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EXAM > Brand/Generic > Flashcards

Brand/Generic Flashcards

1
Q

Dexedrine, Dextrostat

A

amphetamine

C-II

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2
Q

Amytal

A

amobarbital
sedative/hypnotic
C-II

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3
Q

codeine

A

C-II

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4
Q

Dexmethylphenidate

A

Focalin XR

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5
Q

Adderall

A

Dextroamphetamine and Amphetamine

C-II

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6
Q

Dihydrocodeine

A

C-II

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7
Q

Diphenoxylate

A

C-II

Diphenoxylate is an antidiarrheal medication

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8
Q

Embeda

A

morphine and naltrexone

C-II

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9
Q

Ethylmorphine

A

C-II

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10
Q 
Duragesic
Actiq
Fentora
Subsys
Onsolis
Ionsys
Sublimaze
Lazanda
A

fentanyl

C-II

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11
Q 
Vicodin
Lortab
Norco
Maxidone
Xodol
Zydone
A

hydrocodone and acetaminophen

C-II

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12
Q

Vicoprofen

A

hydrocodone with ibuprofen

C-II

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13
Q

Dilaudid

Exalgo

A

hydromorphone

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14
Q

Glutetimide

A

Glutethimide is a hypnotic sedative used as a safe alternative to barbiturates to treat insomnia.
C-II

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15
Q

Levorphanol

A

narcotic

C-II

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16
Q

Vyvanse

A

Lisdexamfetamine
used to treat ADHD
C-II

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17
Q

Demerol

A

meperidine

C-II

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18
Q

methamphetamine

Schedule?

A

C-II

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19
Q 
Concerta
Ritalin
Daytrana
Metadate CD
Methylin
A

methylphenidate

C-II

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20
Q

opium

A

C-II

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21
Q 
Kadian
Avinza (ER)
MS Contin
Duramorph 
Astramorph
Depodur
Arymo ER
A

morphine

C-II

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22
Q

Oxycontin
Oxyir
Oxyfast
RoxyBond

A

oxycodone

C-II

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23
Q

Combunox

A

oxycodone and ibuprofen

C-II

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24
Q

Opana

Numorphan

A

oxymorphone

C-II

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25
Q

PENtobarbitual

A

C-II

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26
Q

Phencyclidine

Phenmetrazine

A

C-II
Also known as PCP
known hallucinogen

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27
Q

Secobarbital

A

C-II

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28
Q

Percocet
Tyler
Roxicet
Endocet

A

oxycodone/acetaminophen

C-II

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29
Q

Percodan

A

oxycodone/aspirin

C-II

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30
Q

Nucynta

A

tapentadol

C-II

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31
Q

Zohydro ER

A

hydrocodone bitartrate ER capsules

C-II

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32
Q

Remoxy

A

oxycodone SR

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33
Q

Hysingla ER

A

hydrocodone sustained release

C-II

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34
Q

Troxyca ER

A

oxycodone and naltrexone

C-II

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35
Q

Xtampza ER

A

oxycodone

C-II

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36
Q

Vantrela ER

A

hydrocodone

C-II

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37
Q

Apadaz

A

benxhydrodrocodone and APAP

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38
Q

What is OBOT?

A

“Office based opioid treatment”, or “OBOT”, means treatment of opioid addiction utilizing a schedule III, IV or V controlled substance narcotic.

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39
Q

“Extended-release or long-acting opioid analgesic” means an opioid analgesic that:

(1) Has United States food and drug administration approved labeling indicating that it is an extended-release or controlled release formulation;
(2) Is administered via a transdermal route; or
(3) Contains methadone

A

Know

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40
Q

A physician can utilize anabolic steroids, growth hormones, testosterone or its analogs, human chorionic gonadotropin (“HCG”), or other hormones for the purpose of enhancing athletic ability. (T/F)

A

False; this is illegal

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41
Q

Under which 2 circumstances are we permitted to utilize the schedule II controlled substance cocaine hydrochloride?

A

The only time cocaine hydrochloride can be used is for the following 2 medical purposes:

(a) As a topical anesthetic in situations in which it is properly indicated; or
(b) For in-office diagnostic testing for pupillary disorders.

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42
Q

A physician CANNOT a prescribe schedule II controlled substance STIMULANT in any of the following circumstances: select all (3)?

(a) For purposes of weight reduction or control;
(b) When the physician knows or has reason to believe that a recognized contraindication to its use exists; or
(c) In the treatment of a patient who the physician knows or should know is pregnant.
(d) Treatment of narcolepsy
e. ) Treatment of abnormal behavioral syndrome (attention deficit disorder)

A

A, B, C

A physician CANNOT a prescribe schedule II controlled substance stimulant in any of the following circumstances: select all

(a) For purposes of weight reduction or control;
(b) When the physician knows or has reason to believe that a recognized contraindication to its use exists; or
(c) In the treatment of a patient who the physician knows or should know is pregnant.

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43
Q

Prior to utilizing a schedule II controlled substance stimulant for a patient; the physician must complete what 3 assessments on a patient?

A

Before initiating treatment utilizing a schedule II controlled substance stimulant, the physician shall perform all of the following:

(a) Obtain a thorough history;
(b) Perform an appropriate physical examination of the patient; and
(c) Rule out the existence of any recognized contraindications to the use of the controlled substance stimulant to be utilized.

