Chapter 01- HIT 116 Pharmacology


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Chapter 01- HIT 116 Pharmacology

  1. 1. 1 Introduction to Pharmacology and the History of Drugs
  2. 2. Learning Objectives <ul><li>Describe the origin of the words pharmacology , drug , medicine , and other words related to specialty fields within pharmacology. </li></ul><ul><li>Describe the three general medical uses for drugs. </li></ul><ul><li>Give the origin and meaning of the symbol Rx . </li></ul>
  3. 3. Learning Objectives <ul><li>Name at least five drugs historically derived from plant, animal, or mineral sources that are still in use today. </li></ul><ul><li>Describe the process of the preparation of drugs in the 1800s to early 1900s. </li></ul><ul><li>Name 10 major pharmaceutical milestones that have occurred since the 1800s. </li></ul>
  4. 4. Learning Objectives <ul><li>Describe the use of mislabeled and dangerous drugs and the problem they presented in the past for consumer safety. </li></ul><ul><li>Describe the origin and content of the various drug laws. </li></ul><ul><li>Describe the function of the Food and Drug Administration (FDA) with respect to approving or removing drugs from the market. </li></ul>
  5. 5. Learning Objectives <ul><li>Differentiate between prescription and over-the-counter (OTC) drugs. </li></ul><ul><li>Define schedule drugs and describe the five categories of controlled substances. </li></ul><ul><li>Define orphan drugs . </li></ul>
  6. 6. Introduction to Pharmacology <ul><li>Pharmacology </li></ul><ul><ul><li>fascinating and multifaceted discipline </li></ul></ul><ul><ul><li>impacts </li></ul></ul><ul><ul><ul><li>chosen career in health care </li></ul></ul></ul><ul><ul><ul><li>personal lives </li></ul></ul></ul><ul><ul><li>plays a part in our lives </li></ul></ul><ul><ul><ul><li>from our role as healthcare team members </li></ul></ul></ul><ul><ul><ul><li>to that of consumers </li></ul></ul></ul>
  7. 7. Introduction to Pharmacology <ul><li>Study of pharmacology covers a broad spectrum of diverse, yet interrelated, topics: </li></ul><ul><ul><li>botany </li></ul></ul><ul><ul><li>molecular chemistry </li></ul></ul><ul><ul><li>research </li></ul></ul><ul><ul><li>toxicology </li></ul></ul><ul><ul><li>legislation </li></ul></ul><ul><ul><li>patient education </li></ul></ul>
  8. 8. Introduction to Pharmacology <ul><li>Pharmacology is amazing in its scope, ranging from: </li></ul><ul><ul><li>historical and present day uses of herbs and plant extracts </li></ul></ul>
  9. 9. Introduction to Pharmacology <ul><li>Pharmacology is amazing in its scope, ranging from: </li></ul><ul><ul><li>day-to-day painstaking research </li></ul></ul><ul><ul><ul><li>produces unusable products </li></ul></ul></ul><ul><ul><ul><li>produces life-saving drugs </li></ul></ul></ul><ul><ul><ul><li>genetic manipulation </li></ul></ul></ul><ul><ul><ul><li>molecular pharmacology </li></ul></ul></ul><ul><ul><ul><li>adult stem cell therapy </li></ul></ul></ul><ul><ul><ul><li>seemingly limitless potential for discovery </li></ul></ul></ul>
  10. 10. Introduction to Pharmacology <ul><li>The study of pharmacology covers: </li></ul><ul><ul><li>botany </li></ul></ul><ul><ul><li>molecular chemistry </li></ul></ul><ul><ul><li>research </li></ul></ul><ul><ul><li>toxicology </li></ul></ul><ul><ul><li>legislation </li></ul></ul><ul><ul><li>patient education </li></ul></ul>
  11. 11. Origins of Pharmacology Words <ul><li>Pharmacology </li></ul><ul><ul><li>the study of drugs and their interactions with living organisms </li></ul></ul><ul><ul><li>derived from </li></ul></ul><ul><ul><ul><li>the Greek word pharmakon (meaning medicine or drug ) </li></ul></ul></ul><ul><ul><ul><li>suffix –logy (means the study of ) </li></ul></ul></ul>
  12. 12. Origins of Pharmacology Words <ul><li>Pharmacology </li></ul><ul><ul><li>pharmac/ology </li></ul></ul><ul><ul><ul><li>Pharmac-( pharmakon ( medicine or drug )) </li></ul></ul></ul><ul><ul><ul><li>-ology ( the study of ) </li></ul></ul></ul><ul><ul><li>the study of medicine or drug </li></ul></ul>
