Pharmacy Law, Ethics, and Regulatory Agencies

Question 1

Law that enacted in 1914 to curb the recreational use of opium

H_______ N______ Act

Answer 1

Harrison Narcotics Act

Question 2

Law that is enacted in 1906 to stop the sale of inaccurately labeled drugs.

P___ F___ and D___ Act

Answer 2

Pure Food and Drug Act

Question 3

Law that is enacted in 1938 to define the exact labeling for products and defined misbranding and adulteration as illegal

F___, D___ and C____ Act

Answer 3

Food, Drug, and Cosmetic Act

Question 4

Amendment that is added in 1962 in an attempt to ensure the safety and effectiveness of all new drugs on the market. Also, it prevented the sale of thalidomide in the US; It became the source of birth defects

K______- H_____ Amendments

Answer 4

Kefauver-Harris Amendments

Question 5

Amendment that is added in 1951 whereas it required a label on prescription drugs; Required a doctor’s order and supervision for certain drugs.

D_____- H_____ Amendment

Answer 5

Durham-Humphrey Amendment

Question 6

Law that established in 1970 whereas Drug Enforcement Administration (DEA) enforce the laws covering controlled substances and their distribution.

C________ D___ A____ P____ and C____ Act

Answer 6

Comprehensive Drug Abuse Prevention and Control Act

Question 7

Law that is restricted in 1983 to ease restriction( and thus costs) for development of new drugs for those with a rare disease ((affecting 1 in 200,000 people).

O___ D___ Act

Answer 7

Orphan Drug Act

Question 8

The law helps to prevent counter drugs and ingredients from entering the supply chain. Also,
it limits diversion of pharmaceutical samples and prescription drugs

P______ D___ M_____ Act

Answer 8

Prescription Drug Marketing Act

Question 9

Law enacted in 1970 that required all medication to be placed in containers with childproof caps or packaging
(Includes both OTC and legend drugs)

P____ P____ P____ Act

Answer 9

Poison Prevention Packaging Act

Question 10

A law that deals specifically with practicing pharmacists. It is enacted because of reimbursement regulations for people who are covered by Medicaid or Medicare

O_____ B____ R_____ Act

Answer 10

Omnibus Budget Reconciliation Act (OBRA ’90)

Question 11

Law that deals with patient’s right to continuance of health insurance even when changing employers.

H____ I____ P____ and A_____ Act (HIPAA)

Answer 11

Health Insurance Portability and Accountability Act (HIPAA)

Question 12

Law that enacted where physicians can prescribe controlled substances to persons suffering from opioid addiction

D___ A______ T______ Act (DATA 2000)

Answer 12

Drug Addiction Treatment Act (DATA 2000)

Question 13

Law that provides a drug discount card to those with low incomes who require assistance from a pharmacy company to obtain medications

M_____ M_______ Act

Answer 13

Medicare Modernization Act

Question 14

Law that enacted in 2005 where it addresses all areas of the manufacture and sale of pseudoephedrine (an ingredient used to make methamphetamine), as well as law enforcement

C____ M___ Act

Answer 14

Combat Meth Act

Question 15

Law whereas FDA tracked system for bulk compounding supplies

D___ Q____ and S____ Act (DQSA)

Answer 15

Drug Quality and Security Act (DQSA)

Question 16

An administration that enforces guidelines for manufacturers to ensure the safety and effectiveness of medications.

F___ and D____ A______

Answer 16

Food and Drug Administration

Question 17

Technicians guidelines for manufacturers to ensure safety and effectiveness of medications and prevents privileged information about a customer from being disclosed without his or her consent

P_____ C_____

Answer 17

Patient Confidentiality

Question 17

Technicians guidelines for manufacturers to ensure safety and effectiveness of medications and prevents privileged information about a customer from being disclosed without his or her consent

P_____ C_____

Answer 17

Patient Confidentiality

Question 18

Under Recalled Drugs, what is Class 1?

Class 1: Products…

Answer 18

Products that could cause serious harm or prove fatal

Question 19

Under Recalled Drugs, what is Class 2?

Class 2: Products …

Answer 19

Products found to cause a temporary health problem or pose a slight threat of serious harm

Question 20

Under Recalled Drugs, what is Class 3?

