Intro To Pharmacy Law Exam

Front 1

A pharmacist photocopies from the newspaper an article about Drug X. The pharmacist places copies of the article in the bag with Drug X when Drug X is dispensed to patients. This is a value added service the pharmacist provides to patients. Under the FDCA, how would this photocopied article be classified?
a.A package insert.
b.A medication guide.
c.A label.
d.Labeling.
e.Educational material.

Back 1

d.Labeling.

Front 2

1.Under the FDCA, how would a article that is applied to the body, and is intended to diagnose, cure, mitigate or treat a disease through nonchemical means, be classified?
a.Drug.
b.Cosmetic.
c.Dietary supplement.
d.Medical device.
e.Botanical.

Back 2

d.Medical device.

Front 3

A drug is introduced into interstate commerce and everything in the drug packaging is completely truthful and it not misleading in any way. But the manufacturer has failed to make affirmative disclosure requirements known as full disclosure with fair balance. How will this drug be classified under the FDCA?
a.Adulterated.
b.Unapproved.
c.Mislabeled.
d.Misbranded.
e.Counterfeit.

Back 3

d.Misbranded.

Front 4

Off-label use of FDA approved drugs violates the FDCA.
a.True.
b.False.

Back 4

b.False.

Front 5

What is a key concept in the definition of an “addict” under the CSA?
a.High doses.
b.Polypharmacy.
c.Doctor shopping.
d.High functionality.
e.Loss of self-control.

Back 5

e.Loss of self-control.

Front 6

Into what CSA schedule will a drug be placed if it is in the most highly restricted category of the drugs that have an accepted medical use?
a.I.
b.II.
c.III.
d.IV.
e.V.

Back 6

b.II.

Front 7

Under federal law, what schedule of drugs may be refilled without a date or time restriction, as long as the prescription is for a medical purpose?
a.I.
b.II.
c.III.
d.IV.
e.V.

Back 7

e.V.

Front 8

.What factor determines the second letter of the two-letter combination that begins every DEA registration number?
a.Age of the registrant.
b.Geographic location of the registrant.
c.Name of the registrant.
d.Drugs that may be prescribed.
e.Type of practice of the registrant.

Back 8

c.Name of the registrant.

Front 9

A distributor DEA registration number could be expected to begin with which of the following letters?
a.A.
b.D.
c.M.
d.P.
e.X.

Back 9

d.P.

Front 10

For how long must records of controlled substance acquisition and dispersal be retained by a pharmacy, according to DEA regulations?
a.1 year.
b.2 years.
c.5 years.
d.7 years.
e.10 years.

Back 10

b.2 years.

Front 11

If a pharmacist fills a purported prescription, it is a violation of federal law only if the pharmacist did so knowingly.
a.True.
b.False.

Back 11

a.True.

Front 12

Pharmacists do not obtain DEA registrations to dispense controlled substances, but the pharmacy in which they work must be registered with the DEA for its pharmacists to dispense controlled substances.
a.True.
b.False.

Back 12

a.True.

Front 13

1.A C-II prescription may be authorized verbally in an emergency situation, and the prescriber must deliver to the pharmacy a written prescription to cover this emergency dispensing within what period of time under federal law?
a.Immediately.
b.48 hours.
c.72 hours.
d.7 days.
e.10 days.

Back 13

d.7 days.

Front 14

Under federal law, a facsimile of a C-II prescription of a drug prescribed for infusion therapy may serve as the original but only if the drug is a narcotic.
a.True.
b.False.

Back 14

a.True.

Front 15

Under federal law, a facsimile of a C-II prescription of a drug prescribed for a patient who is a resident of a long term care facility may serve as the original but only if the drug is a narcotic.
a.True.
b.False.

Back 15

b.False.

Front 16

Under federal law, a facsimile of a C-II prescription of a drug prescribed for a patient who is enrolled in hospice care may serve as the original but only if the drug is a narcotic.
a.True.
b.False.

Back 16

a.True.

Front 17

Under federal law, a pharmacist who is unable to supply the full quantity of a C-II prescription may dispense a partial supply, and the balance must be dispensed within what period of time, or the balance may not be dispensed at all and the prescriber must be contacted?
a.24 hours.
b.48 hours.
c.72 hours.
d.7 days.
e.21 days.

Back 17

c.72 hours.

