Dispensing

Radiopharmaceuticals and
Cytotoxics

Dr/ Menna Faisal

Lecturer of Pharmaceutics
Zagazig University
Definition:
• A radiopharmaceutical is a pharmaceutical that,
incorporates one or more radionuclides (radioactive
isotopes).
• Radiopharmaceuticals are used for:
 diagnosis
 therapeutic treatment of human diseases.
• Radionuclides are unstable nuclei that are stabilised upon radioactive decay
• A radionuclide may decay by emitting different types of ionising radiation:
 alpha (α),
beta (β- ),
positron (β+)
Decay of
gamma (γ) radiation
radionuclides
• Diagnostic radiopharmaceuticals should decay by gamma emission or positron
emission, and never emit alpha particles or even beta particles.
• Therapeutic radiopharmaceuticals should decay by particulate decay (alpha or
beta) since the intended effect is in fact radiation damage to specific cells.
 Radioactivity is expressed in Becquerels (Bq).

Radioactivity
One Becquerel is defined as one disintegration per
second (dps).
units
• Every radionuclide is characterised by a half-life, which is defined as the
time required to reduce its initial activity to one half.
Principles of radiation protection

• For protection against gamma radiation,

walls made of heavy concrete or lead bricks
are used.
 Preparing & Dispensing
Radiopharmaceuticals

• All manipulation of radioactive

materials should be carried out, using
aseptic techniques, within the shielded
contained workstation or laminar flow
cabinet (LAFC).
• No food or drink, cosmetic or smoking
materials should be brought into an
area where unsealed radioactive
substances are used.
Preparing & Dispensing Radiopharmaceuticals
Personnel monitoring
• All staff classified as radiation workers must wear a personal
dosimeter
Protective clothing
- staff should ensure that they wash their hands thoroughly.
- any cut or break in the skin should be covered.
- Protective coats or gowns should be worn for preparation
and dispensing of radiopharmaceuticals.
- Gloves worn must be powder free in order to prevent
clogging of the air filters within the cabinet. Alcohol rub
should be rubbed onto gloves and allowed to evaporate
- Hands should be washed again after removal of gloves.
- Upon leaving the radiopharmacy, disposable gowns should
be removed.
Preparing & Dispensing
Radiopharmaceuticals
Protective equipment
1. tools for maximising the distance
from the source, for example tongs and
forceps,
2. syringe shields,
3. vial shields,
4. drip trays for minimising the spread
of contamination in the case of spillage,
5. shielded syringe carriers and
6. decontamination kit
Waste management:
Non-radioactive waste should be separated from radioactive
waste to minimise storage requirements; and it should be
disposed of as normal hospital waste.

Radioactive waste generated daily within the radiopharmacy

includes syringes, elution vials, pharmaceutical vials, needles and
swabs. Waste arising from the preparation and dispensing of
radiopharmaceuticals should be primarily disposed in the waste
bin.
Disposal of waste
• All radioactive waste - should be securely stored and
monitored regularly. Waste should be checked by using a
suitable meter in a low background environment and should
be disposed of
Dispensing cytotoxic drugs
Cytotoxic drugs/
antineoplastics
describe a group of medicines
that contain chemicals which are
toxic to cells, preventing their
replication or growth, and so are
used to treat cancer.

They can also be used to treat a

number of other disorders such
as rheumatoid arthritis and
multiple sclerosis.
What is the risk?
The toxicity of cytotoxic drugs means that they can present significant risks to those
who handle them

• Inadequate control measures

could lead to:
• Abdominal pain, hair loss, nasal
sores, vomiting, and liver damage
• Contact dermatitis and local
allergic reactions.
• Foetal loss in pregnant women
and malformations in the children
of pregnant women
• Alterations to normal blood cell
count
• Abnormal formation of cells and
mutagenic activity or mutations
forming
Recommendations:
1. Personal and Protective Equipment
• a cap,
• surgical or procedure mask,
• shoe covers,
• a protective gown
• 2 pairs of gloves

• Gloves: • Gown:
• - Gowns used for handling
• - Nitrile, polyurethane,
neoprene, or latex cytotoxic drugs should be
disposable;
• -When administering
reconstituted • - should be made of lint-free,
medications or if the low-permeability fabric;
gloves become torn, should have long sleeves
punctured, or visibly with tight-fitting cuffs; and
contaminated with a should fasten in the back.
cytotoxic drug , workers • - Gowns have to be changed
should change gloves in the event of
immediately contamination, spillage, or
rips, and at the end of the
procedure
Facial Protection
Surgical or procedure
masks are required
when handling and
preparing medications
in a biological safety
cabinet
Respiratory Protection
Apparatus
Fit-tested respirators such as
those certified N95 or N100
Shoe Covers
Shoe covers should be removed
immediately when leaving the
sterile prep room to avoid
contamination of other areas
 2. Receiving and Transport
• check the integrity of the external
packaging upon receipt;
• in the event of breakage or a damaged
parcel likely to cause a spill, apply the Spill
Protocol from your institution
• Delivery containers should be taken
immediately to the pharmacy department
• The delivery containers should be handled
with care to avoid breakage of the
cytotoxic drug containers and not be left
unattended in a corridor.
 3. Damaged Containers or Spills
• The manufacturer or distributor should be notified if a container is
received in a damaged state.
• To limit exposure, a damaged container should never be returned to
the manufacturer or distributor.
• 4. Unpacking and Storage
The unpacking area should be a separate space, separate from eating
areas and preferably a separate room (anteroom) .
• A receptacle for cytotoxic waste should be available in the unpacking
area for the disposal of secondary packaging.
 5. Cytotoxic Drug Preparation

• A class II, type B biological safety cabinet is

required, with preference for the type B2
because it ensures that there is no
recirculation of air within the cabinet
• The furniture and equipment in the sterile
preparation room should be kept to minimum.
• The sterile preparation room and the
pharmacy should have a visual link
• Access to the sterile room should be limited
to trained and authorized workers
• Emergency eye washing should be able to
provide 15 minutes of flushing to both eyes. A
full shower should be accessible
A. Organization of the Work

• cover the work surface with a disposable

absorbent plastic-backed sterile pad
• place the sterile products in the centre and
the non-sterile products (for example, the
waste receptacle) along the sides of the
cabinet
B. Preparation, Priming, and
Removing Air from Tubing

• Intravenous tubing should be

primed and air removed in the
pharmacy, before the cytotoxic
drug or drugs are added to the
infusion solution.
• Glass containers are not
recommended
 6. Labelling and Final Packaging

• Cytotoxic drugs should display the

“Cytotoxic” hazard symbol
• Place each cytotoxic drug container
(for example, syringe, bag) as well as
the administration supplies (for
example, tubing) in a clear, leak-proof
plastic bag, to facilitate identification
by the nurse without having to
remove the container from the bag
 7. Management of Waste
• packaging material;
• protective equipment;
• preparation supplies such as
syringes, tubing, drug bags.
• should be placed in a waste
container clearly identified with
the “Cytotoxic” hazard symbol
• Cytotoxic waste should be
incinerated at a high temperature
(that is, 800–1200°C)