By Vishani Ragobeer

TWO years since three children died at the Georgetown Public Hospital Corporation (GPHC) following the mis-administration of cancer drugs, the United States (US) Food and Drug Administration is working with drug application holders to update the labels on the drugs to prevent future adverse and fatal outcomes.

In 2019, three children who were receiving treatment at the GPHC for leukemia, a form of cancer, lost their lives. Seven-year-old Curwayne Edwards succumbed on January 14; Roshani Seegobin, three, died on January 18 and Sharezer Mendonca, six, passed away on January 24.

Following their deaths, it was reported that one drug, vincristine, was administered incorrectly, leading to adverse and later, fatal reactions in the young patients. The vincristine was administered intrathecally (injected into the spine) when it should have been administered intravenously (injected into the veins).

This mis-administration has been the subject of concern internationally and since then, pressure has been mounting on the FDA to disallow the preparation of the drug by syringes and instead encourage preparation through intravenous infusion bags only.

On January 15, this year, the FDA announced that it is working with the drug application holders to update the labels on vinca alkaloids, a group of chemotherapy agents that includes the vincristine sulfate injection. The updated labels recommend preparation in the intravenous bags only.

Since 2008, the National Patient Safety Agency in the United Kingdom, suggested that dispensing these vinca alkaloids prepared in intravenous bags reduces the risk of medication errors due to erroneous intrathecal administration.

“FDA also requested more extensive labelling changes for the preparation of vinblastine sulfate (for) injection products. These labelling changes will remove instructions for preparation in a syringe and add instructions for preparation in an intravenous infusion bag. The changes should be completed during 2021,” the FDA said in a statement.

In addition to the three children in Guyana who received vincristine incorrectly, the Institute for Safe Medication Practices (ISMP), also reported that one child in Norway died similarly.

“The child from Norway had a brain tumor and was just 6 years old when vincristine was injected into the spinal fluid via an intraventricular catheter instead of methotrexate,” the ISMP said.

In 2019, the ISMP highlighted that the most effective way to prevent patient harm is to supply the drugs in mini-bags, so that the risk of confusion with the syringes is avoided. The institute said it has been advocating for this since 2001.

The World Health Organization (WHO) has promoted dilution of vinca alkaloids in mini-bags since 2007. And, it was reported that most practitioners in the US dilute vincristine (and other vinca alkaloids) in a mini-bag prior to administration to patients.

Though the mis-administration of the drug led to the death of the three Guyanese children, an investigation launched by the GPHC concluded that “human deficiencies and systemic challenges” contributed to the unfortunate loss of the three children. These included the lack of supervision and inadequate staffing – stretched between various departments – in addition to the mis-administration of the drugs.

The Guyana Chronicle understands that three doctors, including one senior doctor, were sanctioned by the GPHC. The employment contracts the senior doctor and one of the two junior doctors had with the GPHC had not been renewed, while the other junior doctor was terminated.

In addition to being sanctioned by the GPHC, the doctors who were employed through the Health Ministry would also be placed before the medical board. Former Chief Medical Officer (CMO), Dr. Shamdeo Persaud confirmed that these sanctions were imposed on the doctors. That matter is still, reportedly, undergoing “final review.”