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Radiopharmaceuticals Design and safety handling

Radiopharmaceuticals used in cancer treatment are small, simple substances, containing a radioactive isotope or form of an element. They are targeted to specific areas of the body where cancer is present. Radiation emitted from the isotope kills cancer cells. These isotopes have short half-lives,

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Radiopharmaceuticals Design and safety handling

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    1. Radiopharmaceuticals Design and safety handling

    2. Radiopharmaceuticals used in cancer treatment are small, simple substances, containing a radioactive isotope or form of an element. They are targeted to specific areas of the body where cancer is present. Radiation emitted from the isotope kills cancer cells. These isotopes have short half-lives, meaning that most of the radiation is gone within a few days or weeks. 2222

    3. Application of radiopharmaceuticals Treatment of disease: (therapeutic radiopharmaceuticals) Chromic phosphate P32 for lung, ovarian, uterine, and prostate cancers Sodium iodide I 131 for thyroid cancer Samarium Sm 153 for cancerous bone tissue Sodium phosphate P 32 for cancerous bone tissue and other types of cancers Stronium chloride Sr 89 for cancerous bone tissue

    5. Strontium-89 is injected into a vein. The usual dosage is 4 millicuries, depending on age, body size, and blood cell counts. Repeated doses may be required. The usual dosage of samarium Sm 153 lexidronam is 1 millicurie per kg (0.45 millicurie per lb) of body weight, injected slowly into a vein. Repeated doses may be necessary. Because samarium Sm 153 lexidronam may accumulate in the bladder, it is important to drink plenty of liquid prior to treatment and to urinate often after treatment. This reduces the irradiation of the bladder.

    6. The dosage of sodium phosphate P 32 depends on age, body size, blood cell counts, and the type of treatment. The usual dosages range from 1–5 millicuries. Repeated doses may be required.

    7. Precautions Before Treatment With Sodium Iodide I 131 Foods containing iodine, such as iodized salt, seafoods, cabbage, kale, or turnips, should be avoided for several weeks prior to treatment with sodium iodide I 131. The iodine in these foods will be taken up by the thyroid, thereby reducing the amount of radioiodide that can be taken up. Radiopaque agents containing iodine sometimes are used to improve imaging on an x ray. A recent x-ray exam that included such an agent may interfere with the ability of the thyroid to take up radioiodide.

    8. Precautions After Treatment With Radiopharmaceuticals Strontium-89, samarium Sm 153 lexidronam, and large total doses of sodium iodide I 131 may temporarily lower the number of white blood cells, which are necessary for fighting infections. The number of blood platelets (important for blood clotting) also may be lowered. Precautions for reducing the risk of infection and bleeding include: avoiding people with infections seeking medical help at the first sign of infection or unusual bleeding using care when cleaning teeth avoiding touching the eyes or inside of the nose avoiding cuts and injuries

    9. It is important to drink plenty of liquids and to urinate often after treatment with sodium iodide I 131. This flushes the radioiodide from the body. To reduce the risk of contaminating the environment or other people, the following procedures should be followed for 48–96 hours after treatment is sodium iodide I 131: avoiding the handling of another person's eating utensils, etc. avoiding close contact with others, especially pregnant women washing hands after using or cleaning the toilet using separate washcloths and towels washing clothes, bed linens, and dishes separately flushing the toilet twice after each use

    10. I131 THERAPY PROCEDURES   Minor therapies of I131 are single doses of 30 mCi or less. Major therapies of I131 are single doses greater than 30 mCi. Handling Instructions      All I 131 should be opened under a fume hood prior to administration to a patient to allow for escape of vapor in the vial. The activity of each dosage shall be measured in a dose calibrator and verified to be within 10% of the prescribed dose.    Since the exposure rate on the outside of the lead pig and shipping box may be quite high, adequate precautions must be taken when transporting sources.

    12. The dose is usually administered with the patient sitting on the edge of the bed. The bedside table should be covered with an absorbent pad. A physicist or technician from Radiation Safety must be present during administration and is responsible for disposing of the waste. The patient must remain hospitalized until the activity is less than 30 mCi or the measured dose rate at one meter from the patient is less than five millirems per hour.      The nursing instruction form contains specific rules for care of the patient by nurses, visitors restrictions, and handling waste, linens, and eating utensils.     

    13. Patient rooms used for major therapies may not be released for use by other patients until documented surveys by Radiation Safety staff demonstrate that there is no removable contamination in excess of 200 dpm/100 cm2.

