RADIO PHARMACEUTICALSRADIO PHARMACEUTICALS
Handling and packagingHandling and packaging
ByBy
Nagaraju BNagaraju B
DEFINITIONDEFINITION
Radiopharmaceuticals are the radioactiveRadiopharmaceuticals are the radioactive
substances or radioa...
COMPOSITIONCOMPOSITION
a radioactive isotope that can be injected
safely into the body, and
a carrier molecule which deliv...
RadioisotopeRadioisotope
• A version of a chemical element that hasA version of a chemical element that has
an unstable nu...
how does it work?
UsesUses
• TherapeuticTherapeutic
• DiagnosingDiagnosing
• Designed to deliver therapeutic dose ofDesigned to deliver therapeutic dose of
ionizing radiation to specific disease si...
• used to derive detailed description of theused to derive detailed description of the
morphology and dynamic functioning ...
ADVANTAGESADVANTAGES
• It can be used as diagnosis and treatmentIt can be used as diagnosis and treatment
of patientsof pa...
ADVANTAGESADVANTAGES
• Can provide fast onset of pain reliefCan provide fast onset of pain relief
• Single dose is effecti...
• Nuclear medicine tests are notNuclear medicine tests are not
recommended for pregnant womenrecommended for pregnant wome...
SNSN
OO DESCRIPTIONDESCRIPTION
RADIOACTIVRADIOACTIV
EE
ISOTOPEISOTOPE
USESUSES
AMMONIUM BROMIDEAMMONIUM BROMIDE
CALCIUM CH...
• Technetium 99mTc :Technetium 99mTc : possesses a relativelypossesses a relatively
short half life of 6 hours , which all...
GENERAL PRECAUTIONSGENERAL PRECAUTIONS
A radioisotope administrationA radioisotope administration
sheet is placed in the m...
NUCLEAR PHARMACYNUCLEAR PHARMACY
• it’s a relatively newer branch of pharmacy that involvesit’s a relatively newer branch ...
Procurement and storageProcurement and storage
• Because of the short life of the radiopharmaceuticals the nuclearBecause ...
Preparation of the radioPreparation of the radio
pharmaceuticalpharmaceutical
• Radio nuclide generator can be defined as ...
99mtc is formed by the decay of 99mo99mtc is formed by the decay of 99mo
in a radionuclide generatorin a radionuclide gene...
Formulation issueFormulation issue
• The radio pharmaceuticals have very short usableThe radio pharmaceuticals have very s...
• Formulation of radio pharmaceuticals isFormulation of radio pharmaceuticals is
therefore a bit more complex than normalt...
Code of good radiation practicesCode of good radiation practices
(GRP)(GRP)
• Strict personnel hygieneStrict personnel hyg...
• Drawing out a manual of standardized procedures ofDrawing out a manual of standardized procedures of
safe handling and s...
Code Of Good ManufacturingCode Of Good Manufacturing
Practices (GMP)Practices (GMP)
• Proper selection and in service trai...
• Assignment of responsibilities in writingAssignment of responsibilities in writing
• Facilities for minimizing of surfac...
Dispensing of radiopharmaceuticalsDispensing of radiopharmaceuticals
• the dispensing of radiopharmaceuticals should be sa...
• The cold kit preparation should be capableThe cold kit preparation should be capable
of terminal sterilization preferabl...
Compounding of radio pharmaceuticalsCompounding of radio pharmaceuticals
requires receipt (or anticipation) of:requires re...
Directions while compoundingDirections while compounding
• Involves reconstituting reagent kits, radio labeling, andInvolv...
Radiopharmaceutical productRadiopharmaceutical product
• Radiopharmaceuticals are generally expected toRadiopharmaceuticals are generally expected to
conform to specifications u...
LabellingLabelling
All products should be clearly identified by label which mustAll products should be clearly identified ...
Production and distribution recordsProduction and distribution records
• The processing records of regular productionThe p...
– DispensingDispensing
 Recommends dosage levels based onRecommends dosage levels based on
patient history, age, weight, ...
-Dispensing-Dispensing
 Develops policies and procedures to ensure that theDevelops policies and procedures to ensure tha...
-Distribution-Distribution
Complies with all applicable regulations concerning packaging,Complies with all applicable reg...
HEALTH & SAFETYHEALTH & SAFETY
 AllergiesAllergies
• If you will be receiving albumin in the form ofIf you will be receiv...
