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66 Cards in this Set
- Front
- Back
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Who is legally responsible if a drug is ordered incorrectly and the nurse and EMT gives the drug ordered?
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Both the prescriber and the person who administers the incorrect order is responsible
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Know sources of drug information
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- 1906 United States Pharmacopoeia
- American Hospital Formulary Services - Drug Facts and Comparisons - PDR |
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Know dates and names of legislative action and the main effect of the legislation
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- 1906; Food and Drugs Act; First attempt to protect public; no enforcement agency
- 1936; Food, Drug, and Cosmetic Act; Established Food and Drug Administration (FDA); All new drugs tested for toxicity; enforced by the FDA - 1951; Durham-Humphry Amendment; established "Legend" drugs (these are drugs that when sold, marked with a legend/caution label. For example, "This medication can not be sold without a prescription." 1962; Kefauver-Harris Amendment; require proof of safety AND efficacy; enforced by the FDA 1970; Comprehensive Drug Abuse, Prevention, and Control Act of 1970; established the Drug Enforcement Agency (DEA) in 1973; controlled substances (those with potential for abuse, for example morphine); DEA #; institutional protocols (Controlled Substance Log) - 1983; Orphan Drug Act; financial incentives to drug companies to make drugs (those that are not wide spread/used often/popular) - 1997; Food and Drug Administration Modernization Act; quick FDA approval for specific cases |
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What are the steps (in correct order) in the approval process of a new drug?
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1. Preclinical (animal studies)
2. Investigational New Drug Application (INDA) 3. Clinical testing (phases I-III) 4. New drug application 5. Approval; trade name; NDC; drug reaches market; manufacture has exclusive rights for about 20 yrs; post-surveillance |
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Know how to calculate TI
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LD50 divided by ED50
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What federal government agencies play a part in regulation of drugs; what are the responsibilities of each?
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- Drug development overseen by the FDA
- All new drugs are tested for toxicity; enforced by the FDA - Proof and efficacy enforced by the FDA - Drug Enforcement Agency (DEA); controlled substances; DEA #; institutional protocols - The quick approval of drugs for specific cases by the FDA |
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What are scheduled drugs?
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- Drug prohibition law is prohibition-based law by which governments prohibit, except under licence, the production, supply, and possession of many, but not all, substances which are recognised as drugs, and which corresponds to international treaty commitments in the Single Convention on Narcotic ...
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How are scheduled drugs regulated differently?
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For the potential of abuse, physical or psychological dependence, medicinal use (or not) in the U.S.
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What are the pregnancy categories? If a woman is pregnant, which category may she take most safely/least safely?
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1. What are the pregnancy categories?
Answer: A, B, C, D, and X 2. If a woman is pregnant, which category may she take most safely? Answer: Category A 3. If a woman is pregnant, which category may she take least safely? Category X A- No fetal risk B- No fetal risk in animals; women not tested C- Some fetal risk in animals; benefits may out way the risk D- Fetal risk; in rare cases the benefits may out weigh the risk (mother with cancer) X- No reason to take while pregnant |
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What is the difference between generic and brand name drugs? How are they the same and how are they different?
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- A generic name is agreed upon by the drug company and the United States Adopted Names Council
- generic names start with a uncapitalized letter. For example, diazepam - A brand name is registered with the Patent Office and is used only by the manufacturing company (usually for about 20 yrs) - A brand name begins with a capital letter. For example, Valium - Brand and generic names have the same active ingredients, in the same amount, and have the identical clinical effect - INERT ingredients may vary in the generic drug |
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Illustrate time response curves and doses response curves (see page 8 in the book)
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blank
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What are the mechanisms by which drugs move through the body?
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1. Absorption
2. Distribution 3. Metabolism (biotransformation) 4. Excretion |
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What is the minimal effect of a drug? Why do you care about it?
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1. Minimal effective concentration (MEC) of a drug is the minimal amount of drug in the blood plasma that causes a desired effect
2. We care about it because it may affect the dosing of a drug; know when the drug is going to take effect (MEC); and when the drug is below MEC, which means the drug does not show clinical effect; some drugs may need a loading dose |
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Know the different forms in which drugs may be administered and why we may choose one form over another
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- Tablet (absorbed through the gut)
- Capsule (may bypass the gut and absorbed in the intestines) - Powder (longer shelf-life) |
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What does the pharmacokinetcs of a drug describe? Be very clear about the sequence of events a drug is taken into and then excreted from the body.
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- The movement of drug in the body. From absorption, distribution, metabolism, and excretion from the body.
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Know the routes by which you may administer drugs. Understand why we may need to use different routes for various drugs.
