Objective To clarifying the professional orientation of clinical radio-chemist (CRC) and radio-pharmacist (RP) in China, and to promote standardization of their education.Methods The legal status, responsibilities and competence requirements of CRC and RP are reviewed. Limitations of current educational system are also analyzed. Except that, suggestions for improvement are proposed.Results The number of these practitioners is insufficient now in China. Their academic background and professional skills are various and sometimes unsatisfying. The probable reasons are: 1) professional orientation of CRC and RP recognized by academic societies, governmental administrations and medical institutions are actually not clear; 2) the status quo of educational system for CRC and RP is far from perfect. The historical experience from European Union and United States is valuable as reference.Conclusions The survey of demand for CRC and RP practitioner, the improvement of legal system and educational system for CRC and RP, and more propaganda and communication in professionals should be in plan. Along with the progress of nuclear medicine, the variety of radio-pharmaceuticals involved in keeps growing and their formulations become more and more complex. The trend that clinical radio-chemical and radio-pharmaceutical service (including preparation, quality control and administration) are charged by professional CRC and RP is becoming more and more certain. CRC and RP will be increasingly important in nuclear medical team.
Zhang Weishan
,
Ye Jiajun
,
Li Yang
,
Li Guiyu
,
Li Miao
. The status quo of professional orientation and education of clinical radio-chemist and radio-pharmacist in China[J]. Chinese Journal of Medical Education, 2017
, 37(6)
: 839
-844
.
DOI: 10.3760/cma.j.issn.1673-677X.2017.06.009
[1] Duatti A, Bhonsle U. Strengthening radiopharmacy practice in IAEA Member States[J]. Semin Nucl Med, 2013,43(3):188-194. DOI: 10.1053/j.semnuclmed.2012.11.009.
[2] Elsinga PH, Lppchen T, Laverman P, et al. A new profession: Clinical radiochemist towards excellence in nuclear medicine[J]. Tijdschrift Voor Nucleaire Geneeskunde, 2014, 36(1): 1200-1201.
[3] 夏振民,钟建国. 中国放射性药品发展史简述[J]. 同位素, 2002, 15(2): 100-104.
Xia ZM, Zhong JG. The brief introduction of the history of radiopharmaceuticals in China [J]. Journal of Isotopes, 2002, 15(2): 100-104.
[4] 中华医学会核医学分会. 2016年全国核医学现状普查结果简报[J]. 中华核医学与分子影像杂志, 2016, 36(5): 479-480. DOI: 0.3760/cma.j.issn.2095-2848.2016.05.024.
Chinese Society of Nuclear Medicine. A brief report on the results of the national survey of nuclear medicine in 2016[J]. Chin J Nucl Med Mol Imaging, 2016, 36(5): 479-480. DOI: 0.3760/cma.j.issn.2095-2848.2016.05.024.
[5] Cox PH, Coenen HH, Deckart H, et al. Report and recommendations on the requirements for postgraduate training in radiopharmacy and radiopharmaceutical chemistry 1989[J]. Euro J Nucl Med Mol Imaging, 1990, 17(5): 203-211.
[6] Coordinator GW, Johannsen B. Postgraduate education of persons responsible for the small-scale production and quality control of radiopharmaceuticals (radiopharmaceutical chemists/radiopharmacists) [J]. Euro J Nucl Med Mol Imaging, 1997, 24(3): BP5-BP7.
[7] Welch MJ. Training needs for chemists in nuclear medicine research and production[J]. Journal of Radioanalytical and Nuclear Chemistry, 1993, 171(1): 267-269.
[8] Machulla H, Wiebe L, Mercer J, et al. Proceedings from the international radiopharmaceutical education consortium workshop[J]. J Pharm Pharmaceut Sci, 2001, 4(2): 52-75.
[9] DNV GL. Competence matrix-clinical radiochemist[EB/OL]. (2013-11-26)[2017-06-06]. https://www.dnvgl.nl/Images/Competence matrix Clinical Radiochemist Approvedv3-102015_tcm10-61050.pdf.
