radiopharmaceuticals advantages and disadvantages of radiopharmaceuticals protocols of handling and application of radiopharmaceuticals

1. RADIOPHARMACEUTI
CALS
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2. Contents
• Introduction
• Principle
• Advantages/Disadvantages
• Safety Profile
• Protocols for handling
• Storage
• Application
• Facilities in Pakistan
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3. Introduction and Principle
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4. INTRODUCTION
• Radiopharmaceuticals are unique medicinal formulations containing
radioisotopes which are used in major clinical areas for diagnosis
and/or therapy.
• The facilities and procedures for the production, use, and storage of
radiopharmaceuticals are subject to licensing by national and/or
regional authorities. This licensing includes compliance both with
regulations governing pharmaceutical preparations and with those
governing radioactive materials. Additional regulations may apply for
issues such as transportation or dispensing of radiopharmaceuticals.
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5. Radiopharmaceuticals can be divided into four
categories:
1-Radiopharmaceutical preparation
A radiopharmaceutical preparation is a medicinal product in a ready-to-use
form suitable for human use that contains a radionuclide. The radionuclide is
integral to the medicinal application of the preparation, making it appropriate
for one or more diagnostic or therapeutic applications.
2-Radionuclide generator
A system in which a daughter radionuclide (short half-life) is separated by
elution or by other means from a parent radionuclide (long half-life) and later
used for production of a radiopharmaceutical preparation.
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6. Continued
3- Radiopharmaceutical precursor
A radionuclide produced for the radiolabeling process with a resultant
radiopharmaceutical preparation.
4- Kit for radiopharmaceutical preparation
In general a vial containing the nonradio nuclide components of a
radiopharmaceutical preparation , usually in the form of a sterilized,
validated product to which the appropriate radionuclide is added or in
which the appropriate radionuclide is diluted before medical use. In
most cases the kit is a multidose vial and production of the
radiopharmaceutical preparation may require additional steps such as
boiling, heating, filtration and buffering. Radiopharmaceutical
preparations derived from kits are normally intended for use within 12
hours of preparation.
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7. How do they work?
The radiotracer, injected into a vein, emits gamma radiation as
it decays. A gamma camera scans the radiation area and
creates an image.
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Principle

8. Advantages and Disadvantages
of Radiopharmaceuticals
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9. Advantages Of Radiopharmaceuticals
• Nuclear medicine provides functional and anatomic information.
Nuclear medicine tests provide information about the functionality of the body and
patient anatomy that are unique to other procedures available to doctors today.
This technology can even help to determine if a disease is present in the body before it
starts to cause symptoms.
• It is a useful tool for determining the status of cancer.
Not only does nuclear medicine provide information about whether a tumor is malignant
or benign, but it can also let doctors know if a cancer has metastasized or returned after
remission. The advanced imaging procedures that are possible with this technology make
it possible to identify where the cancer cells are so that another treatment option
becomes possible. This advantage eliminates the need for painful exploratory surgeries
that didn’t always provide surgeons with the detailed feedback necessary to perform a
diagnosis.
• It can also analyze the function of your spleen and kidneys, scan lungs to determine if
there are blood-flow or respiratory problems, and identify blockages that occur in the
gallbladder.

10. Continued
• This technology can provide answers for unclear or abnormal lab results.
Nuclear medicine gives doctors another option to consider for patients
who receive unclear or abnormal lab results regarding their bone health. A
three-phase scan, used in conjunction with -rays and computed
tomography or MRIs, can evaluate the source of bone pain for a patient. It
has the ability to detect cancer in the bones if it is present.
• Nuclear medicine has the ability to help the heart.
This testing method is extremely effective at diagnosing coronary artery
disease, which develops over time as plaque and cholesterol build-up to
block the supply of blood, nutrients, and oxygen to the heart. It can cause
some side effects that are unpleasant, but the results are often worth the
discomfort that the tests can create.

11. Continued
• The amount of radiation distributed to patients in this procedure is
minimal.
Before any type of procedure is used involving nuclear medicine, it must be
justifiable to ensure that the benefits to the patient outweigh whatever
risks may be present. That’s because too much exposure to radiation can
damage tissues or organs.
• The accuracy of the imaging leads to a more accurate diagnosis.
Nuclear medicine makes it easier to manage a complex diagnosis for a
patient who may be suffering from several diseases or conditions
simultaneously. It can also help surgeons perform complicated procedures
with greater accuracy, including the option for remote or robotic surgery.
This advantage makes it safer to conduct medicine because there is less
need to be invasive with the diagnostic process.

