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
critical site
tip of syringe- any place at risk of direct contact with air - not a perfect seal
direct compounding area
where compounding is done
first air
air coming out of the HEPA filter
order of cleaning and disinfecting the laminar airflow workbench
- ceiling - HEPA filter grill (do not saturate filter) - bar and hooks - sides - floor use a clean wipe surface for each step
never measure less than ___ of the volume of the syringe
20%
critical sites on the needle
everything is a critical site
supplies brought into sterile compounding area from shipping carton
sprayed or wiped with sterile 70% isopropyl alcohol (IPA)
supplies brought into sterile compounding area from sterile supplies received in sealed pouches
- remove from pouch as introduced to PEC - do not need to disinfect individual sterile item - cover protects sterile bag and decreases evaporation - sometimes you can see condensation inside the cover
placement of supplies in the laminar airflow workbench
- place 3 in from the back and side walls of the LAFW - place at least 6 inches from the front edge of LAFW. front 6 inches is unsafe area and must discard uncovered sterile products if it goes in this area - do not block first air - critical sites should receive first air - maintain clear direct compounding area (DCA)
when laminar airflow is accessible to all sides of an object, zone of turbulence extends to ___ times the diameter of the object
3
when laminar airflow is not accessible to all sides of an object, zone of turbulence extends to ___ times the diameter of the object
6
how to remove fluid from a vial
- swab vial septum with 70% IPA and allow to dry - draw a volume of air equal to volume of fluid to be removed into a syringe - position needle at a 45 degree angle on vial with bevel up - while pushing the needle through the stopper reposition at a 90 degree angle and invert and inject air into vial - withdraw desired volume (tapping out bubbles and readjusting volume
single dose- container
open or needle-punctured single-dose containers shall be used. - NEVER if opened outside an ISO class 5 area and any remaining fluid discarded - within 6 hrs if opened in a ISO 5 area
define multi-dose containers
shall not be used after 28 days once opened or needle-punctured
sharps container is for
needles, glass, etc
yellow bin is for
pharmaceutical waste
trash can is for
garb, non-pharmaceutical waste
rationale for TPN
nutritional support for patients unable to take medications enterally - severe pancreatitis, short-bowl syndrome, inflammatory bowel disease - infant with very low birth weight - patients with cancer receiving hematopoietic cell never a medical emergency pharmacists need to monitor over-use of short-term TPN
peripheral TPN
short-term only (10-14 days) must be aware of excessive osmolarity to avoid phlebitis
Central TPN
administered via catheter directly into the superior vena cava - allows for greater osmolarity central venous line, hickman, medi port, PICC
TPN Lipids
“emulsified fatty acids” - can be separate bottle or mixed in with AA and dextrose (3 to 1) 10% is 1.1 kcal / mL 20% kcal / mL
TPN Amino Acids
provides protein content for TPN available as 8.4% and 10% solutions 4 kcal/g can be weight basis g/kg/day buffers the acidity of dextrose some preps also have phosphorous
24 hour urinary urea nitrogen
protein g needed = (UNN + 4) x 6.25
TPN dextrose
source of carbs for TPN stock solution of 50% or 70% is often used 3.4 kcal/g slightly acidic molecule (pKa 12) never mix dextrose solution with lipids alone - amino acids buffer and crack the emulsion bc acid and base
TPN additives
electrolytes, vitamins, trace elements, pepsid (ulcers), insulin
total fluid volume formula
1500 + ((wt in kg - 20) x 20) = mL for 24 hours must add sterile water for this injection to the TPN
basal energy expenditure for females
655.1 + (9.56xW) + (1.85 x H) - (4.68 x age)
basal energy expenditure for males
66.47 + (13.75xW) + (5 x H) - (6.76 x age)
BEE adjusted for activity and stress factors
activity - 1 to 1.3 stress - 1.2 to 2.1
TPN compounding considerations must:
- adhere to aseptic technique - be able to perform unit version - be aware of peripheral vs central admin - pay attention to stability considerations - triple check calcium and phosphate
calcium and phosphate in TPN
- both required electrolytes for nutritional supplementation - calcium is recommended to be given as the gluconate salt - phosphate can be admin as sodium or phosphate salts - ca and PO can form 2 different types of salts with one another depending on pH amino acid solutions can help to bind or chelate the calcium so that it is not able to complex with phosphate
calcium and phosphate mixing considerations
- compatibility must be considered at the time of mixing, not based on final volume - addd phosphorous first, calcium last - EFA may mask a precipitate if it should form - higher AA conc lower pH may enhance solubility - avoid CaCl as the source for Ca - routinely agitate the bag to disperse contents and check for particulate matter
Compatibility rules of thumb
calcium should be no greater than 1:2 ratio with phosphate - total mEq should not exceed 45 mEq/L at the time of mixing mmol = mEq
asceptic processing
A mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and of the package (containers–closures or packaging material for medical devices) and the transfer of the product into the container and its closure under at least ISO Class 5 conditions
preperation
Also called a CSP; a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products
product
A commercially manufactured sterile drug or nutrient that has been evaluated for safety and efficacy by the FDA. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer’s labeling or product package insert.
