Mega Super DDS Study Set: IE 3

IE 3 contains two multiple choice calculation questions, they are not on here

What route are sterile products usually administered?

Parenteral route (injectable)

What is the different between a bactericide and a bacteriostatic?

Bactericide is an agent that kills bacteria while bacteriostatic is an agent that prevents the growth of a bacteria

What is the difference between disinfection and sterilization?

Both kill microorganisms but sterilization kills the spore forms as well, disinfection does not

What is USP 797?

It provides definitions/descriptions/requirements for sterilization compounding

• It sets the rules of what compounding is and is not

What is USP 800?

Rules/regulations regarding hazardous drugs

What is the difference between USP 795 and 797?

Both pertain to compounding however:

• 795: Non-sterile preparations

• 797: Sterile preparations

What administration route is the most dangerous and why?

IV route because it bypasses all of the body’s natural barrier

When the pharmacists is verifying a compounded prescription what do they check for?

• Whether or not there is matter that should not be there

• The correct calculations were used

• The right drug was used

• The right diluent AND its volume was used

Harirforoosh said this would be on the test*** (easy though)

What are the different routes (and their abbreviations) and their injection site?

• Intravenous (IV) → Vein

• Intramuscular (IM) → Muscle tissue

• Intradermal (ID) → Dermis of the skin

• Epidural → Epidural space of the spinal cord

• Intra-arterial → Artery

• Intra-articular → Joint space

• Intracardiac → Heart

• Intraocular → Eye

• Intraperitoneal → Peritoneal cavity

What are some advantages to the parenteral route?

• Cant take medicine orally

• Avoids first pass effect

• Faster onset of action

• Avoids stomach upset

• Option for a local effect

• Good for long acting drugs

What are some disadvantages to the parenteral route?

• It requires proper technique

• Its inconvenient

• Once you administer it you cannot remove it

  • Cost more money and harder to make

What is a disadvantage that comes with administering an IV bolus dose?

Side effects occur more rapidly

For intermittent infusion how many doses are given and over what time frame?

Multiple 50-100ml doses, each given over a short time every few hours

For constant infusion how many doses are given and over what time frame?

Single dose, but given continuously over a long time

For IV push how many doses are given and over what time frame?

Small volume, single dose given over a short time

What is the bioavailability for the intramuscular route?

Anywhere between 0 and 1

Which one is easier to inject: intravenous or intramuscular?

Intramuscular (IM)

You want to administer a larger volume of a drug, which route would you use: intravenous or intramuscular?

Intramuscular (IM)

Which route has better absorption and why? Intramuscular or subcutaneous?

Intramuscular because the muscle tissue has more blood supply

Approximately how man mL can be administered intramuscularly?

2-5 ml

Is absorption for the subcutaneous route slow or fast?

Slow

What dosage form is used for IV?

Solution (ALWAYS)

What is the difference between [Drug] injection and [Drug] for Injection?

• Example: Penicillin injection and Penicillin for Injection?

• [Drug] injection: A liquid perception that is a drug substance or a solution

• [Drug] for Injection: Dry solids that, upon the addition of suitable vehicles, produce a solution for injection

True or False: Something can still be considered sterile even though it contains pyrogens

True: Sterile objects may still contain pyrogens

• Common sterilization processes are inadequate to eradicate pyrogens

What is the most potent type of pyrogen?

Endotoxin

In terms of parenteral packaging, what do open & closed systems refer to?

Whether or not they allow the passage of air once they are opened

What is a small volume parenteral (SVPs)?

Usually stuff like preservative, antioxidants, excipients, etc.

• Less than 100 mL

What is the most common source of contamination during sterile compounding?

Touch

What is USP 788?

Particulate Matter in Injections:

• Limits the number of particles present in IV or IA injections

  • Because particles can’t be completely eliminated, just controlled

What ISO level is sufficient for sterile compounding?

At least 5

What ISO level is achieved when you use a HEPA filter?

Maintains ISO class 5 air quality within the work zone

What is considered a low-risk level compounding?

Aseptic manipulations within ISO class 5 only involving transfer, measuring, and mixing with closed or sealed packaging

What risk level compounding is commonly seen in inpatient pharmacies?

Medium-Risk level

What is considered high-risk level compounding?

Using aseptic products to ultimately make a sterile product and the exposure of the sterile ingredients to air less than ISO class 5

What do the following provide: chemical or microbial stability?

• Buffer

• Antioxidant

• Chelating Agent

• Antimicrobial agent

• Cryoprotectants

• Buffer: Chemical

• Antioxidant: Chemical

• Chelating Agent: Chemical

• Antimicrobial agent: Microbial

• Cryoprotectants: Chemical

Does water for injection have to be sterile?

No, but it cannot contain pyrogens

What is the limit to total solid in water for injection?

1 mg/100 mL

Can sterile water for injection contain pyrogens?

No, it must be sterile and pyrogen free

Can bacteriostatic water for injection contain pyrogens?

No, it must be sterile and pyrogen free

What are the two non-aqueous vehicles that are not okay to use?

Oils containing mineral oil or paraffin

What are the components of the following preparation?

• Active ingredient:

• Vehicle (solvent):

• Preservative:

• Active ingredient: Testosterone Enanthate

• Vehicle (solvent): Sesame Oil

• Preservative: Chlorobutanol

What are two examples of tonicity-adjusting agents?

Sodium chloride 0.9% and dextrose 5%

What is the acceptable pH range for IV preparations?

3-9 (4-8 for other routes)

What is the purpose of an antioxidant?

It protects the active ingredient by preventing it from being oxidized

What is the common antioxidant Harirforoosh wants us to know?

Vitamin C aka Ascorbic acid

What is freeze-drying (lyophilization) and why is it done?

Process of drying in which water is sublimed from the product after it is frozen and it is done in order to increase the stability of a drug that is usually unstable in an aqueous solution

• “sublimed” definition: (of a solid substance) change directly into vapor when heated, typically forming a solid deposit again on cooling

What is the most widely used method of sterilization and how is it done?

Steam sterilization and it is hot steam under pressure using an autoclave

What differs in dry heat sterilization compared to steam sterilization?

No pressure involved, higher temperatures required, more time consuming

How does filtration work?

It is physical removal → sterile product

What is the bubble point test?

It is a way to test for the integrity of a filter. It is non-destructive and it estimates the pore size in the filter

What chemical is used in gas sterilization?

Ethylene oxide

What biological indicators/spores should be known?

What is the test that is used to detect the presence of bacterial endotoxins?

Limulus amebocyte lysate (LAL) test

Medium, there are 5 ingredients involved

What are two examples of primary engineering controls (PECs)?

Laminar flow workbenches and biological safety cabinets

In the context of secondary engineering controls (SEC), what are the ISO classes needed in their areas?

Direct compounding area (DCA) represents ISO classes 3 or 4

Do laminar flow workbenches protect the operator?

No, only the product, we do see some protection of the operator in the higher levels

What are the components of a needle we need to know?

In terms of aseptic technique, do we want coring?

No, we avoid it and this is done as shown in the image

What is the relationship between the gauge number and the thickness of the needle?

The larger the gauge the thinner the needle