  13. 13. Origins of Pharmacology Words <ul><li>Molecular pharmacology </li></ul><ul><ul><li>the study of the chemical structures of drugs and the action of drugs at the molecular level within cells. </li></ul></ul><ul><li>Pharmacodynamics </li></ul><ul><ul><li>the mechanism of action by which drugs produce their effects (desired or undesired) based on time and dosage </li></ul></ul>
  14. 14. Origins of Pharmacology Words <ul><li>Pharmacogenetics </li></ul><ul><ul><li>how the genetic makeup of different people affects their responses to certain drugs </li></ul></ul><ul><li>Pharmacogenomics </li></ul><ul><ul><li>using genome technology to discover new drugs . </li></ul></ul>
  15. 15. Origins of Pharmacology Words <ul><li>Pharmacokinetics </li></ul><ul><ul><li>how drugs move through the body in the processes of absorption, distribution, metabolism, and excretion. </li></ul></ul><ul><li>Pharmacotherapy </li></ul><ul><ul><li>using drugs to affect the body therapeutically. </li></ul></ul>
  16. 16. Drugs and Medicines <ul><li>The word drug </li></ul><ul><ul><li>Dutch word droog (means dry ) </li></ul></ul><ul><ul><li>refers to the use of dried herbs and plants as the first medicines. </li></ul></ul><ul><li>Latin word for drug is medicina </li></ul><ul><ul><li>derive the words medicine and medication . </li></ul></ul><ul><li>A drug or a medicine is: </li></ul><ul><ul><li>nonfood chemical substance </li></ul></ul><ul><ul><li>affects the mind or the body </li></ul></ul>
  17. 17. Drugs and Medicine <ul><li>The word medicine </li></ul><ul><li>a drug deliberately administered for its medicinal value as a: </li></ul><ul><ul><li>preventive agent </li></ul></ul><ul><ul><li>diagnostic agent </li></ul></ul><ul><ul><li>therapeutic agent </li></ul></ul><ul><li>The word drug </li></ul><ul><li>can be used interchangeably with the word medicine </li></ul><ul><li>can refer to chemical substances that do not have: </li></ul><ul><ul><li>preventative use </li></ul></ul><ul><ul><li>diagnostic use </li></ul></ul><ul><ul><li>therapeutic use </li></ul></ul>
  18. 18. <ul><li>Figure 1-1 Medications. Medications or medicines are drugs that are used to prevent, diagnose, or treat symptoms, signs, conditions, and diseases. Steve Bartholomew © Dorling Kindersley. </li></ul>
  19. 19. Medical Uses For Drugs <ul><li>Drugs have three medical uses </li></ul><ul><ul><li>prevent disease </li></ul></ul><ul><ul><li>diagnose disease </li></ul></ul><ul><ul><li>treat symptoms, signs, conditions, diseases </li></ul></ul><ul><li>The study of these uses is know as pharmacotherapy . </li></ul>
  20. 20. Medical Uses For Drugs <ul><li>Preventive Use: </li></ul><ul><ul><li>prevent the occurrence of diseases or conditions. </li></ul></ul><ul><ul><li>prophylaxis (Greek origin: to keep guard before) </li></ul></ul><ul><ul><li>Examples: </li></ul></ul><ul><ul><ul><li>prevent motion sickness prior to traveling </li></ul></ul></ul><ul><ul><ul><li>prevent pregnancy </li></ul></ul></ul><ul><ul><ul><li>vaccinations </li></ul></ul></ul>
  21. 21. Medical Uses For Drugs <ul><li>Diagnostic Use: </li></ul><ul><ul><li>by themselves </li></ul></ul><ul><ul><li>in conjunction with procedures/tests </li></ul></ul><ul><ul><li>Examples: </li></ul></ul><ul><ul><ul><li>Radiopaque contrast dye </li></ul></ul></ul><ul><ul><ul><li>Cardiac Stress Test </li></ul></ul></ul>
  22. 22. <ul><li>Figure 1-2 Preventive use of drugs. Dramamine is an over-the-counter drug that is taken to prevent motion sickness and vomiting. The word vomiting does not appear on the drug package, but the word antiemetic, which means pertaining to against vomiting, appears at the top right. </li></ul>
  23. 23. Clinical Applications <ul><li>The American Academy of Pediatrics issues an annual immunization schedule to prevent childhood diseases. All children must receive certain immunizations before they are permitted to enroll in school. Exceptions are granted for religious reasons or when immunization are medically inadvisable. </li></ul>
