Regulation of nuclear medicine services: Perception of the problems and challenges in Colombia for the approach to cancer
Abstract
Introduction: Colombia has modified the nuclear medicine norms that impact the administration of radioactive iodine therapy in the treatment of thyroid cancer.
Objective: To identify the areas of agreement regarding the issue, as well as the current and emergent requirements associated with the normative for the operation of nuclear medicine services that have an impact on the care of patients with thyroid cancer in Colombia.
Materials and methods: We conducted a two-round Delphi study for each expert, clinical, and regulatory group. The first round explored views on the implications of the regulations that apply to nuclear medicine. The second round rated the statements from the first round by their relevance.
Results: The issues regarding nuclear medicine services were related to the normative clarity and the lack of synergy and coherence among inspection, surveillance, and
control bodies. The demands on the waste management system require a high economic investment that can influence the service offer and have an impact on the integral control of thyroid cancer. Unification of the auditors’ criteria, delimitation of the acting agent functions, technical assistance to the services to comply with the normative, and the oversight of the inspection, surveillance, and control bodies by the regulatory entities are among the current and future needs.
Conclusions: Our findings suggest that nuclear medicine services are going through a time of multiple institutional, regulatory, and economic challenges that put at risk the development and maintenance of nuclear medicine in cancer care.
Downloads
References
Langbein T, Weber WA, Eiber M. Future of theranostics: An outlook on precision oncology in nuclear medicine. J Nucl Med. 2019;60:13S-9S. https://doi.org/10.2967/jnumed.118.220566
Peng S, Yang Y, Xie X, Qian D. Current status and prospects of reactor produced medical radioisotopes in China. Chinese Sci Bull. 2020;65:3526-37. https://doi.org/10.1360/TB-2020-0374
Vargas-Uricoechea H, Herrera-Chaparro J, Meza-Cabrera I, Agregado-Delgado V. Epidemiología del cáncer de tiroides. Análisis de resultados de Sudámerica y Colombia. Rev Med. 2015;37:140-63.
Estorch M, Mitjavila M, Muros MA, Caballero E. Tratamiento del cáncer diferenciado de tiroides con radioyodo a la luz de las guías y de la literatura científica. Rev Esp Med Nucl Imagen Mol. 2019;38:195-203. https://doi.org/10.1016/j.remn.2018.12.008
Vogiatzi S, Liossis A, Lamprinakou M. Thyroid cancer radioiodine therapy: Health service performance and radiation safety. Radiat Prot Dosimetry. 2015;165:434-8. https://doi.org/10.1093/rpd/ncv064
Murcia E, Aguilera J, Wiesner C, Pardo C. Oncology services in Colombia. Colomb Med. 2018;49: 89-96. https://doi.org/10.25100/cm.v49i1.3620
Hossain F. Natural and anthropogenic radionuclides in water and wastewater: Sources, treatments and recoveries. J Environ Radioact. 2020;225:106423. https://doi.org/10.1016/j.jenvrad.2020.106423
Ministerio de Minas y Energía. Usos pacíficos de la energía nuclear. Fecha de consulta: 9 de noviembre de 2020. Disponible en: https://www.minenergia.gov.co/asuntos-nucleares
Ministerio de Minas y Energía. Resolución 180005 de 2010 Colombia. Fecha de consulta: 10 de noviembre de 2020. Disponible en: https://www.minenergia.gov.co/reglamentacionnuclear1
Ministerio de Minas y Energía. Resolucion 41178 de 2016. Fecha de consulta: 10 de noviembre de 202. Disponible en: https://www.minenergia.gov.co/reglamentacion-nuclear1
Paez D, Giammarile F, Orellana P. Nuclear medicine: A global perspective. Clin Transl Imaging. 2020;8:51-3. https://doi.org/10.1007/s40336-020-00359-z
European Commission. RP 180 Medical Radiation Exposure of the European Population, Part 1 & Part 2. 2015. Fecha de consulta: 15 de noviembre de 2020. Disponible en: https://ec.europa.eu/energy/content/rp-180-medical-radiation-exposure-european-population-part-1-part-2_en
Páez D, Orellana P, Gutiérrez C, Ramírez R, Mut F, Torres L. Current status of nuclear medicine practice in Latin America and the Caribbean. J Nucl Med. 2015;56:1629-34. https://doi.org/10.2967/jnumed.114.148932
