Law Questions Exam 2

Front 1

In 1951, the Durham-Humphrey Amendments established what important distinction in the Food, Drug and Cosmetics Act?

Back 1

established 2 classes of drugs:
prescription and over-the-counter

Hint 1

this amendment also authorized oral/verbal prescriptions and refills

Front 2

In 1962, the Kefauver-Harris Amendments established which of the follow:
a. prescription labels must contain the symbol "RX only"
b. prohibition of adulteration and misbranding of foods and drugs
c. new drugs must be proven to be safe to the FDA
d. good manufacturing practices

Back 2

d. good manufacturing practices.

answer (a) is part of the 1997 FDA Modernization act.
answer (b) is part of the 1906 pure food and drug act
answer (c) is part of the original 1938 Federal Food, Drug and Cosmetic Act (FDCA)

Hint 2

This amendment was prompted by the "thalidomide disaster" which also established that drugs must be proven to be effective, and that informed consent was required of research subjects in drug trials.

Front 3

True/false: a drug that does not contain necessary labeling is known as an adulterated drug

Back 3

False.
a drug or device that has inadequate labeling is known as a misbranded drug

Front 4

All of the following are part of the definition of an adulterated drug except (choose all correct answers):
a. it fails to have required statements prominently displayed and easily understood
b. it consists of any filthy, putrid or decomposed substances
c. it has been prepared, packaged or held under unsanitary conditions where it may have become contaminated
d. its container is composed of any poisonous or deleterious substances.
e. its container is misleading
f. it has an unsafe color additive
g. its quality or strength has been reduced by the addition or substitution of other substances.
h. its labeling is false or misleading

Back 4

a, e, h, are all definitions of misbranded drugs, not adulterated.

Front 5

true/false: in regards to what a drug is, the definition for an over the counter drug is different than the definition of a prescription drug

Back 5

False. there is no differentiation between prescription and over the counter drugs when defining what a "Drug" is. The main definition of a drug is: articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

Front 6

complete the sentence:
a drug is an article intended for the use in the diagnosis, ____, ______, treatment, or ______ of disease in man or other animals.

Back 6

cure, mitigation and prevention.

Hint 6

other definitions of a drug include:
a. articles recognized in the US Pharmacopeia, Homeopathic Pharm. or National Formulary.
c. articles intended to affect the structure or any function of the body of man or other animals.
d. articles intended for use as a component of one of the above 3 categories.
note: there is no differentiation between rx and otc. manufacturer's intent = whether an article is a drug.

Front 7

According to the FDCA, a prescription label must contain 7 different items. is the name of the drug one of those items?

Back 7

No. the 7 items that are required by the FDCA are:
1. name and address of the pharmacy
2. serial number of the prescription
3. date of the prescription filling
4. name of the prescriber
5. name of the patient
6. directions for use
7. cautionary statements if indicated on the prescription.

Front 8

Which of the following items has to be a prescription label, according to the FDCA?
a. name of final evaluation pharmacist
b. address of patient
c. number of refills remaining
d. serial number of the prescription
e. date prescription was issued

Back 8

d. serial number of the prescription

Front 9

According to the FDCA, the name of the prescriber, the name and address of the pharmacy, and the name of the patient all have to be on the prescription label

Back 9

True.

Front 10

If you are making drugs per immediate demand, and you are exempt from NDA and current GMP, are you compounding, or manufacturing drugs?

Back 10

Compounding.

Hint 10

one main difference between compounding and manufacturing is that compounding is state board regulated, while manufacturing is FDA inspected and regulated.

Front 11

If you resale drugs to a 3rd party, and you sell wholesale, are you manufacturing drugs, or compounding drugs?

Back 11

manufacturing

Hint 11

One main difference between compounding and manufacturing is that compounding can only be done for immediate demand, while manufacturing can be done for future demand of a drug.

Front 12

What two characteristics make a substance a schedule 1 drug?

Back 12

1) high potential for abuse
2) no accepted medical use in U.S.

Front 13

Which of the following drug(s) are a schedule 1 drug?
a. opium
b. fentanyl
c. cocaine
d. marijuana
e. fiorinal
f. phentermine
g. ecstasy
h. heroin
i. pentobarbital
j. mescaline

Back 13

a. opium
d. marijuana
h. heroin
j. mescaline

Front 14

There are six schedule 1 drugs you need to memorize. heroin, LSD, and marijuana are 3 of them, what are the other 3?

