EXAM 1 STUDY GUIDE Flashcards
DEA #s:
if first letter is A
indicates a practitioner
DEA #s:
if first letter is B
indicates a practitioner
DEA #s:
if first letter is F
indicates a practitioner
DEA #s:
if first letter is M
indicates a mid-level practitioner
DEA #s:
if first letter is P
indicates a manufacturer/distributor/researcher
DEA #s:
if first letter is R
indicates a manufacturer/distributor/researcher
DEA #s:
What is the second letter of the DEA #?
the FIRST LETTER of the registrants LAST NAME
DEA #s:
How to tell if DEA # is legitimate:
- add together 1st, 3rd, 5th digits
- add together 2nd, 4th, 6th digits. double it.
- add two totals together
- the second digit in the total is the LAST digit in DEA # (check digit)
GOOGLE PRACTICE READING AN DEA # TO MAKE SURE I CAN DO IT.
:-)
How to read NDC code
first part of # (1st 5 digits) = labeler/company
middle part of # (3 digits) = drug
last part of # (last 2 digits) = package size
When must you counsel the patient?
a. if patient is a NEW patient
b. if there is a CHANGE in drug therapy
What do you need to become a certified immunizer?
a. CPR training every 2 years
b. immunization training
c. “I” on permit
do you need blood borne pathogen (BBP) training to become an immunizer?
NO, needs to be completed before you give 1st shot
How long is your intern permit good for?
5 years
How long can you renew your intern permit for?
2 years
What is the PHARMACIST to INTERN ratio?
UNLIMITED
What is the TECH to PHARMACIST ratio?
2 techs (unlicensed personel) to 1 pharmacist
Can you have ONE pharmacist, TWO technicians, and ONE cashier?
YES, cashier must NOT start filling drugs.
What are the basic spatial/temperature requirements of a pharmacy?
a. 300 sq ft
b. 100 sq ft of working area
c. 2-8 degrees C or 36-46 degrees F for fridges
d. drugs only, NO FOOD
Written = ?
written = ELECTRONIC
SAME rules apply to both written and electronic prescriptions
Fax = ?
telephonic, NOT elecontronic
Can you transmit prescriptions computer to fax?
NO
How many drugs can you write on a blank for verbal orders?
can write MANY drugs on ONE blank
How many drugs can be on a blank for written/electronic orders?
only ONE drug per ONE blank for written/electronic orders in NYS
How many square feet must a pharmacy be?
300 sq ft
How many sq ft of working area must a pharmacy have?
100 sq ft
What must the temperature be for fridges in the pharmacy?
2-8C or 36-46F
Can food be in the pharmacy?
NO
Does the 1 drug per 1 blank for electronic/written orders apply to all states?
NO, only NYS
How many hours of continuing education is needed every 3 years?
45 hours every 3 years
____ hours of continuing education is needed every ____ years
45 hours every 3 years
How many hours of continuing education must be LIVE?
23 hours must be live (or more)
What is the maximum amount of continuing education hours that can be online, home study, etc. (NOT live)?
22 hours of online, home study, etc. (not live)
How long must continuing education records be kept for?
6 years
Continuing education records must be kept for ______ years
6 years
How many hours must be spent on medication error prevention and safety?
at least 3 hours, can be live or home study
Can the hours spent on medication error prevention and safety be home study (not live)?
YES
At least 3 hours of continuing education must be spent on _____________
medication error prevention and safety
How many hours are required for CPR course?
- initial
- for renewal
- initial = 5 hours
- renewal = 3 hours
How many hours are required for BLS (Basic Life Support) course?
- initial
- for renewal
- initial = 5 hours
- renewal = 3 hours
How many hours are required for ACLS (Advanced Cardiovascular Life Support) course?
- initial
- for renewal
- initial = 12 hours
- renewal = 6 hours
How many hours are required for EMT course?
- initial
- for renewal
- initial = 10 hours
- renewal = 5 hours
Do first aid classes count towards continuing education (CE) credit?
- initial
- for renewal
NO, first aid classes do NOT count for CE credit
Your registration must be renewed every ______ years
every 3 years
How often does your registration need to be renewed?
every 3 years
How often must you renew your CPR certification?
every 2 years
CPR certification must be renewed every _____ years
every 2 years
How often must your BBP (blood borne pathogen) training be renewed?
