Practice of Medicine
Medical Negligence Alleged Following Failure to Maintain Written Protocols
November 26, 2013
This case involved a woman who underwent a routine, elective hysterectomy in the hospital setting. The surgery was without incident and the patient was medicated for pain by the recovery room staff. She was transferred to the floor where she received additional pain medication by the nursing staff. Approximately one hour after being transferred to the floor, the patient was found to be unresponsive. Naloxone was administered and CPR was initiated. Although resuscitation efforts were successful, the patient suffered severe brain damage and remained in a persistent vegetative state. The injuries sustained by the patient left her permanently and totally disabled, and in need of full time care. At the time of the trial, the patient was unable to accomplish any activity of daily living.
According to the medical records, the hysterectomy lasted approximately 2 hours and 25 minutes. In the subsequent twenty minute period that patient was in the PACU, the patient received 1 mg of Dilaudid IV and two (2) 5 mg doses of Morphine Sulfate IV (for a total of 10 mg.) The hospital did not have a policy or protocol for the administration of pain medications in the recovery room. The narcotics were given pursuant to a verbal order from the anesthesiologist.
After being transferred to the floor, the patient received two additional dosages of Dilaudid 1 mg, for a total of 2 milligrams within a period of 50 minutes. Twenty minutes after the first dosage was given the floor nurse, the patient’s vital signs were recorded at BP102/57, pulse -62 and respirations -18. Twenty-five minutes after the vital signs were taken, there was a notation in the record that the patient stated that the medications given for pain had relieved symptoms. Five minutes later, the second 1 mg of Dilaudid was administered by the nurse. Three minutes later, the nurse noted that the patient was unresponsive. Three doses of Naloxone were administered. CPR was initiated and a code was called.
From the time the patient received the first post operative dose of narcotic until the time the patient was found to be unresponsive, approximately I hour and 58 minutes had elapsed and the patient had received a total of 3 milligrams of Dilaudid and 15 milligrams of Morphine Sulfate.
The complaint named the hospital, the anesthesiologist and the company that employed the anesthesiologist at the time as being “jointly and severally liable” for their negligence in the care of this patient.
The plaintiff alleged that the patient was given a narcotic overdose and that was administered pursuant to a verbal order. It was further alleged that the failure to document a written order for the administration of a narcotic was a violation of the standard of care as well as the applicable state laws.
The case went to trial approximately two years and nine months after the incident occurred. On the second week of the trial, the co-defendant hospital settled for an undisclosed amount before the plaintiff rested. Six months later, the complaint was re-filed, alleging the anesthesiologist and his employer group practice of negligence per se. After filing a motion for summary judgment on behalf of the defendants, the plaintiff pursued an appeal on the negligence per se issue. The state Court of Appeals ruled that the physician was negligent as to one of the counts of the complaint because of a violation of state statute regarding the administration of the narcotic on the basis of a verbal order. The case was appealed to the state Supreme Court and the petition was denied from any further appeal from the Court of Appeals ruling. Despite the disadvantage posed by the negligence per se ruling, it was believed that the case was still defensible on the remaining counts. The case went to trial for the second time almost nine years after the incident occurred. Midway through the second week of the trial, the case was settled on behalf of the defendant physician and his employer for a large amount.
Risk Management Commentary
One of the complaints in this case was the allegation that the patient was given a narcotic overdose that caused the brain damage. There were different expert opinions about the amount of narcotics that the patient received. Experts for the plaintiff opined that the amount of narcotic given was excessive, while experts for the defense testified that the dosage of narcotics given by the physician were within the acceptable range.
Perhaps the most difficult obstacle for the defense team to overcome was the Court of Appeals finding that the defendant physician was negligent in delegating to the PACU nurses the authority to administer pain medications without a written protocol, which was required by state law. Regardless of the state, each practice and facility should maintain current, written protocols for those administering medications, particularly controlled substances and other high risk medications.
Beginning in January 2001, the Joint Commission set forth standards for ensuring that pain would be assessed and managed in all patients. The Commission concluded that acute and chronic pain were major causes of patient dissatisfaction in our health care system, leading to slower recovery times, creating a burden for patients and their families, and increasing the costs to the health care system. With these factors in mind, new standards were developed to create higher expectations for the assessment and management of pain in hospitals and other health care settings. (The Joint Commission) The American Pain Society and many other national organizations have endorsed this standard.
With improved awareness of patient pain, more doses of pain medications, especially opioids, are prescribed. Not surprisingly, more adverse drug events (ADE) related to pain management occur. Vila et al found more than a two-fold increase in opioid over-sedations after implementation of a patient pain management program in a population of adult cancer patients. (Vila H Jr, 2005)
In 2004, American Society of Anesthesiologists updated its publication, “Practice Guidelines for Acute Pain Management in the Perioperative Setting.” (American Society of Anesthesiologists, Inc., 2004) Below is summary of the recommendations.
Institutional Policies and Procedures for Providing Perioperative Pain Management Institutional policies and procedures include (but are not limited to):
- Education and training for healthcare providers
- Monitoring of patient outcomes
- Documentation of monitoring activities
- Monitoring of outcomes at an institutional level
- Twenty-four hour availability of anesthesiologists providing perioperative pain management
- Use of a dedicated Acute Pain Service
- Preoperative Evaluation of the Patient A directed pain history, a directed physical examination, and a pain control plan should be included in the anesthetic preoperative evaluation.
- Preoperative Preparation of the Patient Preoperative patient preparation includes:
- Adjustment or continuation of medications whose sudden cessation may provoke a withdrawal syndrome
- Treatment(s) to reduce preexisting pain and anxiety
- Premedication(s) prior to surgery as part of a multimodal
- Analgesic pain management program, and
- Patient and family education (including behavioral pain control techniques).
- Perioperative Techniques for Pain Management
- Epidural or intrathecal opioid analgesia;
- PCA with systemic opioids; and
- Regional analgesic techniques, including but not limited to intercostals blocks, plexus blocks, and local anesthetic infiltration of incisions.
- Multimodal Techniques for Pain Management Whenever possible, anesthesiologists should:
- Employ multimodal pain management therapy
- Unless contraindicated, all patients should receive an around-the-clock regimen of NSAIDs, COXIBs, or acetaminophen.
- Patient Subpopulations
- Pediatric patients,
- Geriatric patients, and
- Critically ill or cognitively impaired patients, or other patients who may have difficulty communicating.
American Society of Anesthesiologists, Inc. (2004). Practice Guidelines for Acute Pain Management in the Perioperative Setting. Anesthesiology , 100 (6), 1573-1581.
The Joint Commission. (n.d.). www.jcaho.org. Retrieved August 16, 2010, from The Joint Commission Website: http://www.jointcommission.org/NewsRoom/health_care_issues.htm
Vila H Jr, S. R. (2005). The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: Is patient safety compromised by treatment based solely on numerical pain ratings? Anesth Analg , 101, 474-480.
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