Coordinating Human Development and Culture Minister Puan Maharani. (Reuters Photo/Darren Whiteside)
Investigation Into Deadly Drug Mix-Up Continues
FEBRUARY 24, 2015
Jakarta. The government says it has instructed Indonesia’s largest pharmaceutical firm, Kalbe Farma, to halt production of its anesthetic and anti-bleeding products at the center of investigations into the death of two women, while they were undergoing surgeries at Siloam Hospital in Tangerang earlier this month.
Coordinating for Human Resources and Culture Development Minister Puan Maharani on Monday said Kalbe Farma had been ordered to cease production of Buvanest, an anesthetic, and generic tranexamic acid, commonly used to treat or prevent excessive blood loss during surgery.
As initial indications pointed to Kalbe Farma’s fault, the minister has also ordered the withdrawal of the two products to protect the public, while promising the investigation can be concluded quickly.
Preliminary findings of the ongoing investigation suggest Kalbe Farma incorrectly packaged the two drugs, resulting in the death of one woman in surgery on Feb. 12 and another on Feb. 13.
The two women were undergoing a relatively routine Caesarian section and a cystoscopy, respectively (the latter is a urology procedure), before their deaths.
Investigators at Siloam believe the patients, who were prescribed 4 milliliter spinal injections of Buvanest, were administered tranexamic acid instead from ampules that had been mislabeled by the manufacturer as Buvanest.
Both drugs are produced by Kalbe Farma. Buvanest comes in 4ml vials; tranexamic acid in 5ml vials.
Minister Puan said Kalbe Farma had been ordered to halt its production of the two medicines pending investigations into the cases by the Ministry of Health and the Food and Drug monitoring Agency (BPOM).
“The instruction for Kalbe Farma [to halt the production] will stay in effect until investigation’s results come out,” Puan said in Jakarta on Monday.
She added that scrutiny was also extended to other pharmaceutical manufacturers in Indonesia.
“We’ve sent [Kalbe] a warning that there must be no repeat of this incidence. And we need thorough examinations of all drug manufacturers because this incidence has taken lives,” Puan said.
She added that the government would sanction Kalbe Farma if it was proven to have incorrectly packaged the drugs.
The Ministry of Health also has dispatched a team to investigate the Siloam hospital in Karawaci. The probe will look at the hospital’s operating permit, as well as interview anesthesiologists, obstetricians, gynecologists and nurses involved.
The ministry has said preliminary investigation results show Siloam Hospitals had followed standard operating procedures, including those for medicine storage.
The House of Representatives’ health commission has also formed a special investigative team, which has visited Kalbe Farma’s factory in the outskirts of Jakarta, according to a deputy head of the commission, Pius Lustrilanang.
He added that the team found that Kalbe Farma’s ampules labeled as Buvanest Spinal and tranexamic acid looked exactly the same.
“Only the labels are different,” Pius said.
Siloam Hospitals says the deceased patients surgeries’ were supervised by experienced senior physicians and anestheticians at Siloam Lippo Village.
Siloam Hospitals says it conducted an immediate and instant audit once the patients had their adverse reactions, while at the same time intervening in an attempt to save the patients’ lives.
An internal audit showed that Siloam Hospitals did everything right and followed procedures that it believes are correct, the hospital operator says, adding that it provides excellent medical care.
For Kalbe Farma’s part, the manufacturer was notified and invited to immediately look in to the matter, when it set up its own investigation.
Siloam said in a statement that it is only because of Siloam’s robust counter-check system on all adverse drug reaction outcomes, as a part of it overall and strict clinical governance system, that it was able to detect this incident in a such timely manner, following the death of its second patient from the same error.
After establishing the cause, it reported the incident to the authorities for further action, thereby preventing any future potential adverse outcomes across the country.
In a statement, Siloam Hospitals reiterated its pride in patient and staff safety systems and said that by being the first to bring to light this incident.
By doing so openly and clearly, Siloam said it showed its leadership mandate to uphold clinical excellence and provide international standards of health care.
Siloam Hospitals is Indonesia’s largest health-care provider and is listed on the Indonesian Stock Exchange.
Its 20 national hospitals and nine medical centers treats more than two million patients per year.
In 2014 Siloam Hospitals added four hospitals to its network and expects to add 10 additional hospitals to its national network throughout 2015.
Siloam Hospitals says its vision is to empower Indonesia’s physicians and health care specialists and workers to be able to serve patients excellently and with compassion.
It strives to be at the forefront of clinical excellence and its flagship hospital is the first in Indonesia to be accredited by the prestigious Joint Commission International.
Siloam Hospitals is supported by 2,000 physicians and over 5,000 nursing professionals, as well as other health care professionals and staff.
The Jakarta Globe and Siloam Hospitals are both affiliated with Lippo Group.