NUCLEAR PHARMACY

Bilal Hassan
M.Phil Pharmaceutics
 TERMINOLOGY

Isotopes of an atom have the same number of protons, but a different number of neutrons.
Radioisotopes & Radionuclides: unstable isotopes which are distinguishable by radioactive
transformation.
Radioactivity: the process in which an unstable isotope undergoes changes until a stable state is
reached. When the atomic nucleus undergoes spontaneous transformation, called radioactive
decay, radiation is emitted .(alpha particles, beta particles and gamma rays).
Radiation: refers to particles or waves coming from the nucleus of the atom (radioisotope or
radionuclide) through which the atom attempts to attain a more stable configuration.
+ Radioactive decay is the process in which an unstable atomic nucleus spontaneously loses energy
by emitting ionizing particles and radiation.
 INTRODUCTION

 Nuclear pharmacy is a service to improve and to promote health through safe and efficacious
use of radiopharmaceuticals for diagnosis, therapy and palliation. sometimes the term nuclear
pharmacy is used interchangeably radio pharmacy.

 Radio pharmacy is subspecialty of pharmacy deals with receiving, preparation, quality control,
storage, and dispensing of radiopharmaceuticals. The radio pharmacy also deals with disposal
of radioactive wastes and documentation of each operation. Furthermore, radio pharmacy may
be engaged in research, designing and development Of new radiopharmaceuticals.
 INTRODUCTION

 The term radiopharmaceutical is derived from two words, viz. radioactive and
pharmaceutical. It is a medicinal product containing a radionuclide as an integral
part of the main ingredients. The medicinal part of the radiopharmaceutical,
available in a minute quantity is not intended for pharmacological actions. Rather, it
carries the radioactivity to site of action and thus called radioactive tracer or just a
tracer. The second part of the radiopharmaceutical is a radionuclide. The
radionuclide is a species of radioactive atom with a specific atomic number,
neutron number and a defined nuclear state.
 ORGANIZATION

 The radiopharmaceutical service is rendered from a division of hospital pharmacy or

by a section under Nuclear Medicine department. The nuclear medicine is a clinical
specialty dealing with the application of radionuclides. As an integral part of. nuclear
medicine department. Radio pharmacy functions under management of head of
nuclear medicine department who is a physician. This environment may, be unfamiliar
for a pharmacist
DISCRIMINATORY PROPERTIES OF RADIOPHARMACEUTICAL

 A radiopharmaceutical has the following discriminating features:

 PRESENCE OF RADIOACTIVITY
 Due to the presence of a radionuclide (radioactive atoms) as an integral part of

radiopharmaceutical. it is associated with emission of radiation. Thus, requiring special

precautions during handling.

 SCARCITY OF PHARMACOLOGIC EFFECT
 The radiopharmaceuticals do not produce pharmacologic effects since the quantities of active

pharmaceutical ingredients range from picogram to nanogram per kilogram of administered

dose.
 DISCRIMINATORY PROPERTIES OF
RADIOPHARMACEUTICAL

 HAVING SHORT SHELF LIFE

 Due to the presence of radioactivity, radiopharmaceuticals have short shelf life. Thus, a

pharmacist has to keep a constant eye on expiry of a radiopharmaceutical.

 USUAL ROUTE OF ADMINISTRATION
 Most of the radiopharmaceuticals are prepared as sterile, pyrogen-free intravenous solutions to

be administered directly to patients.

