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PHM 730: Law > Law (Concepts) > Flashcards

Law (Concepts) Flashcards

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1
Q

What are the requirements in NYS for a pharmacist to get licensed

A
  1. application: file an application with the department
  2. education
  3. experience: 1040 hrs
  4. examination
  5. age: be at least 21 years old
  6. citizenship or immigration status: US citizen or lawfully admitted for permanent residence in US
  7. character: good moral character
  8. pay fees
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2
Q

Who can be a pharmacy interns

A
  • student enrolled in the last 2 yeras of a registered program (????)
  • graduate of a pharmacy program whose initial licensure is pending
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3
Q

What can a pharmacy intern do

A

practice as an rph under the immediate personal supervision of a licensed pharmacist

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4
Q

cost of a pharmacy intern permit

A

70$

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5
Q

how long is a pharmacy intern permit good for

A

5 years from date of issue
- limited permits may be renewed once for a period not to exceed 2 yrs

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6
Q

Qualifications for licensure as a registered pharmacy techs

A
  1. application
  2. education (high school grad or equivalent)
  3. certification
  4. age: at least 18
  5. character: good moral character
  6. fee
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7
Q

what can a registered pharmacy tech do

A

under direct personal supervision of a licensed rph assist in
- compounding
- perparing, labeling or dispensing drugs

can do everything that an unlicensed person can do + compound

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8
Q

What board governs the practice of pharmacy in NYS

A

board of education

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9
Q

CE requirements

A
  • 45 hrs every 3 years
  • 23 must be live
  • categories
    - 3 hrs on reducing med and rx errors
    - 3 hrs onn compounding

NO jurisprudence needed

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10
Q

What can a pharmacist do in pharmacy practice

A
  • administer, prepare, compound, preserve, or dispense drugs, medicines, and therapetuic devices in pursuant to rx or other legal authoratiy and collaborative drug therapy management
  • immunize
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11
Q

What can unlicensed personnel do in pharmacy practice

A
  1. receive written or electronically transmittted rx
  2. type rx labels
  3. key rx data
  4. get drugs from stock and return to stock
  5. get rx files
  6. count drugs
  7. place drugs in appropriate container
  8. put rx label on containers
  9. prepare records of dispensing for rph signature
  10. check out a pt
  11. perform other funcitons
  12. canNOT compound
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12
Q

ratio: 1 rph to pharmacy techs

A

2 licensed techs

no more than 4 heads at a time per rph (doesn’t matter what they are) - interns not included

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13
Q

ratio: 1 rph to unlicensed personnel

A

4 unlicensed personnel
- exception: instiutioal setting when supplying unit dose to med carts

no more than 4 heads at a time per rph (doesn’t matter what they are) - interns not included

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14
Q

ratio: 1 rph to intern

A

1 rph to 1 intern (can do 2 part-time interns)

per Pattin (panopto from 2/19 time stamp 26:26)

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15
Q

who are prescribers in NYS

A
  • mid level:
    • PA
    • NP
    • optomotrist(not an md)
    • midwives
  • MDs/DOs
  • vets
  • dentists
  • podiatrist
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16
Q

what does it mean for a prescription to be written for a legitimate medical purpose

A

the person authorized to write the script is writing it for some medical need of the pt based on their assessment and it’s for medical means (some sort of disease state)

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17
Q

what is corresponding responsibility

A

when you are filling a prescription, you are responsible for making sure that it is for a legitimate medical purpose

if somehting goes wrong, can’t just say “that’s what the script said”

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18
Q

max day supply you can fill for controlled sustance

and when can you fill more than normal

A

30 days (??), can do a 7 day early fill (7 day rule)

condition codes for CII, benzos, and anabolic steroids

  • A: AHHHHHHH - Panic disorders
  • B: bored - ADD
  • C: chronic conditions
  • D: debillitating pain
  • E: sleeeeep
  • F: females, males, enbys… who cares, anyone can take sterods
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19
Q

who are exempt from using a NYS blank

A
  • veterinarians
  • out of state
  • fed gov
  • waiver
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20
Q

out of stock fills for controlled substance

A

If you are out of CS, must you fill the remaining qty within 72 hrs

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21
Q

partial filling for controlled substances

A
  • If a pt wants less than what is written, pt will forfeit the remaining qty
  • dr pattin also says in his 3/25 zoom at 12:54 that we canNOT partial a CII, benzo or anabolic steroid (exception: terminally ill or longterm care fcility) <- different from OOS

When filling a partial, these need to be recorded on back of Rx
- Date of filling
- Qty filled
- Qty remaining
- RPh signature and date

