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Pharmaceutical Jurisprudence and Ethics Part I

Total questions: 100

Worksheet time: 52mins

Name
Class
Date
1.

The special law on counterfeit drug is known as RA__________

a)

7394

b)

3720

c)

8203

d)

5921

e)

NOTA (none of the above)

2.

Based on the PNDF, the following are acting on the CNS except:

a)

Anti-gout

b)

Anti-schistosoma

c)

Anti-parkinsonism

d)

Anti-vertigo

3.

It refers to the prevailing specified range of temperature, humidity, and other environment factors within optimal stability of the product:

a)

Storage conditions

b)

Temperature range

c)

Stability

d)

Expiry date

4.

Requirement/s for registration of “Me-Too” or identical products includes:

a)

Toxicology data

b)

Pharmaceutical form of the drug

c)

Clinical evaluation data

d)

Mutagenicity

5.

Government office where professionals register & where license is issued:

a)

PRC

b)

BFAD

c)

PPhA

d)

DDB

6.

Equipment used for manufacturing, processing, packing, labeling, testing and control of drugs must be:

a)

Of suitable size

b)

Absorptive

c)

Impalpability

7.

As defined in RA 8203, this refers to any entity, whether a single proprietorship, partnership, or corporation engaged in or doing business in the Philippines:

a)

residency

b)

business establishment

c)

brokering

d)

ownership

8.

This refers to any facility used for the illegal manufacture of any dangerous drug/or controlled precursors and essential chemical.

a)

classrooms

b)

clandestine laboratory

c)

licensed establishment

d)

all of the above

9.

Every prescription for external use filled in the drugstore shall bear a red label showing in black ink the components for such prescription and the word ______ at the bottom label:

a)

“Warning: May be habit-forming”

b)

“For External Use Only”

c)

“For Internal Use Only”

d)

“Flammable”

10.

It refers to any establishments that imports raw material, active ingredients and finished products for its own use or for its own use or for distribution to other drug establishment or outlets:

a)

Exporter

b)

Importer

c)

Wholesaler

d)

Retailer

11.

It refers to a licensed establishment carrying on the retail business of sale of drugs and medicines to customers:

a)

Exporter

b)

Importer

c)

Wholesaler

d)

Retailer

12.

Ointments, creams, and other semi-solid preparations are tested for:

a)

Melting point

b)

Homogeneity

c)

Impalpability

d)

All of the above

13.

Laboratory controls are required for:

a)

Finished products

b)

Components

c)

In-process drug

d)

All of the above

14.

Example/s of Cosmetic Specialty Qualified for Listing without Pre-Market Approval:

a)

Lipsticks

b)

After shave lotion

c)

Perfumes

d)

AOTA

15.

PRC means:

a)

Philippine Regulation Commission

b)

Professional Regulatory Commission

c)

Philippine Regulatory Commission

d)

Professional Regulation Commission

16.

INN means:

a)

International Non-Proprietary Name

b)

International Proprietary Name

c)

International Non-Proprietary

d)

International Name

17.

Under AO 56,s. 1989, the renewal of the LTO has a validity of ___ years:

a)

5

b)

3

c)

2

d)

1

18.

In accordance to AO 56, s. 1989, the initial LTO has a validity of ___ years:

a)

5

b)

3

c)

2

d)

1

19.

An act to ensure the safety & purity of foods & cosmetics, and the purity, safety, efficacy, and quality of drugs and devices being made available to the publie, vesting the BFAD with authority to administer & enforce the laws pertaining thereto, & for other purposes:

a)

RA 3720

b)

RA 6675

c)

RA 9165

d)

RA 9502

20.

An act instituting the Comprehensive Dangerous Drugs Act of 2002, repealing RA 6425, as amended, providing funds therefore, and for other purposes:

a)

RA 3720

b)

RA 6675

c)

RA 9165

d)

RA 9502

21.

An act to promote, require, and ensure the production of an adequate supply, distribution, use, and acceptance of drugs and medicines identified by their generic names:

a)

RA 3720

b)

RA 6675

c)

RA 9165

d)

RA 9502

22.

