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WorksheetsPHAR AD1 - QUIZ 3 (Pharmaceutical Regulation in the Phil) G2
Total questions: 20
Worksheet time: 3600secs
Laws governing the practice of pharmacy is not legal boundaries of the pharmacy profession are complex and voluminous?
True
False
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”
True
False
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.
True
False
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.
True
False
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.
Statement 1 is correct; Statement 2 is incorrect
Statement 1 is incorrect; Statement 2 is correct
Both statement are correct
Both statement are incorrect
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.
True
False
Republic Act 9711 is otherwise known as _____________________?
"Comprehensive Dangerous Drugs Act of 2002"
“Food and Drug Administration (FDA) Act of 2009”
"Universally Accessible Cheaper and Quality Medicines Act of 2008"
“Consumer Act of the Philippines.”
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.
True
False
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
"Comprehensive Dangerous Drugs Act of 2002"
“Food and Drug Administration (FDA) Act of 2009”
"Universally Accessible Cheaper and Quality Medicines Act of 2008"
"Philippine National Drug Policy"
The four pillars that anchor the Philippines National Drug Policy includes the following except:
Quality insurance
Self-reliance
Rational drug use
Tailored Procurement
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
Pre-Clinical Trials
Clinical Trials
New Drug Application Review
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.
Phase I
Phase II
Phase III
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.
Phase I
Phase II
Phase III
The agency reviews the labelling to ensure that it adequately and accurately communicates necessary information about the drug to health care professionals and consumers.
True
False
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
"Generics Act of 1988"
“Food and Drug Administration (FDA) Act of 2009”
"Universally Accessible Cheaper and Quality Medicines Act of 2008"
"Philippine National Drug Policy"
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.
REPUBLIC ACT NO. 7394
REPUBLIC ACT NO. 9502
Presidential Decree No. 856, s. 1975
REPUBLIC ACT NO. 9711
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
"Comprehensive Dangerous Drugs Act of 2002"
“Food and Drug Administration (FDA) Act of 2009”
"Universally Accessible Cheaper and Quality Medicines Act of 2008"
"Philippine National Drug Policy"
Key components of Philippine medicines Policy include :
Accountability, secrecy and good governance
True
False
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
True
False
Key components of Philippine medicines Policy include :
Irrational drug use
True
False
