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Nuclear pharmacy, also known as radiopharmacy, involves preparation of
radioactive
Radioactive decay (also known as nuclear decay, radioactivity, radioactive disintegration, or nuclear disintegration) is the process by which an unstable atomic nucleus loses energy by radiation. A material containing unstable nuclei is consi ...
materials for patient administration that will be used to diagnose and treat specific diseases in
nuclear medicine
Nuclear medicine or nucleology is a medical specialty involving the application of radioactive substances in the diagnosis and treatment of disease. Nuclear imaging, in a sense, is " radiology done inside out" because it records radiation emi ...
. It generally involves the practice of combining a
radionuclide tracer with a pharmaceutical component that determines the biological localization in the patient.
Radiopharmaceutical
Radiopharmaceuticals, or medicinal radiocompounds, are a group of pharmaceutical drugs containing radioactive isotopes. Radiopharmaceuticals can be used as diagnostic and therapeutic agents. Radiopharmaceuticals emit radiation themselves, which ...
s 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.
Due to these intersecting risks, nuclear pharmacy is a heavily regulated field. The majority of diagnostic nuclear medicine investigations are performed using
technetium-99m
Technetium-99m (99mTc) is a metastable nuclear isomer of technetium-99 (itself an isotope of technetium), symbolized as 99mTc, that is used in tens of millions of medical diagnostic procedures annually, making it the most commonly used medical ra ...
.
History
The concept of nuclear pharmacy was first described in 1960 by Captain William H. Briner while at the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
(NIH) in
Bethesda, Maryland
Bethesda () is an unincorporated, census-designated place in southern Montgomery County, Maryland. It is located just northwest of Washington, D.C. It takes its name from a local church, the Bethesda Meeting House (1820, rebuilt 1849), which in ...
. Along with Mr. Briner, John E. Christian, who was a professor in the School of Pharmacy at
Purdue University
Purdue University is a public land-grant research university in West Lafayette, Indiana, and the flagship campus of the Purdue University system. The university was founded in 1869 after Lafayette businessman John Purdue donated land and mone ...
, had written articles and contributed in other ways to set the stage of nuclear pharmacy. William Briner started the NIH Radiopharmacy in 1958. 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
A technetium-99m generator, or colloquially a technetium cow or moly cow, is a device used to extract the metastable isotope 99mTc of technetium from a decaying sample of molybdenum-99. 99Mo has a half-life of 66 hours and can be easily transp ...
was commercially available, followed by the availability of a number of Tc-99m based radiopharmaceuticals.
In the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...
nuclear pharmacy was the first
pharmacy specialty established in 1978 by the
Board of Pharmacy Specialties
The Board of Pharmacy Specialties (BPS) was established in 1976 and is an independent division of the American Pharmacists Association that grants recognition within the United States to appropriate pharmacy practice specialities and establishes s ...
.
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
A radionuclide generator is a device which provides a local supply of a short-lived radioactive substance from the decay of a longer-lived parent radionuclide. They are commonly used in nuclear medicine to supply a radiopharmacy. The generator prov ...
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
A cleanroom or clean room is an engineered space, which maintains a very low concentration of airborne particulates. It is well isolated, well-controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientif ...
or isolator to provide radiation shielding and sterile conditions.
For
Positron Emission Tomography (PET),
Fludeoxyglucose (18F) is the most common radiopharmaceutical, with the radioactive component usually obtained from a cyclotron.
The short half life of
Fluorine-18
Fluorine-18 (18F) is a fluorine radioisotope which is an important source of positrons. It has a mass of 18.0009380(6) u and its half-life is 109.771(20) minutes. It decays by positron emission 96% of the time and electron capture 4% of the time ...
and many other PET
isotope
Isotopes are two or more types of atoms that have the same atomic number (number of protons in their nuclei) and position in the periodic table (and hence belong to the same chemical element), and that differ in nucleon numbers (mass numb ...
s necessitates rapid production. PET radiopharmaceuticals are now often produced by automated computer controlled systems to reduce complexity and radiation doses to staff.
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
Ionizing radiation (or ionising radiation), including nuclear radiation, consists of subatomic particles or electromagnetic waves that have sufficient energy to ionize atoms or molecules by detaching electrons from them. Some particles can travel ...
, preparation of medicines, patient exposure to ionising radiation, transport of radioactive materials, and environmental exposure to ionising radiation. 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.
Staff working in nuclear pharmacies require extensive training on aspects of
good manufacturing practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...
,
radiation safety concerns and
aseptic dispensing. In the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...
an authorised nuclear pharmacist must be a fully qualified pharmacist with evidence of additional training and qualification in nuclear pharmacy practice. Several
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been de ...
directives cover radiopharmaceuticals as a special group of medicines, reflecting the wide range of types of producers and staff groups that may be involved. In the UK qualified pharmacists may be involved along with clinical scientists or technologists, with relevant training.
See also
*
Nuclear medicine
Nuclear medicine or nucleology is a medical specialty involving the application of radioactive substances in the diagnosis and treatment of disease. Nuclear imaging, in a sense, is " radiology done inside out" because it records radiation emi ...
*
Pharmacy
*
Radiopharmacology
References
{{Pharmacy
Pharmacy
Nuclear medicine
Medical physics