HEALTH & SAFETYHEALTH & SAFETY
 PregnancyPregnancy
•
Radiopharmaceuticals usually are not recommendedRadiopharmaceuticals...
HEALTH & SAFETYHEALTH & SAFETY
 Breast-feedingBreast-feeding
• Some radiopharmaceuticals pass into theSome radiopharmaceu...
HEALTH & SAFETYHEALTH & SAFETY
 ChildrenChildren
• For most radiopharmaceuticals, the amountFor most radiopharmaceuticals...
HEALTH & SAFETYHEALTH & SAFETY
• Side effectsSide effects
• When radiopharmaceuticals are used in veryWhen radiopharmaceut...
HEALTH & SAFETYHEALTH & SAFETY
> Are radiopharmaceuticals safe?> Are radiopharmaceuticals safe?
• Absolutely. Like any med...
HEALTH & SAFETYHEALTH & SAFETY
>Is the radioactivity harmful?
• Although exposure to radioactivity in veryAlthough exposur...
RADIATION SAFETYRADIATION SAFETY
PROCEDURESPROCEDURES
• RadiationRadiation Safety is a term applied to conceptsSafety is a...
• It is necessary to mark the area in which theIt is necessary to mark the area in which the
radio active work is carried ...
• Do not pipette by mouth. Work areas should beDo not pipette by mouth. Work areas should be
covered with a plastic glass ...
WASTE STORAGE ANDWASTE STORAGE AND
DISPOSALDISPOSAL
• Radioactive materials no longer required must beRadioactive material...
ReferenceReference
• Hospital Pharmacy-William HassanHospital Pharmacy-William Hassan
• Ansels Pharmaceutical Dosage Form ...
radiopharmaceuticals
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  1. 1. RADIO PHARMACEUTICALSRADIO PHARMACEUTICALS Handling and packagingHandling and packaging ByBy Nagaraju BNagaraju B
  2. 2. DEFINITIONDEFINITION Radiopharmaceuticals are the radioactiveRadiopharmaceuticals are the radioactive substances or radioactive drugs forsubstances or radioactive drugs for diagnostic or therapeutic interventionsdiagnostic or therapeutic interventions
  3. 3. COMPOSITIONCOMPOSITION a radioactive isotope that can be injected safely into the body, and a carrier molecule which delivers the isotope to the area to be treated or examined.
  4. 4. RadioisotopeRadioisotope • A version of a chemical element that hasA version of a chemical element that has an unstable nucleus and emits radiationan unstable nucleus and emits radiation during its decay to a stable form.during its decay to a stable form. • All isotopes are not radioisotopes.All isotopes are not radioisotopes.
  5. 5. how does it work?
  6. 6. UsesUses • TherapeuticTherapeutic • DiagnosingDiagnosing
  7. 7. • Designed to deliver therapeutic dose ofDesigned to deliver therapeutic dose of ionizing radiation to specific disease site,ionizing radiation to specific disease site, such as cancerous tumors, with highsuch as cancerous tumors, with high specificity in the body.specificity in the body. • Historically, used to treat Thyroid cancer,Historically, used to treat Thyroid cancer, Graves’ disease, hyperthyroidism, andGraves’ disease, hyperthyroidism, and bone pain pallitation associated withbone pain pallitation associated with skeletal metastasis.skeletal metastasis.
  8. 8. • used to derive detailed description of theused to derive detailed description of the morphology and dynamic functioning ofmorphology and dynamic functioning of the various internal organs of the body.the various internal organs of the body.
