A severe shortage of essential pediatric drugs in South Korea has been attributed to fragmented administration among the Ministry of Health and Welfare, the Ministry of Food and Drug Safety (MFDS), and the Health Insurance Review and Assessment Service (HIRA), according to a report by Pharm's View. The crisis, described as a man-made disaster, is pushing private pharmaceutical companies out of the market and endangering young patients.
Ativan injection, a first-line treatment for pediatric seizures to prevent permanent brain damage, is nearly depleted. An emergency survey by the Korean Society of Pediatric Hospitalists found that 25 out of 35 pediatric hospitals (71%) have either exhausted their Ativan stock or expect to run out within one to two months.
The sole manufacturer ceased production, citing the low reimbursement price of 782 won per ampoule, which could not cover the costs of enhanced Good Manufacturing Practice (GMP) regulations imposed by the government. Although the MFDS announced it has filled the gap, clinical reality suggests it will take at least 6 to 12 months for contract manufacturing and distribution to resume, leaving hospitals unprotected for over half a year.
The government maintains that alternatives such as midazolam or diazepam are available, but pediatric specialists argue this is a desk-bound theory that ignores clinical realities. Alternative drugs carry risks of respiratory depression or drug accumulation in children, making them unsuitable for one-to-one substitution.
Another essential drug, hydrocortisone injection (Cortisoru), used for blood pressure maintenance in extremely premature infants and acute adrenal insufficiency shock, faces a severe supply cliff. Once a reimbursed item, it is now non-reimbursed, effectively outside the government's price and supply management framework. Supply disruptions are expected from September due to facility maintenance, with normal supply resuming in November, leaving a months-long gap.
The government suggests replacing it with oral formulations or other injections, but the pediatric hospital association argues that instructing an unconscious child or a premature infant under 1 kg on mechanical ventilation to swallow oral medication is tantamount to medical homicide. Other steroid injections lack neonatal safety data and have different pharmacological properties, making substitution clinically impossible.
The crisis extends beyond these drugs: Ventolin has been in short supply for two years due to global supply chain issues, Pulmicort runs out every seasonal change, and syrup antipyretics and antibiotics disappear annually as insurance drug prices fail to keep pace with raw material cost increases. This chain reaction is collapsing the entire essential pediatric drug supply.
As a result, pediatricians are transferring patients to other hospitals, borrowing small quantities of drugs from nearby facilities, and experiencing extreme stress due to concerns over side effects from alternative medications. South Korean children are tragically forced to receive adult drugs split into smaller doses.
The report blames the crisis on dereliction of duty by government agencies. The MFDS spent 1 year and 4 months on internal reviews after receiving reports of supply disruptions, only acting just before the drugs ran out. The MFDS imposes regulations, HIRA controls prices, and the Ministry of Health and Welfare holds meetings only after shortages occur. The fragmented administration leaves children in emergency rooms and intensive care units as the sole victims.
The Korean Society of Pediatric Hospitalists calls for a systemic shift from reactive measures to proactive prevention. It recommends mandatory supply impact assessments before introducing any drug regulations, recognizing that regulations lacking supply stability constitute violence against patients' lives. Essential drugs should be treated as a matter of national health security, not cost reduction, with a separate track ensuring 100% cost and management fee coverage. The crisis of children lacking essential medicines must end completely in South Korea's pediatric care settings.
Source: Read the original report | Published: May 26, 2026