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Sterile Products > sterile final > Flashcards

sterile final Flashcards

1
Q

CPOE

A

computer-based systems that facilitate the ordering process, often integrated with clinical decision support systems or interactive software that assists in clinical decisions

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2
Q

Viable airborne particle sampling

A

collects between 400 and 1000 L of air per sample, The air collected blows onto a petri dish inside the collecting device. After the sample is collected, it is covered and incubated for 2 days to check for growth of bacteria plus 5 more days to grow mold or fungus.

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3
Q

error prone abreviations

A

μg instead of mcg
Trailing zeros
QD versus QID
U instead of “units” interpreted as a zero or “o”
Lack of space between words/names and numbers

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4
Q

Smart pumps

A

built-in safety features such as alerts, clinical calculators, dose limits, and drug libraries; safety limited by inconsistencies between pumps, override features, and drug libraries

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5
Q

Patient-centered integrated model

A

In this model, all pharmacists accept responsibility for the MUP.
pharmacists role:
- Perform clinical and distributive functions
- Assist prescribers in mediation selection
Provide education to patients and staff
- Serve as a member of an interdisciplinary team

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6
Q

Non-viable airborne particle

A

collects 1-2 liters of air with a minimum sample time of 1 minute. The number of samples collected is based on the ISO 14644-1 2015 table.
Readings are converted to reflect particles per cubic meter.

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7
Q

Bar coding

A

affixed to patient wrist band and medication; scanning confirms a match between the patient and medication orders; interfaces with CPOE and eMAR

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8
Q

Measures to correct the error

A

Monitoring: observing or recording relevant physiological or psychological signs
Intervention: provision of change in therapy or active medical/surgical treatment
Intervention Necessary to Sustain Life: addition of cardiovascular and respiratory support (e.g., CPR, defibrillation, intubation, etc.)

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9
Q

Manual to detect ADE

A

Direct observation
Medical record or chart review
Computerized surveillance (automated)
Voluntary reporting

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10
Q

closed system transfer device and situations for its use

A

a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system - use a CTSD which use a physical barrier or an air-cleaning technology to prevent the escape of hazardous drugs into the work environment

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11
Q

human factors of medication error

A 
Knowledge deficit
Performance deficit (boredom, stress, drugs or alcohol, fatigue/lack of sleep, frustration, fear, illness, too busy)
Computer programming errors
Stocking errors
Transcription errors
Drug preparation errors
Cultural barriers (work culture)
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12
Q

media fill test

A

must be as difficult as the most difficult CSP that the facility produces (including quantity), and it must be performed by all compounding personnel.
Product is then incubated and observed for cfu.

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13
Q

D:

A

an error occurred that reached the patient and required monitoring to confirm it resulted in no harm to the patient and/or required intervention to preclude harm
Mild

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14
Q

PPP component and competencies

A

collect, assess, plan, implement, follow-up

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15
Q

EHR

A

digital version of a patient’s chart containing medical history, diagnoses, medications, treatment plans, immunization dates, allergies, radiology images, and laboratory and test results

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16
Q

Degrees of Harm (Severity)- Moderate

A

actual errors that result in significant change in vital signs and/or require treatment for resolution; hospitalization may or may not be increased

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17
Q

residency programs

A

PGY1, PGY1 with focus, PGY2 advanced practitioner generalist, PGY2 practitioner specialist

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18
Q

Adverse Drug Reaction (ADR)

A

an injury caused by taking a medication; an ADE where causative relationship can be shown

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19
Q

vent on the roof must be ___ ft high

A

10

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20
Q

Therapeutic equivalents

A

drug products with different chemical structures but of the same pharmacological and/or therapeutics class, expected to have similar therapeutic effects and adverse effects

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21
Q

garb difference compounding HD vs non-HD

A

HD: 2 pairs chemo gloves, 2 pairs of shoe covers, remove gloves and gown within compounding room as you exit, may not reuse chemo gowns