Class 3: Products …

Answer 20

Products that may have a minor defect or other condition that would not harm the patient

Question 21

Hinga ka muna oy easyhan mo lang hahaha

Answer 21

Game! ,.l.,

Question 22

Controlled substances that is addictive and derived from opium or opium-like substance

Answer 22

Narcotics

Question 23

______ comes from the poppy seed plant and has analgesic effects and also affects mood and behavior

Answer 23

Opium

Question 24

O____, such as codeine and morphine, are substances created from opium

Answer 24

Opioids

Question 25

Under the Ratings of Scheduled (Controlled) Substances, which are classified as all medicinal narcotics drugs? C__, C__, C___, and C__

Answer 25

C-II, C-III, C-IV, C-V

Question 26

Under the Ratings of Scheduled (Controlled) Substances, which is the strongest potential for abuse; no medicinal use in the United States (for example, LSD, heroin)? C_

Answer 26

C-I

Question 27

Under the Ratings of Scheduled (Controlled) Substances, which is kept OTC in some states because of low potential abuse? C?

Answer 27

C-V

Question 28

Under the Ratings of Scheduled (Controlled) Substances, which are those that must be locked up because of high potential abuse? C__

Answer 28

C-II

Question 29

Government official that assigns the schedule for a drug

Answer 29

U.S. Attorney General

Question 30

New scripts have up to eight different tamper-proof security marks on them. To prevent forgery and fraud

Answer 30

Tamper-Proof Prescriptions

Question 31

Under the Registration Required for Maintaining Narcotics, which registration form is needed by the pharmacy to dispense controlled substances. Form ____

Answer 31

Form 224

Question 32

Under the Registration Required for Maintaining Narcotics, which registration form is needed to manufacture or distribute controlled substances Form ____

Answer 32

Form 224

Question 33

Under the Registration Required for Maintaining Narcotics, which registration form is needed to run a narcotic treatment program or compound narcotics Form ___

Answer 33

Form 363

Question 34

Under the Registration Required for Maintaining Narcotics, which registration form whereas it returns to reverse distributor Form ___

Answer 34

Form 41

Question 35

Form ___ must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencil

Answer 35

Form 222

Question 36

_____ and ____ with carbon paper are sent to the supplier or manufacturer

Answer 36

Top copy and Middle Copy

Question 37

Under Refilling Controlled Substances, a strict guideline stated that drugs rated C-III through C-V can be refilled a maximum of __ times or within 6 months of the original order, whichever comes first

Answer 37

5 times within 6months

Question 38

It is done by making an initial count of all controlled substances, and then monitoring the count as drugs are dispensed by subtracting the amount taken out of stock and adding to the count all drugs received by the pharmacy and placed into stock. P______ I_____

Answer 38

Perpetual inventory

Question 39

On refilling of C-II through C-V; what controlled substance doesn't need refills?

Answer 39

C-II

Question 40

On refilling of C-II through C-V; what controlled substance has no restrictions?

Answer 40

C-V

Question 41

It prevents drug diversion and all controlled substances that are unwanted, unusable, or outdated that is returned to the distributor

Answer 41

Reverse Distributor

Question 42

Under Partial Filling, C_ must have remainder dispensed within 72 hours C- __

Answer 42

C- II

Question 43

Under Partial Filling, C_, C_, and C__ must have remainder dispensed within 6 months C-__, C-__, and C-__

Answer 43

C-III, C-IV, and C-V

Question 44

Under Partial Filling, controlled substances C-_ through C-__may be mailed as long as contents are not identified on the packaging

Answer 44

C-II through C-V

Question 45

Monographs/ Package Inserts Contained in the P_____ D___ R_____ (PDR) in doctor’s office and Facts and Comparisons in pharmacy

Answer 45

Physicians’ Desk Reference (PDR)

Question 46

It where was instructions for use; they’re a written chemical “recipe” for a drug that the U.S. Pharmacopeia (USP) uses to standardize products made by various manufacturers.

Answer 46

Monographs/Package Inserts

Question 47

Boxed warnings are also called as...?

Answer 47

Black Box Warning

Question 48

______ was a teratogenic drug

Answer 48

Thalidomide

Question 49

How does Ethics differ from Morals?

Answer 49

Morals: A person’s beliefs concerning right and wrong Ethics: A set of values used in a profession

Question 50

It contains information on storage requirements, handling, and what to do in case of a spill or contact with the eyes

Answer 50

Safety Data Sheet (SDS)