125 Post Midterm

Parenteral

Injections through skin or other external boundary tissue, rather than the alimentary canal

Which of the following is not a necessity of a parenteral?

- Sterile

- Isotonic

- No pyrogenic contamination

- Stable

Isotonic (should but not a must)

For MgCl2, 1 mole = __ osmole/L

3

Sterility assurance level (SAL)

Probability that a single unit that has been subjected to sterilization remains non-sterile

A sterile compound needs an SAL of ______

0.001 (1/1000 units are nonsterile)

Steam sterilization (autoclave)

Superheated water transfers heat to microorganisms and kills via denaturation and coagulation of proteins

Limitations of steam sterilization

Plastics melt, chemicals may breakdown, typically can't use most compounded products

What method of sterilization may be suitable for a heat-stable item that is adversely affected by steam?

Dry-heat sterilization / depyrogenation

Dry heat sterilization

dry heat dehydrates and burns (oxidizes) organisms

Gas sterilization

Fill chamber with gas that works by interfering with cell metabolism. Good for heat labile products

Limitations of gas sterilization

Gas is inflammable, toxic, and carinogenic

Between radioisotope decay (gamma) and electron-beam radiation (beta), which method of sterilization is faster but does not penetrate as deep?

Electron-beam radiation

What type of sterilization is used for products unable to withstand heat sterilization or when there are concerns about the safety of gas

Ionizing radiation

How does the ionizing radiation method of sterilization work?

Ionizing water to form free radicals that kill cells

This method of sterilization uses physical removal of microorganisms

Sterilization by filtration

In stabilization by filtration, the product is considered sterile if it passes through a _____ micrometer filter

0.22

What is an issue with stabilization by filtration?

It may miss small molecules that pass through the filter such as pyrogens

The beyond use date is set by the _________________ (manufacturer/pharmacy) meanwhile the expiry date is set by the _________________ (manufacturer/pharmacy)

Pharmacy; manufacturer

What is the discrepancy between BUD definitions with USP and NAPRA?

NAPRA says that administration must begin before the BUD has passed whereas USP797 says that BUD is the date or time after which a CSP cannot be used

Bacterial growth phases

lag phase, exponential phase, stationary phase, death phase

Sterile unit

vial, ampoule, or bag that is sterile

True or false. The more sterile units, the greater the contamination risk level

True

In use times

The time before which a product must be used, after it has been opened or needle-punctured.

True or false. Beyond use date of a single use vial changes based on the environment it was opened in

True

Multi use vial BUD is _____ days unless otherwise specified

28

Intramuscular and subcutaneous injections are limited to __ mL

3

Subcutaneous injection

Administered as a bolus into the subcutis. Subcutaneous tissue has few blood vessels so drugs injected here are for slow, sustained rates of absorption

What type of IV is most common?

Peripheral IV

Why is IV not recommended when IM/SC would be possible

Risk of infection

Central catheters

IV delivery into a large vein that goes to the heart

Which is not true about central catheters

- Large volume and high infusion rates tolerated

- Lots of blood flow lets us dilute the medication

- Short term use only

- Higher infection rate

Short term use only

A cerebrospinal fluid injection is injected into lumbar ____________ space of the spinal cord to bypass BBB

Epidural

Intrathecal injection

Injected into subarachnoid space of spinal cord to bypass BBB

Critical site

Any surface likely to come into contact with a sterile drug or liquid or any exposed opening that is likely to be in direct contact with the ambient air.

First air

laminar flow exiting HEPA filter

True or false. Critical sites may only come into contact with first air.

True

Direct compounding area

Area where compounding occurs

Primary Engineering Controls (PEC)

Provides an ISO Class 5 environment for the direct compounding area.

Anteroom

transition room from the buffer zone to the pharmacy

Buffer room

Clean room for compounding sterile products that has the PEC in it

A higher ISO class level indicates a ________________ (cleaner/dirtier) environment

Dirtier

Types of PEC

- Laminar airflow workbench (LAFW)

- Biological safety cabinets (BSC)

- Compounding aseptic isolators (CAI) and compounding aseptic containment isolators (CACI)- less common

Two types of laminar airflow workbench

Horizontal or vertical

Disadvantage of laminar airflow workbench

Does not protect user (exhaust is directed at user) so its only suitable for nonhazardous compounding

What class of biological safety cabinet (BSC) is most common for sterile compounding

Class II

Secondary Engineering Control (SEC)

Buffer and ante rooms

Segregated compounding area

A non isolated area with a PEC. There is increased risk of microbial contamination. This limits what type of compounds you can prepare

A buffer room needs to be ISO class __ or better

7

Where in the buffer room is it cleanest (other than the PEC)

Top of the room

A ante room needs to be ISO class __ or better

8

When compounding hazardous drugs, the buffer room needs to be __________________ pressure compared to the ante room

Negative

How are large volume parenterals usually administered

Through a pump

Disadvantage of 5% dextrose in water (D5W) as an isotonic solution

Need to avoid water intoxication (D5W does not include electrolytes)

Lactated Ringer's

Used for electrolyte replacement, hydration and for mild to moderate acidosis. Caution with hepatic disease and lactic acidosis.