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44
Q

A physician may utilize a schedule II controlled substance stimulant only for one of the following purposes:

A

(a) The treatment of narcolepsy, idiopathic hypersomnia, and hypersomnias due to medical conditions known to cause excessive sleepiness;
(b) The treatment of abnormal behavioral syndrome (attention deficit disorder, hyperkinetic syndrome), and/or related disorders;
(c) The treatment of drug-induced or trauma-induced brain dysfunction;
(d) The differential diagnostic psychiatric evaluation of depression;
(e) The treatment of depression shown to be refractory to other therapeutic modalities, including pharmacologic approaches, such as antidepressants;
(f) As ADJUNCTIVE therapy in the treatment of the following:
(i) Chronic severe pain;
(ii) Closed head injuries;
(iii) Cancer-related fatigue;
(iv) Fatigue experienced during the terminal stages of disease;
(v) Depression experienced during the terminal stages of disease; or
(vi) Intractable pain
(g) The treatment of binge eating disorder.

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45
Q

What is the maximum day supply for adults used to treat acute pain?

A

7 day supply limit

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46
Q

What is the maximum day supply for minors used to treat acute pain?

A

5 day supply limit and WITH a written consent from the parent/guardian

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47
Q

The total morphine equivalent dose (MED) for acute pain cannot exceed what number?

A

CANNOT exceed an average of 30 MED per DAY

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48
Q 
Which 3 things can NEVER be changed on a C-II prescription? (select all) 
A.) Patient's name
B.) Drug form
C.) Prescriber's signature 
D.) Quantity of the drug
E.) Drug prescribed
A

Patient’s name
Prescriber’s signature
Drug prescribed

All 3 can never be changed on a C-II.

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49
Q 
Any changes made to a C-II must only be changed after the pharmacist has spoken to whom? (select all)
A.) Prescriber's agent
B.) Nurse
C.) PA
D.) Prescriber
A

Prescriber himself (D)

Any changes made to a C-II by a pharmD. can only be done after speaking DIRECTLY to the prescriber himself.

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50
Q

Can C-IIs be used for weight reduction? (T/F)

A

False

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51
Q

A patient MUST have A BMI of ___to initiate a controlled substance for weight loss?

A

BMI of 30 to initiate a controlled substance for weight loss; or BMI of 27 with an existing comorbidity factor such as diabetes, heart disease.

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52
Q

Physicians can prescribe how many days supply of controlled substance for weight reduction?

A

30 day supply only
The physician shall meet face-to-face with the patient for the initial visit and at least every 30 days during the first 3 months of treatment.

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53
Q 
Package inserts for weight reduction medications describe duration of use as a "few weeks", how long is this?
A.) 8 weeks
B.) 12 weeks
C.) 15 weeks
D.) 5 weeks
A

B.) 12 weeks of therapy

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54
Q 
A patient may restart a weight reduction program with a CS how many months after the last date a short-term CS was taken for weight reduction?
A.) 1 year
B.) 3 months
C.) 2 years
D.) 6 months
A

D.) 6 months

Example: patient takes Adipex-P for 12 weeks; start date July 1, 2018.
The patient CANNOT start another CS for weight reduction until January 1, 2019.

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55
Q

What is the generic of Qsymia?

A

Qsymia (Phentermine / Topiramate)

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56
Q

What is the generic of Belviq?

A

Belviq (lorcaserin)

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57
Q

What is the generic of Qsymia?

A

Qsymia (Phentermine / Topiramate)

58
Q

However, the physician may resume utilizing a controlled substance short term anorexiant following an interruption of treatment of more than 7 days if the interruption? Select all (3)

(a) Illness of or injury to the patient justifying a temporary cessation of treatment; or
(b) Unavailability of the physician; or
(c) Unavailability of the patient, if the patient has notified the physician of the cause of the patient’s unavailability.
(d) Failure to meet face-to-face with the physicican

A

a, b, c

59
Q 
Which of the following are controlled substances used for weight reduction? (Select all)
A.) Saxenda 
B.) Contrave
C.) Belviq
D.) Qsymia
A

C, D

Belviq, Qsymia are the CS used for weight reduction.

60
Q

Under which 2 conditions; can a physician discontinue utilizing any controlled substance anorexiant immediately upon ascertaining or having reason to believe (2):

(a) That the patient has repeatedly failed to comply with the physician’s treatment recommendations
(b) That the patient is losing weight faster than expected
(c) That the patient is pregnant
(d) That the patient is has had a 5 day treatment interruption

A

(a) That the patient has repeatedly failed to comply with the physician’s treatment recommendations; or
(c) That the patient is pregnant.

61
Q 
Belviq is which schedule?
A.) C-II
B.) C-III
C.) IV
D.) V
A

Belviq (lorcaserin) is C-IV.

62
Q 
Qsymia (Phentermine / Topiramate) is which schedule?
A.) C-II
B.) C-III
C.) IV
D.) V
A

Qsymia (Phentermine / Topiramate) is C-IV.

63
Q 
Which 2 weight reduction medications are not controlled  (2)?
A.) Saxenda 
B.) Contrave
C.) Belviq
D.) Qsymia
A

A, B
Saxenda (liraglutide)
Contrave (naltrexone/bupropion)

64
Q

Can physician obtain a schedule V controlled substance for personal use? (T/F)

A

True

just like everyone else can

65
Q

A physician may never have such a relationship with himself or herself. (T/F)

A

True

66
Q

Which of the following regarding federal and/or state pharmacy law is true?