  24. 24. Medical Use for Drugs <ul><li>Therapeutic use: </li></ul><ul><ul><li>used for symptoms, conditions, or diseases, to control, improve, or cure </li></ul></ul><ul><ul><li>Examples: </li></ul></ul><ul><ul><ul><li>antibiotic drugs </li></ul></ul></ul><ul><ul><ul><li>analgesic drugs </li></ul></ul></ul><ul><ul><ul><li>insulin </li></ul></ul></ul>
  25. 25. Drugs in Ancient Times <ul><li>Egyptians </li></ul><ul><ul><li>treated diseases with </li></ul></ul><ul><ul><ul><li>frogs’ bile </li></ul></ul></ul><ul><ul><ul><li>sour milk </li></ul></ul></ul><ul><ul><ul><li>Lizards blood </li></ul></ul></ul><ul><ul><ul><li>pigs’ teeth </li></ul></ul></ul><ul><ul><ul><li>sugar cakes </li></ul></ul></ul><ul><ul><ul><li>dirt </li></ul></ul></ul><ul><ul><ul><li>spiders’ webs </li></ul></ul></ul><ul><ul><ul><li>hippopotamus’ oil </li></ul></ul></ul><ul><ul><ul><li>toads’ eyelids </li></ul></ul></ul><ul><ul><li>applied moldy bread to abrasions </li></ul></ul><ul><ul><ul><li>has some therapeutic basis </li></ul></ul></ul><ul><ul><ul><li>penicillin was extracted from a mold </li></ul></ul></ul>
  26. 26. Drugs in Ancient Times <ul><li>Egyptians </li></ul><ul><ul><li>Ebers Papyrus (1500 B.C.) contained the names of 800 different herbal formulations and prescriptions. </li></ul></ul><ul><ul><li>extracted the oil from plants known for healing properties. </li></ul></ul><ul><ul><li>King Tutankhamum’s tomb had 350 alabaster jars of plant oils in it. </li></ul></ul>
  27. 27. Drugs in Ancient Times <ul><li>Chinese </li></ul><ul><ul><li>practiced healing arts </li></ul></ul><ul><ul><ul><li>emphasized use of herbs and some minerals </li></ul></ul></ul><ul><ul><ul><ul><li>herbal preparations were used in conjunction with </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>acupuncture </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>massage </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>exercise </li></ul></ul></ul></ul></ul><ul><ul><ul><li>few animal products </li></ul></ul></ul><ul><ul><li>Shen Nong: </li></ul></ul><ul><ul><ul><li>wrote first Chinese book on herbal medicine </li></ul></ul></ul><ul><ul><ul><li>contained 365 different herbal remedies </li></ul></ul></ul>
  28. 28. <ul><li>Figure 1-3 Chinese herbal medicines. This Chinese pharmacist prepares herbal medicines in much the same way that his ancestors did, by using dried herbs which are then crushed into powder. He is making four batches of the same medicine, each of which contains the same mixture of herbs. The wall behind him holds drawers of many different types of dried herbs. In 1970, the Chinese Academy of Medical Science compiled a collection of traditional herbal remedies. American pharmacists evaluated those remedies and found that 45 percent of them were therapeutic, according to Western standards of medicine. © Phil Schermeister/CORBIS. </li></ul>
  29. 29. Drugs in Ancient Times <ul><li>Other Cultures </li></ul><ul><ul><li>Native Americans of North America </li></ul></ul><ul><ul><ul><li>Aztec Indians of Mexico </li></ul></ul></ul><ul><ul><ul><ul><li>grew herbs with medicinal properties </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Montezuma maintained royal gardens of medicinal plants. </li></ul></ul></ul></ul><ul><ul><li>Greeks and Romans </li></ul></ul><ul><ul><ul><li>furthered the study of medicine </li></ul></ul></ul><ul><ul><ul><li>important first steps </li></ul></ul></ul>
  30. 30. Drugs in Ancient Times <ul><li>Ancient drugs were prepared according to standard recipes </li></ul><ul><ul><li>involved drying, crushing, and combining a variety of </li></ul></ul><ul><ul><ul><li>plants </li></ul></ul></ul><ul><ul><ul><li>substances from animals </li></ul></ul></ul><ul><ul><ul><li>minerals. </li></ul></ul></ul>
  31. 31. Drugs in Ancient Times <ul><li>The symbol Rx </li></ul><ul><ul><li>Latin word for recipe (meaning take) </li></ul></ul><ul><ul><li>indicates a prescription </li></ul></ul><ul><ul><ul><li>the combining of ingredients to form a drug. </li></ul></ul></ul>