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22
Q

adv and disadv of centralized pharmacy

A

adv: fewer staff members required and decreased cost of medication inventory
disadv: may increase time required to provide medication doses and offers limited opportunity for face-to-face interactions

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23
Q

assessment of risk for handling HDs

A
  1. Identify drugs to be assessed.
  2. Assess the risk: odds of contact, who will be affected, how frequently, is product wrapped or contained, length of exposure, severity of consequences of exposure
  3. Treat the risk
  4. Monitor and review the risk.
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24
Q

Hospital formulary

A

a continually updated list of medications and related information, representing the clinical judgement of pharmacists, physicians, and other experts in the diagnosis and treatment of disease and promotion of health; includes but is not limited to:
List of approved medications and medication-associated products
Medication use policies and guidelines
Drug information
Medication safety information
Decision support tools

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25
Q

how readings of non-viable airborne tests are converted

A

particle reading on machine / liters of air pulled by machine = x particles per cubic meter / 1000L

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26
Q

Problem with Different Manufacturer of Same Medicine

A

Any differences in therapeutic response after switching from one manufacturer to another (failures or toxicities)

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27
Q

4 steps when cleaning hazardous drug residue

A
  1. Don gear as if HD compounding.
  2. Use an appropriate oxidizing agent to decontaminate and deactivate HD residues.
  3. Clean with proper prepared germicidal detergent/sporicidal agent.
  4. Disinfect with sterile 70% isopropyl alcohol.
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28
Q

MedWatch

A

Voluntary

Reports submitted via FDA Form 3400

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29
Q

medication management system

A 
Selection and Procurement
Storage
Prescribing and Transcribing
Preparing and Dispensing
Administering
Monitoring
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30
Q

Define Hazardous Drug (HDs).

A
  1. Antineoplastic/ cancer-causing: risk of cancer/ infertile
  2. Organ toxicity
  3. Genotoxicity: ll causing mutations which may lead to cancer
  4. Reproductive and developmental damage causing: harm a fetus or reproductive function
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31
Q

eMAR

A

list of medications including dose, route, frequency, and duration with a date and time stamp record of when it was given and next due

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32
Q

ISO Class 7 cfu

A

> 10 cfu per cubic meter

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33
Q

centralized pharmacy

A

pharmacists responsible for:

  • Coordinating dispensing activities
  • Supervising technicians
  • Sterile and non-sterile compounding
  • Controlled substance handling
  • Maintaining ADCs (automated dispensing cabinets)
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34
Q

normal vial procedures are not done with HDs

A

Do NOT adjust air and liquid inside the vial to stay neutral—you want the vial to have negative pressure.
Do NOT add air when pulling out liquid—let a vacuum develop.
Remove air first when adding a liquid.
Do NOT expel air or liquid into air.

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35
Q

prevented error

A

a mistake that IS detected and corrected prior to administration to the patient

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36
Q

describe spill cleanup of hazardous drugs

A
  • If direct exposure has occurred, medical treatment must be sought.
  • Remove all personnel from the area.
    Post a sign that spill has occurred.
  • Cover the spill if possible.
  • Contact person(s) trained to handle spills.
  • Use a spill kit.
  • Use the respirator and gown, gloves, and shoe covers.
  • Pick up spill if possible.
    Decontaminate spill area.
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37
Q

Educational initiatives

A

may modestly decrease ADE

Can be face-to-face (best way), web-based, policy-based standardization, or via performance-driven feedback

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38
Q

Medication reconciliation:

A

Verification: review medication history to get an accurate list
Clarification: ensure medications and doses are appropriate and consistent with orders
Reconciliation: identify discrepancies, make changes, document, and communicate

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39
Q

common clinical pharmacist specialty areas in institutional setting

A

Critical care, oncology, infectious diseases, psychiatric, emergency medicine, internal medicine, health system administration and leadership, solid organ transplant, cardiology