An act providing for cheaper and quality medicines, amending for the purpose RA 8293, RA 6675, and RA 5921, and for other purposes:

a)

RA 9165

b)

RA 9257

c)

RA 9502

d)

RA 8485

23.

An act regulating the practice of pharmacy and setting standards of pharmaceutical education in the Philippines and for other purposes:

a)

RA 3720

b)

RA 5921

c)

RA 9165

d)

RA 9502

24.

Under RA 6675, which of these prescriptions shall be filled:

a)

Violative Rx

b)

Erroneous Rx

c)

Impossible Rx

25.

Heavy metals to be tested in the herbal and/or traditional drugs except:

a)

Hg

b)

Pb

c)

As

d)

Cu

26.

Which of the following statement indicates that product is a prescription drug?

a)

RX symbol

b)

For external use

c)

A vignette of skull and bones

d)

“shake well”

27.

_________shall be the policy-making and strategy-formulating body in the planning and formulation of policies and programs on drug prevention and control

a)

BOP

b)

DDB

c)

PDEA

d)

BFAD

e)

NBI

28.

Who shall accredit and monitor drug testing laboratories to safeguard the quality of results?

a)

DOH

b)

DOJ

c)

BFAD

d)

PDEA

e)

NBI

29.

Indian hemp is also known as

I. bhang

II. churrus

III. hashish

IV. she-bang

a)

I only

b)

I & II

c)

I, II & III

d)

I-IV

30.

Which of the following is a practice of Pharmacy?

I. teaching pharmacy subjects

II. analyzing drug

III. conducting research

IV. manager of a chain drugstore

a)

3 only

b)

1 & 2 only

c)

1, 2 & 3 only

d)

AOTA

31.

This refers to the prohibited and regulated drugs

a)

List A

b)

List B

c)

Rx

d)

OTC

32.

RA 6675 is more commonly known as__________

a)

Comprehensive Dangerous Drugs Act

b)

Pharmacy Law

c)

Food, Drug and Device and Cosmetic Act

d)

Generics Act of 1988

33.

This is a simpler term for the scientifically recognized active ingredient of a drug.

a)

generic name

b)

brand name

c)

chemical name

d)

street name

34.

What are the pillars of the National Drug policy?

I. Quality Assurance of Drug

II. Quality Control

III. Rational Use of Drug

IV. National Self-sufficiency in Pharmaceuticals

a)

1 & 2

b)

1, 2 & 3

c)

1, 3 & 4

d)

1, 2 & 4

35.

This is a policy and program of the National government to ensure that the safe and effective drugs are made available to all Filipinos at any time and place and at reasonable and affordable cost.

a)

National Drug Policy

b)

National Formulary

c)

Dangerous Drugs Board Policy

36.

”The Expanded Senior Citizens Act” is also known as_________

a)

RA 9265

b)

RA 9165

c)

RA 9275

d)

RA 9257

37.

It refers to a state of psychic or physical dependence, or both on any dangerous drug, arising in a person following administration or use of that drug on a periodic or continuous basis

a)

druggist

b)

drug dependence

c)

pusher

d)

coddler

38.

What is the color of the label for prescriptions used externally?

a)

white

b)

red

c)

green

d)

blue

39.

The records for the sale of poisons must be kept for a period of __________

a)

5 years

b)

1 year

c)

3 years

d)

2 years

40.

An ordinary prescription shall be preserved for a period of ___________

a)

5 years

b)

1 year

c)

3 years

d)

2 years

41.

RA 5921 is more commonly known as__________.

a)

Senior Citizen’s Act

b)

Pharmacy Law

c)

Comprehensive Dangerous Drugs Act

d)

Special Law on Counterfeit Drug

42.

Which of the following is/are example of regulated drug?

a)

morphine

b)

opium

c)

secobarbital

d)

heroin

43.

Which of the following is/are example of prohibited drug?

a)

heroin

b)

morphine

c)

phenobarbital

44.

Opium is an example of a/an __________drug.

a)

prohibited drug

b)

regulated drug

c)

exempt dangerous drug

d)

none of the above

45.

