Pharmacology Unit 1

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Pharmacology Unit 1
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  1. Pharmacotherapeutics
    • A branch of pharmacology
    • "The clinical aspect of drug therapy/pharmacology" (for humans)

    • -Branch concerned w/ drugs used to prevent disorders &/or diagnose and treat disease
  2. Pharmacodynamics
    • -Mechanism of action and observable effects, both: biochemical & physiological
    • Interactions between foreign chemicals w/ living tissues at a molecular & physiological level
    • "Shows us how drug work"
    •   (How/why drug works or act on the body)

    • (Receptor theory - Most drugs bind at a target molecules called receptors
    •   Predominant way drugs acts in body
    •     How individual drug molecules will bind to specific receptor
    •     To how a drug work & physiological effects
    •   These receptors found on target tissues/organs)
  3. Receptor theory
    • Most drugs bind at a target molecules called receptors 
    • Predominant way drugs acts in body   
    • -How individual drug molecules will bind to  specific receptor
    • To how a drug work & physiological effects 
    • These receptors found on target tissues/organs
  4. Pharmacokinetics
    -Movement of drugs through (into, around, & out of) the body

    • What the body does to the drug: (Dynamic)
    • 1) Absorption
    •       -where & how
    • 2) Distribution
    •      -where (fluids? Fats? blood brain barrier?)
    •      -how (dissolve in plasma, or maybe tied to plasma proteins)
    • 3) Metabolism or Biotransformation (changed)
    •      -active/inactivate?
    •      -where?
    •           >Majority of metabolism or changes is at Liver (primarily), or kidney
    • 4) Excretion
    •      -how and where drug eliminated from body (how long it takes: primarily by Kidney, but also GI tract & etc)
  5. Toxicology
    • (ALL DRUGS HAVE CONSEQUENCES)
    • -Study of harmful effects of drugs (differ per drug/per person)
    • Best one can say: "Beneficial effects outweigh harmful effects: for most patients, most of the time."
  6. What are the branches of pharmacology?
    • Pharmacotherapeutics
    • Pharmacodynamics
    • Pharmacokinetics
    • Toxicology
  7. What are the difference between therapeutic effect, side effect, and toxic effect?
    • 1) Therapeutic effects      
    • –the effect for which the drug is administered
    •         (why it is given)

    • 2) Side effects
    • –any effect of a drug other than the one
    • for which the drug is administered
    •  Ex: dry mouth etc.
    •          Or not so bad, anti-inflammatory
    •   
    • 3) Toxic (untoward) effects
    • – a side effect regarded as harmful or very
    • unpleasant to the individual
    •  [Toxicity to the ear, or nephrotoxicity (harmful for the kidney)]
  8. Therapeutic effects
    • the effect for which the drug is
    • administered
    •  (why it is given)
  9. Side effects
    • –any effect of a drug other than the one
    • for which the drug is administered

    • Ex: dry mouth etc.
    •       Or not so bad, anti-inflammatory
  10. Toxic (untoward) effects
    • a side effect regarded as harmful or very
    • unpleasant to the individual
    •        (Toxicity to the ear, or nephrotoxicity (harmful for the kidney)
  11. What are the 3 cardinal rules (or 3 general rules) of drug action?
    • 1) Cardinal Rule 1
    •   -ALL drugs are potential poison

    •   Drug (Greek word meaning harm)
    •      -a chemical agent other than food that is capable of interacting* w/ living organisms to produce biological effects
    •      (interaction*: how drug is going to affect a living organism tissue)


    • 2) Cardinal Rule 2
    • – ALL drugs have multiple effects
    •    For each drug group:  
    •      a) several therapeutic effects
    •            (ex: aspirin = pain reliever/ analgesic?, decrease fever/ antipyretics, anti-inflammation, platelet aggregation inhibitor (keeps platelets from sticking together)
    •      b) & several side effects
    •           (ex: aspirin = hard on stomach, ears)

    •     
    • Cardinal Rule 3
    • – (w/ few exceptions) Drugs DO NOT CURE a
    • disease
    •     Instead: relieves symptoms
    •       Exceptions:
    •         a) Antibiotics – (eliminate invading microbe)
    •         b) Maybe chemotherapeutic agents – (if eradicate cancer = patient survives)
  12. Cardinal Rule 1
    –ALL drugs are potential poison

