Bad
Medicine: Kalbe Farma and Siloam Hospitals both face investigations by the Health
Ministry to determine if their procedures were adequate
Jakarta Globe, Feb 24, 2015
 |
| Puan Maharani, coordinating minister for human resources and culture development. (Reuters Photo/Darren Whiteside) |
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.
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