Ministerio de Salud y Proteccion Social. Registro Especial de Prestadores de Servicios de Salud-REPS. Fecha de consulta: 11 de noviembre de 2020. Disponible en: https://prestadores.minsalud.gov.co/habilitacion/
Krawczyk E, Piñero-García F, Ferro-García MA. Discharges of nuclear medicine radioisotopes in Spanish hospitals. J Environ Radioact. 2013;116:93-8. https://doi.org/10.1016/j.jenvrad.2012.08.011
Martínez J, Peñalver A, Baciu T, Artigues M, Danús M, Aguilar C, et al. Presence of artificial radionuclides in samples from potable water and wastewater treatment plants. J Environ Radioact. 2018;192:187-93. https://doi.org/10.1016/j.jenvrad.2018.06.024
Mulas D, Camacho A, Garbayo A, Devesa R, Duch MA. Medically-derived radionuclides levels in seven heterogeneous urban wastewater treatment plants: The role of operating conditions and catchment area. Sci Total Environ. 2019;663:818-29. https://doi.org/10.1016/j.scitotenv.2019.01.349
International Atomic Energy Agency. Management of radioactive waste arising from medical establishments in the European Union. 2000. Fecha de consulta: 12 de noviembre de 2020. Disponible en: https://op.europa.eu/mt/publication-detail/-/publication/588a7131-8e01-46feaada-e671f241bc8e
Fenner FD, Martin JE. Behavior of Na 131I and Meta (131I) Iodobenzylguanidine (MIBG) in municipal sewerage. Health Phys. 1997;73:333-9. https://doi.org/10.1097/00004032-199708000-00005
McGowan DR, Pratt BE, Hinton PJ, Peet DJ, Crawley MT. Iodine-131 monitoring in sewage plant outflow. J Radiol Prot. 2014;34:1-14. https://doi.org/10.1088/0952-4746/34/1/1
Rose PS, Swanson RL, Cochran JK. Medically-derived 131I in municipal sewage effluent. Water Res. 2012;46:5663-71. https://doi.org/10.1016/j.watres.2012.07.045
Consejo de Seguridad Nuclear, Sociedad Española de Protección Radiológica, Sociedad Española de Física. Criterios de alta de pacientes y medidas para la protección radiológica del público después de tratamientos metabólicos con 131I. Fecha de consulta: 15 de noviembre de 2020. Disponible en: https://www.csn.es/documents/10182/1006281/Criterios
de alta de pacientes y medidas para la protección radiológica del público -después de tratamientos metabólicos con Yodo-131
Fischer HW, Ulbrich S, Pittauerová D, Hettwig B. Medical radioisotopes in the environment - following the pathway from patient to river sediment. J Environ Radioact. 2009;100:1079-85. https://doi.org/10.1016/j.jenvrad.2009.05.002
International Atomic Energy Agency. Release of patients after radionuclide therapy, Safety Reports Series No. 63, IAEA, Vienna (2009). Fecha de consulta: 15 de noviembre de 2020. Disponible en: https://www.iaea.org/publications/8179/release-of-patients-after-radionuclidetherapy
Mosos F, Velásquez AM, Mora ET, Tello CD. Determination of 131I activity concentration and rate in main inflows and outflows of Salitre wastewater treatment plant (WWTP), Bogotá. J Environ Radioact. 2020;225. https://doi.org/10.1016/j.jenvrad.2020.106425
Petrucci C, Traino AC. Focus on the legislative approach to short half life radioactive hospital waste releasing. Phys Medica. 2015;31:726-32. http://doi.org/10.1016/j.ejmp.2015.06.001
Ministerio de Salud y Proteccion Social. Resolución 3100 de 2019, Colombia; 2019. Fecha de consulta: 15 de noviembre de 2020. Disponible en: https://www.minsalud.gov.co/Normatividad_Nuevo/Resolución No. 3100 de 2019.pdf
Ministerio de Salud y Protección Social. Resolución 4245 de 201,5, Colombia. Fecha de consulta: 15 de noviembre de 2020. Disponible en: https://www.minsalud.gov.co/Normatividad_Nuevo/Resolución 4245 de 2015.pdf
Mayani AN, Basari. Evaluation on requirements of nuclear medicine facility building. AIP Conference Proceedings. 2019;2180. https://doi.org/10.1063/1.5135558
Salehzahi J, Tse F. Shielding commissioning factors in nuclear medicine facilities. J Radiol Prot. 2020;40:165-80. https://doi.org/10.1088/1361-6498/ab504e
Ruiz-Guijarro JA. Desarrollo de un dispositivo portátil basado en un nuevo concepto de tratamiento y gestión de las excretas radiactivas procedentes de pacientes sometidos a terapia metabólica con yodo 131. Tesis. Málaga: Universidad de Málaga; 2015.
