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Pharmacology > Chapters 1 and 2 > Flashcards

Chapters 1 and 2 Flashcards

1
Q

Best Pharmaceuticals for Children Act

A

2002

  • Encouraged pharmaceutical companies to conduct studies and label drugs for use in children
  • Provided funds for 5-years for pediatric drug studies
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2
Q

Medicare Prescription Drug Improvement & Modernization Act

A

2003

  • Afforded the largest overhaul of Medicare in the 38-year history of the program
  • Provided entitlement benefit for prescription drugs and other benefits for seniors and those with medical disabilities.
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3
Q

Combat Methamphetamine Epidemic Act

A

2005

  • Established federal law that regulates retail OTC sales of ephedrine, pseudoephedrine, and phenylpropranolamine products due to their use in making illegal drugs. Specifically, those drugs are:
    1. Kept behind the counter or in a locked case.
    2. Limited in purchase to no more than 3.6 g/day and 9 g/month.
    3. ID required and log must be signed to purchase.
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4
Q

Ryan Haight Online Pharmacy Consumer Protection Act

A

2008

  • Applies to all controlled substances in all schedules.
  • Established federal law that it is illegal to deliver, distribute, or dispense a controlled substance by means of the Internet unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy.
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5
Q

Orphan Drug Act

A

1983

*Decreased taxes and competition for manufacturers who would produce drugs to treat selected serious rare diseases.

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6
Q

1987

A

Established new regulations designed to speed up the approval process for high-priority medications.

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7
Q

Prescription Drug User Fee Act

A

1992

  • Allowed the FDA to collect user fees from pharmaceutical companies with each new drug application to shorten the review time.
  • Specified a review time of 12 months for standard drugs and 6 months for priority drugs.
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8
Q

NIH Revitalization Act

A

1993

*Requires inclusion of women and minorities in NIH-funded research studies, including Phase III clinical drug trials.

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9
Q

FDA Modernization Act

A

1997

  • Updated regulation of biologic products.
  • Increased patient access to experimental drugs and medical devices.
  • Accelerated review of important new drugs.
  • Allowed drug companies to disseminate information about off-label (non-FDA-approved) uses and costs of drugs.
  • Extended user fees.
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10
Q

1945 Amendment

A

Required governmental certification of biological products, such as insulin and antibiotics.

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11
Q

Durham-Humphrey Amendment

A

1951
*Designated drugs that must be prescribed by an MD and dispensed by a pharmacist (eg. Controlled substances, drugs considered unsafe for use except under supervision by a health care provider, and drugs limited to prescription use under a manufacturer’s new drug application).

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12
Q

Kefauver-Harris Amendment

A

1962

  • Required a manufacturer to provide evidence (from well-controlled research studies) that a drug was effective for claims and conditions identified in the product’s labeling.
  • Gave the federal government the authority to standardize drug names.
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13
Q

Comprehensive Drug Abuse Prevention & Control Act; Controlled Substance Act

A

1970

  • Regulated distribution of narcotics and other drugs of abuse.
  • Categorized these drugs according to therapeutic usefulness and potential for abuse.
  • Title II Controlled Substances Act updated or replaced all previous laws regarding narcotics and other dangerous drugs.
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14
Q

Drug Regulation Reform Act

A

1978

  • Established guidelines for research studies and data to be submitted to the FDA by manufacturers.
  • Shortened the time required to develop and market new drugs.
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15
Q

Prototype

A

Often the first drug of a particular drug class to be developed. Usually the standard against which newer, similar drugs are compared

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16
Q

Pure Food & Drug Act

A

1906

  • Established official standards and requirements for accurate labeling of drug products.
  • Established forerunner of US FDA
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17
Q

Shirley Amendment

A

1912

*Prohibited fraudulent claims of drug effectiveness.

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18
Q

Harrison Narcotic Act

A

1914
*Restricted the importation, manufacture, sale, and use of opium, cocaine, marijuana, and other drugs that the Act defined as narcotics.

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19
Q

Food, Drug, & Cosmetic Act

A

1938

  • Revised and broadened FDA powers and responsibilities; gave FDA control over drug safety.
  • Required proof of safety from the manufacturer before a new drug could be marketed.
  • Authorized factory inspections.
  • Established penalties for fraudulent claims and misleading labels.
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20
Q

OTC drugs

A

Medications available for purchase without a prescription.

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21
Q

Pharmacoeconomics

A

Costs of drug therapy, including costs of purchasing, dispensing, storage, administration, and lab and other tests used to monitor patient responses. Also considers losses due to expiration.

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22
Q

Pharmacotherapy

A

Use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes.

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23
Q

Placebo

A

Inert substance containing no medication and given to reinforce a person’s expectation to improve.

24
Q

Prescription Drugs

A

Medications that are ordered in writing by a licensed health care worker.

25
Q

Brand Name

A

Manufacturer’s chosen name for a drug, which is protected by a patent.

26
Q

Controlled Substances

A

Drugs that are categorized by federal law according to therapeutic usefulness and potential for abuse. AKA Scheduled Drugs.