Front 18

Under federal law, a C-II prescription for a patient who is a resident of a long-term care facility or who is terminally ill may be partially filled over what period of time?
a.14 days.
b.21 days.
c.30 days.
d.60 days.
e.120 days.

Back 18

d.60 days.

Front 19

Which of the following pieces of information on a C-II prescription may not be changed by the pharmacist even after consulting with the prescriber according to the DEA?
a.Patient’s name.
b.Patient’s address.
c.Drug strength.
d.Drug quantity.
e.Directions for use.

Back 19

a.Patient’s name.

Front 20

1.How many pharmacist members are there of the Florida Board of Pharmacy?
a.11.
b.9.
c.7.
d.5.
e.3.

Back 20

c.7.

Front 21

1.Under Florida pharmacy laws, as what class of institutional pharmacy will a hospital pharmacy be classified?
a.I.
b.II.
c.III.
d.IV.
e.V.

Back 21

b.II.

Front 22

Under Florida law, what words must be written on a prescription by a prescriber to prevent generic substitution?
a.Brand necessary.
b.Do not substitute.
c.No substitution allowed.
d.Dispense as written.
e.Medically necessary.

Back 22

e.Medically necessary.

Front 23

Under Florida law, when a patient has run out of refills on a maintenance medication, the pharmacist may dispense an emergency refill. What is the maximum supply that the pharmacist can dispense pursuant to an emergency refill?
a.24 hours supply.
b.48 hour supply.
c.72 hour supply.
d.7 day supply
e.30 day supply.

Back 23

c.72 hour supply.

Front 24

In Florida, if the prescriber faxes a prescription to a pharmacy, then the fax may serve as the original, subject to any applicable restrictions under federal law.
a.True.
b.False.

Back 24

a.True.

Front 25

A Florida pharmacist must take how many hours of continuing education classes each two year period to maintain the pharmacist’s license?
a.8 hours.
b.15 hours.
c.25 hours.
d.30 hours.
e.60 hours.

Back 25

d.30 hours.

Front 26

A Florida pharmacist can order a very few drugs that are classified as prescription only under federal law. What is the maximum quantity of drugs that a pharmacist can order under this provision of the law?
a.7 days.
b.14 days.
c.21 days.
d.30 days.
e.34 days.

Back 26

e.34 days.

Front 27

If given permission by the Florida Board of Pharmacy to have the maximum number of technicians allowed per pharmacist, how many technicians per pharmacist may a Florida pharmacy have?
a.1.
b.2.
c.3.
d.4.
e.5.

Back 27

c.3.

Front 28

For how many hours per week must a Florida community pharmacy be open?
a.20.
b.40.
c.60.
d.80.
e.100.

Back 28

b.40.

Front 29

What would prevent a community pharmacy to advertise a 20% discount on all prescriptions in a web site that lists all of their drugs?
a. This activity is financially risky
b. WEB advertising is covered under internet pharmacy license
c. Pharmacies may not advertise controlled substances
d. Violates the American Pharmacists Association code of ethics
e. Violation of a community pharmacy license

Back 29

c. Pharmacies may not advertise controlled substances

Front 30

True/False
Any prescription drug that has been returned to a community pharmacy can be re-dispensed.

Back 30

False. cannot be re-dispensed.

Front 31

In order for a Florida pharmacist to have their license renewed by the Florida Department of Health how many hours of CE must the pharmacist submit to the Board of Pharmacy?
a. 10
b. 15
c. 5
d. 30

Back 31

d. 30

Front 32

Which of these is a highly directed, highly individualized postgraduate program designed to prepare the participant to become an independent researcher?
a. PGY2
b. Fellow
c. Fellowship
d. BCPS
e. PGY1

Back 32

c. Fellowship

Front 33

What must a doctor write on a prescription to keep the pharmacist from switching a name brand medication to a less expensive generic brand?
a. Switching to generic is not preferred
b. Please use name brand only
c. Nothing is required
d. Medically necessary

Back 33

d. Medically necessary

Front 34

Which conference is the largest gathering of pharmacy residency programs?
a. American Association of Colleges of Pharmacy (AACP) annual conference
b. American Pharmacist Association (APhA) annual meeting
c. National Community Pharmacists Association (NCPA) annual meeting
d. American College of Clinical Pharmacist (ACCP) winter symposium
e. American Society of Health Systems Pharmacy (ASHP) midyear meeting

Back 34

e. American Society of Health Systems Pharmacy (ASHP) midyear meeting

Front 35

True/False
A pharmacy technician under the supervision of a pharmacist is allowed to counsel patients on their medications.