    14. Therapeutic procedures can usually be divided into two classes: Treatment with sealed sources, which are mechanically inserted. Treatment with solutions. Sealed sources are encapsulated and therefore the risk of contamination is very small Ex. Radiopharmaceutical Iodine-125 seeds, used to treat prostate cancer. Ex of radiopharmaceutical solutions, Iodine-131, Strontium-89

    15. As an aid in the diagnosis of disease (diagnostic radiopharmaceuticals) Radiopharmaceuticals used in tracer techniques for measuring physiological parameters (e.g. 51 Cr-EDTA for measuring glomerular filtration rate). Radiopharmaceuticals for diagnostic imaging (e.g. 99m TC-methylene diphosphonate (MDP) used in bone scanning).

    16. Radiopharmaceuticals can be classified into four categories: 1- Ready-for-use radioactive products. 2- Radionuclide generators. 3-Non-radioactive components (kits) for the preparation of compounds with a radioactive component (usually the elute from a radionuclide generator). 4- Precursors used for radiolabeling other substances before administration.

    18. There are three units related to radiation: ( R) the roentgen for exposure Is the amount of x or ? radiation that produces ionization of one electrostatic unit of either positive or negative charge per cubic centimeter of air at 0 ºC and 760 mmHg.

    19. (rad) radiation absorbed dose is a more universal unit, it is a measure of the energy deposited in unit mass of any material by any type of radiation. The dose equivalent unit (rem) roentgen equivalent man rem has been developed to account for the differences in effectiveness of different radiations in causing biological damage. In radiobiology, the rem is defiend as Rem= rad ? RBE RBE is the relative biological effectiveness of the radiation.

    20. The basic unit for quantifying radioactivity (i.e. describes the rate at which the nuclei decay). Curie (Ci): A unit of radioactivity. A curie is defined as 3.7 x 1010 disintegrations per second. In 1980, The new basic unit for quantifying radioactivity. Becquerel (Bq): A unit of radioactivity. One becquerel is equal to 1 disintegration per second.

    21. Generator, Radionuclide: A device in which a short-lived daughter is separated chemically and periodically from a long-lived parent adsorbed on adsorbent material. For example, 99mTc is separated from 99Mo from the molybdenum generator by eluting with saline. Half-Life (Tl/2): A unique characteristic of a radionuclide, defined by the time during which an initial activity of a radionuclide is reduced to one half. It is related to the decay constant (?) by tl/2 = 0.693/?.

    23. Labeled Compound: A compound containing radionuclide as integral component of the molecule. Radiolysis: A process by which radio labeled compounds are broken up by radiations from the radionuclide in labeled molecules. Radiosynthesizer Unit (RSU) A closed-system device for the automated synthesis of radioactive drug substances. The system may be controlled by graphical computer software programs.

    25. Standard operating procedure (SOP): An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.

    27. Radiation protection principles: There are several types of radiation that can be emitted from radioactive substances. The basic types of radiation are alpha, beta and gamma. Radiopharmaceuticals administered to patients are usually either beta or gamma emitting or a combination of both. Beta radiation doesn't penetrate more than a few millimeters through tissue. Gamma emitting radioactive materials can penetrate through tissue and therefore pose an external radiation hazards.

    28. There is an important difference between radiation exposure and radioactive contamination. Radiation exposure of a person can occur at a distance from the radioactive materials or source. Radiation exposure usually occurs as a result of gamma rays being emitted by the radioactive materials and traveling through air. Gamma rays that are absorbed by the body can cause harm.

    29. If a person is contaminated it means that the person has come into contact with a radioactive substance and that this material is present on skin, clothing or on objects. Contamination is hazardous because the radioactive materials can be inhaled or ingested.

    33. Services   Biological Safety Chemical Safety EHOS Fire safety Radiation safety

    34. The regulatory procedures necessary to control radiopharmaceutical products are in large part determined by the source of these products and methods of manufacture. Manufacturing procedures within the scope of these guidelines include: The manufacturing of radiopharmaceuticals in centralized radiopharmacies. The manufacturing of radiopharmaceuticals in nuclear and institutes and industrial manufacturers. The manufacturing of radiopharmaceuticals in positron emission tomography (PET) centers.

    35. Introduction Radiopharmacy’s prime responsibility is the preparation of high quality, radioactive, medicinal products for use in diagnosis and therapy.  Our products are Medicines and are made under the terms of a Department of Health Manufacturing “Specials” license.  Our manufacturing facility in Medical Physics is an aseptic suite designed to accommodate the handling of radioactive substances, mostly short lived materials emitting gamma radiation. The manufacturing facilities are regularly audited by Medicines Control Agency and Environment Agency Inspectors. Facilities

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