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Food, Drug, and Cosmetic Act of 1938
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Kefauver-Harris Amendment (1962)
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HOSA Pharmacology
study flashcards for HOSA Pharmacology Knowledge Test
| Term | Definition |
|---|---|
| Food, Drug, and Cosmetic Act of 1938 | A New drug could not be marketed until proven safe, tested for toxicity, and required adverse drug effects to be reported. |
| Kefauver-Harris Amendment (1962) | Requires proof of safety and efficacy of a drug for approval before marketing |
| Drug Listing Act of 1972 | Drugs must have a National Drug Code number. |
| Drug Regulation and Reform Act of 1978 | Quicker development and distribution of new drugs |
| Anabolic Steroid Control Act of 1990 | Placed all into category III drugs (CSA) |
| Prescription Drug Amendments of 1992 | Allowed rapid approval of drugs for life-threatening diseases |
| Food and Drug Administration Modernization Act of 1997 | Allowed rapid approval of drugs by the FDA |
| Plasma Binding | When proteins bind to drugs and the decrease the amount of free-flowing drug in the bloodstream allowing the drug to stay in the body for longer. |
| Benzodiazepines | Category 4 meds |
| Benign Tumor | Localized, is smooth and freely movable, and do not break the skin |
| What is another name for antineoplastic agents? | Chemotherapeutic agents |
| What is an anticonvulsant? | A drug used to treat seizures, neuropathic pain, Bipolar disorder, and anxiety disorder |
| How do anticonvulsants work? | By depressing abnormal nerve impulse discharges in the CNS. (central nervous system) A person taking oral contraceptive should not take anticonvulsants. |
| Anticonvulsant | Diazepam |
| Which name (trade or generic) starts with a lowercase letter? | Generic |
| What are the 5 stages of the cell cycle? | G1, S, G2, M, G0 |
| Select the option that shows the cell kill theory. | 90% of 100% Killed, 10% left, 90% of 10% Killed, 1% left Body attacks rest of the cancer |
| Gemcitabine | Used For: Solid tumors: pancreatic, NSCLC |
| Nelarabines | C11H15N5O5 |
| Platinum-based drugs | Cisplatin, oxaliplatin, carboplatin |
| What drug has the chemical formula of C16H20FN3O4? | Linezolid |
| What is one example of a Topical Anti inflammatory or Corticosteroid Agent? | Hydrocortisone |
| Pharmacodynamics | The branch of pharmacology concerned with the effects of drugs and the mechanism of their action. |
| Pharmacology | The branch of medicine concerned with the uses, effects, and modes of action of drugs. |
| Pharmacokinetics | The branch of pharmacology concerned with the movement of drugs within the body. |
| Pharmacotherapeutics | A branch of Pharmacology, which is defined by Merriam-Webster as "the study of the therapeutic uses and effects of drugs" this is a study of beneficial and adverse effects of drugs. |
| Potentiation | The increase in strength of nerve impulses along pathways that have been used previously, either short-term or long-term. |
| Recombinant DNA technology | Segments of two or more different DNA molecules. |
| Safe drug | A drug that causes no harmful effects when taken in high doses over a long period of time. |
| Distribution | Is a branch of pharmacokinetics which describes the reversible transfer of a drug from one location to another within the body. |
| Drug blood level | The concentration of drug and/or its active metabolite(s) or chemical present in the blood (serum or plasma); amount of drug present in blood. |
| Drug half | When 0.5 concentration or amount of drug in the body reduced. |
| Drug interaction | Affects the activity of a drugs when both are administered together. |
| Excretion | Any one of a number of processes by which a drug is eliminated (that is, cleared and excreted) from an organism either in an unaltered form (unbound molecules) or modified as a metabolite. |
| First pass | Metabolism of a drug before it reaches the systemic circulation or through absorption. |
| Glycoside | A sugar is bound to another functional group |
| Habituation | Tolerance to the effects of a drug acquired through continued use. |
| Hypersensitivity reaction | An immune-mediated reaction to a drug. |
| Ideal drug | Effective and safe, producing no side effects or adverse reactions |
| Antagonist | Medication that binds to a receptor |
| Allergic Reaction | Hypersensitivity to a drug |
| Denominator | Part of a fraction representing the total number of parts |
| Dosage strength | Amount of drug in the given form, such as tablet or capsule |
| Adverse reaction | Undesirable drug effect. |
| Dimensional analysis | Newer method of calculating drug dosages based on fractions metric system. System of measurement based on units of 10. |
| Numerator | Part of a fraction representing the number of parts taken (the number above the line). |
| Solvent | Fluid in which a solid dissolves; also called the diluent. |
| Antagonism | Cancellation or reduction of one drug's effect by another drug |
| Nonprescription Drugs | Safe when taken as directed, can be obtained without a prescription. |
| What is a common adverse reaction to chemotherapy drugs? | Hair loss |
