Pharmacology: Food and Drug Administration and Prescription Drug

1. Describe the linguistic origin/etiology of the following words * Pharmacology: The study of drugs and the interactions with living tissue. * Origin of Pharmacology: Greek word pharmakon meaning medicine or drug * Drug: Any nonfood chemical substance that affect the mind and body.

* Origin of Drug: Dutch word droog meaning dry for dried herbs and plants that were the 1st medicine. * Medicine: A drug administered for preventative, diagnostic, or therapeutic agent. * Origin for Medicine: Latin word for drug is medicina meaning medicine or medication 2. How are the definitions of drug and medicine the same?

How are they different * The definitions of Drug and Medicine are the same because they both mean medicine. * They are different because a street drug is a chemical substance that does not have preventative, diagnostic or therapeutic use, while medicine is used for all of the above.

3. Describe the three uses for drugs and give examples 1. Preventive use: are used to prevent the occurrence of disease or conditions the administration of preventive drugs is known as prophylaxis. Examples: * Drugs taken prior to traveling to prevent motion sickness * Contraceptive drugs taken to prevent pregnancy.

* Vaccinations given to immunize children or adults against certain diseases such as polio, diphtheria, or influenza 2. Diagnostic Use: are used by themselves or in conjunction with radiologic procedures and other types of medical tests provide evidence of a disease process. Examples:

* Radiopaque contrast dyes used during x-ray procedures * Drugs that mimic the cardiac effect of exercise in patients who cannot undergo regular cardiac exercise stress testing. 3. Therapeutic use: The majority of drugs are used to control, improve or cure symptoms, signs, conditions or diseases of physiologic or psychological nature.

Examples: * Antibiotic drugs to kill bacteria and cure an infection * Analgesic drugs to control the pain and inflammation of arthritis * Insulin to treat diabetes 4. Give the meaning of and describe the linguistic origin of RX.

*The symbol RX comes from the Latin word recipe meaning take, which indicates a prescription, the combining of ingredients to form a drug. Some ingredients had the value but others were worthless or actually harmful. 7. Name three ancient “medicines” that seem silly or outrageous to us today. * Spider webs * Dirt, * Sour Milk 10.

Describe the social and consumer safety circumstances that led to the passage of each a. The Food and Drugs Act of 1906: This worthless, mislabeled and dangerous drugs led to 1st drug laws with an accurate labeling law added in 1912 b. The Food, Drug, and Cosmetic Act of 1938:

Sulfonamide tested for flavor and fragrance but not safety, children died and 350 more were poisoned. This act made it so the sale of unsafe drugs could be stopped, that toxic drugs could be seized, and the burden of proof was given to the manufactures to show data of safety experiments. c.

Kefauver-Harris Amendment of 1962: Thalidomide used for morning sickness in West Germany which led to 8000 deformed baby limbs. The USA refused to approve. The Act tighten control on new and prescription drugs, while drugs had to be shown to be safe and effective before market, and the drug companies had to report adverse effects. d. FDA Modernization Act of 1987:

Drugs were being used in Europe for up to 10 years before FDA approval in US. The Act accelerated approval process for certain drugs like Inderal for hypertension and arrhythmia and Indinavir as a protease inhibitor for HIV. 11.

What federal agency is empowered to review data on a drug’s safety and clinical effectiveness and approve drugs for marketing FDA Food and Drug Administration: The federal agency empowered to review data, drug safety, clinical effectiveness, and give approval for marketing 1. Define the following phrases: prescription drug, over-the-counter- drug.

Prescription Drug: drugs that are not safe to use except under professional medical supervision. Over-the-counter drugs: a drug that can be purchase without a prescription which is generally safe if label directions and conditions are followed.

2. Describe how The Controlled Substances Act categorized drugs of potential abuse. Controlled Substances Act: established DEA (Drug Enforcement Administration Act) divided drugs in to five categories or schedules based on potential for physical or psychological dependence.

3. What is the purpose of the 1983 Orphan Drug Act? What three incentives does it offer to drug companies to develop orphan drugs? 1983 Orphan Drug act: new drugs for rare diseases Three incentives offered to drug companies for developing Orphan Drugs: 1) Grants to offset drug development.

2) Tax Credit = deduction of up to 75% of the cost of clinical trials 3) Streamlined FDA approval and 7 year exclusive marketing rights 4. What part of the wording of a drug label tells you that it is a prescription drug? The part of the wording of a drug label that tells you that it is a prescription drug is Legend drugs 18. What is the meaning of this symbol?

The symbol mean that it is a Schedule III Controlled Substances Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

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