  9. 9. ADVANTAGESADVANTAGES • It can be used as diagnosis and treatmentIt can be used as diagnosis and treatment of patientsof patients • It is common cure to cancersIt is common cure to cancers • Can treat multiple disease sitesCan treat multiple disease sites • Widely available mode of treatmentWidely available mode of treatment • Directly treats tumor, especially useful forDirectly treats tumor, especially useful for bone metastasisbone metastasis
  10. 10. ADVANTAGESADVANTAGES • Can provide fast onset of pain reliefCan provide fast onset of pain relief • Single dose is effective for some patientsSingle dose is effective for some patients • Nuclear medicine tests can be performedNuclear medicine tests can be performed on childrenon children • Nuclear medicine procedures are costNuclear medicine procedures are cost effective and painlesseffective and painless • Nuclear medicine procedures have noNuclear medicine procedures have no side effects and are completely safeside effects and are completely safe
  11. 11. • Nuclear medicine tests are notNuclear medicine tests are not recommended for pregnant womenrecommended for pregnant women because unborn babies have a greaterbecause unborn babies have a greater sensitivity to radiation than children orsensitivity to radiation than children or adultsadults • Filling in patients' teeth, dental braces andFilling in patients' teeth, dental braces and permanent bridges may cause somepermanent bridges may cause some distortion around the mouth areadistortion around the mouth area
  12. 12. SNSN OO DESCRIPTIONDESCRIPTION RADIOACTIVRADIOACTIV EE ISOTOPEISOTOPE USESUSES AMMONIUM BROMIDEAMMONIUM BROMIDE CALCIUM CHLORIDECALCIUM CHLORIDE Chromium EDTAChromium EDTA Colloidal goldColloidal gold Chromium chlorideChromium chloride Human serum albuminHuman serum albumin Potassium chloridePotassium chloride TriolenTriolen 82Br82Br 45Ca45Ca 51Cr51Cr 198Au198Au 51Cr51Cr 125I125I 24Na24Na 125I125I STUDY OF EXTRACELLULARSTUDY OF EXTRACELLULAR MEASUREMENTMEASUREMENT Study of ca metabolismStudy of ca metabolism Determination of glomerular filtrationDetermination of glomerular filtration raterate Treatment of neo-plastic conditionsTreatment of neo-plastic conditions and general investigation ofand general investigation of reticuloendothelial cellsreticuloendothelial cells Studies of GIT protein loss in vivoStudies of GIT protein loss in vivo labelling and absorption studieslabelling and absorption studies Study of cardiac cavity imagingStudy of cardiac cavity imaging scanning of sub-arachnoid spacesscanning of sub-arachnoid spaces detection of brain tumoursdetection of brain tumours Determination of exchangeableDetermination of exchangeable poassiumpoassium Fat absorption studiesFat absorption studies
  13. 13. • Technetium 99mTc :Technetium 99mTc : possesses a relativelypossesses a relatively short half life of 6 hours , which allowsshort half life of 6 hours , which allows administration of higher amounts of activity foradministration of higher amounts of activity for faster and clearer images while exposing thefaster and clearer images while exposing the patient to a low radiation dose. it offers anpatient to a low radiation dose. it offers an abundance of gamma photons for imagingabundance of gamma photons for imaging • 99mTc exametazime-99mTc exametazime- cerebral perfusion radiocerebral perfusion radio labelinglabeling • 99mTcmacroaggregated albumin-99mTcmacroaggregated albumin- pulmonarypulmonary perfusionperfusion • 99mTcmedronate-99mTcmedronate- bone imagingbone imaging • 99mTcpertechnetate-99mTcpertechnetate- imaging of thyroid salivaryimaging of thyroid salivary glands,glands,
  14. 14. GENERAL PRECAUTIONSGENERAL PRECAUTIONS A radioisotope administrationA radioisotope administration sheet is placed in the medicalsheet is placed in the medical record by the isotoperecord by the isotope administrator at the time ofadministrator at the time of treatment and is to remaintreatment and is to remain there permanently as anthere permanently as an isotope to sign at the entranceisotope to sign at the entrance of the room or unit by theof the room or unit by the administratoradministrator The isotope administrator willThe isotope administrator will provide a substitute who mayprovide a substitute who may be contacted in care thebe contacted in care the administrator is not readilyadministrator is not readily Abc HOSPITALAbc HOSPITAL Radioactive isotope administrationRadioactive isotope administration Tracer therapyTracer therapy Isotope____Isotope____ Effective half life______Effective half life______ Dose_______Dose_______ Route of administration_______________Route of administration_______________ The patient received radio isotope on_______The patient received radio isotope on_______ all precautions must be meticulously observed ifall precautions must be meticulously observed if there is spillage make no attempts to clean the area.there is spillage make no attempts to clean the area. Notify at once to the undersigned and theNotify at once to the undersigned and the radiological houseradiological house signed______M.Dsigned______M.D radiocative isotope administratorradiocative isotope administrator