    • Drug (Greek for: harm)
    •     -a chemical agent other than food that is capable of interacting* w/ living organisms to produce biological effects
    • (interaction*: how drug is going to affect living organism tissue)
  13. Cardinal Rule 2
    • – ALL drugs have multiple effects
    •    For each drug group:  
    •      (a) several therapeutic effects
    •           (ex: aspirin = pain reliever/ analgesic?, decrease fever/ antipyretics, anti-inflammation, platelet aggregation inhibiter (keeps platelets from sticking together)
    •      (b) & several side effects
    •          (ex: aspirin = hard on stomach, ears)
  14. Cardinal Rule 3
    • – (w/ few exceptions) Drugs DO NOT CURE a
    • disease
    •   Instead: relieves symptoms
    •     Exceptions:
    •       a) Antibiotics – (eliminate invading microbe)
    •       b) Maybe chemotherapeutic agents – (if eradicate cancer = patient survives)
  15. What are the major laws passed in the US and the significant legislative outcomes?
    • 1) 1906 - Pure Food & Drug Act
    •   (1st law on drugs/ improved LABELING)
    •   -REQUIRED drugs to be labeled & manufactured according to standards set in USP & NF
    •   -LISTED 11 narcotic & habit-forming drugs: which required to be labeled
    •   Too many loopholes: drugs DIDN'T have to be SAFE or EFFECTIVE
    •   (1901: 10 kids died during diphtheria epidemic by false serum from infected horse)

    • 2) 1938 - Federal Food, Drug, and Cosmetic Act
    •   -SAFETY INSURED- test required before petitioning FDA for approval to market drug:
    •     a) Toxicity in animals
    •     b) Human clinical trials
    •     (need more than labels, but also safety insured = test needed)
    •   -QUALITY and PURITY of origin assured
    •         a) most conform to standards outlined in 2 official publications (USP and NF)
    •   -LABELING approved
    •        a) habit forming are labeled w/ WARNING
    •        b) DIRECTIONS for use...
    •             i) Dosages for adults, child, and infants
    •            ii) limitations or contraindications
    •   [Due to 1937 Another "Incident": Elixir of Sulfanilamide (Anti-infective Agent)
    •      -107 deaths:
    •      -Elixir: good tasting preparation of drugs, combined w/ alcohol, sugar, & some nice smelling substance (aromatic)
    •      -Solvent used to dissolve Sulfanilamide: diethylene glycol (antifreeze mixture)
    •      -Only law company broke: "mislabeling"/ elixir implied alcohol]

    • 3) 1952 - Durham-Humphrey Amendment
    •     -(1st time to) Distinguishes Prescription vs OTC (over-the-counter drugs)
    •        a) Prescription drugs: [has LEGEND* drugs: "Caution, Federal law prohibits the transfer of this drugs to any person other than the patient whom it was prescribed.]
    •         (are drugs that can't be safely used w/o medical supervision = needs to be prescribed by licensed practitioner)
    •         b) vs over-the-counter drugs (OTC)
    •    -Expanded dispensing laws for prescription drugs
    •         a) oral or telephone prescriptions
    •         b) refills
    •    -State controls physicians license to prescribe: non-controlled legend drugs ["Controlled Substances" disgnated in 1970s]

    • 4) 1962 - Kefauver-Harris Drug Amendments
    •     -drug Must BE EFFECTIVE as well as SAFE
    •       >Senator Kefauver start investigating drug industry in 1958
    •           a)Thalidomide incident helped legislation pass (doesn't work: sleeping pill for pregnant women = cause birth defects)
    •       >Safety also improved!
    •          a) Need more animal data prior human testing approved
    •          b) Pregnant animal test prior market to pregnant women
    •          c) Drug's effective/usefulness must outweigh dangers
    •    -Significance of Effectiveness
    •        a) No drugs is completely safe
    •        b) Drug interactions may occur
    •        c) May prevent patient from getting effective help

    • [Over-the-counter (OTC) drugs also cause problems:
    •     Problems:
    •        a) OTC drug companies change labels often
    •        b) Deal w/ symptoms, & not for traceable to specific disease
    •     Solutions:
    •        a) Define 25 categories of drugs
    •        b) List of acceptable active ingredients & certain combinations
    •        c) List acceptable dosage ranges, indications for use, and directions