 DOSE MEASUREMENT IN TERMS OF RADIOACTIVE UNITS
 The dose of a radiopharmaceutical is measured in units of radioactivity rather than mg. ml etc.
 DISCRIMINATORY PROPERTIES OF
RADIOPHARMACEUTICAL
 HALF LIFE
 The half lives of radiopharmaceuticals' taken in consideration are physical half life. biological half life and

effective half life. The Physical half life of a radiopharmaceutical is time necessary for the radioactive

atoms to decay to one half of their original number. Biologic half life is the time required for the body to

eliminate one-half of the administered doses of any radiopharmaceutical by the processes of biologic

elimination. Effective half life of a radiopharmaceutical is the time required for an administered

radiopharmaceutical dose to be reduced by one-half due to both physical decay and biological elimination.
 PRACTICE REGULATIONS
 The practice of radiopharmaceuticals as well as the premises for this practice requires NOC from Pakistan

Atomic Energy Commission

 RESTRICTIONS ON QUANTITY USED
 Prescribed amount can be handled per year in a clinical setting.
 APPLICATION OF RADIOPHARMACEUTICALS

 The radiopharmaceuticals are applied for diagnosis, treatment and palliative care.
 DIAGNOSTIC APPLICATIONS
 In diagnostic application, gamma (y) emitting radiopharmaceuticals are used to probe physiologic or
pathophsiological functions of human body. These radiopharmaceuticals are ,localized in organs of
interest so as their images can be acquired externally with gamma camera. A large number of
radiopharmaceuticals are available to trace one or more particular functions of human body.
 For optimal detection efficiency by a gamma camera, y energies of between 100 keV and 200 keV
are desirable. The diagnostic radiopharmaceuticals used are technetium-99m, iodine-I23. indium-
111, thallium-201 and gallium-67.
 APPLICATION OF RADIOPHARMACEUTICALS

 THERAPEUTIC APPLICATIONS
 The radiation emitted from therapeutic radiopharmaceuticals cause damage selectively to

neoplastic cells within body. The energy of the particles should ideally be within the range 0.5 - 1.0

MeV to prevent widespread dissemination of radiation from the target. The half-life is normally of

the order of several days in order to provide reasonable time for action. lodine-131 and

phosphorous-32 are the commonly used therapeutic radiopharmaceuticals.

 PALLIATIVE APPLICATIONS
 The radiopharmaceuticals used to improve quality of life of a patient but can not irradicate a

disease provide palliative care. Strontium-89 and phosphorous-32 are the examples that are used

to relieve the pains due to cancer metastasis in bone at terminal cancer stage patients.
 BASIC REQUIREMENTS FOR RADIOPHARMACY

 In general the following are the requirements for establishment of radiopharmacy section in a
hospital.
 LICENSURE
 The radioisotopes are potentially dangerous. Therefore, their use is subjected to control and
supervision of Atomic Energy Commission, a Federal Government agency. Radioisotopes can be
used only by duly licensed individuals in premises complying with the requirements of Atomic
Energy Regulations. As mentioned before, license restricts the use of the isotopes to those listed
on license. In addition, the regulations require that an institutional licensee have a medical
isotope committee to evaluate all proposals for research, diagnostic, and therapeutic uses of
isotopes within the hospital.
 BASIC REQUIREMENTS FOR RADIOPHARMACY

 FACILITIES
 Space
 The nuclear pharmacy area shall be separated from the pharmacy areas for non-radioactive drugs
and shall be secured from unauthorized personnel. A radioactive storage and product decay area
must be separated from compounding, dispensing, quality assurance and office area. Detailed
Floor Plans are to be submitted to the Atomic Energy Commission before approval of the license.
 Equipments
 The Minimum equipment requirements for a radio pharmacy are as: laminar flow hood, Fume
hood for the fume, generating radiopharmaceuticals, Dose calibrator, Refrigerator (lead-lined),
balance of greater sensitivity, Microscope etc.
 BASIC REQUIREMENTS FOR RADIOPHARMACY

 Nuclear Pharmacist
 Hiring a radio pharmacist is not vet a legal requirement for a radio pharmacy in Pakistan. However, if
their abilities and knowledge are utilized they have excellent potentials for radiopharmaceutical
services. A pharmacist intended to become a radio pharmacist must have training in the following
areas:
 Radio pharmacy
 Research methodology
 Instrumentation
 Mathematics, statistics and computer science
 FORMULATION OF RADIOPHARMACEUTICALS

