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