A. When federal law and state law conflict, the federal law should always be followed.
B. When federal law and state law conflict, state law should always be followed.
C. When federal law and state law conflict, the more strict law should be followed.
D. State laws must never conflict with federal laws, and vice versa.

A

✓C. When federal law and state law conflict, the MORE strict law should be followed.

67
Q

Which of the following regarding federal and/or state pharmacy law is true?

A. The Ohio Revised Code is made up of rules set forth by the Ohio State Board of Pharmacy
B. The Ohio Administrative Code consists partly of rules set forth by the Ohio State Board of Pharmacy in response to laws passed by the Ohio state legislature.
C. Pharmacy practice laws in states other than Ohio are exactly the same as pharmacy practice laws in Ohio.
D. The DEA Pharmacist’s Manual consists of guidances to pharmacists regarding the filling, filing, and dispensing of non-controlled substances.

A

B. The Ohio Administrative Code consists partly of rules set forth by the Ohio State Board of Pharmacy in response to laws passed by the Ohio state legislature.

68
Q

The FDA Modernization Act change the labeling requirement for prescription drugs (legend drugs), authorizing the use of the “Rx Only” symbol. Prior to the passage of this Act in 1997, the label read as which of the following:

A. Caution: Federal law prohibits the transfer of this prescription to anyone other than the person for whom it was prescribed.
B. Caution: Federal law prohibits dispensing without a prescription.
C. Caution: Federal law restricts this device to sale by or on the order of a physician or a properly licensed practitioner.
D. Only a licensed physician can advise you on the use of this drug.

A

✓B. Caution: Federal law prohibits dispensing without a prescription.

69
Q

The Food, Drug and Cosmetic Act defines the term drug as an article listed in official compendia. Which of the following is NOT one of the recognized compendia listed in this definition? Select all that apply.

A. Homeopathic Pharmacopeia of the United States
B. National Formulary
C. Tyler’s Honest Herbal
D. Any supplement to any of the official compendia

A

✓C. Tyler’s Honest Herbal

70
Q

A drug manufacturer has accidentally left off the drug’s quantity from the label. Using such a label would render the drug product:

A. adulterated
B. counterfeit
C. dangerous
D. misbranded

A

D.) Misbranded

Anything with a label
Misbranded think of being “outside the bottle”

71
Q

A drug packed under unsanitary conditions is said to be:

A. adulterated
B. counterfeit
C. dangerous
D. misbranded

A

A.) Adulterated

Adulterated think “dirty”
Adulterated think “inside the bottle”

72
Q

If a Patient Package Insert is not included in the labeling of a designated drug, under federal law the drug is said to be:

A. adulterated
B. counterfeit
C. dangerous
D. misbranded
E. Unlabeled
A

D.) Misbranded

73
Q

If a drug and its container are so made, formed or filled as to be misleading, the drug is deemed to be:

A. adulterated
B. counterfeit
C. dangerous
D. misbranded

A

D.) Misbranded

Misbranded think “outside the bottle”

74
Q

According to the Food Drug and Cosmetic Act, if a “…listed drug is marketed, sold, or distributed directly or indirectly to a retail class of trade under a different labeling, packaging, product code, labeler code, trade name or trademark than the listed drug,” it is a (an):

A. approved drug product
B. authorized generic drug
C. brand name drug
D. therapeutic equivalent

A

B. authorized generic drug

75
Q

A generic drug must have all the following: select all (3)?

A.) identical active ingredients
B.) identical inactive ingredients
C.) meets either the identical or its own respective compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times, and/or dissolution rates.
D.) it has not been listed by the FDA as having proven bioequivalence problems

A

A, C, D

A generic drug does not need to have the same inactive ingredients.

76
Q

According to FEDERAL law, which of the following is NOT required on a written prescription for a controlled substance?

A. Patient's full name
B. Patient's address
C. Prescriber's telephone number
D. Quantity of drug prescribed
E. Dosage form
A

✓C. Prescriber’s telephone number

77
Q

Which of the following people may issue a prescription for a C-II controlled substance?

A. A physician authorized by state law to prescribe controlled substances
B. A physician’s assistant working in a federal prison
C. A veterinarian registered with the DEA
D. All of the above
E. A&C only

A

✓D. All of the above.

78
Q

What is the federal requirement for the time period required for storage of prescriptions and most pharmacy records?

A. 1 year
B. 2 years
C. 3 years
D. 6 years

A

B. 2 years

79
Q

Which of the following statements is true?

A. If the expiration date on a manufacturer stock bottle is marked as “January 2020”, the product may only be used through January 1st, 2020.
B. A physician may require that a pharmacist provide EZ open closures for all of her patients using a blanket waiver.
C. Child resistant closures must be used for all hospitalized patients.
D. Sulbingual and chewable isosorbide dinitrate 5 mg tablets may be dispensed with non-child resistant closures (EZ off caps) without asking the patient for a waiver.

A

✓D. Sulbingual and chewable isosorbide dinitrate 5 mg tablets may be dispensed with non-child resistant closures (EZ off caps) without asking the patient for a waiver.

80
Q

What does REMS stand for?

A

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

81
Q

Which of the following statements is true regarding MedGuides and PPI’s?