[10] DNV GL. Competence × assessment-clinical radiochemist [EB/OL]. (2015-09-01)[2017-06-06]. https://www.dnvgl.nl/Images/Competence%20x%20Assessment-30-4-2015_tcm10-61051.pdf.
[11] 祝嫣然. 全国放化师只有266人 人才稀缺成中国核医学最大瓶颈[EB/OL]. (2016-06-08)[2017-06-06]. http://www.yicai.com/news/5025123.html.
[12] 卫生部. 卫生部关于印发《医疗器械临床使用安全管理规范(试行)》的通知(卫医管发 [2010] 4号)[Z]. 2010-01-18.
[13] 卫生部. 卫生部关于印发《医疗卫生机构医学装备管理办法》的通知(卫规财发 [2011] 24号)[Z]. 2011-03-29.
[14] 国务院办公厅. 国务院关于第三批取消和调整行政审批项目的决定(国发 [2004] 16号) [Z]. 2005-08-06.
[15] 国家食品药品监督管理局. 关于开展换发《放射性药品使用许可证》工作的通知(国食药监安 [2003] 199号)[Z]. 2003-08-21.
[16] 国家食品药品监督管理局. 关于印发《医疗机构制备正电子类放射性药品管理规定》的通知(国食药监安 [2006] 4号)[Z]. 2006-01-05.
[17] 喻小勇. 我国药师立法问题研究[D]. 南京: 南京中医药大学, 2016.
Yu XY. Research on the legislation of Chinese pharmacists [D]. Nanjing: Nanjing University of Chinese Medicine, 2016.
[18] 李园园, 葛卫红, 于锋. 国外核药师发展现状及其对我国临床药师专业设置的启示[J]. 中国药师, 2013, 16(5): 762-764.
[19] Board on Chemical Sciences Technology, Commission on Physical Sciences, Mathematics and Resources, National Research Council. Training requirements for chemists in nuclear medicine, nuclear industry and related areas: Report of a workshop [M]. Washington D.C.: National Academy Press, 1988:Appendix J,198.
[20] National Research Council and Institute of Medicine Committee on State of the Science of Nuclear Medicine. Education and training of nuclear medicine personnel [M] //National Research Council and Institute of Medicine Committee on State of the Science of Nuclear Medicine. Advancing nuclear medicine through innovation. Washington D.C.: National Academies Press, 2007:118-130.
[21] How to become a nuclear pharmacist [EB/OL]. [2017-06-06]. http://www.nuclearpharmacyjob.com/70/32/How-to-become-a-nuclear-pharmacist.html.
[22] Nuclear pharmacy certification [EB/OL]. [2017-06-06]. http://www.nuclearpharmacyjob.com/72/32/Nuclear-Pharmacy-Certification.html.
[23] Schwarz SW. SNMMI leadership update: Quality systems personnel training program for radiopharmaceutical manufacturing[J]. J Nucl Med, 2016, 57(11): 22N.
[24] Cox PH, Garritsen FA. Current trends in the training and education of pharmacists in radiopharmacy [M]//Kristensen K, N?rbygaard E. Safety and efficacy of radiopharmaceuticals 1987. Dordrecht: Springer Netherlands, 1987:363-368.
[25] Cox PH. The development of a co-ordinated training programme in radiopharmacy in Europe [M]//Schubiger P A, Westera G. Progress in radiopharmacy. Dordrecht: Springer Netherlands, 1992: 201-205.
[26] Mather SJ. VirRAD——A “virtual” radiopharmacy learning community: Your input needed [J]. Euro J Nucl Med Mol Imaging, 2002, 29(9): 1107-1108.
[27] Mather SJ, Westera G. Education in radiopharmacy and radiopharmaceutical chemistry: Recent developments[J]. Euro J Nucl Med Mol Imaging, 2001, 28(3): BP48-BP50.