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Pharmaceutical drug which emits radiation, used as a diagnostic or therapeutic agent

Nuclear pharmacy, also known as radiopharmacy, involves preparation of radioactive materials for patient administration that will be used to diagnose and treat specific diseases in nuclear medicine. It generally involves the practice of combining a radionuclide tracer with a pharmaceutical component that determines the biological localization in the patient.^[1]^[2] Radiopharmaceuticals are generally not designed to have a therapeutic effect themselves, but there is a risk to staff from radiation exposure and to patients from possible contamination in production.^[3] Due to these intersecting risks, nuclear pharmacy is a heavily regulated field.^[4]^[5] The majority of diagnostic nuclear medicine investigations are performed using technetium-99m.^[6]

History

The concept of nuclear pharmacy was first described in 1960 by Captain William H. Briner while at the National Institutes of Health (NIH) in Bethesda, Maryland. Along with Mr. Briner, John E. Christian, who was a professor in the School of Pharmacy at Purdue University, had written articles and contributed in other ways to set the stage of nuclear pharmacy. William Briner started the NIH Radiopharmacy in 1958.^[7]^[8] John Christian and William Briner were both active on key national committees responsible for the development, regulation and utilization of radiopharmaceuticals. A technetium-99m generator was commercially available, followed by the availability of a number of Tc-99m based radiopharmaceuticals.

In the United States nuclear pharmacy was the first pharmacy specialty established in 1978 by the Board of Pharmacy Specialties.^[9]

Various models of production exist internationally. Institutional nuclear pharmacy is typically operated through large medical centers or hospitals while commercial centralized nuclear pharmacies provide their services to subscriber hospitals. They prepare and dispense radiopharmaceuticals as unit doses that are then delivered to the subscriber hospital by nuclear pharmacy personnel.

Operation

A few basic steps are typically involved in technetium based preparations. First the active technetium is obtained from a radionuclide generator on site, which is then added to a non-radioactive kit containing the pharmaceutical component. Further steps may be required depending on the materials in question to ensure full binding of the two components. These procedures are usually carried out in a clean room or isolator to provide radiation shielding and sterile conditions.^[10]^[11]

For Positron Emission Tomography (PET), Fludeoxyglucose (¹⁸F) is the most common radiopharmaceutical, with the radioactive component usually obtained from a cyclotron.^[11] The short half life of Fluorine-18 and many other PET isotopes necessitates rapid production. PET radiopharmaceuticals are now often produced by automated computer controlled systems to reduce complexity and radiation doses to staff.^[12]

Training and regulation

Radiopharmacy is a heavily regulated field, as it combines several practices and fields which may come under the purview of multiple regulators and legislation. These include occupational exposure of staff to ionising radiation, preparation of medicines, patient exposure to ionising radiation, transport of radioactive materials, and environmental exposure to ionising radiation.^[13] Different regulations may cover the various stages involved in radiopharmacies, ranging from production of "cold" (non-radioactive) kits, to the marketing and distribution of final products.^[14]

Staff working in nuclear pharmacies require extensive training on aspects of good manufacturing practice, radiation safety concerns and aseptic dispensing. In the United States an authorised nuclear pharmacist must be a fully qualified pharmacist with evidence of additional training and qualification in nuclear pharmacy practice.^[15] Several European Union directives cover radiopharmaceuticals as a special group of medicines, reflecting the wide range of types of producers and staff groups that may be involved.^[16] In the UK qualified pharmacists may be involved along with clinical scientists or technologists, with relevant training.^[17]

