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BCOP- Joey > Practice Management > Flashcards

Practice Management Flashcards

1
Q

Which hazardous drugs can be stored with other inventory?

A

-Non-antineoplastic
-reproductive risk only
-final dosage forms of antineoplastics

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2
Q

Storage of hazardous drugs

A

-externally ventilated negative pressure room
-12 ACPH

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3
Q

Receipt of hazardous drugs

A

-Neutral or negative pressure area
-not in sterile area

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4
Q

HD c-pec reqs for non-sterile and sterile compounding

A

-separate rooms unless IOS 7
-if same room, place 1 meter apart

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5
Q

Non-sterile HD compounding engineering controls reqs

A

-externally ventilated or redundant hepa filter
-12 ACPH
-neg pressure 0.01-0.03 in water column

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6
Q

Sterile HD compounding engineering controls reqs

A

-externally ventilated
-if IOS 7 anteroom and buffer room then 30 ACPH
-if unclassified C-SCA then 12 ACPH
-negative pressure 0.01-0.03 in of water column pressure

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7
Q

Sink placement

A

-Anteroom at least 1 meter from buffer room entrance
-in unclassified C-SCA place sink 1 meter from c-pec

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8
Q

When are closes system transfer devices (CSTD) required

A

-required for administration (when dosage form allows)
-recommended for compounding

*not a substitute for a C-PEC
*should have ONB product code

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9
Q

Environmental wipe sampling for HD

A

-SHOULD (not must) be done q6 month
Include:
-interior of c-pec and equipment
-pass through chamber
-surfaces in staging or work areas
-areas near c-pec
-area immediately outside buffer room or C-CSA
-patient administration areas

This is Testing for HD residue

No standard for acceptable limits exist

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10
Q

When are two pairs of gloves needed?

A

-Compoundingsterile and non-sterile HDs (outer pair must be sterile)
-gather drugs and supplies
-administration of antineoplastic HDs
-repackaging liquid HD
-crushing /splitting solid dosage forms

*powder free

I think 1 pair is ok for receiving, unpacking, and storing- per Brooke

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11
Q

When are single pair of gloves ok

A

-Handling all HDs including non-anteneoplastic and reproductive risk only
-includes unpackaging/receiving
*powder free
-repackaging intact SOlID dosage forms (two gloves for liquid)

Note: gloves are needed for all HDs including non-antineoplastic and reproductive risk only

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12
Q

How often must gloves be changed?

A

Every 30 minutes

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13
Q

How often to change gowns

A

According to manufacturer or q2-3hrs

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14
Q

When to wear 2 shoes covers

A

-When compounding HD
-when cleaning up a HD spill!

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15
Q

When to wear eye protection

A

-risk for spills/splashes
-administration in surgical suite
-working at or above eye level
-cleaning a spill

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16
Q

Respiratory protections

A

-elastomeric half mask with multi gas cartridge and p100 filter when unpacking HD until integrity of packaging is assessed (unless HD contained in plastic)
-airborne particles: NIOSH n95
-gases and vapors: full face piece chemical cartridge type or PARP (also use for large spills, cleaning under c-pec, known airborne exposure of powders or vapors)

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17
Q

When to change plastic mat in c-pec

A

With each spill, regularly during use, and end of day

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18
Q

Priming HD

A

In c-pec with non-hazardous drug

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19
Q

Cleaning

A

Deactivation: render inert-epa registered oxidizers (peroxide m, sodium hypochlorite

Decontaminate: remove hd residue- etoh, water, peroxide, sodium hypochlorite

Cleaning: remove organic and inorganic material- germicidal

Disinfect: kill microorganisms- epa registered disinfectant or sterile etoh

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20
Q

When to decontaminate c-pec

A

-at least daily when used
-spills
-before and after certification
-any time voluntary interruption
-ventilation tool moved

-clean areas under the work tray at least monthly- deactivate, decontaminate, and clean

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21
Q

How often are HD SOPs reviewed and revised?

A

annually

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22
Q

Medical surveillance

A

Monitoring health of employees that handle HDs

Not required- only a recommendation

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23
Q

How often is HD training done

A

Annually

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24
Q

How full can a syringe with HD be?

