Extraordinary occurrence?
EG contamination in syrup and liquid medication is believed to be the likely culprit behind AKI incidents in Indonesia. Based on a Health Ministry investigation, children who suffered from AKI had consumed several types of syrups that contain EG, DEG and ethylene glycol butyl ether (EGBE), which should not be present or should only be used at very low concentrations in the syrups.
The Indonesian Pharmacists Association (IAI) states that EG and DEG compounds are not used in drug formulations, but they may be present as contaminants in the production process. The IAI board, via letter B2- 382/PP.IAI/2226/X/2022, spelled out tolerance level of 0.1 percent for glycerin and propylene glycol, and 0.25 percent for polyethylene glycol. This means that if those substances are present within a tolerance level, they would not be likely to cause adverse health effects. This is also in line with the guidance set by the Indonesian and the US Pharmacopeia, which sets quality, purity and strength standards for medicine.
Despite rising hospitalizations and deaths among children, AKI has yet to be designated an extraordinary occurrence (KLB). Pandu Riono, an epidemiologist at the University of Indonesia (UI), said the measures taken by the Health Ministry have been appropriate. In addition, Former WHO Southeast Asia Director Prof. Tjandra Yoga Aditama said AKI cannot be categorized as KLB, because it is not an infectious disease that can potentially lead to widespread outbreaks.
However, Dicky Budiman, an epidemiologist at Australia’s Griffith University, begged to differ. He argued that AKI should be declared a KLB. “Based on the rate of morbidity and mortality, this has met the criteria set forth in the Health Minister’s regulation 1501/2010,” he explained.
“KLB status should be declared before more deaths occur. By designation AKI as an outbreak, a public health emergency response at all levels can be strengthened,” said Dicky. Furthermore, the status can help patients who have difficulty accessing health care services, according to the Health Ministry’s referral system. “With a KLB status, health agencies and related agencies will be prompted to respond. This also fulfills the constitutional mandate to protect Indonesian children according to Law 35/2014,” he said.