A. Medication guides are FDA approved and must be dispensed with new and refilled prescription medications that cause a serious and significant health concern
B. Patient Package Inserts (PPI’s) must be dispensed with all new and refilled prescription products that contain estrogen.
C. In a hospital, pharmacists must dispense a PPI for diethylstilbesterol prior to the first dose and every 30 days.
D. All of the above are true

A

✓D. All of the above are true

82
Q

Which of the following statements regarding REMS is true?

A. REMS stands for Required Elements of Medication Safety
B. IPledge is a REMS program for the medication clozapine
C. The REMS program was put in place to ensure that the benefits of using a medication outweighs its risks.
D. All of the above are true.

A

✓C. The REMS program was put in place to ensure that the benefits of using a medication outweighs its risks.

83
Q

Which of the following statements is a narrow therapeutic index drug? Select all that apply.

A. Levothyroxine
B. Warfarin
C. Phenobarbital
D. Digoxin

A

✓A. Levothyroxine
✓B. Warfarin
C. Phenobarbital
✓D. Digoxin

84
Q

Which of the following would be a generically substituable drug? Choose the best answer.

A. One that is lower in cost with a therapeutically similar active ingredient
B. Only one that has identical active and inactive ingredients, made by a different manufacturer.
C. One that is both pharmacutically equivalent and bioequivalent.
D. One that is B rated

A

✓C. One that is both pharmacutically equivalent and bioequivalent.

85
Q

Which of the following is true regarding selecting a substitutable drug using the Orange Book? Select all that apply.

A. The RLD is the drug which is the proprietary name drug to which generics are compared.
B. A medication that is AB2 rated may be substituted for a drug that is AB3 rated
C. An “AB” rated drug may be substituted for a reference listed drug, as long as the strength is the same.
D. Digoxin is not required to be listed the Orange Book.

A

✓A. The RLD is the drug which is the proprietary name drug to which generics are compared.
B. A medication that is AB2 rated may be substituted for a drug that is AB3 rated
✓C. An “AB” rated drug may be substituted for a reference listed drug, as long as the strength is the same.
✓D. Digoxin is not required to be listed the Orange Book.

“AB:” actual or potential bioequivalence problems have been resolved through adequate in vivo and/or in vitro testing. Often some therapeutic codes are followed by a number, such as AB1, AB2, AB3 etc. This is particularly when there are two or more drug products, containing the same ingredient, with the same strength and dosage form, which are not bioequivalent to each other. For example, a generic rated AB1 can be substituted for a brand rated AB1, but cannot be substituted for a brand rated AB2.

86
Q

Which of the following is/are true? Select all that apply.

A. Controlled substances may be mailed using the United States Postal Service (USPS) as long as the outside of the package is clearly labeled regarding the contents of the package.
B. A List II chemical is anything other than a List I chemical used to manufacture a controlled substance in violation of the Controlled Substances Act.
C. A drug that has left the pharmacy with a patient may be returned if it is unopened.
D. A patient who is hospitalized must receive a patient package insert for any product containing estrogent on the first day and every 30 days if the patient is still hospitalized.

A

✓B. A List II chemical is anything other than a List I chemical used to manufacture a controlled substance in violation of the Controlled Substances Act.

✓D. A patient who is hospitalized must receive a patient package insert for any product containing estrogen on the first day and every 30 days if the patient is still hospitalized.

87
Q

Which of the following regarding registration is/are true? Select all that apply.

(A.) To possess or participate in activities with controlled substances, researchers, manufacturers, wholesale distributors and pharmacies must be registered with the DEA

(B.) Application for registration of a pharmacy with the DEA must be completed using a DEA Form 225

(C.) Renewal applications for registration end with an “A”

(D.) Registrations are valid for 36 months.

A

✓A. To possess or participate in activities with controlled substances, researchers, manufacturers, wholesale distributors and pharmacies must be registered with the DEA
✓C. Renewal applications for registration end with an “A”
Original registration for DEA license is Form 224
DEA re-registration form after you file after 3 years is Form 224a
✓D. Registrations are valid for 36 months (3 years)

88
Q

Which one of the following is considered a C-III substance and why?
A.) Fiorinal
B.) Fioricet

A 
Fiorinal is a scheduled class III substance. 
Fioricet has a non-scheduled status.

Fioricet contains:
325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.

New capsule reformulation of Fioricet contains:
300 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.

Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.

The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet.

89
Q

Which of the following regarding DEA schedules is/are true? Select all that apply.

A. The DEA schedule of a drug must be easily visible on its label without removing it from the shelf.
B. Schedule III medications have a lower potential for abuse relative to drugs in C-I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence.
C. C-V drugs include buprenophine and phentermine (know medications in textbook for all schedules)
D. Exempt substances include Librax and Fioricet (see slide)

A

✓A. The DEA schedule of a drug must be easily visible on its label without removing it from the shelf.
✓B. Schedule III medications have a lower potential for abuse relative to drugs in C-I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence.
✓D. Exempt substances include Librax and Fioricet (see slide)

Librax (chlordiazepoxide and clidinium) used to treat irritable bowel syndrome is NOT a controlled substance.

90
Q

Which of the following drugs must be ordered on a separate DEA Form 222 (i.e., may not be ordered on the same form as other C-II medications)? Select all that apply.

