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Radiopharmaceutical facilities in pakistan 1
- 2. Contents • Introduction • Principle • Advantages/Disadvantages • Safety Profile • Protocols for handling • Storage • Application • Facilities in Pakistan 2
- 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. 4
- 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. 5
- 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. 6
- 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. 7 Principle
- 8. Advantages and Disadvantages of Radiopharmaceuticals 8
- 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
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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. 22
- 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. 23
- 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. 24
- 25. Storage and Applications of Radiopharmaceuticals 25
- 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. 26
- 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. 27
- 28. Applications of Radiopharmaceuticals • Radioisotopes and Radiopharmaceuticals are widely used in many branches of medicine and surgery: • Diagonstic applications • Radiotherapy • Sterilization techniques • Research applications 28
- 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. 29
- 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. 31
- 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. 32
- 33. Facilities Available in Pakistan 33
- 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 34
- 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 43