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1 RADIOPHARMACY RADIOPHARMACY EXPERIENCE IN TURKEY EXPERIENCE IN TURKEY Prof.Dr Prof.Dr.A.Yekta Özer .A.Yekta Özer World World Congress Congress of of Pharmacy Pharmacy and and Pharmaceutical Pharmaceutical Sciences Sciences 2006/66 2006/66 th th Int Int Congress Congress of FIP of FIP 25-31 25-31 st st August August 2006 2006 Salvador Salvador Bahia Bahia/Brazil Brazil Turkey Turkey 780 000 780 000 km km 2 , , area area 67.8 67.8 million million population population 81 81 provinces provinces Health Health Expences Expences per per Capita Capita(2003, US$ (2003, US$ ) Source: OECD Health at a Glance, OECD Indicators, 2005. 5.635 3.807 3.781 3.705 3.115 3.001 2.996 2.976 2.903 2.827 2.763 2.703 2.699 2.451 2.394 2.302 2.258 2.231 2.139 2.118 2.011 1.886 1.835 1.797 1.298 1.269 1.074 777 744 583 513 USA Norway Switzerland Luksemburg _celand Canada Germany Holland France Belgium Denmark Sweden Australia (2002) Ireland OECD Average Austria Italy UK (2002) Japan (2002) Finland Greece New Zeland Spain Pertugal Check Rep Hungary Korea Slovakya Poland Mexico Turkey HISTORICAL BACKGROUND HISTORICAL BACKGROUND WORLD: WORLD: 1896 1896……………… ………………Roentgen Roentgen ( (Uranium Uranium Salts Salts, radiation radiation) 1897 1897……………… ………………Rutherford Rutherford ( (α α and and β β irradiation irradiation) 1898 1898……………… ………………Pierre Pierre and and Marie Marie Curie Curie (Radioactivity Radioactivity and and Uranium Uranium) 1900 1900……………… ………………Villard Villard ( (rays rays) 1913 1913……………… ………………Rutherford Rutherford and and Saddy Saddy (Radioisotopes Radioisotopes) ROENTGEN ROENTGEN…...X- ...X-rays rays…… …….. ..Radiology Radiology 1945 1945……………… ………………USA USA……… ………II. II.World World War War…Atom Atom Bomb Bomb
Transcript of RADIOPHARMACY EXPERIENCE IN TURKEY - fip.org ppt/30(4...1 RADIOPHARMACY EXPERIENCE IN TURKEY...
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RADIOPHARMACYRADIOPHARMACYEXPERIENCE IN TURKEYEXPERIENCE IN TURKEY
Prof.DrProf.Dr.A.Yekta Özer.A.Yekta Özer
WorldWorld CongressCongress of of PharmacyPharmacy andandPharmaceuticalPharmaceutical SciencesSciences
2006/662006/66th th IntInt CongressCongress of FIP of FIP25-3125-31st st AugustAugust 2006 2006
Salvador Salvador BahiaBahia//BrazilBrazil
TurkeyTurkey 780 000780 000 kmkm22, , areaarea
67.8 67.8 millionmillionpopulationpopulation
8181 provincesprovinces
HealthHealth ExpencesExpences perperCapitaCapita(2003, US$ (2003, US$ ))
Source: OECD Health at a Glance, OECD Indicators, 2005.
