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Jakarta Post

Kalbe targeted by House investigation

The House of Representatives says it will launch a probe into pharmaceutical giant PT Kalbe Farma’s role in last week’s death of two patients at Siloam Hospital in Lippo Karawaci, Tangerang, Banten

Hans Nicholas Jong (The Jakarta Post)
Jakarta
Sat, February 21, 2015 Published on Feb. 21, 2015 Published on 2015-02-21T06:46:01+07:00

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T

he House of Representatives says it will launch a probe into pharmaceutical giant PT Kalbe Farma'€™s role in last week'€™s death of two patients at Siloam Hospital in Lippo Karawaci, Tangerang, Banten.

The announcement came after a preliminary investigation into the deaths '€” thought to be caused by the accidental swap of two drugs '€” exonerated the hospital of malpractice.

The move suggested that Kalbe '€” which produced anesthetic drugs until its licences were suspended by the Food and Drug Monitoring Agency (BPOM) following the incident '€” would be held responsible for the tragedy.

'€œThe procedures [at the hospital] were followed,'€ Amelia Anggraini, a member on House Commission IX overseeing health, told The Jakarta Post on Friday. '€œThat'€™s our preliminary conclusion. But we have to wait for the final conclusion from the BPOM and the Health Ministry who handled the case.'€

Amelia, along with eight other commission members, visited the Siloam Hospital on Friday to look for evidence of a swap of the two drugs in question '€” the anaesthetic Buvanest Spinal and the antihemorrhagic Asam Tranexamat Generik.

'€œThe hospital bought two batches of the anaesthetic, each consisting of 150 vials. So, there were 300 vials in total. In one of the batches, there were four vials labeled '€˜anesthetic'€™ which consisted of antihemorrhagic agents. Further, the vials listed the volume at 4 miligrams, but it was actually 5 miligrams,'€ she said.

The incident occurred last week during urological surgery on one patient and a C-section on another.

As part of the both procedures, the medical teams injected Buvanest Spinal into the patients'€™ spinal cords.

Siloam Hospital spokesman Heppi Nurfianto said that the operations had been conducted according to standard procedures.

'€œWhen we registered the anaesthetic, it turned out the content didn'€™t match the label [...] After that, the patients began suffering from itching and muscle spasms, so we took them to the ICU [Intensive Care Unit],'€ he said on Tuesday.

Less than 24 hours after the spinal injections, both patients were pronounced dead.

'€œWe were confused. We took the drugs to our pharmacy and we spoke about the problem with the drug vendor, Kalbe Farma, and they acknowledged that the contents [of the anaesthetic] had been switched [with the antihemorrhagic],'€ said Heppi.

Amelia said there could have been a manufacturing error as the company was working against the clock to meet a surge in demand due to the implementation of the national health insurance (JKN) program.

House Commission IX chairman Pius Lustrilanang, who visited a Kalbe Farma facility in Cikarang, West Java, with a team of 12 lawmakers on Friday, said he had not been able to draw any conclusions as his team was only on site to evaluate the company'€™s manufacturing procedures.

'€œWe were only looking at the production process, what their ingredients were, what their labeling process looked like. And then we looked to see if there was any chance for an accidental swap,'€ he told the Post. '€œBut we only briefly looked into the process.'€

As a follow-up, the team has asked the company to submit a production-record of the anesthetic for the month of October 2014, the month the drugs were shipped to the Siloam Hospital.

'€œWe haven'€™t obtained the record but we have asked them to submit it and they are obliged to do so immediately,'€ Pius said.

Kalbe Farma corporate secretary Vidjongtius said on Friday that the company would continue to work with the BPOM to investigate the accident.

The House has also aired plans to establish a working committee to monitor the production and distribution of drugs in the country.

'€œThe team could even start working during the recess period with permission from the House speaker,'€ Pius said. '€œWe will ask in one or two days to hold a hearing.'€

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