RADIO PHARMACEUTICALS

Handling and packaging

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
• 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 macro aggregated albumin- pulmonary

perfusion
• 99mTc medronate- bone imaging
• 99mTc pertechnetate- imaging of thyroid salivary
glands,
• 99mTc sulfur colloid- imaging of reticulo endothelial
system bone marrow
 GENERAL PRECAUTIONS
A radioisotope administration Abc HOSPITAL
Radioactive isotope administration
sheet is placed in the
Tracer therapy
medical record by the Isotope____
isotope administrator at the Effective half life______
time of treatment and is to Dose_______
Route of administration_______________
remain there permanently as
The patient received radio isotope
an isotope to sign at the on_______
entrance 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. Notify at
The isotope administrator will once to the undersigned and the radiological house
provide a substitute who
may be contacted in care the signed______M.D
administrator is not readily radiocative isotope administrator
 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
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
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
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
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 record keeping, including Witten
procedures and lot-specific information to ensure
traceability;
• Validation/verification of the compounding
procedure, storage conditions, and expiration
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.
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