PITOCIN AS A HIGH-ALERT MEDICATION: Errors, Allegations, & Liability Risk Reduction
It’s estimated that approximately half of all paid obstetrical litigation claims involve allegations of Pitocin misuse. Recognizing that Pitocin is a high alert medication warranting safe initiation, and management consistent with standardized evidence-based practices reduces patient harm, while reducing litigation risk for perinatal team members, and hospital systems.
In this blog, I’ll identify what Pitocin is, and what it’s used for. I’ll also address why Pitocin is considered a high alert medication. Additionally, I’ll highlight common allegations related to Pitocin management identified in past obstetrical related law suits. I’ll close by offering some risk management approaches that can be integrated into practice.
What is Pitocin? Pitocin is the synthetic (made by chemical synthesis) form of oxytocin, and serves as the most common labor induction agent. Pitocin is chemically, and physiologically identical to endogenous oxytocin that is made, and circulated by the body. Endogenous oxytocin is synthesized by the hypothalamus in the brain, then is transported to the posterior lobe of the pituitary gland where it is then released into maternal circulation. Oxytocin is typically released in response to breast stimulation, sensory stimulation of the lower genital tract, and cervical stretching which results in uterine contractions. The half-life of Pitocin is between 10-12 minutes with uterine response typically occurring within 3-5 minutes of intravenous (IV) administration.
What are high alert medications? High alert medications are defined as those bearing a heightened risk of harm when they are used in error, and that may require special safeguards to reduce the risk of error.
In 2007, Pitocin was added to the Institute for Safe Medication Practices (ISMP) list of high-alert medications due to the potential negative maternal, and fetal effects (patient harm) that can occur when used in error, such as inappropriate timing of administration, and/or excessive dosing.
It’s important to note that Pitocin administration using pharmacological principles can be therapeutic during labor. Pitocin is not a high-risk or dangerous drug, but rather a high-alert medication warranting safe initiation, and management. If managed properly, Pitocin has no inherent risks.
Examples of other high alert medications utilized in labor and delivery settings, include:
- Promethazine intravenously: an antihistamine, sedative, antiemetic commonly used to treat nausea, and vomiting
- Methotrexate: an immune-system suppressant used to treat ectopic ‘tubal’ pregnancies
- Magnesium Sulfate intravenously: used for the prevention of eclamptic seizures in pregnant women diagnosed with severe preeclampsia
- Insulin: used to treat diabetes in pregnancy, and during the course of labor
- Epinephrine (adrenaline): used for resuscitative efforts
General Incidence of Adverse Drug Events (ADEs): It has been reported that 400,000 Americans die annually as a result of medication errors. In 2016, the CDC identified unintentional death, including medical mistakes, as the third leading cause of death in the U.S. The CDC’s Healthy People 2030 indicated that annual adverse drug events (ADEs) or harm resulting from medication errors, have led to 1.3 million emergency department encounters, 350,000 hospitalizations, and over $3.5 billion in excess medical costs. ADEs remain a significant public health issue, with most instances being preventable.
How do ADEs relate to the use of Pitocin? Pitocin is the most frequently used medication for labor induction, and augmentation. Additionally, Pitocin is the medication most commonly associated with preventable adverse events during childbirth. The risks of Pitocin are generally dose related, and include uterine tachysystole, excessive uterine activity, fetal compromise, neonatal acidemia, placental abruption, and uterine rupture.
Other types of Pitocin errors, and ALERTS include:
- Mistaken intravenous (IV) fluids with oxytocin in the management of IV fluid resuscitation during indeterminate or abnormal fetal heart rate (FHR) patterns and/or maternal hypotension
- Inappropriate elective (in the absence of a medical indication) administration to women < 39 completed weeks of gestation
- Failure to respond to high/low alerts:
- The Joint Commission issued a sentinel event alert concerning medical devise alarm safety as alarm related events have been associated with permanent loss of function or death. Among the most common contributing factors were improper alarm settings, alarm settings turned off inappropriately, alarm signals not audible to staff.
- Risk Management Approach: Ensure FHR, and maternal vital signs alarm limits are set appropriately, and that alarms of turned on, functioning properly, and audible to staff. Follow hospital guidelines regarding prevention of alarm fatigue.
- Failure to reconnect the postpartum oxytocin infusion at the time of patient transfer, transition of care:
- The Joint Commission issued a sentinel event alert related to managing the risk during transition. Tubing connector standards are designed to prevent dangerous tubing misconnections, which can lead to serious patient injury, and death.
- Risk Management Approach: During the transition of care, be sure to trace the tubing, and catheter from the patient to the point of origin before connecting or reconnecting any device or infusion, at any care transition (such as a new floor, unit, hospital, or service), and as part of the hand-off process; route tubes, and catheters with different purposes in different standardized directions; when there are different access sites, or several bags are hanging, label the tubing at the distal and proximal ends; use tubing, and equipment only as intended; and store medications for different delivery routes in separate locations.