A

No more than 3/4 full

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25
Q

Where can you compound non-sterile HD

A

Class I or II BSC, cve, caci

C-pec for sterile compounding ok but must be cleaned decontaminated and disinfected

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26
Q

Allowable/acceptable level of HD surface concentration

A

No standards exist for this yet

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27
Q

BUDs

A

Category 1 (SCA)
-room temp: </=12h
-fridge: </= 24h

Category 2
Only sterile components
-Room temp: 4 d
-fridge: 10 d
-freezer: 45 d
1+ non-sterile component
-room temp: 1 d
-fridge: 4 d
-freezer: 45 d
Passed sterility test
-room temp: 30 d
-fridge: 45 d
-freezer: 60 d
Terminally sterilized, no sterility test
-room temp: 14 d
-fridge: 28 d
-freezer: 45 d
Terminally sterilized, passed sterile test
-room temp: 45d
-fridge: 60 d
-freezer: 90 d

Category 3
Passed sterility test
-room temp: 60 d
-fridge: 90 d
-freezer: 120d

Terminally sterilized and passed sterility test
-room temp: 90 d
-fridge: 120 d
-freezer: 180 d

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28
Q

RCRA definition: characteristic waste

A

Ignitable, corrosive, reactive, or toxic

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29
Q

RCRA definition: Large quantity generator

A

Facilities that generate
-1000kg+ of hazardous waste
->1 kg acute Hw (p listed waste )
->100 kg residue or contaminated soil, waste or other debris resulting from the clean up of a spill, into or on ant land or water if any acute HW

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30
Q

RCRA definition: small quantity generator

A

Facilities that generate between 100-1000kg of HW

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31
Q

RCRA definition: conditionally exempt small quantity generator

A

Facilities that generate:
-less than or equal to 100 kg HW AND
-less than or equal to 1 kg of acute HW (p listed) and
-less than or equal to 100kg of any residue or contaminated soil, waste or other debris resulting from clean up of a spill, into or on any land or water if any acute HW

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32
Q

RCRA definition: p-listed waste

A

-Acutely hazardous
-orallethal dose of 50 mg/kg or less (LD50)-this is amount give that causes death in 50% of subjects

Arsenic, epinephrine, nicotine, NTG, phentermine, physostigmine, warfarin (>0.3%)

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33
Q

RCRA definition: u-listed waste

A

Hazardous waste but not acute hazardous waste

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34
Q

RCRA definition: RCRA empty

A

All contents removed that can be removed and no more than 3% by weight remains

-considered trace HW

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35
Q

Trace hazardous waste

A

RCRA empty containers, needles/syringes, trace contaminated gowns, gloves, pads, empty iv sets, gauze, masks

Yellow bucket

double check handout on syringes

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36
Q

Bulk hazardous waste

A

-not RCRA empty containers (>3%)
-materials from HD spill
-chemo vials (empty or partially full)
-syringes
-materials used to clean prep area

Black bucket

double check handout on syringes

37
Q

Red bucket

A

Stuff that has blood on it- (HW vendors cants deal with medical/infectious waste)- even if there is hazardous waste on it I believe

38
Q

Is nicotine hazardous waste?

A

NRT (gum, patches, lozenges) are not longer

But other forms like e-cigs, prescription nicotine, nicotine in research facilities, and stuff like that is

39
Q

Reverse distributor v res verse logistics

A

Distributor: for prescription pharmaceuticals are considered waste

Logistics: non-rx- non-prescription (OTC) are not considered waste if they can be reused/reclaimed. (These are not subject to RCRA regulations)

40
Q

What type of Hw is potentially creditable

A

Original packaging, undispensed, unexpired or less than 1yr since exp, not recalled

Exempt from RCRA

Non-creditable: broken, leaking, dispensed, exp >1y, investigational new drug, contaminated PPE, floor sweepings, clean up material

41
Q

Do healthcare facilities need to track how much HW and separate acute and non-acute HW?

Do they have to separate acute and non-acute HW

A

No and no

42
Q

How long can you accumulate HW in HW containers

A

1 year

43
Q

What type of diagram is used for RCA?

