RADIO PHARMACEUTICALS

Handling and packaging

By
Nagaraju B
DEFINITION

Radiopharmaceuticals are the radioactive

substances or radioactive drugs for
diagnostic or therapeutic interventions
COMPOSITION
a radioactive isotope that can be injected
safely into the body, and

a carrier molecule which delivers the isotope

to the area to be treated or examined.
Radioisotope

• A version of a chemical element that has

an unstable nucleus and emits radiation
during its decay to a stable form.

• All isotopes are not radioisotopes.

how does it work?
Uses
• Therapeutic

• Diagnosing
• Designed to deliver therapeutic dose of
ionizing radiation to specific disease site,
such as cancerous tumors, with high
specificity in the body.

• Historically, used to treat Thyroid cancer,

Graves’ disease, hyperthyroidism, and
bone pain pallitation associated with
skeletal metastasis.
• used to derive detailed description of the
morphology and dynamic functioning of
the various internal organs of the body.
ADVANTAGES
• It can be used as diagnosis and treatment
of patients
• It is common cure to cancers
• Can treat multiple disease sites
• Widely available mode of treatment
• Directly treats tumor, especially useful for
bone metastasis
ADVANTAGES

• Can provide fast onset of pain relief

• Single dose is effective for some patients
• Nuclear medicine tests can be performed
on children
• Nuclear medicine procedures are cost
effective and painless
• Nuclear medicine procedures have no
side effects and are completely safe
• Nuclear medicine tests are not
recommended for pregnant women
because unborn babies have a greater
sensitivity to radiation than children or
adults

• Filling in patients' teeth, dental braces and

permanent bridges may cause some
distortion around the mouth area
SN
DESCRIPTION USES
RADIOACTIV
O E
ISOTOPE
AMMONIUM BROMIDE 82Br STUDY OF EXTRACELLULAR
MEASUREMENT
CALCIUM CHLORIDE 45Ca Study of ca metabolism
Chromium EDTA 51Cr Determination of glomerular filtration
rate
Treatment of neo-plastic conditions
Colloidal gold 198Au
and general investigation of
reticuloendothelial cells

Chromium chloride 51Cr

Studies of GIT protein loss in vivo
labelling and absorption studies

Human serum albumin 125I Study of cardiac cavity imaging

scanning of sub-arachnoid spaces
detection of brain tumours
Potassium chloride 24Na Determination of exchangeable
poassium

Triolen 125I Fat absorption studies

• Technetium 99mTc : possesses a relatively
short half life of 6 hours , which allows
administration of higher amounts of activity for
faster and clearer images while exposing the
patient to a low radiation dose. it offers an
abundance of gamma photons for imaging
• 99mTc exametazime- cerebral perfusion radio
labeling
• 99mTcmacroaggregated albumin- pulmonary
perfusion
• 99mTcmedronate- bone imaging
• 99mTcpertechnetate- imaging of thyroid salivary
glands,
GENERAL PRECAUTIONS
Abc HOSPITAL
Radioactive isotope administration
A radioisotope administration
Tracer therapy
sheet is placed in the medical
Isotope____
record by the isotope
Effective half life______
administrator at the time of
Dose_______
treatment and is to remain
Route of administration_______________
there permanently as an
isotope to sign at the entrance The patient received radio isotope on_______
of the room or unit by the
administrator all precautions must be meticulously observed if
there is spillage make no attempts to clean the area.
The isotope administrator will Notify at once to the undersigned and the
provide a substitute who may radiological house
be contacted in care the
administrator is not readily
signed______M.D
radiocative isotope administrator
NUCLEAR PHARMACY

