T

he Food and Drug Monitoring Agency (BPOM) will continue its investigation into PT Kalbe Farma concerning the mix-up of medicines that claimed two lives, as BPOM'€™s initial probe into the Southeast Asia'€™s biggest pharmaceutical company fail not uncover the '€œroot causes'€ of the problem.

In a visit to The Jakarta Post'€™s office recently, BPOM chairman Roy Alexander Sparringa said that although the agency had concluded that the root cause of the problem was still unclear, a preliminary assessment had shown that Kalbe had committed a violation: its production facilities '€œdid not fully conform to government-sanctioned good manufacturing practices'€.

'€œ[The breach of good manufacturing practices] opened up the possibility of a mix-up during the production process. This is unacceptable, since drug manufacturers must always apply a zero-tolerance policy,'€ Roy said.

Roy refused to go into detail when asked which manufacturing procedures Kalbe violated. He, however, said the mix-up of pharmaceuticals '€œcould have happened during the labeling process'€.

'€œWe will soon perform a systemic audit of Kalbe Farma'€™s production facilities to find the root cause of this problem,'€ Roy said, adding that the results of the audit would determine whether BPOM continued suspending Kalbe'€™s license to distribute the drugs that had been involved in the mix-up.

The incident implicating Kalbe occurred on Feb. 12, when the Siloam Hospital in Lippo Karawaci, Tangerang, conducted urological surgery on one patient and a C-section on the other.

In the course of the procedure, the medical teams injected an anesthetic called Buvanest Spinal into the patients'€™ spinal cords. However, as the patients started showing physical resistance in course of the surgery, the medical team began to suspect that the contents of the drug were not the same as what was listed on the label.

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

In response to the tragedy, BPOM suspended Kalbe'€™s license to distribute the two drugs that likely been involved in the mix-up, Buvanest Spinal and antihemorrhagic Asam Tranexamat Generik. The patients likely died because of an accidental swap of these two drugs during their surgeries.

The Jakarta Police, according to spokesperson Sr. Comr. Martinus Sitompul, had also been investigating the incident. Martinus said recently that the investigation would determine whether the police would issue criminal charges for Kalbe Farma or Siloam.

Roy said the BPOM would not intervene in the police'€™s investigation as both the police and the agency must conduct their investigations independently.

'€œBut we'€™re always willing to help the police if they need supporting data or expert witnesses,'€ he said.

Kalbe director Vidjongtius repeatedly said that the company would continue to work with BPOM to investigate the accident.

Separately, Health Ministry health development director general Akmal Taher said on Wednesday that the government had not found any improper procedures at the Siloam Hospital that could cause deaths.

'€œIn general, the way they handle their patients is in line with the standard operating procedures,'€ he said.

'€œBut we did find small things [that deviate from standard procedures]. That said, differing opinions between doctors on medical service is normal, there are no fatal differences [of opinion that could lead to tragedies].'€

While the ministry has not yet found any irregularities, it will reprimand the hospital for failing to report the incident to the local health agency in Tangerang immediately, according to Akmal.

'€œThe least they could have done would have been to report the incident so that there could have be government officials to monitor the hospital, since this is such an extraordinary incident,'€ he said. '€œBut it was not until the second day [after the incident] that they reported it.'€