A. Ecognine
B. Etorphine hydrochloride
C. Buprenorphine
D. Carfentanil
E. Diprenorphine
A 
A. Ecognine ( this is not even a drug) 
✓B. Etorphine hydrochloride
C. Buprenorphine (not a controlled substance) 
✓D. Carfentanil
✓E. Diprenorphine

A separate DEA Form 222 or an electronic order must be submitted when ordering:

  1. ) Thiafentanil
  2. ) Carfentanil
  3. ) Etorphine hydrochloride,
  4. ) Diprenorphine

Usually used for animals, these are VERY potent drugs so must be ordered on a SEPARATE DEA FORM 222.

91
Q

On Saturday, a patient presents you the second of three prescriptions that were issued as multiple prescriptions for a schedule II controlled substance. The patient says that she wants to fill the prescription on Saturday because the “do not fill by” date on the prescription is the next day, which is a Sunday, and your pharmacy is not open on Sunday. Because your pharmacy is closed on Sunday, the applicable DEA regulation allows you to dispense the prescription on Saturday prior to the “do not fill by” date. Is this statement TRUE or FALSE

A

False

Prescription CANNOT be filled until the “do not fill date”.

92
Q

Which of the following drugs is/are C-IV controlled substance? Select all that apply

A. codeine
B. phendimetrazine
C. Phentermine
D. Eszopiclone
E. Promethazine with codeine
A 
A. codeine (C-II)
B. phendimetrazine (C-III) 
✓C. Phentermine (Adipex-P) 
✓D. Eszopiclone (Lunesta) 
E. Promethazine with codeine (C-V)
93
Q

Which of the following drugs requires the use of a DEA Form 222 when purchasing? Select all that apply.

A. Amobarbital
B. Dronabinol
C. Ketamine
D. Oxymorphone
E. Testosterone
A 
✓A. Amobarbital
B. Dronabinol
C. Ketamine
✓D. Oxymorphone
E. Testosterone
94
Q

An electronic order for meperidine, alprzolam and levorphanol maynotbe filled if which of the following is true?

A. The required data fields are not completed.
B. The order is not signed using a digital certificate issued by the DEA.
C. The digital certificate used has expired or has been revoked prior to signature.
D. The validation of the order shows that the order is invalid
E. All of the above

A

✓E. All of the above

95
Q

Who may request drug samples?

A. Drug manufacturers
B. Research facilities
C. Indigent care facilities
D. Anyone with a DEA number
E. A practitioner licensed to prescribe
A

✓E. A practitioner licensed to prescribe

96
Q 
The label on a sample distributed must have what 3 components on it: 
A.) Dosage
B.) Patient name
C.) Name of the prescriber
D.) Direction for use
E.) Quantity
A

A.) Patient Name
B.) Name of prescriber
C.) Directions of use

97
Q

A physician writes a prescription for 100 tablets of oxymorphone 5 mg. She notes on the prescription that the patient is terminally ill. How long does the pharmacist have to dispense in partial quantities up to the 100 tablets ordered?

A. The pharmacist must dispense all of the tablets at once.
B. The pharmacist must complete the dispensing within 72 hours.
C. The pharmacist may partially fill the prescription for 30 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed).
D. The pharmacist may partially fill the prescription for 60 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed).
E. The pharmacist may partially fill the prescription for 90 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed).

A

D. The pharmacist may partially fill the prescription for 60 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed).

98
Q

Dr. Carrie White is a neurologist treating attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) patients. Among her treatments for these patients, she prescribes Ritalin, Concerta, and Adderall. Her general policy is that patients using these medications must be seen in her office every 3 months for evaluation. Because most of her patients prefer to obtain their prescriptions locally and third-party prescription drug plans will reimburse only for a 30-day supply, Dr. Wilson is forced to issue three prescriptions to provide adequate medication between office visits. According to the applicable DEA regulation on issuing multiple prescriptions for a schedule II controlled substance, for how many total days’ supply of a schedule II controlled substance may Dr. Wilson issue multiple prescriptions to a patient?

A. 30
B. 60
C. 90
D. 120

A

✓C. 90

On an outpatient basis, the law PROHIBITS dispensing more than a 90-day supply limit of a C-II.

99
Q

A patient has a prescription for 20 tablets of alprazolam 1 mg, 1 tid prn for anxiety, with 5 refills. She wants to pick up 10 tablets every week. Which of the following statements is correct? The applicable section of the DEA Pharmacist’s Manual is Section X.

A. The patient will receive a total of only 60 tablets (10 at the first filling, plus 10 more at each subsequent refill).
✓B. The patient will receive 10 tablets a week up to the 120 tablets originally prescribed if no dispensing occurs beyond 6 months from the date on which the prescription was issued
C. The patient may receive only 5 refills, and she must receive 20 tablets each time.
D. The patient may refill this prescription only once per month.
E. The prescription may only be partially filled 5 times.

A

✓B. The patient will receive 10 tablets a week up to the 120 tablets originally prescribed if no dispensing occurs beyond 6 months from the date on which the prescription was issued

Remember to always calculate the total dose over the next 6 months.
20 tabs for initial fill
100 for the next 5 refills
=total of 120 tabs

100
Q

You receive a facsimile (faxed) prescription from a practitioner authorizing refills for diphenoxylate with atropine. The facsimile has no signature but has been marked “OK” by the receptionist. Can you legally dispense from this facsimile.

A. YES
B. NO

A

NO

101
Q

You receive a facsimile (faxed) prescription from a practitioner authorizing refills for diphenoxylate with atropine. The facsimile has no signature but has been marked “OK” by the receptionist. Can you legally dispense from this facsimile.

