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Dosage Forms II > Exam 2 Parenteral Products 1 > Flashcards

Exam 2 Parenteral Products 1 Flashcards

1
Q

What was the NECC case and how did that change the federal law?

A

the manufacturers put antifreeze in the product instead of propylene glycol which caused children to die → the FDA became more strict and came out with an act that only tells you what to do but not how to do it

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2
Q

Are uncontrolled environments still in use today?

A

yes → studies show that uncontrolled environments are still in use

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3
Q

What inadequate controls could increase the incidence of medication errors?

A
  1. incorrect ingredients
  2. incorrect strengths of ingredients
  3. contamination with pathogens
  4. contamination with pyrogens
    all big no no for injectables!
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4
Q

What is compounding?

A

like admixing where you are adding things to a mixture

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5
Q

How is the FDA regulating the compounding of sterile products?

A

making it illegal for any sterile drug product that is compounded not in accordance with the USP 797 → applicable to any practice setting where sterile products are compounded

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6
Q

Why are outbreaks no longer local?

A

the injectable products are sent all over the country from compounding pharmacies → not just local outbreaks, but also national outbreaks

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7
Q

What happened with the incidence of the repackaged Avastin injections?

A

a pharmacy in Florida repackaged Avastin from sterile injectable single use preservative free vials into individual single use syringes and gave them to patients → caused Streptococcus endophthalmitis eye infections and even blinded people

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8
Q

What is the main takeaway with the Avastin incident?

A

Avastin is a single use product (not to be given to multiple people) → if it is a single use used as a multiple use, contamination will occur since single use vials are preservative free → will cause many problems

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9
Q

Why are sterile products important to every pharmacist?

A

the pharmacist is the last line of defense between harm and the patient in which they are THE health care professional responsible for inspecting and approving or rejecting all formulas, calculations, substances, containers, closures and in-process materials pertaining to compounded sterile preparations

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10
Q

What is the flow of admixture orders like in a hospital?

A

physician writes the prescription → order goes to the pharmacy → pharmacist reviews the order → everything is checked → label is generated → components are assembled → admixture is prepared → the expiration time is stamped → pharmacist checks again → admixture is delivered → nurse obtains the admixture → nurse verifies it → admixture is administered

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11
Q

What is important to know about USP chapters with numbers > 1000?

A

they are recommendations (nice to have but not required to but it is better if you do)

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12
Q

What is important to know about USP chapters with numbers < 1000?

A

they are enforceable so they must be followed

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13
Q

How are the USP chapters critical to parenteral products?

A
  1. USP <797> is for pharmaceutical compounding of sterile preparations → all injectables fall under 797
  2. USP <800> is for hazardous drugs → like chemotherapy since some injectables can be hazardous
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14
Q

What are important things to know about USP <797>?

A
  1. it is the law of compounding sterile (parenteral) preparations (admixtures)
  2. every pharmacist must be familiar with it as it is part of their general knowledge
  3. if your job has anything to do with parenteral products, you have to be able to interpret USP <797> and apply it
  4. the College of Pharmacy has a license for Purdue students to access the document from USP
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15
Q

What is the rudimentary definition of a parenteral?

A

taken into the body or administered in a manner other than through the digestive tract, as by intravenous or intramuscular injection

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16
Q

What should we know about parenteral products?

A
  1. from a strict etymological point of view, the term parenteral means “other than through the GI tract”
  2. in practice, the term is restricted to products administered by injection
  3. the conventional meaning of the term involves all injectable products
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17
Q

What is the FDA CDER’s definition of the parenteral route?

A

parenteral delivery introduces drugs into the body outside the enteral route (outside the GI tract) → this route can be used to administer drugs directly to specific body organs and tissues to produce a desired therapeutic effect at a target site while minimizing systemic side effects

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18
Q

What are some considerations about parenteral products?

A
  1. administration of the therapeutic agent requires an injury to the body → have to pierce the skin with a needle
  2. administration bypasses the body’s natural defense barriers
  3. administration makes the body vulnerable
  4. must meet some stringent requirements
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19
Q

What are the requirements for all parenteral products?

A
  1. sterile
  2. particle free
  3. pyrogen free

all these attributes have significant implications pertaining to the manufacturing, compounding, and handling of sterile preparations

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20
Q

All dosage forms must have what requirements?

A
  1. have the right potency

2. is properly labeled

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21
Q

What are the objectives of compounding a sterile preparation?

A
  1. have the right potency
  2. is properly labeled
  3. sterile
  4. is particle free
  5. is pyrogen free
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22
Q

What was the process of USP <797> like?

A

effective in Jan. 2004 → revised in 2008 → revised in 2015 → revised in 2019 along with USP <800> → official in 2021

23
Q

How does USP <797> reduce risks?

A

it is a directive to reduce the risk of harm to the patient

24
Q

What are the 5 risks of harm to the patient according to USP <797>?

A
  1. microbial contamination (nonsterility)
  2. excessive bacterial endotoxins (not pyrogen free)
  3. variability in the intended strength of correct ingredients (quality of every pharmaceutical)
  4. unintended chemical and physical contaminants (not particle free)
  5. ingredients of inappropriate quality (quality of every pharmaceutical)
25
Q

What does it mean for a parenteral to be sterile?

A

parenteral formulations must be free of microbial organisms

26
Q

How is sterilization achieved in a parenteral product?