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40
Q

communications

A

Error-prone abbreviations
Sloppy handwriting
Spelling
Not repeating verbal orders back for verification
Using apothecary system instead of metric increases errors

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41
Q

ISO class 5 particles max

A

maximum of 3,520 particles per cubic meter

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42
Q

routes of exposure and how to handle- skin/transfer

A

PPE

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43
Q

A:

A

“potential errors”—circumstances or events that have the capacity to cause error

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44
Q

buffer room must have ___ air exchanges per hour

A

30

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45
Q

H:

A

an error occurred that required intervention necessary to sustain life
Severe (Sentinel)

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46
Q

practice guideline and best practices

A

Practice guidelines are voluntary guidelines a profession develops and imposes on itself, and these should exceed the minimum requirements of the law.
ASHP publishes a best practices document with positions on standards of care and guidance documents.

47
Q

Vaccine Adverse Events Reporting System (VAERS)

A

Legal requirement; there is a list of reportable events

48
Q

non-hospital areas of insitutional pharmacy practice

A

Home infusion or infusion centers, specialty pharmacy, hospice, long term care, correctional facilities, managed care, nuclear pharmacy, ambulatory care

49
Q

pharmacy and therapeutics

A

oversight for medication management.
Establish and maintain a drug formulary
Develop policies and procedures for rational medication use
Evaluate and promote use of drug therapy guidelines
Evaluate medication use through medication use evaluations (MUEs)
Review medication error reports
Review reports of suspected adverse drug reactions (ADRs)

50
Q

policies and procedures

A

Institutions establish their own rules that inform practice with the goals of optimizing patient care while reducing costs and liability.

51
Q

surface sampling

A

should be done for all classified areas and conducted at least monthly, including the interior of the PEC and the equipment contained in it, staging or work areas near the PEC, frequently touched surfaces such as pass-through chambers, and the floor.
The surface is swabbed using a sterile cotton swab, the swab is used to inoculate an agar plate, and the plate is incubated to see what grows.

52
Q

buffer room ACPH

A

no less than 30 ACPH

53
Q

functions of clinical pharmacist

A

Clinical problem solving, judgement, and decision making, Communication and education, Medical information evaluation and management, Management of patient populations, Therapeutic knowledge areas

54
Q

Characteristics of high-alert medications

A

Administered parenterally (IV, IM, SC)
Concentrated formulations (e.g. heparin, KCl, NaCl)
Complex measurement or dosing schedules (e.g. insulin, chemotherapy)
Narrow therapeutic index (e.g. warfarin, digoxin)
Close monitoring required for safe use (e.g. immunosuppressants, anticoagulants)

55
Q

healthcare quality assurance orgs that focus on med safety

A

ISMP (Institute for Safe Medication Practices)

NCCMERP (National Coordinating Council for Medication Error Reporting and Prevention)

56
Q

name confusion or labeling - look alike sound alike drugs

A

Be familiar with ISMP’s Confused Drug Names list
Be aware of “confirmation bias”
Look for the addition of suffixes (LA, XL, SR, XR, etc)
Use the FDA/ISMP-recommended Tall Man Lettering for confused drug names
Beware of “umbrella names” for OTC and Rx/OTC switch products that use an older, well-known/recognizable product name for a new product that contains a different active ingredient.

57
Q

product problem

A

Any concerns about the quality, authenticity, performance, or safety of any medication or device

58
Q

F:

A

an error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization
Moderate

59
Q

accreditation

A

Accreditation organizations set standards that inform practice such that a certain quality of care is provided.