    • Narcotic Laws and Drug Controls:
    • 5) 1970 - Drug Abuse Prevention & Control Act "Controlled Substance Act"
    •    (1st time drugs categories based on abuse/addiction)
    •   -Applies to ALL dependence causing drugs
    •       No longer just narcotics
    •        Include amphetamines, barbiturates, Valium ®, etc
    •   -Obtainable only by prescription or “federal permission” (see Schedule I&V discussion)
    •      ***Not a simple prescription medication***
    •   -A very comprehensive law:
    •     (a) Research into & prevention of drug abuse
    •     (b) Treatment & retaliation of drug abusers
    •     (c) Strengthen law enforcement authority
    •     (d) Improve regulation of manufacture and distribution
    •   -Controlled drugs prescribed only by listened physician, dentist, veterinarian
    •    (a) Apply for federal permission
    •    (b) Given registration number
    •       (i) Must appear on each prescription
    •      (ii) Renewed each year by Department of Justice, Drug Enforcement Administration
    •    (c) Records kept 2 years
    •      (i) Note: some states allow nurses to prescribe some medications under a physician’s supervision.

    1.      California currently has nurse practitioners/physician’s assistants
  16. 1906 - Pure Food & Drug Act
    • (1st law on drugs/ improved LABELING)
    •   -REQUIRED drugs to be labeled & manufactured according to standards set in USP & NF
    •   -LISTED 11 narcotic & habit-forming drugs: which required to be labeled
    •   Too many loopholes: drugs DIDN'T have to be SAFE or EFFECTIVE
    •   (1901: 10 kids died during diphtheria epidemic by false serum from infected horse)
  17. 1938 - Federal Food, Drug, and Cosmetic Act
    •   -SAFETY INSURED- test required before petitioning FDA for approval to market drug:
    •     a) Toxicity in animals
    •     b) Human clinical trials
    •     (need more than labels, but also safety insured = test needed)
    •   -QUALITY and PURITY of origin assured
    •         a) most conform to standards outlined in 2 official publications (USP and NF)
    •   -LABELING approved
    •        a) habit forming are labeled w/ WARNING
    •        b) DIRECTIONS for use...
    •             i) Dosages for adults, child, and infants
    •            ii) limitations or contraindications
    •   [Due to 1937 Another "Incident": Elixir of Sulfanilamide (Anti-infective Agent)
    •      -107 deaths:
    •      -Elixir: good tasting preparation of drugs, combined w/ alcohol, sugar, & some nice smelling substance (aromatic)
    •      -Solvent used to dissolve Sulfanilamide: diethylene glycol (antifreeze mixture)
    •      -Only law company broke: "mislabeling"/ elixir implied alcohol]
  18. 1952 Durham-Humphrey Amendment
    • -(1st time to) Distinguishes Prescription vs OTC (over-the-counter drugs)
    •        a) Prescription drugs: [has LEGEND* drugs: "Caution, Federal law prohibits the transfer of this drugs to any person other than the patient whom it was prescribed.]
    •         (are drugs that can't be safely used w/o medical supervision = needs to be prescribed by licensed practitioner)
    •         b) vs over-the-counter drugs (OTC)
    •    -Expanded dispensing laws for prescription drugs
    •         a) oral or telephone prescriptions
    •         b) refills
    •    -State controls physicians license to prescribe: non-controlled legend drugs ["Controlled Substances" disgnated in 1970s]
  19. 1962 Kefauver-Harris Drug Ammendments
    • -drug Must BE EFFECTIVE as well as SAFE
    •       >Senator Kefauver start investigating drug industry in 1958
    •           a)Thalidomide incident helped legislation pass (doesn't work: sleeping pill for pregnant women = cause birth defects)
    •       >Safety also improved!
    •          a) Need more animal data prior human testing approved
    •          b) Pregnant animal test prior market to pregnant women
    •          c) Drug's effective/usefulness must outweigh dangers
    •    -Significance of Effectiveness
    •        a) No drugs is completely safe
    •        b) Drug interactions may occur
    •        c) May prevent patient from getting effective help
  20. What are the problems OTC (over-the-counter drugs) caused, and what were the solutions?
    • Problems:
    •        a) OTC drug companies change labels often
    •        b) Deal w/ symptoms, & not for traceable to specific disease
    • Solutions:
    •        a) Define 25 categories of drugs
    •        b) List of acceptable active ingredients & certain combinations
    •        c) List acceptable dosage ranges, indications for use, and directions
  21. 1970- Drug Abuse Prevention & Control Act
    "Controlled Substance Act"
    • [Narcotic Laws and Drug Controls:]
    • (1st time drugs categories based on abuse/addiction)
    •   -Applies to ALL dependence causing drugs
    •       No longer just narcotics
    •        Include amphetamines, barbiturates, Valium ®, etc
    •   -Obtainable only by prescription or “federal permission” (see Schedule I&V discussion)
    •      ***Not a simple prescription medication***
    •   -A very comprehensive law:
    •     (a) Research into & prevention of drug abuse
    •     (b) Treatment & retaliation of drug abusers
    •     (c) Strengthen law enforcement authority
    •     (d) Improve regulation of manufacture and distribution
    •   -Controlled drugs prescribed only by listened physician, dentist, veterinarian
    •    (a) Apply for federal permission
    •    (b) Given registration number
    •       (i) Must appear on each prescription
    •      (ii) Renewed each year by Department of Justice, Drug Enforcement Administration
    •    (c) Records kept 2 years
    •      (i) Note: some states allow nurses to prescribe some medications under a physician’s supervision.