5.6
35
3.8
07
3.7
81
3.7
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2.4
51
2.3
94
2.3
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58
2.2
31
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HISTORICAL BACKGROUNDHISTORICAL BACKGROUND WORLD:WORLD:
18961896………………………………RoentgenRoentgen ( (UraniumUranium SaltsSalts,,radiationradiation))
18971897………………………………RutherfordRutherford ( (αα andand ββ irradiationirradiation)) 18981898………………………………PierrePierre andand MarieMarie CurieCurie
((RadioactivityRadioactivity andand UraniumUranium)) 19001900………………………………VillardVillard ( (raysrays)) 19131913………………………………RutherfordRutherford andand SaddySaddy
((RadioisotopesRadioisotopes)) ROENTGENROENTGEN……...X-...X-raysrays…………....RadiologyRadiology 19451945………………………………USAUSA………………II.II.WorldWorld WarWar……AtomAtom
BombBomb
2
19451945……..AbottAbott LabsLabs………………I-131I-131((RadioiodineRadioiodine) ) TyroidTyroid diseasedisease
P-32P-32((RadiophosphorusRadiophosphorus))
PolystemiPolystemi RubraRubra VeraVera
TURKEY: TURKEY: İİSTANBULSTANBUL
19521952……………………....İİstanbul stanbul UnivUniv, , FacFac. . MedMed, Haseki , Haseki HospitalHospital
RadioisotopeRadioisotope LabLab(Prof. Suphi (Prof. Suphi ArtunkalArtunkal))
EndocrinologicEndocrinologic InvestigationsInvestigations
19651965…………Haseki Haseki HospitalHospital, , TherapyTherapy CenterCenter
Lineer Lineer ScannerScanner
IodineIodine UptakeUptake, , nuclearnuclear hematologyhematology, , fatfat absorptionabsorption teststests
++
AllAll scintigraphicscintigraphic teststests
NuclearNuclear MedicineMedicine InstituteInstitute andand NuclearNuclear MedicineMedicine CenterCenter
ANKARA:ANKARA:
19631963……………….Ankara .Ankara UnivUniv, , FacFac. . MedicineMedicine,,InstInst..RadiobiologyRadiobiology
MoMo-99/-99/TcTc-99m -99m JeneratorJenerator elutionselutions
3
InIn General: General:
77 77 UniversitiesUniversities
49 49 FacultiesFaculties of of MedicineMedicine
41 41 DepartmentDepartment of of NuclearNuclear MedicineMedicine
8 (3) 8 (3) FacultiesFaculties of of PharmacyPharmacy
3 (5) 3 (5) DepartmentsDepartments of of RadiopharmacyRadiopharmacy (1994) (1994)
CURRENT STATUS:CURRENT STATUS:
CurrentCurrent StatusStatus of of RadiopharmacyRadiopharmacy LabsLabs in inTurkeyTurkey andand TheirTheir ComplianceCompliance toto GRP GRP andand
QualityQuality ManagementManagement SystemsSystems..
PharmPharm. I.. I.EthemEthem Atak Atak
Hacettepe Hacettepe UnivUniv, , FacFac..PharmPharm..DepDep. . RadiopharmacyRadiopharmacy
MasterMaster ThesisThesis..Ankara, 2004.Ankara, 2004.
SuperviserSuperviser: : Prof.DrProf.Dr.A.Yekta Özer.A.Yekta Özer
TableTable 1. 1. DistributionDistribution of of RadiopharmacyRadiopharmacy labslabs andandRelatedRelated ProvincesProvinces
No Province Number of Labs
1 Adana 3
2 Ankara 18
3 Antalya 6
4 Aydın 1
5 Bursa 4
6 Denizli 2
7 Diyarbakır 2
8 Düzce 1
9 Edirne 1
10 Elazı_ 1
11 Erzurum 1
12 Eski_ehir 1
13 Gaziantep 3
14 Hatay 1
15 _çel 2
