A lawmaker said the nation’s drug regulator failed to spot problems in its Drug Utilization Review system, showing a report that physicians still prescribed banned antihypertensive drugs that used Chinese valsartan.
Rep. Kim Kwang-soo of the minor opposition Party for Democracy and Peace said he analyzed the Health Insurance Review and Assessment Service (HIRA)’s report, which checked the DUR system to identify any prescriptions or preparations of the prohibited 115 valsartan-containing medicines.
According to Kim, even after the Ministry of Food and Drug Safety prohibited sales of hypertension drugs using valsartan manufactured by a Chinese firm at 12 p.m. on July 7, physicians at 59 medical institutions prescribed or dispensed 141 banned drugs to patients from July 8-16.
The HIRA said on July 8 that it completed updating all the valsartan-containing medications to add the label, “prescription prohibited,” which made it impossible to prescribe valsartan. However, the DUR system somehow failed to keep physicians from prescribing the prohibited drugs to patients.
“Even though the Chinese valsartan fiasco raised serious public concerns, the HIRA’s poor DUR system missed out 141 cases of wrong drug prescriptions and preparations,” Kim said. “The HIRA should address the issue of the DUR system as quickly as possible, as it could cause serious harm to patient safety.”
Kim added that the HIRA should review the DUR system and actively take actions to ensure its effectiveness.
“They should keep in mind that if the government responds to this kind of issue inadequately and passively, the damage will eventually go to the public. The government should do its best to prevent such a mishap,” the lawmaker said.