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1. Enteral (oral; absorbed in the gut)
2. Parental (injected with a needle; fastest administration of a drug) 3. Percutaneous (absorbed through the skin; can result in a localized effect) |
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List factors that affect the absorption of drugs
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- ROUTE of administration (enteral, paternal, or percutaneous)
- ABSORBING SURFACE; blood flow; if decrease of blood flow, a decrease of drug absorption - SOLUBILITY of a drug; dissolves in water or fat |
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What does "systemic absorption" mean?
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The drug is absorbed throughout the body
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Explain how pH affects a drug's absorption. How can we change a drug's solubility?
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- pH affects a drugs absorption by being either fat soluble or water soluble. Fat soluble drugs can go directly through a cell membrane, whereas water soluble drugs must "leak" around the cells in the cell membrane
For example: (drug/media) A/A= fat soluble; non-ionized (better absorption) B/B= non-ionized A/B= water soluble; ionized (harder absorption) B/A= ionized |
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How does ph potentially affect excretion of drugs?
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- fat soluble drugs are absorbed faster, so can stay around in the cells longer, whereas water soluble drugs are harder to absorb into the cells, so are potentially excreted faster
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What is protein binding? Explain how it can cause drug-drug interactions.
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- Protein binding; some drugs are bound to protein in the blood plasma. Those drugs that are bound to protein do not cause a clinical effect. Because drugs vary in their ability to bind to plasma, drugs that are less bound to protein plasma may cause drug to drug interactions by causing an increase in clinical effect
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How does protein binding affect volume of distribution?
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Some drugs are "highly" protein bound, so you may need more drug, or a higher dose of drug, to produce more unbound/free drug in the body to cause a clinical effect. The higher the protein binding of a drug, the less volume of distribution
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What is bioavailability? What sort of things could affect bioavailability?
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Bioavailability is metabolism (of a drug)
- The body's attempt to clear the drug from the body Things that affect bioavailability are: - Age - Nutritional status - chronic illness - genetic make-up |
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What is the blood-brain barrier? How do drugs cross it?
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- The barrier to the brain
- fat-soluable |
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What is the placental barrier? If there is a placental barrier, why do we need pregnancy categories?
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1. A semipermeable membrane made up of placental tissues and limiting the kind and amount of material exchanged between mother and fetus <thiazides cross the placental barrier and appear in cord blood—Resident & Staff Physician>
2. Categories that cross the placental barrier are needed because some drugs (i.e. fat soluble drugs) can cross the barrier and potentially affecting the fetus |
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Not all drugs in a person's body may be available to cause a clinical effect . Where is the drug which is available to cause effects? Where might a drug be in the body and be unable to cause any therapeutic effect?
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Cause effect:
- In the blood Not cause effect: - Stored in tissue until released |
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What is metabolism?
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The body's attempt to rid the drug from the body
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What is the primary organ responsible for metabolism of drugs?
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The liver
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List things which may alter a person's ability to metabolize drugs.
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- The ability of liver enzymes to convert drugs to water soluble solutions
- Age - Nutritional status - Chronic illness - Genetics |
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What is the cytochrome P 450 enzyme?
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Liver enzyme
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What is a substrate?
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In biochemistry, a substrate is a molecule upon which an enzyme acts
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What is an inducer and what potential effect does it have on drug plasma levels?
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An inducer speeds up drug metabolism (increase work of the enzyme) but decrease plasma levels of drug
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What is an inhibitor and what potential effect does it have on drug plasma levels?
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An inhibitor slows down drug metabolism (decreases the work of the enzyme) but increases plasma levels of drug
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Inducers
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"Paul's Pecs" (P PECS)
- phenobarbital (Luminal), - phenyton (Dilantin), - ETOH- chronic, - carbamazepine (Tegretol), - smoking |
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inhibitors
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"Chris' Face" (C Face)
- cimetidine (Tagamet) - fluoxetine (Prozac) - allopurinol - calcium channel blockers - erythromycin |
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What is First Pass Effect?
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- drugs absorbed in the gut then to liver
- drugs metabolized in the liver |
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What routes of administration are bypassed by the First Pass Effect?
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- Drugs not absorbed by the gut
For example: - buccal, SL (NOT FIRST PASS EFFECT) - parental (IV, SC, IM) - percutaneous (vaginally, inhalation, TD) |
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Why is First Pass Effect important in a drug's pharmacokinetics?
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Drugs that pass through the liver are metabolized faster
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Are all drugs affected by First Pass Effect?
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- No; drugs that are not absorbed by the gut then sent to the liver are not effected by First Pass Effect
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How does route of administration affect first pass effect?