A

Fishbone

44
Q

Biosimilar reqs

A

No clinically meaningful differences in safety, quality (purity, and potency), and efficacy

not just bioequivalence (+/-20% like generics

Look for Safety, purity, and potency

-same amino acid sequence but different post translational modifications, protein folding, excipients

-FcRN- recycling of mAb
-FcyR- apoptosis/ antibody mediated cytotoxicity

45
Q

Specialty pharmacy accreditation agencies

A

-ACHC
-URAC

46
Q

Oral oncolytic: when should initial monitoring of symptoms and adherence occur ?

A

7-14 days after start of tx

Then at each clinical encounter or at least before each refill

Note: separate visit should take place before starting the med but after the MDs initial visit

47
Q

What constitutes a hazardous drug?

A

-carcinogenicity
-teratogenicity or developmental toxicity
-reproductive toxicity
-organ toxicity at low doses
-genotoxicity
-structure and toxicity profile mimics existing hazardous drugs

48
Q

Sterile vs non-sterile compounding device

A

Non-sterile: class I or II BSC, CVE, CACI

Sterile: class II BSC (A2, B1, B2), CACI

Note: class III BSC rarely used, expensive, for extremely toxic or infectious stuff

49
Q

Group 1, 2 and 3 HD meaning

A

Group 1: antineoplastic
Group 2: meets HD criteria
Group 3: reproductive risk

50
Q

QOPI standards

How soon to give chemo for BC?

Pet/CT?

Serum tumor marker?

A

Chemo: Within 4 months of diagnosis

Pet/ct:
-within 60 after dx for st I-IIB
-30-365 days for curative intent

Tumor marker: 30-365d within dx for curative intent

Other standards:
-G-CSF- lower is better
-bisphosphonates
-tamoxifen or AI within a year
-testing got her-2 and hormone status
-trastuzumab for her-2 positive

51
Q

How soon to give chemo for stage III colon CA

QOPI standard

A

Within 4 months of diagnosis

-also test for kras/nras for metastatic colon ca

52
Q

QOPI standards:

How soon to give chemo for NSCLC?

Pet/CT?

Other standards?

SCLC standards?

A

Chemo: Within 60 days after curative resection for stage II-IIIa
-lower is better for stage IA

Pet/ CT: 0-12 months after tx for curative intent

Other standards:
-adjuvant RT 1b-II (lower is better)
-pfs documented for metastatic ca
-EGFR if appropriate (Lower is better if EGFR/alk status is unknown
-g-CSF (lower better)
-molecular testing turnaround time

Standards for SCLC:
-ppx cranial RT for pts with limited stage
-overtx with platinum based chemo (lower is better)
-early thoracic RT for limited stage

53
Q

MTX best practice

A

-default orders to weekly not daily
-hard stop daily to confirm CA
-pt/family education for oral MTX discharge orders

54
Q

Gravimetric vs robotic compounding

A

Robotic is more accurate but slower

55
Q

When NOT to round dose

A
  1. Clinical trial that has specific rounding protocol
  2. PK determined drugs (HD-busulfan for HCT)
  3. Poor PFS, major organ dysfunction, extensive tx hx, enzyme/genetic differences, or hx of dose reduction d/t toxicity
56
Q

Hazardous anteroom requirements

A

-at least 0.02 positive pressure to adjacent spaces
-at least 0.01 positive pressure to HD buffer room
-30 ACPH
-hand washing sink

57
Q

PPE for Injectable HD administration

A

Gowns and gloves required-2 pairs

58
Q

OCM quality measures

A

-# ED visits
-# hospital admissions
-hospice admit < 3 days before death
-ED visits in last 30 d of life
-plan for pain management
-pt experience survey score
-psychosocial screening/tx

No difference in OCM v non-OCM groups except for slight decline in hospitalization in last month of life

59
Q

ISMP best practice standards

A

-default to weekly MTX. Pt education
-compounding: independent verification of ingredients and amount prior to adding to final container
-no fent patches for opioid naiive
-eliminate injectable promethazine
-verify opioid status (naiive v tolerant) and type of pain prior to LA opioids
-Swiss cheese effect. And limit independent double checks to select meds (chemo, opioids, heparin)
-barcode utilization
-vinc in mini bag

Others:
-weigh each pt asap
-separate neuromuscular blocking agents
-give infusions via programmable infusion pump software and monitor compliance (95% compliance with dose error reduction systems), monitor compliance monthly
-readily available antidotes/rescue agents (have policies and directions)
-seek info and take action on med safety risks from other institutions
-limit meds that can be removed from ADC on override, require order, monitor overrrides
-safeguard oxytocin errors

