EXAM 1 STUDY GUIDE Flashcards

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1
Q

DEA #s:

if first letter is A

A

indicates a practitioner

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2
Q

DEA #s:

if first letter is B

A

indicates a practitioner

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3
Q

DEA #s:

if first letter is F

A

indicates a practitioner

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4
Q

DEA #s:

if first letter is M

A

indicates a mid-level practitioner

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5
Q

DEA #s:

if first letter is P

A

indicates a manufacturer/distributor/researcher

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6
Q

DEA #s:

if first letter is R

A

indicates a manufacturer/distributor/researcher

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7
Q

DEA #s:

What is the second letter of the DEA #?

A

the FIRST LETTER of the registrants LAST NAME

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8
Q

DEA #s:

How to tell if DEA # is legitimate:

A
  1. add together 1st, 3rd, 5th digits
  2. add together 2nd, 4th, 6th digits. double it.
  3. add two totals together
  4. the second digit in the total is the LAST digit in DEA # (check digit)
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9
Q

GOOGLE PRACTICE READING AN DEA # TO MAKE SURE I CAN DO IT.

A

:-)

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10
Q

How to read NDC code

A

first part of # (1st 5 digits) = labeler/company

middle part of # (3 digits) = drug

last part of # (last 2 digits) = package size

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11
Q

When must you counsel the patient?

A

a. if patient is a NEW patient

b. if there is a CHANGE in drug therapy

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12
Q

What do you need to become a certified immunizer?

A

a. CPR training every 2 years
b. immunization training
c. “I” on permit

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13
Q

do you need blood borne pathogen (BBP) training to become an immunizer?

A

NO, needs to be completed before you give 1st shot

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14
Q

How long is your intern permit good for?

A

5 years

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15
Q

How long can you renew your intern permit for?

A

2 years

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16
Q

What is the PHARMACIST to INTERN ratio?

A

UNLIMITED

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17
Q

What is the TECH to PHARMACIST ratio?

A

2 techs (unlicensed personel) to 1 pharmacist

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18
Q

Can you have ONE pharmacist, TWO technicians, and ONE cashier?

A

YES, cashier must NOT start filling drugs.

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19
Q

What are the basic spatial/temperature requirements of a pharmacy?

A

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

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20
Q

Written = ?

A

written = ELECTRONIC

SAME rules apply to both written and electronic prescriptions

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21
Q

Fax = ?

A

telephonic, NOT elecontronic

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22
Q

Can you transmit prescriptions computer to fax?

A

NO

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23
Q

How many drugs can you write on a blank for verbal orders?

A

can write MANY drugs on ONE blank

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24
Q

How many drugs can be on a blank for written/electronic orders?

A

only ONE drug per ONE blank for written/electronic orders in NYS

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25
Q

How many square feet must a pharmacy be?

A

300 sq ft

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26
Q

How many sq ft of working area must a pharmacy have?

A

100 sq ft

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27
Q

What must the temperature be for fridges in the pharmacy?

A

2-8C or 36-46F

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28
Q

Can food be in the pharmacy?

A

NO

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29
Q

Does the 1 drug per 1 blank for electronic/written orders apply to all states?

A

NO, only NYS

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30
Q

How many hours of continuing education is needed every 3 years?

A

45 hours every 3 years

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31
Q

____ hours of continuing education is needed every ____ years

A

45 hours every 3 years

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32
Q

How many hours of continuing education must be LIVE?

A

23 hours must be live (or more)

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33
Q

What is the maximum amount of continuing education hours that can be online, home study, etc. (NOT live)?

A

22 hours of online, home study, etc. (not live)

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34
Q

How long must continuing education records be kept for?

A

6 years

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35
Q

Continuing education records must be kept for ______ years

A

6 years

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36
Q

How many hours must be spent on medication error prevention and safety?

A

at least 3 hours, can be live or home study

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37
Q

Can the hours spent on medication error prevention and safety be home study (not live)?

A

YES

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38
Q

At least 3 hours of continuing education must be spent on _____________

A

medication error prevention and safety

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39
Q

How many hours are required for CPR course?

  • initial
  • for renewal
A
  • initial = 5 hours

- renewal = 3 hours

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40
Q

How many hours are required for BLS (Basic Life Support) course?

  • initial
  • for renewal
A
  • initial = 5 hours

- renewal = 3 hours

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41
Q

How many hours are required for ACLS (Advanced Cardiovascular Life Support) course?

  • initial
  • for renewal
A
  • initial = 12 hours

- renewal = 6 hours

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42
Q

How many hours are required for EMT course?