    1.      California currently has nurse practitioners/physician’s assistants
  22. What are controlled substances and how do they differ from “regular” prescription drugs?
    • A) Schedule of Controlled Drugs
    •    i) I- most stringent/ V- least strict
    •   ii) Placement changed by Attorney General (Administrative action)
    •  iii) Based upon:
    •      (1) –medical usefulness
    •      (2) –potential abuse

    • B) Same:
    •    i) Both going to have a “Legend”
    •        (1) “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

    • C) Difference: “Regular” Legend vs Controlled Drugs
    •   i) “Regular” Legend Drugs
    •      (1) State Permission
    •      (2) Not likely to be abused
    •          (a) Antibiotics, cortisone shots, bronchodilators, BP medications
    •   ii) Controlled Substances
    •      (1) Federal Permission (DEA under Dept. of Justice)
    •      (2) Registration # renewed yearly
    •      (3) Records kept 2 years
    •      (4) Abuse penalties greater
  23. Schedule of Controlled Drugs
    • A) Schedule of Controlled Drugs
    •    i) I- most stringent/ V- least strict
    •   ii) Placement changed by Attorney General (Administrative action)
    •  iii) Based upon:
    •      (1) –medical usefulness
    •      (2) –potential abuse
  24. Some characteristics of "Regular" Legend Drugs
    • Going to have a “Legend”
    •        (1) “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

    • Difference:
    •      (1) State Permission
    •      (2) Not likely to be abused
    •          (a) Antibiotics, cortisone shots, bronchodilators, BP medications
  25. Some characteristics of Controlled Substances
    • Going to have a “Legend”
    •        (1) “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

    • Difference:
    •      (1) Federal Permission (DEA under Dept. of Justice)
    •      (2) Registration # renewed yearly
    •      (3) Records kept 2 years
    •      (4) Abuse penalties greater
  26. What are the schedule? How drugs are place on the schedule?
    • Schedule I
    • -use is forbidden, except for research
    • -All drugs starts here
    • -Drugs remain here: if no therapeutic use even w/ medical supervision
    •    (if too high for abuse)
    •    [California law- possession less than 1 oz marijuana is misdemeanor $100 max fine]
    •  >Researchers must apply to FDA for clearance to use
    •  >Obtain IND- "investigational new drug exemption"