TableTable 1. 1. DistributionDistribution of of RadiopharmacyRadiopharmacy LabsLabs andandRelatedRelated ProvincesProvinces ( (ContCont. d). d)
No Province Number of Labs
16 _stanbul 51
17 _zmir 12
18 Kayseri 4
19 Kocaeli 2
20 Konya 2
21 Malatya 2
22 Manisa 1
23 Rize 1
24 Samsun 2
25 Sivas 1
26 _anlı Urfa 1
27 Tekirda_ 1
28 Trabzon 2
29 Van 1
30 Zonguldak 1
31 TOTAL 131
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StatisticalStatistical MethodMethod: : SimpleSimple LayeredLayeredRandomRandom SamplingSampling MethodMethod
TableTable 2. 2. RadiopharmacyRadiopharmacy LabsLabs ChosenChosen SimpleSimple LayeredLayered RandomRandomSamplingSampling MethodMethod
Proviences Number Layered Sample Number
_stanbul 51 51/131 = 0,39 0.39x35 = 13
Ankara 18 18/131 = 0,14 0.14x35 = 5
_zmir 12 12/131 = 0,09 0.09x35 = 3
Antalya 6 6 /131 = 0,04 0.04x35 = 2
Kayseri 4 4/131 = 0,03 0.03x3 5 = 1
Bursa 4 4/131 = 0.03 0.03x35 = 1
Gaziantep 3 3/131 = 0,03 0.03x35 = 1
Di_er _ehirler 33 33/13 = 0,25 0.25x35 ! 9
Total 131 100 35
TableTable 3. 3. StagesStages of of thethe ResearchResearch
Stage Duration (Month )
a) Plan ning 1
b) Application 9
c) Statistical Evaluation and Interpretation 1
d) Report Writing 2
Budget 5000 YTL
RESULTS:RESULTS:TableTable 4. 4. RegionalRegional DistributionDistribution of of NuclearNuclear MedicineMedicine DepsDeps..
Region Number %
Marmara 14 40
Ege 3 8.6
Akdeniz 4 11.4
G.Do_u Anadolu 2 5.7
Do_u Anadolu 2 5.7
Karadeniz 2 5.7
Orta Anadolu 8 22.9
Total 35 100.0
Tablo 5. Tablo 5. DistributionDistribution of of RadiopharmacyRadiopharmacy LabsLabsDependingDepending on on HealthHealth ManagementManagement SystemsSystems
Type Number %
State Hospital 4 11.4
University Hospital 12 34.3
Military Hospital 2 5.7
Social Sec. Body (SSK) Hospital 1 2.9
Private Univ. Body. Hospital 0 0.0
Private Hospital 5 14.3
Private Nucl. Med. Lab. 11 31.4
Total 35 100.0
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TableTable 6. 6. EducationalEducational StatusStatus of ofRadiopharmacyRadiopharmacy LabLab. . ResponsibilitiesResponsibilities
Educational Status
Bi ologist Chem Eng. Physician Graduee
(Fac)
Responsible Sayı % Sayı % Sayı % Sayı %
Total
Radiopharmacist 1 50.0 1 50.0 - - 2
Nucl.Med.Speci. - - - - 27 100.0 - - 27
Graduee (Fac) - - - - - - 6 100.0 6
Total 1 - 1 27 6 35
TableTable 7. 7. DistributionDistribution of of ResponsiblesResponsiblesAccordingAccording toto thethe HealthHealth BodiesBodies
Radiopharmacy Lab Responsible (%)
Radiopharmacist Nucl.Med. Special. Graduee Total
Body
Number % Number % Number % Number %
State Hosp. - - 4 14.8 - - 4 11.4
Univ. Hosp. 1 50.0 6 22.2 5 83.3 12 34.3
Milita ry Hosp. 1 50.0 1 3.7 - - 2 5.7
SSK Hosp. - - - - 1 16.7 1 2.9
Private Hosp. - - 5 18.5 - - 5 14.3
Private Nucl. Med. Lab. - - 11 40.7 - - 11 31.4
Total 2 100.0 27 100.0 6 100.0 35 100.0
TableTable 8. 8. EducationalEducational StatusStatus of of RadiopharmacyRadiopharmacyLabLab StaffStaff
10035Total
46,416Graduee (High School)
26,49Graduee (High School- 2 year)
21,28Graduee (Fac)
3,81Nucl. Med Assist.
