2018-05-23 17:07:43 - 8

Brazil: Call for Actions

Paulo R. Costa1; Alair ASMD dos Santos2; Lidia V. de Sá3; Hugo R. Schelin4; Cinthia Kotzian5; Luis AG Magalhães6; Simone Kodlulovich3; Helen J. Khoury7 1 Department of Nuclear Physics, Institute of Physics, University of São Paulo 2 Vice-President CBR/ Rio de Janeiro and Prof. Associate and Head of the Radiology Service at Hospital Universitário Antônio Pedro at Universidade Federal Fluminense, Brazil 3 National Nuclear Energy Commission, Brazil 4 Pelé Pequeno Príncipe Research Institute, Curitiba, Brazil 5 Bioseguridad Committee, Hospital Universitario de Saltillo, Universidad Autónoma de Coahuila, Mexico 6 Radiological Sciences Laboratory, Roberto Alcântara Gomes Institute of Biology, State University of Rio de Janeiro, Rio de Janeiro, Brazil 7 Department of Nuclear Energy - Federal University of Pernambuco, Brazil The text that follows aims to share experiences recently lived by the authors with fellow radiologists, physicists, regulators, radiological protection professionals, equipment manufacturers, educators and all those who, directly or indirectly, contribute to the development and application of the culture of radiation protection in medicine. These experiences took place in the week between 11 and 15 December 2017 in Vienna, during the International Conference on Radiation Protection in Medicine: Achieving Change in Practice. This conference was organized by the International Atomic Energy Agency (IAEA), the Pan American Health Organization (PAHO) and the World Health Organization (WHO), in addition to having the support of another sixteen institutions of great international prestige. The event was attended by 534 speakers from 97 countries. About 80 posters were presented and 8 sessions were held with oral presentations, 4 round tables, in addition to several other presentations by participants and institutions that supported the event. In addition, more than 25,000 people watched the communication sessions through Facebook. Brazil was represented through the participation of 25 professionals, including representatives of CNEN/IRD, CBR (Brazilian College of Radiology), and researchers from several universities and members of other organizations, with poster presentations and oral presentations at the Conference. This conference was a follow-up to the International Conference on Radiation Protection in Medicine - Setting the Scene for the Next Decade, held in Bonn in December 2012. The event brought together more than 500 participants and observers from 77 countries and also 16 organizations related to radiation protection in medicine to set the stage in this area for the next decade. The idea was to identify responsibilities and present a proposal of priorities that should be addressed by relevant professionals and entities in this area. The result of this discussion was summarized in a document, widely disseminated in several languages, called Bonn: Call for Actions (BCfA)[1]. In short, the WHO and IAEA initiative had the following goals:
  • Indicate flaws in current approaches to radiology protection in Medicine;
  • Identify tools to improve radiological protection in Medicine;
  • Review advances, challenges and opportunities in the field of radiological protection in Medicine; It is
  • Evaluate the impact of the International Plan of Action for Radiological Protection of Patients in order to prepare new international recommendations, taking into account new developments.
There is consensus among the institutions involved in defining the actions of the BCfA that the use of radiation in medicine must seek a balance between the benefits resulting from the possibility of improving human health with the risks associated with the use of technologies that use ionizing radiation for this purpose. This consensus considers, among other things, that “There is a need for a holistic approach that includes the partnership of national governments, civil society, international organizations, researchers, educators, institutions and professional associations with the objective of identifying, advocating and implementing solutions to face the existing and emerging challenges, as well as leading, harmonizing and coordinating activities and procedures at an international level.” (extracted from the brochure of the BCfA in Portuguese). Thus, five main objectives were established that permeated the discussions held at the 2012 meeting. These objectives were:
  • Strengthen the radiological protection of patients and health professionals in general;
  • Achieve the greatest benefit with the lowest possible risk for all patients through the safe and appropriate use of ionizing radiation in medicine;
  • Support the full integration of radiological protection into health systems;
  • Help improve the risk/benefit dialogue with patients and the public;
  • Increase the safety and quality of procedures in nuclear medicine, radiodiagnosis and radiotherapy.
Based on these objectives, ten main actions were highlighted, each one broken down into sub-actions, which were considered essential for the improvement of radiological protection conditions in Medicine. These actions, to be implemented over a period of ten years from 2012, are presented below.[2]:
  • 01 - Improve the application of the principle of justification;
  • 02 - Improve the implementation of the principle of optimization of protection and security;
  • 03 - Reinforce the role of manufacturers in contributing to the general safety regime;
  • 04 - Strengthen the education and training of health professionals in protection; radiological;
  • 05 - Outline and promote a strategic research agenda for radiological protection in medicine;
  • 06 - Increase the availability and quality of global information on radiological and occupational exposures in medicine;
  • 07 - Improve the prevention of incidents and accidents with radiation used in a clinical context;
  • 08 - Strengthen the radiological safety culture in the health area;
  • 09 - Foster a better dialogue about the risk-benefit in the use of radiation;
  • 10 - Strengthen the implementation of security requirements at a global level.