  15. 15. NUCLEAR PHARMACYNUCLEAR PHARMACY • it’s a relatively newer branch of pharmacy that involvesit’s a relatively newer branch of pharmacy that involves the procurement , compounding , dispensing and qualitythe procurement , compounding , dispensing and quality control of radioactive pharmaceuticals intended to becontrol of radioactive pharmaceuticals intended to be used for investigation or treatment of some diseases inused for investigation or treatment of some diseases in humans or animalshumans or animals • PRACTICE OF NUCLEAR PHARMACYPRACTICE OF NUCLEAR PHARMACY • nuclear pharmacy is a patient oriented service thatnuclear pharmacy is a patient oriented service that embodies the scientific knowledge and professionalembodies the scientific knowledge and professional judgment required to improve and promote healthjudgment required to improve and promote health through assurance of safe and officious use of drugs forthrough assurance of safe and officious use of drugs for diagnosis and therapydiagnosis and therapy • General activities of nuclear pharmacy areGeneral activities of nuclear pharmacy are
  16. 16. Procurement and storageProcurement and storage • Because of the short life of the radiopharmaceuticals the nuclearBecause of the short life of the radiopharmaceuticals the nuclear pharmacist will order the drug directly from manufacturer usuallypharmacist will order the drug directly from manufacturer usually through over night deliverythrough over night delivery • In addition knowledge of calibration time shipping/ deliveryIn addition knowledge of calibration time shipping/ delivery schedules and radio active decay associated with the ordered radioschedules and radio active decay associated with the ordered radio pharmaceutical weigh heavily in the ordering processpharmaceutical weigh heavily in the ordering process • Isotope storage areas should be as per the rules. there should be aIsotope storage areas should be as per the rules. there should be a separate lab for the manipulation and preparation of radioseparate lab for the manipulation and preparation of radio pharmaceutical dosage and another for calibration of doses.pharmaceutical dosage and another for calibration of doses. treatment room must also be differenttreatment room must also be different
  17. 17. Preparation of the radioPreparation of the radio pharmaceuticalpharmaceutical • Radio nuclide generator can be defined as convenient means ofRadio nuclide generator can be defined as convenient means of producing in lab a plentiful supply of short lived radioproducing in lab a plentiful supply of short lived radio pharmaceuticalpharmaceutical • If this radio nuclide has the same atomic number as one of theIf this radio nuclide has the same atomic number as one of the nuclides already present in the molecule, the addition or substitutionnuclides already present in the molecule, the addition or substitution is termed as isotope labeling ( eg sodium o-iodohippurate inis termed as isotope labeling ( eg sodium o-iodohippurate in which some of the iodine -127 atoms have been replaced by iodinewhich some of the iodine -127 atoms have been replaced by iodine -125 atoms)-125 atoms) • On the other hand a substance may be selected as a medium forOn the other hand a substance may be selected as a medium for introducing into subject a radionuclide having an atomic numberintroducing into subject a radionuclide having an atomic number which differs from any other nuclide already present in substancewhich differs from any other nuclide already present in substance which is called as non –isotopic labelling or sometimes foreignwhich is called as non –isotopic labelling or sometimes foreign labellinglabelling
  18. 18. 99mtc is formed by the decay of 99mo99mtc is formed by the decay of 99mo in a radionuclide generatorin a radionuclide generator
  19. 19. Formulation issueFormulation issue • The radio pharmaceuticals have very short usableThe radio pharmaceuticals have very short usable life of the radio active product compared withlife of the radio active product compared with injectable pharmaceuticals . In contrast to ordinaryinjectable pharmaceuticals . In contrast to ordinary pharmaceutical many radio pharmaceuticals havepharmaceutical many radio pharmaceuticals have to be manufactured and quality tested and thento be manufactured and quality tested and then administered to the patient within a short period ofadministered to the patient within a short period of time, often within the same working day fromtime, often within the same working day from dispensing point of view the presence ofdispensing point of view the presence of radioactivity in a pharmaceutical has followingradioactivity in a pharmaceutical has following connotationsconnotations • A) the radio active properties must be specified on the labelA) the radio active properties must be specified on the label • B) in controlling the conventional pharmaceutical qualitiesB) in controlling the conventional pharmaceutical qualities