| In what drug schedule would you find heroin and other specialty drugs? | Schedule 1 |
| Pure Food and Drug Act (1906) | Forbade the manufacture, sale, and transportation of adulterated or mislabeled foods and drugs. |
| Shirley Amendment of 1912 | Prevented fraudulent therapeutic claims by drug manufacturers |
| Harrison Act of 1914 | Established the word narcotic and required the use of a stamp on narcotic drug containers. Also regulated the importation, manufacture, sale, and use of opium, codeine, and their derivatives. |
| Durham-Humphrey Amendment (1951) | Replaced Laws of 1938. Required designation of whether or not the drug was prescription or OTC |
| Schedule I | This type of drug has no accepted medical use in the United States and has a high potential for abuse |
| Schedule II drugs | Accepted for medical use but with severe restrictions (high potential for abuse) |
| Schedule III drugs | Have low potential for abuse with an accepted medical use. Prescription only |
| Schedule IV | Abuse potential exists, but less than Sch III. Examples are: Ambien, Darvocet and Lorazepam. |
| Schedule V drugs | Lowest potential for abuse. May be sold OTC to people that show ID |
| Controlled Substances Act (1970) | Replaced all laws passed prior to it concerning drug control. 5 drug schedules put in place based on potential for abuse. |
| Poison Prevention Packaging Act (1970) | Implemented child resistant packaging |
| Orphan Drug Act of 1983 | Established funding for research of rare chronic illnesses for new and old drugs. |
| Drug Price Competition and Patent Term Restoration Act of 1984 | Eased requirements for marketing generic drugs |
| Omnibus Budget Reconciliation Act (OBRA 1990) | Mandated that OTC drugs be documented |
| Examples of Sulfonamides | Sulfamethoxazole, sulfisoxazole, sulfadiazine |
| Uses for Sulfonamides | Treating UTIs, Ulcerative colitis, 2nd and 3rd degree burns |
| Drugs that interact with Sulfonamides | Oral anticoagulants, methotrexate, and hydantoins |
| What are the 4 groups of penicillin? | Natural penicillins, penicillinase-resistant penicillins, aminopenicillins, extended-spectrum penicillins |
| Uses for Penicillins | UTIs, Septicemia, Meningitis, Intra-Abdominal infections, Sexually Transmitted Infections (syphilis), Pneumonia and other respiratory infections |
| What variables can effect drug dosage? | Weight, Age, Height, Gender, Genetics, Diet |
| Another name for antianxiety drugs | Anxiolytics |
| 3 Examples of antianxiety drugs | Alprazolam, Doxepin, Lorazepam |
| Acronym for cancer in adults? | CAUTION |
| What are the common signs of childhood cancer and the abbreviation? (CHILD CANCER) Part 1 | C ontinued unexplained weight loss H eadaches, often with early morning vomiting I ncreased swelling or persistant pain in bones, joints, back, or legs |
| What are the common signs of childhood cancer and the abbreviation? (CHILD CANCER) Part 2 | L ump or mass, especially in the abdomen, neck, chest, pelvis, or armpits D evelopment of excessive bruising, bleeding, or rash |
| What are the common signs of childhood cancer and the abbreviation? (CHILD CANCER) Part 3 | C onstant infection A whitish color behind the pupil N ausea that that persists or vomiting without nausea |
| What are the common signs of childhood cancer and the abbreviation? (CHILD CANCER) Part 4 | C onstant tiredness or noticeable paleness E ye or vision changes that occur suddenly and persist R ecurrent and persistent fevers of unknown origin |
| What chemotherapy targets? | Fast-dividing cells |
| What is the difference between stage and grade in cancer diagnosis? | Stage is how invasive a tumor is, grade is used to classify how abnormal a cancer cell looks under a microscope |
| Malignant Tumor | A tumor that metastasizes to different parts of the body through the lymph nodes and blood vessels |
| Poly-Pharmacy | The simultaneous use of multiple drugs to treat a single ailment or condition. |
| Receptor site | A molecular site or the docking port on the surface of, or within, a cell, usually involving proteins that are capable of recognizing and binding with specific molecules; supplement. |
| Replacement therapy | Treatment aimed at making up a deficit of a substance normally present in the body. |
| Solubility | Ability of particles to be dissolved. |
| Unbound Drug | A drug is kept in the bloodstream |
| Idiosyncratic | An unexpected, unusual response to a Drug. |
| Indication | Reason to use a particular drug for a particular disorder. |
| Alkaloid | A drug that is combined with acids to make salts |
| Anti-Inflammatory Drug | A drug that reduces inflammation |
| Biotransformation | Chemical changes that a substance undergoes in the body |
| Curative | Medication prescribed to kill the causative agents |
| Demulcent | Drug used to soothe a body part or to relieve symptoms of irritation |
| Gram | Mass metric measure equivalent to one thousandth of a kilogram |
| Liter | Metric measure of volume, roughly equivalent to quart in household measure |
| Prescription Drugs | Potentially harmful unless their use is supervised by a licensed health care provider, such as a nurse practitioner, physician, or dentist. |
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