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Sterile Products > Test 1 > Flashcards

Test 1 Flashcards

1
Q

define compounding

A

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

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2
Q

why do we compound

A

traditional pharmacy practice. serves as a role for patients whose needs cannot be met by an FDA drug product

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3
Q

USP chapter number: 0-999

A

standard all enforceable under standard law

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4
Q

503-A

A

traditional pharmacy practice is allowed to compound as long as it operates within the patient, physician, and pharmacist (in a licensed pharmacy)

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5
Q

3 sections of that are exempted from food, drug cosmetic act of 1983

A
  1. 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)
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6
Q

503-B

A

outsourcing facility register with FDA and inspected by FDA products compounded by or under direct supervision of licensed pharmacist

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7
Q

2 sections FD&C act of 198exempted from 503B

A
  1. 502 f1: labeling of drugs with adequate directions 2. 505: approval of drugs under new drug applications (NDA)
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8
Q

who inspcets licensed pharmacists for compliance with sterile compounding standard

A

albop

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9
Q

objective/purpose of 797 is to describe conditions and practices to prevent harm and death to patients that could result from_____ (5)

A
  1. 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
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10
Q

dosage forms that must comply with 797

A
  1. aqueous bronchial and nasal inhalation 2. bath for organs 3. injections 4. irrigations wounds/cavities 5. ophthalmic drops and ointments 6. tissue implants
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11
Q

Clean room equipment and supplies

A

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

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12
Q

stocking the clean room

A
  • 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
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13
Q

ISO

A

International Organization of Standards - defines the level of airborne particulate cleanliness in terms of ISO class number

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14
Q

ISO classifications

A
  • 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
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15
Q

ISO 8

A

anti room- where you get ready if it is sterile non-hazardous

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16
Q

ISO 7

A

standard for hazardous/non-hazardous buffer room, or hazardous ante room

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17
Q

ISO 5

A

inside the hood - HEPA filtered air

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18
Q

room temp of a compounding facility

A

68 degrees F or 20 degrees C

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19
Q

is the ante room a primary or secondary engineering control

A

secondary

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20
Q

ante room ceiling

A

junctures covered and tiles caulked so they do not move

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21
Q

ante room walls

A

smooth and painted with a regulation paint to prevent accumulation of dust

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22
Q

ante room floors

A

floors should be seamless and covered where they meet the wall

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23
Q

ante room fixtures

A

hanging or dust collecting fixtures should be avoided

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24
Q

ante room surfaces and carts

A

stainless steel to avoid dust collection - NO wood - cart in ante room never goes into buffer room - cart cleaned very day even wheels

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25
Q

sterile non-hazardous/hazardous postive or negative pressure?

A

positive - non hazardous negative - hazardous

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26
Q

buffer room

A

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.

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27
Q

segregated compounding area

A

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.

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28
Q

Primary Engineering Controls

A

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.

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29
Q

the _____ HEPA filtered airflow in the PEC must provide _______

A

unidirectional; sufficient velocity to sweep particles away from the direct compounding area during compounding activities

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30
Q

how do you demonstrate the unidirectional airflow?

A

smoke studies

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31
Q

CAI

A

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.

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32
Q

if isolators placed outside of ISO 7 area

A

must have documentation from manufacturer

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33
Q

power and utility interuptions

A

facility’s emergency management plan should include steps to meet patient care needs

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34
Q

containment isolator

A

nothing in there can escape - used for chemo

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35
Q

access to the clean room

A

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

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36
Q

items not brought into the sterile compounding area

A

nothing that is not brand new or nothing not sterilized

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37
Q

excluded from the sterile compounding area if you are experiencing

A

CANNOT go in if you are sick or experiencing any of the following: - rash - sunburn - weeping sores - conjunctives - active respiratory infections

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38
Q

how long to wash hands

A

at least 30 seconds, use of scrub brushes or hand dryer not recommended - sinks have no handles and only foot peddles

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39
Q

order of garbing

A

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

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40
Q

aseptic technique

A

using practices and procedures to prevent contamination from pathogens and risk of infection

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41
Q

critical site

A

tip of syringe- any place at risk of direct contact with air - not a perfect seal

42
Q

direct compounding area

A

where compounding is done

43
Q

first air

A

air coming out of the HEPA filter

44
Q

order of cleaning and disinfecting the laminar airflow workbench

A
  • ceiling - HEPA filter grill (do not saturate filter) - bar and hooks - sides - floor use a clean wipe surface for each step
45
Q

never measure less than ___ of the volume of the syringe

A

20%

46
Q

critical sites on the needle

A

everything is a critical site

47
Q

supplies brought into sterile compounding area from shipping carton

A

sprayed or wiped with sterile 70% isopropyl alcohol (IPA)