A
  1. steam (autoclave)
  2. filtration (bacteria retentive membrane)
  3. dry heat (oven) → the vials should also be sterile
  4. gas (ethylene oxide)
  5. irradiation (gamma rays)
27
Q

What are pyrogens?

A

also called bacterial endotoxins in which they are contaminants that “produce fever” and can also produce septic shock → when the body gets attacked by these endotoxins, the body tries to fight it off by increasing the body temperature (fever)

28
Q

Where do pyrogens come from?

A

they are remnants from microorganisms

29
Q

Does sterilization eliminate pyrogens?

A

NO → sterilization kills and makes dead microorganism bodies but those dead bodies/pyrogens still set off the body in which the body then increases the temperature (fever) to get rid of it → the body can’t distinguish/ doesn’t care if the microorganisms are dead or alive so it produces a fever to get rid of it

30
Q

What is septicemia?

A

infection of the blood

31
Q

What is septic shock?

A

an acute reaction to bacterial endotoxins

32
Q

Why is it important that parenterals be particle free?

A
  1. foreign particles can trigger immune response
  2. can produce damage to the lungs → since it can block the lungs and cause the patient’s life to be in danger
  3. can produce damage to the kidneys → can block the kidneys but won’t be life threatening to the patient, they will live a long painful life
  4. can and have killed people
33
Q

What are the different types of parenteral products?

A
  1. solutions ready for injection
  2. dry, soluble preparations ready to be combined with a solvent before use
  3. suspensions ready for injection
  4. dry, insoluble preparations ready to be combined with a vehicle before use → to make a suspension
  5. emulsions → example is parenteral nutrition (TPN)
  6. liquid concentrates ready for dilution prior to administration
34
Q

Why are suspensions okay to be parenteral products?

A

they are a mixture of liquid and solid → has particles but this is desired so it’s okay since it is most likely being injected to the muscle

35
Q

What are the different definitions from USP <1>? (is mandatory since 1 < 1000)

A
  1. injection
  2. for injection
  3. injectable emulsion
  4. injectable suspension
  5. for injectable suspension
36
Q

What is the definition of an injection from USP <1>?

A

liquid preparations that are drug substances or solutions thereof

37
Q

What is the definition for injection from the USP <1>?

A

dry solids or liquid preparations that, upon the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections

38
Q

What is the definition of injectable emulsion from the USP <1>?

A

liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium

39
Q

What is the definition of an injectable suspension from the USP <1>?

A

liquid preparations of solids suspended in a suitable liquid medium

40
Q

What is the definition of for injectable suspension?

A

dry solids that, upon the addition of suitable vehicles, yield preparations conforming in all respects to the requirements for injectable suspensions

41
Q

What does “for” mean?

A

can’t use it as is, you have to do something to it before injecting → have to do something to it before being able to inject it into a patient!

42
Q

How are violations of USP <1> common?

A

violations on properly identifying the product → can be healthcare professionals, information materials about parenteral products, and even labels of products used in compounding parenteral products

43
Q

What are some fake examples of parenteral products and if it can be injected as is or not?

A
  1. Purduemycin Injection → drug in solution, may or may not be aqueous (can be injected as is)
  2. Purduemycin for Injection → sterile liquid or solid that needs to be reconstituted with a vehicle (cannot inject as is)
  3. Purduemycin Injectable Suspension → can inject as is
  4. Purduemycin for Injectable Suspension → cannot inject as it
  5. Purduemycin Injectable Emulsion → can inject as is
44
Q

What are large volume parenterals (LVP)?

A

single dose injections packaged in a container containing more than 100 mL (>100 mL)

45
Q

What are small volume parenterals?

A

100 mL or less

46
Q

Why should we worry about the size of the preparation?

A

if it’s a large volume parenteral (LVP) and there is something wrong with the product, it will go wrong big time and have more effects compared to if it was something wrong with a small volume parenteral

47
Q

What are vehicles?

A

solvents or mediums for the administration of therapeutic agents

48
Q

What are the requirements for vehicles?

A

whatever the vehicle, it has to meet USP standards for the pyrogen (aka bacterial endotoxin) test → is the minimum you have to meet but it is not required to exceed USP but it would be a good idea → brand names usually exceed USP

49
Q

What is the most common and preferred vehicle used in parenteral products?

A

water

50
Q

What are the three primary types of water used in parenteral products?

A
  1. water for injection USP (WFI) → pyrogen free, non sterile, single use sealed container
  2. sterile water for injection USP (SWFI) → pyrogen free, sterile, packed in sealed containers not larger than 1000 mL →→ HAVE TO IDENTIFY IT IS STERILE OR WILL BE IN TROUBLE
  3. bacteriostatic water for injection USP (BWFI) → pyrogen free, sterile with antimicrobial agent added
    (4. sterile water for irrigation)
51
Q

Is water and sterile water the same thing?

A

NO → they are 2 completely different things

52
Q

What are the properties of water, specifically SWFI?

A
  1. pharmacologically/biologically safe
  2. sterile
  3. particle free
  4. pyrogen free
53
Q

What should you never do with plain water (aka SWFI)?

A

NEVER INJECT PLAIN WATER DIRECTLY INTO THE BLOODSTREAM

Dosage Forms II (20 decks)

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