Government will charge drugmakers for re-prescription costs incurred by the impurity

The government has said drug companies should cover the costs of re-prescribing and redistributing drugs incurred by detecting impurities next year.

The announcement came as health authorities were changing the way they bill the costs of re-prescribing / redistributing drugs to replace drugs containing a foreign substance.

The government will charge drug companies the costs of re-prescribing and redistributing drugs to replace drugs found to contain impurities.

To detect impurities in ranitidine, nizatidine, and metformin in recent years, health officials will claim around 2.9 billion won ($ 2.4 million) from 108 drugmakers as of January 2022.

The Department of Health and Welfare released its response plan to drugs containing impurities at a meeting of the Health Insurance Policy Review Committee on Wednesday.

According to the ministry, five drugs have contained impurities since 2018: valsartan in July 2018, ranitidine in September 2019, nizatidine in November 2019, metformin in May 2020 and losartan in November 2021.

The Ministry of Food and Pharmaceutical Safety (MFDS) recently found an azido impurity in losartan for the treatment of hypertension in 295 items manufactured by 98 companies. The products exceeded or risked exceeding the permissible daily level (1.5 per day) of azido.

Unlike N-nitrosodimethylamine (NDMA), which was detected in the other four agents, azido was only found in drugs containing losartan. Mutagenicity of Azido has been confirmed, but carcinogenicity has not been verified.

Pharmaceutical companies are voluntarily recalling losartan products. Eighty companies recalled 241 products in full and 18 companies recalled 54 products in part. Seven drugmakers have yet to recall 11 products.

After consultation with the MFDS, medical associations, hospital associations, pharmacists, pharmaceutical associations and drug manufacturers, the Ministry of Health and Welfare has decided to charge drug manufacturers for the cost of re-prescribing. and drug redistribution.

Following the government decision, a pharmaceutical company must pay the costs of re-prescribing and re-distribution directly to medical institutions after detecting impurities.

In the past, the National Health Insurance Service (NHIS) made the payment first and claimed the cost from a pharmaceutical company.

The Department of Health and Welfare said it would claim 2.94 billion won from 108 drug companies as of January 2022 for the cost of re-prescribing and redistributing drugs after detection of the drug. impurities in ranitidine nizatidine and metformin.

At Monday’s meeting of the Health Insurance Policy Review Committee, the Department of Health and Welfare revealed the status of the dispute between the department and pharmaceutical companies over the detection of impurities in valsartan.

The MFDS has ordered a temporary suspension of sales and a recall in the valsartan case. The Department of Health and NHIS halted health insurance coverage for the drug and paid the cost of re-prescribing and redistributing the drugs to replace the remaining valsartan drug. In this case, the patients did not have to pay for the new prescription and the new dispensing.

As a result, NHIS had to pay 4.97 billion won to cover the costs. Next, NHIS asked 69 drug makers to pay 2.3 billion won for the cost of replacing valsartan with other drugs due to the detection of impurities. In contempt, 36 companies have filed a lawsuit to confirm no debt against NHIS’s claim for damages.

In September, the Seoul Central District Court recognized the right of the NHIS to seek damages and the responsibility of the drugmakers to be compensated in the first lawsuit.

In October, the 34 companies filed an appeal.

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