Back 35

False. is not allowed.

Front 36

True/False
Dr. Vedder faxes in a prescription of Hydrocodone (which is a Schedule II medication) for his patient, Jeremy. When Jeremy arrives at the pharmacy to pick up the prescription you are able to give Jeremy the prescription because a fax is a legal representation of the Dr. Vedder's original prescription.

Back 36

False

Front 37

Under Florida law, when a patient has run out of refills on a maintenance medication, the pharmacist may dispense an emergency refill. What is the maximum supply that the pharmacist can dispense pursuant to an emergency refill?
a. 30 day supply
b. 72 hours supply.
c. 7 day supply
d. 48 hours supply.
e. 24 hours supply.

Back 37

b. 72 hours supply.

Front 38

As a future Florida pharmacy graduate how many hours of internship hours must you complete before you can apply for Florida pharmacist licensure?
a. 1200 hours
b. None are required
c. 1500 hours
d. 2000 hours

Back 38

b. None are required

Front 39

To do no harm to others is the duty of?
1. Beneficence
2. Gratitude
3. Nonmaleficence
4. Justice

Back 39

3. Nonmaleficence

Front 40

True/False
Autonomy means that an individual can do whatever he or she wants.

Back 40

False

Front 41

You are working in the pharmacy and you receive a prescription for oxycontin (a Schedule II Controlled Substance) 100 tablets. You look through your supply and find that you only have 50 tablets. What is the correct response to this situation?
1. Write and I.O.U note to the patient for the other 50 tablets that he can come and pick up any time after since it is your fault for not having a full supply.
2. Write on the face of the prescription that it is a partial fill and how much you have filled and how much is left to fill
3. Fill the balance within 72 hours after the partial fill
4. A and B
5. B and C

Back 41

5. B and C

Front 42

You are working in the pharmacy and you receive a phone call from Dr. Xavier. He wants you to fill a schedule 2 drug for one of his patients. The correct response to this call would be.
1. I am sorry, but since it is a schedule 2 drug I cannot fill an oral prescription
2. You are able to fill the oral schedule 2 drug if it is only for an emergency period, and the prescriber mails you the original within 7 days.
3. You do not fill the prescription because you know that schedule 2 drugs have a high potential for abuse and do not want to contribute to the drug problem
4. A and C
5. B and C

Back 42

2. You are able to fill the oral schedule 2 drug if it is only for an emergency period, and the prescriber mails you the original within 7 days.

Front 43

Why was the prescription drug Amendment act of 1951 enacted?
1. To differentiate prescription and OTC classes of drugs
2. To establish the federal caution requirement for all prescription drugs
3. To ensure that labels on prescription drug contains the prescriber’s direction
4. All of the above

Back 43

4. All of the above

Front 44

Dr. Smith spoke about the limitations of the 1906 law in relation to the sulfonamide elixir tragedy of 1937. Why was this drug recalled?
1. 170 deaths were recorded so the FDA could withdraw the drug
2. The elixir did not contain alcohol as the solvent; hence it was classified as a misbranded product. It was a requirement that elixirs contain alcohol.
3. The FDA stated that the elixir was unsafe and thus it was recalled
4. All of the above
5. None of the above

Back 44

2. The elixir did not contain alcohol as the solvent; hence it was classified as a misbranded product. It was a requirement that elixirs contain alcohol.

Front 45

Of the three subdivisions of consequentialism which ones deals with an action being morally right if the consequences of that action are more favorable than unfavorable only to the agent performing the action?
1. Teleological
2. Utilitarianism
3. Ethical Egoism
4. Ethical Altruism

Back 45

3. Ethical Egoism

Front 46

The following statements are true:
1. Only pharmacists are legally allowed to dispense prescriptions
2. Physicians may dispense prescriptions except for controlled substances
3. Veterinarians may dispense controlled substances in the area that they work to humans
4. All of the above are true
5. None of the above are true

Back 46

5. None of the above are true

Front 47

Which Act was created to help streamline the approval of generic medications and therefore increased access to generic products in the market place?
1. Kefauver-Harris Amendment 1962
2. FDA Modernization Act of 1997
3. Hatch-Waxman Act
4. Orphan Drug Act of 1983

Back 47

3. Hatch-Waxman Act

Front 48

The duty to make up for wrongful acts previously done to others such as to compensate is:
1. Reparation
2. Gratitude
3. Nonmaleficence
4. Fidelity

Back 48

1. Reparation

Front 49

Fulfill both explicit and implicit promises or agreements into which one has entered (honoring contracts)

Back 49

Fidelity

Front 50

Make up for wrongful acts previously done to others. Compensate or make amends with others when harmed.