  32. 32. Drugs in Ancient Times <ul><li>Because little was known , it was a matter of much guessing </li></ul><ul><li>Some drug ingredients </li></ul><ul><ul><li>based on medical lore and superstition </li></ul></ul><ul><ul><li>had therapeutic value </li></ul></ul><ul><ul><li>others were worthless or harmful </li></ul></ul>
  33. 33. Drugs in Ancient Times <ul><li>Medieval physicians </li></ul><ul><ul><li>prescribed a broad range of drugs </li></ul></ul><ul><ul><ul><li>herbs </li></ul></ul></ul><ul><ul><ul><li>metals (e.g., powered gold) </li></ul></ul></ul><ul><ul><ul><li>addictive substances (e.g., opium) </li></ul></ul></ul><ul><ul><li>1600s, patients advised to </li></ul></ul><ul><ul><ul><li>eat soap to cure blood in the urine </li></ul></ul></ul><ul><ul><ul><li>put mercury in beer to cure intestinal worms </li></ul></ul></ul>
  34. 34. <ul><li>Figure 1-4 Foxglove plant. This beautiful wild flowering plant is commonly known as foxglove, but its scientific name is Digitalis lanata. The drug digitalis (which is no longer in use) came from this plant, as does the modern drug digoxin (Lanoxin), which is used to treat congestive heart failure. </li></ul>
  35. 35. Modern Drugs Derived From Natural Sources <ul><li>Drugs Derived from Plants </li></ul><ul><ul><li>foxglove plant </li></ul></ul><ul><ul><ul><li>derivative, drug digoxin (Lanoxin) for congestive heart failure </li></ul></ul></ul><ul><ul><li>belladonna plant </li></ul></ul><ul><ul><ul><li>original source of two drugs </li></ul></ul></ul><ul><ul><ul><ul><li>atropine </li></ul></ul></ul></ul><ul><ul><ul><ul><li>scopolamine </li></ul></ul></ul></ul>
  36. 36. Modern Drugs Derived From Natural Sources <ul><li>Drugs Derived from Plants </li></ul><ul><ul><li>opium poppy </li></ul></ul><ul><ul><ul><li>used as a painkiller </li></ul></ul></ul><ul><ul><ul><li>recreational drug </li></ul></ul></ul><ul><ul><ul><li>sap from the seedheads contain opium </li></ul></ul></ul><ul><ul><ul><ul><li>source of illegal street drug heroin </li></ul></ul></ul></ul><ul><ul><ul><ul><li>source of the prescription drug morphine </li></ul></ul></ul></ul>
  37. 37. Modern Drugs Derived From Natural Sources <ul><li>Drugs Derived from Plants </li></ul><ul><ul><li>Colchicine </li></ul></ul><ul><ul><ul><li>drug used to treat gout </li></ul></ul></ul><ul><ul><ul><li>derived from autumn crocus known as Colchicum autumnale </li></ul></ul></ul><ul><ul><li>Ephedrine </li></ul></ul><ul><ul><ul><li>present in the leaves of a bushy shrub </li></ul></ul></ul><ul><ul><ul><li>Chinese burned leaves to treat respiratory ailments </li></ul></ul></ul><ul><ul><ul><li>ephedrine present in over-the-counter bronchodilators </li></ul></ul></ul><ul><ul><li>Yams </li></ul></ul><ul><ul><ul><li>estrogen hormone replacement therapy drugs </li></ul></ul></ul>
  38. 38. Did You Know? <ul><li>Herbs have been a part of all cultures for centuries and have been mentioned frequently in literature. Henbane, a very toxic herb, was supposed to have been the poison that Claudius used to kill his brother, Hamlet’s father. “Henbane should not be confused with wolfsbane. Students of literature know wolfsbane to be useful as a vampire repellant (Dracula, 1897); however, we should point out that double-blind studies demonstrating the effectiveness of this plant have not as yet been conducted.” (Michael C. Gerald, Pharmacology: An Introduction to Drugs, 2nd ed. Englewood Cliffs, NJ: Prentice Hall, 1981, p. 149, out of print.) </li></ul>
  39. 39. Modern Drugs Derived From Natural Sources <ul><li>Drugs Derived from Plants </li></ul><ul><ul><li>daffodil bulbs </li></ul></ul><ul><ul><ul><li>The Alzheimer’s drug galantamine (Razadyne) </li></ul></ul></ul><ul><ul><li>Drugs dissolved into plant sources </li></ul></ul><ul><ul><ul><li>gums </li></ul></ul></ul><ul><ul><ul><li>oils (many drugs contain a type of oil) </li></ul></ul></ul><ul><ul><ul><li>bases </li></ul></ul></ul>
  40. 40. Table 1-1 Other plant sources of some modern drugs Getty Images, Inc.