CSP and examples
compounded sterile product or preparation. Dosage forms that must comply with USP Chapter <797> include: aqueous bronchial and nasal inhalation, Baths and soaks for live organs and tissues, Injections (e.g. colloidal dispersions, emulsions, solutions, suspensions), Irrigations for wounds and body cavities, Ophthalmic drops and ointments, Tissue implants
inside the primary engineering control (PEC) air must be iso 5 which means
no more than 3,520 particles per m^3
how many particles in the buffer room
325,000 per m3
particles in ante room if connected hazardous compounding room
has to be iso 7 - so 325000 particles per m3
iso 8 ante room can have ___ particles
3,250,000 particles per m3 because the air will not flow into the buffer room, therefore does not have to be as clean
activities that occur in the buffer room
Application of waterless alcohol-based surgical hand scrub Donning of sterile gloves Actual compounding activities
CACI
hazardous portable PEC. Biological Safety Cabinet is a non-portable compounding area for hazardous compounding.
LAFW
laminar airflow workbench and is the standard for non-hazardous sterile compounding (this is what we have in the labs at school).
standard operating procedures used to stock clean room
A systematic process of entering and exiting the clean room must be done to minimize contamination. Food, drinks, and gum are prohibited. Shedding paper and cardboard packaging must be removed before the buffer room because they release particles.
how to set up your workbench
how clean yoru compounding area
To clean the hood you must do things in this order:
Ceiling
Hepa filter (do not spray the HEPA filter ever because it will be ruined)
Bars and hooks
Sides
Floor
** use two 70% Isopropyl alcohol wipes and fold them. Wipe in the motion like we did in lab this is fairly self explanatory**
major milestones and initiatives shaping clinical pharmacy
Team rounding - 1957
Unit dose 1964
Hilton head conference - 1985
Specialty growth- 1980s
Pharmaceutical care - 1988
clinical pharmacist competencies
- All patients have the right to the pharmacist care
- Pharmacists must be responsible for patient outcomes
- Drug therapy management should be provided by a pharmacist
- Pharmacists should have medication order privileges- enter orders and write in chat
- Completion of residency training or equivalent experience
- Pharmacists should be certified through BPS - do all certifications
- Clinical specialist positions are necessary
- Technician functions should be optimized- get outside 8-5 hours - 24 hour coverage
clinical pharmacist specialty areas in institutional setting
- Critical care
- Oncology
- Infectious disease
- Psychiatric
- Pediatric
- Emergency medicine
- Internal medicine
- Health system admin and leadership
- Solid organ transplant
- cardiology
PGY1
one year pharmacy residency training, organized by accredited program, enhance general competencies in managing medication use systems and supports optimal medication therapy outcomes for patients with a broad range of disease states
PGY2
post grad year two of pharmacy residency that is organized and directed that builds upon the PGY1 - in practice areas where board certification exists prepared to pursue the certification
about BPS
Grant recognition of appropriate pharmacy practice specialties based on criteria established by BPS
Establish standards for certification and recertification of pharmacists in their specialties
Serve as a coordinating agency and information clearinghouse for organizations and pharmacists
Enhance public/consumer protection by developing effective certification programs for specialty practices in pharmacy
functions of a clinical pharmacist in an institutional setting
Therapeutic drug monitoring- order serum levels and adjust medication doses
Drug therapy management- initiating, modifying, monitoring, lab test ordering, assessing response to therapy, medication counseling
ADE- identify, review, participate in quality improvement initiatives
what does a clinical pharmacist need to have
- licensed pharmacists- naplex / mpje
- Provide comprehensive medication management - entire patient to make sure everything is optimized
- Have specialized advanced education
- Possess clinical competencies
- Practice in team-based environments
- Direct patient care
- Residency training required
- Board certification required once eligible
training requirements for compounding sterile preperations 797
Anyone who prepares CSP should be trained by experts about theoretical principles and practical skills of garbing procedures, aseptic work, maintaining ISO 5, environmental, cleaning and disinfecting procedures
surface sampling
interior of the PEC and the equipment inside, staging or work areas near the PEC, frequently touched surfaces, pass through chambers etc. - needs to be done monthly
media fill test / finger tip test
gowning, gloving, conducting the test, defined as zero colony-forming units, defined as less than or equal to 3 cfu, finger tip test repeat 3 times when certified, requalification every 3 months
non-viable airborne particle testing
collect 1-2 liters with a minimum sample time of 1 minute
vaible airborne particle testing
each sample must be within standard as well as the average, technician cant be in a room dressed however they want, there is a petri dish inside collection device, after collecting sample cover the dish and tape, incubate for 2 days for growth of bacteria plus 5 more for growth of mold and fungus and then count and identify organisms- 400-1000 liters per sample
quality assurance
involves the development and implementation of a system that provides confidence in products quality and safety – achieved through planned systematic activities and implemented in a quality system to ensure requirements for product development are fulfilled
quality control
act of controlling the process associated with the product manufacture and evaluating product quality - done at various steps from raw materials to the final packaged product that reaches the consumer