EVERY YEAR
You must renew your BBP training _____ year
EVERY YEAR
When must you notify the state board for a transfer of ownership?
minimum of 6 weeks
If there is a change in supervising pharmacist, notify ….
notify the state board within 7 DAYS
if there is a change in corporate officer, notify ….
notify the state board within 30 days
If there is a fire, flood, or disaster, notify ….
notify the state board within 48 hours
if there is heavy rainfall and your pharmacy is damaged, notify….
notify the state board within 48 hours
If your pharmacy is relocating, an application for endorsement to another address must be made ________
at least 30 days before the expected date of relocation
If your pharmacy is relocating, an ______ ___ ______ to another address must be made at least ____ ____ PRIOR to _______ ____ __ _______.
If your pharmacy is relocating, an APPLICATION FOR ENDORSEMENT to another address must be made at least 30 DAYS prior to EXPECTED DATE OF RELOCATION.
What is a sunset clause?
a measure within a regulation/law that provides the law shall crease to have effect after a specific date, unless further legislative action is taken to extend the law.
When does the current sunset law that allows pharmacists to vaccinate in NYS end?
July 1st 2022
What ends on July 1st 2022
the sunset law allowing pharmacists to vaccinate in NYS
Who can come in and inspect you for what
OPD, NYSDH (BNE), DOJ (DEA), NYS education department, medicaid, medicare, state police, insurance companies, OSHA
What can the OPD inspect?
anything
What can the NYSDH (department of health) inspect?
controls
What can the BNE (bureau of narcotic enforcement) inspect?
controls
what department does the BNE (burea of narcotic enforcement) fall under?
BNE is under the NYSDH (dept of health)
What can the DOJ (department of justice) inspect?
controls
What can the DEA inspect?
controls
what department does the DEA fall under?
DEA is under DOJ (dept of justice)
can the NYS Education Department inspect your pharmacy?
YES, will often send a letter in advance
what can medicaid inspect?
claims of medicaid patients, can make copies of medicaid prescriptions and records
what can medicare inspect?
claims of medicare patients, can make copies of medicare prescriptions and records
What can the state police inspect?
pepper spray only, no warrant needed
What can insurance companies inspect?
can audit only
can insurance companies take copies of prescriptions and records?
NO
what can OSHA inspect?
safety hazards, needle safety, exposure plans
How long must records be kept in a pharmacy under FEDERAL law?
2 years
How long must records be kept in a pharmacy under NYS law?
5 years
How long must records be kept in a pharmacy under HIPAA law?
6 years
How long must records be kept in a pharmacy for medicaid?
6 years
How long must records be kept in a pharmacy for medicare?
10 years
How long must records be kept in a pharmacy for immunizations?
for the lifetime of the patient
How many hours are required for immunization training in NYS?
20 hours total, 8 live hours
How many LIVE hours are required for immunization training in NYS?
8 hours
who can prescribe?
- physicians
- OD (optometrist)
- PA
- dentist
- podiatrist
- veterinarians
- NP
- midwives
who can prescribe CII?
- physicians
- OD
- PA
- dentist
- podiatrist
- veterinarians
- NP
- midwives
Is an ophthalmologist a physician?
YES
is a neurosurgeon a physician?
YES
is a dermatologist a physician?
YES
is a urologist a physician?
YES
What can midwives prescribe?
- only for women of childbearing age
- Oral contraceptives
- azithromycin for patient and their partner for STDs (chlamydia)
What can dentists prescribe?
for oral cavity only
What can veterinarians prescribe for?
animals only
Are animals covered under HIPAA?
NO, animals are “property”
what can podiatrists prescribe for?
ankle down? (I think)
What do physician assistants need to prescribe?
need to have a supervising physician name on blank
All prescribers are able to prescribe….
CII substances
Physicians can prescribe anything EXCEPT…
CI substances (illegal)
PA must have their _____ ______ countersigned by a supervising physician within __ ____
PA must have their MEDICAL ORDERS (NOT prescriptions) countersigned by a supervising physician within 24 HOURS
Can someone else pick up a prescription for the patient?