Back 50

Reparation

Front 51

Thank those who have helped. Repay those for past favors done.

Back 51

Gratitude

Front 52

Prevent a mismatch by recognizing merits. Benefits should be distributed according to merits.

Back 52

Justice

Front 53

Improve the conditions of others in respect to virtue, intelligence, or pleasure.

Back 53

Beneficence

Front 54

Be good to yourself

Back 54

Self-Improvement

Front 55

Not injure, kill or steal from others. To do no harm to others.

Back 55

Nonmaleficence

Front 56

Every location where controlled substances are manufactured, distributed, or dispensed must have its own DEA registration except in which cases?

Back 56

warehouses to store controlled substances, practitioner's offices where drugs are prescribed but not administered or dispensed, or common carriers such as USP or FedEx.

Front 57

These are examples of Schedule ____ drugs.
Ritalin, adderall, percocet, oxycontin

Back 57

II

Front 58

These are examples of Schedule ____ drugs.
Barbituates, acetaminophen, or aspirin with codeine, amphetamines, anabolic steroids, GHB, paregoric

Back 58

III

Front 59

These are examples of Schedule ____ drugs.
Benzodiazepine, barbital, chlorohydrate, phenteramine, ambien

Back 59

IV

Front 60

These are examples of Schedule ____ drugs.
Antitussive with codeine or anti-diarrheals with an opiate.

Back 60

V

Front 61

Which class of drugs can lead to limited physical dependence of psychological dependence?

Back 61

BOTH IV & V

Front 62

Which class of drugs can lead to moderate or low physical dependence or high psychological dependence?

Back 62

III

Front 63

Which class of drugs can lead to severe physical or psychological dependence?

Back 63

II (and I?)

Front 64

Before the FDA approves an NDA, the manufacturers must provide extensive information to the agency such as what?

Back 64

full reports of investigations showing the drug's safety and efficacy, the drug's components and composition, the methods, facilities and controls used in manufacturing, processing and packaging the drug, samples of the drugs and its components, and proposed labeling of the drug.

Front 65

Prohibits adulturation (consists of any filthy, peurtred, or decomposed substances or stored in unsanitary conditions) and misbranding (labeling is false or misleading) of food and drugs in interstate commerce. Did not prevent any false or misleading efficacy claims and caused manufacturers to omit information.

Back 65

Pure Food and Drug Act of 1906

Front 66

Claimed on the label that the drug was effective against cancer knowing that the representation was false. Prompted amendment for Pure Food and Drug Act in 1912 to prohibit false and fraudulent efficacy claims but the intent was difficult to prove.

Back 66

United States vs. Johnson of 1911

Front 67

Manufacturer used diethylene glycol as solvent, which was an antifreeze and was not tested in humans prior. Caused 107 deaths. The only way the FDA could remove the product from the market was on a technicality misbranding violation, that the elixir did not contain alcohol. Supported the passage of the Food, Drug and Cosmetic Act.

Back 67

Sulfanilamide Elixir Tragedy of 1937

Front 68

New Drugs must be proven safe for the use under conditions prescribed on the label and approved by the FDA before marketed. Expanded the definitions of adulteration and misbranding requiring that labels must contains adequate instructions for use and warnings of the habit-forming propensities of certain drugs.

Back 68

Food, Drug and Cosmetic Act of 1938.

Front 69

Requires batch-certification of the safety and efficacy of insulin and antibiotics to ensure uniform potency. Ended requirements in 1997 with FDA Modernization Act.

