Pharmaceutical Jurisprudence and Ethics (Red PACOP)

D

The following persons shall be liable for violation(s) of RA 8203 except:

A. the manufacturer of the counterfeit drugs

B. importer or agents of counterfeit drugs

C. the registered pharmacist who has actual or constructive knowledge about the counterfeit drugs

D. the registered pharmacist who has no actual or constructive knowledge about the counterfeit drugs

E. none

D

Which of the following statement is/are true for detail man?

A. an initial fee of twenty pesos is needed upon registration

B. he shall be, preferably a graduate of a College of Pharmacy

C. to be employed, he needs to possess the necessary credentials issued by the PRC

D. only A and B

E. All of the above

C

This order gives comprehensive guidelines on the registration of pharmaceutical products to be consistent with RA 6675:

A. AO 220

B. AO 42

C. AO 67

D. AO 90

E. AO 56

B

This order defines rules & regulations governing the registration and sale of herbals and/or traditional drugs to ensure their quality and safety:

A. AO 220

B. AO 42

C. AO 56

D. AO 67

E. AO 90

A

Any person who shall violate RA 6675, sec 12 (a) for the first conviction shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the:

A. PRC

B.BOP

C. DDB

D. CPE

E. PPhA

B

They ensure the provision of safe, effective and quality drugs, for improved patient care and quality of life by helping individuals protect themselves against diseases, maintain good health and make the best use of their medication.

A. teachers

B. pharmacist

C. medical technologist

D. veterinarian

E. pharmacy technician

C

An article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance:

A. device

B. drugs

C. cosmetics

D. poison

E. biologic products

B

It refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form:

A. pharmacologic category

B. indication

C. dosage formulation

D. dosage form

E. expiry date

D

A drug which has been used for at least five (5) years and involving at least 5,000 patients:

A. investigational drugs

B. established drugs

C. new drugs

D. tried & tested drug

E. Innovation of the tried and tested drug and established drug

A

In Human Studies- Clinical Pharmacology III:

A. Controlled Clinical Trials

B. Safety and Efficacy

C. Tolerance and Safety

D. Post Marketing Surveillance

E. Provisional Monitored Release

A

It is a drug which contains no amount of, or a different active ingredient, or less than 80% of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration:

A. Counterfeit drug

B. New drug

C. Investigational drug

D. Tried & Tested drug

E. Ethical drug

B

Any person whether related to the senior citizen or not who takes care of him/her as dependent:

A. head of the family

B. benefactor

C. beneficiary

D. protector

E. dependent

B

It is a license issued by the Director General of the Intellectual Property Office (IPO) to exploit a patented invention without the permission of the patent holder either by manufacture or through parallel importation:

A. Certificate of Product Registration

B. Compulsory license

C. batch certificate

D. PRC license

E. NOTA

A

It refers to pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent:

A. multisource pharmaceutical products

B. multi-pharmaceutical products

C. source pharmaceutical products

D. generic products

E. pharmaceutical products

D

Any person who sells, trades, administers, dispenses, delivers, or gives away to another, on any term whatsoever, or distributes dispatches in transit or transport dangerous drugs or who act as a broker in any such transactions:

A. practitioner

B. coddler

C. protector

D. pusher

E. drug syndicate

A

If the entire batch of product is marketed under one company, only the lot number needs to be indicated:

A. the statement is incorrect

B. the statement is correct

C. both the batch and the lot number should be indicated

D. only the registration number is needed

E. None of the above

E

Dangerous drug prescriptions shall be retained by the pharmacist for a period of:

A. 3 years

B. 2 years

C. 4 years

D. 5 years

E. 1 year

C

Drug Registration of Herbal and/or Traditional Drugs (Local & Imported):

A. AO 63

B. AO 62

C. AO 42

D. AO 55

E. AO 56

B

Revised Rules and Regulations to implement Prescribing Requirements under the Generics Act of 1988:

A. AO 63

B. AO 62

C. AO 42

D. AO 55

E. AO 67

D

Revised Regulations for the licensing of Drug Establishments and Outlets:

A. AO 42

B. AO 90

C. AO 64

D. AO 56

E. AO 55

B

The Universally Accessible Cheaper and Quality Medicines Act of 2008 is known as R.A:

A. 9257

B. 9502

C. 9165

D. 9205

E. 9527

C

The Expanded Senior Citizens Act of 2003 is known as R.A:

A. 9527

B. 9502

C. 9257

D. 9165

E. 9205

E

The Pharmacy Law is known as R.A:

A. 5291

B. 6675

C. 3720

D. 8203

E. 5921

B

The Generics Act of 1988 is known as R.A:

A. 5921

B. 6675

C. 3720

D. 8203

E. 8293

C

The Intellectual Property Code of the Philippines in known as R.A:

A. 7432

B. 7581

C. 8293

D. 7394

E. 7581

D

The Special Law on Counterfeit Drug is known as R.A:

A. 5921

B. 6675

C. 3720

D. 8203

E. 8293

C

The Comprehensive Dangerous Drug Act of 2002 is known as R.A:

A. 9257

B. 9502

C. 9165

D. 9205

E. 9711

E

Revised Rules and Regulations to Implement Prescribing Requirements under the Generic Act of 1988:

A. AO 63

B. AO 67

C. AO 42

D. AO 55

E. AO 62

A

Revised Rules and Regulations to Implement Dispensing Requirements under the Generic Act of 1988:

A. AO 63

B. AO 62

C. AO 42

D. AO 55

E. AO 56

A

Revised Rules and Regulations on Registration of Pharmaceutical Products:

A. AO 67

B. AO 90

C. AO 64

D. AO 56

E. AO 42

B

The principal Display Panel comprises ____% of the total surface of the container:

A. 10

B. 40

C. 80

D. 95

E. 85

A

The test for alcohol content for registration of herbal and/of traditional drugs should not be more than ____%:

A. 10

B. 40

C. 80

D. 95

E. 15

A

Amount of marijuana subject to life imprisonment to death and a fine ranging from 500,000 pesos to 10M pesos:

A. 500g

B. 10g

C. 50g

D. 40g

E. 30g

B

Amount of heroin subject to life imprisonment to death and a fine ranging from 500,000 pesos to 10M pesos:

A. 500g

B. 10g

C. 50g

D. 40g

E. 30g

D

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

A. 10 days

B. 15 days

C. 60 days

D. 30 days

E. 25 days

C

The confiscated or seized dangerous drugs, plant sources, controlled precursor and essential chemicals shall be submitted to PDEA Forensic Laboratory for a quantitative examination within:

A. 12 hours

B. 48 hours

C. 24 hours

D. 16 hours

E. 6 hours

C

The decision of the Board of Pharmacy in administrative cases involving a pharmacist becomes final and executor after the lapse of:

A. 15 days

B. 60 days

C. 30 days

D. NMT 6 months from notice to respondent

E. 10 days

E

Drug test certificates issued by accredited drug testing centers shall be valid for _____ period from the date of issued:

A. 2 years

B. 1 month

C. 3 months

D. 6 months

E. 1 year

A

Responsible in granting a license to exploit a patented invention, even without the agreement of the patent owner, in favor of any person who has shown the capability to exploit the invention:

A. Director General of the IPO

B. Director General of PDEA

C. Director of NBI

D. Director of BFAD

E. Director of FDA

A

According to A.O 55, under the formulation, drugs with multiple components must be arranged in order of:

A. decreasing pharmacologic activity

B. increasing pharmacologic activity

C. alphabetically

D. according to use

E. according to pharmacologic category

E

Authorized to establish and initiate a price monitoring and regulation system for drugs and medicines:

A. Secretary of the FDA

B. Secretary of the DTI

C. Secretary of the DENR

D. Both B and C

E. Secretary of the DOH

D

For products containing 3 or more active ingredients, the official name for the combination shall be designated by:

A. DOST

B. DTI

C. DOH

D. BFAD

E. FDA

A

The one responsible in ensuring that all drugs authorized for marketing in the country conform to international standards for the content, purity and quality of pharmaceutical products as established in the International Pharmacopeia is:

A. BFAD

B. DTI

C. DOH

D. DOST

E. DENR

E

The following must be displayed conspicuously inside the drug outlet:

A. certificate of product registration

B. diploma of the pharmacist-in-charge

C. certificate of registration of the pharmacy

D. certificate of registration of the pharmacy technician-in-charge

E. certificate of registration of the pharmacist-in-charge

A

Grounds for suspension of LTO of Drug Establishment:

A. lapses in record keeping of invoices

B. sale of antibiotics without batch certification

C. selling of misbranded drugs

D. serious repeated or rampant violation of existing laws, rules & regulations

E. lapses in record keeping of CPR

E

Requirements for product registration, except:

A. prescription

B. brand identification

C. prescribing & dispensing regulations applicable

D. available scientific evidence

E. price

D

The source or circumstances of drug production is/are:

A. imported as finished

B. locally manufactured from local materials

C. locally manufactured from imported materials

D. all of the above

E. none of the above

C

In a drug establishment, personnel responsible for directing the manufacture and control must:

A. be inadequate of number

B. graduate of any 4 year course

C. has capabilities to commensurate with assigned function

D. experience is not necessary

E. all of the above

D

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

A. Hg

B. Pb

C. As

D. Cu

E. Mercury

A

Requirements for registration of local herbal and/or traditional drugs:

A. technical specifications of the ingredients used as component

B. Government certificate of clearance

C. free sale of drug

D. certification of the importation of the drug

E. certification of the exportation of the drug

B

It is the science of philosophy of laws:

A. ethics

B. jurisprudence

C. morality

D. rules

E. regulation

A

It refers to viruses, sera, toxins and analogous products used for the prevention or cure of human diseases:

A. biologic products

B. poison

C. device

D. Both A and C

E. Both B and C

A

An instrument, apparatus or contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals:

A. device

B. drug

C. cosmetics

D. poison

E. biologic products

D

Drug intended for use for animals:

A. poison

B. antibiotics

C. new drugs

D. new veterinary drugs

E. biologic products

B

Any drug intended for use by man containing any quantity of any chemical substance which is produced by microorganism and which has the capacity to inhibit or destroy microorganism in dilute solution:

A. poison

B. antibiotics

C. new drugs

D. new veterinary drugs

E. biologic products

A

The concentration of known active drug substance in formulation:

A. strength

B. net content

C. component

D. stability

E. expiry date

D

Articles (other than food) intended to affect the structure or any function of the body of man and recognized in the Philippine National Formulary:

A. medicinal plants

B. traditional drugs

C. herbal drugs

D. Both B and C

E. none of the above

A

It refers to the classification of the product based on its therapeutic action as specified in the product registration:

A. pharmacologic category

B. indication

C. dosage form

D. dosage formulation

E. formulation

B

It refers to the statement regarding the occurrence of potential hazards and side effects associated with the use of the product

and the limitation of its use:

A. contraindication

B. warning

C. precautions

D. indications

E. pharmacologic category

C

It refers to the instructions and special care required in the use of product to avoid undesired effects and to ensure the safe and effective use of the drug:

A. contraindications

B. warning

C. pharmacologic category

D. indications

E. precautions

A

_____drugs not covered by patent protection and which are labeled solely by their international non-proprietary name:

A. generic

B. innovator

C. branded

D. essential

E. non-essential

C

The term "Drug Outlet" does not include:

A. botica

B. drugstore

C. drug laboratory

D. Both A and B

E. none of the above

B

It is an act providing protection to consumers by stabilizing the prices of basic necessities & prime commodities and by prescribing measures against undue price increases during emergency situations and like occasions:

A. RA 7394

B. RA 7581

C. RA 7432

D. RA 3720

E. RA 8293

A

This order prescribes the conditions and requirements for good manufacturing practice applied to premises, equipment, personnel, product and warehouse:

A. AO 220

B. AO 42

C. AO56

D.AO 67

E. AO 90

C

This order prescribes the activities involving drug products that need to be covered by a licensed from BFAD:

A. AO 220

B. AO 42

C. AO56

D.AO 67

E. AO 90

C

Under R.A 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 NMT:

A. 1 year

B. 30 days

C. 6 months

D. 60 days

E. 10 days

A

Under R.A 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. adulterated

B. mislabeled

C. ineffective

D. all of the above

E. none of the above

C

Any person who shall be employed as detailman by any pharmaceutical establishment shall be required to register with the:

A. BFAD

B. PRC

C. Board of Pharmacy

D. DOH

E. PPhA

B

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

A. President of PACOP

B. President of the Philippines

C. PRC Commissioner

D. Director of BFAD

E. President of PPhA

A

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

A. DDB

B. PDEA

C. FDA

D. DOH

E. PRC

B

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

E. none of the above

B

Maximum penalty shall be imposed if the sale, trading, administration, delivery or distribution of dangerous drugs and/or controlled precursor and essential chemical transpires within ____meters from school:

A. 50

B. 100

C.101

D.30

E. 10

D

Penalty for unlawful prescription of dangerous drugs:

A. fine of 100,000 pesos to 500,000 pesos

B. life imprisonment to death

C. fine of 500, 000 pesos to 10M pesos

D. b and c

E. a and c

D

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

E. Both A and B

E

Penalty for illegal acts of price manipulation of any drug and medicines subject to price regulation:

A. imprisonment of NLT 5 years nor more than 15 years

B. fine of NLT 100,000 nor more than 10M pesos

C. imprisonment of NLT 10 years

D. imprisonment of NLT 5 YEARS

E. Both A and B

B

_____contains the active ingredients and quantity of the drug per dosage unit:

A. dosage form

B. formulation

C. mode of administration

D. excipient

E. preservatives

B

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 of the label:

A. "Warning: May be habit-forming"

B. "For external use only"

C. "For internal use only"

D. "Flammable"

E. "Inflammable"

B

The provision of this act on warranty shall not applied to professional services of CPA, architects, engineers, lawyers, veterinarians, optometrists, pharmacists, nurses, nutritionist, dieticians, physical therapists, salesman, medical and dental practitioners and other professional engaged in their respective professional endeavors:

A. RA 7581

B.RA 7394

C. RA 7432

D. RA 8293

E. RA 8203

C

______for products other than biological products means the date (month & year) during which the processing of the product, from which the goods are to be filled is completed:

A. expiry date

B. date of distribution

C. date of manufacture

D. storage date

E. stability

A

Under A.O 55, the Rx symbol should be printed in a type size _____ of the height of the PDP:

A. NLT 1/5

B. NMT 1/5

C. NLT 1/2

D. NMT 1/2

E. None of the above

D

The following persons shall be liable for violation(s) of RA 8203, except:

A. the manufacture of the counterfeit drugs

B. importer or agents of counterfeit drugs

C. the registered pharmacist who has actual or constructive knowledge about the counterfeit drugs

D. the registered pharmacist who has no actual or constructive knowledge about the counterfeit drugs

E. exporter or agents of counterfeit drugs

D

If the unregistered imported drug product has a registered counterpart brand in the Philippines, the product shall be considered:

A. acceptable for distribution

B. acceptable for importation

C. Both A and B

D. counterfeit

E. None of the above

A

______shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he or she has sold or in possession of is counterfeit, such as but not limited to the knowledge, that the drug was not covered by any sales invoice or evidence of delivery or purchase from a BFAD licensed establishment:

A. constructive knowledge

B. destructive knowledge

C. limited knowledge

D. suspicious

E. full knowledge

B

The maximum administrative penalty shall be imposed when the counterfeit drug products are:

A. not life-saving drug products

B. life-saving regardless of the volume

C. the volume of the product is more than 100,000 pesos

D. the number of counterfeit drug products is NMT 3 brands

E. Both A and C

B

Product which fails to comply with an applicable consumer product safety rule which creates a substantial risk of injury to the public is referred to:

A. misbranded

B. substandard

C. adulterated

D. expired

E. counterfeit

C

Basis for non-renewal of LTO:

A. poor housekeeping

B. failure to comply with PRC standards and requirements

C. serious, repeated or rampant violation of existing laws, rules & regulations

D. persistent performance that assures safety, efficacy and quality of drug products

E. All of the above

A

Only establishment with a valid LTO required under _____ can apply to register a drug product:

A. AO 56

B. AO 62

C. AO 55

D.AO 90

E.AO 63

D

If the government officials and employees are found guilty of the unlawful acts under RA 9165, they shall be penalized by:

A. perpetual absolute disqualification from any public office

B. imprisonment

C. maximum penalty

D. Both A and C

E. Both A and B

D

An establishment where pharmaceuticals, proprietary medicines or pharmaceutical specialties are prepared, compounded, standardized, and distributed or sold:

A. botica

B. Pharmaceutical Laboratory

C. Pharmaceutical Manufacturing Laboratory

D. Both B and C

E. Both A and B

B

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. biologic products

B. poison

C. abortive products

D. all of the above

E. none of the above

B

An article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man and animals:

A. device

B. drugs

C. cosmetics

D. poison

E. none of the above

E

The date stated in the label of a drug or device after which the drug is not expected to retain its claimed safety, efficacy, and quality or potency or after which it is not permissible to sell the drug or device:

A. manufacturing date

B. registration date

C. production date

D. stability date

E. expiration date

D

It is the pharmaceutical form of the preparation based on official pharmacopeia:

A. pharmacologic category

B. indication

C. dosage formulation

D. dosage form

E. dosage

B

The process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution or transfer of pharmaceutical products containing active ingredient/s of known chemical structure and properties determined to be safe, efficacious, and of good quality according to standards of BFAD:

A. CGMP

B. registration

C. assay

D. drug evaluation

E. licensing

B

It is a drug, the safety and efficacy of which has been demonstrated through long years of general use and can be found in the current official USP-NF, and other internationally recognized pharmacopeias:

A. investigational drugs

B. established drugs

C. new drugs

D. tried and tested drugs

E. Innovative drugs

A

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

A. National Drug Policy (NDP)

B. National Drug Formulary (NDF)

C. National Drug Committee (NDC)

D. none of the above

E. all of the above

A

It is a special group within the DOH which oversees the implementation of the NDP:

A. NDP Management Committee

B. National Drug Formulary (NDF)

C. National Drug Committee (NDC)

D. none of the above

E. all of the above

B

It is composed of a core list of medicines considered essential and a complementary list of drugs considered useful if not essential:

A. National Drug Policy (NDP)

B. National Drug Formulary (NDF)

C. National Drug Committee (NDC)

D. none of the above

E. all of the above

C

It is a team of pharmacologist, pharmacists and clinicians whose main task is to prepare the National Drug Formulary and recommend to the BFAD the drug for delisting:

A. National Drug Policy (NDP)

B. National Drug Formulary (NDF)

C. National Drug Committee (NDC)

D. none of the above

E. all of the above

A

It is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound:

A. chemical name

B. generic name

C. INN

D. Both B and C

E. Both A and C