• it’s a relatively newer branch of pharmacy that involves

the procurement , compounding , dispensing and quality
control of radioactive pharmaceuticals intended to be
used for investigation or treatment of some diseases in
humans or animals
• PRACTICE OF NUCLEAR PHARMACY
• nuclear pharmacy is a patient oriented service that
embodies the scientific knowledge and professional
judgment required to improve and promote health
through assurance of safe and officious use of drugs for
diagnosis and therapy
• General activities of nuclear pharmacy are
Procurement and storage
• Because of the short life of the radiopharmaceuticals the nuclear
pharmacist will order the drug directly from manufacturer usually
through over night delivery
• In addition knowledge of calibration time shipping/ delivery
schedules and radio active decay associated with the ordered radio
pharmaceutical weigh heavily in the ordering process
• Isotope storage areas should be as per the rules. there should be a
separate lab for the manipulation and preparation of radio
pharmaceutical dosage and another for calibration of doses.
treatment room must also be different
Preparation of the radio
pharmaceutical
• Radio nuclide generator can be defined as convenient means of
producing in lab a plentiful supply of short lived radio
pharmaceutical
• If this radio nuclide has the same atomic number as one of the
nuclides already present in the molecule, the addition or substitution
is termed as isotope labeling ( eg sodium o-iodohippurate in
which some of the iodine -127 atoms have been replaced by iodine
-125 atoms)
• On the other hand a substance may be selected as a medium for
introducing into subject a radionuclide having an atomic number
which differs from any other nuclide already present in substance
which is called as non –isotopic labelling or sometimes foreign
labelling
99mtc is formed by the decay of 99mo
in a radionuclide generator
 Formulation issue
• The radio pharmaceuticals have very short usable
life of the radio active product compared with
injectable pharmaceuticals . In contrast to ordinary
pharmaceutical many radio pharmaceuticals have
to be manufactured and quality tested and then
administered to the patient within a short period of
time, often within the same working day from
dispensing point of view the presence of
radioactivity in a pharmaceutical has following
connotations
• A) the radio active properties must be specified on the label
• B) in controlling the conventional pharmaceutical qualities
• Formulation of radio pharmaceuticals is
therefore a bit more complex than normal
pharmaceuticals. Good Radiation
Practices (GRPs) and Good
Manufacturing Practices (GMPs) should
be strictly followed during manufacturing
and dispensing operations
Code of good radiation practices
(GRP)
• Strict personnel hygiene
• Avoidance of risk methodology
• Operations only in the recommended zones of the hot
lab
• Proper techniques of distance and shielding
• Isolated storage , refrigeration of radionuclides and
labelled compounds
• Trial run using dummy or inactive source
• Adequate washing facilities including showers
• Proper in service training of qualified personnel
• Drawing out a manual of standardized procedures of
safe handling and step by step processing , testing
and waste disposal of radio active compounds and
animals
• Facilities of minimizing radiation levels , removal of
surface and air borne contaminants , calibration and
maintenance of instruments for radioactivity
measurements
• Provision of appropriate personnel monitoring and
protective devices
• Periodic inspection of protective devices for wear
and tear and performance
• Establishment of well understood emergency
procedures
• Proper documentation system is required by law
Code Of Good Manufacturing
Practices (GMP)
• Proper selection and in service training of
qualified personnel
• Drawing out of in house specifications for
raw materials
• Generating test and storage standards
• Drawing out a manual of standardized
procedures of safe handling and step by
step processing ,testing and waste
disposal
• Assignment of responsibilities in writing
• Facilities for minimizing of surface and
airborne contamination routine
• Periodic inspection of protective devices
for wear and tear and performance
• Establishment of well understood
emergency procedures
• Proper documentation system is required
by law
Dispensing of radiopharmaceuticals

• the dispensing of radiopharmaceuticals should be safe,

straightforward and reliable
• An important factor in radiopharmaceutical dispensing
has been the production of ready to use kits or cold kits
which provide individual/ multiple doses and can be
reconstituted by the addition of the radionuclide at the
time of intended use.
• chemical reagents are prepared in a sterile environment
using apyrogenic raw materials and dispensed into
single/multiple unit dose containers . The preparation of
individual doses can be carried out rapidly and safely
when required with minimum manipulation
• The cold kit preparation should be capable
of terminal sterilization preferably by
autoclaving or if not by membrane filtration
for removal of microbes
• Radio pharmaceuticals never go directly to
the patient they are provided to trained
health care professionals at the hospital or
clinic and then administered to the patient
Compounding of radio pharmaceuticals
requires receipt (or anticipation) of:
• a valid prescription/drug order
• appropriate components, supplies, and
equipment
• a suitable environment, especially for sterile
dosage forms
• appropriate recordkeeping, including witten
procedures and lot-specific in formation to
ensure traceability;
• Validation/verification of the compounding
Directions while compounding
• Involves reconstituting reagent kits, radio labeling, and
strict aseptic technique must be followed during
compounding.
• A kit involves pre-packed set of sterile ingredients.
• The freeze-dried kit is reconstituted by aseptically
transferring the necessary activity of sodium
pertechnetate using a sterile syringe and needle.
• The reconstituted kit is aseptically subdivided to provide
each patient dose with a sufficient activity after
administration.
• A diluents may be added to the final dose to give the
desired radioactive concentration.
Radiopharmaceutical product
• Radiopharmaceuticals are generally expected to
conform to specifications under the following
heading:
a. Radionuclide concentration
b. Radiochemical purity
c. Chemical purity
d. Sterility
e. Apyrogenicity
f. Absence of foreign particulate matter
g. Particle size (if appropriate)
h. pH
i. Biological distribution
Labelling
All products should be clearly identified by label which must
remain permanently attached to the containers under all
storage condition
The label on the container should show the;
a). Name of the drug product and product code, b). The
name of radio nuclide, c). The name of manufacturer or
the company, d). The radioactivity per unit dose, e). The
route of administration, f). The expiry date, g). The
amount of radioactivity at dispatch time and h). In case
of cold kits; -the direction of preparing and -a statement
of shelf life of the prepared radio pharmaceutical and
-the radiation dose that the patient would receive
Production and distribution records
• The processing records of regular production
batches must provide a complete account of the
manufacturing history of each batch of a radio
pharmaceutical, showing that it has been
manufactured, tested, dispersed into containers
and distributed in accordance.
• Separate records for the recent storage, use and
disposal of radio active products must be
maintained.
• Distribution records should be kept since the
return of radioactive products is not practical, the
purpose of recall procedures for such products
is to prevent their use rather than actual return.
– Dispensing