1,91Nuc. Med. Specialist%%NumberNumberProfessionProfession
TableTable 9. 9. RadiopharmaceuticalsRadiopharmaceuticals ConsumedConsumed in inRadiopharmacyRadiopharmacy LabsLabs
Calculated from n=35
Radiopharmaceutical Group Number % (*)
Rea dy to use 31 88.5
Radi olabelled before administration 35 100.0
Otolog 17 48.5
Dire ctly prepared before a dministration 2 5.7
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TableTable 10. 10. RadionuclidesRadionuclides UsedUsed bybyRadiopharmacyRadiopharmacy LabsLabs
Calculated from n=35
Radionuclides Number % (*)
Tc -99m 35 100.0
I-131 (Hospitalised) 6 17.1
I-131 (Ambulatory) 22 62.8
I-131 (Diagnosis) 28 80.0
Co-57 1 2.85
Ga-67 22 62.8
Tl-201 24 68.5
In-111 10 28.5
Cr-51 5 14.2
P-32 4 11.4
Fe -59 1 2.85
Sr-89 2 5.71
Re -186 1 2.85
Xe-133 3 8.5
Y-90 3 8.5
F-18 2 5.71
TableTable 11. 11. ColdCold KitsKits andand RadiolabelledRadiolabelled CompoundsCompoundsUsedUsed byby RadiopharmacyRadiopharmacy LabsLabs
Kits and Radiolabelled Compounds Number % ( *)
DMSA 35 100.0
DTPA 35 100.0
MAG -3 15 42.8
MDP 31 88.5
Sülfür Kolloid 27 77.1
HSA-Magroagregat 26 74.2
HMPAO 25 71.4
MIBI 9 25.7
Tetrafosmin 13 37.1
Mebrofenin 15 42.8
IDA 20 57.1
Albumin kolloid 21 60.0
Sn-PYP 26 74.2
Sn-MDP 15 42.8
In-111 Octreotid 9 25.7
I-131 Norkolestrol 5 14.2
I-131 MIBG 18 51. 4
Re -186 -HEDP 2 5.7
Others 5 14.2
Calculated from n=35
TableTable 12. 12.DistributionDistribution of of RadiopharmacyRadiopharmacyLabsLabs AccordingAccording toto thethe TypesTypes
Type Number % ( *)
A 6 17.1
B 29 82.9 Total 35 100.0
Calculated from n=35
TableTable 13. 13. QualityQuality ManagementManagement SystemSystemEvaluationEvaluation of of RadiopharmacyRadiopharmacy LabsLabs
Knowledge and Document Number % ( * )
ISO 9000 Document 5 14.2 ISO 9000 Knowledge 13
37.1 SOP Documents 12 34.2
Calculated from n=35
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TableTable 14. 14. LocationLocation andand SituationSituation of ofRadiopharmacyRadiopharmacy LabsLabs
Location and Number of Rooms Number % ( *)
Ground Floor or Labs far from Patient Stream 32 91.4
Labs Located in the Intensive Patient Stream 3 8.6
One -Room Labs 26 74.2 Two-Room Labs 6 17.1
Three -Room Labs 3 8.5
Labs Bigger than 16m 2 9 25 .7
Calculated from n=35
TableTable 15. 15. LayoutLayout of of RadiopharmacyRadiopharmacy LabsLabs
*Calculated from n=35
8,63Quality Control Room
--Sterile Room57,120Shielded Room
74,226Waste Room
2,81Changing Room
8,63Shower
--Air-Lock%(*)%(*)NumberNumberElementsElements
TableTable 16. 16. SituationSituation of of WorkingWorking StationsStations of ofRadiopharmacyRadiopharmacy LabsLabs
Type Number %
Labs with Working Stations 34 97.0 (34/35) Labs with Fume -Hood 31 91.2 (31/34) Labs with LAF 1 2.9 (1/34)
Labs with Glove -Box 2 5.9 (2/34)
Labs with Fume Hood + LAF 8 25.8 (8/31)
TableTable 17. 17. MeasuringMeasuring InstrumentsInstruments UsedUsed in inRadiopharmacyRadiopharmacy LabsLabs
M. Instrument Number % (*)
Dose Calibrator 35 100.0
Area Surveymeter 18 51.4
Portable Surveymeter (GM) 28 80.0
Scintillator 3 8.6
Calculated from n=35
