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MPJE 2022 > Texas 2022 > Flashcards

Texas 2022 Flashcards

1
Q

Which one required new drugs to be safe prior to marketing?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

FDCA

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2
Q

Which one was caused by deaths via sulfanilamide elixir?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

FDCA

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3
Q

Which one established the FDA?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

FDCA

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4
Q

Which one the two classes of drugs (Rx + OTC)?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

DHA

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5
Q

Which one authorized verbal prescriptions and prescription refills?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

DHA

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6
Q

Which one required new drugs to be proven safe and effective for their claimed use?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

KHA

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7
Q

Which one increased safety requirements for drugs?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

KHA

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8
Q

Which one established Good Manufacturing Practices (GMPs)?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

KHA

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9
Q

Which one gave FDA jurisdiction over prescription drug advertising?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

KHA

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10
Q

Which one banned the reimportation of prescription drugs produced in the US?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

PDMA

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11
Q

Which one banned the sale, trade, purchase of Rx drug samples?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

PDMA

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12
Q

Which one established 503B pharmacies?

  • Food, Drug, and Cosmetic Act of 1938
  • Durham-Humphrey Amendments of 1951
  • Kefauver-Harris Amendments of 1962
  • Prescription Drug Marketing Act of 1987
  • Drug Quality and Security Act of 2018
A

DQSA, more specifically the Drug Compounding Quality Act

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13
Q

Who do outsourcing pharmacies (503B) report to and how often?

A

Reports to HHS upon registering + every 6 months

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14
Q

What prescription drugs are exempted from trace and track system in the Drug Supply Chain Security Act?

A

Blood products, radioactive drugs, IV fluids, dialysis, medical gas, compounded drugs, kits, sterile water, irrigation bags

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15
Q

How long are transaction data maintained for by each supply chain?

A

6 years

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16
Q

Per the Drug Supply Chain Security Act, if a pharmacy suspects an illegitimate product, pharmacies must verify how many products?

A

3 products or 10%, whichever is greater

If they have fewer than 3 products, check them all!

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17
Q

Which form should a pharmacy sign off if they find an illegitimate product?

A

Form FDA 3911 + trading partners within 24 hrs

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18
Q

If a product’s strength differs from what it represents, is is adulterated or misbranded?

A

Both

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19
Q

If a drug has something mixed in it that reduces its strength, is it adulterated or misbranded?

A

Adulterated

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20
Q

If a drug is not packaged in a child-resistant container (assuming it is required), is that adulteration or misbranded?

A

Misbranded

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21
Q

Dispensing a prescription without any authorization causes the drug to be (adulterated/misbranded)

A

Misbranded

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22
Q

Misfilling a Rx with the wrong drug is considered (adulteration/misbranded)

A

Misbranded

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23
Q

Misfilling a Rx with the wrong strength is considered (adulteration/misbranded)

A

Both

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24
Q

An expired drug product in a manufacturer’s bottle is considered (adulteration/misbranded)

A

Adulteration

But if it’s used to fill, it’s also misbranding

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25
Q

What warning is put in place for aspartame?

A

PKU: contains phenylalanine ___ mg per ____

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26
Q

What warning is put into place for mineral oil?

A

Take only at bedtime and not to be used in infants (unless seen by physician)
Can not encourage use during pregnancy

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27
Q

What warning is put into place for wintergreen oil?

A

Any drug containing >5% of methyl salicylate should be kept away from kiddos

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28
Q

What warning is put into place for sodium phosphates?

A

Limits the amount to no more than 90mL / container + specific warnings

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29
Q

What warnings are put into place for potassium salts for oral ingestions?

A

Warnings of small bowel lesions in combination with thiazides

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30
Q

What warning is put into place for Ipecac syrup?

A

Red and boxed: “For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room”

Keep out of children + dont use in unconscious persons

Usual dosage is 15mL

Sold only in 30mL containers

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31
Q

What warning is put into place for salicyclates?

A

Retail containers of 1 and 1/4 grain pediatric aspirin cannot be sold in containers more than 36 tablets + warnings against Reye’s syndrome

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32
Q

What warning is put into place for OTC drugs for minor sore throats?

A

Must state “For the temporary relief of minor sore throats”
+
““Warnings of severe or persistent sore throat is bad, go see physician””

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33
Q

Which OTC drugs are exempted from tamper-evident packaging?

A

Dermatological, dentifrice, insulin, or lozenges

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34
Q

Is an OTC drug was not packaged correctly (EX: tamper-evident packaging is not there for ibuprofen), is that considered adulterated or misbranding?

A

Both

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35
Q

Can a pharmacist repackage an OTC drug in a vial for a lesser amount assuming a patient requests a lesser amount?

A

No, unless they have a prescription for it

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36
Q

What are the FDA drug and device recall classifications?