The Comprehensive Dangerous Drugs Act of 2002” is also known as _________

a)

RA 9165

b)

RA 6675

c)

RA 9257

d)

RA 7394

46.

Any substance or mixture of substances which is toxic, corrosive, irritant, is a strong sensitizer, is flammable or generates pressure through decomposition heat or other means:

a)

counterfeit substance

b)

hazardous substance

c)

poisonous substance

d)

radioactive substance

e)

adulterated substance

47.

________ means any substance which will cause on normal living tissue, allergy or photodynamic quality of hypersensitivity which becomes evident on reapplication of the substance.

a)

strong sensitizer

b)

irritant

c)

toxic

d)

radioactive

48.

PDEA stands for:

a)

Philippine Drug Empowerment Agency

b)

Philippine Drug Enforcement Affiliation

c)

Philippine Drug Enforcement Agency

d)

Philippine Drug Establishment Agency

49.

Cannabis is also known as:

a)

shabu

b)

marijuana

c)

indian hemp

d)

ecstasy

50.

Methylenedioxymethampethamine ( MDMA ) is:

a)

shabu

b)

marijuana

c)

ecstasy

d)

opium poppy

51.

Under RA 3720, if a drug’s strength differs from or its safety, efficacy, quality or purity falls below the standards set forth in the compendium, then the drug is deemed to be:

a)

mislabeled

b)

counterfeit

c)

under quality

d)

ineffective

e)

adulterated

52.

Under RA 3720, if the food is an imitation of other food, then the food is deemed to be:

a)

fake

b)

misbranded

c)

misleading

d)

adulterated

e)

counterfeit

53.

The division in BFAD that certifies batches of antibiotics:

a)

Product services

b)

Laboratory services

c)

Legal, Information and Compliance

d)

Inspection services

e)

Administrative

54.

The Comprehensive Dangerous Drugs Act of 2002 is:

a)

RA 6425

b)

RA 5921

c)

RA 9465

d)

RA 6675

e)

RA 9165

55.

A certified true copy of the record of dangerous drugs must be submitted to:

a)

PDEA

b)

BFAD

c)

DDB

d)

DOH

e)

PRC

56.

Prescription for dangerous drug are written in:

a)

duplicate

b)

triplicate

c)

one copy

d)

four copies

57.

The manufacturer, importation, exportation, sale, offering for sale, distribution or transfer of any food, drug, device, or cosmetic that is adulterated or misbranded is a prohibited act under:

a)

RA 3720

b)

RA 5921

c)

RA 8203

d)

RA 9165

e)

RA 7432

58.

This means a quantity of any drug device produced during a given cycle of manufacture.

a)

Batch number

b)

Lot number

c)

Batch

d)

Control number

59.

Which Executive order abolished the Food and Drug Administration and created the BFAD?

a)

EO 137

b)

EO 851

c)

EO 951

d)

EO 147

e)

EO 150

60.

This division shall take charge of the inspection of food, drug and cosmetic establishment engaged in their manufacture and sale.

a)

Licensing Division

b)

Inspection Division

c)

Inspection and Licensing Division

d)

Laboratory Division

61.

RA 3720 is also known as:

a)

Pharmacy Law

b)

Consumer Act of the Philippines

c)

Food, Drugs and Cosmetics and Devices Act

d)

Senior Citizens Act

62.

It is any drug, active principle or preparation of the same, capable of destroying life or seriously endangering health when applied externally to the body or introduced internally in moderate doses.

a)

Adulterated drug

b)

Misbranded drug

c)

Counterfeit drug

d)

Poison

63.

This means characteristic styles or symbols kept from the knowledge of others or disclosed confidentially to only one or few.

a)

Code

b)

Cipher

c)

Secret keys

d)

Substitution

64.

This means a system of words or others system arbitrarily used to present words.

a)

Code

b)

Cipher

c)

Secret keys

d)

Substitution

65.

This means a method of secret writing that substitutes other or characters for the letter intended, or transposes the letter after arranging them in blocks or squares.

a)

code

b)

cipher

c)

secret keys

d)

substitution

66.

