N-nitrosodimethylamine 사태에 대한 국가 간의 사회정책적 대응 비교 (Sociopolitical Responses to N-nitrosodimethylamine Impurities: A Cross-National Comparative Study)

서지정보

· 발행기관 : 한국보건의료기술평가학회
· 수록지 정보 : 보건의료기술평가 / 10권 / 2호 / 84 ~ 88페이지
· 저자명 : 백아람, 한솔아, 김시인, 서혜선

초록

Objectives: To compare sociopolitical responses of countries about N-nitrosodimethylamine (NDMA). Methods: We searched websites of regulatory authorities of six countries (i.e., US, Europe, Australia, Japan, Taiwan, and Korea) without on date or language. We used search term including NDMA, valsartan, ranitidine, nizatidine, metformin. Comparison was conducted by a predetermined analysis frame including damage scales (i.e., number of recalled drugs) and responses by regulatory authorities/manufacturers/patients/health care professionals. Results: The number of products is the largest in Korea. The responses by countries were similar. Regulatory authorities provided a list of recalled drugs and NDMA detection test method. In addition, they assessed theoretical risk and investigate cause of NDMA impurity. Manufacturers performed NDMA test to products and recalled product exceeding the acceptable standard of NDMA. Patients were requested to continue taking medicine without consultation with health care professionals. In Europe, Australia and Taiwan, no nizatidine and metformin product exceeded the standard of NDMA. Conclusion: We hope the results of our study may serve as an important basis for studies that establish the response procedures for NDMA impurities. In addition, to respond appropriately to the NDMA impurities, a compensation system will be also needed and further research is inevitable in this area.

영어초록

Objectives: To compare sociopolitical responses of countries about N-nitrosodimethylamine (NDMA). Methods: We searched websites of regulatory authorities of six countries (i.e., US, Europe, Australia, Japan, Taiwan, and Korea) without on date or language. We used search term including NDMA, valsartan, ranitidine, nizatidine, metformin. Comparison was conducted by a predetermined analysis frame including damage scales (i.e., number of recalled drugs) and responses by regulatory authorities/manufacturers/patients/health care professionals. Results: The number of products is the largest in Korea. The responses by countries were similar. Regulatory authorities provided a list of recalled drugs and NDMA detection test method. In addition, they assessed theoretical risk and investigate cause of NDMA impurity. Manufacturers performed NDMA test to products and recalled product exceeding the acceptable standard of NDMA. Patients were requested to continue taking medicine without consultation with health care professionals. In Europe, Australia and Taiwan, no nizatidine and metformin product exceeded the standard of NDMA. Conclusion: We hope the results of our study may serve as an important basis for studies that establish the response procedures for NDMA impurities. In addition, to respond appropriately to the NDMA impurities, a compensation system will be also needed and further research is inevitable in this area.

참고자료

· 없음