Free replacement pill due for 'possibly cancer-causing' drugs
By Lee Kyung-min
The government said Tuesday it will exempt patients, who have been taking high blood pressure treatment drugs found to contain traces of a possible carcinogen, from paying for doctor's replacement prescriptions. The Ministry of Health and Welfare said the 178,536 patients will be able to ask for new prescriptions or get new pills at pharmacies to replace 115 drugs containing Chinese-made Valsartan. These patients account for 2.9 percent of the country's 6 million high blood pressure patients.
“Patients need not pay for new prescription or for the price of pills to replace the 115 drugs regardless of whether the replacements cost more,” a ministry official said.
Discussions will soon be under way between the ministry and the state-run National Health Insurance Serves on ways to shoulder the cost. The measure will only be effective for those who bring their doctors and pharmacists the remaining pills prescribed earlier. If a patient cannot go to a doctor, the replacement pills will be given to them from a pharmacist based on prior prescription records.
The one-off, emergency measure reflected fury from the patients, whose health conditions require a long-term intake of the drug, following reports that the Chinese-made Valsartan contained N-nitrosodimethylamine (NDMA), a key ingredient in high blood pressure drugs. NDMA, an organic chemical produced as a byproduct of industrial processes, is classified as a group 2A “possible carcinogen,” by the International Agency for Research on Cancer under the World Health Organization.
The Ministry of Food and Drug Safety banned the import and sales of all 219 drugs made by 82 pharmaceutical companies containing the substance in question Saturday. One-hundred-and-four drugs were cleared of the measure Monday while the remaining 115 carcinogen-containing pills remain off the market, following component analyses.
The ban followed a recall order made by the European Medicines Agency last week after it found NDMA in Valsartan made by Zhejiang Huahai Pharmaceutical in China. The drug regulator for the European Union said it would conduct an assessment of the severity of the problem for those who are currently taking drugs containing Valsartan.
However, not all Valsartan contains the carcinogen, only that made in China, the drug ministry noted. Of 484,682 kilograms of Valsartan imported over the last three years, only 13,770 kilograms, or 2.8 percent contain ingredients from China. It initiated on-site investigations of 82 companies to check whether the drugs contain NDMA. The 219 drugs containing Chinese-made Valsartan are among 571 available drugs in Korea that contain the ingredient coming from other countries.
The Korea Institute of Drug Safety and Risk Management, supervised by the drug ministry, recommended patients to swiftly report any drug-related side effects.