60
Q

Accreditation

A

a “voluntary” process in which an outside agency assesses the quality of care provided by a hospital or other healthcare facility

61
Q

how pharmacist contribute to imporved pt safety

A
  1. ensure med access
  2. supply med info
  3. evaluate med appropriateness
  4. improve med adherence
  5. provide health and wellness
  6. perform med management
  7. assess pt health status
  8. coordinate care transisitons
62
Q

ISO Class 8 cfu

A

> 100 cfu per cubic meter

63
Q

High-alert medications (“A PINCH”)

A 
Anti-infectives
Potassium (and other electrolytes)
Insulin
Narcotics (controlled substances and other sedatives)
Chemotherapy
Heparin (and other anticoagulants)
64
Q

ante room ACPH

A

Iso 7, no less than 30

Iso 8, no less than 20

65
Q

ante room must be ISO ___

A

7

66
Q

Clinical pharmacist-centered model:

A

Pharmacists are typically distributive or clinical.
Distributive pharmacists (1) review and verify medication orders
(2) check medications prepared by technicians
(3) assume responsibility for dispensing medication doses.
Clinical pharmacists are active at the point of care.
Participate with other members of the medical team
Spend most time in patient care areas
Focuses on mediation management
Has little or no responsibility for medication dispensing

67
Q

MUP

A

Prescribing: complete and accurate Rx/order issued
Order Entry: accurate transcription of current drug therapy between providers
Dispensing: Rx/order evaluated, verified, and dispensed correctly; effective communication between providers to clarify Rx/order
Administration: accurate check/double check against Rx/order prior to drug administration; patient understands treatment and dosage instructions
Monitoring: response to therapy appropriately monitored

68
Q

potential error

A

situations that pose a hazard and may develop into errors

69
Q

technological to detect ADE

A 
EHRs
CPOE
eMARs
Bar coding
Smart pumps
Pharmacist interventions
Medication reconciliation
Educational initiatives
70
Q

donning garb

A

same as non-hazardous just with additional gloves and shoe coverings

71
Q

hazard communication program

A

Substances that present a potential health hazard to workers must be included in an employer’s hazard communication program, and it should be readily available and accessible to all including temporary workers, contractors, and trainees.”
Training with documentation
Appropriate signage

72
Q

state personnel responsibilities when handling HD

A

All staff who participate in compounding must be trained and sign a statement saying they understand hazardous drugs, the risks involved, how to protect themselves while compounding, and are willing to participate in compounding.

73
Q

The Joint Commission

A

the U.S.’s oldest and largest standards setting body in healthcare

74
Q

ISO Class 8 particles max

A

maximum of 3,520,000 particles per cubic meter

75
Q

laws, regulations, rules

A

Law enforcement bodies act to protect the public, impose fines, and take legal action. Regulatory agencies issue regulations or rules to provide details to implement laws.
Federal regulatory agencies include the FDA, DEA, CMS, CDC, and OSHA.
State regulatory agencies include state Boards of Pharmacy and Departments of Public Health.
The USP is a nongovernmental, standards setting organization.

76
Q

High-alert patient groups

A

Pediatric
Geriatric
Polypharmacy
Pregnant or breastfeeding
Impaired (hepatic and/or renal, physically)
Sick (chronic conditions, infections, oncology)

77
Q

training program for CSP

A

audio-video instructional sources and professional publications in the theoretical principles and practical skills of aseptic manipulations and in achieving and maintaining ISO Class 5
shall perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, at least annually thereafter for low- and medium-risk level compounding, and semiannually for high-risk level compounding

78
Q

routes of exposure and how to handle- aerolosization

A

cancer drugs aerosolize more than other drugs- why they are compounded in a BSC or CACI w/ vertical air flow in a negative pressure room vented to the outside.

79
Q

ISO Class 5 cfu

A

> 1 cfu per cubic meter

80
Q

Antimicrobial stewardship

A

a coordinated program to promote appropriate use of antimicrobials with the goals of optimizing patient outcomes, minimizing unintended consequences of antimicrobial use (such as development of resistance), and reducing health care costs

81
Q

Types of errors correspond to the nodes of the MUP:

A

Prescribing, Order Entry, Dispensing, Administration, Monitoring

82
Q

drug dosage calculations

A

Double check AND have another person check your work
Verify units are correct
Specify how a dose is calculated
Verify concentrations, volumes, and infusion rates
Dispense medications ready for administration (reduce risk of last-minute calculations at bedside or by patient)
Use approved abbreviations

83
Q

tertiary care

A

healthcare that requires highly specialized equipment and expertise such as specialized ICUs, transplant surgery, neurosurgery, severe burn treatment, and pediatrics/special populations.