  20. 20. • Formulation of radio pharmaceuticals isFormulation of radio pharmaceuticals is therefore a bit more complex than normaltherefore a bit more complex than normal pharmaceuticals. Good Radiationpharmaceuticals. Good Radiation Practices (GRPs) and GoodPractices (GRPs) and Good Manufacturing Practices (GMPs) shouldManufacturing Practices (GMPs) should be strictly followed during manufacturingbe strictly followed during manufacturing and dispensing operationsand dispensing operations
  21. 21. Code of good radiation practicesCode of good radiation practices (GRP)(GRP) • Strict personnel hygieneStrict personnel hygiene • Avoidance of risk methodologyAvoidance of risk methodology • Operations only in the recommended zones of the hotOperations only in the recommended zones of the hot lablab • Proper techniques of distance and shieldingProper techniques of distance and shielding • Isolated storage , refrigeration of radionuclides andIsolated storage , refrigeration of radionuclides and labelled compoundslabelled compounds • Trial run using dummy or inactive sourceTrial run using dummy or inactive source • Adequate washing facilities including showersAdequate washing facilities including showers • Proper in service training of qualified personnelProper in service training of qualified personnel
  22. 22. • Drawing out a manual of standardized procedures ofDrawing out a manual of standardized procedures of safe handling and step by step processing , testingsafe handling and step by step processing , testing and waste disposal of radio active compounds andand waste disposal of radio active compounds and animalsanimals • Facilities of minimizing radiation levels , removal ofFacilities of minimizing radiation levels , removal of surface and air borne contaminants , calibration andsurface and air borne contaminants , calibration and maintenance of instruments for radioactivitymaintenance of instruments for radioactivity measurementsmeasurements • Provision of appropriate personnel monitoring andProvision of appropriate personnel monitoring and protective devicesprotective devices • Periodic inspection of protective devices for wearPeriodic inspection of protective devices for wear and tear and performanceand tear and performance • Establishment of well understood emergencyEstablishment of well understood emergency proceduresprocedures • Proper documentation system is required by lawProper documentation system is required by law
  23. 23. Code Of Good ManufacturingCode Of Good Manufacturing Practices (GMP)Practices (GMP) • Proper selection and in service training ofProper selection and in service training of qualified personnelqualified personnel • Drawing out of in house specifications forDrawing out of in house specifications for raw materialsraw materials • Generating test and storage standardsGenerating test and storage standards • Drawing out a manual of standardizedDrawing out a manual of standardized procedures of safe handling and step byprocedures of safe handling and step by step processing ,testing and wastestep processing ,testing and waste disposaldisposal
  24. 24. • Assignment of responsibilities in writingAssignment of responsibilities in writing • Facilities for minimizing of surface andFacilities for minimizing of surface and airborne contamination routineairborne contamination routine • Periodic inspection of protective devicesPeriodic inspection of protective devices for wear and tear and performancefor wear and tear and performance • Establishment of well understoodEstablishment of well understood emergency proceduresemergency procedures • Proper documentation system is requiredProper documentation system is required by lawby law
  25. 25. Dispensing of radiopharmaceuticalsDispensing of radiopharmaceuticals • the dispensing of radiopharmaceuticals should be safe,the dispensing of radiopharmaceuticals should be safe, straightforward and reliablestraightforward and reliable • An important factor in radiopharmaceutical dispensingAn important factor in radiopharmaceutical dispensing has been the production of ready to use kits or cold kitshas been the production of ready to use kits or cold kits which provide individual/ multiple doses and can bewhich provide individual/ multiple doses and can be reconstituted by the addition of the radionuclide at thereconstituted by the addition of the radionuclide at the time of intended use.time of intended use. • chemical reagents are prepared in a sterile environmentchemical reagents are prepared in a sterile environment using apyrogenic raw materials and dispensed intousing apyrogenic raw materials and dispensed into single/multiple unit dose containers . The preparation ofsingle/multiple unit dose containers . The preparation of individual doses can be carried out rapidly and safelyindividual doses can be carried out rapidly and safely when required with minimum manipulationwhen required with minimum manipulation
  26. 26. • The cold kit preparation should be capableThe cold kit preparation should be capable of terminal sterilization preferably byof terminal sterilization preferably by autoclaving or if not by membrane filtrationautoclaving or if not by membrane filtration for removal of microbesfor removal of microbes • Radio pharmaceuticals never go directly toRadio pharmaceuticals never go directly to the patient they are provided to trainedthe patient they are provided to trained health care professionals at the hospital orhealth care professionals at the hospital or clinic and then administered to the patientclinic and then administered to the patient