Ringer's injection

Electrolyte replacement, hydration. Can cause fluid overload in congestive conditions

0.45% sodium chloride is _____tonic

Hypo

3% sodium chloride is ______tonic

Hyper

0.9% sodium chloride is ______tonic

Iso

Line of demarcation

Line in the anteroom to get dressed in full PPE before going into clean room

Where packaging allows, compounding equipment/products must be disinfected with ________________________________ just before being introduced into the anteroom/cleanroom/PEC

sterile 70% isopropyl alcohol (sIPA)

What type of pressure inside the vial is used with hazardous drugs?

Negative Pressure: Volume of air added to vial less than volume of solution removed. This prevents aspiration of the liquid

Closed-system drug-transfer device (CSTD)

A drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapor concentrations outside the system.

Number of _______________ = Atomic mass - atomic number

Neutrons

Non-ionizing radiation

Refers to any type of electromagnetic radiation that does not carry enough energy per quantum to ionize atoms or molecules (i.e. to completely remove an electron from an atom or molecule)

Ionizing radiation

Consists of subatomic particles or electromagnetic waves that are energetic enough to detach electrons from atoms or molecules.

Which is a type of non-ionizing radiation?

- Electrons

- X-rays

- Neutrons

- Microwave

Microwave

Which is not a type of non-ionizing radiation?

- Protons

- Ultrasound

- Infrared

- Laser

Protons

Neutrons are an example of ________________ ionizing radiation

Indirectly

Alpha particles are an example of __________________ ionizing radiation

Directly

Order the following types of ionizing radiation by their range (furthest range to least range)

- Gamma

- Alpha

- Neutrons

- Beta

1. Neutrons

2. Gamma

3. Beta

4. Alpha

This type of ionizing radiation has no mass or charge

Gamma

This type of ionizing radiation has a helium nucleus (2 protons, 2 neutrons)

Alpha

This type of ionizing radiation has no charge and is fairly large

Neutrons

This type of ionizing radiation is highly charged and is very large

Alpha

Radiation having no charge indicates that it will have _________ (low/high) penetrating power

High

Radioisotope

An unstable isotope that emits radiation during its decay to a stable state

True or false. All isotopes are radioisotopes

False

Radioactive decay (radioactivity)

a phenomenon in which radiation is given off by an unstable nuclei to become stable: spontaneous or nuclear reaction

Radioactive decay is a ___________ order process

First

Secular equilibrium

A condition reached when the half life of the parent radioactive nuclei is many times greater (100-1000 times more) than the half life of the daughter. The daughter can't decay until it is formed, and so the rate of formation of the daughter equals the rate of decay of the parent, which is very slow. Therefore the parent and daughter appear to have the same half-lives

Transient equilibrium

A condition reached when the half life of the parent radioactive nuclei is approximately 10 times greater than the half life of the daughter radioactive nuclei

The interaction of _________ particles as charged particles and gamma radiation as electromagnetic radiation is the most important from the point of view of using them in nuclear medicine

Beta

The five mechanisms by which gamma rays interact with matter

Rayleigh Scattering

Photoelectric Interaction *

Compton Interaction *

Pair Production

Photo Nuclear Interaction

*Important ones

Photoelectric Interaction

In this process a photon interacts with the innermost shell of an atom and ejects an orbital electron from the atom. The entire energy of the photon is transferred to the electron to eject it from the atom

Compton interaction

In this process, the photon interacts with an atomic electron as though it were a free electron. The photon transfers some energy to the electron ejecting it out of the atom with some kinetic energy. The photon is then scattered with degraded energy

Brachytherapy is an example of ____________________ radiation

Internal

Which of the following is not a functional image?

- MRI

- SPECT

- PET

- fCT

MRI

__________________ imaging is a medical imaging technique of detecting or measuring changes in metabolism or blood flow.

Functional

Two components of a radiopharmaceutical

- Radionuclide or radioactive isotope; required for the treatment or imaging

- Carrier molecule which delivers the radioisotope to the area to be treated or examined

Effective half-life

the combination of the physical half-life and the biological half-life

Physical (T1/2) vs Biological (Tb) half life

Physical: The period of time required for half of the nuclei for a given radioisotope to decay

Biological: Period of time required for half of the radioactive substance to leave the body

The most common radioisotope used in diagnosis

Technetium-99m

The ideal effect half life of a radiopharmaceutic is ___________ (short/long)

Short

________________ rays are used for diagnostics because they are transient

Gamma

________________ rays are used for radiopharmaceutic therapies because they deposit int he body

Alpha or beta

Which is not a method of manufacturing radionuclides?

- Nuclear fission

- Scintillation

- Neutron bombardment

- Charged particles (cyclotrons)

Scintillation

Radionuclide generators produce ________-lived radioisotopes

Short

This method of producing radionuclides involves a self-contained system housing a parent/daughter mixture in equilibrium

Radionuclide generator system

The process of removing the daughter from the radionuclide generator is referred to as _____________; the solution used to remove the daughter is called the ___________; and the solution collected from the generator containing the daughter radioisotope is called the ___________

Elution; eluent; eluate

The radionuclide generator should be eluted with ___________________________

0.9% saline solution