  • initial
  • for renewal
A
  • initial = 10 hours

- renewal = 5 hours

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43
Q

Do first aid classes count towards continuing education (CE) credit?

  • initial
  • for renewal
A

NO, first aid classes do NOT count for CE credit

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44
Q

Your registration must be renewed every ______ years

A

every 3 years

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45
Q

How often does your registration need to be renewed?

A

every 3 years

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46
Q

How often must you renew your CPR certification?

A

every 2 years

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47
Q

CPR certification must be renewed every _____ years

A

every 2 years

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48
Q

How often must your BBP (blood borne pathogen) training be renewed?

A

EVERY YEAR

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49
Q

You must renew your BBP training _____ year

A

EVERY YEAR

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50
Q

When must you notify the state board for a transfer of ownership?

A

minimum of 6 weeks

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51
Q

If there is a change in supervising pharmacist, notify ….

A

notify the state board within 7 DAYS

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52
Q

if there is a change in corporate officer, notify ….

A

notify the state board within 30 days

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53
Q

If there is a fire, flood, or disaster, notify ….

A

notify the state board within 48 hours

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54
Q

if there is heavy rainfall and your pharmacy is damaged, notify….

A

notify the state board within 48 hours

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55
Q

If your pharmacy is relocating, an application for endorsement to another address must be made ________

A

at least 30 days before the expected date of relocation

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56
Q

If your pharmacy is relocating, an ______ ___ ______ to another address must be made at least ____ ____ PRIOR to _______ ____ __ _______.

A

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.

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57
Q

What is a sunset clause?

A

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.

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58
Q

When does the current sunset law that allows pharmacists to vaccinate in NYS end?

A

July 1st 2022

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59
Q

What ends on July 1st 2022

A

the sunset law allowing pharmacists to vaccinate in NYS

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60
Q

Who can come in and inspect you for what

A

OPD, NYSDH (BNE), DOJ (DEA), NYS education department, medicaid, medicare, state police, insurance companies, OSHA

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61
Q

What can the OPD inspect?

A

anything

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62
Q

What can the NYSDH (department of health) inspect?

A

controls

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63
Q

What can the BNE (bureau of narcotic enforcement) inspect?

A

controls

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64
Q

what department does the BNE (burea of narcotic enforcement) fall under?

A

BNE is under the NYSDH (dept of health)

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65
Q

What can the DOJ (department of justice) inspect?

A

controls

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66
Q

What can the DEA inspect?

A

controls

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67
Q

what department does the DEA fall under?

A

DEA is under DOJ (dept of justice)

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68
Q

can the NYS Education Department inspect your pharmacy?

A

YES, will often send a letter in advance

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69
Q

what can medicaid inspect?

A

claims of medicaid patients, can make copies of medicaid prescriptions and records

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70
Q

what can medicare inspect?

A

claims of medicare patients, can make copies of medicare prescriptions and records

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71
Q

What can the state police inspect?

A

pepper spray only, no warrant needed

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72
Q

What can insurance companies inspect?

A

can audit only

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73
Q

can insurance companies take copies of prescriptions and records?

A

NO

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74
Q

what can OSHA inspect?

A

safety hazards, needle safety, exposure plans

75
Q

How long must records be kept in a pharmacy under FEDERAL law?

A

2 years

76
Q

How long must records be kept in a pharmacy under NYS law?

A

5 years

77
Q

How long must records be kept in a pharmacy under HIPAA law?

A

6 years

78
Q

How long must records be kept in a pharmacy for medicaid?

A

6 years

79
Q

How long must records be kept in a pharmacy for medicare?

A

10 years

80
Q

How long must records be kept in a pharmacy for immunizations?

A

for the lifetime of the patient

81
Q

How many hours are required for immunization training in NYS?

A

20 hours total, 8 live hours

82
Q

How many LIVE hours are required for immunization training in NYS?

A

8 hours

83
Q

who can prescribe?

A
  • physicians
  • OD (optometrist)
  • PA
  • dentist
  • podiatrist
  • veterinarians
  • NP
  • midwives
84
Q

who can prescribe CII?

A
  • physicians
  • OD
  • PA
  • dentist
  • podiatrist
  • veterinarians
  • NP
  • midwives
85
Q

Is an ophthalmologist a physician?

A

YES

86
Q

is a neurosurgeon a physician?

A

YES

87
Q

is a dermatologist a physician?

A

YES

88
Q

is a urologist a physician?

A

YES

89
Q

What can midwives prescribe?