12. Continued
• Nuclear medicine provides a painless way to gather information.
Nuclear imaging is painless, safe, and often cost-effective. That’s why it is a
popular choice when doctors need to gather information that may be unavailable
or too risky to obtain when using other diagnostic tests.
• There are therapeutic benefits to consider.
It is also useful in the treatment of thyroid cancer and issues with
hyperthyroidism. Some blood disorders can stabilize when this option is available
for use as well.
• Most of the radioactivity will pass through the body.
The radiation dosages involved with nuclear medicine are carefully measured and
handled so that everyone stays safe. Once you take the radiopharmaceuticals or
tracers, then the particles that give off the gamma rays will eventually pass out of
the body in the urine or your stool. Anything that remains afterward will typically
disappear over time because of the natural loss of radioactivity.

13. Disadvantages Of Radiopharmaceuticals
• It may offer adverse impacts on women who are pregnant or
breastfeeding. The one exception here is for women who are
pregnant or breastfeeding so that a doctor can determine if a specific test
is safe for the baby.
• There is a threat of severe allergic reactions with nuclear medicine.
Most of the side effects that people experience when using tracers or
undergoing a treatment involve dizziness, abnormal heart rhythms,
headaches, and a temporary dip in their blood pressure numbers.
• The cost of nuclear medicine is unmanageable without insurance or
subsidies.
Most people cannot afford the cost of nuclear medicine unless they have
health insurance that covers the procedure or subsidies from the
government that reduces their obligation.

14. Continued
• Nuclear medicine does not provide a 100% accuracy rate.
Medical procedures and diagnoses are more accurate thanks to nuclear
medicine, but it is also not a perfect system. There can still be failures that
occur because of the principle of individual variability.
• There are specific preparations you must follow to be ready for a
procedure.
If your doctor wants to use nuclear medicine to scan for inflammation,
bone-related pain, lymphatic system issues, renal concerns, pulmonary
health, or brain conditions, then there are no special preparations required
for the procedure under most circumstances. If your condition falls outside
of that window, then you may need to follow some specific instructions to
ensure that the result of the imaging is reflective of your current health
status.

15. Continued
• Thyroid scans can require the stoppage of specific medications prior to the
scan, which means a delay of 2-4 weeks may be necessary for some
situations.
Cardiac exams require at least 4 hours of fasting before the procedure.
• You must stay for the entire appointment.
Nuclear medicine is not a treatment option that you can suspend because
you have a family or work emergency developing. You must stay for the
entire appointment for the results to be useful, which means it could be a
long-time commitment in some situations.
• Some patients may require a catheter in the bladder.
There are some special studies that nuclear medicine can complete that
may require a catheter to be placed in the bladder. This process can often
cause temporary discomfort that may last for some time after the tubing is
removed

