Cancer in Developing Countries: Facing the Challenge
Safe and Appropriate Use of New Radiation Medicine Technology in New Surroundings
Radiotherapy is an effective way of treating cancer and it is estimated that 50% to 60% of cancer patients would benefit from radiotherapy. As many developing countries have very limited or no access at all to this treatment modality, expanding radiotherapy into areas without current access has the potential to save a great number of lives. It is, however, mandatory that the expansion is done with safety in mind, considering the complexity of this high-technology treatment modality and the potential for serious consequences from accidents. Radiation accidents involving medical uses have accounted for more acute radiation deaths than any other source, including Chernobyl. Accidents involving radiotherapy might also undermine the public´s confidence in the treatment, which is a serious concern in its own right.
The participants in this final session (four scientists and health professionals joined three representatives from regulatory authorities and technical service organizations) examined the challenges in ensuring safety and effectiveness when establishing a radiotherapy programme, in particular in settings where there are constraints on capacity and infrastructure, as well as exploring practical measures to enhance safety and effectiveness under these circumstances.
National Institute of Radiological Sciences, Japan
Professor Yoshiharu Yonekura, President, National Institute of Radiological Sciences, Chiba, Japan, discussed What is, and what should be, the evidence base for introducing new radiation medicine technology? When it comes to balancing benefits and risks in medical practice, it is essential that scientific evidence is used. A statistical approach in interpreting clinical evidence is vital, and science should also be used to clarify variability. When new technology for clinical use is being considered, both the technology´s effectiveness and the optimization of the clinical protocols for diagnosis and treatment must be analyzed, using clinical research to establish the evidence. The safety of new technology relies on careful and rational design of clinical protocols based on basic research in physics and biology, proper monitoring of the process, and education and training.
Department of Radiation Oncology, St-Luc University Hospital, Belgium
Professor Pierre Scalliet, Chairman, Department of Radiation Oncology, St. Luc University Hospital, Brussels, Belgium, looked at the Safety Challenges in Radiotherapy: Human Impact of Accidents. The psychological impact of medical injury must be considered. Patients might feel extreme shock, anxiety, depression, uncertainty and that they are injured by the people trusted to care for them. Patients want disclosure in case of an event - to be told about the incident that affected them; acknowledgement of the distress caused; a genuine expression of regret for distress; a factual explanation of what happened; a clear explanation of what will be done now; and a plan to correct or repair harm done. They also want the organization to learn, so that this will be avoided in the future.
German Cancer Research Centre, Germany
Professor Dr. Günther Hartmann, Deputy Director, Department of Medical Physics and Radiation Therapy, German Cancer Research Centre, Heidelberg, Germany, discussed issues regarding Capacity Building for Sustained Safe Use of New Radiation Medicine Technology in New Surroundings. Establishing new treatment facilities is a long process and requires strong governmental support. Requirements to meet before initiating a new treatment program include program specification (in addition to registration and licensing); facility planning and construction; equipment specification, procurement and installation; acceptance testing and commissioning; design of protocol and procedure manuals; and staff education and training. Typically, about five years are needed to complete all phases. Sustained effective use of equipment greatly depends upon well-balanced investments in equipment and infrastructure.
Radiological Sciences Laboratory, State University of Rio de Janeiro, Brazil
Professor Carlos Eduardo de Almeida, Chairman, "Laboratório de Ciências Radiológicas, Universidade do Estado de Rio de Janeiro", Brazil, explained Measures to Ensure Appropriate Use of New Technology by the Developing Countries from a Safe, Economical and Societal Viewpoint. Patient safety depends on measures being taken in the implementation of clinical procedures and quality assurance, as well as independent auditing, staff training and professional accreditation. Cost-benefit evaluations should take into consideration not only initial investment costs, but also how many patients will benefit, and importantly the cost of maintaining trained staff and sustaining optimal technical maintenance. When considering purchasing new high-tech equipment, this could translate into higher initial and operational costs, a higher level of staff training to maintain, and potentially a smaller number of patients treated due to advanced techniques and QA and maintenance time. Planning high technology centers in developing countries must consider the social and economic aspects, as well as the evidence of real benefits in terms of increased survival, specific to the cancer scenario for each country.
