NUCLEAR PHARMACY

LECTURE 04

Mr. Hassaan Umar R.Ph. (Punjab) M.Phil. (Pharmaceutics)

Lecturer (Pharmaceutics)
Faculty of Pharmacy
Hajvery University (HU)
 LEARNING OUTCOMES

• NUCLEAR PHARMACY
• NUCLEAR PHARMACIST
• ORGANIZATION
• PROPERTIES OF RADIOPHARMACEUTICALS
• PLANNING OF NUCLEAR PHARMACY
• APPLICATIONS OF RADIOPHARMACEUTICALS
• RADIATION PROTECTION
 Nuclear Pharmacy
• 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 with radiopharmacy.
• Radiopharmacy is a subspecialty of pharmacy deals with
receiving, preparation, quality control, storage, and dispensing
of radiopharmaceuticals. The radiopharmacy also deals with
disposal of radioactive wastes and documentation of each
operation.
• The term radiopharmaceutical is derived from two words, viz.
radioactive and pharmaceutical.
• Due to the use of radiopharmaceuticals, this service and the unit
from where it is provided is also called radiopharmacy or hot
laboratory. The person who rendered this service is called a
radiopharmacist.
 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,
radiopharmacy functions under management of head of nuclear
medicine department who is a physician.
• In pharmacy department, radiopharmacy unit performs under
the directions of pharmacy director. As premises, the
radiopharmacy may be located within the pharmacv
department, or in the nuclear medicine department of the
institution adjacent to radioisotope administration area.
 DISCRIMINATORY PROPERTIESOF
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.
 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. This also poses constrain for
quality control check before administration of the
radiopharmaceutical to patients. Administered to patient even
before the results of quality control tests
USUAL ROUTE OF ADMINISTRATION
•Most of the radiopharmaceuticals are prepared as sterile,
pyrogen-free intravenous solutions to be administered directly to
patients. Other less common routes of administration include
oral, interstitial, and inhalation e.g., radioactive gases, aerosols.
 DOSE MEASUREMENT IN TERMS OF RADIOACTIVE UNITS
•The dose of a radiopharmaceutical is measured in units of
radioactivity rater than mg, ml etc.
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.
 APPLICATION OF RADIOPHARMACEUTICALS
• The radiopharmaceuticals are applied for diagnosis, treatment
and palliative care.
DIAGNOSTIC APPLICATIONS
• In diagnostic application, gamma emitting radiopharmaceuticals
are used to probe physiologic or pathophysiological functions of
human body. These radiopharmaceuticals are localized in organs
of interest so as their images can be acquired externally with
gamma camera (Figure 1). 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, gamma
energies of between 100 keV and 200 keV are desirable. The
diagnostic radiopharmaceuticals used are technetium-99m,
iodine-123, indium-1 1 1, thallium-201 and gallium-67.
THERAPEUTIC APPLICATIONS
• The radiation emitted from therapeutic radiopharmaceuticals cause
damage selectively to neoplastic cells within body. The
radiopharmaceuticals for therapeutic use normally contain a
radionuclide that decays by emitting a ß particle. The energy of the ß
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. Iodine-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 eradicate 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

• A pharmacist, in order to render high quality

radiopharmaceutical services must know the legal and
professional requirements for both, individuals and
institutions before instituting radioisotope program. In
general the following are the requirements for establishment
of radiopharmacy section in a hospital.
• LICENSURE
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.
 FACILITIES
Space
•Nuclear pharmacy must have adequate space, matching with the
scope of services required and provided, meeting minimal space
requirements for efficient working. 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 radiopharmacy are as:
• Isolators or laminar flow hood.
• Fume hood for the fume generating radiopharmaceuticals.
• Dose calibrator.
• Refrigerator (lead-lined).
• Class A prescription balance or balance of greater sensitivity.
• Single or multiple channels gamma scintillation counter.
• Microscope.
• A radiochemical hood and filter system.
• Other equipments necessary for services of radiopharmaceutical.
 Instrumentation
• Principles of radiation detection and detectors.
• Dose calibrator.
• Gamma well counter.
• Function QC of dose calibrators.
 Radiation biology and radiation protection
• Safe handling.
• General principles of production.
• Formulation.
• Pharmacokinetics
In vitro studies
• Microanalytical techniques (RIA etc.).
• Radioassays.
• Binding capacity studies (receptor assays).
 Radioisotope committee
• Radioisotope committee is a board established for supervision
and control of hospital isotope program. Typically the
committee may include a medical physicist, a clinical
radiologist, a hematologist and a surgeon. In addition to the
above, it is also suggested that a representative from
administration, pharmacy and nursing service should also be
included on the committee register.
• The pharmacist may assist in the purchasing, receiving and
storage of isotopes. The administrator can contribute to the
development of the entire program and the nurses will
become familiar with type of work carried out, the associated
dangers and the means whereby the patient, doctor and
nurse may protect themselves.
 Responsibilities:

