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38 Cards in this Set
- Front
- Back
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List the branches of study
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Pharmacotherapeutics
Pharmacodynamics Pharmacokinetics Toxicology |
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Pharmacotherapeutics
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That branch concerned w/ drugs used to prevent disorders and/or diagnose and treat Dx. "Clinical pharmacology".
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Pharmacodynamics
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Mechanism of action and observable effects, both biochemical and physiological (i.e. how and why the drugs act on the body.)--- interactions between foreign chemicals and living tissues at the molecular and physiological level
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Pharmacokinetics
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Movement of drugs through the body... what the body does to the drug.
Absorption-where and how Distribution-Where? Fluids? Fats? Brain? How? may be tied to plasma proteins Metabolism or bio transformation-activated or inactivated? Where? liver, kidney Excretion-How and where eliminated from the body. |
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Toxicology
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Study of harmful effects
Best one can say: beneficial effects outweigh harmful effects for most patients, most of the time |
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Pharmacology
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Greek:
Pharmako-Drugs, logos-sciens or study of) 1. overlaps many disciplines (biology, physiology, biochemistry, microbiology, psychology...) 2. Has many sub divisions |
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Therapeutic effect
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the effect for which the drug is administered
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Side effect
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any effect of a drug other than the one for which the drug is administered
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Untoward effect
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a side effect regarded as harmful or very unpleasant to the individual.
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3 Cardinal rules of drug action
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1. All drugs are potential poison
Drug- from the Greek word meaning harm- a chemical agent other than food that is capable of interactin w/ living organisms (tissues) to produce biological effects 2. All drugs have more than one effect-all have multiple effects... Therapeutic, side, untoward 3. With few exceptions, drugs do not cure a Dx, they merely relieve the symptoms. Exception: antibiotics, chemotherapeutic agents) |
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1906: Pure Food and Drug Act
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1. Required drugs to be labeled and manufactured according to standards set in U.S.P. and N.F.
2. Listed eleven narcotic and habit-forming drugs and required that they be labeled. 3. Too many loopholes-drugs did not have to be safe or effective 1937 Elixir of Sulfanilamide Incident (Antiinfective) 107 deaths Elixir-good tasting preparation of drugs combined w/ alcohol,sugar, and some aromatic or pleasant smelling substance. solvent used- diethylene glycol (antifreeze) only law company broke was "mislabeling" ...elixir implied alcohol. |
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1938 Federal Food, Drug and Cosmetic Act
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1. Safety insured- Drug companies test for toxicity in animals and in clinical trials before petitioning FDA for approval
2. Quality and purity of origin assured-must conform to standards outlined in two official publications (U.S.P. and N.F.) 3. Labeling improved A. Habit-forming drugs named and strength given; "warning" on label. B. Label must have adequate direction for use; dosages for adults, infants, and children;limitations or contraindications |
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1952 Durham-Humphrey Amendment
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1. Distinguishes prescription drugs (legend drugs: Caution, federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed.) from OTC drugs (no prescription)
2. Expanded laws on dispensing of Rx drugs oral or telephone Rx's; refills vs. renewals. 3. Each state controls physicians license to prescribe non-controlled legend drugs. |
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1962 Kefauver-Harris Drug Amendments
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Drug must be effective as well as safe.
1. Senator Kefauver started investigating drug industry in 1958. 2. Thalidomide incident helped legislation pass. review pg.7 |
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1970 Drug abuse prevention and control act
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Applies to all dependence causing drugs
Obtainable only by Rx (Controlled substance Act) A very comprehensive law: -research into and prevention of drug abuse -Tx and rehabilitation of drug abusers -strengthen law enforcement authority -improve regulation of manufacture and distribution These controlled drugs prescribed only by licensed physician, dentist, veterinarian -apply for federal permission -given registration number- must appear on each Rx, must be renewed every 3 years by department of justice, DEA -Records kept for 2 years |
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Schedule 1
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Use forbidden except for research. All drugs begin here whether destined to become OTC products, or Rx only, or a "controlled" medication
Drugs remain here if no therapeutic use even w/ medical supervision (too high potential for abuse) Ex. Heroin, LSD, Marijuana -Researchers must apply to FDA for clearance to use- obtain "investigational new drug exemption" (IND) |
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Schedule II -IV
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Can be ordered w/ a Rx; physician must renew registration number yearly w/ DEA and Department of Justice
Records kept for 2 years DEA Sets quotas for amount manufactured and distributed through pharmacies and health care agencies. Has responsibility of monitoring distribution and sales of all controlled substances and can request records at any time from physicians, pharmacisits and manufacturers. States help monitor compliance w/ this data collection and supply records requested/ |
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Schedule V
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DEA monitors distribution
Will include "signature" drugs (no Rx necessary)- amount or concentration of narcotic controlled (i.e. codeine in cough syrup.) Pharmacy keeps record of purchaser, address, date for 2 years. Note: California law does not permit schedule V drugs to be dispensed w/o a Rx. Even though federal law allows "signature" drugs, the more strict state law applies in this state.j |
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Schedule Rx writing policy
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Law no longer requires triplicate forms for sched II drugs. As of Jan. 06 California requires that Rx's be written on "tamper resistant security Rx" forms or "security paper" that includes each physician's license #'s and business address. When copied or faxed the word "VOID" appears across the Rx from a hidden watermark. This "Security Paper" is required for all controlled substances Rx written II-V. The state is electronically collecting and complind data on both sched II and sched III drugs and placing them in a database in the public domain that will provide info on physicians and the Rx they write. Although individual pt data is nto publically accessible, once yearly , physicians may request info on their pts as to sched II and sched II Rx filled. Note that this system meets the Federal DEA requirement to follow controlled substances from site of manufacture through physicians and pharmacies to the pts.