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TableTable 18. 18. OtherOther InstrumentsInstruments UsedUsed in inRadiopharmacyRadiopharmacy LabsLabs
Instrument Number % (*)
Microscope 4 11.4
Centrifuge 16 45.7
Hemacytometer 2 5.7
Electronic Balance 10 28.5
Jacketed magnetic Stirrer 7 20.0
Refrigerator 31 88.5
pH -meter 5 14.3
Bath 16 45.7
Having all Instruments 1 2.9
Calculated from n=35
TableTable 19. 19. Personnel DosimetersPersonnel Dosimeters UsedUsed in inRadiopharmacyRadiopharmacy LabsLabs
Dosimeter Type Number % (*)
Film-Badge 35 100.0
Ring - -
TLD 1 2,8
Pocket 4 11.4
Calculated from n=35
TableTable 20. 20. ClassificationClassification of of WasteWaste DisposalDisposal in inRadiopharmacyRadiopharmacy LabsLabs
Classification Number % (*)
Labs Calssifying Wastes 17 48.6
Labs Not Classifying W astes 18 51.4
Calculated from n=35
TableTable 21. 21. LabsLabs ApplyingApplying QualityQualityControlControl TestsTests toto thethe SelfSelf--ProducedProducedRadiopharmaceuticalsRadiopharmaceuticals
Labs Number %(*)
Applying Quality Control Tests 7 20.0
Not Applying Control Tests 28 80.0
Calculated from n=35
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TableTable 22. 22. QualityQuality ControlControl TestsTests AppliedApplied in inthethe RadiopharmacyRadiopharmacy LabsLabs
Quality Control Tests Number % (*)
Radionuclidic Purity 2 5.7
Radiochemical Purity 7 20.0
Chemical Purity 1 2.8
Sterility, Apyrogenity, radioassay, pH, size, etc. - -
Calculated from n=35
TableTable 27. 27. FateFate of of GeneratorsGenerators in inRadiopharmacyRadiopharmacy LabsLabs ReturningReturning toto thethemarketingmarketing CompanyCompany
ReturningReturning thethe MarketingMarketing CompanyCompany………….. 100 %.. 100 %
CONCLUSIONCONCLUSIONNUCLEAR MED. SPECIALIST RADIOPHARMACIST
(Diagnosis/Treatment) (Pharmacy, Dosage Forms, Pharmacology)
Pa tient check -up, diagnosis, treatment,
appropriate clinical methods
Radiopharmaceutical formulation,
preparation and quality control
Right decision for the selection of radiop harmaceuticals
“together”
Prescribes Radiopharmaceuticals Dispenses the Radiopharmaceutical doses
Administers Radiopharmaceuticals Controls the Radiopharmaceuticals
Applies Nuclear Medicine Methods Evaluates ph armacokinetics and pharmacodynamics
Interpretes Nuclear Medicine Studies Evaluates Drug -Radiopharmaceutical interaction
Successful Nucl. Medicine Study Successful Radiopharmacy Study
Successful Patient care Successful Pharmaceutical C are
Patient Pleasure and R eal T reatment
COLLABORATIONCOLLABORATION
Prof.DrProf.Dr.Reha .Reha AlparAlpar Dep Dep..StatisticsStatistics Prof.DrProf.Dr..M.AliM.Ali Özgüven Özgüven DepDep. . NuclNucl. . MedMed.. TurkishTurkish AtomicAtomic EnergyEnergy AgencyAgency (TAEK) (TAEK) DepDep. . RadiationRadiation HealthHealth andand SafetySafety TurkishTurkish PharmacistsPharmacists AssociationAssociation (TEB) (TEB)
PharmPharm, , M.SciM.Sci, N. , N. SelcanSelcan Turker DepTurker Dep. . RadiopharmacyRadiopharmacy
PREPARATIONPREPARATION
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