  41. 41. Modern Drugs From Natural Sources <ul><li>Drugs Derived from Animals </li></ul><ul><ul><li>Thyroid supplement drugs </li></ul></ul><ul><ul><ul><li>composed of dried (desiccated) animal thyroid gland tissue </li></ul></ul></ul><ul><ul><ul><li>used to treat hypothyroidism </li></ul></ul></ul>
  42. 42. Modern Drugs From Natural Sources <ul><li>Drugs Derived from Animals </li></ul><ul><ul><li>Pregnant Mare’s urine </li></ul></ul><ul><ul><ul><li>drug Premarin, a female hormone replacement </li></ul></ul></ul><ul><ul><ul><ul><li>used to relieve the symptoms of menopause </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Pre gnant Mar e’s Ur in e </li></ul></ul></ul></ul>
  43. 43. Modern Drugs From Natural Sources <ul><li>Drugs Derived from Animals </li></ul><ul><ul><li>Lanolin </li></ul></ul><ul><ul><ul><li>common ingredient of topical skin drugs </li></ul></ul></ul><ul><ul><ul><li>obtained from the purified fat of sheeps wool </li></ul></ul></ul><ul><ul><li>Insulin </li></ul></ul><ul><ul><ul><li>In the past, only source from ground-up animal pancreas </li></ul></ul></ul>
  44. 44. <ul><li>Figure 1-6 NPH Iletin II insulin. The drug label clearly shows that the source of this insulin is from pork (in vertical capital letters). Copyright Eli Lilly and Company. Used with permission. </li></ul>
  45. 45. Drugs Derived from Minerals <ul><li>Minerals </li></ul><ul><ul><li>individual dietary supplements </li></ul></ul><ul><ul><li>Potassium: potassium chloride </li></ul></ul><ul><li>Trace minerals </li></ul><ul><ul><li>included in many multivitamin supplements </li></ul></ul><ul><ul><li>quinapril (Accupril) contains red iron oxide as an inert ingredient </li></ul></ul>
  46. 46. Drugs in the 1800s and 1900s <ul><li>Pharmacists prepared the drugs they dispensed </li></ul><ul><ul><li>made daily: </li></ul></ul><ul><ul><ul><li>milk of magnesia </li></ul></ul></ul><ul><ul><ul><li>paregoric </li></ul></ul></ul><ul><ul><ul><li>syrup bases for liquid medicines </li></ul></ul></ul><ul><ul><li>hand-rolled cocoa butter suppositories </li></ul></ul><ul><ul><li>measured out drugs (apothecary system of measurement) </li></ul></ul>
  47. 47. Drugs in the 1800s and 1900s <ul><li>Pharmacists prepared the drugs they dispensed </li></ul><ul><ul><li>apothecary system of measurement </li></ul></ul><ul><ul><ul><li>minims </li></ul></ul></ul><ul><ul><ul><li>drams </li></ul></ul></ul><ul><ul><ul><li>ounces </li></ul></ul></ul><ul><ul><ul><li>grains </li></ul></ul></ul><ul><ul><ul><li>scruples </li></ul></ul></ul>
  48. 48. Drugs in the 1800s and 1900s <ul><li>Much has changed since then </li></ul><ul><ul><li>Many now completely synthetic </li></ul></ul><ul><ul><li>Other natural drugs, to create new drugs, have undergone </li></ul></ul><ul><ul><ul><li>chemical modifications </li></ul></ul></ul><ul><ul><ul><li>molecular restructuring </li></ul></ul></ul><ul><ul><li>Pharmacists no longer prepares medications </li></ul></ul><ul><ul><ul><li>dispenses them </li></ul></ul></ul><ul><ul><ul><li>provides patient information and education. </li></ul></ul></ul>
  49. 49. Major Pharmaceutical Milestone <ul><li>1803 Morphine isolated from crude opium </li></ul><ul><li>1827 Merck & Company, a German drug company, begins the first commercial production of morphine. </li></ul><ul><li>1843 Dr. Alexander Wood of Scotland creates the syringe and injects patients with morphine. </li></ul><ul><li>1899 Aspirin introduced. </li></ul>
  50. 50. Major Pharmaceutical Milestone <ul><li>1908 Sulfanilamide introduced (first anti-infective drug). </li></ul><ul><li>1912 Phenobarbital introduced for epilepsy (first antiepileptic drug) </li></ul><ul><li>1913 Vitamins A and B discovered </li></ul><ul><li>1922 Insulin introduced (first drug for diabetes mellitus </li></ul><ul><li>1938 Dilantin introduced for epilepsy </li></ul>