48
Q

supplies brought into sterile compounding area from sterile supplies received in sealed pouches

A
  • 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
49
Q

placement of supplies in the laminar airflow workbench

A
  • 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)
50
Q

when laminar airflow is accessible to all sides of an object, zone of turbulence extends to ___ times the diameter of the object

A

3

51
Q

when laminar airflow is not accessible to all sides of an object, zone of turbulence extends to ___ times the diameter of the object

A

6

52
Q

how to remove fluid from a vial

A
  • 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
53
Q

single dose- container

A

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

54
Q

define multi-dose containers

A

shall not be used after 28 days once opened or needle-punctured

55
Q

sharps container is for

A

needles, glass, etc

56
Q

yellow bin is for

A

pharmaceutical waste

57
Q

trash can is for

A

garb, non-pharmaceutical waste

58
Q

rationale for TPN

A

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

59
Q

peripheral TPN

A

short-term only (10-14 days) must be aware of excessive osmolarity to avoid phlebitis

60
Q

Central TPN

A

administered via catheter directly into the superior vena cava - allows for greater osmolarity central venous line, hickman, medi port, PICC

61
Q

TPN Lipids

A

“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

62
Q

TPN Amino Acids

A

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

63
Q

24 hour urinary urea nitrogen

A

protein g needed = (UNN + 4) x 6.25

64
Q

TPN dextrose

A

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

65
Q

TPN additives

A

electrolytes, vitamins, trace elements, pepsid (ulcers), insulin

66
Q

total fluid volume formula

A

1500 + ((wt in kg - 20) x 20) = mL for 24 hours must add sterile water for this injection to the TPN

67
Q

basal energy expenditure for females

A

655.1 + (9.56xW) + (1.85 x H) - (4.68 x age)

68
Q

basal energy expenditure for males

A

66.47 + (13.75xW) + (5 x H) - (6.76 x age)

69
Q

BEE adjusted for activity and stress factors

A

activity - 1 to 1.3 stress - 1.2 to 2.1

70
Q

TPN compounding considerations must:

A
  • 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
71
Q

calcium and phosphate in TPN

A
  • 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
72
Q

calcium and phosphate mixing considerations

A
  • 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
73
Q

Compatibility rules of thumb

A

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

74
Q

asceptic processing

A

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

75
Q

preperation

A

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

76
Q

product

A

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.

77
Q

CSP and examples

A

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

78
Q

inside the primary engineering control (PEC) air must be iso 5 which means

A

no more than 3,520 particles per m^3

79
Q

how many particles in the buffer room

A

325,000 per m3

80
Q

particles in ante room if connected hazardous compounding room

A

has to be iso 7 - so 325000 particles per m3

81
Q

iso 8 ante room can have ___ particles

A

3,250,000 particles per m3 because the air will not flow into the buffer room, therefore does not have to be as clean

82
Q

activities that occur in the buffer room

A

Application of waterless alcohol-based surgical hand scrub Donning of sterile gloves Actual compounding activities

83
Q

CACI

A

hazardous portable PEC. Biological Safety Cabinet is a non-portable compounding area for hazardous compounding.

84
Q

LAFW

A

laminar airflow workbench and is the standard for non-hazardous sterile compounding (this is what we have in the labs at school).

85
Q

standard operating procedures used to stock clean room

A

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.

86
Q

how to set up your workbench

A
87
Q

how clean yoru compounding area

A

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**

88
Q

major milestones and initiatives shaping clinical pharmacy

A

Team rounding - 1957

Unit dose 1964

Hilton head conference - 1985

Specialty growth- 1980s

Pharmaceutical care - 1988

89
Q

clinical pharmacist competencies

A
  • 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
90
Q

clinical pharmacist specialty areas in institutional setting

A
  • Critical care
  • Oncology
  • Infectious disease
  • Psychiatric
  • Pediatric
  • Emergency medicine
  • Internal medicine
  • Health system admin and leadership
  • Solid organ transplant
  • cardiology
91
Q

PGY1

A

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

92
Q

PGY2

A

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

93
Q

about BPS

A

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

94
Q

functions of a clinical pharmacist in an institutional setting

A

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

95
Q

what does a clinical pharmacist need to have

A
  • 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
96
Q

training requirements for compounding sterile preperations 797

A

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

97
Q

surface sampling

A

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

98
Q

media fill test / finger tip test

A

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

99
Q

non-viable airborne particle testing

A

collect 1-2 liters with a minimum sample time of 1 minute

100
Q

vaible airborne particle testing

A

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

101
Q

quality assurance

A

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

102
Q

quality control

A

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

Sterile Products (2 decks)

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