Pharmaceutical industry

Question 1

ACTIVITIES IN A PHARMACEUTICAL MANUFACTURING LABORATORY

Answer 1

Research

Production

Quality Control

Distribution or Marketing

Question 2

Pharmacist play a role in the formulation of the most suitable dosage forms

Answer 2

Research

Question 3

They determine whether the medication should be given orally, injected, inhaled or rubbed on.

Answer 3

research

Question 4

Stability, packing, mode of action and released at the intended site are some of the problems solved by the research team.

Answer 4

Research

Question 5

Research activities directed to the ______

Answer 5

creation of new drugs for new products

Question 6

New drugs may be intentionally or accidentally produced from ____

Answer 6

Natural sources or by chemical synthesis

Question 7

Identifying a promising compound

Answer 7

Lead Compound Selection

Question 8

(Compound design and testing)

Answer 8

Discovery Testing

Question 9

(Safety testing in lab animals)

Answer 9

Pre-Clinical Research

Question 10

(Technical development)

Answer 10

Manufacture Research

Question 11

(Assessing safety of testing in humans)

Answer 11

Investigational New Drug (IND) Application

Question 12

(Safety and efficacy testing)

Answer 12

Clinical Trials: Phase I, Phase II, Phase III

Question 13

(Assessing safety and efficacy for marketing)

Answer 13

New Drug Application (NDA)

Question 14

(Safety and efficacy in general population)

Answer 14

Post-Marketing Surveillance

Question 15

Exploratory, to establish if agent will work as desired

Answer 15

Phase 0

Question 16

Determine basic pharmacological and toxicological information in humans especially on safety

Answer 16

Phase I

Question 17

Conducted on a larger number of patients to further evaluate the safety of the treatment and to determine how well it works

Answer 17

Phase II

Question 18

Involves a large number of patients to asses risks and
benefits

Answer 18

Phase III

Question 19

Post marketing study to determine if drug works over time and if it works for purposes other than what it was intended for

Answer 19

Phase IV

Question 20

How many years is the development process of a drug

Answer 20

15 years in total

Question 21

Products sold under a brand name by the owner of the patent.

Answer 21

Patented drug or products

Question 22

Embraces all those activities, which are involved in the conversion of “raw materials” into “finished products”

Answer 22

Production

Question 23

Production embraces all those activities, which are involved in the conversion of ____

Answer 23

“raw material” into “finished products”

Question 24

The pharmacist supervises the operation.

Answer 24

Production

Question 25

Pilot Plant provides a link between the research and production.

Answer 25

Production

Question 26

The raw materials, the intermediate and the finished products including packaging components are subjected to qualitative and quantitative check for control purposes.

Answer 26

Quality control

Question 27

Detailmen

Answer 27

DISTRIBUTION or MARKETING

Question 28

Detailmen responsibility

Answer 28

Responsible primarily for personally contacting potential prescribers and pharmacists regarding their company’s products.

Question 29

Is the maintenance or improvement of health via the prevention, diagnosis, and treatment of disease, illness, injury, and other physical and mental impairments in human beings

Answer 29

Healthcare

Question 30

A state of complete physical, mental and social well-being and not merely the absence of disease of infirmity

Answer 30

Health

Question 31

Is a person's perception of how he or she feels

Answer 31

illness

Question 32

Is a judgement of one's state of health by medical professional

Answer 32

disease

Question 33

Proportion of illness in a population

Answer 33

Morbidity

Question 34

Incidence of deaths in a population

Answer 34

Mortality

Question 35

Is a very dynamic, complex, and challenging, characterized by an abundance of business opportunities there for the picking by everyone, despite of the fact that multinational drug companies dominated the industry for many decades up to the present

Answer 35

Philippine pharmaceutical market

Question 36

True or False: Women tend to live longer than men for four years

Answer 36

False, five

Question 37

Average life expectancy is ____

Answer 37

72 years

Question 38

The most important development within the national scene which has direct bearing on the Pharmaceutical Industry was the formulation of _________ and the signing into law of the Generic Drug Act of 1988 now known as RA 6675.