Cruz E, Mayorga-Betancourt M, Quiverio N, Villada J. Planteamiento de un sistema de remoción de 131I de vertimientos líquidos en una unidad sanitaria de medicina nuclear empleando 127I como patrón de referencia. Brazilian J Radiat Sci. 2014;1-14. https://doi.org/10.15392/bjrs.v3i1-A.4
Latif NF, Rozi SM, Jaafar KN, Jamaludin F, Abdul Razab MK, Mansor MS, et al. Characterization of GO:I-131 for radioactive clinical waste water management in nuclear medicine. Mater Sci Forum. 2020;1010:561-6. https://doi.org/10.4028/www.scientific.net/MSF.1010.561
Silva JAC da. Avaliação de custo-efetividade nas terapias oncológicas, emprego de modelos de Markov: Uma revisão integrativa da literatura. REAS. 2019;11:e1169. https://doi.org/10.25248/reas.e1169.2019
Berenguer PD, Chang TM, Silva RA, Neto AH, Santos MA, Belo IB. Impacto financeiro da radioiodoterapia ambulatorial com iodeto de sódio I-131 para tratamento de pacientes com carcinoma diferenciado da tireóide de baixo risco em relação às doses hospitalares. Fecha de consulta: 10 de noviembre de 2020. Disponible en: https://inis.iaea.org/collection/NCLCollectionStore/_Public/49/041/49041963.pdf
Pulgar D, Luque G, Parra J, Campos C, Vargas J. Administracion de radioyodo en cáncer diferenciado de tiroides bajo régimen hospitalario. A propósito de la implementación del aislamiento de radioyodoterapia en un hospital regional. Rev Cir. 2020;72:101-6. https://doi.org/10.35687/s2452-45492020002517
Higashi T, Kudo T, Kinuya S. Radioactive iodine (131I) therapy for differentiated thyroid cancer in Japan: Current issues with historical review and future perspective. Ann Nucl Med. 2012;26:99-112. https://doi.org/10.1007/s12149-011-0553-4
Bashir H, Numair Younis M, Rehan Gul M. Nuclear medicine theranostics: Perspective from Pakistan. Nucl Med Mol Imaging. 2019;53:38-41. https://doi.org/10.1007/s13139-018-00566-7
Sasaki Y. Nuclear oncology as seen by me in Japan: A historical review and future perspective. Ann Nucl Med. 2020;34:1-12. https://doi.org/10.1007/s12149-019-01413-1
Filippi L, Chiaravalloti A, Schillaci O, Cianni R, Bagni O. Theranostic approaches in nuclear medicine: Current status and future prospects. Expert Rev Med Devices. 2020;17:331-43. https://doi.org/10.1080/17434440.2020.1741348
Institute of Medicine and National Research Council. Advancing nuclear medicine through innovation. Washington, D.C.: National Academies Press; 2007. https://doi.org/10.17226/11985
Hung MC, Hwang JJ. Trends in the utilization of nuclear medicine and radiopharmaceuticals in an aging population. Nuklearmedizin. 2016;55:139-44. https://doi.org/10.3413/Nukmed-0778-15-11
Some similar items:
- Luz Elena Velásquez, Catalina Gómez, Erika Valencia, Laura Salazar, Eudoro Casas, Paragonimosis in the peri-urban zone of Medellín, Antioquia , Biomedica: Vol. 28 No. 3 (2008)
- Sandra Milena Arias, Lina Marcela Salazar, Eudoro Casas, Alexandra Henao, Luz Elena Velásquez, Paragonimus sp. in crabs and awareness of the educational community to aquatic ecosystems in La Miel and La Clara, Caldas, Antioquia , Biomedica: Vol. 31 No. 2 (2011)
- Jaiberth Cardona-Arias, Luz Peláez-Vanegas, Juan López-Saldarriaga, Marcela Duque-Molina, Oscar Leal-Álvarez, Health related quality of life in adults with HIV/AIDS in Colombia , Biomedica: Vol. 31 No. 4 (2011)
- Carolina Wiesner, Cancer research in the SARS-CoV pandemia , Biomedica: Vol. 40 No. 2 (2020)
- Alejandro Martí , Sarai Morón, Eliana González , Julián Rojas , Incidental findings of COVID-19 in F18-FDG PET/CT from asymptomatic patients with cancer in two healthcare institutions in Bogotá, Colombia , Biomedica: Vol. 40 No. Supl. 2 (2020): SARS-CoV-2 y COVID-19
- Carolina Rivero-Rubio, Angélica I. Navarro-Rodríguez, María C. Castro-Reyes, Oscar Araujo-Quintana, José Moreno-Montoya, Jesús A. Estevez-García, Pablo A. Martínez-Silva, Álvaro J. Idrovo, Claudia Amaya-Castellanos, Health conditions of Hitnü indigenous people potentially exposed to crude oil in Arauca, Colombia , Biomedica: Vol. 42 No. 4 (2022)
- Ana Yibby Forero Torres, Luis Carlos Forero, Comparison between anthropometric measurements and indices to evaluate general and abdominal obesity, Colombia ENSIN 2015 , Biomedica: Vol. 43 No. Sp. 3 (2023): Enfermedades crónicas no transmisibles
- Sandra Aruachan Vesga, Manuel González , Danis M. Rojas, Javier Ospina, Santiago Varela, Andrés Castaño , Avoided costs to the Colombian health system due to the implementation of externally funded oncology clinical trials , Biomedica: Vol. 45 No. 1 (2025): Publicación anticipada

Article metrics | |
---|---|
Abstract views | |
Galley vies | |
PDF Views | |
HTML views | |
Other views |