YES, only need patient identifiers
Can pharmacists give out samples?
NO
who can give out samples?
physicians
who can give out samples of controlled substances?
physicians/ other prescribers
can physicians give out samples of controlled substances?
YES
Who is responsible for passing law in the United States?
Congress
______ is responsible for passing laws in the US.
congress
What vaccinations can pharmacists give?
- influenza
- pneumonia
- meningitis
- tetanus
- diphtheria
- pertussis
- Shingles (Zoster)
- COVID19
- due to COVID 19 - pharmacists are able to give all childhood vaccinations ages 3+
- not measles, hepB or DTaP? check with Fiebelkorn at review
What do you need BEFORE giving an immunization?
- written consent from patient
- counsel patient on outcome, contraindications, SEs
- obtain allergy profile
- give patient the VIS
- discuss cost
- have emergency supplies (epi-pen) prepared incase
What do you need to do DURING vaccine administration?
- screen and assess the patient for any contraindications
- provide private area for immunization
- patient must be sitting on arm chair with arm rests so they don’t fall over incase of syncope
What do you need to do AFTER giving an immunization?
- report to NYSIIS (within 14 days if over 19y/o) with consent from patient
- report to NYC cite wide immunization registry (within 14 days if living in NYC)
- report to patient’s PCP within 1 month
- report to NYSDOH within 14 days (or NYC Dept of Health)
- report adverse events to CDC
- educate patient on importance of having a PCP appointment after vaccination
When must you report a vaccination to NYSIIS?
within 14 days if the patient is over 19 years old
information must be de-identified, patient must consent
When reporting vaccinations to NYSIIS, the info must be ______
de-identified
Before reporting vaccinations to NYSIIS, you must _____
obtain the patient’s consent
When would you report vaccinations to the NYC cite wide immunization registry?
within 14 days if living in NYC
How long do you have to report a vaccination to the patient’s PCP?
one month
When would you report a vaccination to the NYSDOH?
within 14 days, info must be de-identified
When reporting vaccinations to NYSDOH or NYC Department of Health and Mental Hygiene, info must be ______
de-identified
If you give an immunization to a patient at CVS in buffalo, you must report this to…
- NYSIIS within 14 days, de-identified with patient consent
- patient’s PCP within 1 month
- NYSDOH within 14 days, de-identified
Who do you report adverse effects of vaccinations to?
CDC
What requires tamper resistant packaging?
- cosmetic liquid oral hygiene products (mouthwash, breath fresheners,
- cosmetic vaginal creams,
- contact lens solution/tablets,
- eye drops, ear drops
What is EXEMPT from tamper resistant packaging? (does not require)
- dermatological creams/lotions
- dentifrice
- insulin
- lozenge products
- floss
Does floss require temper resistant packaging?
NO
Does mouthwash require temper resistant packaging?
YES
Do breath fresheners require temper resistant packaging?
YES
Do vaginal creams require temper resistant packaging?
YES
Do contact lenses require temper resistant packaging?
YES
Does insulin require temper resistant packaging?
NO
Do eye drops require temper resistant packaging?
YES
Do ear drops require temper resistant packaging?
YES
Do dermatological creams require temper resistant packaging?
NO
Does dentifrice require temper resistant packaging?
NO
Do lozenge products require temper resistant packaging?
NO
What is a 503A?
- traditional compounding pharmacies
- compounds pursuant to an order from a physician (prescriptions)
- does NOTh ave to abide by CGMP
- includes local retail pharmacies
CVS is an example of a _____
503A
Traditional compounding pharmacies are an example of ______
503A
______ do NOT have to abide by CGMP.
503A
Do 503A have to abide by CGMP?
NO
Walgreens is an example of a ______
503A
______ have to abide by CGMP
503B
Do 503B have to abide by CGMP?
YES
When must 503B renew their registration?
registration renewed annually
What do 503B pharmacies do?
- manufactures under FDA jurisdiction
- manufacture drugs without prescriptions
- ship to hospitals/health offices (different states)
Can 503B ship to different states?
YES
Are 503B pharmacies the same as wholesalers?
