Flashcards
NY Board member req
9 licensed pharmacist (5yrs in NY)
2 registered technicians
2 public representatives (selected board of regents)
Who does BOP fall under
under the Board of Regents (oversees all professional licensing)
Who chairs the board
chairman and vice-chairmen elected annually by BOP members
How are board members selected?
appointed by Regents on recommendation of commissioner
How long do board members serve
5 years
How often does board meet?
no law req
Who can attend meetings?
open to public except “executive” sessions
Who can apply for pharmacist
- good moral character
- atleast 21 yrs old
- meet education, examination and experience req
Pharmacist application fee
$339
for foreign grads have to be intern (+ $70)
How many CE hours req for renewal
minimum of 45hrs every 3 years
CE hour requirements
45 hours, 23 have to be live
3 credits on reducing med/rx errors
3 credits on compounding
CDTM - 5 hours in area of practice
Pharmacist intern hour requirements
PharmD = no additional
BS in Pharm = 6 months full time or 1040hrs
Foreign = 12 months (2080hrs) as intern after passing NAPLEX
Degree req Pharmacist
ACPE-Accredited PharmD or BPharm
Foreign = degree In pharm
Pharmacist exam Req
NAPLEX/MPJE within 5yrs, no longer need Part III (compounding) after 1/1/2022
Foreign: Pass TOEFL iBT and FPGEE and obtain FPGEC cert, then NAPLEX, then MPJE
Documents for Pharmacist application
New: Form 2 or official transcript w/ conferral date
Transfer: App for license (form 1), school must complete section 2 and return along with transcripts
Foreign: Apply (Form 1), do Form 2 and have school fill it out, apply for intern permit (Form 5) and work as intern and certify (Form 4)
Pharmacist renewal period and fee
3 yrs and $224
Pharmacy intern req/info
can perform anything pharmacist can under supervision except immunizations unless have certificate
can only be intern once P1 year or grad of foreign program
Who can apply to be intern
enrolled and completed 1st professional year or grad of foreign program
intern application fee
$70
intern good standing req
being enrolled in a pharmacy program
Intern preceptor requirement
intern has to be supervised by a pharmacist have to have been practicing for at least 1 yr
how long does intern permit last?
5 years, can renew once for 2yrs
pharmacy technician requirement
at least high school grad
18yrs old
good moral character
certification from a nationally accepted pharm tech program
who can access the pharmacy?
has to be under supervision and management of licensed pharmacist at all hours while open
State BOP, Dept of ED & employees can enter at anytime
minimum space req
300sq ft with 100sq dedicated to compounding, manufacturing, dispensing
pharmacy security system requirements
A pharmacy operated as a department of a general merchandising establishment shall be enclosed
permanently by a partition
at least nine feet six inches in height, except where the ceiling is less than nine feet six inches in height in which case the partition shall be from floor to ceiling.
How to file control and non-control prescriptions
C2 separate
C3-C5 together
non-control separate
Drug storage
adequate heating and ventilation to safeguard purity and potency of drugs (§63.6(b)(2))
Access to controlled substances stocks shall be limited to the minimum number of employees actually required to efficiently handle the substances
Storage of prescription hard copies on site
must be kept on premise for 5yrs and available
storage of prescription copies has to be locked?
system shall provide adequate safeguards against improper manipulation or alteration of stored records
signage required for counseling?
not required
signage required for hours of operation?
exterior sign showing the hours clearly if not open during all hours that the establishment in which it is located is open
Sign requirement for PIC?
not required
Sign requirement for closures?
N/a
Other signage requirements
sign bearing full name of registrant on exterior/entrance
sign notifying people of drug retail space, and drug prescription space
sign saying free oral translation services available
statements in each of pharmacy primary languages posted where rx picked up, dropped off, at cash registers, counseling
Time to notify board of changes in ownership?
within 30 days of change in ownership
Applies to change in officers of corp or in stockholder holding 10%+ in the corp
Time to notify board of PIC changes?
owner must notify within 7 days
Time to notify board of changes in address?
at least 30 days prior to relocation
Type of prescription balance required
Class A balance (6mg) and metric weights if needed for balance operation
equipment required in pharmacy
devices capable of leasing volumes 0.1ml to 500ml
mortar and pestle
refrigerator equipped with a thermometer and providing at times a storage temp of 2-8c limited to the storage of drugs
a copy of laws, rules, and regulations, governing the practice of Pharmacy in New York
Hot and Cold running water in compounding and dispensing area
Must Rph be on site for access to pharmacy
every pharmacy must be under the immediate and supervision and management of a licensed pharmacist at all hours when open.
Mail order info in NY state
Yes - considered “off premises” delivery
out of state must register as nonresident establishment
must be licensed/registered with home state to seek registration in NY
must provide toll-free number during business hours and atleast 40hrs/wk for communication btwn pt/pharmacist
must designate resident agent in NY state
exemption if < 600 scripts/yr or < $10,000
Fee for pharmacy licensure
Application: $345
Renewal: $260 every 3 yrs
Relocation: $50
Who can apply for pharmacy ownership
anyone of good moral character
for corporation, all stock holders/members that apply have to be good moral character
do you have to be a registered pharmacist to own a pharmacy?
no
additional pharmacy ownership requirements
if RpH isnt owner then…..
