Batch of anaesthetic withdrawn from Chandigarh after PGI deaths

Tribune News Service

Chandigarh, September 6

Amid reports of five deaths at the PGIMER following the administration of anaesthetic (Propofol), the UT Administration has directed the distributor of the drug to ensure injections of the particular batch are not sold or used in the city, even as it has seized the remaining four injections available at the pharmacy based in the hospital.

The drug was purchased by patients’ attendants from a private chemist at the emergency shop after doctors prescribed it.

On September 1, a matter regarding unexplained hypotension (sudden drop in blood pressure) in intraoperative (occurring or performed during the course of a surgical operation) period with anuria (failure of the kidneys to produce urine) and/or jaundice in post-operative period in a few patients over the past few days was brought to the notice of the Medical Superintendent by two department heads.

A meeting was convened, which was attended by senior faculty from multiple departments. Taking a serious view of the matter, a high-level committee was constituted by the Director, PGI, under the chairmanship of Prof SK Gupta, Head, Department of Neurosurgery, to thoroughly investigate the incident. The committee has already met twice and the final report is awaited.

“We do not claim the cause of death has been due to a particular anaesthetic only as other factors are also being probed. The drug has been used time and again during surgical procedures previously as well. The committee will submit its report after detailed investigation,” said a senior PGI doctor involved in the committee investigating adverse event.

“In the meantime, the Drug Controller, UT, and Central Drug Standard Control Organisation (CDSCO), Baddi, have been informed to examine and fact find the case. Their reports are awaited. Based on the inferences of the awaited reports from all quarters, appropriate action will be taken," the official statement of PGI also reads.

On the issue of deaths, the UT Administration said it was not aware of the actual cause. However, a joint team of drug inspectors of UT and CDSCO had taken samples from the pharmacy and were being sent for testing.

All four available injections of the particular batch had been removed from the pharmacy, it added.

"The distributor in Panchkula has been contacted to ensure injections of the particular batch are not sold/used till analysis is completed. No more injections of the particular batch are available with any of the pharmacies in the UT. Till the samples are analysed, it may not be appropriate to make any comment as to whether there was any issue with the particular batch or not," said Yashpal Garg, UT Health Secretary.

Propofol injection

It’s an anaesthetic/ sedative used to help relax or sleep before and during surgery or other medical procedures. Abuse/ recreational use can cause death due to rapid onset of unconsciousness and apnea. It is commonly used in hospital settings as an intravenous anaesthetic and sedative agent.

Bought from pvt chemist in emergency wing

• Drug purchased by patients’ attendants from private chemist at emergency shop
• Fault is suspected in a “particular batch” only at the hospital pharmacy
• No suspected deaths have been reported after the September 1 incident
• Same anaesthetic of different batch is used for operative procedures
• Batch samples sent to Central Drug Standard Control Organisation, Baddi

Probe reports awaited

• On Sept 1, five deaths reported after incidents of sudden drop in BP during surgical operation period, with failure of kidneys to produce urine and/or jaundice in post-operative period in some
• Matter was brought to MS’ notice by two department heads and a meeting convened. A high-level committee was constituted by PGI Director to probe the incident. The report is awaited
• Also, the Drug Controller, UT, and Central Drug Standard Control Organisation, Baddi, told to examine case. Their reports are awaited. Based on these, action will be taken, said PGI

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