Condition Improves after Antidote Fomepizole Is Used
The use of fomepizole as an antidote indicates an improvement in renal function in acute kidney injury patients. This drug also made new acute kidney injury cases and deaths decreased significantly.
By
PRADIPTA PANDU MUSTIKA
·3 minutes read
JAKARTA, KOMPAS — As of 1 Nov., 2022, there were 325 cases of acute kidney injury with 178 deaths. Thanks to the administration of the antidote fomepizole, there have been improvements in the patients’ kidney function.
This was disclosed by Health Minister Budi Gunadi Sadikin in a working meeting with Commission IX of the House of Representatives at the House complex in Senayan, Jakarta, on Wednesday (2/11/2022). A hearing was also held with the head of the Food and Drug Supervisory Agency (BPOM), the Indonesian Pediatric Association (IDAI), the Indonesian Pharmaceutical Company Association and the International Pharmaceutical Manufacturers Group (IPMG).
"The death rate is 54 percent and has decreased from the previous condition, which reached almost 60 percent," said Budi.
One of the quick steps taken by the Health Ministry in responding to the increase in cases was to prohibit the circulation of syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG). The prohibition on drug distribution, Budi said, had an impact on the average number of cases, causing them to decrease from 6-7 per day to 2-3 per day.
In addition, the Health Ministry is also continuing to increase the supply of fomepizole as an antidote. Fomepizole is imported from several countries, such as Singapore, Australia, Japan and Canada, through a purchase or donation scheme. As of 1 Nov., 2022, 146 vials of fomepizole had been distributed in 17 hospitals that treat patients with acute kidney disorders.
According to Budi, after the use of fomepizole, there were indications of improvement in the kidney function of patients with acute kidney injury. This was discovered after the Health Ministry conducted rapid clinical research at the Cipto Mangunkusumo Hospital (RSCM) in Jakarta in the second week of October. The study found that the patient recovery rate had reached nearly 90 percent.
“Since we took action with BPOM to ban the circulation of syrups and bring in fomepizole, there has been a drastic decrease in new cases. There was also a significant reduction in mortality after the use of fomepizole," he said.
Importation scheme
BPOM head Penny Kusumastuti Lukito admitted that there were loopholes that were used by a number of parties in making syrups containing propylene glycol (PG) or polyethylene glycol (PEG) solvents. Drugs containing these compounds entered not through the supervision of the BPOM, but through the Trade Ministry, which did not have prohibition and restriction rules.
"The entry of this drug is not through an import certificate from BPOM. This means that BPOM cannot monitor its quality and safety when entering Indonesia. This has been reported to the President and there have been follow-ups from across sectors," she said.
In response to this, the BPOM proposed changing the import scheme of PG and PEG to prohibition and restriction rules with imports through the BPOM's import certificate (SKI). This scheme change would enable the BPOM to control the entry of raw materials or additional materials in accordance with pharmaceutical standards.
“The BPOM will ensure that the pharmaceutical industry is responsible for fulfilling product quality, efficacy and safety. The deterrent effect also needs to be increased in the field of drug and food crimes," she said.
IDAI chairman Piprim Basarah Yanuarso emphasized that for IDAI and everyone else, the life of a single child was very precious. IDAI asked that legal charges be brought if it was shown that a serious criminal violation had occurred.