Pharmacology Quiz: Drug Sources and Laws

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Questions and Answers

What is the primary purpose of the Nightingale's Pledge?

To emphasize the importance of drug administration

To commit to personal purity and professional integrity (correct)

To outline the history of pharmacology

To describe the sources of drugs

What does the term 'pharmakon' refer to in the study of pharmacology?

The history of medical practices

Research on drug toxicity

The practice of clinical medicine

A substance used to treat illness (correct)

Which act required the labeling of drugs and banned adulterated products?

Food Safety Modernization Act

Pure Food and Drug Act (1906) (correct)

Controlled Substances Act

Federal Food, Drug and Cosmetic Act (1938)

Which of the following best defines pharmacology?

The science concerned with the biological effects of chemicals Signup and view all the answers

What was a significant factor that led to the creation of the Federal Food, Drug and Cosmetic Act?

The death of patients due to a toxic medication Signup and view all the answers

What are the natural sources of drugs mentioned in pharmacology?

Animal products and inorganic compounds Signup and view all the answers

What is one of the aims of the U.S. Food and Drug Administration (FDA) as empowered by the Federal Food, Drug and Cosmetic Act?

To oversee the safety of food and drugs Signup and view all the answers

Which of the following reflects a commitment made in the Nightingale's Pledge?

Maintain confidence in all personal matters Signup and view all the answers

What is a key requirement of the Durham-Humphrey Amendment?

Certain drugs must be dispensed with a prescription. Signup and view all the answers

Which act requires drug manufacturers to prove both safety and efficacy before market approval?

Kefauver-Harris Act Signup and view all the answers

What defines over-the-counter (OTC) medications?

Medications that can be bought without a prescription. Signup and view all the answers

What does the Controlled Substances Act (CSA) establish?

Federal drug policy concerning substances' manufacture and distribution. Signup and view all the answers

What is the purpose of the Orphan Drug Act of 1983?

To facilitate the development of drugs for rare diseases. Signup and view all the answers

What is a key definition of 'active ingredient' in pharmaceuticals?

The component responsible for the therapeutic effect. Signup and view all the answers

What does the Generic Act of the Philippines promote?

The identification of drugs by their generic names. Signup and view all the answers

Which of the following statements is true regarding OTC medications?

They can be purchased without a prescription and are safe when used correctly. Signup and view all the answers

What is referred to as the proprietary name given by the manufacturer to distinguish its product?

Brand name Signup and view all the answers

What does the 'Core List' in the Essential Drugs List represent?

Essential drugs for the majority of the population Signup and view all the answers

Which pregnancy category indicates that drug use may have benefits that outweigh risks?

Category D Signup and view all the answers

In which phase of the FDA evaluation process is the drug cleared for large-scale clinical studies?

Phase 3 Signup and view all the answers

Which of the following best describes 'Generic Drugs'?

Drugs without patent protection labeled by their generic name Signup and view all the answers

What are 'Drug Outlets' according to the provided definitions?

Stores selling drugs and medicines Signup and view all the answers

What is the primary purpose of the Essential Drugs List?

To identify necessary medications based on health conditions Signup and view all the answers

What is a 'Placebo Effect' in drug evaluation?

A psychological benefit from receiving an inactive treatment Signup and view all the answers

Study Notes

Pharmacology

The study of the biological effects of chemicals.
The science concerned with drugs, their sources, appearance, chemistry, actions, and uses.

Natural Sources of Drugs

Plants
Animal Products
Inorganic Compounds

Synthetic Sources of Drugs

Many drugs are now synthesized in laboratories

Drug Laws

Pure Food and Drug Act (1906): Required labelling of drugs, banned interstate traffic in adulterated or mislabeled food and drug products, and established purity levels for drugs.
Federal Food, Drug and Cosmetic Act (1938): Mandated tests for toxicity and recall procedures, empowering the FDA.
Durham-Humphrey Amendment (1951): Classified drugs as prescription or over-the-counter (OTC). Prescription drugs must carry the statement "Caution: Federal law prohibits dispensing without prescription."
Kefauver-Harris Act (1962): Required manufacturers to prove the effectiveness of drugs before marketing, mandated reporting of side effects, and required evidence of effectiveness through clinical studies.
Controlled Substances Act (1970): Established federal U.S. drug policy to control drugs with abuse potential.
Orphan Drug Act (1983): Provided incentives for the development of drugs for rare diseases.
Generic Act - Philippines (1988): Promoted the production, distribution, and use of generic drugs, labeled by their international non-proprietary name.

Generic Act (1988) Terminologies

Generic Name or Generic Terminology: The scientifically recognized active ingredient or official generic name.
Active Ingredient: The chemical component responsible for the therapeutic effect.
Chemical Name: The complete chemical structure description of the drug.
Drug Product: The final form containing active and inactive ingredients.
Drug Establishment: Organizations involved in manufacturing, importing, repacking, or distributing drugs.
Drug Outlets: Drugstores, pharmacies, and businesses selling drugs.
Essential Drugs List/National Drug Formulary: A list of drugs updated by the Department of Health based on Philippine and international criteria.
Core List: Essential drugs for most of the population.
Complementary List: Alternative drugs used when core drugs are not effective, cause hypersensitivity, or cannot be administered.
Brand Name: The proprietary name given by the manufacturer.
Generic Drugs: Drugs not covered by patent protection, labeled by their generic name.

FDA Evaluation Process for Drugs

Preclinical Trials: Testing for potential therapeutic activity in laboratories.
Phase 1 Trials: Human testing is initiated.
Phase 2 Trials: Limited clinical testing is carried out.
Phase 3 Trials: Large-scale clinical studies are conducted.
Phase 4 Trials: The drug is approved for marketing by the FDA.
Continued Evaluation: Ongoing monitoring for safety and effectiveness.

Placebo Effect

A phenomenon where a patient experiences a beneficial effect from a treatment even if it is inactive (e.g., a sugar pill).

FDA Pregnancy Categories

Category A: Safe in pregnant women with evidence from controlled studies.
Category B: No risk in animals, but human data is limited, or animal studies showed risk but not in humans.
Category C: Risk in animals, human data is unavailable.
Category D: Potential risk in humans, but benefits outweigh risks in some cases.
Category X: Proven risk in humans, risks outweigh benefits.
Teratogenic: Capable of causing birth defects.

12 Rights of Medication Administration

Right Drug: Ensure the correct drug is being administered.
Right Dose: Verify the accurate dosage.
Right Time: Administer at the prescribed time.
Right Route: Use the correct method (e.g., oral, intravenous).
Right Patient: Confirm the patient's identity.
Right Documentation: Record administration accurately.
Right Reason: Understand the reason for the drug.
Right Assessment: Monitor patient for side effects and effectiveness.
Right Response: Assess patient response to medication.
Right to Refuse: Respect the patient's right to refuse medication.
Right Education: Provide adequate information regarding the medication.
Right Evaluation: Ensure the appropriate medication is being used for the patient's current medical status.

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Description

Test your knowledge of pharmacology with this quiz focusing on the natural and synthetic sources of drugs, as well as key drug laws including the Pure Food and Drug Act and the Federal Food, Drug, and Cosmetic Act. Explore how these laws have shaped drug regulation and safety standards in the pharmaceutical industry.