84
Q

Degrees of Harm (Severity)- Severe (Sentinel):

A

actual errors that result in ongoing (>14 days) or permanent harm or contribute directly to a patient’s death

85
Q

where you may locate a list of hazardous drugs

A

National Institute for Occupational Safety and Health (NIOSH) - division of the CDC

86
Q

Risk Evaluation and Mitigation Strategies (REMS)

A

FDA requirement for certain medications; strategies to manage known or potential serious risks associated with drugs or biologicals
May require medication guides, specialty trained pharmacists and prescribers, monitoring programs (registries)

87
Q

written orders reduce errors

A

Use the metric system for units
Avoid decimals when possible
Never leave a decimal point naked (use a leading zero)
Never use a trailing zero
Space between name and dose
Confirm that the SIG makes sense for the drug
Use approved abbreviations (when in doubt, write it out)

88
Q

monitoring ingredients and devices

A

Brand and serial number
Cubic feet or liters the machine pulls per minute
Time the technician ran the machine to get the sample
You also need to check that the technician did the math to convert the sample correctly.
Do NOT simply accept a number of particles!

89
Q

fingertip test

A

Personnel preps and gowns through putting on sanitized gloves in the buffer room but does NOT use alcohol-based hand sanitizer or alcohol wipes on gloves
myst re-qualify every 12 months
must be done 3 times when first certified

90
Q

Drug distribution-centered model

A

Pharmacist less commonly initiate changes in therapy and are less involved in the medication use process.
Primary roles of the pharmacist are (1) process new medication orders, (2) distribute medications, and (3) assess MD orders as written

91
Q

Degrees of Harm (Severity)- Mild

A

prevented (B) or actual errors resulting in no harm to the patient but may transiently and minimally affect vital signs and/or require increased level of patient monitoring, but ultimately resolve without treatment

92
Q

adverse effects

A

Any incident in which a medical product was suspected to have resulted in an undesirable experience for the patient

93
Q

G:

A

an error occurred that may have contributed to or resulted in permanent patient harm
Moderate

94
Q

I:

A

an error occurred that may have contributed to or resulted in the patient’s death
Severe (Sentinel)

95
Q

E:

A

an error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention
Mild

96
Q

discuss labeling, packaging, transport and disposal of HD

A
  • Products wiped down after compounding and placed in closed bags
  • Products must be labeled as hazardous product.
  • All HDs that are APIs, injectable antineoplastics, or antineoplastics that will be crushed or otherwise “manipulated” other than simple counting and packaging MUST be stored in a separate, negative pressure, externally vented room with at least 12 air exchanges per hour.
    Sterile and non-sterile hazardous products can be stored in the same refrigerator.
  • HDs cannot be placed in pneumatic tubes.
  • Chemo tablets/capsules have to have their own separate counting tray. They cannot be put through a machine counter because it may generate powder.
  • If tablets must be split, this must be done in a negative pressure room, so do not do this in a regular community pharmacy.
  • Capsules/tablets may be kept on a regular shelf.
97
Q

major milestones shape clinical pharmacy

A

1957: Team rounding at the University of Kentucky
1964: Unit doses implemented at the University of Iowa
1985: ASHP’s Hilton Head Conference articulated that pharmacy is a clinical profession.
1980s: Growth of specialty practice areas in pharmacy
1988: Concept of “pharmaceutical care” expanded by Hepler and Strand
Defined pharmaceutical care as a covenantal relationship between the pharmacists and the patient in which the pharmacist’s primary responsibility was to identify, prevent, and resolve drug-related problems and articulated the responsibility of the pharmacist to work directly with the patient to optimize drug therapy.

