Chapter 4: Regulations (Key Terms) Flashcards
Addiction
a substance that encourages dependence on it
Chemical name
drug name that reflects the chemical makeup of the drug
Clinical trials
scientific tests that research the efficacy and safety of a medication
Compassionate use
the use of an investigational new drug (IND) in patients who are suffering greatly and may die without the drug
Control group
group of people in clinical trials who receive the placebo or usual treatment, in contrast to the group given the treatment or medication being studied
Controlled Substances Act
a law enacted in 1971 to control the distribution and use of all depressant and stimulant drugs and other drugs of abuse or potential abuse as may be designated by the Drug Enforcement Administration of the Department of Justice
Double-blind
neither the patient nor the researcher in the clinical trial knows who has the placebo and who has the drug being tested
Drug Enforcement Agency (DEA)
Enforces the laws on drug use.
Regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, and anabolic steroids, as well as the substances used in their production
Food and Drug Administration (FDA)
Created to establish guidelines and regulations for food quality and drug development to maintain public safety.
Oversees the safe development of new drugs. This act requires drug manufacturers to show product effectiveness and safety, to report adverse events, and to ensure that any advertisements to physicians disclose a product’s risks and benefits.
Generic name
official name of the drug; nonproprietary
Investigational New Drug (IND)
What the drug is known as during the first 3 phases of clinical trials. Its use is limited to persons who meet specific criteria for inclusion in the trial.
New drug application (NDA)
If the clinical trails show that the drug is safe and effective, and a therapeutic dose is established, the manufacturer next applies to the FDA for approval. Results of the scientific testing are submitted with this application.
Occupational Safety and Health Administration (OSHA)
A branch of the Department of Labor that helps ensure that all workers not be exposed to unnecessary job-related risks, such as electrical cords placed where workers could fall over them or a lack of portable fire extinguishers.
Patent medicine
remedy of questionable value that may harm the patient
Placebo
inactive substance given to satisfy a patient’s demand for medicine; a drug or treatment used as a nonspecific or inactive control in a test of a therapy that is suspected of being useful for a particular disease or condition
