centralized radiopharmacy in brazil: present scenery and ... · centralized radiopharmacy in...
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Centralized Radiopharmacy in Brazil:
present scenery and challenges
XII ENAN - INAC
2015/ October
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Centralized Radiopharmacy
CONCEPTRadiopharmacy with highly specialized manipulation and
distribution processes
Precise dose based on a physician prescription
Distribution of ready to use radiopharmaceuticals
Radiopharmaceuticals available in unit dose form
Shared by many nuclear medicine departments
Transportation logistics
High scale gain
KEY FEATURES
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Physician prescription
Nuclear Medicine
Department
Requisition toCRP
Analysis andplanning
Elution, Labeling, QC
Fractionate
Dispatch
Transportation
Centralized Radiopharmacy - CRP
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1
3
2
5
6
4
Laboratory preparation; Elution of the generators
Labeling and incubation: (Higher margins and added value)
QC: Simultaneous to fractioning
Fractioning: (Avoiding waste of raw material)
Shipping bag assembly
Transportation: (More efficient logistics)
10 min
20 min
25 min
110 min
20 min
60- 90 min
• 2 Manipulators
• 1 Dose/Minute
• 110 min.
• 3 Manipulation
Batteries
• 660 Doses/Day
321
456
The process begins one day before the dose delivery – Planning
Centralized Radiopharmacy – Process
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Centralized Radiopharmacy – International Scenery -
USA
Source: Purdue University. https://nuclear.pharmacy.purdue.edu/nukeinus/?state=NY
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Centralized Radiopharmacy – International Scenery -
USA
Triad Isotop Independents -
UPPI
Cardinal Health
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• 350 Centralized Radiopharmacy inUSA, in 2007
• Large private networks and small/independent companies
• Responsable by 81% of the totalmanipulated and dispatcheddoses in USA, in 2007
Centralized Radiopharmacy – International Scenery
USA Market
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• Vantagens:High activity generators
High resources optimization
Centralized Radiopharmacy – International
Scenery
USA Market
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• Placed in a strategic location
• Qualified team
• Personalized dose to patiente
• Total Traceability Software
• Decrease risk to patient
• Properly calibrated
• Drug efficacy assurance
Safety
Quality
Patient
Efficacy
Centralized Radiopharmacy
Advantages
Gopal B. Saha. Fundamentals of Nuclear Pharmacy. Fifth Edition. Springer. P. 187-188, 2004.
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• High activity generators
• Resources optimization (Cold kits and radiation)
• Convenience to the user is significant
• Significant savings of personnel time
• Decrease employee radiation exposition and contaminations
• Decrease radioactive waste
• Training center for young professionals
Centralized Radiopharmacy
Advantages
Gopal B. Saha. Fundamentals of Nuclear Pharmacy. Fifth Edition. Springer. P. 187-188, 2004.
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Standards Compliance
QC performed
Introduction of new radiopharmaceuticals
Infrastructure and equipment
Qualified suppliers
Centralized Radiopharmacy
Advantages
Gopal B. Saha. Fundamentals of Nuclear Pharmacy. Fifth Edition. Springer. P. 187-188, 2004.
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CHALLENGESSupply Chain
Regulatoryaffairs
Logistics in a big city
Pioneering
Paradigm Shift
NM Needs
Marketing plan
Centralized Radiopharmacy - Challenges
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Technetium-99m crisis in 2009
Frequent shortage of this radioisotope
Forecast for an upcoming crisis in 2016
• Closing major global reactors
• Risk to society: lack of access
SolutionCRP
•Optimizes at least 50% of radiation
•Sustainable supply chain
Centralized Radiopharmacy
CHALLENGES - Supply chain
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2015
2016
2018
2018
Centralized Radiopharmacy
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Centralized Radiopharmacy
ANVISA – Agência Nacional de Vigilância Sanitária
(health aspects - similar to FDA)
•Main legislation: RDC 67/07 - Provides on Good
Practices for Handling Preparations for Human Use in
pharmacies.
• Use of just registered radiopharmaceuticals according
to RDC 70/2014
CNEN – Comissão Nacional de Energia Nuclear
(radiological aspects - subordinated to
IAEA)
CHALLENGES - Regulatory affairs
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Centralized Radiopharmacy – Challenges - Paradigm
Shift
Pharmaceutical Industry
Industrial Radiopharmacy
Nuclear Medicine Service
Hospitalar Radiopharmacy
Compounding Pharmacy
Centralized
Radiopharmacy
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Centralized Radiopharmacy – Nuclear Medicine
Departments in Brazil
RPH
RPH
2016
1st Centralized
Radiopharmacy in Brazil
Southeast region 54%
São Paulo – Capital 52
São Paulo – other cities 61
Minas Gerais 58
Rio de Janeiro 48
Espírito Santo 14
54%15%
15%
10%6%
Southeast region
South region
Northeast region
Midwest region
North region
Source: CNEN - 2015/Aug
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Centralized Radiopharmacy
1st Centralized Radiopharmacy in Brazil will be based in São Paulo’s
market (the biggest city and economic center in LatAm)
Compounding Pharmacy of Sterile Medicines
Radiopharmaceuticals
• Ready for injection
• Individualized doses
Partnership: Beneficência Portuguesa de São Paulo
• Provided a space area of 157,07 m2
RPH GROUP
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