The event that took place in Vienna in December 2017, in turn, had as its central objective the evaluation and review of actions and initiatives taken in the context of the goals defined in Bonn, five years after the 2012 conference. need to monitor progress made by IAEA Member States over this period. These actions cover wide areas such as optimization and justification of medical exposures, safety in the use of ionizing radiation in medicine and radiological protection of occupationally exposed individuals and the public, when ionizing radiation is used in diagnosis, interventionism, therapy or in research. In this way, the central idea was the dissemination and review of the approaches adopted for the implementation of the BCfA and, furthermore, the harmonization of ongoing activities between international organizations and professionals involved in radiological protection in Medicine. In addition, the event should encourage those involved and decision makers in this area to carry out future projections based on successful initiatives and the learning obtained in these last five years. The authors of this document understand that extensive summaries of all the topics addressed by the renowned presenters of the invited topics would not fit here. Much of this information, including complete papers, is available on the event's website.[3]. Below, some observations interpreted as important for understanding the state-of-the-art in radiological protection in medicine are highlighted, emphasizing the points that, according to the authors' understanding, should be prioritized by all entities involved with the subject, including societies professionals, equipment manufacturers, educators and regulators. As previously highlighted, the Conference presentations were divided between oral sessions and round tables, in addition to Breakout Sessions held during the lunch break, where institutions such as the European Community (CE), United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) and the International Society of Radiology (ISR) presented topics related to the goals of the BCfA. In general, the most intensely discussed topics referred, directly or indirectly, to the need for improvements in risk communication, in the justification of practices and in the absence of more reliable diagnostic reference levels (DRL). The issue of patient autonomy was also discussed with respect to their decision to accept or not a diagnosis and/or therapy with ionizing radiation, based on one of the four principles of Bioethics. Just as an example, the researcher Margareth Murphy, from Ireland, dealt with the issue of patients' lack of knowledge regarding the risks associated with the use of techniques with ionizing radiation. It is understood that patients have a false sense of security when undergoing medical procedures involving radiation. He emphasized the need for mechanisms for correct communication with patients so that these risks are better understood and not minimized. Finally, he highlighted that the future strategy should focus on increasing patients' awareness through education and tools that facilitate dialogue. Another presentation worth mentioning was given by Eliseu Vaño, from Spain, who dealt, point by point, with what had been done since the proposal of the document BCfA, what results were obtained and how practices were modified. Furthermore, Prof. Vaño discussed what can be done to better implement the actions and also what are the future challenges when dealing with issues associated with occupational radiological protection in the field of interventional radiology. The researcher pointed to the identification of more research actions, more regulations, a greater amount of training materials and guides that lead to the improvement of radiological protection conditions. He also highlighted that the number of publications in the area of radiation protection in interventional radiology increased from 100-300% after the Bonn conference. Finally, he highlighted the need to reinforce training actions in radioprotection and personnel monitoring, both in traditional areas and in new hybrid technologies, including the development of tools that facilitate these actions. During breaks, coffee break and lunch break, of the Conference, several presentations were provided in which the different programs implemented to improve the practice of radiological protection worldwide were made known. Topics related to the following scientific communities and the programs adopted worldwide were addressed, in the following order: SAFRON[4], European Community experience, WHO[5], SEVRRA-SAFROM[6], UNSCEAR[7] (considering the sixth action of the BCfA), accesses to RPOP[8], ISEMIR[9], ISR[10], and SAFRAD[11], allowing for an open and full discussion regarding relevant topics in the area of Radiological Safety. The final sessions, however, were the ones that summarized, in a more objective way, the necessary mobilization to establish concrete action plans to improve radiological protection in Medicine in the next five years. From this final session, the authors highlight Dr. Ana Maria Larcher, who presented the recent activities of the Ibero-American Forum of Radiological and Nuclear Regulatory Bodies. This Forum is an association created in 1997 with the aim of promoting radiological, nuclear and physical safety at the highest level in the Ibero-American region. In her presentation, Dr. Larcher highlighted the absence of specifically defined competences, the need to think in perspective, aiming at effective future actions, and the weakness of regulatory bodies, the latter made explicit in the Ibero-American Conference on Radiation Protection in Medicine, held in Madrid in October 2016. Another highlight associated with the future actions of the Forum, in the 2017-2022 horizon, is the explicit definition of elements that contribute to the implementation of the actions defined in Bonn, mainly those associated with the regulatory area. Finally, he highlighted that the Forum has been reinforcing its contributions to building adequate training that results in better regulation in the Ibero-American region for areas associated with medical practices. In this same final session, presentations were made by other institutions related to radiological protection, such as the Conference of Radiation Control Program Directors (CRCPD), the Heads of the European Radiological Protection Competent Authorities (HERCA) and the International Radiation Protection Association (IRPA). Noteworthy, however, were presentations by representatives of the Israeli, Malaysian and Cuban ministries of health. These representatives demonstrated the action plans of their countries towards the implementation of the actions defined in the BCfA. This official and active institutional involvement on the part of the regulators seems, to the authors of this document, a necessary prerogative for the effective and harmonious implementation of these actions throughout the country. In a new presentation, Prof. Eliseu Vaño organized, using different interrelated topics, five problems associated with some highlight in the eight oral sessions that made up the Conference. In his conclusions, he highlighted:
  • Need for improvements in training, initial and continued, in radiological protection in Medicine and in the culture of radiological safety;
  • Need to improve and update regulations and guides;
  • Need to improve the training of inspectors;
  • Insufficient number of medical physicists in the Area of Diagnostic Imaging in General and in Radiotherapy;
  • Promote the use of Diagnostic Reference Levels (DRL-Diagnostic Reference Levels);
  • Efforts to prevent medical exposure incidents and accidents; It is
  • Efforts for the safe use of new technologies in medicine.