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Main Points
Sched II |
High potential for abuse, may lead to severe psychological or physiological dependence.
Ex morphine, methadone, secobarbial (Seconal-short acting, lipid soluable, barbiturate,) amphetamines Rx- may be for 30 day supply (Max - May not be refilled. In an emergency or "managed care" setting, prescriptions may be renewed by telephone, but a written Rx must follow withing 72 hrs. This is NOT a Refill but is an entirely new order "reorder" Dec. 2007: DEA amended to allow practitioners to provide individual pts w/ multiple Rx for a sched II drug to allow a 90 day supply (methylphenidate is an example) |
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main points sched III
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Abuse potential medium ...I.e Less than I and II but more than IV
-moderate to low physical dependence -perhaps high psychological dependence -Ex. many barbituartes (especially longer acting), drugs combined with codeine or other narcotics (higher concentration than in cough syrup) Rx- Must renew ("rewrite") Rx's for schd III and IV meds after 6 months or 5 refills -May renew by telephone (if pharmacist writes down immediately) or FAX ("reorder") -Physicicans use a regular Rx form for the FAX so the word "VOID" does not appear, but must write in the required info and licenses on the form to make it legal. |
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Main points Shed IV
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Lower potential for abuse
-may lead to limited physical or psychological dependence -ex. Some tranquilizers, meprobamate, chlordiazepoxide (Librium), diazepam (valium) Rx- Same as for Sched III but can be different in penalties for illegal possession. |
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Because controlled substances require Rx, the label of II, III, and IV must include:
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"Caution: Federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed."... the "legend"
Often is abbreviated to "Rx only" |
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FDA
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Under HHS (formerly HEW)
Supervises and controls research and manufacture of all drugs. I.e. reasearchers mus apply to FDA before studying new drug in humans a. FDA must approve studies before drug can be marketed b.Quality control in the manufacturing process c. Certain biologics like serums and vaccines, but no longer insulin and antibitoics (changed 1997) must be certified batch by batch. |
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Public Health Service
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Also of HHS
Helps with biologics. If company makes serums, antitioxins, etc. Department of Public Health -inspects and licenses establishment -examines and licenses products |
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D.E.A.
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Under Department of Justice
Established in 1973 by Executive Order (takes over for Department of Treasury)- controls distribution and sale of all drugs, i.e. nation's sole legal drug enforcement agency. Note: this division of drug manufacuture and control is important and a big improvement since it separates drug enforcement from approval of new drugs |
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Federal Trade Commission
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Controls misleading advertising for OTC.
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Who controls advertising for Rx products
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FDA
Federal Trade commission controls advertising for OTC drugs only |
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Basic Procedure
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Drug company usese animal trial data to apply to the FDA for investigational ne drug (IND) approval. Once license obtained may begin human trials.
Phase I: Healthy volunteers. Record all data in areas such as purity, bioavailability, potency, efficacy, safety, toxicity. Phase II: Test on relatively few individuals (at most a several hundred) who need the drug therapeutically. Continue monitoring safety and toxicity. Add info on potency and efficacy, as well as short term side effects and risks. Phase III: Expanded clinical trials (several hundred to several thousand people). Provides info about more rare adverse effects. Provides additoanl info regarding effectiveness and safety in order to establish overall benefit vs. risk relationship. FDA then reevaluates. If favorable, company may file a New Drug Application (NDA) Phase IV: Voluntary monitoring of drug through the first years of its use. Company collects and monitors data on the product. Post-approval research. |
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efficacy
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Maximum effect produced by a drug. i.e. how effective it is at producing a given pharmacologic effect. Note: has nothing to do with the dose needed to achieve this effect
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Potency
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Amount of drug necessary to produce a given pharmacologic effect. Note: has nothing to do with the maximum effect that the drug can produce.
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Therapeutic dose
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is used to mean the same thing as effective dose, i.e. the amount of drug necessary to produce a therapeutic effect.
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Therapeutic index=
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Lethal dose 50/ Effective dose 50 Can only be calculated in animals.
Indicates relative margin of safety Desire a high number In humans, verify using dose for adverse effects in place of lethal dose. |
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Additive
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when the combined effect of two or more drugs administered at the same time is equal to the sum of their individual effects (2 + 2= 4)
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Antagonistic
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two or more drugs are given together and the combined effect are less than the algebraic sum of the individual effects (2+2=1)
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Synergistic
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When the combined effect of two or more drugs administered at the same time is greater than anticipated from the sum of their individual effects (2+2=6)
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Potentiation
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The increase in effectiveness seen when a drug that has no effect by itself increases the effectiveness of a different drug (0+2=3)
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Teratogenic
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capable of causing birth defects
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