The Main Causes Of Acute Kidney Disorders Must Be Found Immediately, Further Research Is Needed

JAKARTA - The Ministry of Health has again renewed its policy regarding the prohibition of the use of syrup drugs as a measure to anticipate the increasing number of patients with acute kidney disorders. This follows the results of testing by the Food and Drug Administration (BPOM).

So far, 156 syrup drugs have been declared safe without additives.

"Do not use propylene glycol, polyethylene glycol, sorbitol, and or glycerin/glycerol, it is safe as long as it is used according to the rules of use," said a Spokesperson for the Ministry of Health, dr. M Syahril in a press release, Tuesday (25/10).

Of this number, there are 23 drugs searched by the Ministry of Health at the patient's home, namely:

Alerfed Syrup (Guardian Pharmatama)

Amoxan (Sanbe Farma)

Amoxicillin (Mersifarma TM)

Azithromycin Syrup (Natura/Quantum Labs)

Cazetin (Ifras Pharmaceutical Laboratories)

Cefacef Syrup (Caprifarmindo Labs)

Cefspan syrup (Kalbe Farma)

Cetirizine (Novapharin)

Devoxix drop 15 ml (Ifras Pharmaceutical Laboratories)

Domperidone Syrup (Afi Farma)

Etamox syrup (Errita Pharma)

Interzinc (Interbat)

Nytex (Pharos)

Omemox (Mukti Farma Pearl)

Rhinos Neo drop (Dexa Medica)

Vestein (Erdostein) (Kalbe)

Yusimox (Ifras Pharmaceutical Laboratories)

Zinc Syrup (Afi Farma)

Zincpro syrup (Hexpharm Jaya)

Zibramax (Guardian Pharmatama)

Renalyte (Priest Nirmala)

Amoxicillin (-)

Erythromycin (-)

"These drugs can be re-prescribed, including 133 other drugs in accordance with BPOM recommendations," said Syahril.

In addition, BPOM also found that 3 syrups containing ethylene glycol and diethylene glycol exceeded the safe threshold. Head of BPOM Penny K. Lukito suspected that the ethylene glycol and diethylene glycol contamination came from the use of propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol as solvents.

"The use of solvents is indeed not prohibited as long as the production process is well maintained. As long as it is at a minimum, it can be tolerated, then it is considered safe. Of course, it must also match the method of using the drug, the dosage, and the duration of the drug's use," explained Penny in a press conference at the BPOM Office. on October 23, 2022.

The three drugs are:

1. Unibebi Cough Syrup (Universal Pharmaceutical Industries)
2. Unibebi Fever Drops (Universal Pharmaceutical Industries)
3. Unibebi Fever Syrup (Universal Pharmaceutical Industries)

According to Pharmacopoeia references and recognized national standards, the safe or Tolerable Daily Intake (TDI) for ethylene glycol and diethylene glycol contamination is 0.5 mg/kg body weight per day.

However, said Professor of Pharmacochemistry ITB Prof. Rahmana Emran Kartasasmita, crossing the safety threshold does not mean poisoning, but is at risk of experiencing health problems.

"So there needs to be a more in-depth analysis related to it," he said on the same occasion.

BPOM will continue to monitor. Penny also appealed to the public to be more vigilant. Buy drugs at pharmacies, licensed drugstores, health centers, or hospitals. Not in any places.

"We also encourage health workers and the pharmaceutical industry to actively report drug side effects to the National Pharmacovigilance Center/MESO through the e-MESO Mobile application," added the Head of BPOM.

Further Research

Pharmacy Observer, Anthony Charles Sunarjo considered that what the Ministry of Health and BPOM had done was to take emergency action by prohibiting the use of syrup medicines.

However, it is even more ideal if research continues to be carried out to find the main causes of acute kidney disorders, which mostly attack toddlers.

"Right now it's still a provisional guess. After all, why is it only now that an outbreak has occurred, even though it has been a dozen or even decades that they have used these drugs. How can it cause acute kidney failure?” said the former chairman of the Indonesian Pharmacy GP to VOI, Tuesday (25/10).

Then related to the three drugs found by BPOM, Anthony also questioned whether all patients with acute kidney disorders, both those who had died or those who were still being treated, used the three drugs.

“The logic is simple, so my conclusion needs further research. Not only on drugs, but also other factors, so that if a case like this happens again, we can handle it more easily," he said.

Indeed, continued Anthony, the possibility of 'defects' in the drug production process could occur, but it is very small. This is because the production process in the pharmaceutical industry in Indonesia is very strict.

"If you look at the existing regulations, the term pharmaceutical industry is difficult to breathe, because it is full of regulations. Starting from producers, distribution, to pharmacy services and drugstores, there are special standards that have been determined in the regulations," said Anthony.

Example of a production process. The purchase of raw materials must be accompanied by a certificate of analysis from the manufacturer. When the order arrives, it must be placed in a temporary room for quality control first and take samples for laboratory checks.

“After complying with the factory specifications including the impurity check, the goods enter the permanent warehouse. Then the quality control is carried out again. Then it is released to the finished goods warehouse for production. This is called in process control,” Anthony explained.

Not only that, but every drug manufacturer must also have a retain sample so that if something happens later, the drug can be re-examined through the existing samples.

As a result, if there is any contamination, it may occur in the supply of auxiliary raw materials or so-called solution materials. Not in the main raw material.

"Perhaps there is a change in suppliers due to the impact of the pandemic limiting the flow of people and goods in a number of drug-producing countries, such as in China and India," Anthony suspected.

“Usually they still have the same certificate. If the goods can be obtained from other suppliers, it means that you have to start from zero again to check. Maybe the impurity check was missed," he added.

According to dr. M Syahril, there have been 255 cases of acute kidney disease in Indonesia as of October 22, 2022, from 26 provinces, 143 of whom died.

"So far, the ban on the use, sale, and prohibition of prescribing syrup medicines temporarily has succeeded in preventing the addition of new cases at the RSCM as a national referral hospital for kidney failure. There have been no new cases added since October 22, 2022," said a spokesman for the Ministry of Health. the.