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22
Q

what DEA forms are used when

A
  • DEA 222: for moving around CII (buying, transferring)
  • DEA form 41: for when a reverse distributor destroys controlled substances
  • DEA 106: reports a loss or theft
  • DEA 224: new registration of a phramcy to handle and distribute CS
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23
Q

limits for pseudoephedrine sales per pt

A
  • Max 3.6 g of the chemical in a single day
  • Max 9 g of the chemical in a 30 day period
    • CanNOT mail out >7.5/9 g in that 30 day period
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24
Q

example of red flags

A
  • repeated dispensing “cocktailed” prescriptions
  • prescriber does not individualize rx
  • filling multiple rx for the strongest formulation
  • request for early refills
  • doctor located 100 miles awar from pharmacy
  • large portion (75%) of rx filled by the pharmayc were CS written by one physician
  • rph doesn’t reach out to other rphs to find out why they aren’t filling a particular doctor’s rx
  • patients travel in groups ot the pharmacy
  • filling a large % of cash rx
  • “verification” of rx as “legitimate” was not satisifed
  • PMP suggests pt “doctor shops”
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25
Q

what are the responsibilities of a designated person

A
  • oversee the responsibilities of compounding nonsterile preparations
  • responsible for devloping and overseeing policies and procedures (SOP)
    - SOP needs to be reviewed annually and as new compounds, equipemnet, other arise
    - keep old policies for at least 3 yrs
  • ensures copmliance with laws, regulations, standards
  • ensure competencey of all personnel involved in compoundiing
  • ensure environmental controls of facilities used for storing and compounding
  • deelop master formulation records
  • monitor BUD

does NOT have to be an rph

one person can be the designated person for multipe sites

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26
Q

training requirements for USP 795

A
  • all personnel involved in compounding need to be trained according to the new USP 795 standards (canNOT just be a wrtten course, needs “observation”)
  • competency must be documented Q 12 mo (in his lecture he said “training” instead of compentency…)
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27
Q

training requirements for USP 797

A
  • competence in the following areas
    - organizational policies and procedures
    - use of garb
    - use of equipment
    - selection of copmoentes
    - spill management
  • competency must be docmumented prior to compoudning by yourself for pts

ASHP provides checklists and competence documents

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28
Q

competency recertificatoin fof 797

A
  • must complete (at least 3 times in a row for initial ceritifaction)
    - garing adn gloved fingertip testing
    - media fill and post media fill gloved fingertip testing
    - surface sampling
  • frequency
    - Category 1 and 2: Q6 mo
    - Category 3: Q3 mo
    - personell who oversee but do not directly compound recertify Q12mo (e.g. designated person)
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29
Q

facility requirements for USP 797

A
  • primary engineering control (PEC): hood - ISO 5 or lower
  • ssecondary engineering control (SEC): room that contains the hood
    - buffer room - ISO 7
    - anteroom - ISO 7 if it opens to negative pressure, ISO 8 if it opens to positive pressure
    - segregated compounding area (SCA)
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30
Q

drugs that require sterile preparation

A
  • opthalmicc
  • inhation
  • other irrigations intended for internal cavities

irrigations for mouth, rectal, and sinus cavity are NONSTERILE

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31
Q

drugs that require nonsterile preparation

A
  • tablets
  • capsules
  • liquids
  • creams
  • oints
  • rectal and vaginal suppositories
  • nasal sprays and otic preparations (except for use with perforated eardrums)
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32
Q

master formulation record vs. compounding record

A
  • master formulation: recipe book
  • compounding record: what products did you use to make the compound (lot, exp date, BUD) + a copy of the rx label
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33
Q

how to recognize when a drug may be hazardous

A

not somethig he went over lol
- but NIOSH proides info on how to identify potentially hazardous drugs - if there is insufficient info to make an informed decision, just assume hazardous
- entites that deal with HD should do a rsik assessment adn identify containment strategies (bascially how to handle HD in the facility)

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34
Q

differenes in copounding hzardous and nonhaardous

A
  • engeering controls: containment primary engineerinng control (needs to be ISO-5) and a containemnet secondary engineering control (tldr a C-PEC inside an C-SEC)
    - needs to be externally vented
    - physically sepearted
    - have an appropriate air exchange
    - have negative pressure (0.01-0.03 incches of water column) relative to all adjacent areas
  • sink for handwashing
  • eye wash station and/or other emergency/safety precautions

sterile compounding doesn’t need that C

35
Q

where do you find the list of hazardous drugs

A

NIOSH

each entity that handles HD must have an updated ist of NIOSH drugs that they deal with whcih they update annually