- Failure to adhere to sterile technique at the time of initiating IV access:
- The Centers for Medicare and Medicaid Services considers vascular catheter-associated infection to be a hospital acquired condition because it can be reasonably prevented using a variety of best practices.
- Risk Management Approach: Follow evidence-based infection prevention practices, such as performing hand hygiene, maintaining sterile no-touch technique when preparing, and administering infusions, and performing a vigorous mechanical scrub of needless connectors to reduce the risk of vascular catheter-associated infections.
Risk Management Perspectives: It’s estimated that approximately half of all paid obstetrical litigation claims involve allegations of Pitocin misuse.
- Common Allegations:
- initiation of Pitocin in the absence of evidence of fetal well-being. Failure to complete a non-stress test prior to initiation of Pitocin.
- failure to accurately assess maternal-fetal status during labor induction. Continuous fetal monitoring not performed; failure to assess, and document fetal heart rate, and uterine activity per organizational policy, and standard of care.
- excessive doses of Pitocin resulting in uterine tachysystole, with or without an indeterminate or abnormal FHR pattern.
- failure to discontinue or decrease Pitocin in the presence of a Category II and/or Category III FHR tracing unresolved with intrauterine resuscitation.
Pitocin management also serves as a source of clinical conflict between nurses, midwives, and physicians during labor. Such clinical conflict increases the risk of patient harm, and litigation. By developing a shared mental model across specialties, and incorporating agreed upon standardized policies, clinical conflict, and inter-observer variability is reduced leading to positive birth outcomes, as well as less liability risk for the perinatal teams, and hospital systems.
Additional Risk Management Strategies:
- Prior to the administration of Pitocin, have another nurse perform a double check (2nd RN verification) to verify patient identity, and to make sure you have the correct medication in the prescribed concentration, the medication indication corresponds with the patient diagnosis, the dosage calculations are correct, and the dosing formula used to derive the final dose is correct, the prescribed route of administration is safe, and proper for the patient, the pump settings are correct, and the infusion line is attached to the correct port.
- Utilize pre-oxytocin, and in-use oxytocin safety checklists.
- Have standardized policies for oxytocin dosing, definitions, and interventions for indeterminate, and abnormal FHR patterns, as well as excessive uterine activity that are agreed upon by all members of the perinatal team, used to guide management, and consistent with the standards of care.
- Ensure completion of a full assessment of uterine activity in labor including contraction frequency, duration, intensity or strength, resting tone, and relaxation time.
- 2008 NICHD workshop report: “uterine contractions are quantified as the number of contractions present in a 10-minute window, averaged over 30 minutes. Contraction frequency alone is a partial assessment of uterine activity. Other factors such as duration, intensity, and relaxation time between contractions are equally important in clinical practice to safe guard fetal, and uterine acid-base status”.
- Ensure hospital systems are not guided by limiting tachysystole protocols exclusively, but rather on excessive uterine activity protocols.
- consider the clinical context (stage/phase of labor, maternal, and fetal risk factors, labor progress)
- Ensure that nurses and Ob providers are properly trained. Implement multidisciplinary education related to electronic fetal monitoring, assessment of uterine activity, and Pitocin management.
- Maintain a 1:1 nurse-patient ratio while managing Pitocin.
- Real-time, and complete documentation including a full evaluation of uterine contractions, and a complete assessment of the fetal status, using a flowsheet or progress note.
- Be knowledgeable about fetal heart rate, and uterine activity physiology, including the significance of adequate relaxation time between contractions.
- Remain current with your professional organization, and remain current with organizational literature.
The purpose of this blog is to educate, and inform in an effort to promote patient, and perinatal team safety, promote positive birth outcomes while reducing the incidence of obstetrical related medical malpractice lawsuits by lowering the recurrence risk of errors.
References
American College of Obstetricians and Gynecologists, 2020. ACOG Practice Bulletin No. 107: Induction of labor.
Centers for Medicare and Medicaid Services, 2020. Condition of participation: 42 C.F.R.
Centers for Disease Control and Prevention, 2024. Leading causes of death.
Institute for Safe Medication Practices, 2024
Makary, 2016. Medical error – The third leading cause of the death in the U.S.
Simpson, et al., 2021. AWHONN Perinatal nursing, 5th ed.
The Joint Commission, 2021. Standards NPSG. Comprehensive accreditation manual for hospitals.
U.S. Department of Health and Human Services. Healthy People 2030.
COMMENT AND SHARE: Do you have experience with an adverse drug event related to Pitocin? What was the outcome? Were organizational, or system changes made to minimize the risk of recurrence?