Archived:
-oral solutions in oral of ENfit syringe
-oral admin devices on in metric scale
-eliminate glacial acetic acid
-1000 mL bags of swfi only in pharmacy

60
Q

Where is 12 ACPH ok

A

-HD storage
-non-sterile HD compounding
-sterile unclassified C-SCA (containment segregated compounding areas)

other sterile and anteroom is 30 ACPH

61
Q

Alcohol % to sanitize stuff with before putting in c-pec

A

70%

62
Q

Safe handling of hazardous drugs- ASCO standards

A
  1. Endorsement of existing standards for handling HDs
  2. Medical surveillance
  3. CSTDs
  4. External ventilation
  5. Alternate duty (pregnant workers)
63
Q

Potentially creditable HW

A

Original manufacturer packaging (except recalls), undispensed, unexpired (or less than 1 yr since exp)

64
Q

Reimbursement of outpatient IV oncology drugs under Medicare

A

Went from ASP + 6% to ASP + 4.3%

65
Q

Drug pricing

A

AWP (average wholesale price): sticker price, price reported by publishing houses (red book). AWP= wac x1.2

WAC (wholesale acquisition cost): list price from wholesalers. May not reflect what is being paid by providers d/t discounts from manufacturer

ASP (average sales price): replaced AWP for basis of how most drugs are covered

66
Q

340B highlights

A

Covered entities: public and non-profit hospitals, children’s hospitals, critical access hospitals, federally qualified centers servicing underserved population (12% or more), free standing cancer centers

Doesn’t cover: physician office practices or inpatient settings

Medicaid patients are NOT eligible

CMS pays: ASP minus 22.5% (but this was overruled I believe by Supreme Court)

67
Q

Investigation drug record keeping duration

A

Drug receipt, dispensing and return: 15 years after study closure

Clinical research study files: 2 years after market approval or discontinuation

68
Q

Specialty pharmacy drugs

A

-high cost
-complex regimens/monitoring
-special handling/storage/delivery
-need for companion correlative tests
-limited distribution networks
-rare diseases
-defined as specialty by payers

69
Q

Specialty pharmacy models

A

Traditional- basically regular cvs

Coordinated- specialty Cvs, helps with payment and stuff but no access to medical records

Integrated- pharmacist involved in medical team

70
Q

Patient assistance funds

A

-assistance fund
-cancer care copay foundation
-chronic dx fund
-genetech access to care foundation
-health well foundation
-Johnson and Johnson pt assistance fund
-the Lois Merrill foundation
-leukemia and lymphoma society
-medication assistance tool
-Novartis oncology pt assistance fund
-national organization for rare disorders
-pt access network foundation
-patient advocate foundation

71
Q

Prevention

A

Primary: vaccines and education
Secondary: screening
Tertiary: tx dx
Quaternary: don’t repeat tests
Primordial: broad steps to prevent (not individual based)

72
Q

Asco/ons standards update

A

-assess financial and social determinants of tx
-use EHR for ordering chemo when able
-document wt/ht in METRIC (kg/cm)
-document herbal and dietary supplements (esp important for antioxidants- anthracyclines, bortezomib, docetaxel?)
-patient education- 12 elements (diagnosis, goal of tx, duration, logistics, side effects long and short term including fertility, symptoms requiring seeking help or stopping drug, follow up plans, contact information for organization, what happens if missed appointment)
-added fourth verification step (Rph, rn x2, then another check upon giving med)
-institutions should have policies on CRS management

73
Q

When is accelerated approval appropriate study?

A

Investigational drug demonstrates benefit in area with unmet need in seriously I’ll patient (without established next tx line)

Note: these drugs often don’t have any clinical drug drug interaction studies (only had in vitro interaction studies)

74
Q

What must IND submission contain?

A

-animal studies and toxicity data
-manufacturing info
-clinical protocols
-data from prior human research
-info about investigator

Don’t necessarily need to test genotoxicity, carcinogenicity, mutagenicity, teratogenicity/reproductive- since these drugs are intended for oncology patients

75
Q

What to do when temp or humidity is out of range?