These conclusions, according to the researcher, can serve as a roadmap for improving radiological protection in Medicine, supporting the identification of mechanisms to promote catalyzing actions by international organizations and regional networks to implement the proposed solutions to the identified problems. The final conclusions of the event were presented by the chair, PhD Madan Rehani, and the President of Congress, PhD Geoffrey Ibbott. The first began by questioning whether the BCfA it was working. It concluded that yes, and presented a series of performance indicators, such as:
  • Increase in publications in the literature;
  • Emergence of national and regional campaigns dealing with the theme;
  • Actions and tools initiated by various associations;
  • Success stories presented at the Conference, particularly from developing countries; It is
  • Temporal variation of doses in patients and workers.
He went on to explore some common points that constitute challenges that must be considered by those involved in the process of implementing the BCfA goals. Prof. Rehani commented that the moment in radiological protection in medicine is unusual, with high interest in the subject, especially due to the increase in the number of procedures, the emergence of new techniques and the fact that the areas of imaging and radiation therapies have shown a rate incorporation of new technologies greater than in other areas of medical practice. With these facts, a series of common points and existing gaps were associated that require solution alternatives in order to achieve, in a global way, the goals of the BCfA. Some highlights:
  • Existence of well-established protocols in developed countries and frequently updated, while in most of the world these protocols do not exist;
  • Reinforcement of the principle of justifying the procedure with doctors and dentists who actually request imaging tests;
  • Inadequate material associated with risks and benefits for patients;
  • The need to establish DRLs, quality assurance and designation of medical physicists should be included in national regulations for implementing the requirements of the basic safety and radiological protection recommendations contained in the IAEA document GSR-Part 3[12]
  • The need for individualized clinical dosimetry in radionuclide therapy and the inherent responsibilities of the professionals involved, physicians and medical physicists;
  • Countries should investigate models through which they can expand the number of medical physicists in the field of diagnosis and therapy; It is
  • The need to include quality audits and risk assessment in nuclear medicine, radiodiagnosis and radiotherapy practices.
As a conclusion, the President of the Conference presented, for each of the ten goals established in the document BCfA, which tools exist, which ones are under development and which tools are necessary for the continuity of the actions proposed in 2012. In the understanding of the authors of this document, this general summary of the Conference offers fundamental resources for the good planning of future actions, in particular for the definition of public policies that help pave the way for Brazil to follow the right path in the area of radiological protection in Medicine. Our reading of the situation in Brazil is as follows: Our country was a protagonist in Latin America for many years in frontier areas that are associated with radiological protection in medicine. The country has a good number of medical physicists, regulatory agencies and a regulatory structure with well-defined responsibilities, structured and good quality residency programs in Medical Physics, offering scholarships, training courses in radiological protection for technicians and technologists, associations well-established medical professionals, etc. However, there is a lack of greater involvement and organization in some of the regulatory entities that allow the perception that the actions are being carried out in the same direction of the goals defined in the BCfA, as clearly presented by other countries during the Conference in Vienna. One example is the revision of Portaria 453. This document, published in the late nineties, was part of the history of Brazil's leading role in the regulatory area of diagnostic radiology. Praised by many and used as a basis for the development of local regulations in other countries, it is out of date after almost twenty years of its publication. The regulatory agency responsible for its implementation, ANVISA – Agência Nacional de Vigilância Sanitária, has been trying to carry out revisions of this normative text since the end of the last decade, without success. The Agency presented new texts in public consultations, all of which failed and with the proposed texts intensely rejected by the active community in the area. A possible reading of these facts is precisely the gap between the proposed texts and the concepts listed during the two conferences organized by the WHO and the IAEA, in 2012 and 2017. Another notable feature in the Conference presentations, which have low resonance in Brazil , were the strong cooperative actions between different countries and societies, especially in the European Community. A recent exception is the Latin Safe, inspired by Image Gently and Image Wisely, has as one of its missions to promote the radiological protection of patients in Latin America, following the ideas proposed in the BCfA. O Latin Safe it has a large participation of