Sterile Solution forms Flashcards
New England Compounding Center tragedy
-2012 compound pharmacy
-poop in product
-menningitis and DIED
-sparked changes in law
Reasons for Concern
-uncontrolled environments are still in use
-inadequate controls increase incidence of medication errors
Possible medication errors from uncontrolled environments
-incorrect ingredients
-incorrect strengths
-contamination with pathogens or pyrogens
Pharmacist responsibilities
-inspecting all formulas, calculations, substances, containers, closures and in-process materials pertaining to compounded sterile preparations
Avastin 2011
-infection risk from repackaged injections
-pharmacist wrongly told someone they could reuse vial
=blind
Flow of Admixture Orders
…
5. Label generated
6. Components assembled
7. Admixture prepared
8. expiration time stopped
9. pharmacist checks
…
USP chapters > 1000
-recommendations
USP chapters < 1000
-enforcable
-must follow
USP chapters
-critical to parenteral products
USP <797>
-law of compounding sterile (parenteral) preparations (admixtures)
-every pharmacist must be familiar with it
Parenteral Products
-taken into body other than by GI tract
-products administered by INJECTION
Parenteral Route
-can be used to admin drugs directly to specific body organs and tissues to produce effect at site while minimizing side effects
Considerations about parenteral products
-admin requires an injury to body
-admin bypasses body’s natural defense barriers
-admin makes body vulnerable
-must meet stringent requirements
Sterile Preparation requirements
-sterile
-particle free
-pyrogen free
all dosage form requirements
-right potency
-proper label
Risks of parenterals to patients
-microbial contamination
-excessive bacterial endotoxins
-variability in intended strength
-unintended contaminants
-inappropriate quality of products
Sterile
-free of microbial organisms
Sterilization
-steam (autoclave)
-filtration (bacteria retentive membrane)
-dry heat (oven)
-gas (ethylene oxide)
-irradiation (gamma rays)
pyrogens
-contaminants that produce fever
-also produce septic shock
-remnants from microbes
septicemia
infection of blood
septic shock
acute reaction to bacterial endotoxins
why particle free?
-foreign particles can trigger immune response
-can produce damage to lungs and kidneys
-can and have killed ppl
Types of parenteral products USP <1>
-solutions
-dry, soluble preparations
-suspensions
-dry, insoluble preparations
-emulsions
-concentrates
Injection
-liquid preparations that are drug substances or solutions
For Injection
-dry solids or liquid preparations
-add vehicle to yield solution
Injectable emulsion
-liquid prep of drug dissolved or disperesed in emulsion medium
Injectable suspension
-liquid prep of solids suspended in liquid medium
For Injectable suspension
-dry solids
-add vehicle to yield suspension
Detective Assignemnt
-keep an eye on HC professionals
-info materials about parenteral products
-labels of products
-find violations of USP <1>
Sizes of parenteral preparations
-Large Volume parenteral (LVP)
-Small Volume parenterals (SVP)
Large volume parenterals (LVP)
-single dose injections packaged in container with more than 100 mL
small volume parenterals
100mL or less
Vehicles of parenteral products
-solvents or mediums for the administration of therapeutic agents
-must meet USP pyrogen requirements
-water most common and preferred
3 types of water for parenteral products
-water for injection (WFI)
-Sterile water for injection (SWFI)
-Bacteriostatic water for injection (BWFI)
water for injection USP (WFI)
-pyrogen free
-non-sterile
-single use sealed container
Sterile water for injection USP (SWFI)
-pyrogen free
-sterile
-packed in sealed containers no bigger than 1000mL
Bacteriostatic water for injection USP (BWFI)
-pyrogen free
-sterile with antimicrobial agent added
sterile water for irrigation
-idk why he listed this
Never inject
plain water into blood stream