  51. 51. Major Pharmaceutical Milestone <ul><li>1941 Penicillin introduced (first antibiotic drug) </li></ul><ul><li>1945 Benadryl introduced (first antihistamine drug) </li></ul><ul><li>1948 Cortisone introduced (first corticosteroid drug) </li></ul><ul><li>1952 Thorazine introduced for psychosis (first antipsychotic drug) </li></ul>
  52. 52. Major Pharmaceutical Milestone <ul><li>1952 Hydrocortisone introduced (first topical corticosteroid drug) </li></ul><ul><li>1957 Librium introduced for neurosis (first antianxiety drug) </li></ul><ul><li>1958 Haldol introduced for psychosis </li></ul><ul><li>1966 Clotting factors introduced for hemophilia </li></ul>
  53. 53. Major Pharmaceutical Milestone <ul><li>1967 Inderal introduced for hypertension (first beta-blocker drug) </li></ul><ul><li>1970 Levodopa introduced for Parkinson’s disease </li></ul><ul><li>1972 Researchers discover a receptor in the brain that responds to drugs derived from opium </li></ul><ul><li>1977 Tagament introduced for peptic ulcers (first H 2 blocker drug) </li></ul>
  54. 54. Major Pharmaceutical Milestone <ul><li>1978 First portable insulin pump introduced </li></ul><ul><li>1981 Verapamil introduced for heart arryhthmia (first calcium channel blocker drug) </li></ul><ul><li>1982 Humulin (human insulin) (first drug made using recombinant DNA technology) </li></ul>
  55. 55. Major Pharmaceutical Milestone <ul><li>1983 Topical prescription drug hydrocortisone approved for over-the-counter sales </li></ul><ul><li>1985 ACE inhibitor drugs introduced for hypertension </li></ul><ul><li>1986 Orthoclone OKT3 introduced (first monoclonal antibody) </li></ul>
  56. 56. Major Pharmaceutical Milestone <ul><li>1987 Mevacor introduced (first statin drug for high cholesterol 1987 Alteplase (Activase) introduced for dissolving blood clots (first tissue plasminogen activator drug) </li></ul><ul><li>1987 AZT (zidovudine, Retrovir) introduced (first drug for HIV) </li></ul><ul><li>1992 Proscar introduced for benign prostatic hypertrophy </li></ul>
  57. 57. Major Pharmaceutical Milestone <ul><li>1993 Cognex introduced (first drug for Alzheimer’s disease) </li></ul><ul><li>1994 Combination drug therapy introduced for peptic ulcers caused by Helicobacter pylori </li></ul><ul><li>1995 Cozaar introduced for hypertension (first angiotension II receptor blocker drug) </li></ul><ul><li>1996 Invirase introduced for HIV (first protease inhibitor drug) </li></ul>
  58. 58. Major Pharmaceutical Milestone <ul><li>1996 Fosamax introduced for osteoporosis (first nonhormonal drug treatment) </li></ul><ul><li>1996 Nicoderm introduced (first prescription-strength drug for stopping smoking) </li></ul><ul><li>1998 Viagra introduced (first oral drug for erectile dysfunction in men) </li></ul>
  59. 59. Major Pharmaceutical Milestone <ul><li>1999 Celebrex introduced for arthritis (first COX-2 inhibitor drug) </li></ul><ul><li>2000 Deciphering of the human genome opens the field of gene therapy in pharmacology 2001 Anthrax attack on the United States creates high demand for the antibiotics ciprofloxin and doxycycline </li></ul><ul><li>2002 Botox introduced for the treatment of facial wrinkles </li></ul>
  60. 60. Major Pharmaceutical Milestone <ul><li>2003 Fuzeon introduced (first fusion inhibitor drug for HIV </li></ul><ul><li>2004 Lunesta introduced for long-term treatment of chronic insomnia </li></ul><ul><li>2005 Requip introduced (first drug for restless legs syndrome) </li></ul><ul><li>2006 Gardasil introduced (first vaccine against cervical cancer caused by HPV) </li></ul>
