standardisation and security of nuclear medicine services · alternative radiopharmaceuticals...
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Standardisation and Security of Nuclear Medicine Services
Alan Perkins
University of Nottingham
The analysts’ dilemma. RSC 30 June 2011
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Warning!
This presentation may require revision to meet the required standards.
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Standardisation Dictionary definitions: •cause (something) to conform to a standard. •determine the properties of (something) by comparison with a standard. •the process of establishing a standard which could be a technical standard, standard test method, standard definition, standard procedure (or practice)….
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The National Institute for Health and Clinical Excellence (NICE) provides guidance, sets quality standards and manages a national database to improve people's health and prevent and treat ill health. Technology appraisals Recommendations on the use of new and existing medicines and treatments within the NHS, such as: •Medicines •medical devices (for example, hearing aids or inhalers) •diagnostic techniques (tests used to identify diseases) •surgical procedures (such as repairing hernias) •health promotion activities (for example, ways of helping people with diabetes manage their condition).
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Standards in Nuclear Medicine
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References
1. International basic safety standards for protection against ionizing radiation and for the safety of radiation sources. Safety series 117 IAEA Vienna 1996.
2. Applying radiation safety standards in nuclear medicine. Safety reports series 40 IAEA Vienna 2005.
3. Nuclear Medicine Resources Manual. IAEA Vienna 2006. 4. ICRP Publication 94: Release of Patients after Therapy with Unsealed
Radionuclides. International Commission on Radiological Protection ISBN 0080445608 2005
5. Medical and dental guidance notes. IPEM York 2002
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Global Perspective of Safety Standards
• Different perception of value of nuclear medicine
• Difference in priorities between different countries
• Complex relationships between practitioners,
researchers, industry and regulatory authorities
• Variable safety standards
• Implementation through peer review and audit
• Vast discrepancy in resources between different
countries
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Guidelines in Nuclear Medicine have been, and continue to be, developed by a number of organisations throughout the world. National regulations on the administration of radioactive substances and differences in clinical service delivery mean that guidelines do not readily apply across regional and national boundaries. In Europe, the European Association of Nuclear Medicine (EANM) is coordinating the development of guidelines, but recognises the need for national guidelines.
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Audit and Standards Quality of Service Health and Safety
Standards relate to Legal requirements Regulatory obligations Notes for guidance Peer reviewed publications Accepted good clinical practice (GCP)
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Example Radiopharmaceuticals for GI transit
Beef stew 99mTc Chicken liver 99mTc Dietry fibre 111In, 131I Egg sandwich 99mTc Filter paper in corn flakes (Technicrispies) 99mTc Mushrooms 99mTc Oatmeal 99mTc Pancake 99mTc,111In Porridge 99mTc,51Cr Rice 99mTc Scrambled egg on toast 99mTc
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SNM guideline Wide range of test meals used yet rarely validated 118ml (4oz) liquid egg whites 18 – 37MBq Tc-99m Su colloid Cook eggs in microwave oven to consistency of an omelette. 2 slices of toasted white bread 30g jam or jelly 120ml water May be eaten as a sandwich!
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Security
• Safety.
• Continuation of service through secure supplies.
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Post 9/11….. In the UK the police and Environment Agency Inspectors have been visiting departments to assess security. Previously dealing with accidental spill or loss but now…….
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WARNING ! RADIO INACTIVE
New Scientist 13 September 2008 British Medical Journal 2008;337:a1577
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Medical Molybdenum Production
Reactor Tc-99m
Generator Manufacturing
Uranium-235 Mo-99 Tc-99m
Nuclear Pharmacy
Tc-99m and Companion Drug
Bulk Mo-99 Processing
Patient
Decay of Isotopes (“Half Life”)
• Mo-99: 66 hours
• Tc-99m: 6 hours
About 3-4 days
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Molybdenum Deficiency
• Molybdenum deficiency is very rare recessive disorder that occurs when the body is lacking or cannot break down molybdenum.
• Like many other minerals, molybdenum is necessary for the the metabolisation of fats, carbohydrates, copper and nitrogen.
• It is normally obtained through a diet of beans, dark green leafy vegetables, rice and cereals.