98
Q

facility requirements for receiving, storing, compounding HDs

A

C-PECs must have vertical laminar airflow, ISO Class 5 air if sterile compounding, vented to the outside with a 10-foot pipe on the roof.
Buffer room must be under negative pressure and ISO Class 7 if sterile compounding.
Ante room must also be ISO Class 7 if sterile compounding.
USP <800> also requires that certain HD areas have negative pressure from surrounding areas to contain HDs and minimize risk of exposure.
room designated for compounding

99
Q

decentralized pharmacy

A

Pharmacist provides clinical services and education and participates as a member of the medical team.

  • Uses patient information to formulate treatments plans if necessary and contacts physicians about medication recommendations.
  • Rounding with medical team
  • Medication reconciliation
  • Drug therapy monitoring
  • Pharmacokinetic consults
  • Antimicrobial stewardship
  • Participation in codes
  • Patient and staff education
  • Transition of care programs
100
Q

BPS

A 
Nuclear pharmacist (BCNP)
Pharmacotherapy specialist (BCPS)
Nutrition support pharmacist (BCNSP)
Psychiatric pharmacist (BCPP)
Oncology pharmacist (BCOP)
Geriatric pharmacist (BCGP)
Ambulatory care pharmacist (BCACP)
Pediatric pharmacy specialist (BCPPS)
Critical care pharmacist (BCCCP)
Cardiology pharmacist (BCCP)
Infectious disease pharmacist (BCIDP)
Sterile compounding pharmacist (BCSCP)
101
Q

product use error

A

Any medication or medical product error regardless of patient involvement and outcome
Also report circumstances that have the capacity to cause error such as similar label appearance

102
Q

Air (Ex)changes Per Hour

A

airflow into the room in volume per hour divided by the volume of the room. In other words, it is how many times that a volume of air equivalent to the entire room enters each hour.

103
Q

Cost Avoidance

A

intervention that reduces or eliminates additional expenditure that may have been incurred.
Examples within drug therapy monitoring include dose rounding, discontinuation of medications no longer needed, and consultation with MD on non-formulary medication orders.

104
Q

adv and disadv decentralized pharmacy

A

adv: pharmacist provides clinical service and education and participates as a member of the medical team
disdv: requires more pharmacist and technicians and may increase the cost of inventory

105
Q

actual error

A

a mistake that is NOT detected and corrected prior to administration to the patient (a mistake that reaches the patient)

106
Q

environmental

A 
Interruptions/distractions (noise, temperature, clutter, motion)
Lighting
Unnatural workflow
Poorly designed procedures/devices
Staffing deficits
Training issues
Policy/procedure
Communication
107
Q

therapeutic interchange

A

the authorized exchange or substitution of a therapeutic alternative in accordance with approved written guidelines of a P & T Committee

108
Q

action plan needed if…

A

number of cfu exceeds the action plan level or if any highly pathogenic organisms are detected, regardless of cfu count

109
Q

C:

A

an error occurred that reached the patient but did not cause patient harm
Mild

110
Q

ISO class 7 particles max

A

maximum of 352,000 particles per cubic meter

111
Q

Medication Use Evaluation (MUE)

A

a performance improvement method that focuses on evaluating and improving medication-use processes with the goal of optimal patient outcomes

112
Q

doffing garb

A

Remove outer pair of sterile gloves (those that touched the HD CSP) inside the C-PEC.
Remove outer shoe covers one at a time, stepping over the doffing line.
Remove gown, starting by pulling at the shoulders and turning inside out, careful not to let the gown touch the garb underneath. Discard in yellow trace waste.
Remove inner gloves. Discard in yellow trace waste.
Exit the C-SEC and perform hand hygiene.

113
Q

how often a finger test method should be done

A

every 6 months

114
Q

B:

A

an error occurred, but the error did NOT reach the patient

Can be mild, moderate, or severe

Sterile Products (2 decks)

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