A

I = serious AE on health or death

II = May cause temporary or reversible AE

III = not likely to cause issues

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37
Q

Rx drug advertising is regulated by the (FDA/FTC)

A

FDA

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38
Q

OTC drug advertising is regulated by the (FDA/FTC)

A

FTC

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39
Q

Hospitalized or institutionalized patients must be provided a patient package insert how often?

A

First administration of drug and every 30 days thereafter

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40
Q

Failing to give a patient their patient package insert caused the drug to be (adulterated/misbranded)

A

Misbranded

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41
Q

On the side effects statement for prescription drugs, it must state “ Call your doctor for medical advice about side effects. You may report side effects to FDA at _________”

A

1-800-FDA-1088

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42
Q

What is the max supply of a isotretinoin (Accutane)? How many refills?

A

30 day supply + no refills

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43
Q

What is the max supply of a thalomid (Thalidomide)? How many refills?

A

28 days + no refills, subsequent dispenses are for 7 days or less on existing prescription

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44
Q

Are prescription drugs required to have an NDC number on the drug’s label?

A

No, but are usually included to facilitate processing of drug data

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45
Q

Should NDC numbers appear on non-drug products like medical devices or dietary supplements?

A

No, its considered misbranding

Medical devices have unique device identifiers (UDIs) instead of NDC

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46
Q

What is the FDA Orange Book?

A

Determines generic equivalency of drugs

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47
Q

What is the FDA Purple Book?

A

Lists biologics that are considered biosimilars

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48
Q

In Texas, biologics that have been designated “interchangable” may be substituted by a pharmacist. Which ones are they?

A

Only one product = Semglee (glargine) -> Lantus

Still requires a prescriber intervention in order though

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49
Q

Who regulates companies that manufacture and repackage medical devices?

A

FDA

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50
Q

Classification of medical devices?

A

Class I = low risk = dental floss

Class II = higher risk = syringes

Class III = highest risk, requires premarket approval = replacement heart valves

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51
Q

Who regulates drugs intended to be used by animals?

A

FDA

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52
Q

The Poison Prevention Packaging Act (PPPA) is administered by whom?

A

Consumer Product Safety Commission (CPSC)

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53
Q

PPPA + fluoride exemptions?

A

Sodium fluoride contains no more than 264mg / package

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54
Q

Who can request all of future prescriptions to be exempt from PPPA?

A

Only the patient

The physician can request a non child resistant container on an individual prescription

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55
Q

If a pharmacy does not comply with PPPA, who are they violating and who enforces them?

A

Violating PPPA -> CPSC enforces them

Also a misbranding violation of FDCA -> FDA enforces

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56
Q

PPPA + nitroglycerin or isosorbide dinitrate exemptions?

A

SL nitroglycerin regardless

<10mg isosorbide dinitrate

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57
Q

PPPA + Erythromycin granules for suspension exemptions?

A

Package contains <8g

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58
Q

PPPA + erythromycin tablet exemptions?

A

Package contains no more than 16g

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59
Q

PPPA + prednisone exemptions?

A

No more than 105mg / package

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60
Q

PPPA + methylprednisolone exemptions?

A

Contains no more than 84mg / package

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61
Q

Pharmacy services at LTCF in regards to Centers for Medicare and Medicaid Services, how often should a pharmacist review LTC patients?

A

Every 30 days

62
Q

Pharmacy services at LTCF in regards to Centers for Medicare and Medicaid Services, if a drug is used PRN, drugs are limited to how many days?

A

14 days

63
Q

Non-controlled drugs can be mailed to the ultimate user, unless it contains what?

A

Alcoholic beverages, poisons, or flammable substances

64
Q

Controlled substances can be mailed as long as they follow these rules:

A

Outer wrapper is free of nature of contents, including name of pharmacy

65
Q

Pharmacies are required to reply to a request of a patient’s PHI info within how many days?

A

15 days per TSBP (30 via HIPAA)

66
Q

HITECH Act, when do covered entities such as pharmacies required to notify individuals of a breach?

A

Within 60 calendar days after breach is discovered

67
Q

HITECH + breaches affecting <500, what’s the process?

A

Covered entities must maintain a log of breaches and notify HHS annually

68
Q

HITECH + breaches affecting >500, what’s the process?

A

Secretary of HHS and local media must be notified in addition to affected individuals within 60 days of discovery

69
Q

Barbiturates (such as PENTObarbital, secobarbital, or amobarbital) are classified as Schedule ___ drugs

A

C2

70
Q

Tylenol#3 is classified as a Schedule ___ drug

A

C3

71
Q

Barbiturates (such as PENTObarbital, secobarbital, or amobarbital) in a SUPPOSITORY form are classified as Schedule ___ drugs

A

C3

72
Q

Ketamine is classified as a Schedule ___ drug

A

C3

73
Q

Anabolic steroids are classified as Schedule ___ drugs

A

C3

74
Q

For difenoxin/atropine to be considered as a C4 drug, how much should it have?