  27. 27. Compounding of radio pharmaceuticalsCompounding of radio pharmaceuticals requires receipt (or anticipation) of:requires receipt (or anticipation) of: • a valid prescription/drug ordera valid prescription/drug order • appropriate components, supplies, andappropriate components, supplies, and equipmentequipment • a suitable environment, especially for sterilea suitable environment, especially for sterile dosage formsdosage forms • appropriate recordkeeping, including wittenappropriate recordkeeping, including witten procedures and lot-specific in formation toprocedures and lot-specific in formation to ensure traceability;ensure traceability; • Validation/verification of the compoundingValidation/verification of the compounding
  28. 28. Directions while compoundingDirections while compounding • Involves reconstituting reagent kits, radio labeling, andInvolves reconstituting reagent kits, radio labeling, and strict aseptic technique must be followed duringstrict aseptic technique must be followed during compounding.compounding. • A kit involves pre-packed set of sterile ingredients.A kit involves pre-packed set of sterile ingredients. • The freeze-dried kit is reconstituted by asepticallyThe freeze-dried kit is reconstituted by aseptically transferring the necessary activity of sodiumtransferring the necessary activity of sodium pertechnetate using a sterile syringe and needle.pertechnetate using a sterile syringe and needle. • The reconstituted kit is aseptically subdivided to provideThe reconstituted kit is aseptically subdivided to provide each patient dose with a sufficient activity aftereach patient dose with a sufficient activity after administration.administration. • A diluents may be added to the final dose to give theA diluents may be added to the final dose to give the desired radioactive concentration.desired radioactive concentration.
  29. 29. Radiopharmaceutical productRadiopharmaceutical product
  30. 30. • Radiopharmaceuticals are generally expected toRadiopharmaceuticals are generally expected to conform to specifications under the followingconform to specifications under the following heading:heading: a.a. Radionuclide concentrationRadionuclide concentration b.b. Radiochemical purityRadiochemical purity c.c. Chemical purityChemical purity d.d. SterilitySterility e.e. ApyrogenicityApyrogenicity f. Absence of foreign particulate matter g. Particle size (if appropriate) h. pH i. Biological distribution
  31. 31. LabellingLabelling All products should be clearly identified by label which mustAll products should be clearly identified by label which must remain permanently attached to the containers under allremain permanently attached to the containers under all storage conditionstorage condition The label on the container should show the;The label on the container should show the; a). Name of the drug product and product code, b). Thea). Name of the drug product and product code, b). The name of radio nuclide, c). The name of manufacturer orname of radio nuclide, c). The name of manufacturer or the company, d). The radioactivity per unit dose, e). Thethe company, d). The radioactivity per unit dose, e). The route of administration, f). The expiry date, g). Theroute of administration, f). The expiry date, g). The amount of radioactivity at dispatch time and h). In caseamount of radioactivity at dispatch time and h). In case of cold kits; -the direction of preparing and -a statementof cold kits; -the direction of preparing and -a statement of shelf life of the prepared radio pharmaceutical andof shelf life of the prepared radio pharmaceutical and -the radiation dose that the patient would receive-the radiation dose that the patient would receive
  32. 32. Production and distribution recordsProduction and distribution records • The processing records of regular productionThe processing records of regular production batches must provide a complete account of thebatches must provide a complete account of the manufacturing history of each batch of a radiomanufacturing history of each batch of a radio pharmaceutical, showing that it has beenpharmaceutical, showing that it has been manufactured, tested, dispersed into containersmanufactured, tested, dispersed into containers and distributed in accordance.and distributed in accordance. • Separate records for the recent storage, use andSeparate records for the recent storage, use and disposal of radio active products must bedisposal of radio active products must be maintained.maintained. • Distribution records should be kept since theDistribution records should be kept since the return of radioactive products is not practical, thereturn of radioactive products is not practical, the purpose of recall procedures for such productspurpose of recall procedures for such products is to prevent their use rather than actual return.is to prevent their use rather than actual return.