    • Schedule II-IV
    • -ordered w/ a prescription: Physicians must renew registration# yearly w/ Drug Enforcement Administration in Department of Justice (DEA) [must have DEA #]
    • -Records kept for 2 years
    • -DEA sets quotas for amount manufactured/distributed
    •   >Monitors distribution & sales of all controlled substance
    •   >May request records any time from physicians, pharmacist, manufacturers, etc
    •   >State help monitor, collect data, supply records (i.e. new "security paper")
    • -Distinguish by:
    • (1)   Schedule II
    •   (a)    High potential for abuse
    •     (i)     Severe psychological or physiological dependence
    •     (ii)   Ex: morphine, methadone, secobarbital (short acting, lipid
    • soluble, barbiturate), amphetamines
    •   (b)   Prescription may not be refilled
    •     (i)     Maximum 30 day supply
    •    (ii)   Then must rewrite the prescription on “security paper”
    •   (c)    Emergency in managed care setting:
    •     (i)     Prescriptions may be renewed by telephone…but
    •    (ii)   Written prescription must follow w/in 72 hours
    • (2)   Schedule III
    •   (a)    –abuse potential medium
    •    (i)     Less than I and II, but more than IV
    •   (b)   Perhaps high psychological dependence
    •    (i)     Ex: many of the barbiturates (especially longer acting), drugs
    • combined w/ codeine or other narcotics (higher concentration than in cough syrup)
    •   (ii)   Must renew prescription for schedule III & IV medication after 6 months or 5 refills
    •  (iii) May be renewed by telephone or FAX (but need non-security form w/ required license numbers and info)
    • (3)   Schedule IV
    •   (a)    –lower potential for abuse
    •   (b)   May lead to limited physical or psychological dependence
    •     (i)     Ex: include some tranquilizers:
    •        1.      Meprobamate
    •        2.       Chlordiazepoxide (Librium®)
    •        3.      Diazepam (Valium®)
    •   (c)    Same prescription issues as Schedule III but different penalties for  illegal possession
    • (4)   Schedule III and IV
    •   (a)    Do not differ in how prescribed (can be different in penalties for illegal possession)
    •   (b)   Prescription  can be refilled up to 5 times, good only for 6 months, may be given to pharmacist by telephone (if pharmacist writes down immediately).
    •     (i)     Q: how are these the same… and how are they different from regular prescription drugs?