Answer 38

Philippine National Drug Policy (PNDP)

Question 39

The most important development within the national scene which has direct bearing on the Pharmaceutical Industry was the formulation of the Philippine National Drug Policy (PNDP) and the signing into law of the _____ now known as RA 6675.

Answer 39

Generic Drug Act of 1988

Question 40

The most important development within the national scene which has direct bearing on the Pharmaceutical Industry was the formulation of the Philippine National Drug Policy (PNDP) and the signing into law of the Generic Drug Act of 1988 now known as _____

Answer 40

RA 6675.

Question 41

It came about because of the confluence of favorable factors and circumstances:

Answer 41

New Government ff. the EDSA revolution. The strong-felt need to provide essential drugs of high quality, safety, and efficacy to the people. The ongoing Cooperation Project in Pharmaceuticals among ASEAN The worldwide concern about the problem of inadequate access to essential drugs and irrational use of drugs.

Question 42

The goal of the PNDP is ________

Answer 42

make essential drugs available, accessible, and affordable to the people

Question 43

Four pillars anchoring the PNDP

Answer 43

Quality assurance Rational drug use Self-reliance Tailored procurement

Question 44

When was the GENERICs ACT OF 1988 established

Answer 44

September 13, 1988

Question 45

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

Answer 45

RA 6675

Question 46

To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients;

Answer 46

RA 6675

Question 47

To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution;

Answer 47

RA 6675

Question 48

To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness; and

Answer 48

RA 6675

Question 49

The full implementation of the Generics Act of 1988 was covered by Administrative Orders only on

Answer 49

Generic Labeling Generic Advertising Generic Prescribing Generic Dispensing for single active ingredient products and subsequently also for multiple active ingredient

Question 50

This law as pointed out by _____, improved equity or access to essential drugs, by simple expedient of requiring use of generic names and giving the patient or buyer informed choice and the option to buy cheaper alternatives.

Answer 50

DOH

Question 51

True or False: Under the Generic Prescribing Guidelines of RA 6675, the doctor still retains the responsibility of determining the AI of the drug his patient and he directs how it will be used.

Answer 51

True

Question 52

True or False: retains the right to indicate his preferred brand although the patient/ consumer is not obligated to choose that particular brand, especially if he cannot afford it

Answer 52

True

Question 53

Inevitably, the ____, until now has major apprehensions on the possible adverse effects of the Generics Law particularly on the marketing of their branded drug products whose market shares are gradually being eroded by the purely Generic Drug preparations which are fast gaining a strong foothold in the market.

Answer 53

Philippine Drug Industry

Question 54

But most certainly, RA 6675 never did and never will toll the death knell for branded drug products. At worst, the Generics Law created _____ wherein branded products co- exist with the generic drug lines.

Answer 54

a two-tier marketing system

Question 55

" is a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complementary list.

Answer 55

Essential Drugs List" or "National Drug Formulary

Question 56

is a list of drugs that meets the health care needs of the majority of the population.

Answer 56

"Core List"

Question 57

is a list of alternative drugs used when there is no response to the core essential drug or when there is hypersensitivity reaction to the core essential drug or when for one reason or another, the core essential drug cannot be given.

Answer 57

Complementary List"

Question 58

________ is an integral component of the Philippine National Drug Policy, aimed at making available and accessible, essential medicines of proven efficacy, safety and quality at affordable cost.

Answer 58

The Philippine National Drug Formulary (PNDF)

Question 59

The PNDF Volume I, ______, is a major step towards rational use of medicines in the country. The medicines are selected with due regard to public health relevance, evidence of efficacy and safety and comparative cost‐effectiveness. The national list of essential medicines is a subset of registered medicines divided according to different levels of care.

Answer 59

the Essential Medicines List

Question 60

provided by physicians and dentists, also by pharmacists in hospitals, industrial, and medicinal clinics.

Answer 60

MEDICAL CARE

Question 61

patients caring for themselves

Answer 61

SELF-CARE

Question 62

precludes guidance by a licensed pharmacist or physician. The trend toward self- medication places an increased professional responsibility on pharmacists, one which requires pharmacists to analyze each patients’ condition and make a decision on minor illness referred to, for appropriate medication

Answer 62

Self Medication