 Some radiopharmaceuticals are available in ready to use form and not demand any of the
preparatory steps. Iodine-131 and galium-67 are the examples of such radiopharmaceuticals.
 Formulation of other radiopharmaceuticals requires the radiolabeling techniques whereby a
radionuclide is tagged with a pharmaceutical moiety.
 Technetium-99m is the most widely used radionuclide for such purpose because of its almost ideal
physical properties. It is used in the preparation of a wide variety of radiopharmaceuticals, which
have different biological fates and hence are used for various diagnostic investigations. The 6-hour
half-life of technetium-99m is suitable for the majority of radiopharmaccutical investigations.
 FORMULATION OF RADIOPHARMACEUTICALS

 It can be obtained from a technetium generator containing its parent nuclide, molybdenum-99 alumina
column. Molybdenum-99 decays to technetium-99m. On passing through column, normal saline
solution selectively carries only technetium-99m as sodium pertechnetate form. This collection of
technetium-99m in a vial is called elution. The molybdenum continues to decay to technetium-99m. The
simplest and most widely available formulation consists of a single, sterile, freeze-dried, rubber-capped
vial containing necessary non-radioactive ingredients to prepare aseptic radiopharmaceutical. Such
vials, commonly referred to as 'kits', can be obtained commercially and are available for all technetiurn-
99m radiopharmaceuticals in routine use for diagnosis of various physiological functions.
 FORMULATION OF RADIOPHARMACEUTICALS
 The preparation of the radiopharmaceutical is achieved by the single-step addition of sterile
sodium pertechnetate to the kit in accordance with the manufacturers instruction, The activity of
sodium pertechnetate injection required is calculated and is injected into the kit vial. An equivalent
volume of gas is drawn front the space above the solution before withdrawing the syringe from
the vial. The manufacturer specifies the minimum and maximum range of activity that can be
added into a particular kit, The vial is shaken to dissolve the contents. Aseptic technique is used
throughout to maintain sterility of the final product and to ensure adequate protection of the
operator from radiation.
 QUALITY CONTROL

 The radioactive materials administered to the patients are medicinal products and therefore, are
expected to have the same degree of quality and safety as any other pharmaceutical. The majority of
diagnostic investigations are performed with radiopharmaceutical containing short-lived radionuclides,
which have to be prepared and used on the same day. The results for quality control test can not be
achieved before the administration of the radiopharmaceutical.
 essential means of ensuring that the quality of materials and procedures in radiopharmacy are being
maintained at a high level. After a long period of continuous satisfactory testing. the
radiopharmaceutical laboratory can be confident about the safety of the products currently dispensed.
 The quality control tests are performed on retrospective basis and are done for sterility and
pyrogenicity of the products. Recently the limulus amebocyte 'lysate (LAL) test is considered of merit
for pyrogen testing of radiopharmaceuticals which gives an instant result.
 DISPENSING OF RADIOPHARMACEUTICAL

 For the radiopharmaceuticals not requiring preparation can be prescribed at any time. The physician
provides necessary information regarding the dose and time of administration. The pharmacist then
makes necessary calculations. For dispensing, calculated radioactivity containing volume is
transferred from stock container and placing it in a paper cup within a lead container is ready for
administered to patient. Prior to dispense, a label is affixed appropriately containing the earlier
mentioned information and the material is transported to administration area.
 DISPENSING OF RADIOPHARMACEUTICAL

 For the radiopharmaceuticals requiring preparation, a list is furnished to radio pharmacist

one day prior to their administration. This is because the fresh technetium-99m elution is
available in the morning. The physician, upon deciding to prescribe radioactive material,
calls the pharmacist and provides him with all of the necessary information. The
radiopharmaceutical is prepared as mentioned above, radioactivity in vial is measured,
placed in a lead container and label is affixed bearing name of the radiopharmaceutical, the
total volume in the vial and the activity measured at specified time. Ideally, labeling is done
both, on the kit vial and on lead container. This container carrying kit is.transported.to the
injection area and is ready' for administration.