Back 69

Batch-certification Amendment of 1941

Front 70

Food, Drug and Cosmetic Act extends to the intrastate transactions of prescriptions between the pharmacy (the drug being was manufactured and had a wholesaler in different states) and customers in order to protect the public

Back 70

United States vs. Sullivan of 1948

Front 71

Differentiates prescriptions and OTC classes of drugs. To establish the federal caution requirement for all prescription drugs. To ensure that labels on prescription drug contains the prescriber’s direction. Authorizes oral prescriptions and refills of prescription drugs.

Back 71

Durham-Humphrey Amendment (Prescription Drug Amendment) of 1951

Front 72

Sedative thalidomide was marketed in Europe but withheld for final approval of the New Drug Application (NDA) pending additional safety information. It was discovered that it caused birth defects in thousands of infants in Europe which the FDA prevented in the United States.

Back 72

Thalidomide Tragedy of 1961

Front 73

Strengthened the new drug approval process by requiring that (new and old) drugs be proved safe and effective. Transferred jurisdiction of prescription drug advertising from the Federal Trade Commission (FTC) to the Food and Drug Administration (FDA). Established good manufacturing practice requirements, and added more exhausted controls for clinical investigators by requiring informed consent of research subjects and reporting adverse reactions.

Back 73

Kefauver-Harris Amendment (Drug Efficacy Amendment) of 1962

Front 74

Provided tax and exclusive licensing incentives for manufacturers to develop and market drugs for the treatment of rare diseases (affecting under 200,000 Americans). Dramatically increased the amount of orphan drugs available (over 172) and even more are in research.

Back 74

Orphan Drug Act of 1983

Front 75

Abbreviated drug approval process. Streamline the approval of generic medications (from 3 years to 3 months) and therefore increased access to generic products in the market place at a lower price

Back 75

Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act)

Front 76

Establishes sales restrictions and record keeping requirements for prescription drug samples. Only instituitional (hospital) pharmacies can have a limited amount of drug samples. Prohibits hospitals from reselling pharmaceutical purchases to other hospitals or physicians. Required state licensing of drug wholesalers.

Back 76

Prescription Drug Marketing Act

Front 77

Directs states to implement programs designed to identify and reduce the frequency of patterns of fraud, abuse, gross overuse, the providing of inappropriate or medically unnecessary care and medications by physicians and pharmacists. Requires each state to provide drug use review (DUR) to reduce patient non-compliance with medications to decrease lost working hours and earnings, and to conserve Medicaid resources. Does not impose requirements on pharmacists.

Back 77

OBRA-90 (Omnibus Budget Reconcilliation Act)

Front 78

Authorized the FDA to collect (application, establishment, and product) user fees from drug manufacturers which expedite the drug approval process for proper FDA staffing.

Back 78

The Prescription Drug User Fee Act

Front 79

Increases the FDA public accountability, requires an FDA mission statement to define the scope of the FDA's responsibilities, and requires the FDA to publish a compliance plan to eliminate back logs in the approval process and to ensure a timely review of applications.

Back 79

FDA Modernization Act

Front 80

Creates a fast-track approval process for drugs intended to treat serious or life-threatening diseases and establishes a database of information of clinical trials, authorizes scientific panels to review clinical investigations and allow manufacturers to explore unlabeled uses of drugs. Manufacturers cannot advertise unlabeled or unapproved uses.

Back 80

FDA Modernization Act

Front 81

Expands the FDA's authority over over-the-counter drugs, and establishes ingredient labeling requirements for inactive ingredients. Affects the regulation of medical devices by requiring priority review for breakthrough technologies, and allows the FDA to contract with outside scientific experts for review of medical device applications.

Back 81

FDA Modernization Act

Front 82

Broadens and upgrades the FDA drug safety program, increase resources for review of television drug advertising that requires pre-approval with fee paid per advertisement by manufacturers, and facilitates more efficient development of safe and effective new medications.

Back 82

FDA Ammendment Act

Front 83

Establishes a registry data bank of NIH clinical trials with results (positive and negative).

Back 83

FDA Amendment Act

Front 84

(part of the) Reagan-Udall Foundation identifies unmet scientific needs in the development, manufacture and evaluation of safety and effectiveness of the FDA regulated products, including post-market evaluation. It also establishes scientific projects and programs to address those particular needs. REM (Risk Evaluation and Mitigation) Project requires post-marketing approval if safety and information become available. Both generic and brand drug manufacturer's must submit a REM project.

Back 84

FDA Amendment Act of 2007