References

^ Christian, John E. (June 1948). "The applications of radioactive tracer techniques to pharmacy and pharmaceutical research". Journal of the American Pharmaceutical Association (Scientific Ed.). 37 (6): 250–253. doi:10.1002/jps.3030370614. PMID 18865179.
^ Vallabhajosula, Shankar; Owunwanne, Azu (2006). "Pathophysiology and Mechanisms of Radiopharmaceutical Localization". In Elgazzar, Abdelhamid H. (ed.). The pathophysiologic basis of nuclear medicine (2nd ed.). Berlin: Springer. pp. 29–49. ISBN 978-3-540-47953-6.
^ IAEA (2008). Operational guidance on hospital radiopharmacy: a safe and effective approach. Vienna: International Atomic Energy Agency. ISBN 978-92-0-106708-1.
^ Gill, J R; Turner, J L (1995). "Regulatory Requirements for the Dispensing and Supply of Radiopharmaceuticals". In Sampson, Charles B. (ed.). Textbook of radiopharmacy: theory and practice (2nd ed.). Luxembourg: Gordon and Breach. p. 181. ISBN 9782881249730.
^ Elsinga, Philip; Todde, Sergio; Penuelas, Ivan; Meyer, Geerd; Farstad, Brit; Faivre-Chauvet, Alain; Mikolajczak, Renata; Westera, Gerrit; Gmeiner-Stopar, Tanja; Decristoforo, Clemens (20 March 2010). "Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals" (PDF). European Journal of Nuclear Medicine and Molecular Imaging. 37 (5): 1049–1062. doi:10.1007/s00259-010-1407-3. PMC 2854359. PMID 20306035.
^ IAEA (2009). Technetium-99m radiopharmaceuticals: status and trends. Vienna: International Atomic Energy Agency. ISBN 978-92-0-103509-7.
^ Shaw, SM; Ice, RD (March 2000). "Nuclear pharmacy, Part I: Emergence of the specialty of nuclear pharmacy" (PDF). Journal of Nuclear Medicine Technology. 28 (1): 8–11, quiz 20. PMID 10763775.
^ Troy, David B. (2005). Remington: The science and practice of pharmacy (21st ed.). Philadelphia, PA: Lippincott, Williams & Wilkins. p. 1915. ISBN 9780781746731.
^ "Board of Pharmacy Specialties Celebrates 40th Anniversary". BPS. Retrieved 5 January 2017.
^ "Radiopharmaceuticals". The International Pharmacopoeia (6th ed.). WHO. 2016.
^ ^a ^b IAEA (2007). "Annex II Radiopharmaceuticals: Production and Availability" (PDF). Nuclear Technology Review. Vienna: International Atomic Energy Agency. p. 60.
^ Jacobsen, Mark S; Steichen, Raymond A; Peller, Patrick J (2012). "PET Radiochemistry and Radiopharmacy". In Peller, Patrick; Subramaniam, Rathan; Guermazi, Ali (eds.). PET/CT and PET-MRI in Oncology : a practical guide. Berlin: Springer. pp. 19–30. doi:10.1007/174_2012_703. ISBN 978-3-642-01138-2.
^ Ballinger, James R (2016). "Hospital Radiopharmacy in the UK". In McCready, R; Gnanasegaran, G; Bomanji, J (eds.). A history of radionuclide studies in the UK. Springer. pp. 129–134. doi:10.1007/978-3-319-28624-2_17. ISBN 978-3-319-28623-5. PMID 29787092.
^ IAEA (2008). Operational guidance on hospital radiopharmacy: a safe and effective approach. Vienna: International Atomic Energy Agency. ISBN 978-92-0-106708-1.
^ "10 CFR 35.55 Training for an authorized nuclear pharmacist". NRC. 2015. Retrieved 5 January 2017.
^ Verbruggen, Alfons; Coenen, Heinz H.; Deverre, Jean-Robert; Guilloteau, Denis; Langstrom, Bengt; Salvadori, Piero A.; Halldin, Christer (9 August 2008). "Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU" (PDF). European Journal of Nuclear Medicine and Molecular Imaging. 35 (11): 2144–2151. doi:10.1007/s00259-008-0853-7. PMID 18690437. S2CID 12062317.
^ "What does a Radiopharmacist do?". BNMS. Retrieved 5 January 2017.