Test 1 Flashcards
define compounding
practice in which a licensed pharmacist, physician, or a person supervised by a pharmacists combines, mixes, alters ingredients of a drug to create a medication tailored to the needs of an individual patient
why do we compound
traditional pharmacy practice. serves as a role for patients whose needs cannot be met by an FDA drug product
USP chapter number: 0-999
standard all enforceable under standard law
503-A
traditional pharmacy practice is allowed to compound as long as it operates within the patient, physician, and pharmacist (in a licensed pharmacy)
3 sections of that are exempted from food, drug cosmetic act of 1983
- section 501 a2b: good manufacturing practice 2. 502 f1: labeling of drugs with adequate directions 3. 505: approval of drugs under new drug applications (NDA)
503-B
outsourcing facility register with FDA and inspected by FDA products compounded by or under direct supervision of licensed pharmacist
2 sections FD&C act of 198exempted from 503B
- 502 f1: labeling of drugs with adequate directions 2. 505: approval of drugs under new drug applications (NDA)
who inspcets licensed pharmacists for compliance with sterile compounding standard
albop
objective/purpose of 797 is to describe conditions and practices to prevent harm and death to patients that could result from_____ (5)
- microbial contamination (non-sterility) 2. excessive bacterial endotoxins 3. variability in intended strength of correct ingredients that exceeds either monograph limits for official articles 4. unintended chemical and physical contaminants 5. ingredients of inappropriate quality in compounded sterile preparations everyone who compopunds must comply with 797
dosage forms that must comply with 797
- aqueous bronchial and nasal inhalation 2. bath for organs 3. injections 4. irrigations wounds/cavities 5. ophthalmic drops and ointments 6. tissue implants
Clean room equipment and supplies
only the things required for compounding may be in the room. the items must maintain results from equipment calibration, annual maintenance reports and other routine maintenance records
stocking the clean room
- have a special process of entering/exiting clean room to avoid contamination - no food, drinks, gum in sterile compounding areas - shedding paper and corrugated cardboard packaging must be eliminated prior to entering the clean room suite
ISO
International Organization of Standards - defines the level of airborne particulate cleanliness in terms of ISO class number
ISO classifications
- particulates classified more than 0.5 micro meters in diameter - maximum number of particles per cubic meter - important because bacteria are unable to change locations on their own - transported on particles in the air - limit particles in the air ( on particulates) or on surfaces; bacteria should also be limited
ISO 8
anti room- where you get ready if it is sterile non-hazardous
ISO 7
standard for hazardous/non-hazardous buffer room, or hazardous ante room
ISO 5
inside the hood - HEPA filtered air
room temp of a compounding facility
68 degrees F or 20 degrees C
is the ante room a primary or secondary engineering control
secondary
ante room ceiling
junctures covered and tiles caulked so they do not move
ante room walls
smooth and painted with a regulation paint to prevent accumulation of dust
ante room floors
floors should be seamless and covered where they meet the wall
ante room fixtures
hanging or dust collecting fixtures should be avoided
ante room surfaces and carts
stainless steel to avoid dust collection - NO wood - cart in ante room never goes into buffer room - cart cleaned very day even wheels
sterile non-hazardous/hazardous postive or negative pressure?
positive - non hazardous negative - hazardous
buffer room
the room that contains the PEC and connects to an ante room. Buffer room design requirements are the same as the ante room except there should be no sources of running water or floor drains.
segregated compounding area
non-classified space or room equipped with a PEC of ISO Class 5. SCAs should be away from the unsealed windows, doors that connect to the outdoors, and significant traffic flow. They can not be located adjacent to construction sites, warehouses, food preparation areas, and other environmental issues.
Primary Engineering Controls
ISO 5 stands for “Primary Engineering Control” and is a general term for anything that provides an ISO Class 5 environment. They must contain a HEPA filter and can have vertical or horizontal airflow. It is KEY that when the smoke study is done on a PEC that there are no swirls in the smoke.
the _____ HEPA filtered airflow in the PEC must provide _______
unidirectional; sufficient velocity to sweep particles away from the direct compounding area during compounding activities
how do you demonstrate the unidirectional airflow?
smoke studies
CAI
portable PEC for non-hazardous compounding. It does not have to be in a buffer room but it needs to have a guarantee from the manufacturer.
if isolators placed outside of ISO 7 area
must have documentation from manufacturer
power and utility interuptions
facility’s emergency management plan should include steps to meet patient care needs
containment isolator
nothing in there can escape - used for chemo
access to the clean room
should be restricted to qualified personnel with specific responsibilities or assigned tasks in the area- traffic flow in and out of the area should be minimized and no one enters without proper garbing
items not brought into the sterile compounding area
nothing that is not brand new or nothing not sterilized
excluded from the sterile compounding area if you are experiencing
CANNOT go in if you are sick or experiencing any of the following: - rash - sunburn - weeping sores - conjunctives - active respiratory infections
how long to wash hands
at least 30 seconds, use of scrub brushes or hand dryer not recommended - sinks have no handles and only foot peddles
order of garbing
ante room- First you remove all jewelry from your body besides glasses if you need them to see. Next you begin with the feet, then the hair (including beard cover if needed), then the face mask. Next you wash your hands the proper way DO NOT USE A SCRUB BRUSH! Put on your gown and without any gloves on your hands walk backwards into the buffer room using your back to push the door. dirtiest to cleanest - 1. shoe covering 2. hair net
aseptic technique
using practices and procedures to prevent contamination from pathogens and risk of infection