36
Q

USP 795 (nonsterile) personal hygeine and garbign

A
  • gloves must be worn when compouding (powder and latex free, does nOT hve to be sterile gloves)
  • garb NOT required but shouuld be assessed for necessity based on products compounding (can refer to API, SDS, and NIOSH)
  • wash hands all the way up to elbows fo 30s prior to compouding
37
Q

garb vs ppe

A
  • garb protects products being made
  • ppe protects compounder
38
Q

api

A
  • active pharmaceutical ingredient
  • should come from supplier registered wth FDA
  • should be marked USP or NF on container
  • to assess a product, need Certificate of Analysis (doc that tells you the quality stadnards related to the component)
  • products with no expiraton date should be discareded 3yrs after receipt
  • chemicals wth ACS may not be safe to use because they have not been tested for use in humans and anmals
39
Q

water use in nonsterile prodcuts

A
  • “water activity levels”
  • need purifed water or better
  • once a bottle is opened, can be sstored in the fridge for later use (label “not for sterile use” and add BUD)
40
Q

do nonsterile products need a ccontainment ventilated enclosure (CVE) or biological closet (BSC)?

A

yes, if it can be aerosolized

aerosolized not the same as airborne particles (?)

need separate ones for hazardous and nonhazardous - an exeptio to this is that if the hazardous hood has negative pressure, you can use occasionally use it for nonhazardous

41
Q

is temp monitoring iin the compounding area required for USP 795

A

yes, and the temp needs to be written down daily

42
Q

BUD: nonsterile nonpreserved aqueous disage form

A

14 days in fridge

43
Q

BUD: nonsterile preserved aqueous disage forms

A

35 days in fridge or at room temp

44
Q

BUD: nonsterile oral nonaqueous liquids

A

90 days in fridge or at room temp

45
Q

BUD: nonsterile nonaqeous dosage forms (other than oral liquids)

A

180 days in fridge or at room temp

46
Q

When can a CSP NOT follow USP 797

A

if the product being made is being done so according to manufacturer’s label - does NOT need to follow USp standards
- must be for a single pt
- canNOT be stored for future use
- NON hazardous only

47
Q

immediate use sterile compounds must be used within ____

A

4 hrs
- still needs aseptic technique and all that
- canNOT be a ahzarodous drug

48
Q

true or false: repackaging falls in the scope of 797 and 795 for sterile ad nonsterile respectively

A

false, 795 does NOT deal with repackaging
- 797 includes prepackaing form vial to unit dose syringe and repacking becuse it has to deal with sterility and stability and there needs to be an assessment of chnage of container and closure

49
Q

797 category 1

A
  • ISO 5 PEC
  • unclassified SCA
  • sterile ingrediants
  • no addditional testing
50
Q

797 category 2

A
  • cleanroom suite
  • sterile or nonsterile ingredients
  • aseptic processing
51
Q

797 category 3

A
  • cleanroom suite
  • sterile or nonsterile ingredients
  • additional garbinng, cleaning, and EM requiremetns
52
Q

environmentl monitoring for 797

A
  • category 1 and 2: air sampling Q6mo and surface sampling Qmo
  • catgeory 3: air sampling Q mo and surface QW
53
Q

expiration date

A

official date of expiry set by manufacturer of a product

54
Q

BUD

A

date of expiry set by compounder for drug prep after which a compounded drug prep must not be used or adminsitration started. BUD is determiend from the date/time that the prep of the compounded drug is iniated

55
Q

in use time

A

the timeframe form when a prodcut or prep is punctured or opened until the point it can no longer be used

56
Q

infusion time

A

timme a product or prep is being admined to pt

57
Q

BUD: sterile compound Category 1

prepared in SCA

A
  • room temp: 12 hours
  • fridge: 24 hrs
58
Q

BUD: sterile copmound category 2 - aseptically processed, no sterility testing, and has a non-sterile component

prepared in cleanroom suite

A
  • room temp: 1 day
  • fridge: 4 days
  • freezer: 45 days
59
Q

BUD: sterile copmound category 2 - aseptically processed, no sterility testing, and only sterile componentes

prepared in clean room suire

A
  • room temp: 4 days
  • frdige: 10 days
  • freezer: 45 days
60
Q

BUD: sterile copmound category 2 - aseptically processed and passed sterility testing

prepared in cleanroom sutie

A
  • room temp: 30 days
  • frdige: 45 days
  • freezer: 60 days
61
Q

BUD: sterile copmound category 2 - terminally sterilized and no sterility testing

prepared in cleanroom suite

A
  • room temp: 14 days
  • frdige: 28 days
  • freezer: 45 days
62
Q

BUD: sterile copmound category 2 - terminally sterilized and passeed sterility testing