A. YES
B. NO

A

NO

diphenoxylate is a C-II.

102
Q

Which statement is true regarding DEA Form 222?

A. The supplier receives the blue and green copy and the supplier sends the green copy back to the pharmacy
B. The ordering pharmacy keeps the top copy and sends the other two copies to the DEA
C. The pharmacy keeps the 3rd copy and sends the first two copies to the supplier; the supplier sends the top copy to the DEA
✓D. The pharmacy keeps the 3rd copy and sends the first two copies to the supplier; the supplier sends the middle copy to the DEA

A

✓D. The pharmacy keeps the 3rd copy and sends the first two copies to the supplier; the supplier sends the middle copy to the DEA

Top(blue copy): supplier
Middle (green copy): DEA
Bottom (brown copy): pharmacy

Note that the DEA has recently changed the DEA222 forms; they no longer have carbon copies. The old forms may be used until they are used up. When pharmacies order new DEA 222 forms they are only one copy; the pharmacy makes copies and sends them.

103
Q

In which of the following cases may a pharmacist fill and file a faxed prescriptions and treat the fax as an original prescription? Select all that apply.

A. In order to get a meperidine prescription ready to expedite it for the patient
B. When the prescription is for a compounded morphine drip for IV administration
C. When the prescription is for levorphanol for a patient in a nursing home
D. When the prescription is for tapentadol for a patient in a licensed hospice care program

A

✓B. When the prescription is for a compounded morphine drip for IV administration
✓C. When the prescription is for levorphanol for a patient in a nursing home
✓D. When the prescription is for tapentadol for a patient in a licensed hospice care program

104
Q

You receive a prescription signed by a hospital resident who is working at Mercy Hospital. The resident previously had a DEA number with a suffix assigned at St. Luke’s Hospital, but he is no longer working there. He has a new DEA number with suffix at Mercy Hospital and forgot to use it, and instead he used the St. Luke’s DEA number on the prescription containing the Mercy Heading. Is the pharmacist permitted to fill this prescription?

A. Yes, if state law permits it and the pharmacist speaks directly with the prescriber
B. No, federal law does not permit the pharmacist to change a DEA #

A

✓A. Yes, if state law permits it and the pharmacist speaks directly with the prescriber

105
Q

Which of the following must be done if an emergency prescription for generic Vicodin is called in to a pharmacy?

A. Pharmacist must immediately reduce the prescription to writing and include all information required on a C-II prescription
B. If the pharmacist does not know the prescriber, the pharmacist should determine the legitimacy of the prescription by calling the prescriber back using a phone number obtained from a telephone directory
C. The pharmacist should match up a “cover” prescription; a mailed cover prescriptions must be postmarked within 7 days.
D. Notify the DEA if no cover prescription is received from the prescriber
E. All of the above
F. C and d only

A

E. All of the above

106
Q

A pharmacist began receiving an increased number of prescriptions, all written by the same prescriber, for large quantities of controlled substances. Many of the prescriptions were written for the same four drugs, oxycodone 80 mg q8h #90; oxycodone with acetaminophen 10/325 1 or 2 q4h prn #120; alprazolam 1 mg tid #90; and carisoprodol 200 mg 1 tid #90. The diagnosis code was the same for all of these prescriptions. Several patients per day were coming in with these same four prescriptions. When the pharmacist first began receiving these prescriptions, he called the prescriber to confirm their validity, and the prescriber assured the pharmacist that the prescriptions were for legitimate medical purposes. Over a 6 month period as a result of these prescriptions, pharmacist dispensed more than 5,000 prescriptions for more than 500,000 dosage units of controlled substances. A DEA investigation showed that these prescriptions were false and fraudulent. Is this pharmacist guilty of violating the Controlled Substance Act?

A. Yes, the pharmacist should have known that the prescriptions lacked a legitimate medical purpose.
B. No, the pharmacist completely satisfied his legal obligations when he called the prescriber the very first time, to confirm the validity of prescriptions coming from that office

A

✓A. Yes, the pharmacist should have known that the prescriptions lacked a legitimate medical purpose.

107
Q 
Which of the following is an authentic DEA number for a physician's assistant named Julie Campbell?

A. BJ4459877
B. MC4459877
C. MJ4459878
D. BC4459877
A

✓B. MC4459877

108
Q 
A suppository dosage form of secobarbital is likely to be classified under which of the following controlled substance categories (schedules)?

A. C-I
B. C-II
C. C-III
D. C-IV
E. C-V
A

✓C. C-III

Any suppository dosage form containing amobarbital, secobarbital, pentobarbital is C-III.

109
Q

The Poison Prevention Packaging Act is basically under the jurisdiction of the (select the correct answer)

A. Consumer Product Safety Commission
B. Federal Trade Commission
C. FDA
D. Health Care Financing Administration (HCFA)

A

✓A. Consumer Product Safety Commission

110
Q

A regular patient of yours has a bad cough. Your state law permits a non-prescription sale of 120 mL cough syrup containing codeine. You sold him a bottle a week ago. After purchasing 120 mL, how many hours does he need to wait before he can get another 4 oz bottle?

A. 24
B. 36
C. 48
D. 72

A

✓C. 48 HOURS

111
Q

The Combat Methamphetamine Act (CMEA) places limits on the sale of OTC pseudoephedrine, ephedrine, and phenylpropanolamine. Which of the following statements is true?

