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Dosage II > Sterile Solution forms > Flashcards

Sterile Solution forms Flashcards

1
Q

New England Compounding Center tragedy

A

-2012 compound pharmacy
-poop in product
-menningitis and DIED
-sparked changes in law

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2
Q

Reasons for Concern

A

-uncontrolled environments are still in use
-inadequate controls increase incidence of medication errors

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3
Q

Possible medication errors from uncontrolled environments

A

-incorrect ingredients
-incorrect strengths
-contamination with pathogens or pyrogens

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4
Q

Pharmacist responsibilities

A

-inspecting all formulas, calculations, substances, containers, closures and in-process materials pertaining to compounded sterile preparations

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5
Q

Avastin 2011

A

-infection risk from repackaged injections
-pharmacist wrongly told someone they could reuse vial
=blind

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6
Q

Flow of Admixture Orders

A

…
5. Label generated
6. Components assembled
7. Admixture prepared
8. expiration time stopped
9. pharmacist checks
…

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7
Q

USP chapters > 1000

A

-recommendations

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8
Q

USP chapters < 1000

A

-enforcable
-must follow

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9
Q

USP chapters

A

-critical to parenteral products

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10
Q

USP <797>

A

-law of compounding sterile (parenteral) preparations (admixtures)
-every pharmacist must be familiar with it

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11
Q

Parenteral Products

A

-taken into body other than by GI tract
-products administered by INJECTION

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12
Q

Parenteral Route

A

-can be used to admin drugs directly to specific body organs and tissues to produce effect at site while minimizing side effects

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13
Q

Considerations about parenteral products

A

-admin requires an injury to body
-admin bypasses body’s natural defense barriers
-admin makes body vulnerable
-must meet stringent requirements

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14
Q

Sterile Preparation requirements

A

-sterile
-particle free
-pyrogen free

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15
Q

all dosage form requirements

A

-right potency
-proper label

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16
Q

Risks of parenterals to patients

A

-microbial contamination
-excessive bacterial endotoxins
-variability in intended strength
-unintended contaminants
-inappropriate quality of products

17
Q

Sterile

A

-free of microbial organisms

18
Q

Sterilization

A

-steam (autoclave)
-filtration (bacteria retentive membrane)
-dry heat (oven)
-gas (ethylene oxide)
-irradiation (gamma rays)

19
Q

pyrogens

A

-contaminants that produce fever
-also produce septic shock
-remnants from microbes

20
Q

septicemia

A

infection of blood

21
Q

septic shock

A

acute reaction to bacterial endotoxins

22
Q

why particle free?

A

-foreign particles can trigger immune response
-can produce damage to lungs and kidneys
-can and have killed ppl

23
Q

Types of parenteral products USP <1>

A

-solutions
-dry, soluble preparations
-suspensions
-dry, insoluble preparations
-emulsions
-concentrates

24
Q

Injection

A

-liquid preparations that are drug substances or solutions

25
Q

For Injection

A

-dry solids or liquid preparations
-add vehicle to yield solution

26
Q

Injectable emulsion

A

-liquid prep of drug dissolved or disperesed in emulsion medium

27
Q

Injectable suspension

A

-liquid prep of solids suspended in liquid medium

28
Q

For Injectable suspension

A

-dry solids
-add vehicle to yield suspension

29
Q

Detective Assignemnt

A

-keep an eye on HC professionals
-info materials about parenteral products
-labels of products
-find violations of USP <1>

30
Q

Sizes of parenteral preparations

A

-Large Volume parenteral (LVP)
-Small Volume parenterals (SVP)

31
Q

Large volume parenterals (LVP)

A

-single dose injections packaged in container with more than 100 mL

32
Q

small volume parenterals

A

100mL or less

33
Q

Vehicles of parenteral products

A

-solvents or mediums for the administration of therapeutic agents
-must meet USP pyrogen requirements
-water most common and preferred

34
Q

3 types of water for parenteral products

A

-water for injection (WFI)
-Sterile water for injection (SWFI)
-Bacteriostatic water for injection (BWFI)

35
Q

water for injection USP (WFI)

A

-pyrogen free
-non-sterile
-single use sealed container

36
Q

Sterile water for injection USP (SWFI)

A

-pyrogen free
-sterile
-packed in sealed containers no bigger than 1000mL

37
Q

Bacteriostatic water for injection USP (BWFI)

A

-pyrogen free
-sterile with antimicrobial agent added

38
Q

sterile water for irrigation

A

-idk why he listed this

39
Q

Never inject

A

plain water into blood stream

Dosage II (20 decks)

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