- must have licensed supervising pharmacist
- can only be PIC of one pharmacy
- PIC must be full time (30hrs) or majority hours of operation
Rules of sales/transfer of pharmacy
notify board within 30 days of change in ownership
can sell drugs at auction, notify board atleast 7 days prior
pharmacy ownership application fees
$50 for location change
no fee for name change/renovation/owner change
Pharmacist to Tech ratio
2 registered techs or 4 unlicensed techs
How long to notify board after damage/flood/fire?
within 48hrs
Pharmacist to Intern ratio
Interns dont count towards Rph:Tech ratio
Pharmacist can supervise 1 full time intern or 2 part time
must dispense 5,000 scripts annually per intern
Rph to Staff ratio
2 registered persons or 4 unregistered, no more than 4 people per pharmacist
What is considered an outsourcing facility?
any facility that compounds sterile drugs
outsourcing facility info
anyone facility engaged in compounding has to register with the FDA
cant dispense to anyone with a RX unless its also a pharmacy
every 6 months have to submit report of what they’ve done over 6 months
Compounding without a prescription
has to be for patient specific order
exception is compounding for a patient before receiving order based on hx of pt orders
if has history of patient rx, can do small amount before receiving rx
Who is required to register with FDA as outsourcing facility?
only if doing sterile compounding
which drugs are required to be behind the counter
products containing ephedrine, pseudoephedrine, or phenylpropanolamine
Pseudophed documenting requirements
maintain records for at least 2 yrs
3.6g per day or 9g/30 days
7.5g/30 day if mail order
not required for purchase < 60mg
What documentation required for pseudophed
products by name, quantity sold, names & address of purchasers, date/time of sales, signature of purchaser
ID or government ID
Dispensing syringes without prescription
18yrs+ w/ safety insert
pharmacy cant advertise availability of syringe without rx
have to kept behind counter
RX syringes allowed, valid 2yrs, transferred once
Which vaccines can pharmacists do?
need certificate, $100 every 3yrs
can give to pts 18yrs or older, 2-18yrs old for flu
Which medications can pharmacists administer
epinephrine for anaphylaxis for pts 18yrs or older
Facility requirements for administration of immunizations
have to provide an area for the patients
have to have visible important adult vaccines
have education materials
What drugs can pharmacist dispense in emergency?
Naloxone, epinephrine, PrEp, 7 day supply of HIV PEP
Can pharmacist refuse to fill valid prescription
have to tell owner/supervisor if their beliefs will limit drug products that they dispense, company can find ways to accommodate this
if med is outside prescribers scope of practice then they shouldn’t dispense.
if believe can cause harm to patient, pharmacist doesnt have to dispense
Actions that can be taken against a pharmacist refusal to fill?
abandoning or neglecting a patient considered professional misconduct and will be investigated upon complaint and determine penalty as appropriate
appeals process for actions of Rph
Rph can appear at initial hearing and represented by counsel as well as produce witness, evidence and cross-examine.
decision of board of regents can be reviewed by court if Rph doesnt agree with decision
Who can dispense/ administer medicine in longterm setting
controlled substances in emergency kit have to be given by authorized personnel
if oral order for control, has to be written within 48hrs
have to notify pharmacy anytime emergency kit is used
who can access dispensing units in long term care
all drugs and biologics should be in locked cabinets under temp control and only appropriate personal access
ie nurse, etc
who can access meds without pharmacy staff?
bulk stocks can be moved around without pharmacy staff present
requirements of IV labeling and dispensing unit
labeling in accordance with article 137, 8 NYCRR Part 29
drug dispensed inpatient can be labeled with policy adapted by board of the facility
requirements on multi dose/repackaging
labeling and recording req have to keep records for 5yrs
all info req by law
name, strength, quantity, physical description
address/ phone # of dispenser
exp date 12 months or 50% of manufactures date, whichever is shorter
Req for storage of controls in longterm care facility
separately locked, permanently affixed compartments for storage
C1-2: GSA Class 5 rated steel cabinet, bolted to floor if less than 750lbs, vault with locks
C3-5: stored in separate lock cabinet, can be stored dispersed within non-control drugs
pt specific controlled meds can be stored for 72hrs with patients other meds
Nuclear Rph requirements
certified as nuclear pharmacist by board or have 200 contact hours of didactic instructions, and minimum of 500 hours of clinical nuclear pharmacy training under supervision of nuclear pharmacist
Nuclear pharmacy facility requirements
Laminar flow hood, dose calibrator, exhaust hood and filter system, chromatography apparatus, apparatus or
materials for the determination of pH, single-channel and/or multichannel scintillation detection system,
microscope
A pharmacy which dispenses both radioactive drugs and nonradioactive drugs shall maintain a separate
area for the storage and dispensing of radioactive drugs, which area shall be secured from unauthorized
personnel.