Back 14

peyote, mescaline, ecstasy

Hint 14

2 of them are sort of redundant (i.e. we're talking about the same active ingredient).

Front 15

A schedule II drug is a drug that meets the following criteria:
a. high potential for abuse and no accepted medical use in U.S.
b. high psychological dependence, moderate to low physical dependence, and accepted medical use in the U.S.
c. severe physical or psychological dependence potential, and accepted medical use in the U.S.
d. low or limited physical or psychological dependence potential, and accepted medical use

Back 15

c. severe physical or psychological dependence potential and accepted medical use in the U.S.

Front 16

What are the 4 brand names you need to know for Oxycodone with ASA or APAP?

Back 16

Percodan, Percocet, Roxicet, Tylox

Hint 16

Roxy Purrs like a Tiger.

Front 17

Which of the following drugs are schedule II?
a. opium
b. Marinol
c. Propoxyphene
d. Tylenol with codeine elixir
e. pentobarbital
f. amobarbital
g. methylphenidate
h. Vicodin

Back 17

a. opium
e. pentobarbital
f. amobarbital
g. methylphenidate

Front 18

Which one of the following brand-generic name matches is correct?
a. hydrocodone & APAP - Percocet
b. methylphenidate - Ritalin
c. fentanyl - Demerol
d. paregoric - Lomotil

Back 18

b. methylphenidate - Ritalin

Front 19

What is the brand names and schedule class for the following drugs?
a. meperidine
b. hydomorphone
c. THC
d. APAP with codeine

Back 19

a. meperidine is Demerol, a schedule II
b. hydomorphone is Dilaudid, a schedule II
c. THC is Marinol, a schedule III
d. APAP with codeine is Tylenol 3, a schedule III

Front 20

A pharmacist can change, with the prescriber's authorization, which of the following items on a prescription for a controlled substance?
a. patient name
b. CS prescribed
c. patient address
d. drug strength
e. c & d
f. all of the above

Back 20

e. patient address and drug strength are two things the pharmacist can change. as well as the drug quantity, direction, and issue date.

the pharmacist cannot change patient name, CS prescribe (except generic, per state law), and signature of prescriber. all these changes would require a new hard copy of the prescription.

Front 21

true/false: a drug that has a moderate to low physical dependence and a moderate to low psychological dependence potential is a schedule III drug

Back 21

false. a schedule III drug has a moderate to low physical dependence potential, but a HIGH PSYCHOLOGICAL dependence potential

Front 22

true/false: a drug that has low or limited physical or psychological dependence potential is a schedule V drug

Back 22

false. this is the definition of a schedule IV drug, a schedule V drug has extremely low physical or psychological dependence potential

Front 23

Provide the drug schedule for the following drugs:
a. fiorinal
b. Lomotil
c. Dronabinol
d. Darvocet
e. Phenobarbital

Back 23

a. III
b. V
c. III
d. IV
e. IV

Front 24

Every how many years does a DEA registration need to be renewed?

Back 24

3 years

Front 25

true/false: hospital employees and agents may use hospital's DEA #, as long as there is an internal code associated with each person who uses it.

Back 25

true (i.e AU1234563-012)

Front 26

completed the sentence:
"A prescription for a controlled substance to be effective must be issued for a ______________ (3) by an individual practitioner acting in the usual course of his professional practice..."

Back 26

legitimate medical purpose

Front 27

true/false: a controlled substance prescription for the prescriber's office use is a legitimate purpose violation

Back 27

true.

Front 28

there are ten different legitimate purpose/corresponding duty violations listed in the Federal CSA. five of them include:
1. forged / false rx
2. CS Rx for abetting a narcotic habit
3. rx for a fictitious person
4. rx for a person other than the person named as the patient on the rx
5. CS rx for the prescriber's office use.

what are the other 5 violations?

Back 28

1. large number of rx's; large quantities
2. simultaneous antagonistics drugs (uppers and downers)
3. too freqeunt refills
4. patient filling other people's rx
5. numerous, similar rx from same doctor.

Front 29

true/false: the federal CSA labeling requirements are the same as the FDCA
(exception: some schedule classes require a no transfer label)

Back 29

true.
both acts require the same items on a prescription label, which are:
1. name and address of the pharmacy
2. serial number of the presription
3. date of the prescription filling
4. name of the prescriber.
5. name of the patient
6. directions for use
7. cautionary statements if on the Rx.

notice that the FDCA and the CSA do not require the name of the drug on the label.

