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Govt freezes Kalbe drug licenses following deaths
The Food and Drug Monitoring Agency (BPOM) has suspended the licenses of two drugs produced by pharmaceutical company PT Kalbe Farma following the recent deaths of two patients at the Siloam Hospital in Lippo Karawaci, Tangerang
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he Food and Drug Monitoring Agency (BPOM) has suspended the licenses of two drugs produced by pharmaceutical company PT Kalbe Farma following the recent deaths of two patients at the Siloam Hospital in Lippo Karawaci, Tangerang.
The agency's preliminary investigation has indicated that Kalbe Farma, the largest publicly listed pharmaceutical company in Southeast Asia, is responsible for the tragedy.
BPOM investigators suspect that the cause of death was an accidental swap of the two drugs ' anaesthetic Buvanest Spinal and antihemorrhagic Asam Tranexamat Generik ' during surgery on the two patients.
'Our investigation suggests that there was a mix-up during the production process [of the two drugs]. We are still investigating how it happened,' BPOM head Roy Sparringa said.
The agency has ordered the company to recall the drugs nationwide and stop producing them during the investigation into the case.
The incident occurred last week when the hospital conducted urological surgery on one patient and a C-section on the other.
As part of the 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. 'When we registered the anaesthetic, it turned out the content didn't match the label, causing resistance from our patients.
'After that, the patients suffered from itching and muscle spasms so we took them to the ICU [Intensive Care Unit],' he said.
Less than 24 hours after the injections, both patients were dead.
'We were confused. We took the drugs to our pharmacy and we communicated the matter to the drugs producer, Kalbe Farma, and they admitted that the contents [of the anaesthetic] had been switched [with the antihemorrhagic],' said Heppi.
Kalbe Farma corporate secretary Vidjongtius said that the company had voluntarily recalled the drugs nationwide as soon as it had learned of the incidents. 'We withdrew the products from distribution because we need to further evaluate them,' he said. 'Currently, the nationwide recall is still in progress.'
However, Vidjongtius said that the company had not yet been able to conclude what went wrong in the production process. In order to prevent further casualties, Roy said that he had instructed all regional branches of the BPOM to monitor and recall the two drugs. Heppi said that the hospital was ready to be held responsible for the cases. 'The incident happened in our hospital,' he said. 'But we have not been able to take any action because we are waiting for the investigation.'
Sularsi of the Indonesian Consumers Foundation's (YLKI) legal affairs division said that the families of the patients could file lawsuits using the Consumer Protection Law.
'In this case, the first allegation is leveled against the Siloam Hospital for registering the drugs. Then Siloam could do a reverse burden of proof to show that it was not their mistake, but Kalbe Farma's,' she told The Jakarta Post. She added that lawsuits could also be filed via the Criminal Code against Kalbe for causing death. 'Their negligence has caused deaths, which is considered as a crime.'