16. Safety Profile
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21. Protocols for Handling
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22. Protocols for Handling
All doses will be handled with the concept of ALARA (As low as reasonably Achievable).
Procedures/Recommendations in Appendix T of WisReg will be followed, as listed below.
1. Attire a. Wear laboratory coats or other protective clothing at all times in areas where
radioactive materials are compounded or administered. b. If compounding a multi-
dose kit, wear appropriate attire as outlined in policies for compounding of sterile
pharmaceuticals, which includes radiopharmaceuticals (see Pharmacy P&P 6.1) c.
Wear disposable gloves at all times while handling radioactive materials.
2. 2. Product Preparation a. Use appropriate kit vial shields when compounding
radiopharmaceuticals b. Use syringe shields for reconstitution of radiopharmaceutical
kits and administration of radiopharmaceuticals to patients, except when their use is
contraindicated (e.g., recessed veins, infants). In these exceptional cases, use other
protective methods, such as remote delivery of the dose (e.g., use a butterfly needle.)
c. Use tongs, when possible, when manipulating syringes during compounding or
assaying d. Do not eat, store food, drink, smoke, or apply cosmetics in any area where
licensed material is stored or used. e. Never pipette by mouth.
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23. Continued
3. Product Dose Verification a. For prepared dosages, assay each patient
dosage in the dose calibrator (or instrument) before administering it.
4. Monitoring of Employee Radiation Exposure
a. After each procedure, or before leaving the area, monitor your hands for
contamination in a low-background area using an appropriate survey instrument.
b. Wear personnel monitoring devices, if required, at all times while in areas where
radioactive materials are used or stored.
1. These devices shall be worn as prescribed by the RSO.
2. 2. When not being worn to monitor occupational exposures, personnel monitoring devices
shall be stored in the work place in a designated low-background area.
c. Wear extremity dosimeters, if required, when handling radioactive material.
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24. Continued
5.Monitoring and Surveying for Radioactive Materials
a .Wipe-test unsealed radioactive material storage, preparation, and
administration areas weekly for contamination.
1. If necessary, decontaminate the area.
b. Survey with a radiation detection survey meter all areas of licensed material
use, including the generator storage, kit preparation, and injection areas daily for
contamination.
1. If necessary, decontaminate the area.
2. Areas used to prepare and administer radiopharmaceutical therapies must be surveyed
c. Store radioactive solutions in shielded containers that are clearly labeled.
6. Disposal of Radioactive Waste a. Dispose of radioactive waste only in
designated, labeled, and properly shielded receptacles.
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25. Storage and Applications of
Radiopharmaceuticals
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26. Storage
• In order to have protection from hazards of radiation, radioactive
materials must be stored in an area not frequently visited by people.
• Shielding may be required. Thick glass or Perspex Containers provide t
shielding.
• To protect from gamma rays (high penetration power), lead shielding
has to be used.
• The storage area should be regularly checked for radioactivity via
radioactive detectors.
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27. Continued
• Radiopharmaceuticals should be stored in airtight, suitable labelled
containers shielded by brick bricks to protect personnel from
exposure to primary or secondary emission and that complies with
national and international regulations concerning the storage of
radioactive substances.
• During storage, the containers may darken due to irradiation. Such
darkening does not necessarily involve deterioration of the
preparation.
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28. Applications of Radiopharmaceuticals
• Radioisotopes and Radiopharmaceuticals are widely used in
many branches of medicine and surgery:
• Diagonstic applications
• Radiotherapy
• Sterilization techniques
• Research applications
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29. Continued
1- Diagonistic Applications:
Phosphorous 32
This is used as sodium phosphate for the diagnosis of malignant neoplasms
affecting eye, brain and skin.
Chromium 51
This is used as sodium chromate sterile solution and is used to label RBC’s to
measure their survival, volume and gastrointestinal blood losses.
Cobalt 57 and 58
These are labelled with cyanocobalamine (vit-B12) preparation for
measurement of absorption, diagnosis of pernicious anaemia and other
malabsorption syndromes.
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30. Continued
Technetium-99m complexes
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31. Continued
2- Radiotherapy:
Iodine 131 and 123
These are used in the study of thyroid function, in the treatment of
thyrotoxicosis and thyroid carcinoma.
Yttrium 90
This is used as colloidal suspension of Yttrium silicate for the treatment of
arthritic conditions of joints.
Phosphorus 32
Sodium phosphate is used in the treatment of polycynthaemia by IV
injection.
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32. Continued.
3- Sterilization Techniques
Radioisotopes are employed in the sterilization of heat liable drugs like hormones,
vitamins, antibiotics and surgical dressings disposable syringes, catheters and
surgical dressings.
Cobalt 60
In the sterilization of disposable syringes, catheters and surgical dressings.
4- Research Applications:
Radioisotopes are used in biochemical research for determination of mechanism of
reaction.
Iodine 131
Used in the determination of effective renal plasma flow.
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33. Facilities Available in Pakistan
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34. Nuclear Medicine & Radiation Therapy in
Pakistan
The Beginning
• First Nuclear Medical & Oncology center established at Karachi
(Sindh) in 1960 in JPMC, Karachi in two room barracks
• Second at Lahore (Punjab) in 1963 in basement of Mayo Hospital
OPD. Medical Isotope Institute (now called CENUM)
• Third center at Jamshoro (Sindh) in 1965. First *PAEC center to have
diagnostic as well as therapy facilities
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35. Nuclear Medicine Institutes / Departments in
Pakistan
46 NM
Institutes/Dept
18 *PAEC
25
NonPAEC/private
03 Armed Forces
*Pakistan Atomic Energy Commission

38. The Pakistan Institute of Nuclear Science and
Technology
• The Pakistan Institute of Nuclear Science and Technology (also known
as PINSTECH), is a multiprogram science and technology national
research institute managed for the Ministry of Science and
Technology (Pakistan) by the Pakistan Atomic Energy
Commission (PAEC).
• Located in Nilore, it maintains a broad portfolio in providing post-
graduate and post-doctoral research opportunities
in supercomputing, Renewable
energy, physical, philosophical, materials, environmental and mathem
atical sciences

39. Continued
PINSTECH has particle accelerators and also operates two small
nuclear research reactors, a reprocessing plant and another
experimental neutron source based on:
• PARR-I Reactor-Utilize Low-Enriched Uranium (LEU)
• PARR-II Reactor-Utilize High-Enriched Uranium (HEU)
• New Labs-Plutonium reprocessing (PR) facility.
• Charged Particle Accelerator- a nuclear particle accelerator.
• Fast Neutron Generator- An experimental neutron generator.

40. Radioisotope Processing Facilities
• Iodine-131 Production Cell (Technique).(Wet Distillation)
• Iodine-131 Production Cell (Dry Distillation Technique)
• Phosphorus-32 Production Cell (Dry Distillation Technique).
• Sulpher-35 Production Glove Box
• Molybdenum-99 Loading Facility for preparation of 99mTc
generators.(100Ci/batch)
• Mo-99 Production facility. Hot Cell with Master Slave Manipulators.
• Fume Hoods and Glove Boxes (for small scale production of different
radionuclides and R&D work)
• Workshop for target preparation and sealed source fabrication
• Laboratories for determination of radionuclidic, radiochemical and
biological purity

43. Thank-You
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