Front 30

true/false: C-II, C-III, C-IV and C-V drug labels must contain a cautionary statement, stating "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

Back 30

false. this is only required on C-II to C-IV, but not C-V!

Front 31

For how many years must controlled substance records be kept?

Back 31

2 years

Front 32

Every how many years must a new controlled substance inventory be taken?

Back 32

2 years

Front 33

Which CS drugs have to have an exact count?

Back 33

all C-II drugs and any C-III to C-V drugs that are in an open container that holds more than 1000 tablets/capsules.

Front 34

Colorado state law requires that dispensing files be separated into 3 different categories. what are those categories?

Back 34

1. C-II
2. C-III, IV, and V
3. all non-cs drugs

Front 35

How many times can a C-II be transferred?

How many times can a C-III to C-V be transferred?

Back 35

C-II can not have a refill, so they cannot be transferred.

C-II to C-V can be transferred once (exception is if you have a shared real-time, on-line data base in which you maintain the same rx number throughout the transfers, like Kaiser has).

Front 36

How many times can a C-III to C-V be refilled?

Back 36

5 times in 6 months

Front 37

generally, C-II prescriptions cannot be faxed. There are three exceptions, what are they?

Back 37

the following institutions can have a C-II scripted faxed to them:
1. home infusion/IV pain
2. long term care facility
3. hospice

Front 38

in emergency situations, a C-II can be dispensed based on prescriber's authorization via fax or phone. the prescriber still must provide a signed, written prescription to the pharmacist. when does the prescriber need to do this, and what happens if the prescriber doesn't?

Back 38

presriber must provide a written prescription within 7 days according to DEA, and within 72 hours according to Colorado State Board. Otherwise, pharmacist must notify the DEA or SBOP, respectively.

Front 39

true/false: pharmacist is allowed to partially dispense a C-II at any time.

Back 39

false. generally, partial dispensing is only allowed if full quantity is not available.

Front 40

if a C-II is partially dispensed, how soon must the balance of the prescription be dispensed before a new prescription must be written?

Back 40

72 hours

Front 41

there is an exception to the partial dispensing rule, in which the balance of the prescription must be dispensed within 72 hours. what is that exception, and how much longer is the prescription valid for?

Back 41

the exception if for long term care facilities or terminally ill patients (which would be noted on the prescription). in this case, partial fills are allowed for a maximum of 60 days.

Front 42

What as an NTP?

Back 42

A narcotic treatment program. it is a maintenance/detoxification of narcotic addicts, and is registered with the DEA.

Front 43

narcotics must be dispensed and administered at a registered NTP. what is the one exception?

Back 43

Buprenorphine

Front 44

there are three restrictions on a non-NTP doctor administrating narcotics, what are they?

Back 44

narcotics can be administered by a non-NTP doctor if:
1) the purpose is to relieve acute withdrawal symptoms
2) dose is not more than a 1 day dose for 3 days.
3) narcotic administration is for treatment other than addiction

Front 45

what controlled substance drug schedule is buprenorphine

Back 45

C-III

Front 46

What are the two brand names for buprenorphine?

Back 46

Subutex (induction treatment)
Suboxone (long-term treatment)

Front 47

What three agencies need to be informed if controlled substance drugs are stolen/missing from pharmacy?

Back 47

1) DEA
2) Local law enforcement
3) State board of pharmacy

Front 48

what is the limit on the amount of controlled substances that a pharmacy can distribute to a practitioner or another pharmacy?

Back 48

amount cannot exceed 5% of dispensed controlled substances in a calender year.

Front 49

What is the brand name for butalbital/caffeine/aspirin, and what schedule is it?

Back 49

Fiorinal, schedule III

Front 50

What is the brand name for butalbital/caffeine/acetaminophen, and what schedule is it?

Back 50

Fioricet, non-controlled.

Front 51

true/false: failure to properly label a controlled substance prescription label with pharmacy name and address, prescription date, prescription number, prescriber name, patient name, and directions of use is an unlawful act under the colorado controlled substance act

Back 51

true. a proper label will have all of the following:
1) pharmacy name
2) pharmacy address
3) date prescription was filled
4) prescription serial number
5) prescriber name
6) patient name
7) directions for use

Front 52

true/false: colorado csa allows the sale of c-v on an otc basis.

Back 52

false. colorado csa does not allow the sale of c-v on an otc basis.

