Propofol batch had 3 toxic impurities, says PGI Chandigarh report

Chandigarh: The PGI's report on chemical analysis of Propofol batch, which had adverse events and suspected to have caused five deaths subsequently, found 26 impurities - three of them toxic and the others were contaminated.

One chemical, Protirelin, was found to produce coma, hypotension (sudden drop in blood pressure), tachycardia (fast heart rate) and dyspnea (shortness of breath). Moreover, the PGI's internal inquiry committee headed by Prof SK Gupta, neurosurgeon, ruled out any inadvertent error related to dosing route of the drug, giving a clean chit to the hospital staff on any medical error.

The committee formed on September 1 in PGI (a copy is with the TOI) concluded that Propofol with the brand name, Propoven, was the common factor in all the eight adverse events reported. "Operative notes or management did not suggest any deviation from routine procedures that could explain the changes in clinical profile of the patients who were given Propofol from the suspected vials. Drug charts of all the patients were reviewed. Inadvertent drug toxicity because of any errors related to dosing route of administration were excluded," mentioned the report.

The committee also obtained details of purchase from the emergency medical shop from where the suspected vials were bought. It was revealed that within 15 days from August 28, 170 vials of Propoven, from Nixi Laboratory from the same suspected batch was bought from 'Gupta Medicos' in PGI's emergency, while adverse events were reported from August 22 and September 1 onwards. The details of procurement of these vials from August 20 were not submitted by the chemist during the PGI's investigation.

The PGI sent the samples to CDSCO regional drug laboratory, Chandigarh, as they did not have a facility to test endotoxin to test sterility in the drug. The committee's report documented that as compared to other types of surgeries, higher doses of Propofol are usually used in neurosurgeries. The pharmacovigilance unit of the department of pharmacology provided details of adverse drug reactions (ADR) in PGI in the last one month in August. "No other similar ADR has been reported in the institute," mentioned the report.