A
  • only for women of childbearing age
  • Oral contraceptives
  • azithromycin for patient and their partner for STDs (chlamydia)
90
Q

What can dentists prescribe?

A

for oral cavity only

91
Q

What can veterinarians prescribe for?

A

animals only

92
Q

Are animals covered under HIPAA?

A

NO, animals are “property”

93
Q

what can podiatrists prescribe for?

A

ankle down? (I think)

94
Q

What do physician assistants need to prescribe?

A

need to have a supervising physician name on blank

95
Q

All prescribers are able to prescribe….

A

CII substances

96
Q

Physicians can prescribe anything EXCEPT…

A

CI substances (illegal)

97
Q

PA must have their _____ ______ countersigned by a supervising physician within __ ____

A

PA must have their MEDICAL ORDERS (NOT prescriptions) countersigned by a supervising physician within 24 HOURS

98
Q

Can someone else pick up a prescription for the patient?

A

YES, only need patient identifiers

99
Q

Can pharmacists give out samples?

A

NO

100
Q

who can give out samples?

A

physicians

101
Q

who can give out samples of controlled substances?

A

physicians/ other prescribers

102
Q

can physicians give out samples of controlled substances?

A

YES

103
Q

Who is responsible for passing law in the United States?

A

Congress

104
Q

______ is responsible for passing laws in the US.

A

congress

105
Q

What vaccinations can pharmacists give?

A
  • 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
106
Q

What do you need BEFORE giving an immunization?

A
  • 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
107
Q

What do you need to do DURING vaccine administration?

A
  • 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
108
Q

What do you need to do AFTER giving an immunization?

A
  • 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
109
Q

When must you report a vaccination to NYSIIS?

A

within 14 days if the patient is over 19 years old

information must be de-identified, patient must consent

110
Q

When reporting vaccinations to NYSIIS, the info must be ______

A

de-identified

111
Q

Before reporting vaccinations to NYSIIS, you must _____

A

obtain the patient’s consent

112
Q

When would you report vaccinations to the NYC cite wide immunization registry?

A

within 14 days if living in NYC

113
Q

How long do you have to report a vaccination to the patient’s PCP?

A

one month

114
Q

When would you report a vaccination to the NYSDOH?

A

within 14 days, info must be de-identified

115
Q

When reporting vaccinations to NYSDOH or NYC Department of Health and Mental Hygiene, info must be ______

A

de-identified

116
Q

If you give an immunization to a patient at CVS in buffalo, you must report this to…

A
  • NYSIIS within 14 days, de-identified with patient consent
  • patient’s PCP within 1 month
  • NYSDOH within 14 days, de-identified
117
Q

Who do you report adverse effects of vaccinations to?

A

CDC

118
Q

What requires tamper resistant packaging?

A
  • cosmetic liquid oral hygiene products (mouthwash, breath fresheners,
  • cosmetic vaginal creams,
  • contact lens solution/tablets,
  • eye drops, ear drops
119
Q

What is EXEMPT from tamper resistant packaging? (does not require)

A
  • dermatological creams/lotions
  • dentifrice
  • insulin
  • lozenge products
  • floss
120
Q

Does floss require temper resistant packaging?

A

NO

121
Q

Does mouthwash require temper resistant packaging?

A

YES

122
Q

Do breath fresheners require temper resistant packaging?

A

YES

123
Q

Do vaginal creams require temper resistant packaging?

A

YES

124
Q

Do contact lenses require temper resistant packaging?

A

YES

125
Q

Does insulin require temper resistant packaging?

A

NO

126
Q

Do eye drops require temper resistant packaging?

A

YES

127
Q

Do ear drops require temper resistant packaging?

A

YES

128
Q

Do dermatological creams require temper resistant packaging?

A

NO

129
Q

Does dentifrice require temper resistant packaging?

A

NO

130
Q

Do lozenge products require temper resistant packaging?

A

NO

131
Q

What is a 503A?

A
  • traditional compounding pharmacies
  • compounds pursuant to an order from a physician (prescriptions)
  • does NOTh ave to abide by CGMP
  • includes local retail pharmacies
132
Q

CVS is an example of a _____

A

503A

133
Q

Traditional compounding pharmacies are an example of ______

A

503A

134
Q

______ do NOT have to abide by CGMP.

A

503A

135
Q

Do 503A have to abide by CGMP?

A

NO

136
Q

Walgreens is an example of a ______

A

503A

137
Q

______ have to abide by CGMP

A

503B

138
Q

Do 503B have to abide by CGMP?

