding the second prescription of ketorolac. One reviewing surgeon questioned why there was no discussion at any time during the patient’s admission between General Surgeon A and the pharmacy regarding this prescription.
Disposition
This case was settled on behalf of General Surgeon A.
Risk management considerations
Ketorolac is a medication used in the management and treatment of acute moderate to severe pain and is in the nonsteroidal anti-inflammatory drug class. Ketorolac (brand name: Toradol) has been noted to be a safe and effective pain relief for short-term management postoperatively and has been used as an alternative to opioid therapy. (1, 2 )
Like other nonsteroidal anti-inflammatory drugs (NSAIDs), ketorolac use is associated with significant gastrointestinal, renal, and cardiovascular risks. (2) Potential adverse effects of ketorolac increase significantly when used in higher doses, for durations over five days. (3)
The Food and Drug Administration (FDA) states a physician should monitor for signs or symptoms of serious adverse reactions and risks when prescribing NSAIDS. (4) The FDA identifies liver problems, kidney problems, stomach pain, nausea, vomiting, and dizziness as potentially serious side effects of ketorolac.
Two days postoperatively, General Surgeon A noted that the patient was experiencing post ERCP pancreatitis; however, no lab work was ordered before prescribing more pain medications including morphine and continuing ketorolac. By the fifth day postoperatively, the patient was experiencing spots in vision and swelling.
The surgical consultants reviewing this case were critical of General Surgeon A for not requesting blood work or monitoring electrolytes daily, as the elevated creatinine levels would have been noted sooner. This information may have prevented acute renal failure and the need for hemodialysis.
Hospital protocols should address the ability of physicians to override system drug discontinuation and what process should be followed if override is initiated. Even though the pharmacy’s automated unit dose distribution system cancelled the ketorolac prescription on the fifth day, the physician was able to prescribe this medication past the recommended five-day window with no bloodwork or documentation of reasoning to proceed.
In this case, General Surgeon A prescribed a medication known to have high risks without documentation of medical necessity. Ordering and reviewing labs timely or documenting the reasoning for not ordering lab work may have helped the physician’s defensibility.
Consistent review of the nurse’s notes was also not evident within the medical record, which may have prompted the physician to order labs in a timelier manner.
Sources
- DeAndrade JR, Maslanka M, Maneatis T, et. al. The use of ketorolac in the management of postoperative pain. Orthopedics. February 1994. Available at https://pubmed.ncbi.nlm.nih.gov/8190679/. Accessed August 7, 2023.
- Mahmoodi AN, Kim PY. Ketorolac. [Updated 2022 Apr 9]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545172/. Accessed August 7, 2023.
- Vacha ME, Huang W, Mando-Vandrick J. The Role of Subcutaneous Ketorolac for Pain Management. Hospital Pharmacy. Volume 50, February 2015. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336012/. Accessed August 7, 2023.
- Food and Drug Administration. (n.d.). Toradol oral (Ketorolac tromethamine tablets) RX - Food and Drug ... Toradol. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf. Accessed August 1, 2023
Wayne Wenske can be reached at wayne-wenske@tmlt.org.
Emma Louise can be reached at emma-louise@tmlt.org.