A
  • room temp: 45 days
  • fridge: 60 days
  • freezer: 90 days
63
Q

BUD: sterile copmound category 3 - ascepticallyl prepared

A
  • room temp: 60 days
  • fridge: 90 days
  • freezer: 120 days
64
Q

BUD: sterile copmound category 3 - terminally sterilized

A
  • room temp: 90 days
  • fridge; 120 days
  • freezer: 180 days
65
Q

dispense

A

final assocation of a drug with a particular pt pusuant to an rx, drug order, or other lawful order of a prescriber adn teh professional judgement of and the responsibility for interpreting, preparing, compoundinng, labeling, adn packaging

66
Q

hazardous drug

A

any drug listed on the NIOSH list of antineoplastic and oterh hazardous drugs in healthcare setting

antineoplastic: dangerous drug that blocks formation of neoplasms

67
Q

usp 800

A

describes practive and quality standards for handling hazardous drugs to promote pt safety, worker safety, and environmela protection
- applies to healthcare personnel who handle hazardous preps and all entities that store, prep, transport, or administer hazardous drugs

68
Q

what must be included in the health an safety management system for entities that handle hazardous drugs

A
  • list of hazardous drugs
  • faccility and engieering controls
  • competent personnel
  • safe work practices
  • proper suse of PPE
  • policies for HD waste segregatio and dispolsa
69
Q

facility and engineering controls for entities handling hazardous drugs

not compoundinh

A
  • signs indicating that HD are potentiallly around
  • access to areas where HDs are handled ust be restricted to authrozied personnel
  • HD handling must be located away from break rooms refressment areas, pts and visitors
70
Q

T/F: there must be a person designated to develop and implement appropriate procedures for handling hazardous drugs

A

true

71
Q

USP 800 trianing

A
  • personnel should be re-assessed Q12mo
  • training should include
    - overview of entity’s list HD and their risk
    - review of entities SOPs related to handling of HD
    - proper PPE
    - proper use of equipent and deies
    - response to known or suspected HD exposure
    - spill management
    - proper disposal of HD and trace-contaminated materilas
72
Q

Do CII need to be stored in a safe

A

no, as long as they are dispersed in a way that makes it hard to be stolen (or something)

73
Q

PMP (I-STOP) key points

A
  • prescribers need to check not RPh (needs to be checked 24hrs or less in advance)
  • pharmacies need to REPORT ALL dispensing to I-STOP within 24 hrs
  • zero dispensing must be reported to I-STOP in 14 days
74
Q

general opioid use should not exceed _____

A
  • 3 months (unless chronic pain situation where appropriate which should be documented)
  • acute opioid prescribing - not to exceed 7 days for acute pain or for initial consultation (does not apply to chronic pain, cancer, hospice, palliative)
75
Q

Drug Addiction Treatment Act (DATA) Waiver

A
  • all DEA registered prescribers can prescribe buprenorphine for substance use disorder
  • there is no cap on how many pts a prescriber can treat
76
Q

emergency orders for CII, benzos, and anabolic steroids

A
  • has to be oral rx or faxed
  • has to be an emergency situation where there are no non-CS alts and there is no reasonable way to get a written or electronic CS Rx

  • Rph needs to “reduce to writing” (idk what he means by this)
  • Rx needs to have everything law requires, except the prescriber signature
  • needs “telephone order” written on it, date filled and time
  • must receive the hard copy (or electronic copy) within 3 days or contact BNE within 7 days (per federal: need to receie in 7 days or contct DEA)
77
Q

what % of RPhs are found to have drug and/or EtOH dependency problems

A

10-15%

78
Q

misuse

A

any devation from rx use

  • using it without an rx
  • using for longer than the rx
  • hoarding pills for future use
  • obtaining rx fraudulently
  • changing ROA
79
Q

dependence

A

uncontrolled use resulting in signficant physical/psychologicial problems and impairment

79
Q

abuse

A

maladaptive pattern of use resulting in significant social/interpersonal/legal probelms or hazardous use

80
Q

in a survey, why did RPhs get involved in abusing rx drugs

A
  • wnated a high, started with recreational pot
  • started with a legitimate rx
  • relieve stress of career
81
Q

in a survey, what didthe rphs identify as risk factors lead to abuse of rx

A
  • access to drugs, unlimited source with no checks
  • stressful (retail esp) environment
  • culture of pharmacy
  • education - they know about the positie effects
82
Q

if an RPh in NY has a substance problem, what can they do

A
  • Professional Assistant Program for Pharmacists
  • https://www.op.nysed.gov/professions/pharmacist
    /professional-assistance-program

PHM 730: Law (3 decks)

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