Front 53

According to the Colorado CSA, it is required of a prescriber of an oral emergency C-II to provide a signed, written prescription to the pharmacist within __ days.
a. 1 day
b. 2 days
c. 3 days
d. 5 days
e. 7 days

Back 53

c. 3 days (72 hours)

Front 54

What are the three things that a pharmacist is NEVER permitted to make changes to a controlled substance prescription?

Back 54

1) patient name
2) controlled substances prescribed (except for generic substitution permitted by state law)
3) prescriber's signature

Front 55

Casual sales cannot exceed ____ percent of total number of
a. 5 percent
b. 10 percent
c. 15 percent
d. 20 percent

Back 55

b. 10 percent
(and of those 10 percent, controlled substances cannot be greater than 5 percent).

Front 56

true/false: drug therapy & patient care is part of the definition of pharmaceutical care

Back 56

true.
in addition, the following is part of the definition of pharmaceutical care:
- prepare and dispense medications
- assess, evaluate pateitn medication needs
- therapeutic plan
- prevent, detect and resolve patient med problems
- DOES NOT INCLUDE prescriptive authority

Front 57

true/false: according to the definition of pharmaceutical care in the state of colorado, pharmacists have some prescriptive authority

Back 57

false. pharmacists do not have any prescriptive authority in the state of colorado

Front 58

how many prescription drug outlets can a pharmacist manager directly control at any given time?

Back 58

1 PDO

Front 59

Which of the following are duties that a pharmacy technician CAN perform?
a. patient counseling
b. pharmaceutical care
c. interpretation or orders
d. labeling of drugs
e. drug research

Back 59

d. labeling of drugs.
all of the other options are only things a pharmacist or pharmacy intern can practice. the other duties that a technician can perform are:
preparation, mixing, assembling, delivery, storage & record keeping (includes compounding)

Front 60

investigating violations, inspecting and fining prescription drug outlets, granting and renewing licenses and registrations, denying, suspending, or revoking licenses or registrations, and promulgating compounding rules are several of the powers and duties of the State Board. What are an additional 5 duties/powers that the state board has?

Back 60

1)examining applicants for licensure
2) keeping records
3) collecting fees
4) subpoenaing witnesses and documents
5) embargo misbranded or adulterated drugs.

Front 61

true/false: pharmacy manager must be a pharmacist

Back 61

true

Front 62

if pharmacy manager terminates employment, the owner of the pharmacy must transfer state board registration to a new manager within ___ days:
a. 7
b. 30
c. 14
d. 10

Back 62

c. 14

Front 63

the prescription drug outlet must display two things. what are they?

Back 63

1) board registration with owner's and manager's name
2) pharmacist and intern licenses

Front 64

true/false: if you change the name of the pharmacy, you must apply to state board to change the name of the pharmacy.

Back 64

true.
this also applies if you are transferring ownership, or changing location

Front 65

to be able to supply a 24 hour drug supply to a registered ER patient by the hospital employee, what two criteria must be met?

Back 65

1. it has to be ordered by a practitioner
2. it has to be given by an employee that can administer or dispense meds (i.e. a nurse)

Front 66

what are the 3 different intern/technician combination that a pharmacist can supervise?

Back 66

1. 2 interns
2. 2 interns and 1 tech
3. 1 intern and 2 techs

Front 67

a pharmacist may fill how many days of an emergency refill?

Back 67

72 hour supply

Hint 67

do not confuse emergency refills with emergency controlled substance supplies.

Front 68

when can a pharmacist not supply an emergency refill?
a. if the pharmacist has not reasonably tried to contact prescriber
b. if the old prescription states "no emergency refill"
c. if the medication is necessary for patient's health
d. a and b

Back 68

d. a and b

Front 69

What additional labeling requirement does the state law have that the federal law doesnt?

Back 69

the drug name.

Hint 69

remember, federal law requires:
rx drug outlet name and address
serial #
date
practitioner name
patient name
directions
cautionary labels

Front 70

under colorado state law, anabolic steroids have an additional labeling requirement. what is the requirement?

Back 70

purpose of the prescription

Front 71

a pharmacist can get his/her licensed for revoke for misrepresentation, fraud deceit; being guilty of / pleading guilty to / deferring judgment for a felony; failing to notify state board within 30 days of any criminal conviction or deferred judgment; violating board rules, or state or federal drug laws; being unfit or incompetent. what other 5 different reasons can a license be revoked for?

