Patient safety alert: Anaesthesiologists, hospitals told to stop using Themis Hyperbaric Bupivacaine for spinal anaesthesia

Hyderabad: Following reports of suspected adverse drug reactions linked to an anaesthesia drug, doctors' associations have issued patient safety advisories urging anaesthesiologists and hospitals across the country to immediately stop using Themis Hyperbaric Bupivacaine for spinal anaesthesia.

While the exact nature and causality of the reported events are still under investigation, hospitals and anaesthesiologists have been urged to stop using the product, isolate existing stock, switch to alternative approved formulations, and report any suspected adverse events.

The advisories have been issued by the Anaesthesia Patient Safety Association (APSA), India, and the Indian Society of Anaesthesiologists (ISA).

Sources from the Indian Society of Anaesthesiologists told Medical Dialogues that suspected adverse incidents linked to Themis Hyperbaric Bupivacaine were reported at Apollo Hospitals and Yashoda Hospitals. They added that Adverse Drug Reactions (ADRs) related to the drug have also been reported.

The Anaesthesia Patient Safety Association (APSA), India, issued a nationwide patient safety advisory on June 29, stating that it had received reports of suspected adverse events following the administration of Themis Hyperbaric Bupivacaine for spinal anaesthesia.

While noting that the exact nature and causality of these events are still under investigation, APSA said the number of reports received was sufficient to warrant immediate caution in the interest of patient safety.

Pending completion of the ongoing investigation, APSA strongly advised clinicians to refrain from using Themis Hyperbaric Bupivacaine for spinal anaesthesia until further notice and said a detailed review is underway, including verification of the reported adverse events, analysis of the batch numbers involved, review of storage, handling and administration practices, and coordination with the concerned regulatory authorities and the manufacturer.

The association requested hospitals and anaesthesiologists to:

1. Identify and isolate available stocks of Themis Hyperbaric Bupivacaine pending further clarification.

2. Record and preserve details of the product, including batch number, manufacturing date, expiry date, and storage conditions.

3. Report any suspected adverse events immediately to APSA with complete clinical details and product information.

4. Use alternative approved formulations of hyperbaric bupivacaine wherever feasible until further recommendations are issued.

"This advisory is issued purely as a precautionary patient safety measure and should not be construed as a definitive conclusion regarding product quality or causality. A comprehensive report, along with further recommendations, will be released upon completion of the ongoing investigation," mentioned the advisory issued by Dr Sunil T. Pandya, National Chairman, APSA.

Separately, the Indian Society of Anaesthesiologists (ISA), Hyderabad Metro City Branch, issued an urgent caution notice directing all consultants, resident doctors, anaesthesia technicians and operation theatre personnel to immediately stop using Themis Bupivacaine for spinal anaesthesia until further orders.

The ISA said the precautionary directive had been issued in the interest of patient safety pending further review and investigation and instructed that no ampoules of the product should be used for neuraxial administration until official clearance is communicated.

The organisation further directed hospitals to immediately identify, segregate and withhold existing stock from clinical use, use alternative approved brands for all spinal anaesthesia procedures, communicate the instruction to all OT staff without exception, and report any inadvertent use immediately to the Head of the Department. 

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