An institutional radioisotope committee typically has following re

sponsibilities:
• Review and approval of the use of isotopes within the institution.
• Prescribe special conditions, such as training of personnel,
designation of limited areas of use, disposal methods and the like.
• Receive reports from the radiation protection officer and review of
the records.
• Recommend remedial action when an individual fails to observe
protection recommendations, rules and regulations.
• Keep a record of actions taken in approving the use of isotopes.
 RESPONSIBILITIES OF A RADIOPHARMACIST

The responsibilities of the pharmacists are the same as that the

radiopharmaceutical practice entails. The radiopharmaceutical
practice and responsibilities are: i
•Ordering, receiving and keeping the record of all radioactive
materials and cold kits.
•Elution of the generator, labeling and dispensing of kits.
•Performing quality control tests.
•Implementation of the good pharmaceutical and good
radiopharmaceutical practices (GRP).
•Radiation monitoring of radiopharmacy laboratory and injection
area.
• Implementation of radiation protection and safety policy in
radiopharmacy laboratory, gamma counter room and injection
area.
• Performing of all in-vitro procedures, processing of data and
providing of the results.
• Support research and active participation in research projects.
• Performing of any other duty related to the clinical and assigned
research work.
• Training to the technologists on the pharmaceutical aspects of
the nuclear medicine, radiation biology and protection.
 RADIATION PROTECTION

• The radiation protection is safekeeping of worker from the

hazards of radiation by minimizing radiation exposure of the
worker to a level as low as reasonably achievable (ALARA
principle). This can be achieved by preventing spills and spread
of contamination outside the laboratory. Another important
aspect of radiation protection is sensible use of time, distance
and shielding. The time spent in radiation area, intensity of
radioactivity, distance from the radiation source and shielding
(TDS) are the basic and critical elements of radiation safety.
 TIME
•A radiation dose for a worker in an area having a particular
radioactive dose rate would be directly proportional to the
amount of time spent. It is thus required that all the quality
control procedures and operations with radioactive sources must
be carried out as rapidly as possible consistent with good
technique and not on the cost of satisfaction and safe
performance of the task.
DISTANCE
•Increasing distance has a dose reduction effect because radiation
intensity decreases by square of distance from radiation source. A
direct contact with radioactive source should be avoided by any
available means, e.g., by using long forceps and remote handling
tongs.
SHIELDING
• The materials capable of absorbing large proportion of
radiation are used for shielding. Lead absorbs gamma rays
and thus, gamma emitters are shielded in lead. The plastic,
glass or aluminum effectively serves as shielding materials for
beta-particulate emitting radiopharmaceuticals.
INTENSITY
• The radiation hazard increases with the intensity of
radioactive source so for safety reasons, it is not
recommended to work unnecessarily with high strength of
radioactivity.
Radiation protection concerning waste disposal

• Disposal for short-lived radionuclides: Used syringes, vials

and contaminated papers have some residual activities and
are disposed of like other solids or dry wastes. These,
materials are disposed of in containers provided for this
purpose in radiopharmacy section. These containers are
emptied into a central shielded waste container for disposal
where wastes are retained for their total decay. After 10 half
lives of the materials, the waste is disposed of like ordinary
materials. This practice eliminates high levels of radiation in
radiopharmacy. The water soluble or dispersible liquids should
be poured in sink specified for this purpose followed with a
copious flow of water, which is designed so that the waste is
stored for its decay
 Disposal for long-lived radionuclides
The wastes of long lived radionuclides are to be transferred to
the authorized commercial firms that bury or burn them at
approved sites. For GRP purpose, each shipment of such
radioactive wastes shall properly be classified, packaged,
marked, and labeled mentioning an identity, activity and volume
of the radionuclide and the names, addresses, and telephone
numbers of the sender/generator of the wastes and the
receiving authority. The vendors instruction, if any must
be-followed for this purpose.
In Pakistan, no such system is in practice. It is therefore,
suggested to construct special waste disposal room in basement
of the institute with special construction materials. This waste
room may be equipped with appropriate shielded large tanks
where, wastes of radioisotope of long half life can be stored till
their decay.
 Documentation of waste disposal

• What ever may be the material to be disposed off, records

must be maintained for all the material stored for decay,
released to the environment, material incinerated and
material transferred to the authority with amount and type of
activity and date/time in a waste disposal log book. The
stored packages must also be labeled with pertinent
information.