A. Purchases are limited to 3.6 grams per day, or 9 grams per 30 day period.
B. Purchases are limited to 3.6 grams per sale, or 9 grams per month.
C. Purchases are limited to 3.6 grams per day, or 9 grams per 7 day period.
D. Purchases for pseudoephedrine are limited to 3.6 gram/day, for epehdrine 4.2 gram/day and phenylpropanolamine 6.3 gram/day.

A

✓A. Purchases are limited to 3.6 grams per day, or 9 grams per 30 day period.

112
Q

Who regulates single ingredient pseudoephedrine products?

State or federal?

A

State law regulates single ingredient pseudoephedrine products

113
Q

Who regulates any product containing pseudoephedrine including liquid (combination products)?
State or federal law

A

Federal law

114
Q

Who regulates any product containing pseudoephedrine including liquid (combination products)?
State or federal law

A

Federal law

Pseudoephedrine is a drug found in both prescription and OTC products used to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratory allergies.
Ephedrine is similar in structure to the synthetic derivatives amphetamine and methamphetamine. It is commonly used as a stimulant, appetite suppressant, concentration aid, and decongestant.

Phenylpropanolamine is an ingredient used in prescription and OTC drug products as a nasal decongestant and in OTC weight control drug products.

These ingredients are commonly used to make methamphetamine.

115
Q

Under federal law, the daily sales limit of ephedrine base, pseudoephedrine base, or phenylpropanolamine base is _____ grams per purchaser, regardless of the number of transactions.

A. 1.8
B. 3.6
C. 7.2
D. 9.0

A

✓B. 3.6 grams PER DAY

116
Q

A pharmacist receives a prescription for 90 tablets of methylphenidate. After checking inventory, he sees that there are only 10 methylphenidate in stock. A shipment is expected the next day, which will restock the supply of this drug. What is the preferred course of action? Select the best answer.

A. Send the patient to another pharmacy because partial fills are not permitted with this drug.
B. With the patient’s permission, partially fill the prescription, complete the remainder within 72 hours, and ask the patient to return for the unfilled portion of the prescription.
C. With the patient’s permission,partially fill the prescription and tell the patient to return within 7 days for the unfilled portion of the prescription.
D. Substitute a B rated drug to fill the prescription in its entirety.

A

✓B. With the patient’s permission, partially fill the prescription, complete the remainder within 72 hours, and ask the patient to return for the unfilled portion of the prescription.

Remember, out of stock; you have 72 hours to fill the rest.

117
Q

Which of the following statements about child-resistant closures are true?

A. A prescription for sublingual nitroglycerin does not require a child-resistant closure.
B. Methylprednisolone in tablet form may be dispensed in a package that is not child-resistant if it does not contain more than 84 mg of the drug.
C. Conjugated estrogens may be dispensed in mnemonic packages that are not child-resistant if they do not contain more than 32 mg of the drug.
D. A vial containing 5 mg of chewable isosorbide dinitrate tablets does not require child-resistant packaging
E. All of the above

A

✓E. All of the above

118
Q

A 40-year-old woman, has severe rheumatoid arthritis in her hands. She tells his physician that she doesn’t always take her medicine because she can’t open the medication bottles. What is the most efficient and legally effective way of resolving this problem for all future prescriptions?

A. The patient needs to sign a blanket waiver at the pharmacy asking for easy-to-open lids on all prescription vials and ovals.
B. The physician may request a blanket waiver that must be honored by the pharmacist.
C. The physician must phone or write to the pharmacist to state that this patient should not have child-resistant closures on any of her prescriptions.
D. The physician should include directions on the current prescription that this prescription should not be dispensed with a child resistant closure, and the pharmacist must honor those directions.
E. All of the above
F. A and D only

A

✓F. A and D only

119
Q

What is DEA Form 41?

A

DISPOSAL/destruction of controlled substances

120
Q

What is DEA Form 104?

A

Used to surrender controlled substances/permit on a voluntary basis. Usually used to close a pharmacy.

121
Q

What is DEA Form 106?

A

Used to report the THEFT or LOST of controlled substances.

122
Q

What is DEA Form 222?

A

Order form for Schedule I and II drugs.

123
Q

What is DEA Form 222a used for?

A

Used to OBTAIN DEA Forms 222 from the DEA. (the actual physical form)

124
Q

What is DEA Form 224 used for?

A

ORIGINAL REGISTRATION for a DEA license for retail pharmacies, hospitals, clinics, practitioners and teaching institutions.

125
Q

What is DEA Form 224a used for?

A

DEA RE-REGISTRATION FORM.

This must be done every 3 years.

126
Q

What is DEA Form 225 used for?

A

license to MANUFACTURE controlled substances

127
Q

What is DEA Form 363 used for?

A

Used for registration for narcotic treatment programs.

128
Q

What is DEA Form 510 used for?

A

Form to register as a CHEMICAL manufacturer, distributor, importer, or exporter (for List 1 chemicals; SLCPs like Sudafed).
NOT required if you are already a pharmacy registered to handle controlled substances

129
Q

DEA Form 82?

A

Notice of INSPECTION - used to inform a registrant that an inspection will be made

130
Q

A patient with rheumatoid arthritis tells her nurse practitioner that she does not want child-resistant packaging. Which of the following statements is true?

