Maternity Nurses, Pharmacy Work Together on Pitocin Potency
In June 2017, nurses noticed that patient labors were just not progressing the way they should, even after Pitocin was administered to encourage contractions. The drug also wasn’t helping patients much following birth, when given to prevent and treat post-partum hemorrhage.
Michele Fernandez, MSN, RNC, ACNS-BC, maternity nursing services manager at Munson Medical Center, and her team began questioning the potency of the Pitocin.
“We had some reports of patients not responding at all, and then when we switched to a different bag [of Pitocin], we’d get results,” Fernandez said.
To delve deeper into the problem and its potential cause, the team turned to Julie Botsford, PharmD, medication safety pharmacist, and Cathi Cornelius, PharmD, BCPS, CDE, clinical pharmacist.
Their findings not only solved the issue at Munson Medical Center, but also lead to a voluntary recall by PharMEDium Services, one of the sterile pharmaceutical compounding companies Munson Healthcare works with to obtain certain medications, including Pitocin.
“It is anecdotal, but it was a cluster of events and we took it seriously,” said Botsford, who connected with the Institute for Safe Medicine Practices on the issue. “We listened to the nurses and we did our due diligence.”
Pharmacy leaders decided to remove all lots of Pitocin available in the maternity unit and send them on to PharmMEDium for testing. In July 2017, PharMEDium informed pharmacy leaders that the tested lots failed to meet threshold potency and were below acceptable levels, which led to the decision to batch oxytocin, or Pitocin, and cease using PharMEDium product until assurance could be made that product is within potency specifications.
A review of oxytocin stability at room temperature in various solutions suggest that Lactated Ringers – the compounded form of the oxytocin which the maternity unit had been using – has loss of potency after 28 days, as compared to stability up to 90 days in Normal Saline, according to the Institute for Safe Medication Practices, which contacted PharMEDium after connecting with Munson Medical Center pharmacists about the issue.
Ultimately, the company initiated a voluntary recall of oxytocin compounded with Lactated Ringers (which had been assigned 40-day beyond-use date for room temperature storage). This was gratifying to the Munson Medical Center team involved with reporting the problem.
“That felt good,” Botsford said. “We’re helping people all across the country potentially.”
Today, the maternity unit uses oxytocin supplied by PharMEDium, but has switched to the oxytocin prepared in Normal Saline, ensuring patient safety.