Law (Concepts) Flashcards
1
Q
What are the requirements in NYS for a pharmacist to get licensed
A
- application: file an application with the department
- education
- experience: 1040 hrs
- examination
- age: be at least 21 years old
- citizenship or immigration status: US citizen or lawfully admitted for permanent residence in US
- character: good moral character
- pay fees
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
3
Q
What can a pharmacy intern do
A
practice as an rph under the immediate personal supervision of a licensed pharmacist
4
Q
cost of a pharmacy intern permit
A
70$
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
6
Q
Qualifications for licensure as a registered pharmacy techs
A
- application
- education (high school grad or equivalent)
- certification
- age: at least 18
- character: good moral character
- fee
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
8
Q
What board governs the practice of pharmacy in NYS
A
board of education
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
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
11
Q
What can unlicensed personnel do in pharmacy practice
A
- receive written or electronically transmittted rx
- type rx labels
- key rx data
- get drugs from stock and return to stock
- get rx files
- count drugs
- place drugs in appropriate container
- put rx label on containers
- prepare records of dispensing for rph signature
- check out a pt
- perform other funcitons
- canNOT compound
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
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
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)
15
Q
who are prescribers in NYS
A
- mid level:
- PA
- NP
- optomotrist(not an md)
- midwives
- MDs/DOs
- vets
- dentists
- podiatrist
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)
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”
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
19
Q
who are exempt from using a NYS blank
A
- veterinarians
- out of state
- fed gov
- waiver
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
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
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
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
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”
25
what are the responsibilities of a designated person
- 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
## Footnote
one person can be the designated person for multipe sites
26
training requirements for USP 795
- 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...)
27
training requirements for USP 797
- 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
28
competency recertificatoin fof 797
- 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)
29
facility requirements for USP 797
- 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)
30
drugs that require sterile preparation
- opthalmicc
- inhation
- other irrigations intended for **internal** cavities
## Footnote
irrigations for mouth, rectal, and sinus cavity are NONSTERILE
31
drugs that require nonsterile preparation
- tablets
- capsules
- liquids
- creams
- oints
- rectal and vaginal suppositories
- nasal sprays and otic preparations (except for use with perforated eardrums)
32
master formulation record vs. compounding record
- 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
33
how to recognize when a drug may be hazardous
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)
34
differenes in copounding hzardous and nonhaardous
- 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
where do you find the list of hazardous drugs
NIOSH
## Footnote
each entity that handles HD must have an updated ist of NIOSH drugs that they deal with whcih they update annually
36
USP 795 (nonsterile) personal hygeine and garbign
- 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
garb vs ppe
- garb protects products being made
- ppe protects compounder
38
api
- 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
water use in nonsterile prodcuts
- "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
do nonsterile products need a ccontainment ventilated enclosure (CVE) or biological closet (BSC)?
yes, if it can be aerosolized
| aerosolized not the same as airborne particles (?)