A. The pharmacist can decide not to use child-resistant packaging when he sees the patient’s swollen hands.
B. The nurse practitioner can request lids that are easier to open, but only on a prescription by prescription basis.
C. The patient may ask that all future prescriptions be dispensed in packages that are easier to open
D. All of the above
E. B and C only

A

✓E. B and C only

131
Q

A pharmacist agrees to accept a telephone emergency prescription for hydrocodone with acetaminophen 5/235. According to federal law, the maximum quantity of the medication allowed for this dispensing is only:

A. enough for 24 hours
B. enough for 48 hours
C. enough for 72 hours
D. enough to treat the emergency period

A

D. enough to treat the emergency period

132
Q 
You break 3 ampules of morphine sulfate. You clean the area and dispose of the glass and any recoverable controlled substance according to DEA requirements. When the disposal occurs, which form should you use to report this event?
A. DEA Form 41
B. DEA Form 106
C. DEA Form 222
D. DEA Form 510
E. DEA Form 666
A

A. DEA Form 41

133
Q

A physician in a same-day surgery center wants to have morphine on hand in her office. How may she get that morphine from your pharmacy?

A. The physician may order it on DEA Form 222, issued by the surgery center.
B. Your pharmacy may order it on DEA Form 222, issued by the pharmacy.
C. The physician may write a prescription “for office use.”
D. The physician may write a prescription using the name of one of the surgery center’s patients.
E. The physician may send an invoice from the surgery center to the pharmacy.

A

A. The physician may order it on DEA Form 222, issued by the surgery center.

134
Q

Under HIPAA, a pharmacist must provide a patient with the “Notice of Privacy Practices” at what point in time?
A. For each new prescription presented by the patient.
B. The day the pharmacy first provides service to the patient.
C. For each new and refill prescription presented by the patient
D. Every two years
E. Every six years

A

B. The day the pharmacy first provides service to the patient.

Specific requirements for certain covered health care providers. A covered health care provider that has a direct treatment relationship with an individual must:

(1. ) Provide the notice
(2. ) No later than the date of the first service delivery, including service delivered electronically, to such individual after the compliance date for the covered health care provider; or(B) In an emergency treatment situation.

135
Q

Which of the following statements is an accurate statement of federal law regarding prescription labeling requirements for a schedule II drug prescribed for an institutionalized patient? Choose the best answer.
A. Prescription labeling requirements apply to the same extent as they apply to a noninstitutionalized patient.
B. Prescription labeling requirements do not apply as long as the patient is institutionalized.
C. Prescription labeling requirements do not apply providing that no more than a 21-day supply is dispensed at one time and the drug is never in the possession of the ultimate user.
D. Prescription labeling requirements do not apply providing no more than a 7-day supply is dispensed at one time and the drug is never in the possession of the ultimate user.

A

D. Prescription labeling requirements do not apply providing no more than a 7-day supply is dispensed at one time and the drug is never in the possession of the ultimate user.

136
Q

Labeling requirements do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is INSTITUTIONALIZED, provided that:

(1) NOT more than 7-day supply of the controlled substance is dispensed at ONE time
(2) The controlled substance is Not in the Possession of the Ultimate User prior to the administration
(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II
(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

A

know

137
Q 
What is the term applied to all written, printed, or graphic matter accompanying any drug article? 
A. Drug label
B. Labeling
C. Medication guide
D. Packaging
E. Patient information
A

B.) Labeling

138
Q

Schedule II controlled substances may be ordered electronically if the pharmacy fills out a paper DEA Form 222 and files that paper with other controlled substances records.
A. True
B. False

A

B. False

Explanation: The statement is false. Any pharmacy permitted to order schedule II controlled substances may do so electronically via the DEA Controlled Substance Ordering System, which allows for secure electronic transmission of controlled substance orders without the supporting paper forms. Requiring a paper copy of the form to be filed would defeat the purpose of electronic ordering.

139
Q

Pharmacist needs to order a number of different medications, including controlled substances listed in Schedules II, III, IV, and V, as well as non-controlled substances. Please choose the most accurate statement that reflects Pharmacist’s options.
A. Pharmacist may order all needed medications using the electronic controlled substance ordering system.
B. Pharmacist may order all needed medications using DEA Form 222.
C. Pharmacist may not use any single method to order all of the needed medications.
D. Pharmacist may order all needed medications using the traditional invoice and receipt method.

A

A. Pharmacist may order all needed medications using the electronic controlled substance ordering system.

140
Q

You manage a pharmaceutical warehouse where schedule II controlled substances are sold to pharmacies. You receive a DEA Form 222 from a pharmacy ordering 10 bottles of 100 count oxycodone/acetaminophen 5/325 mg. It is acceptable for you to send 1 bottle of 1,000 count of the same drug and strength.
A. True
B. False

A

True

141
Q

For a retail pharmacy to transmit a prescription electronically to a central fill pharmacy, which of the following must happen?

A. The retail pharmacy must ensure that all information required to be on a prescription is transmitted to the central fill pharmacy.
B. The retail pharmacy must write “CENTRAL FILL” on the face of the prescription.
C. The retail pharmacy must maintain the original prescription for a period of 2 years from the date the prescription was last refilled.
D. All of the above
E. None of the above

A

D. All of the above

In addition:

  1. ) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common, or contract carrier) and the name of the retail pharmacy employee accepting delivery;
  2. ) For schedules III-V prescriptions, indicate in the information transmitted the number of refills already dispensed and the number of refills remaining (refills for schedule II prescriptions are not permitted).

EXAM (17 decks)

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