A

YES

139
Q

When must 503B renew their registration?

A

registration renewed annually

140
Q

What do 503B pharmacies do?

A
  • manufactures under FDA jurisdiction
  • manufacture drugs without prescriptions
  • ship to hospitals/health offices (different states)
141
Q

Can 503B ship to different states?

A

YES

142
Q

Are 503B pharmacies the same as wholesalers?

A

NO

143
Q

503B is under ___________ jurisdiction

A

FDA

144
Q

___________ lists biological products (biosimilar products)

A

the purple book

145
Q

The Purple Book lists __________

A

biological products (biosimilars)

146
Q

The Orange Book lists __________

A

therapeutic equivalents of drugs that are NOT biologics

147
Q

__________ lists therapeutic equivalents of drugs that are NOT biologicals

A

the orange book

148
Q

The FDA Safety and Innovation Act of 2012…..

A
  • 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
149
Q

__________ reauthorizes Prescription Drug User Fee Act of 1992

A

The FDA Safety and Innovation Act of 2012

150
Q

__________ continues to collect user fees from manufacturers, also NDA for generic drugs and biosimilars

A

The FDA Safety and Innovation Act of 2012

151
Q

__________ combats counterfeiting

A

The FDA Safety and Innovation Act of 2012

152
Q

________ blocks importation of adulterated drugs

A

The FDA Safety and Innovation Act of 2012

153
Q

________ detects and reduces drug shortages

A

The FDA Safety and Innovation Act of 2012

154
Q

________ has authority to inspect foreign manufacturers

A

The FDA Safety and Innovation Act of 2012

155
Q

The Drug Quality and Security Act (DQSA)

A
  • 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.
156
Q

503A is a

A

compounding pharmacy

157
Q

503B is a

A

outsourcing pharamcy

158
Q

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.

A

Compounding Quality Act of 2013 (Under DQSA)

159
Q

The __________ formed 503A and 503B.

A

The Drug Quality and Security Act (DQSA)

160
Q

The OPMC oversees….

A

all physicians

161
Q

The OPD oversees…

A

dental surgeons, dentists, pharmacists, podiatrists

162
Q

Who oversees podiatrists?

A

OPD

163
Q

who oversees dentists/dental surgeons?

A

OPD

164
Q

Who oversees pharmacists?

A

OPD

165
Q

Who oversees all physicians?

A

OPMC

166
Q

Who is HIPAA exempt?

A
  • DEA
  • DOJ
  • Center for Medicaid & Medicare (medicaid/medicare patients only)
167
Q

Can you fill a prescription from a prescriber NOT certified in NYS?

A

NO, must be certified in NYS to prescribe

168
Q

Is there a 503B pharmacy in Buffalo/Western NY?

A

YES, Pine pharmacies

169
Q

What type of pharmacy is Pine Pharmacies?

A

503B

170
Q

In order to prescribe in NYS…

A

you must be registered in NYS

171
Q

Must obtain 2nd dose of Pfizer BioNtech COVID-19 vaccine…..

A

21 days later

172
Q

Must obtain 2nd dose of Modern COVID-19 vaccine….

A

28 days later

173
Q

When is full immunity achieved from the COVID-19 vaccine?

A

14 days after their second dose

174
Q

When do most systemic post-vaccination symptoms occur and resolve with the COVID-19 vaccination?

A

within 3 days after vaccination and resolve within 1-3 days

175
Q

When are post-vaccination symptoms more common with the COVID-19 vaccines?

A

symptoms are more frequent/severe…

  • after 2nd dose
  • among younger people
176
Q

Who is more likely to experience symptoms after their first COVID-19 vaccination dose?

A

people who were previously infected with COVID-19

177
Q

Is there are VIS statement for the COVID-19 vaccinations?

A

NO, because they are NOT FDA approved, but are authorized by FDA.

178
Q

Is there a EUA fact sheet for COVID-19 vaccinations.

A

YES!

179
Q

Define herd immunity

A

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.

180
Q

How long should people be observed after receiving the COVID-19 vaccination?

A
  • 30 minutes for people with history of allergic rxn, with contraindication to another mRNA vaccine
  • 15 minutes for everyone else
181
Q

Acetaminophen is regulated if package contains…..

A

greater than 1 gram of acetaminophen per package

182
Q

If NYS Governor Cuomo is forced to resign, who takes over?

A

Lieutenant Governor Kathy Hochul

183
Q

pharmacists can give the influenza patients if they are ______ years old

A

2 years old and up