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Reviewer ni Kyla > Pharmacy Law, Ethics, and Regulatory Agencies > Flashcards

Pharmacy Law, Ethics, and Regulatory Agencies Flashcards

1
Q

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

H_______ N______ Act

A

Harrison Narcotics Act

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2
Q

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

P___ F___ and D___ Act

A

Pure Food and Drug Act

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3
Q

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

A

Food, Drug, and Cosmetic Act

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4
Q

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

A

Kefauver-Harris Amendments

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5
Q

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

A

Durham-Humphrey Amendment

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6
Q

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

A

Comprehensive Drug Abuse Prevention and Control Act

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7
Q

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

A

Orphan Drug Act

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8
Q

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

A

Prescription Drug Marketing Act

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9
Q

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

A

Poison Prevention Packaging Act

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10
Q

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

A

Omnibus Budget Reconciliation Act (OBRA ’90)

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11
Q

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

H____ I____ P____ and A_____ Act (HIPAA)

A

Health Insurance Portability and Accountability Act (HIPAA)

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12
Q

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

D___ A______ T______ Act (DATA 2000)

A

Drug Addiction Treatment Act (DATA 2000)

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13
Q

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

A

Medicare Modernization Act

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14
Q

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

A

Combat Meth Act

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15
Q

Law whereas FDA tracked system for bulk compounding supplies

D___ Q____ and S____ Act (DQSA)

A

Drug Quality and Security Act (DQSA)

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16
Q

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

F___ and D____ A______

A

Food and Drug Administration

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17
Q

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_____

A

Patient Confidentiality

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17
Q

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_____

A

Patient Confidentiality

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18
Q

Under Recalled Drugs, what is Class 1?

Class 1: Products…

A

Products that could cause serious harm or prove fatal

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19
Q

Under Recalled Drugs, what is Class 2?

Class 2: Products …

A

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

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20
Q

Under Recalled Drugs, what is Class 3?

Class 3: Products …

A

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

21
Q

Hinga ka muna oy easyhan mo lang hahaha

A

Game! ,.l.,

22
Q

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

A

Narcotics

23
Q

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

A

Opium

24
Q

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

A

Opioids

25
Q

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

C__, C__, C___, and C__

A

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

26
Q

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_

A

C-I

27
Q

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

C?

A

C-V

28
Q

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

C__

A

C-II

29
Q

Government official that assigns the schedule for a drug

A

U.S. Attorney General

30
Q

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

A

Tamper-Proof Prescriptions

31
Q

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

Form ____

A

Form 224

32
Q

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

Form ____

A

Form 224

33
Q

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

Form ___

A

Form 363

34
Q

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

Form ___

A

Form 41

35
Q

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

A

Form 222

36
Q

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

A

Top copy and Middle Copy

37
Q

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

A

5 times within 6months

38
Q

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_____

A

Perpetual inventory

39
Q

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

A

C-II

40
Q

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

A

C-V

41
Q

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

A

Reverse Distributor

42
Q

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

C- __

A

C- II

43
Q

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

C-__, C-__, and C-__

A

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

44
Q

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

A

C-II through C-V

45
Q

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

A

Physicians’ Desk Reference (PDR)

46
Q

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.

A

Monographs/Package Inserts

47
Q

Boxed warnings are also called as…?

A

Black Box Warning

48
Q

______ was a teratogenic drug

A

Thalidomide

49
Q

How does Ethics differ from Morals?

A

Morals: A person’s beliefs concerning right and wrong

Ethics: A set of values used in a profession

50
Q

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

A

Safety Data Sheet (SDS)

Reviewer ni Kyla (2 decks)

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