  33. 33. – DispensingDispensing  Recommends dosage levels based onRecommends dosage levels based on patient history, age, weight, surface area,patient history, age, weight, surface area, and/or other factorsand/or other factors  Dispenses prescriptions in conjunction withDispenses prescriptions in conjunction with applicable pharmacy law and keepsapplicable pharmacy law and keeps appropriate recordsappropriate records
  34. 34. -Dispensing-Dispensing  Develops policies and procedures to ensure that theDevelops policies and procedures to ensure that the correct drug in the correct dosage and dosage form iscorrect drug in the correct dosage and dosage form is received by the correct patient at the correct time viareceived by the correct patient at the correct time via the correct route of administrationthe correct route of administration  Develops policies and procedures, supervises, andDevelops policies and procedures, supervises, and reviews the activities of non-pharmacist personnelreviews the activities of non-pharmacist personnel under the pharmacist's supervisionunder the pharmacist's supervision
  35. 35. -Distribution-Distribution Complies with all applicable regulations concerning packaging,Complies with all applicable regulations concerning packaging, labeling, and transportation of radioactive and other materialslabeling, and transportation of radioactive and other materials (e.g., biohazards), demonstrating knowledge of:(e.g., biohazards), demonstrating knowledge of:  DOT regulations concerning packaging, labeling, andDOT regulations concerning packaging, labeling, and transportation of radioactive and other materials.transportation of radioactive and other materials.  Proper procedures and use of equipment necessary toProper procedures and use of equipment necessary to verify that package meet DOT requirementverify that package meet DOT requirement
  36. 36. HEALTH & SAFETYHEALTH & SAFETY  AllergiesAllergies • If you will be receiving albumin in the form ofIf you will be receiving albumin in the form of radioiodinated albumin, technetium Tc 99m albuminradioiodinated albumin, technetium Tc 99m albumin aggregated, technetium Tc 99m albumin colloid, oraggregated, technetium Tc 99m albumin colloid, or technetium Tc 99m albumin for your test, tell your doctortechnetium Tc 99m albumin for your test, tell your doctor if youif you • have ever had any unusual or allergic reaction tohave ever had any unusual or allergic reaction to products containingproducts containing • human serum albumin.human serum albumin.
  37. 37. HEALTH & SAFETYHEALTH & SAFETY  PregnancyPregnancy • Radiopharmaceuticals usually are not recommendedRadiopharmaceuticals usually are not recommended for use during pregnancy. This is to avoid exposing thefor use during pregnancy. This is to avoid exposing the fetus to radiation.fetus to radiation. • This is especially important with radiopharmaceuticalsThis is especially important with radiopharmaceuticals that contain radioactive iodine, which can go to thethat contain radioactive iodine, which can go to the baby's thyroid gland and, in high enough amounts, maybaby's thyroid gland and, in high enough amounts, may cause thyroid damage.cause thyroid damage.
  38. 38. HEALTH & SAFETYHEALTH & SAFETY  Breast-feedingBreast-feeding • Some radiopharmaceuticals pass into theSome radiopharmaceuticals pass into the breast milk and may expose the baby tobreast milk and may expose the baby to radiation. If you must receive aradiation. If you must receive a radiopharmaceutical, it may be necessary forradiopharmaceutical, it may be necessary for you to stop breast-feeding for some time afteryou to stop breast-feeding for some time after receiving it.receiving it.
  39. 39. HEALTH & SAFETYHEALTH & SAFETY  ChildrenChildren • For most radiopharmaceuticals, the amountFor most radiopharmaceuticals, the amount of radiation used for a diagnostic test is very lowof radiation used for a diagnostic test is very low and considered safe.and considered safe.
  40. 40. HEALTH & SAFETYHEALTH & SAFETY • Side effectsSide effects • When radiopharmaceuticals are used in veryWhen radiopharmaceuticals are used in very small doses to study an organ of the body, sidesmall doses to study an organ of the body, side effects are rare and usually involve an allergiceffects are rare and usually involve an allergic reaction. These effects may occur almostreaction. These effects may occur almost immediately or a few minutes after theimmediately or a few minutes after the radiopharmaceutical is given.radiopharmaceutical is given.
  41. 41. HEALTH & SAFETYHEALTH & SAFETY > Are radiopharmaceuticals safe?> Are radiopharmaceuticals safe? • Absolutely. Like any medicine, with great care.Absolutely. Like any medicine, with great care. Before they or tested carefully.Before they or tested carefully. • The quantity of the pharmaceutical part ofThe quantity of the pharmaceutical part of the radiopharmaceutical is very small, generallythe radiopharmaceutical is very small, generally 1/10th of a millionth of an ounce. The risk of a1/10th of a millionth of an ounce. The risk of a reaction is 2-3 incidents per 100,000 injections,reaction is 2-3 incidents per 100,000 injections, over 50% of which are rashes, as comparedover 50% of which are rashes, as compared toto 2000-3000 per 100,000 injections of x-ray2000-3000 per 100,000 injections of x-ray contrast media.contrast media.