    • Schedule V
    • –includes “signature” drugs
    • No prescription necessary (though still federally controlled)
    •   (1)   Small amount or concentration of controlled narcotic
    •     (a)    (i.e. codeine in cough syrups)
    • Pharmacy keeps record purchaser, address, date, etc. for 2 years
    •   (1)   Note: California law doesn’t permit Schedule V drugs to be dispensed w/out a prescription
    •     (a)    Even though federal law allows “signature” drugs, the more strict state law applies in this state
  27. What are the prescription writing policies for schedule drugs?
    • -Triplicate forms no longer required for Schedule II
    • -Tamper resistant security prescription forms required in California for Schedules II-V
    • -State compiling data on Schedule II & III
    •   (1)   Web-searchable database but not by patient
    •   (2)   Physician may request individual patient data per year
  28. Characteristics of Schedule I drugs?
    • -use is forbidden, except for research
    • -All drugs starts here
    • -Drugs remain here: if no therapeutic use even w/ medical supervision
    •    (if too high for abuse)
    •    [California law- possession less than 1 oz marijuana is misdemeanor $100 max fine]
    •  >Researchers must apply to FDA for clearance to use
    •  >Obtain IND- "investigational new drug exemption"
  29. Characteristics of Schedule II drugs?
    • Schedule II-IV
    • -ordered w/ a prescription: Physicians must renew registration# yearly w/ Drug Enforcement Administration in Department of Justice (DEA) [must have DEA #]
    • -Records kept for 2 years
    • -DEA sets quotas for amount manufactured/distributed
    •   >Monitors distribution & sales of all controlled substance
    •   >May request records any time from physicians, pharmacist, manufacturers, etc
    •   >State help monitor, collect data, supply records (i.e. new "security paper")
    • -Distinguish by:
    • (1)   Schedule II
    •   (a)    High potential for abuse
    •     (i)     Severe psychological or physiological dependence
    •     (ii)   Ex: morphine, methadone, secobarbital (short acting, lipid
    • soluble, barbiturate), amphetamines
    •   (b)   Prescription may not be refilled
    •     (i)     Maximum 30 day supply
    •    (ii)   Then must rewrite the prescription on “security paper”
    •   (c)    Emergency in managed care setting:
    •     (i)     Prescriptions may be renewed by telephone…but
    •    (ii)   Written prescription must follow w/in 72 hours
  30. Characteristics of Schedule III drugs?
    • Schedule II-IV
    • -ordered w/ a prescription: Physicians must renew registration# yearly w/ Drug Enforcement Administration in Department of Justice (DEA) [must have DEA #]
    • -Records kept for 2 years
    • -DEA sets quotas for amount manufactured/distributed
    •   >Monitors distribution & sales of all controlled substance
    •   >May request records any time from physicians, pharmacist, manufacturers, etc
    •   >State help monitor, collect data, supply records (i.e. new "security paper")
    • -Distinguish by:
    • (2)   Schedule III
    •   (a)    –abuse potential medium
    •    (i)     Less than I and II, but more than IV
    •   (b)   Perhaps high psychological dependence
    •    (i)     Ex: many of the barbiturates (especially longer acting), drugs
    • combined w/ codeine or other narcotics (higher concentration than in cough syrup)
    •   (ii)   Must renew prescription for schedule III & IV medication after 6 months or 5 refills
    •  (iii) May be renewed by telephone or FAX (but need non-security form w/ required license numbers and info)
    • (4)   Schedule III and IV
    •   (a)    Do not differ in how prescribed (can be different in penalties for illegal possession)
    •   (b)   Prescription  can be refilled up to 5 times, good only for 6 months, may be given to pharmacist by telephone (if pharmacist writes down immediately).
    •     (i)     Q: how are these the same… and how are they different from regular prescription drugs?
  31. Characteristics of Schedule IV drugs?
    • Schedule II-IV
    • -ordered w/ a prescription: Physicians must renew registration# yearly w/ Drug Enforcement Administration in Department of Justice (DEA) [must have DEA #]
    • -Records kept for 2 years
    • -DEA sets quotas for amount manufactured/distributed
    •   >Monitors distribution & sales of all controlled substance
    •   >May request records any time from physicians, pharmacist, manufacturers, etc
    •   >State help monitor, collect data, supply records (i.e. new "security paper")
    • -Distinguish by:
    • (2)   Schedule IV
    •   (ii)   Must renew prescription for schedule III & IV medication after 6 months or 5 refills
    •  (iii) May be renewed by telephone or FAX (but need non-security form w/ required license numbers and info)
    • (3)   Schedule IV
    •   (a)    –lower potential for abuse
    •   (b)   May lead to limited physical or psychological dependence
    •     (i)     Ex: include some tranquilizers:
    •        1.      Meprobamate
    •        2.       Chlordiazepoxide (Librium®)
    •        3.      Diazepam (Valium®)
    •   (c)    Same prescription issues as Schedule III but different penalties for  illegal possession
    • (4)   Schedule III and IV
    •   (a)    Do not differ in how prescribed (can be different in penalties for illegal possession)
    •   (b)   Prescription  can be refilled up to 5 times, good only for 6 months, may be given to pharmacist by telephone (if pharmacist writes down immediately).
    •     (i)     Q: how are these the same… and how are they different from regular prescription drugs?
  32. Schedule V characteristics?
    • –includes “signature” drugs
    • No prescription necessary (though still federally controlled)
    •   (1)   Small amount ar concentration of controlled narcotic
    •     (a)    (i.e. codeine in cough syrups)
    • Pharmacy keeps record purchaser, address, date, etc. for 2 years
    •   (1)   Note: California law doesn’t permit Schedule V drugs to be dispensed w/out a prescription
    •     (a)    Even though federal law allows “signature” drugs, the more strict state law applies in this state
  33. What are the branches of government that relate to pharmacology, and their main responsibility?
    • Under Health and Human Services (Formerly HEW)
    • A) Food and Drug Administration (FDA)
    •  (1)   –supervises and controls research
    • and manufacture of all drugs
    •    (a)    FDA must approve studies before drug can be marketed
    •    (b)   Quality control in the manufacturing process
    •    (c)    Some biologics like serums and vaccines must be certified batch by batch
    •       (i)     Note: modified in 1997: insulin & antibiotics removed from the requirement
    •  (2)   –controls advertising for prescription products

    • B) Public Health Service
    •  (1)   –helps w/ some biologics (Serums, antitoxins, etc.)
    •  (2)   Inspects and licenses establishment
    •  (3)   Examines and licenses products

    • Department of Justice
    • A) Drug Enforcement Administration (DEA)
    •  (1)   Establish in 1973 by Executive Order (takes over Department of Treasury)
    •  (2)   –controls distribution and sale of all drugs
    •     (a)    i.e. nation’s sole legal drug enforcement agency

    • Department of Commerce
    • A) Federal Trade Commission
    •  (1)   –controls misleading advertising for OTC products