A

Contact plant operations, continue compounding with 12 hour BUD

76
Q

Pass through status

A

Biosimilars are given pass through status under 340B policy- which means reimbursed at ASP + 6% rather than ASP minus 22.5%

Given to all biosimilars reimbursed by CMS for first 3 years

77
Q

New technology add on payment

A

Enables additional payments to hospitals above the standard DRG for Medicare patients

78
Q

Donning order

A

Areas dirtiest to cleanest

  1. Head/facial covers
  2. Shoe covers
  3. Hand washing (30 sec)
  4. Gown
  5. Hand scrub
  6. Gloves
79
Q

HD Gown reqs

A

Polyethylene coated polypropylene disposable how.

80
Q

Drug shortages asco recs

A

-re-prioritize non-essential
Use
-increase interval b/w cycles or reduce total tx dose if clinically acceptable
-minimize/omit drug for recurrent or resistance cancers
-multidisciplinary committee to monitor and manage
-evidence based alternative , second opinion
-counseling referrals for shortage distress pts and support for clinicians

You can see list of shortages on fda website

81
Q

Investigational new drugs

A

Form 1572: IDS: list pharmacist contributing significant amount to study, not just dispensing responsibilities (could list this on investigator study records though)

-Rph cv provided to sponsor if listed on form 1571 (IND application) or 1572 (statement of investigator)

-label drugs with: “caution new drug- limited by federal/US law to investigational use”

-need qualified prescriber
-expiration not provided but can be requested

82
Q

QOPI

A

Quality oncology practice initiative: via ASCO for outpatient oncology standards
Domains
1. Creating a safe environment
2. Tx planning, pt consent, education
3. Ordering, preparing, dispensing, administering chemo
4. Monitoring: adherence, toxicity, complications

Core measures:
-Assess pain and emotional wellness By the second visit
Other core measures:
-path report
-staging within a month of first visit
-documented chemo plan
-curative v palliative
-PFS
-plan for oral chemo monitoring
-documented signed consent
-smoking cessation
-action to address emotional well being
-ht wt bsa prior to chemo
-diseases represented in core measures include lung, prostate, breast, colon, and gyn
-appropriate antiemetic therapy

-Institutional staff abstract the data NOT ASCO- QOPI offers 2 rounds per year
-.onsight visit with ASCO/ONS

83
Q

EOM

A

Enhancing oncology model- follow up program to OCM- July 2023-2028

-goal is to ensure quality care for fee for service beneficiaries and to reduce spending
- provides additional payments to physicians for data sharing with CMS
-participant redesign activities (PRA) required for participating providers (pt navigation, document care plan with 13 components, tx based on guidelines, social needs screening, gradual implementation of patient reported outcomes, continuous QI, certified EHR
-identification of health disparities practices: (develop Heath equity plan, collect sociodemographic data, social needs screening, pt navigation to connect then to community resources and supportive services. 24/7 access to clinical with real time access to medical record
-data sharing: quality measures (pt experience, avoid acute care utilization, symptom/tox management, psychosocial health, EOL care), clinical data elements, sociodemographic data, social needs

Other: tele health, home visits post hospital d/c, care management home services

84
Q

Joint commission safety standards

A

-two pt identifiers
-caregiver communication (test results, diagnostics etc)
-all meds and med containers should be labeled (even syringes, cups, basins)
-reduce likelihood of harm with anticoagulation
-accurate pt med info
-improve safety if clinical alarm systems
-reduce risk of healthcare infxns (hand hygiene)
-identify suicide risk (psych hospitals of pts being tx for psych stuff)
-healthcare equity
-pre procedure verification process
-mark procedure site
-time out before procedure

85
Q

Which HD don’t need to follow usp 800

A

-risk assessment performed- final dosage forms and conventionally manufactured products including antineoplastic dosage forms that don’t require further manipulation other than counting/packaging

86
Q

Do not tube

A

-any liquid HD
-ANY antineoplastic HD

87
Q

Volumetric verification

A

Uses photos and barcoding to verify step by step compounding of sterile IV products (Doseedge I think)

88
Q

Not subject to RCRA regulations

A

-pharmaceuticals that may be reused or reclaimed
-OTC, dietary supplements, homeopathic
-recalled drugs
-drugs under preservation order or during investigation/ judicial proceeding
-investigational new drugs
-household waste

BCOP- Joey (11 decks)

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