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PHAR AD1 - QUIZ 3 (Pharmaceutical Regulation in the Phil) G2

Total questions: 20

Worksheet time: 3600secs

Name
Class
Date
1.

Laws governing the practice of pharmacy is not legal boundaries of the pharmacy profession are complex and voluminous?

a)

True

b)

False

2.

RA 10918, An act regulating and modernizing the practice of pharmacy in the Philip, Repealing for the purpose RA No. 9165, otherwise known as the “Pharmacy Law”

a)

True

b)

False

3.

FDA post-market safety monitoring reviews report of problems with prescription and over the counter drugs and can decide to add cautions to the dosage or usage information, as well as other measures for more serious issue.

a)

True

b)

False

4.

Pharmaceutical Regulations it is the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy and quality of medicines, as well as the relevance and accuracy of product information.

a)

True

b)

False

5.

Statement 1: Pharmaceutical Regulations provides requirements and processes that pharmacist must follow in order to protect patients from receiving harmful or dangerous drugs.

Statement 2: Pharmaceutical Regulation by law, your pharmacy is not required to do the following: confirm licensing and registration, confirm that the entities you work with are licensed or registered with the FDA.

a)

Statement 1 is correct; Statement 2 is incorrect

b)

Statement 1 is incorrect; Statement 2 is correct

c)

Both statement are correct

d)

Both statement are incorrect

6.

After to the final approval, the FDA will inspect the manufacturing facility to ensure it's compliant with current Good Manufacturing Practices (cGMP) and it safe.

a)

True

b)

False

7.

Republic Act 9711 is otherwise known as _____________________?

a)

"Comprehensive Dangerous Drugs Act of 2002"

b)

“Food and Drug Administration (FDA) Act of 2009”

c)

"Universally Accessible Cheaper and Quality Medicines Act of 2008"

d)

“Consumer Act of the Philippines.”

8.

In manufacturing facility inspection, the agency reviews the labeling to ensure that it adequately and accurately communicates necessary information about the drug to health care professionals and consumers.

a)

True

b)

False

9.

It was a policy and program of the national government that aimed to ensure the availability of safe and effective drugs to all Filipinos at any time and place and at a reasonable and affordable cost

a)

"Comprehensive Dangerous Drugs Act of 2002"

b)

“Food and Drug Administration (FDA) Act of 2009”

c)

"Universally Accessible Cheaper and Quality Medicines Act of 2008"

d)

"Philippine National Drug Policy"

10.

The four pillars that anchor the Philippines National Drug Policy includes the following except:

a)

Quality insurance

b)

Self-reliance

c)

Rational drug use

d)

Tailored Procurement

11.

This is where a drug sponsor (usually a pharmaceutical company) develops a new compound and seeks to have it approved by the FDA for sale

a)

Pre-Clinical Trials

b)

Clinical Trials

c)

New Drug Application Review

12.

Which phase of clinical trials uses a larger sample of patients who have a certain disease or condition (typically in the 100s) is given the drug. The goal of phase II is to confirm that the drug is effective.

a)

Phase I

b)

Phase II

c)

Phase III

13.

Which phase of clinical trials uses a large sample of patients (typically in the 1000s) is given the drug. These trials gather more information on the safety and effectiveness of the drug across different populations and dosages, and in combination with other drugs.

a)

Phase I

b)

Phase II

c)

Phase III

14.

The agency reviews the labelling to ensure that it adequately and accurately communicates necessary information about the drug to health care professionals and consumers.

a)

True

b)

False

15.

R.A. 6675, also known as ________________ is 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)

"Generics Act of 1988"

b)

“Food and Drug Administration (FDA) Act of 2009”

c)

"Universally Accessible Cheaper and Quality Medicines Act of 2008"

d)

"Philippine National Drug Policy"

16.

It is the policy of the State to protect the interests of the consumer, promote his general welfare and to establish standards of conduct for business and industry.

a)

REPUBLIC ACT NO. 7394

b)

REPUBLIC ACT NO. 9502

c)

Presidential Decree No. 856, s. 1975

d)

REPUBLIC ACT NO. 9711

17.

An act providing for cheaper and quality medicines, amending for the purpose republic act no. 8293 or the intellectual property code, republic act no. 6675 or the generics act of 1988, and republic act no. 5921 or the pharmacy law, and for other purposes

a)

"Comprehensive Dangerous Drugs Act of 2002"

b)

“Food and Drug Administration (FDA) Act of 2009”

c)

"Universally Accessible Cheaper and Quality Medicines Act of 2008"

d)

"Philippine National Drug Policy"

18.

Key components of Philippine medicines Policy include :

Accountability, secrecy and good governance

a)

True

b)

False

19.

The world wide concern on the problem of inadequate access to essential medicines and its irrational use made way for the declaration of the Philippine national Drug Policy

a)

True

b)

False

20.

Key components of Philippine medicines Policy include :

Irrational drug use

a)

True

b)

False