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What percentage of the US population uses a drug daily?
88%
What is the definition of a drug?
A chemical substance that alters physiological functioning when administered, excluding nutrients.
What are the three types of drug names?
Chemical name, Generic name, Trade name.
What is the difference between brand-name and generic drugs?
The active ingredient is the same, but brand-name drugs cost more and may have different inactive ingredients.
What is a street name for cocaine?
Crack.
What is the Comprehensive Drug Abuse Prevention and Control Act?
A 1970 act that classifies drugs into schedules based on abuse potential, medical value, and safety.
What is the significance of the Orphan Drug Act of 1983?
It provides tax breaks and longer patents for companies developing drugs for rare diseases.
What is the average time frame for drug development?
8.5 years, ranging from 5 to 20 years.
What is off-label use of a drug?
Using a prescription drug for an indication or dosage not mentioned on the approved labeling.
What are designer drugs?
Drugs produced by minor modifications in the chemical structure of existing drugs, often evading classification as illegal.
What is the role of the FDA in drug testing?
The FDA evaluates drug safety and efficacy through a rigorous testing and approval process.
What are the phases of clinical studies in drug development?
Phase 1 (1.5 years), Phase 2 (2 years), Phase 3 (3.5 years).
What is the purpose of postmarketing surveillance?
To monitor adverse effects of FDA-approved drugs after they are on the market.
What is the impact of pediatric drug testing?
Most drugs prescribed to children are not tested in children, leading to potential safety issues.
What is the average cost of drug development?
On average, it costs $359 million, with ranges from $200 million to $1.5 billion.
What is the significance of the Pure Food and Drug Act of 1906?
It mandated labeling of drug contents and marked the beginning of government regulation of drugs.
What are the potential issues with drug name confusion?
Confusion can lead to medication errors, with the FDA reporting around 10% of errors stem from this issue.
What is the importance of patient education regarding medications?
Patients should be informed about their medications, including dosages, potential interactions, and side effects.
What are the challenges in classifying drugs?
Many drugs do not fit neatly into existing frameworks, and dose/timing can complicate classification.
What is the impact of drug prices in the US?
Drugs are often much more expensive in the US than in other countries, leading to affordability issues for many.
What is the role of psychopharmacognosists?
They study the origins of recreational drugs, primarily derived from plants.
What does the term 'illicit drugs' refer to?
Substances that are forbidden by laws, rules, or customs, not necessarily illegal.
What is the significance of the FDA Amendments Act of 2007?
It made registering clinical trials mandatory and required reporting of basic results.
What are off-label usage advantages and disadvantages?
Advantages include flexibility in treatment; disadvantages include potential safety concerns and lack of patient awareness.
What is the significance of the Best Pharmaceuticals for Children Act?
It encourages the testing of drugs in children to ensure safety and efficacy.