Back 71

1) being depend on, or habitual/excessive use of liquor/habit forming drug or controlled substance
2) letting an unlicensed person practice pharmacy
3) being disciplined in another state (or failing to notify board within 30 days of being disciplined in another state)
4) misleading, false, or deceptive advertising
5) practicing pharmacy while inactive

Hint 71

there are another 5 reasons that are not in the answer but you can still get your license revoked for:
1) dispensing a C-III, IV, or V more than 6 months after prescription is issued.
2) failing to meet generally accepted standards of pharmacy practice
3) not permitting board to conduct inspections
4) violating board orders
5) committing insurance fraud
6) attempting to deceive board regarding any matter under investigation

Front 72

true/false: pharmacy license can be revoked for committing insurance fraud

Back 72

true

Front 73

What are the 4 types of discipline a pharmacist can receive from state board?

Back 73

1) refusal to renew license, or suspension or revocation of license
2) letter of admonition
3) conditions on license
4) fines

Front 74

what is the largest fine that can be imposed upon a pharmacist by the state board?

Back 74

$5000 per violation

Front 75

true/false: it is unlawful to coerce/use a non-pharmacist to practice pharmacy

Back 75

true

Front 76

who has access to the electronic monitoring of prescription drugs database?

Back 76

1) prescriber practitioners
2) dispensing pharmacists
3) law enforcement officials
4) patient whose receiving the CS

Front 77

pattern of misconduct in pharmacy practice must be reported to the state board in a timely fashion if...?

Back 77

misconduct leads to danger to health, safety, or welfare of a patient or the public.

Front 78

rules of professional conduct are?

Back 78

1) pharmacist can not be employed and dispense for a prescriber
2) patient confidentiality requirement
3) no rx drug outlet referral fees to health profession persons or entities
4) can not interfere with pharmacist-patient counseling (this is a biggy)
5) must comply with board orders
6) rx drugs must be procured from SBOP registered entity/person

Front 79

drug regimen review entails?

Back 79

1) known allergies
2) rational therapy and contraindications
3) reasonable dose, duration of use, and roa (age, gender, other pt factors)
4) reasonable directions for use
5) ADE's, interactions, contraindications
6) therapeutic duplication
7) proper utilization and optimum outcomes
8) abuse/misuse

Front 80

legitimate doctor-patient relationship (per DEA) consists of what four things?

Back 80

1) pt has a medical complaint
2) medical history taken
3) physical exam performed
4) logical connection between complaint, history, exam and prescribed drug

Front 81

what are the three exceptions for being able to redispense return or exchanged drugs?

Back 81

1) unit dose packaging
2) customized patient medication packages (med packs)
3) return to stock (original container and label)

Front 82

under what restrictions can a compounded drug be made in advance (i.e. not for immediate patient use)

Back 82

up to a 3 month supply can be made, based upon prior 6 months history of sales

Front 83

what is the percent of causal sales of a compounded product that a pharmacy is allowed to sale/distribute to authorized practitioners?

Back 83

up to 10%

Front 84

how much time do you have to do a controlled substance inventory once you change a manager?

Back 84

within 72 hours

Front 85

how much time do you have to do a controlled substance inventory once you change owners?

Back 85

no specified time - just within a timely manner

Front 86

what 4 things must a pharmacy have in its professional reference library?

Back 86

1) co pharmacy practice act
2) co controlled substances act
3) board rules and regs
4) DEA CS rules

Front 87

what aspects of the working area is the board concerned about having adequate space and specific measurements?

Back 87

1) amount of continuous square footage in dispensing area
2) space of location satellite
3) space or work surfaces, how much s/f per person, free floor space behind
4) sink, drain, vent
5) floor space between shelf sections
6) no use of tobacco products.

Front 88

if a pharmacist has a BS degree and wants to practice CDTM, what other requirements need to be filled?

Back 88

ACPE certificate program and 40 hours of supervised clinical training in each area of practice

Front 89

what if a pharmacist has a pharm.d and wants to practice CDTM, what other requirements are needed then?

Back 89

40 hours of CE in clinical practice and 40 hours of supervised clinical training in area of practice

Front 90

three types of facilities can have emergency kits of drugs. long term care facilities, hospices, and home health agencies. which ones can have controlled substances and oral dosage forms in their kits?

Back 90

LTCF and inpatient hospices.

HHA and outpatient hospices CANNOT have controlled substances or oral dosage forms in their emergency kits.