PROBLEMS and CHALLENGES in MEETING the STANDARDS for EFFECTIVE RADIOTHERAPY DELIVERY in NIGERIA Timothy Akpa

PROBLEMS AND CHALLENGES IN MEETING THE STANDARDS FOR EFFECTIVE RADIOTHERAPY DELIVERY IN NIGERIA Timothy Akpa Nigerian Nuclear Regulatory Authority, Abuja OUTLINE • Introduction • Requirements for starting a Radiotherapy Facility • Safety Problems in Radiation Therapy Practice in Nigeria • Reflections on the Way Forward INTRODUCTION Prediction on Cancer Occurrence • According to the estimates from World Health Organization (WHO), the incidence of new cancer cases detected globally would rise from the existing 10.1 million in year 2000 to around 15.3 million in 2020 • This rise of 51.4% would be mainly attributed to an increase of 72.2% in the new cancer cases detected in the developing countries, (from 5.4 million in 2000 to 9.3 million in 2020). • In developed countries, the rise during the corresponding period is expected to be just around 27.6%. • Coupled with the rise in incidence of cancer in developing countries, the estimated rise in deaths could be to the tune of 75% from 3.6 million to nearly 6.3 million in the next 20 years • To cater for this predicted increase in cancer incidence in developing countries, at least some options are imperative: • to take adequate comprehensive measures directed towards cancer prevention and early diagnosis – Cancer prevention and education is an important facet of the cancer management strategy , which has to be pursued vigorously . • to establish adequate treatment and palliative care structures . (This will also make early diagnosis effective.) – Radiation therapy is an important component of the integrated cancer treatment – nearly 50 to 60% of the patients would be requiring radiation therapy at some point • to have an effective cancer management strategy, facilities for radiation therapy should be available within easy reach of the patients. – Unfortunately, this requires a large capital investment which most developing countries can not carry alone. – Over and above all, It also requires that very high safety standards must be adopted and regulated. – Radiotherapy is not just making tele-cobalt or an equivalent low energy linear accelerator available, proper radiation therapy, needs other ancillary units like – This would require a huge investment in infrastructure and more importantly in human resources This talk will concentrate on the regulatory requirements and the problems associated with the implementation. REQUIREMENTS TO START A RADIATION THERAPY FACILITY Radiation sources used in radiation therapy are: – Source for telecobalt unit, medical accelerator, sources for gamma knife unit, – Source(s) for remote afterloading brachytherapy unit, – Sources for manual afterloading brachytherapy, – Simulator, – Check source – or any other new modality involving ionizing radiation for therapeutic purposes. -1. Clearance from the Regulatory Authority • Verify from the supplier, that the unit is type approved by the regulatory authority. - this presupposes that the supplier should have availed himself/herself of the approved source types from the regulatory body. • When a unit is to be imported to the country, there must be documents specifying that the design standards meet the requirements of the competent authorities of both importing and exporting countries. • Based on the physical evaluation of the unit, the type approval certificate is then issued to the local supplier to market the same type of unit with certain terms and conditions. • These conditions are primarily meant to protect the user’s interest and ensure safety 2. Siting • The prospective licensee prepares the room layout drawings and the site layout drawing. This is vetted by the regulators. • Information on building material-concrete density, maximum outputs (kV and mAs) for the machines, projected workload and operation staff strength will be needed to estimate the shielding requirements - From regulatory point of view, the location of the installation should be so chosen that it is away from unconnected facilities and is close to the associated facilities , which include the simulator room, minor operation theatre (for brachytherapy), mould room, treatment planning room, physicist(s) room, radiation Oncologist(s) room, patient waiting area etc. • The facility construction is supervised by experts to ensure that it is as per the plan the approved by NNRA and at the location shown in the approved plan. In case of any modification, site approval process has to repeated 3. Staffing • Adequate number of staff must also be provided preferably before commencement or addition to existing facility. There must be – full time radiation oncologists, medical physicists and radiation therapy technologists ( radiation therapy nurses, pharmacists, radiographers with specialized qualification