  61. 61. Major Pharmaceutical Milestone <ul><li>2007 Exelon introduced (first transdermal drug patch for Alzheimer’s disease) </li></ul><ul><li>2007 Zyrtek is the first drug to have the same dosage strength for both its prescription and over-the-counter forms </li></ul><ul><li>2007 Isentress introduced (first integrase inhibitor drug for HIV) </li></ul><ul><li>2008 Xenazine introduced (first FDA-approved drug for Huntington's disease) </li></ul>
  62. 62. Mislabeled and Dangerous Drugs <ul><li>Most physicians attempted to treat patients accurately </li></ul><ul><ul><li>based on what little scientific knowledge was available </li></ul></ul><ul><ul><li>2100 B.C., the Code of Hammurabi gave severe penalties for malpractice </li></ul></ul><ul><ul><li>throughout medical history ineffective, mislabeled, and dangerous drugs have been manufactured, advertised, and prescribed </li></ul></ul>
  63. 63. Mislabeled and Dangerous Drugs <ul><li>During the 1700s and 1800s </li></ul><ul><ul><li>commonly sold without regulation </li></ul></ul><ul><ul><li>accompanied by extravagant claims of cures </li></ul></ul><ul><ul><li>often contained addicting ingredients without its presence being listed </li></ul></ul><ul><ul><ul><li>opium </li></ul></ul></ul><ul><ul><ul><li>morphine </li></ul></ul></ul><ul><ul><ul><li>cocaine </li></ul></ul></ul>
  64. 64. Mislabeled and Dangerous Drugs <ul><li>During the 1700s and 1800s </li></ul><ul><ul><li>even when included in title or on label consumers were often not aware of its addictive qualities </li></ul></ul>
  65. 65. <ul><li>Figure 1-7 Cocaine in a common drug. This 1885 advertisement was for the drug Cocaine Toothache Drops. It was not known at that time that cocaine was a highly addictive drug. Children as well as adults became addicted to this drug. National Library of Medicine. </li></ul>
  66. 66. Mislabeled and Dangerous Drugs <ul><li>Consumer warnings did not exist: </li></ul><ul><ul><li>against the misuse of drugs </li></ul></ul><ul><ul><li>possibility of addiction </li></ul></ul><ul><ul><li>dangerous drug side effects </li></ul></ul><ul><ul><li>prevailing dictum was “Let the buyer beware” </li></ul></ul>
  67. 67. Drug Legislation and Drug Agencies <ul><li>Laws were passed in the 1900s to protect the public </li></ul><ul><ul><li>from unscrupulous drug sellers </li></ul></ul><ul><ul><li>worthless, or mislabeled, dangerous medicines </li></ul></ul><ul><ul><li>passage of The Food and Drugs Act of 1906, the first federal drug law </li></ul></ul><ul><ul><ul><li>1912 amendment required accurate labeling </li></ul></ul></ul><ul><ul><ul><li>only drugs listed in the United States Pharmacopeia or National Formulary could be prescribed </li></ul></ul></ul>
  68. 68. Drug Legislation and Drug Agencies <ul><li>Sulfonamide National Tragedy </li></ul><ul><ul><li>forced update of The Food and Drug Act of 1906 </li></ul></ul><ul><ul><li>widely used anti-infective drug </li></ul></ul><ul><ul><li>elixirs made from a sweetened alcohol base </li></ul></ul><ul><ul><li>drug base was an industrial-strength liquid solvent </li></ul></ul><ul><ul><li>number of children died </li></ul></ul><ul><ul><li>drug manufacturer did not need FDA approval </li></ul></ul><ul><ul><li>The Food, Drug, and Cosmetic Act of 1938 </li></ul></ul>
  69. 69. Drug Legislation and Drug Agencies <ul><li>1951 Durham-Humphrey Amendment </li></ul><ul><ul><li>defined prescription drugs </li></ul></ul><ul><li>thalidomide </li></ul><ul><ul><li>FDA refused to approve U.S. use </li></ul></ul><ul><ul><li>evidence against the safety began to accumulate </li></ul></ul><ul><ul><li>8,000 babies born with deformed limbs </li></ul></ul><ul><ul><li>passage of the 1962 Kefauver-Harris Amendment </li></ul></ul>