    • Summary:
    • Division of drug research & manufacture VS distribution & sale is important
    • (1) Separates drug enforcement from approval of new drugs
  34. Difference between efficacy and potency?
    • A) Efficacy
    • -Maximum effect produced by a drug
    • -How effective it is at producing a desired pharmacologic response
    •   (1)   NOT RELATED TO DOSE

    • B) Potency
    • -Amount of drug necessary to produce a given pharmacologic effect
    •   (1)   NOT RELATED TO MAXIMUM EFFECT that drug can produce
  35. What is the significance of the therapeutic
    index? How is it calculated?
    • T.I. = lethal dose50/effective dose50
    • -Can only be calculated in animals
    • -Verify in humans by using dose for adverse effects in place of lethal dose
    • -Indicates relative margin of safety
    • -Desire a high number
  36. Define Efficacy?
    • -Maximum effect produced by a drug
    • -How effective it is at producing a desired pharmacologic response
    •   (1)   NOT RELATED TO DOSE
  37. Define Potency
    • -Amount of drug necessary to produce a given pharmacologic effect
    •   (1)   NOT RELATED TO MAXIMUM EFFECT that drug can produce
  38. Define Dose
    – amount of drug or treatment given or taken at one time
  39. Define Effective dose
    • – the amount of a drug necessary to produce
    • a therapeutic effect

    (1)   ED50
  40. Define Therapeutic Dose
    • (similar to effective dose)- i.e. amount of
    • a drug necessary to produce a therapeutic effect
  41. Define Toxic dose
    – the amount of a drug necessary to produce untoward effects or symptoms of poisoning
  42. Define Lethal dose
    amount of a drug that will cause death

    (1)   LD50
  43. define term additive
    • The combined effect of 2 or more drugs
    • administered at the same time is equal to the sum of their individual effects
    • (1)   (2+2 =4)
    •   (a)    Ex: Aspirin + Codeine
    •   (b)   (doesn’t affect each other whatsoever)
  44. Define term antagonistic
    • The combined effects of 2 or more drugs
    • given together are less than the algebraic sum of the individual effects
    •  (1)   2+2=1
    •  (2)   How about 2+2=3?
    •  (3)   Ex: Penicillin + Tetracycline
    •    (a)    (one drug makes other weaker)
  45. Define term synergistic
    • The combined effects of 2 or more drugs
    • administered at the same time is greater than the sum of their individual effects
    • (1)    2+2=6
    • (2)   Examples are rare:
    •    (a)    Chloral hydrate + other depressant
    •    (b)   (very prevalent unfortunately)
    •    (c)    (any time you add depressants together = more depression
    •       (i)     & potential for fatal respiratory depression)
  46. Define term potentiation
    • A drug that has no effect by itself, increases the effectiveness of a different drug
    • (1)   0+2=3
    • (2)   Ex: Penicillin + Probenecid
    •   (a)     (Probenecid = can’t eliminate penicillin from kidneys (less permeable to penicillin = there longer)
  47. What is the process for drug approval?
    • Average drug: takes 12 years and $200 million
    • Needs: Laboratory testing and Animal trials
    •   i) many drugs do not pass this stage
    •   ii) data are used to apply to FDA for investigational new drug (IND) approval
    •      a) Preclinical Testing requirement prior to IND is granted (for new drug to be tested on humans)
    •         1) drugs are evaluated for: toxicities, pharmacokinetic properties, & potentially useful biologic effects
    •         2) takes 1-5 years
    •     b) FDA then reevaluates:
    •         1) if favorable: company may file New Drug Application (NDA)
    •             >then FDA work to streamline approval of product

    • Once license is obtained, may start human trials: Phases I-III (or IV)
  48. Human clinical trial: Phase I
    • Who? -Healthy volunteers
    • What are researchers looking for?
    •  i) Main: Purity, bioavailability, safety, toxicity
    • ii) Efficacy & potency if subject is also a patient
  49. Randomized Clinical Trials
    • Used to evaluate all new drugs
    • 3 distinguishing features
    •   1) Use of controls
    •   2) Randomization
    •   3) Blinding
    •      i) single blind - only subjects "blinded"
    •      ii) double blind - both subjects & researchers "blinded" (best type)
  50. What is: investigational new drug (IND)
    • Approval for clinical testing (for new drug to be tested on humans) by the (FDA) Federal Drug Agency