and experience ) • In case of appointment of medical physicists, it is to be ensured that at least one of them is eligible to work as Radiological Safety Officer (RSO). (An RSO must have at least a postgraduate diploma in radiation protection) 4 Personal Radiation Monitoring • Procure Personnel Monitoring Badges from an agency accredited by NNRA for all the radiation workers so that they are available for use during installation of the unit. • Procure a pocket dosimeters with audible and visual alarm for all designated radiation workers. They are meant for measuring radiation dose received by the radiation worker on the spot. The results, together with the one obtained from passive dosimeters, are used for checking safety of workers and adherence to procedures 5 Dosimetry and Environmental Monitoring • Procure appropriate instruments for measurement of radiation output and other dosimetric parameters - Thimble Ionisation Chamber, Parallel Plate Ionisation Chamber, Well type Ionization Chamber, Electrometer, Radiation Field Analyser etc.) • Procure an appropriate monitoring instruments for area monitoring (survey meters, contamination monitors, gamma zone monitors etc.). - Gamma zone monitors for telecobalt unit and remote after loading brachytherapy unit should be of auto-reset type, whereas, that for manual brachytherapy may have manual- reset button. 6. Authorization • To obtain authorisation from NNRA a prospective licensee must send a filled authorization form NNRA/AUT/01 and 02 with a written radiation protection programme and all the necessary documents mentioned in the guideline for filling application for authorization. - It is assumed that the radiation protection programme presented by the licensee addresses all safety issues and how they are going to implement them. On acceptance of the programme, NNRA holds the licensee responsible for the implementation. • Sources that should be declared in the form, must include, sealed radioactive sources, depleted uranium shields, shield containing beryllium and all radiation generating equipments. • Guidelines for importation and transportation of sources are also available in NNRA 7. Installation • All radioactive sources shall be loaded only by the certified and licensed service engineer in the presence of a medical physicist who has relevant experience. • To carry out source loading operation, the engineer must be certified by the manufacturer. • The facility must inform NNRA of this operation at least 30 days before commencing • The facility must perform thorough acceptance test as prescribed by the manufacturer of the unit and the report sent to NNRA. • The facility must keep a copy of the acceptance test result in its records, and produce same during subsequent inspection. 8. Commissioning • NNRA grants a license to commission a facility following the receipt of acceptance test and a quality control test results on the facility. • Commissioning permission will not be granted until adequate number of full-time staff in the department, personnel monitoring badges for all the radiation workers and all the required associated instruments/accessories are available. • No patient treatment should be started without obtaining the commissioning approval from NNRA Safety Problems in Radiation Therapy Practice in Nigeria Stakeholders Meeting 2005 • In November, 2005 the NNRA organized a 1-day Technical Meeting on the State of Radiotherapy Practice in Nigeria • The meeting was organized for the management staff of the Federal Government owned radiotherapy centres and other relevant government agencies. • The aim was to raise awareness of stakeholders in radiation safety in radiotherapy practice in Nigeria Resolution of the Meeting The Meeting noted among other things that: • There were four Federal Government funded Radiotherapy Centres in the country located at LUTH, Ahmadu Bello University Teaching Hospital (ABUTH), National Hospital Abuja(NHA) and University College Hospital (UCH). • There was also one private radiotherapy centre in Lagos, the Eko Hospital Plc. • that the Federal Government was upgrading eight tertiary medical institutions and particularly providing two medical linear accelerators (LINACs) for University of Nigeria Teaching Hospital (UNTH) Enugu and Lagos University Teaching Hospital (LUTH), through the FG/VAMED Project. - However, the upgrading project does not cover the rehabilitation of the existing Radiotherapy Centres. • None of these centres was found to be operating optimally and safely as they do not meet the minimum requirements for good practice in terms of clinical efficacy of cancer treatment and radiation safety of the patients. Equipment • All of the four Government Radiotherapy Centres do not have the full complement of main and ancillary equipment • Local

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