(§63.6(b)(6)(ii-iii))
Which types of providers can receive/store medications? administer?
anyone who can write is allowed to dispense
nurse, np, doc can admin
Restrictions on drug samples
under PDMA
can only be distributed to licensed practitioners, not retail pharmacies.
cant give controls as samples
Prescribers dispensing/preparing prescriptions
Prescriber can dispense up to 72hrs unless (inc control)…
1. prescribers lives 10mi+ from Pharmacy, dispense at no charge, med emergency, AIDs/cancer protocol, compounded by prescriber
How many months supply of control can practitioner prescribe?
up to 3 months of control, inc chronic gonadotropin or 6 months of testosterone
Who can have possession of drugs?
no one who isnt registered as a pharmacy, wholesaler, manufacturer or outsourcing facility
How long do patient records have to be kept
records have to be kept and maintained for 5 years
How long do control prescriptions need to be held?
5 years
How long do regular prescriptions need to be held?
5 years
Reporting requirement for drug monitoring programs?
have to report within 24hrs of filling control substance
Is pharmacy mandated to check PMP before filling a controlled substance?
Nah
Reporting Adverse drug reactions
FDA MedWatch: pharmacy voluntary reporting
VAERS: for immunizations
FDA Class I recall
reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death
FDA Class II recall
use of, or exposure to, a violative product may cause temporary or medically reversible health consequences or where the probability of serious adverse health consequences is remote
FDA Class III recall
use of, or exposure to, a product unlikely to cause adverse health consequences
USP 795 is…
non sterile compounding
USP 800 is…
hazardous compounding
USP 797 is…
sterile compounding
What can pharmacist never add for controlled prescription
Patient name
date written
medication name
signature of prescriber
What type of drug substitutions are allowed
Has to be generic unless prescriber specifies for it to be brand
Refill rules for controls, and C2s?
C2s = no refills (including benzo)
C3-5 = up to 6 months, 5 refills
written prescriptions in New York must be on a….
NYS prescription pad
Out of state prescribers rx filling in NY
allowed to be written on out of state blank and filled in state
How does a faxed prescription have to be signed?
Has to be signed manually
Can controlled medication be faxed in NY?
No
Exceptions for electronic prescribing NY
Vets
temporary technological failure
temporary electronic failure
practitioner determines eRX would take too long/impractical
Electronic prescribing NY
all prescribers excluding vets req to send eRX
Required field for electronic prescription
has to have electronic signature of prescriber
Electronic prescriptions over state line
has to be filled within 30 days
Which prescriptions can be phoned in
any non control can be called in by someone working for the prescriber
for Control, have to meet exceptions to be called in and has to be done by the actual prescriber
Who can take in phone prescriptions
Pharmacy intern can take them in
no one else aside from pharmacist
Can pharmacy interns transfer prescription
Yes
What info does transferring pharmacist need?
name of patient
that authorized refill was transferred
name/address/phone of where transferring to
name of Rph receiving
name of Rph doing the transfer
date of transfer
What info does the receiving pharmacist need for transfer?
name of patient
that authorized refill was transferred
name/address/phone of from who transfer
name of pharmacist receiving
name of pharmacist doing transfer
date of original rx written and transfer
original rx number
How many refills can be transferred in NY?
1 at a time
remaining refills stay at original pharmacy and can be refilled. remaining refills can be transferred one at a time
critical prescription elements
have to be in color or bold type, min 12 pt font
pt name
directions
drug name and strength
Child safety cap requirements
all meds have to be with child proof cap unless requested by patient and documented in records
Counseling req when….
Counseling required for….
- 1st fill rx
- new rx existing patient
- change in dose/strenght/route/directions from previous rx
pts can decline offer
Who can counsel and offer to counsel
Rph/intern can counsel
tech can offer pharmacist to counsel
if med is being delivered, must have written offer to counsel
What should be covered in counseling
- name/description of med + known indications
- Dosage, dosage form, route of admin n duration of therapy
- special directions and precautions for prep
- common severe side effects/ interactions
- techniques for monitoring
- proper storage
- refill info
- what to do if missed dose
Which DEA form required for pharmacy to dispense control?
DEA 224
DEA 224a = renewal every 3 years
PDMP requirements NY
have to submit within 24hrs of dispensing control
72hrs for mail order pharmacies after med is sent out
Rules of phone C2 prescription
- 5 day supply max
- hardcopy or eRx within 72hrs, with “Authorization for emergency dispensing” written on it
- if not received, have to notify dept of health within 7 days
Rules of phone C3-C5 prescription
- 5 days max for C3/C5
- C4 = 30 days max or 100 units, w/e less
- hardcopy or eRX within 72hrs with “followup prescription to oral order”
- if fail to receive, have to document on oral order “follow up prescription not received”
In NY, Benzos are treated like….
C2s
but still filed with C3s/C5s
Other state specific control info in NY
Benzo = C2
Testosterone = C2
Chronic gonadotropin = C3 in NYS
Cannabidiol = C5
How long are control prescriptions valid
C2 = 30 days
C3-5 = up to 6 months
Day supply max on control
C2-C5 = 30 days
C3-C5 = if more than 30 days issued, can only refill once
Prescriber can issue up to how long day supply of control with proper code?
3 months, including chronic gonadotropin
6 months of anabolic steroids
Code for Panic disorder
A