Ombudsman Alleges Maladministration
The Health Ministry and the Food and Drug Monitoring Agency have allegedly committed maladministration leading to the occurrence of cases of acute kidney injury.
JAKARTA, KOMPAS — The Indonesian Ombudsman has alleged that the Health Ministry and the Food and Drug Monitoring Agency or BPOM committed maladministration, with the result that hundreds of children are suffering from atypical progressive acute kidney injury. The Ombudsman plans to summon the two institutions. Both institutions are also given the opportunity to respond to the allegation of maladministration.
Ombudsman member Robert Na Endi Jaweng described the BPOM and the Health Ministry as incapable of accumulating accurate data on acute kidney injury. This has produced negligence in disease prevention, slow determination of the cause of the disease and slow treatment. Inaccurate data have also hampered socialization and fulfillment of the public right to information. Besides, the alleged maladministration of the Health Ministry has arisen because the prevention and treatment of cases failed to meet public service standards.
On the other hand, the BPOM’s alleged maladministration is due to its less than optimal supervision of medicinal products, both before and after product distribution. Moreover, the verification and validation of products before licensing have not been optimal. The licensing is not optimal either because it is not followed by periodic evaluations of the consistency of quality contents of the products.
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“This is something very crucial. We request the government to really work with extraordinary effort. Demonstrate accountability; show responsibility for the settlement of the current problem,” said Robert.
The Ombudsman also asked the government through the Health Ministry to declare this acute kidney injury an extraordinary event (KLB). These cases are seen as fulfilling nearly all KLB criteria, except the provision on transmittable diseases. The declaration of KLB means public service standards will be met, a task force can be formed and coordination with regional administrations and the Social Security and Healthcare Agency can be properly conducted.
“In this way, various steps are coordinated from the central government to regional administrations. Stakeholders and case management do not run separately and confuse the public,” added Robert.
Antidotes
Acute kidney injury cases among children in 26 provinces increased in number to 255 on 24 October 2022. Of the total, 143 deaths were recorded, equivalent to 56 percent. Hundreds of antidotes will soon be imported to treat patients.
Earlier on 23 October 2022, the government listed 245 atypical progressive acute kidney injury cases in 26 provinces. Fatalities totaled 141 cases. It means the latest data indicated 10 more acute kidney injury cases and 2 more deaths.
Health Ministry spokesman Mohammad Syahril said the additional data were not new cases. These cases arose in September-October 2022, but were only recorded later. According to him, there have been no new patients since 22 October 2022.
“Kidney failure cases occur every year, but their number is very small: 1-2 cases per month. Kidney injury cases came under government attention only after a spike at the end of August 2022 with a total of more than 35 cases, just like acute hepatitis cases that were surging suddenly,” said Syahril online on Tuesday (25/10/2022).
The government plans to import a lot more antidotes. Around 200 vials of antidotes will be brought in from Japan and the United States. These drugs will soon be distributed to all government referral hospitals throughout Indonesia and given to patients gratis.
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Previously, 26 vials of Fomepizole antidotes from Singapore and 16 vials from Australia were imported. Fomepizole is recommended by the World Health Organization (WHO) with an effectivity rate of 90 percent.
Fomepizole is given to patients in several government referral hospitals, including Cipto Mangunkusumo Central Hospital (RSCM), Central Jakarta. After being treated with Fomepizole, 10 of 11 patients in RSCM have experienced clinical improvement.
Syahril said there was no death or worsening condition after patients’ Fomepizole treatment. The patients were reported to have been able to urinate. “From laboratory [test] results, the ethylene glycol grade in the 10 children was no longer detected to be dangerous,” he said.
Jakarta Health Office Chief Widyastuti said kidney failure cases in Jakarta had been on the rise since August, September and October. Speedy administration of antidotes is very important.
In Makassar, South Sulawesi Health Office Chief Rosmini said acute kidney injury cases in South Sulawesi had been appearing since July 2022. However, with minimum information about this disease, five children died.
A total of eight cases have been detected since July 2022, and five of the victims died.
According to Rosmini, a review of the health history of children suffering from acute kidney injury in July was made after these cases became top stories recently. The conclusion was that they had died from acute kidney injury.
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The North Sumatra Regional Police examined the management of PT Universal Pharmaceutical Industries producing Unibebi medicinal syrup, in Medan, North Sumatra, on Tuesday (25/10). The police and the BPOM also checked the materials and production process of the syrup medicine.
“We sealed thousands of bottles of PT Universal’s syrup drug in its factory in Medan. The syrup already distributed to the public is being withdrawn,” said North Sumatra Regional Police Chief Insp. Gen. Panca Putra Simanjuntak.
PT Universal’s attorney, Hermansyah Hutagalung, said PT Universal had halted the entire process of production of all kinds of drugs. Apart from three products banned by the BPOM, they also produce some other drugs. But all activities in the factory have been discontinued until there is further legal certainty.
Hermansyah added that the ethylene glycol and diethylene glycol contaminants claimed by the BPOM to have been found in the syrup medicine were not mixed in their factory. The substances were already contained in the medical materials they purchased.
(SKA/ FLO/ REN/ DAN/AIN/HRS/ NSA/JUM)
This article was translated by Aris Prawira.