• Those with the greatest risk of developing it are patients being fed intravenously.
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5 reactors produce over 90% world supply
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Aging Fleet of Major Production Reactors
Location Name Age
Canada, Chalk River NRU 51
Belgium, Mol BR2 47
Netherlands, Petten HFR 47
South Africa, Pelindaba SAFARI-1 43
France, Saclay OSIRIS 42
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Medical Isotopes – Global Supply Chain Structure
OSIRIS
MDS Nordion AECL
Lantheus (BMS)
Covidien
Covidien US
IRE IBA
NTP NTP
NRU
PETTEN
BR-2
Target Irradiation
Mo-99 Extraction
Mo-99 Purification
Tc-99m Generator Manufacturing &
Distribution
SAFARI AEC Amersham
Nuclear Medicine Market
Canada & US
Canada, US & Europe
Europe
Europe and ROW
Canada
Netherlands
Belgium
France
South Africa
Reactors Facilities
Covidien EU
Nihon
Daichi Japan
Czech LWR-15 REZ
MARIA Poland
Czech
Poland
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National Society Role
Communication Establish accurate communication with departments Ensure flow of information for service planning Society website www.bnms.org RSS feed
Engage with clinical departments Working groups Establish best practice Share solutions to short term shortages Include relevant information in surveys Education of users
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Securing the supply Increased co-operation
Producers
Manufacturers
International Agencies e.g. OECD
Professional Societies
Hospital radiopharmacies
Service departments
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Industry: AIPES established 1987
CYCLOPHARMALABORATOIRES
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National and International Collaboration
• COMMUNICATE WITH ALL STAKEHOLDERS IN CASE OF SHORTAGE
• EVALUATE AVAILABLE PRODUCTION AND IDENTIFY ALTERNATIVE SOURCES
• PROPOSE ALTERNATIVE ISOTOPES and DIAGNOSTIC PROCEDURES WHEN AVAILABLE
• PROVIDE ACCESS TO INFORMATION AND EXPERTISE TO THE MEDIA
• WORK WITH INDUSTRY AND AUTHORITIES FOR A LONG TERM SOLUTION
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OCTOBER 2010
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NOVEMBER 2010
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Key Challenges • Isotope Production
– Limited number of aging reactors – Limited new sources of supply – New sources require significant time and investment to
deploy • Supply Chain
– Logistics of delivery of a decaying product – Complex supply chain with multiple public and private
sector participants • Regulation
– Radioactivity + Pharmacueticals (GMP) – Nuclear security – HEU/LEU – Transport
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Maintaining Clinical Services
• Reappraisal of what we do
• Improved equipment performance
• Better use of less activity
• Lower radiation doses
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Establishing Clinical Priority
1. Paediatric studies e.g. oncology and renography 2. Sentinel lymph node localisation 3. Studies in which other imaging modalities are
specifically contraindicated. e.g. patients in renal failure where i.v. contrast
may not be given for CT or MR.
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Maintaining Clinical Services Alternative radiopharmaceuticals Tl-201 I-123 “ An emerging workhorse in nuclear medicine” F-18-NaF Reducing waste Avoid wasteful practice e.g. Tc-99m aerosol production Alternative diagnostic modalities CT MRI
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Transportation
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The silver lining
• The crisis has raised the profile of Nuclear Medicine
• Reappraisal of clinical services.
• Better use of materials and alternative procedures.
• Increased the importance of equipment and software developments.
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Reactor production technologies 1. Conventional U-235 fission: Neutron + U-235 --> Mo-99 + neutrons + other fission products 2. Neutron activation of Mo-98: Neutron + Mo-98 --> Mo-99 Accelerator production technologies 1. Linear accelerator photo-fission of U-238 Photon + U-238 --> Mo-99 + neutrons + other fission products 2. Mo-100 transmutation Photon + Mo-100 --> Mo-99 + neutron 3. Direct cyclotron production of Tc-99m: Proton + Mo-100 --> Tc-99m + 2 neutrons
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From the early early mornin’ to the early early night,
When I caught miss Molly rockin' at the house of blue lights,
Good Golly Miss Moly