GOVT WITHDRAWS ANESTHETIC DRUG AFTER TWO PATIENTS' DEATH IN SILOAM

By Andi Abdussalam

Jakarta, Feb 20 (Antara) - The death last week of two patients after being administered Bunavest Spinal in Siloam Hospital in Tangerang, Banten, prompted the government to order the withdrawal of the anesthetic drug from all pharmaceutical industry traders.          "We ordered the recall of four kinds of anesthetics from all pharmaceutical industry traders across the country," Health Minister Nila F Moeloek said on Friday.          The Food and Drug Monitoring Agency BPOM has also suspended since Tuesday the distribution permit of Buvanest Spinal, the anesthetic produced by Kalbe Farma following the death of the two patients.          According to corporate communications general manager of Siloam, Heppi Nurfianto, the two patients were injected with Buvanest Spinal before undergoing a caesarian section and urology surgeries on Feb. 11.  They were taken to the ICU for treatment but died the next day.          "We are awaiting results of the investigation first. We have made sure that we had done [the surgery] based on procedures," Heppi was quoted by the Jakarta Globe as saying on Wednesday.          Health Minister Nila F Moeloek said her ministry was still investigating the death of the two patients.         "The lawmakers of Commission IX on health affairs of the House of Representatives visited the hospital today. The Drug and Food Monitoring Agency has also sent a team to investigate the incident," the minister stated on Friday.          The lawmakers made an unscheduled inspection to the Siloam Hospital to gather information on the incident.          Commission IX member Chairul Mahfidz said  five legislators visited the hospital to ask for information about the death of the two patients.         "There are five lawmakers of the Commission who came to the hospital. We want to know deeper about the case. So, we hope the public would wait for the results of our investigation," Irgan Chairul said.          The lawmakers' team was welcomed by the Siloam representatives and was taken to the fifth floor of the hospital to get information.          According to Health Minister Nila F Moeloek, besides the Commission IX team, the BPOM has also sent a team of investigation.     .    She noted the teams will conduct a comprehensive investigation, which will look into the standard operation procedures followed by doctors involved, anesthetic used, mistake indications, and assessment of the victims' medical records.          The minister remarked that according to initial reports, the Siloam medical team had injected 0.5 percent of Buvanest Spiral anesthetic into spinal column of both patients.          After being injected, the anesthetic did not have a favorable effect and the patients did not experience numbness. It, however, caused itchiness, convulsions, and finally resulted in their deaths.          "Based on preliminary information and analysis, there was an error in the administration of the anesthetic. It should have been given in a 5-mg dose. However, that is just an assumption, the error is not proven yet," the minister explained.          Buvanest Spinal is commonly used for surgery, such as relieving contraction pains during childbirth. In Tuesday's cases two patients had abnormal symptoms, such as convulsions, short of breath and hives after being injected with the drug.          The anesthetic, produced by PT Kalbe Farma, was believed to contain   Tranexamat acid instead of bupivacaine anesthetic. Tranexamat acid is used to stem bleeding.          Therefore, the BPOM   suspended   the distribution permit of Buvanest Spinal, the anesthetic produced by Kalbe Farma.          Minister Nila pointed out that her office was still waiting for the results of the investigation by the Commission IX and BPOM teams.          If it is found that the hospital or PBF Kalbe Farma (the pharmaceutical company that produced the anesthetic) are at fault for the death, the health ministry will impose sanctions on them, the minister emphasized.        "We will take legal action against agencies that are found guilty. We will revoke their permits," she added.         The minister said her office has also ordered the recall of the Kalbe Farma-produced anesthetics from all over Indonesia.         In the meantime, the BPOM office for Riau Islands said 156 ampoules of Buvanest spinal have been withdrawn from circulation in the province.         "The BPOM for Riau Islands has conducted verification and monitoring on the recall of 156 ampoules of the drug. The withdrawal is done by the distributors," Mardianto of the BPOM for Riau Islands said on Friday.          He said that all of the withdrawn products had been sent back to Jakarta by the distributors.          In Banten, the BPOM for the province is also ordering the withdrawal of the drug from hospitals. It is now gathering information on hospitals which still might use buvanest spinal.         Head of the Drug Verification and Investigation Unit of BPOM for Banten, Lintang, said his agency has deployed a team to inspect hospitals and to assure that none of them uses the drug.         "We take a speed action following the Siloam incident in an effort to prevent the use of buvanest spinal anesthetic," Lintang said.***4*** (T.a014/  ) (T.A014/A/BESSR/A. Abdussalam) 21-02-2015 00:59