 Recommends dosage levels based on

patient history, age, weight, surface area,
and/or other factors

 Dispenses prescriptions in conjunction with

applicable pharmacy law and keeps
appropriate records
-Dispensing

 Develops policies and procedures to ensure that the

correct drug in the correct dosage and dosage form is
received by the correct patient at the correct time via
the correct route of administration

 Develops policies and procedures, supervises, and

reviews the activities of non-pharmacist personnel
under the pharmacist's supervision
-Distribution

Complies with all applicable regulations concerning packaging,

labeling, and transportation of radioactive and other materials
(e.g., biohazards), demonstrating knowledge of:

 DOT regulations concerning packaging, labeling, and

transportation of radioactive and other materials.

 Proper procedures and use of equipment necessary to

verify that package meet DOT requirement
HEALTH & SAFETY
 Allergies

• If you will be receiving albumin in the form of

radioiodinated albumin, technetium Tc 99m albumin
aggregated, technetium Tc 99m albumin colloid, or
technetium Tc 99m albumin for your test, tell your doctor
if you
• have ever had any unusual or allergic reaction to
products containing
• human serum albumin.
HEALTH & SAFETY
 Pregnancy
•
Radiopharmaceuticals usually are not recommended
for use during pregnancy. This is to avoid exposing the
fetus to radiation.

• This is especially important with radiopharmaceuticals

that contain radioactive iodine, which can go to the
baby's thyroid gland and, in high enough amounts, may
cause thyroid damage.
HEALTH & SAFETY
 Breast-feeding

• Some radiopharmaceuticals pass into the

breast milk and may expose the baby to
radiation. If you must receive a
radiopharmaceutical, it may be necessary for
you to stop breast-feeding for some time after
receiving it.
HEALTH & SAFETY
 Children

• For most radiopharmaceuticals, the amount

of radiation used for a diagnostic test is very low
and considered safe.
HEALTH & SAFETY

• Side effects

• When radiopharmaceuticals are used in very

small doses to study an organ of the body, side
effects are rare and usually involve an allergic
reaction. These effects may occur almost
immediately or a few minutes after the
radiopharmaceutical is given.
HEALTH & SAFETY
> Are radiopharmaceuticals safe?
• Absolutely. Like any medicine, with great care.
Before they or tested carefully.

• The quantity of the pharmaceutical part of

the radiopharmaceutical is very small, generally
1/10th of a millionth of an ounce. The risk of a
reaction is 2-3 incidents per 100,000 injections,
over 50% of which are rashes, as compared to
2000-3000 per 100,000 injections of x-ray
contrast media.
HEALTH & SAFETY

>Is the radioactivity harmful?

• Although exposure to radioactivity in very

large doses can be harmful, the
radioactivity in radiopharmaceuticals is
carefully selected by the nuclear medicine
physician to be safe.
RADIATION SAFETY
PROCEDURES
• Radiation Safety is a term applied to concepts
requirements, technologies and operations related to
protection of people against the harmful effects of
ionizing radiation.

Safe Handling of Radio Isotopes :

• Good radiation practices GRP needs to be strictly
followed for operations with unrelated sources to reduce
the chances of getting unwanted and avoidable
radiation exposure.
• It is necessary to mark the area in which the
radio active work is carried out and it should be
monitored regularly at periodic intervals.
• Unnecessary movements of persons or
materials should be avoided in the hot laboratory
or radiopharmacy.
• All the radiation workers must wear suitable
protective clothing and radiation monitoring
devices.
• Surgical gloves is necessary. When not in use,
the radionuclides must be kept in sealed
containers.
• The area should be surveyed regularly for both
contamination and exposure hazards.
• Do not pipette by mouth. Work areas should be
covered with a plastic glass or stainless tray with
absorbent paper should be use to catch any
spills and to prevent the spread of
contamination.
• Do not eat, drink and smoke in areas where
unsealed radionuclides are stored.
• Wash hands thoroughly.
• The radiation survey meter should be used to
ensure safety of worker and public, survey and
wipe test suggested action levels .
For unrestricted area 0.25 mR/hr over background.
For restricted area 20 mR/hr over background.
WASTE STORAGE AND
DISPOSAL
• Radioactive materials no longer required must be
disposed to avoid an environmental hazard.
• Avoid practice that produces large volume of waste.
• Dilute and dispense for low level solid, liquid and
gaseous waste.
• Segregate waste according to half-lives, delay and
decay for waste that contain short lived nuclides. Label
the waste before storing. Release into sewage system
depending on water flow .
• Longer T1/2 radionuclides should be incinerated or
deeply burnt in soil in a separately marked area.
Reference

• Hospital Pharmacy-William Hassan

• Ansels Pharmaceutical Dosage Form And
Drug Delivery
• Pharmaceutical Practice-Winfield N
Richards