Regulatory Problems in Radionuclide Therapy and Suggestions for Systematic Improvement.
- Author:
Jae Min JEONG
1
Author Information
1. Department of Nuclear Medicine, Seoul National University College of Medicine, Seoul, Korea. jmjng@snu.ac.kr
- Publication Type:Review
- Keywords:
radionuclide therapy;
radiopharmaceuticals;
regulations
- MeSH:
Humans;
Insurance, Health;
Korea;
Patient Rights;
Radiopharmaceuticals;
Social Control, Formal;
United States Food and Drug Administration
- From:Nuclear Medicine and Molecular Imaging
2006;40(2):53-57
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
Radionuclide therapy has been used for more than 50 years and proved to be a safe and effective modality. However, the patients' right to have the excellent medical service is seriously disturbed by excessive regulations of government institutions such as Korea Institute of Nuclear Safety (KINS), Health Insurance Review Agency (HIRA) and Korea Food and Drug Administration (KFDA). For example, the patients should wait for more than 6 months to have I-131 treatment in many hospitals. It is strongly recommended to mitigate the regulations to resonable levels to solve the problems. If HIRA allow the hospitals to charge reasonable rate for radionuclide therapy room, then more hospitals would invest to build the radionuclide therapy rooms and the patients' waiting time would decrease. The waiting time would also decrease, if KINS allow 2 patients to share a radionuclide therapy room. Finally, it is strongly recommended to lower the threshold for approval of new therapeutic radiopharmaceuticals by KFDA, which would allow new effective therapeutic radiopharmaceuticals to be introduced to clinical practices more easily.