  51. Human clinical trial: Phase II
    • Who? - Tested on relatively few individuals who need the drug therapeutically
    • Why?
    •   -Continue monitoring safety and toxicity
    •   -Add information on potency and efficacy
  52. Human clinical trial: Phase III
    • Who? -expanded clinical trials on patients who can benefit from the drug
    • Why?
    •    -more data on usefulness
    •    -provides information about more rare adverse effects
  53. Human clinical trial: Phase IV
    • -Voluntary monitoring of drug though the first years of use
    • -Company collects and monitors data on the product
  54. What are the limitations in the design of the experiment?
    • 1) Placebo - an inactive substance given:
    •     i) to satisfy a patient's demand for medication
    •    ii) as part of an experiment.... "a control"
    • 2) Double blind experiment
    •    i) neither the patient nor the investigator, knows who has received the placebo

    • Test vs random sample groups may be biased
    • Need to match:
    • 1) Age
    • 2) Severity of disease
    • 3) Willingness to cooperate

    • A) If testing more than 1 drug:
    •   1) give both to same subject
    •      i) serves as own control
    •      ii) "Crossover Study" - order of drug administration randomized,
    •          i.e. some patients get control medication 1st, others get the test substance first
    • B) Sometimes "control" drug is mixture that mimics side effects of test drug, but has no therapeutic value
    • C) Good study should compare test drug to current drug of choice
  55. Placebo
    • -an inactive substance given:
    •     i) to satisfy a patient's demand for medication
    •    ii) as part of an experiment.... "a control"
  56. Double blind experiment
    • -neither the patient nor the investigator, knows who has received the placebo
  57. If testing more than 1 drug
    • A) give both to same subject
    •      i) serves as own control
    •      ii) "Crossover Study" - order of drug administration randomized,
    •          i.e. some patients get control medication 1st, others get the test substance first
    • B) Sometimes "control" drug is mixture that mimics side effects of test drug, but has no therapeutic value
    • C) Good study should compare test drug to current drug of choice
  58. Define: Crossover study
    •  "Crossover Study" - order of drug administration randomized,
    •          i.e. some patients get control medication 1st, others get the test substance first
  59. How?: not always direct correlation between animal & human studies
    • 1) Species differences
    •     a) other organisms sometimes don't respond same way
    •     b) dose may differ markedly from 1 species to another
    • 2) Can't always detect untoward effects in animals
    •      a) 1966 study on 11k patients identified 45 most common drug-induced side effects
    •            i) half would not be recognized in animals
    • 3) Can't always recognize therapeutic effectiveness in animals either, especially for CNS drugs
    •      -anti-anxiety
    •      -anti-depressant
  60. Long term effects- hard to study
    • A) Drug on market before testing complete
    •   ex: diethylsilbesterol (DES) taken by 4 million mothers,
    •       >found out by 1970 Massachusetts General Hospital's 2 physician: young women of similar age w/ vaginal cancer
    •       >sons have greater infertility & testicular disorders
    • B) Testing should continue - medical personnel should stay alert to undocumented side effects
  61. How?: Individual differences in humans obscure test results
    not every patient responds in the same way or same degree: sometimes appear "better" or "worse"
  62. Summarize Challenges w/ Testing Design
    • 1) Limitations in the design of the experiment
    •      a) test vs random sample groups: may bias [thus need to match age/ severity of disease/ willingness to cooperate]
    • 2) Not always direct correlation between animal & human studies
    •    a) species difference
    •    b) can't always detect untoward effect in aimals
    •    c) can't always recognize therapeutic effectiveness in animals for CNS drugs
    • 3) Long term effects- hard to study
    •    a) drug on market before testing complete = more undiscovered untoward effects
    • 4) Individual differences in humans- obscure test results
  63. Define Bioavailability
    • -% of drug reaching the bloodstream in a form that has an effect
    •  (May be influenced by factors such as route of administration)
  64. Define Half-life (aka "elimination half-life")
    -The time required to eliminate half the amount of a given drug from the body, that was present at the beginning of the time period

    • >Each different drug has its own characteristic half-life
    • >Does not change w/ dosage although there are individual patient differences
    • >Usually w/in 5 half-lives drug will reach steady state (if re-administered) or will effectively eliminated ...97% (if not re-administered)

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