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Jakarta Post

Kalbe Farma case to undergo mediation

The National Police say they have suspended their investigation into the country’s largest pharmaceutical company, PT Kalbe Farma, concerning an alleged mix-up of medicines that claimed the lives of two people

Fedina S. Sundaryani (The Jakarta Post)
Jakarta
Tue, March 24, 2015

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Kalbe Farma case to undergo mediation

T

he National Police say they have suspended their investigation into the country'€™s largest pharmaceutical company, PT Kalbe Farma, concerning an alleged mix-up of medicines that claimed the lives of two people.

'€œFor the time being, all parties have agreed to undergo a mediation session to try to resolve the matter,'€ police spokesman Sr. Comr. Rikwanto told The Jakarta Post on Monday.

He said the mediation session involved the victims'€™ families, representatives of Kalbe and Siloam Hospital representatives. It was held at Lippo Karawaci in Tangerang, Banten, at the site of the accident.

'€œWe will not continue unless the mediation session fails,'€ he said.

The incident in question occurred on Feb. 12, when the Siloam Hospital conducted urological surgery on one patient and a C-section on another.

The medical teams injected a Buvanest Spinal anaesthetic into the patients'€™ spinal cords. However, after the patients started showing physical resistance during the course of the surgery, the medical team began to suspect that the contents of the drug were falsely represented.

Both patients died less than 24 hours later after suffering painful itching and muscle spasms.

After the incident, the Food and Drug Monitoring Agency (BPOM) suspended Kalbe'€™s license to distribute Buvanest Spinal and the anti hemorrhagic Asam Tranexamat Generik.

BPOM chairman Roy Sparingga said the agency had identified several areas where a mix-up could have taken place. The BPOM inspected both Kalbe, the drug producer, and PT Enseval Putera, the company responsible for distribution.

'€œAfter we did a system inspection, we found there were several possible mix-ups that could have happened. The mix-up could have occurred during the secondary packaging, especially during the visual inspection at line production No. 6 for producing injections. It is most likely that there was a mix-up in the labeling,'€ he said.

Roy said the production line had 26 products including the Buvanest Spinal and Asam Tranexamat. However, he acknowledged that the agency did not have solid proof regarding the alleged mix-up, but had based their finding on what they observed during the inspection.

As a result of their investigation, Roy said that BPOM had also ordered the company to stop all production of products on line No. 6. In addition, all Buvanest Spinal still on the market had to be revoked and destroyed.

'€œThe reason we asked them to halt all production on that line was to eliminate any risk of those [dangerous] products being distributed on the market,'€ he said. He declined to say when the ban would be lifted.

When asked if the temporary permit revocation would deter Kalbe and other pharmaceutical firms from making similar mistakes, Roy said it was more important to consider the health and safety of future patients.

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