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Drugs that are processed by the liver are metabolized faster. For example, drugs that are absorbed by the gut then processed to the liver are metabolized faster than drugs that are given via SL or buccal; IV, SQ, vaginally,
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Why do some drugs require a larger dose by mouth than by IV?
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Drugs give by mouth may take longer to be absorbed, distributed, metabolized, and excreted, whereas drugs given via IV are put directly into the blood stream, so they bypass the liver, and are absorbed and distributed very quickly.
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How does a drugs solubility affect excretion?
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Drugs that are water soluble are excreted faster than drugs that are lipid soluble. Water soluble drugs are harder to absorb, so are excreted faster
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What organ is primarily responsible for excretion?
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Kidneys
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How might a person's age affect plasma levels of a drug? Name other things that might affect plasma levels of a drug.
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- Generally, in older adults, metabolism is slower, so plasma levels may be higher
- Other things things that might affect plasma levels are genetics, nutrition, and chronic illnesses |
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What is half-life? What does half-life tell you?
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- Half-life (elimination half-life) of a substance is the time it takes for a drug to lose half of its pharmacologic activity
- When the drug will reach MEC; when to give more drug to maintain therapeutic effect |
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What is drug distribution?
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- It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. In rough terms, drugs with high lipid solubility (non-polar), low rates of ionization or low plasma binding capabilities have higher volumes of distribution than drugs which are more polar, more highly ionized or exhibit high plasma binding in the body's environment
- the total amount of administered drug would have to occupy - Volume of distribution (more drug in the body) may be increased by renal failure (due to fluid retention) and liver failure (due to altered body fluid and plasma protein binding) |
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How is pharmacodynamics different from pharmacokinetics?
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Pharmacodynamics is the MOA of a drug (what it does) and pharmacokinetics is the movement of drug within the body.
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Explain what a drugs mechanism of action is.
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Pharmacodynamics; what a drug does to the body/cells
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What is a cell receptor?
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- protein molecule
- specific proteins located on the cell membrane - receptor= cell binding |
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Once a drug binds to a cell receptor, is this binding permanent?
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No
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What if two drugs are competing for the same cell receptor binding site?
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- The cell with the highest AFFINITY has the advantage.
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What is AFFINITY?
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Affinity is the STRENGTH of the binding of a cell receptor and ligand
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What is a ligand?
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Anything that will bind to the cell receptor (hormones, drugs)
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What is SATURATION?
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- The portion of cell receptors that are OCCUPIED at the time
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What affects cell receptor saturation?
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concentration of a drug on the cell receptors and affinity of the bond
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What are the characteristic of a molecule that affect its affinity for a receptor site?
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- The shape of the molecule and the cell receptor
- The polarization of the molecule and cell receptor Must fit like a puzzle! |
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What if two drugs are competing for the binding site on a plasma protein, what could happen to plasma levels of unbound drug?
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Plasma levels of unbound drug could increase
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If both an agonist and an antagonist are competing for the same cell membrane receptor binding site, what will happen?
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- Less available receptor sites
- The one with the most affinity and saturation will have the most effect - The one with less affinity and saturation has less clinical effect - Might have a decrease in overall clinical effectiveness |
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What characteristic may give a drug a better chance to bind and saturate cell membrane receptors?
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1. Concentration (lots of drug)
2. Affinity (the strength of the bond between the ligand and cell receptor) |
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Explain what saturation of receptors means. Be very sure you understand what can effect saturation.
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- Saturation of receptors means the # of cell receptors that are occupied at a given time.
- Concentration and affinity affect saturation |
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Explain how a drug's MOA may be a drug enzyme interaction
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- If a drug binds to an enzyme, the enzyme speeds up the chemical interactions
- Enzymes (ase) - Drugs can combined with the enzyme or substrate |
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How is a side effect different from an adverse reaction?
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A side effect is a known effect or expected effect of a drug, whereas an adverse reaction is not expected
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What is the difference between a side effect and an allergic reaction?
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A side effect is an unwanted but tolerated and known effect of a drug and an allergic reaction is unexpected and most often serious
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Why do we care about patient's drug allergies?
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So we don't give them drugs that they are allergic to and kill them
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What is an anaphylactic reaction?
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an unexpected reaction to a drug (or something i.e. bee sting) often very serious and in need of immediate medical treatment and intervention
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What is an allergic reaction?
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- It is always adverse and never a "side effect"
- Type I anaphylactic - Immediate (within minutes) - Potentially fatal (IgE) - Immune system causes the anaphylactic reaction - IgE antibody |