## Footnote
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
is temp monitoring iin the compounding area required for USP 795
yes, and the temp needs to be written down daily
42
BUD: nonsterile nonpreserved aqueous disage form
14 days in fridge
43
BUD: nonsterile preserved aqueous disage forms
35 days in fridge or at room temp
44
BUD: nonsterile oral nonaqueous liquids
90 days in fridge or at room temp
45
BUD: nonsterile nonaqeous dosage forms (other than oral liquids)
180 days in fridge or at room temp
46
When can a CSP NOT follow USP 797
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
immediate use sterile compounds must be used within ____
4 hrs
- still needs aseptic technique and all that
- canNOT be a ahzarodous drug
48
true or false: repackaging falls in the scope of 797 and 795 for sterile ad nonsterile respectively
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
797 category 1
- ISO 5 PEC
- unclassified SCA
- sterile ingrediants
- no addditional testing
50
797 category 2
- cleanroom suite
- sterile or nonsterile ingredients
- aseptic processing
51
797 category 3
- cleanroom suite
- sterile or nonsterile ingredients
- additional garbinng, cleaning, and EM requiremetns
52
environmentl monitoring for 797
- category 1 and 2: air sampling Q6mo and surface sampling Qmo
- catgeory 3: air sampling Q mo and surface QW
53
expiration date
official date of expiry set by manufacturer of a product
54
BUD
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
in use time
the timeframe form when a prodcut or prep is punctured or opened until the point it can no longer be used
56
infusion time
timme a product or prep is being admined to pt
57
BUD: sterile compound Category 1
| prepared in SCA
- room temp: 12 hours
- fridge: 24 hrs
58
BUD: sterile copmound category 2 - aseptically processed, no sterility testing, and has a non-sterile component
| prepared in cleanroom suite
- room temp: 1 day
- fridge: 4 days
- freezer: 45 days
59
BUD: sterile copmound category 2 - aseptically processed, no sterility testing, and only sterile componentes
| prepared in clean room suire
- room temp: 4 days
- frdige: 10 days
- freezer: 45 days
60
BUD: sterile copmound category 2 - aseptically processed and passed sterility testing
| prepared in cleanroom sutie
- room temp: 30 days
- frdige: 45 days
- freezer: 60 days
61
BUD: sterile copmound category 2 - terminally sterilized and no sterility testing
| prepared in cleanroom suite
- room temp: 14 days
- frdige: 28 days
- freezer: 45 days
62
BUD: sterile copmound category 2 - terminally sterilized and passeed sterility testing
- room temp: 45 days
- fridge: 60 days
- freezer: 90 days
63
BUD: sterile copmound category 3 - ascepticallyl prepared
- room temp: 60 days
- fridge: 90 days
- freezer: 120 days
64
BUD: sterile copmound category 3 - terminally sterilized
- room temp: 90 days
- fridge; 120 days
- freezer: 180 days
65
dispense
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
hazardous drug
any drug listed on the NIOSH list of antineoplastic and oterh hazardous drugs in healthcare setting
## Footnote
antineoplastic: dangerous drug that blocks formation of neoplasms
67
usp 800
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
what must be included in the health an safety management system for entities that handle hazardous drugs
- 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
facility and engineering controls for entities *handling* hazardous drugs
| not compoundinh
- 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
T/F: there must be a person designated to develop and implement appropriate procedures for handling hazardous drugs
true
71
USP 800 trianing
- 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
Do CII need to be stored in a safe
no, as long as they are dispersed in a way that makes it hard to be stolen (or something)
73
PMP (I-STOP) key points
- 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
general opioid use should not exceed _____
- 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
Drug Addiction Treatment Act (DATA) Waiver
- all DEA registered prescribers can prescribe buprenorphine for substance use disorder
- there is no cap on how many pts a prescriber can treat
76
emergency orders for CII, benzos, and anabolic steroids
- 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
## Footnote
- 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
what % of RPhs are found to have drug and/or EtOH dependency problems
10-15%
78
misuse
any devation from rx use
## Footnote
- using it without an rx
- using for longer than the rx
- hoarding pills for future use
- obtaining rx fraudulently
- changing ROA
79
dependence
uncontrolled use resulting in signficant physical/psychologicial problems and impairment
79
abuse
maladaptive pattern of use resulting in significant social/interpersonal/legal probelms or hazardous use
80
in a survey, why did RPhs get involved in abusing rx drugs
- wnated a high, started with recreational pot
- started with a legitimate rx
- relieve stress of career
81
in a survey, what didthe rphs identify as risk factors lead to abuse of rx
- access to drugs, unlimited source with no checks
- stressful (retail esp) environment
- culture of pharmacy
- education - they know about the positie effects
82
if an RPh in NY has a substance problem, what can they do
- Professional Assistant Program for Pharmacists
- https://www.op.nysed.gov/professions/pharmacist
/professional-assistance-program