The book kept for the purpose of recording the sale of poisons shall be open at all times for inspection and shall be preserved for a period of at least________ years after the last entry.

a)

1

b)

3

c)

5

d)

7

e)

2

67.

Every prescription for external use filled in the drugstore shall bear what label?

a)

red label

b)

white label

c)

red label showing in blank ink the components and the word “For external use only”

d)

white label showing in red ink the word “For external use only”

68.

Filling and refilling of prescription shall be done by:

a)

registered pharmacist

b)

intern with the supervision of a registered pharmacist

c)

nurse

d)

pharmacy aide

69.

The Board of Pharmacy, upon receipt of a formal complaint under oath against a pharmacist, shall furnish the latter a copy of the complaint which he shall answer within _______ days from receipt.

a)

15

b)

10

c)

5

d)

30

e)

60

70.

Under RA 5921, administrative investigation shall be conducted by all members of the Board of Pharmacy. In case of suspension, it shall be for a period of not more than:

a)

60 days

b)

30 days

c)

6 months

d)

3 months

71.

As defined in RA 5921, he is the one who represents any duly authorized manufacturer, dealer, distributor, representative or wholesaler of drugs, pharmaceutical and biologic products whose primary duty is to introduce the product made by the manufacturer.

a)

broker

b)

detailman

c)

retailer

d)

wholesaler

e)

owner

72.

This is the S- license for physicians, dentist, or veterinarian, who prescribes dangerous drugs

a)

S-1

b)

S-2

c)

S-3

d)

S-4

73.

The Board of Pharmacy is vested with the authority to:

a)

examine applicants for the practice of pharmacy

b)

issue certificates of registration of pharmacists

c)

study the conditions affecting the practice of pharmacy in the Philippines

d)

AOTA

74.

According to RA 5921, who shall be the Executive Officer of the Board?

a)

President of the Philippines

b)

BFAD Administrator

c)

PRC Commissioner

d)

Civil Service Commissioner

e)

Chairman of the Council of Pharmaceutical Education

75.

If found guilty and neglect duty, incompetence, malpractice, unprofessional or dishonorable conduct, after having been given the opportunity to defined himself in an administrative investigation, the Chairman or Members of the Board may be removed by:

a)

Chairman of the Council of Pharmaceutical Education

b)

BFAD administrator

c)

PRC Commissioner

d)

Civil Service Commissioner

e)

President of the Philippines

76.

Which of the following statement is/are correct about the tenure of office and fees of board members?

a)

The chairman or member may be reappointed for another term of 3 years but in no case shall he serve continuously for more than 6 years

b)

The most senior of the Board shall automatically be the chairman

c)

The chairman and members shall receive the sum of 60 pesos for each applicant examined

77.

For how many years shall the chairman and members of the Board of Pharmacy hold office after appointment?

a)

3

b)

5

c)

6

d)

2

e)

4

78.

According to RA 5921, the qualifications of members of the Board of Pharmacy include:

a)

natural born citizen in Philippines

b)

of good moral character and of recognized standing in the pharmaceutical profession

c)

a member of good standing of any bona fide national pharmaceutical association of the Philippines

d)

AOTA

79.

To be appointed member of the Board of Pharmacy, a person shall be a duly registered pharmacist and has been in the practice of Pharmacy for at least _________ years.

a)

5

b)

8

c)

10

d)

12

e)

7

80.

Who shall appoint the chairman and the members of the Board of Pharmacy?

a)

BFAD director

b)

BFAD administrator

c)

President of the Philippines

d)

Sec. of Department of Education

e)

Commissioner of Civil Service

81.

The Board of Pharmacy was created for the implementation of RA 5921. This Board is composed of a chairman and _______ members.

a)

2

b)

4

c)

5

d)

6

e)

3

82.

The Council of Pharmaceutical Education was created for the implementation of RA 5921. This council is composed of:

a)

Secretary of Education

b)

BFAD administrator

c)

Chairman of Board of Pharmacy

d)

AOTA

83.

