Practice Management Flashcards
Which hazardous drugs can be stored with other inventory?
-Non-antineoplastic
-reproductive risk only
-final dosage forms of antineoplastics
Storage of hazardous drugs
-externally ventilated negative pressure room
-12 ACPH
Receipt of hazardous drugs
-Neutral or negative pressure area
-not in sterile area
HD c-pec reqs for non-sterile and sterile compounding
-separate rooms unless IOS 7
-if same room, place 1 meter apart
Non-sterile HD compounding engineering controls reqs
-externally ventilated or redundant hepa filter
-12 ACPH
-neg pressure 0.01-0.03 in water column
Sterile HD compounding engineering controls reqs
-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
Sink placement
-Anteroom at least 1 meter from buffer room entrance
-in unclassified C-SCA place sink 1 meter from c-pec
When are closes system transfer devices (CSTD) required
-required for administration (when dosage form allows)
-recommended for compounding
*not a substitute for a C-PEC
*should have ONB product code
Environmental wipe sampling for HD
-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
When are two pairs of gloves needed?
-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
When are single pair of gloves ok
-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
How often must gloves be changed?
Every 30 minutes
How often to change gowns
According to manufacturer or q2-3hrs
When to wear 2 shoes covers
-When compounding HD
-when cleaning up a HD spill!
When to wear eye protection
-risk for spills/splashes
-administration in surgical suite
-working at or above eye level
-cleaning a spill
Respiratory protections
-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)
When to change plastic mat in c-pec
With each spill, regularly during use, and end of day
Priming HD
In c-pec with non-hazardous drug
Cleaning
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
When to decontaminate c-pec
-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
How often are HD SOPs reviewed and revised?
annually
Medical surveillance
Monitoring health of employees that handle HDs
Not required- only a recommendation
How often is HD training done
Annually
How full can a syringe with HD be?
No more than 3/4 full
Where can you compound non-sterile HD
Class I or II BSC, cve, caci
C-pec for sterile compounding ok but must be cleaned decontaminated and disinfected
Allowable/acceptable level of HD surface concentration
No standards exist for this yet
BUDs
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
RCRA definition: characteristic waste
Ignitable, corrosive, reactive, or toxic
RCRA definition: Large quantity generator
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
RCRA definition: small quantity generator
Facilities that generate between 100-1000kg of HW
RCRA definition: conditionally exempt small quantity generator
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
RCRA definition: p-listed waste
-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%)
RCRA definition: u-listed waste
Hazardous waste but not acute hazardous waste
RCRA definition: RCRA empty
All contents removed that can be removed and no more than 3% by weight remains
-considered trace HW
Trace hazardous waste
RCRA empty containers, needles/syringes, trace contaminated gowns, gloves, pads, empty iv sets, gauze, masks
Yellow bucket
double check handout on syringes
Bulk hazardous waste
-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
Red bucket
Stuff that has blood on it- (HW vendors cants deal with medical/infectious waste)- even if there is hazardous waste on it I believe
Is nicotine hazardous waste?
NRT (gum, patches, lozenges) are not longer
But other forms like e-cigs, prescription nicotine, nicotine in research facilities, and stuff like that is
Reverse distributor v res verse logistics
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)
What type of Hw is potentially creditable
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
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
No and no
How long can you accumulate HW in HW containers
1 year
What type of diagram is used for RCA?
Fishbone
Biosimilar reqs
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
Specialty pharmacy accreditation agencies
-ACHC
-URAC
Oral oncolytic: when should initial monitoring of symptoms and adherence occur ?
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
What constitutes a hazardous drug?
-carcinogenicity
-teratogenicity or developmental toxicity
-reproductive toxicity
-organ toxicity at low doses
-genotoxicity
-structure and toxicity profile mimics existing hazardous drugs
Sterile vs non-sterile compounding device
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
Group 1, 2 and 3 HD meaning
Group 1: antineoplastic
Group 2: meets HD criteria
Group 3: reproductive risk
QOPI standards
How soon to give chemo for BC?
Pet/CT?
Serum tumor marker?
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
How soon to give chemo for stage III colon CA
QOPI standard
Within 4 months of diagnosis
-also test for kras/nras for metastatic colon ca
QOPI standards:
How soon to give chemo for NSCLC?
Pet/CT?
Other standards?
SCLC standards?
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
MTX best practice
-default orders to weekly not daily
-hard stop daily to confirm CA
-pt/family education for oral MTX discharge orders
Gravimetric vs robotic compounding
Robotic is more accurate but slower
When NOT to round dose
- Clinical trial that has specific rounding protocol
- PK determined drugs (HD-busulfan for HCT)
- Poor PFS, major organ dysfunction, extensive tx hx, enzyme/genetic differences, or hx of dose reduction d/t toxicity
Hazardous anteroom requirements
-at least 0.02 positive pressure to adjacent spaces
-at least 0.01 positive pressure to HD buffer room
-30 ACPH
-hand washing sink
PPE for Injectable HD administration
Gowns and gloves required-2 pairs
OCM quality measures
-# 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
ISMP best practice standards
-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
Where is 12 ACPH ok
-HD storage
-non-sterile HD compounding
-sterile unclassified C-SCA (containment segregated compounding areas)
other sterile and anteroom is 30 ACPH
Alcohol % to sanitize stuff with before putting in c-pec
70%
Safe handling of hazardous drugs- ASCO standards
- Endorsement of existing standards for handling HDs
- Medical surveillance
- CSTDs
- External ventilation
- Alternate duty (pregnant workers)
Potentially creditable HW
Original manufacturer packaging (except recalls), undispensed, unexpired (or less than 1 yr since exp)
Reimbursement of outpatient IV oncology drugs under Medicare
Went from ASP + 6% to ASP + 4.3%
Drug pricing
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
340B highlights
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)
Investigation drug record keeping duration
Drug receipt, dispensing and return: 15 years after study closure
Clinical research study files: 2 years after market approval or discontinuation
Specialty pharmacy drugs
-high cost
-complex regimens/monitoring
-special handling/storage/delivery
-need for companion correlative tests
-limited distribution networks
-rare diseases
-defined as specialty by payers
Specialty pharmacy models
Traditional- basically regular cvs
Coordinated- specialty Cvs, helps with payment and stuff but no access to medical records
Integrated- pharmacist involved in medical team
Patient assistance funds
-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
Prevention
Primary: vaccines and education
Secondary: screening
Tertiary: tx dx
Quaternary: don’t repeat tests
Primordial: broad steps to prevent (not individual based)
Asco/ons standards update
-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
When is accelerated approval appropriate study?
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)
What must IND submission contain?
-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
What to do when temp or humidity is out of range?
Contact plant operations, continue compounding with 12 hour BUD
Pass through status
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
New technology add on payment
Enables additional payments to hospitals above the standard DRG for Medicare patients
Donning order
Areas dirtiest to cleanest
- Head/facial covers
- Shoe covers
- Hand washing (30 sec)
- Gown
- Hand scrub
- Gloves
HD Gown reqs
Polyethylene coated polypropylene disposable how.
Drug shortages asco recs
-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
Investigational new drugs
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
QOPI
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
EOM
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
Joint commission safety standards
-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
Which HD don’t need to follow usp 800
-risk assessment performed- final dosage forms and conventionally manufactured products including antineoplastic dosage forms that don’t require further manipulation other than counting/packaging
Do not tube
-any liquid HD
-ANY antineoplastic HD
Volumetric verification
Uses photos and barcoding to verify step by step compounding of sterile IV products (Doseedge I think)
Not subject to RCRA regulations
-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