27
Q

Scheduled Drugs

A

Drugs that are categorized by federal law according to therapeutic usefulness and potential for abuse. AKA Controlled Substances

28
Q

Drug Classifications

A

Groups of medications that are categorized according to their effects on particular body systems, their therapeutic uses, and their chemical characteristics

29
Q

Generic Name

A

Chemical or official name of the drug that is independent of the manufacturer and often indicates the drug group.

30
Q

Schedule II Controlled Substances

A

Drugs that are used medically and have high abuse potentials: Opioid analgesics (codeine, hydromorphone, methadone, meperidine, morphine, oxycodone), CNS stimulants (cocaine, methamphetamine, methylphenidate), and barbituate sedative-hypnotics (amobarbital, phenobarbital, secobarbital).

31
Q

Schedule I Controlled Substances

A

*Drugs that have no accepted medical use, lack of accepted safety, and have high abuse potentials: heroin, LSD, marijunana, Quaaludes, MOMA/Ecstasy, mescaline, peyote, tetrahydrocannibinol.

32
Q

Biotechnology

A

Process that may involve manipulating DNA and RNA and recombining genes into hybrid molecules that can be inserted into living organisms (often E. Coli) and repeatedly reproduced.

33
Q

Schedule V Controlled Substances

A

Products containing moderate amounts of controlled substances. They may be dispersed by the pharmacist without a doctor’s prescription, but with some restrictions regarding amount, record keeping, and other safeguards. Included are cough suppressants containing small amounts of codeine and antidiarrheal drugs, such as diphenoxylate and Lamotil.

34
Q

Schedule IV Controlled Substances

A

Drugs with an accepted medical use in the US but with some potential for abuse: benzodiazepines (diazepam, lorazepam, temazepam), other sedative-hypnotics (phenobarbital, chloral hydrate), and some prescription appetite suppressants (mazindol, phentermine)

35
Q

Schedule III Controlled Substances

A

Drugs with less potential for abuse than those in schedules I & II, but abuse may lead to psychological or physical dependence: androgens and anabolic steroids, some depressants (ketamine, phenobarbital, zolazepam), some CNS stimulatns: (Benzphetamine, chlorphentermine) and mixtures containing small amounts of controlled substances. These drugs and substances have an accepted medical use in the US.

36
Q

Serum Drug Level

A

Laboratory measurement of the amount of a drug in the blood at a particular time.

37
Q

Serum Half-life

A

Time required for the serum concentration of a drug to decrease by 50%; also called elimination half-life.

38
Q

Nephrotoxicity

A

Toxic or damaging effect of a substance on the kidney; potentially serious because renal damage interferes with drug accumulation and increased adverse effects.

39
Q

Pharmacodynamics

A

Reactions between living systems and drugs; drug actions on target cells and the resulting alterations in cellular biochemical reactions and functions.

40
Q

Pharmacokinetics

A

Drug movement through the body to reach sites of action, metabolism, and excretion.

41
Q

Prodrugs

A

Initially inactive drugs that exert no pharmacologic effects until they are metabolized.

42
Q

Hypersensitivity

A

Immune-mediated reaction to a drug.

43
Q

Loading Dose

A

Dose larger than the regular prescribed daily dosage of a medication; used to attain a therapeutic blood level.

44
Q

Maintenance Dose

A

Quantity of drug that is needed to keep blood levels and/or tissue levels at a steady state or constant level.

45
Q

Enzyme Induction

A

Production of larger amounts of drug-metabolizing enzymes by liver cells; Process accelerates drug metabolism because larger amounts of the enzymes (and more binding sites) allow larger amounts of a drug to be metabolized during a given time.

46
Q

Enzyme Inhibition

A

Process in which a molecule binds to enzymes and inhibits their activity.

47
Q

Excretion

A

Elimination of a drug from the body; effective excretion requires adequate functioning of the circulatory system and of the organs of excretion (kidneys, bowel, lungs, and skin).

48
Q

First-pass Effect

A

Initial metabolism of some oral drugs as they are carried from the intestine to the liver by the portal circulatory system prior to reaching the systemic circulation for distribution to the site of action.

49
Q

Bioavailability

A

Portion of a drug dose that reaches the systemic circulation and is available to act on body cells

50
Q

Biotransformation

A

When drugs are altered from their original form into a new form by the body; also referred to as metabolism.

51
Q

Metabolism

A

When drugs are altered from their original form into a new form by the body; also referred to as biotransformation.

52
Q

Distribution

A

Transport of drug molecules within the body; after a drug is injected or absorbed into the bloodstream it is carried by the blood and tissue fluids to its sites of action, metabolism, and excretion.

53
Q

Enterohepatic Recirculation

A

Drugs or metabolites that are excreted in bile, reabsorbed from the small intestine, returned to the liver, metabolized, and eventually excreted in urine.

54
Q

Absorption

A

Process that occurs from the time a drug enters the body to the time it enters the bloodstream to be circulated.

55
Q

Agonist

A

Drug that produces effects similar to those produced by naturally occurring hormones, neurotransmitter,s and other substances.

56
Q

Antagonist

A

Drug that inhibits cell function by occupying receptor sites.

57
Q

Antidote

A

Substance that relieves, prevents, or counteracts the effect of a poison.

Pharmacology (7 decks)

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