  42. 42. HEALTH & SAFETYHEALTH & SAFETY >Is the radioactivity harmful? • Although exposure to radioactivity in veryAlthough exposure to radioactivity in very large doses can be harmful, thelarge doses can be harmful, the radioactivity in radiopharmaceuticals isradioactivity in radiopharmaceuticals is carefully selected by the nuclear medicinecarefully selected by the nuclear medicine physician to be safe.physician to be safe.
  43. 43. RADIATION SAFETYRADIATION SAFETY PROCEDURESPROCEDURES • RadiationRadiation Safety is a term applied to conceptsSafety is a term applied to concepts requirements, technologies and operations related torequirements, technologies and operations related to protection of people against the harmful effects ofprotection of people against the harmful effects of ionizing radiation.ionizing radiation. Safe Handling of Radio Isotopes :Safe Handling of Radio Isotopes : • Good radiation practices GRP needs to be strictlyGood radiation practices GRP needs to be strictly followed for operations with unrelated sources to reducefollowed for operations with unrelated sources to reduce the chances of getting unwanted and avoidablethe chances of getting unwanted and avoidable radiation exposure.radiation exposure.
  44. 44. • It is necessary to mark the area in which theIt is necessary to mark the area in which the radio active work is carried out and it should beradio active work is carried out and it should be monitored regularly at periodic intervals.monitored regularly at periodic intervals. • Unnecessary movements of persons orUnnecessary movements of persons or materials should be avoided in the hot laboratorymaterials should be avoided in the hot laboratory or radiopharmacy.or radiopharmacy. • All the radiation workers must wear suitableAll the radiation workers must wear suitable protective clothing and radiation monitoringprotective clothing and radiation monitoring devices.devices. • Surgical gloves is necessary. When not in use,Surgical gloves is necessary. When not in use, the radionuclides must be kept in sealedthe radionuclides must be kept in sealed containers.containers. • The area should be surveyed regularly for bothThe area should be surveyed regularly for both contamination and exposure hazards.contamination and exposure hazards.
  45. 45. • Do not pipette by mouth. Work areas should beDo not pipette by mouth. Work areas should be covered with a plastic glass or stainless tray withcovered with a plastic glass or stainless tray with absorbent paper should be use to catch anyabsorbent paper should be use to catch any spills and to prevent the spread ofspills and to prevent the spread of contamination.contamination. • Do not eat, drink and smoke in areas whereDo not eat, drink and smoke in areas where unsealed radionuclides are stored.unsealed radionuclides are stored. • Wash hands thoroughly.Wash hands thoroughly. • The radiation survey meter should be used toThe radiation survey meter should be used to ensure safety of worker and public, survey andensure safety of worker and public, survey and wipe test suggested action levels .wipe test suggested action levels . For unrestricted area 0.25 mR/hr over background.For unrestricted area 0.25 mR/hr over background. For restricted area 20 mR/hr over background.For restricted area 20 mR/hr over background.
  46. 46. WASTE STORAGE ANDWASTE STORAGE AND DISPOSALDISPOSAL • Radioactive materials no longer required must beRadioactive materials no longer required must be disposed to avoid an environmental hazard.disposed to avoid an environmental hazard. • Avoid practice that produces large volume of waste.Avoid practice that produces large volume of waste. • Dilute and dispense for low level solid, liquid andDilute and dispense for low level solid, liquid and gaseous waste.gaseous waste. • Segregate waste according to half-lives, delay andSegregate waste according to half-lives, delay and decay for waste that contain short lived nuclides. Labeldecay for waste that contain short lived nuclides. Label the waste before storing. Release into sewage systemthe waste before storing. Release into sewage system depending on water flow .depending on water flow . • Longer T1/2 radionuclides should be incinerated orLonger T1/2 radionuclides should be incinerated or deeply burnt in soil in a separately marked area.deeply burnt in soil in a separately marked area.
  47. 47. ReferenceReference • Hospital Pharmacy-William HassanHospital Pharmacy-William Hassan • Ansels Pharmaceutical Dosage Form AndAnsels Pharmaceutical Dosage Form And Drug DeliveryDrug Delivery • Pharmaceutical Practice-Winfield NPharmaceutical Practice-Winfield N RichardsRichards
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