U.S. Nuclear Regulatory Commission, USA
Dr. Gregory B. Jaczko, Chairman, U.S. Nuclear Regulatory Commission, Washington, D.C., U.S.A., made the point that good staff training is crucial, if the goal is to achieve safety. Procedures should be established and followed correctly. While there are certainly very unfortunate incidents that have occurred, most procedures proceed correctly and a balanced view is necessary. A regional approach to dealing with the difficulties encountered could be of great value. Awareness needs to be raised on these issues overall.
French Institute for Radiological Protection and Nuclear Safety, France
Professor Agnès Buzyn, Board of Directors Chairperson, "Institut de Radioprotection et de Sûreté Nucléaire", Fontenay-aux-Roses, France, noted the necessity for strengthening the radiation protection culture in the medical field. Means to engage professional societies, manufacturers, and governments in order to strengthen safety should be explored. The medical community should also consider whether patients can be engaged by providing them with appropriate and accurate information about radiation benefit and risks. Regulation is part of the issue but it is not the only way to ensure safety. Culture and training are at least as important as regulations and standards.
Nigerian Nuclear Regulatory Authority, Nigeria
Professor Shamsideen Elgeba, Director General, Nigerian Nuclear Regulatory Authority, Abuja, Nigeria, highlighted the work of the Forum of Nuclear Regulatory Bodies in Africa (FNRBA) which has a technical working group on radiotherapy safety. A self-assessment on radiotherapy practice has been carried out and an action plan for radiation protection in radiotherapy is being developed. There are many challenges for radiotherapy in Africa, including a lack of human resources and basic equipment. FNRBA is seeking partnership with several organizations in order to improve radiation protection of patients and efficacy of the technology.
Evidence is the key for introducing a new technology, and clinical research should be performed to gain evidence. Each country has a specific cancer scenario, and technologies have to be established accordingly. In addition to the evidence base, cost-benefit issues for introducing new technology also have to be seriously considered. These issues do not only include costs for investments, but also how many patients will benefit, costs for maintenance and adequate staffing, and a high level of training and re-training.
Increased access to clinically proven uses of radiation will undoubtedly save and improve lives for many people, but it is vital that a global expansion of this high-technology is done safely. Accidents can be a severe detriment to the affected patients, and may also undermine the public´s confidence in the treatment. Openness and honesty should be maintained in any dialogue with the affected patients and the public on these issues, and the profession should be willing to learn and improve.
A key issue for the sustained safe use of radiation in medicine in new surroundings is to build local capacity through staff training. Strong governmental commitment is required to ensure comprehensive and appropriate education and training. The vast majority of accidents are caused by a lack of training and safety culture, not by faulty equipment or the lack of the correct equipment.
It is important that regulatory authorities maintain an open dialogue with the medical community and work together with professional societies and manufacturers for the benefit of radiation protection of patients. Maintaining a safety infrastructure in partnership is a must for the safe use of radiation in medicine, but regulations alone are not a panacea. A good safety culture is also essential.
- Yoshiharu Yonekura, President, Independent Administrative Institution, National Institute of Radiological Sciences, Japan.
- Pierre Scalliet, Department of Radiation Oncology, St-Luc University Hospital, Belgium.
- Günther Hartmann, German Cancer Research Centre, Germany.
- Carlos Eduardo de Almeida, Chairman, Radiological Sciences Laboratory, State University of Rio de Janeiro (UERJ), Brazil.
- Gregory Jaczko, Chairman, U.S. Nuclear Regulatory Commission, USA.
- Agnes Buzyn, Chairman of the Board of Directors, French Institute for Radiological Protection and Nuclear Safety (IRSN), France.
- Shamsideen Elgeba, Director-General, Nigerian Nuclear Regulatory Authority, Nigeria.