A

No more than 1mg difenoxin and no less than 25mcg of atropine per dosage unit

75
Q

BZD are classified as Schedule ___ drugs

A

C4

76
Q

PHENObarbital are classified as Schedule ___ drugs

A

C4

77
Q

Stimulants such as amphetamine, methamphetamine, methylphenidate are classified as Schedule ___ drugs

A

C2

78
Q

Phenmetrazine is classified as a Schedule ___ drug

A

C2

79
Q

Chlorphentermine is classified as a Schedule ___ drug

A

C3

80
Q

Phendimetrazine is classified as a Schedule ___ drug

A

C3

81
Q

Benzphentamine is classified as a Schedule ___ drug

A

C3

82
Q

Diethylpropion is classified as a Schedule ___ drug

A

C4

83
Q

Phentermine is classified as a Schedule ___ drug

A

C4

84
Q

Soma is classified as a Schedule ___ drug

A

C4

85
Q

Tramadol is classified as a Schedule ___ drug

A

C4

86
Q

Lyrica is classified as a Schedule ___ drug

A

C5

87
Q

Antitussives containing codeine is classified as a Schedule ___ drug

A

C5

88
Q

Antidiarrheal products containing opium is classified as a Schedule ___ drug

A

C5

89
Q

Antisiezure drugs like brivaracetam (Brivact) is classified as a Schedule ___ drug

A

C5

90
Q

Vimpat is classified as a Schedule ___ drug

A

C5

91
Q

Epidiolex (hemp derivative containing no more than 0.3% THC) is classified as a Schedule ___ drug

A

Not controlled, was a C5

92
Q

If a drug manufacturer believes their own drug may not likely be abused, who do they ask?

A

DEA

93
Q

Who is the scheduling authority for controlled substances federally?

A

US Attorney General (head of Department of Justice, which DEA is under)

94
Q

How does the US Attorney General add, delete, or reschedule substances?

A

Must obtain scientific and medical recommendations from FDA

95
Q

Who is the scheduling authority for controlled substances in the state?

A

Commissioner of Texas Department of State Health Services

96
Q

Can the Commissioner of Texas Department of state Health Services override actions by the legislature in terms of rescheduling substances?

A

Nope

97
Q

What is the C5 codeine limit?

A

2mg/mL

98
Q

What is the C3 codeine limit?

A

1.8g/100mL or 90mg/dosage unit

99
Q

What is the C5 dihydrocodeine limit?

A

1mg/mL

100
Q

What is the C3 dihyrdocodeine limit?

A

1.8g/100mL or 90mg/dosage unit

101
Q

What is the Texas C5 opium limit?

A

0.5mg/1mL (stricter than federal C5 limit of 1mg/mL)

102
Q

What is the C3 opium limit?

A

5mg/mL or 25mg/dosage unit

103
Q

What is the C5 morphine limit?

A

There is none, it’s either a C2 or C3

104
Q

What is the C3 morphine limit?

A

0.5mg/mL

105
Q

Pharmacies and practitioners register how often with the DEA in regards to distribution or dispensing of controlled substances?

A

Every 3 years

106
Q

Any straight narcotic like codeine or opium, with no regard to concentration (like mixing it with water or simple syrup) is always a schedule ____ drug

A

C2

107
Q

Practioner registrations start with what letters? What is their second letter

A 
First letter:
A
B
F
G - DoD contractors

Second letter:
Last name or first letter of pharmacy’s or hospital’s name

108
Q

Who is a mid-level practioner?

A

Practitioners other than physicians, dentists, veterinarians, or podiatrists

EX: PAs, APRN

109
Q

What registration letter do mid-level practitioners get?

A

M

110
Q

Which DEA form is used for dispensers?

A

Form 224

111
Q

In Texas, can a federal practitioner (PHS, Armed Services, etc.) fill a C2 off base?

A

No, but they can fill for C3-C5

112
Q

What is DEA Form 222 for?

A

Ordering C2 drugs

113
Q

When you fill out a DEA form 222, who do you give the original copy to?

A

Send original form to supplier and you must make a copy in paper or electronic form

114
Q

What is an additional rule Texas has on receiving controlled products from a supplier?

A

To initial and date on the invoice

115
Q

If a supplier can not fill an entire control order, how many days do they have to supply the balance?

A

Within 60 days

116
Q

All controlled substances must be initialed by a pharmacist in Texas, except where?

A

Class C-ASC and Class F pharmacies because the person receiving doesnt have to be a pharmacist

117
Q

A pharmacy does not have to register with the DEA as a distributor of controlled substances if and when…

A

They dont exceed 5% of total quantity dispensed during the 12 month period

118
Q

What class of pharmacies must lock up their controlled substances in a locked storage?