For the purpose of implementing RA 5921, this/these was/were created:

a)

Board of Pharmacy

b)

Council of Pharmaceutical Education

c)

PRC

84.

RA 5921 provides for and shall govern:

a)

standardization and regulation of pharmaceutical education

b)

examination and registration of graduates of schools of pharmacy

c)

supervision, control and regulation of the practice of pharmacy in Philippines

d)

AOTA

85.

A complete pharmacy internship are based on RA 5921 article III section 18c shall consist of at least:

a)

480 hours

b)

960 hours

c)

160 hours

d)

980 hours

86.

RA 5921 was signed into law on:

a)

June 23, 1969

b)

June 23, 1963

c)

June 22, 1969

d)

June 22, 1963

87.

If the illness sought to be cured is aggravated by the use of the counterfeit drug, the punishment to be imposed shall be:

a)

imprisonment from 12 years to 15 years

b)

fine of 100,000 pesos to 500,000 pesos

88.

If the counterfeit drug is proximate cause of death of victim who unknowingly purchased and took the counterfeit drug, the penalty to be imposed shall be:

a)

A. life imprisonment

b)

fine of 500,000 pesos to 5M pesos

c)

fine of 100,000 pesos to 10M pesos

89.

The commission of the acts prohibited in RA 8203 shall be punished by:

a)

imprisonment of NLT 6 months and one day but NMT 1 year if the counterfeit drug is intended for animals

b)

imprisonment of 6 years and one day but NMT 10 years

c)

fine of NLT 100,000 pesos but NMT 500,000 pesos

90.

Upon finding that the drugs examined are counterfeit, the Bureau shall file an appropriate proceeding against the registered pharmacist with the PRC for the___________ of professional license.

a)

revocation

b)

suspension

c)

cancellation

91.

Any person in possession of counterfeit drugs shall be exempted from liability after:

a)

presentation of sales invoices, official receipts or legally acceptable document evidencing his

purchase from a drugstore an indicating therein the batch and lot numbers and expiry dates of such drugs

b)

presentation of certificates evidencing the importation and exportation of drugs

c)

presentation of duplicates legally acceptable documents evidencing the purchase and importation or

exportation of the drugs

92.

As defined in RA 8203, this refers to any entity, whether a single proprietorship, partnership or corporation engaged in or doing business in Philippines.

a)

brokering

b)

business establishment

c)

residency

d)

NOTA

e)

ownership

93.

A certain drug is considered counterfeit if it contains less than how many percent of the active ingredient it purports to possess?

a)

80

b)

75

c)

60

d)

90

e)

85

94.

Drugs, as defined in RA 8203, refer to:

a)

any article recognized in the official USP/NF

b)

any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man

or animals

c)

herbal and/ or in traditional drugs which are articles of plant or animal origin used in folk medicine

d)

AOTA

95.

RA 8203 was signed into law on:

a)

Sept. 4, 1996

b)

Oct. 4, 1996

c)

Sept. 13, 1986

d)

Sept. 4, 1992

e)

Sept. 13, 1988

96.

Administrative sanctions for any violators of special law on counterfeit drugs:

a)

fine NLT 100,000 pesos and NMT 500,000 pesos

b)

permanent closure of establishment and revocation of its license to do business

c)

forfeiture, confiscation and destruction of products found to be counterfeit

d)

AOTA

97.

If the seized drug was found to counterfeit, the business establishment must be directed for preventive closure for a period of:

a)

15 days

b)

30 days

c)

60 days

d)

20 days

98.

The parties liable in RA 8203 include:

a)

the pharmacist

b)

inspector

c)

manufacturer

d)

customer

99.

Which of the following is a prohibited act under the special law on counterfeit drugs?

a)

possession of the drug

b)

manufacture, sale, offer for sale, donation, trafficking or importation of drug

c)

unregistered imported drug products

100.

Counterfeit drug refer to the mdicinal products.

a)

recognized in USP/NF

b)

article intended for use in diagnosis, cure, mitigation and treatment of disease.

c)

without active ingredient results in the reduction of drugs safety, efficacy, quality or strength