Mpje Wi Phar Chapter 15

Front 1

What is a class 100 environment?

Back 1

atmospheric environment that contains less than 100 particles 0.5 microns in diameter per cubic foot of air

Front 2

define: parenteral

Back 2

preparation of drug for injection through one or more layers of skin

Front 3

What are the requirements for P&Ps within a pharmacy for the preparation of sterile products?

Back 3

-a pharmacy must maintain a policy and procedure manual for compounding, dispensing, delivering, administering, storing, and using sterile pharmaceuticals
-must include quality assurance program, up-to-date information on the preparation of sterile pharmaceuticals
-must be updated annually or as needed to reflect current practice
-available for inspection by the board

Front 4

What are the physical requirements of a pharmacy for preparing sterile products?

Back 4

-separate room designated for preparation, separate from bulk storage
-class 100 environment
-appropriate disposal containers
-appropriate environmental controls
-temperature-controlled delivery containers as needed
-a sink with hot and cold running water in close proximity
-sufficient reference materials
-closed and disinfected at regular intervals

Front 5

What records and reports must be maintained by pharmacies preparing sterile products?

Back 5

-training and competency evaluations of personnel
-documentation of refrigerator temperatures
-certification of hoods

Front 6

What information is required on a label for a specific patient for a sterile product?

Back 6

-identity of all solutions and ingredients
-corresponding concentrations/volumes
-identity of personnel used in preparation
-date and time of preparation
-expiration date and storage requirements
-control or lot #
-auxiliary labeling

Front 7

Are chemo products prepared in laminar or vertical flow hoods?

Back 7

vertical

Front 8

How often do sterile product hoods have to be inspected and certified?

Back 8

at least annually