A

Class C + F

119
Q

Which DEA form is utilized in regards to theft or loss of controlled substances? When do you have to submit it?

A

DEA Form 106

Does not to be immediately, some time can be needed to investigate the facts

120
Q

If a theft or loss of controlled substances occurred, who do you contact?

A

DEA (in writing) within 1 business day of discovery + TSBP

121
Q

Which DEA form is used if there is a loss or theft of listed chemicals (like pseudoephedrine)? When is it required to be submitted?

A

DEA Form 107

Within 15 days

122
Q

What drugs have this federal transfer warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”?

A

C2 - C4

Exception: controlled substance` dispensed in a blinded clinical study

123
Q

Destruction of controlled substances uses what DEA form?

A

DEA Form 41

124
Q

Which form is required if a pharmacy wants to transfer a controlled substances to a reverse distributor for destruction?

A

NOT DEA Form 41

C2s -> DEA Form 222

C3-5 -> Invoice

125
Q

A pharmacy or hospital is not required to serve as a collector for controlled substances. What do you do if you receive a controlled package and you were not a collector?

A

Notify DEA within 3 business days

126
Q

When do you do controlled inventories?

A

TSBP requires annual inventory, initial inventory required on first day of pharmacy operation + when a drug is newly scheduled

127
Q

When counting C2-C5 for inventory, are there any special rules in terms of exact counts?

A

C2 only = Count the exact amount

C3-C5 = Estimate, unless there are more than 1,000 tabs or caps

128
Q

In Texas, which class of pharmacies require a perpetual inventory?

A

C2s in a Class C pharmacy

All controlls in remote locate, Class C-ASC, and F

129
Q

When does the PIC have to notarize the inventory count of controlled products?

A

Within 3 days

130
Q

Records of controlled substances must be maintained for how many years?

A

2 years

131
Q

What is the filing system of WRITTEN or VERBAL controlled prescriptions?

A

File 1 = C2
File 2 = C3-5
File 3 = Nonscheduled

132
Q

Central records can NOT contain what?

A

DEA order forms
Rx
Inventories

These are kept at the pharmacy

133
Q

A designated agent can communicate a prescription for which controlled products if an electronic prescription is not required?

A

Just C3-5

134
Q

Can an authorized agent of a prescriber verbally communicate emergency C2 Rx to a pharmacist?

A

Nope

135
Q

Prescriptions for opioid drugs in Texas to treat acute pain may not exceed a ___ day supply

A

10

136
Q

What can a pharmacist NOT change on a controlled substance prescription?

A
  1. Name of patient
  2. Name of drug
  3. Name of Dr.
  4. Date of Rx
137
Q

In an emergency, when does the prescriber have to send a valid electronic prescription for a controlled product?

A

Within 7 days after the verbal order

138
Q

In an emergency, how many days supply can you give the controlled product?

A

There is no limit

139
Q

If a pharmacist is unable to fill the entire quantity of a C2, how many days do you have to fill the remainder?

A

3 days

140
Q

All partial fils on controlled substances for terminally ill and LTCF patients must be completed within ____ days

A

60

141
Q

C3-5 drugs can be refilled how many times and for how long?

A

Refilled up to 5 times or 6 months unless for acute pain

142
Q

Automatic refills are permitted in which controlled products?

A

Only C4 + C5

143
Q

C3-5 drugs may be transferred to another pharmacy how many times?

A

Just once, and only the refills, unless they share an electronic database, then it’s unlimited times

144
Q

Can you transfer a C2 drug?

A

Technically yes, as long as both pharmacies can forward and receive the EPCS using a sharing program

145
Q

Who must utilize PMP? Which drugs are checked?

A

Pharmacists
Practitioners except veterinarians

Check for opioids, BZD, barbiturates, or Soma

146
Q

When is PMP not required to be checked?

A

If patient has cancer, sickle cell, hospice care, or if practitioner/pharmacist cant access PMP making good faith effort

147
Q

Buprenorphine and buprenorphine product combos are considered C-_ drugs

A

C3

148
Q

The “X” code on a practitioner’s DEA number signifies what?

A

If they are a DATA-waived practitioner that can prescribe buprenorphine

If they are just prescribing it for pain, X code is not required

149
Q

How old do you have to be to purchase pseudoephedrine? What else are they required to do to purchase?

A

16 years old

Bring an ID, sign logbook, enter name, address, and date/time of sale

150
Q

Which places have a stricter pseudoephedrine sale (compared to a retail pharmacy)?

A

Mail service and mobile retail vendors “flea markets” = 7.5g/30 days

151
Q

For written prescriptions, how is the quantity supposed to be written as?

A

Quantity is written as a figure and spelled as a word

EX: #20 (twenty)

MPJE 2022 (2 decks)

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