NO
503B is under ___________ jurisdiction
FDA
___________ lists biological products (biosimilar products)
the purple book
The Purple Book lists __________
biological products (biosimilars)
The Orange Book lists __________
therapeutic equivalents of drugs that are NOT biologics
__________ lists therapeutic equivalents of drugs that are NOT biologicals
the orange book
The FDA Safety and Innovation Act of 2012…..
- reauthorizes Prescription Drug User Fee Act of 1992
- continues to collect user fees from manufacturers, also NDA for generic drugs and biosimilars
- combats counterfeiting
- blocks importation of adulterated drugs
- detects and reduces drug shortages
- authority to inspect foreign manufacturers
__________ reauthorizes Prescription Drug User Fee Act of 1992
The FDA Safety and Innovation Act of 2012
__________ continues to collect user fees from manufacturers, also NDA for generic drugs and biosimilars
The FDA Safety and Innovation Act of 2012
__________ combats counterfeiting
The FDA Safety and Innovation Act of 2012
________ blocks importation of adulterated drugs
The FDA Safety and Innovation Act of 2012
________ detects and reduces drug shortages
The FDA Safety and Innovation Act of 2012
________ has authority to inspect foreign manufacturers
The FDA Safety and Innovation Act of 2012
The Drug Quality and Security Act (DQSA)
- formed 503A and 503B
- Compounding Quality Act (2013): amends the FFDCA with respect to regulation of compounding drugs; exempts compounding drugs from new drug requirements, labeling requirements, track and trace requirements IF compounded under supervision of licensed pharmacist in a registered outsourcing facility and meets applicable requirements.
503A is a
compounding pharmacy
503B is a
outsourcing pharamcy
The __________ amends the FFDCA with respect to regulation of compounding drugs; exempts compounding drugs from new drug requirements, labeling requirements, track and trace requirements IF compounded under supervision of licensed pharmacist in a registered outsourcing facility and meets applicable requirements.
Compounding Quality Act of 2013 (Under DQSA)
The __________ formed 503A and 503B.
The Drug Quality and Security Act (DQSA)
The OPMC oversees….
all physicians
The OPD oversees…
dental surgeons, dentists, pharmacists, podiatrists
Who oversees podiatrists?
OPD
who oversees dentists/dental surgeons?
OPD
Who oversees pharmacists?
OPD
Who oversees all physicians?
OPMC
Who is HIPAA exempt?
- DEA
- DOJ
- Center for Medicaid & Medicare (medicaid/medicare patients only)
Can you fill a prescription from a prescriber NOT certified in NYS?
NO, must be certified in NYS to prescribe
Is there a 503B pharmacy in Buffalo/Western NY?
YES, Pine pharmacies
What type of pharmacy is Pine Pharmacies?
503B
In order to prescribe in NYS…
you must be registered in NYS
Must obtain 2nd dose of Pfizer BioNtech COVID-19 vaccine…..
21 days later
Must obtain 2nd dose of Modern COVID-19 vaccine….
28 days later
When is full immunity achieved from the COVID-19 vaccine?
14 days after their second dose
When do most systemic post-vaccination symptoms occur and resolve with the COVID-19 vaccination?
within 3 days after vaccination and resolve within 1-3 days
When are post-vaccination symptoms more common with the COVID-19 vaccines?
symptoms are more frequent/severe…
- after 2nd dose
- among younger people
Who is more likely to experience symptoms after their first COVID-19 vaccination dose?
people who were previously infected with COVID-19
Is there are VIS statement for the COVID-19 vaccinations?
NO, because they are NOT FDA approved, but are authorized by FDA.
Is there a EUA fact sheet for COVID-19 vaccinations.
YES!
Define herd immunity
resistance to the spread of an infectious disease within a population that is based on pre-existing immunity of a high proportion of individuals as a result of previous infection or vaccination.
How long should people be observed after receiving the COVID-19 vaccination?
- 30 minutes for people with history of allergic rxn, with contraindication to another mRNA vaccine
- 15 minutes for everyone else
Acetaminophen is regulated if package contains…..
greater than 1 gram of acetaminophen per package
If NYS Governor Cuomo is forced to resign, who takes over?
Lieutenant Governor Kathy Hochul
pharmacists can give the influenza patients if they are ______ years old
2 years old and up