the national medical community, but still little diffusion in other areas that can support the initiatives, such as regulatory agencies and the federal government itself. It is understood that similar tools should be developed to broaden the involvement of the scientific, medical, educators and regulatory communities to disseminate the goals of BCfA and make its implementation a reality, not just rhetoric. The authors of this document ask: what has been done in Brazil? Individual actions are clear, qualified and accommodate the dedication of many professionals in the country. This information, however, seems poorly disseminated and with a low level of organization and leadership. Like this, some of the actions that we understand to be necessary for the resumption of the leadership position and the Brazilian protagonism, at least among the countries of Latin America or of the BRICS bloc, are:
  • Greater involvement of the scientific and medical community, educators, regulators in order to publicize the goals of BCfA;
  • Elaboration of an objective and realistic agenda for common actions towards the proposals of the BCfA;
  • Expand the culture of radiological protection at all levels;
  • Urgent need for paradigm shift: justification and optimization must be priorities;
  • Greater approximation between the societies of professionals involved, such as the Brazilian College of Radiology (CBR), the Brazilian Society of Radiotherapy (SBR), the Brazilian Society of Nuclear Medicine (SBBMN), the Brazilian Association of Medical Physics (ABFM), the Brazilian Society of Radiological Protection (SBPR) etc., to assume a leadership role in the dissemination of actions and also provide scientific and conceptual support to regulatory agencies;
  • Improve communication between the main actors: regulators, human resources trainers, doctors, physicists and other health professionals;
  • Encourage training in radioprotection in medical, veterinary and dental schools;
  • Encourage training in radiation protection for technologists, technicians in radiology, nursing and pharmacy;
  • Establish certification processes for professionals and training courses, in order to ensure the training of the technical staff;
  • Development of tools and training of professionals to expand information that lead to the establishment of reliable national DRLs;
  • Increase attention to radiological protection of critical groups, such as pregnant women and pediatric patients;
  • Development of guides for the execution of quality assurance procedures, in addition to regulatory documents, consistent with current local practices, generated in collaboration with professionals of recognized experience.
In conclusion, this text aims to distribute the collective vision of the authors resulting from the intense week of presentation and discussions in Vienna, in December 2017. The authors intend, with it, to support the broadening of the debate on the BCfA and propose a viable national agenda for the organized implementation of actions, in addition to strengthening collaborative participation. We understand that Good Practices should be supported and used as an example for other institutions. A clear action that is being planned, with the contribution of the authors, is the holding of the II Workshop on Justification and Optimization of Medical Exposures to Ionizing Radiations for Portuguese-speaking Countries, which is being scheduled to take place during the 2018 Brazilian Congress of Radiology, in Rio de Janeiro. This event will be a follow-up to the I Workshop, held in 2015 in Lisbon. This text acknowledges the responsibility that each one of us has in preparing for the future. Finally, our students or residents of today will be responsible for radiological protection and the optimization of practices using ionizing radiation in the Medicine of tomorrow, when it is assumed that the BCfA is concretely implemented. For this reason, leadership development is essential for us to look to the future with optimism. The idea of building bridges and not walls was strongly emphasized during the Conference and it is our understanding that this message should be taken to as many colleagues as possible so that a culture of security can be effectively cultivated in the current and future national context. It is this holistic approach, which was much talked about during the Conference, which will allow the building of competences that lead to the implementation of the goals of the BCfA in our country. We hope that the message is well understood by all actors in this scenario, especially by national regulatory agencies.   [1]  Detailed information, including in Portuguese, can be found at www.who.int/ionizing_radiation/medical_radiation_exposure/call-for-action and on the platform https://www.iaea.org/resources/rpop/resources/bonn-call-for-action-platform [2] It should be noted that the actions were not listed in order of importance. [3] www-pub.iaea.org/iaeameetings/50820/International-Conference-on-Radiation-Protection-in-Medicine [4] https://www.iaea.org/resources/rpop/resources/databases-and-learning-systems/safron [5] http://www.who.int/en/ [6] https://www.iaea.org/sites/default/files/18/01/17-12-safron-update.pdf [7] http://www.unscear.org/ [8] https://www.iaea.org/resources/rpop [9] https://nucleus.iaea.org/isemir [10] http://www.i-s-r.ca/ [11] https://rpop.iaea.org/safrad/ [12] International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014) Click here and download the PDF document.