  70. 70. Drug Legislation and Drug Agencies <ul><li>1962 Kefauver-Harris Amendment </li></ul><ul><ul><li>required </li></ul></ul><ul><ul><ul><li>drugs show that they are safe and effective before being marketed </li></ul></ul></ul><ul><ul><ul><li>manufacturers report adverse side effects </li></ul></ul></ul><ul><ul><li>since that time, many drugs have been kept from the market or removed </li></ul></ul>
  71. 71. Historical Notes <ul><li>Because of its devastating adverse effects in unborn children, thalidomide would have been relegated to an obscure footnote in medical history, but in 1997 it was discovered to be a useful drug in treating cancer, AIDS, and leprosy. The potential adverse effects of this drug are so great that it is only considered as a viable treatment option for these life-threatening diseases. </li></ul>
  72. 72. Historical Notes <ul><li>The FDA regulates the use of thalidomide in two ways: (1) by limiting the number of physicians who can prescribe it and (2) by requiring women taking the drug not to have sexual intercourse or to use two forms of birth control (so that there is virtually no risk of them giving birth to a child with phocomelia). </li></ul>
  73. 73. Historical Notes <ul><li>Thalidomide is now an official prescription drug used to treat multiple myeloma, leprosy, graft-versus-host disease, and several types of cancers. It is also officially recognized as an orphan drug that is used to treat wasting syndrome from HIV, as well as Crohn’s disease. </li></ul>
  74. 74. Drug Legislation and Drug Agencies <ul><li>FDA (Food and Drug Administration) </li></ul><ul><ul><li>weigh the inherent risks against its benefits </li></ul></ul><ul><ul><li>complete review process before it issues a final approval (or rejection) </li></ul></ul><ul><ul><li>1994: Dietary Supplements and Health and Education Act was passed </li></ul></ul><ul><ul><ul><li>FDA guidelines for herbal products and dietary supplements </li></ul></ul></ul>
  75. 75. <ul><li>Figure 1-8 Dietary supplements. Dietary supplements, such as vitamins, minerals, and herbs, are manufactured in tablets and capsules that resemble prescription and over-the-counter drugs. However, the bottle label clearly states “Dietary Supplement,” and the reverse side of the bottle provides information under the heading of “Supplement Facts.” </li></ul>
  76. 76. Drug Legislation and Drug Agencies <ul><li>Early 1990s </li></ul><ul><ul><li>34 month average for FDA approval of a new drug </li></ul></ul><ul><ul><li>for certain critical drugs the process could be much shorter </li></ul></ul><ul><ul><ul><li>1987 first drug effective against HIV was approved in just 107 days </li></ul></ul></ul><ul><li>Critics still pointed to a time lag </li></ul><ul><ul><li>some drugs were available in other countries before FDA approved for use in United States </li></ul></ul><ul><ul><li>took time before approved by the FDA for U.S. use </li></ul></ul>
  77. 77. Drug Legislation and Drug Agencies <ul><li>Inderal </li></ul><ul><ul><li>hypertension and arrhythmias </li></ul></ul><ul><ul><li>available in Europe for 10 years before approval in U.S. (1967) </li></ul></ul><ul><ul><li>response to criticism </li></ul></ul><ul><ul><ul><li>FDA made a concerted effort to streamline the approval process </li></ul></ul></ul><ul><ul><ul><li>particularly with respect to drugs used to treat life-threatening diseases </li></ul></ul></ul>
  78. 78. Drug Legislation and Drug Agencies <ul><li>In 1996 indinavir (Crixivan) was approved by the FDA in a record 42 days </li></ul><ul><li>1997 Food and Drug Administration (FDA) Modernization Act </li></ul><ul><ul><li>gave authority to accelerate approval process for certain types of drugs </li></ul></ul><ul><ul><li>2000 average review time less than 15 months </li></ul></ul><ul><ul><li>critically needed drugs in as little as 6 months </li></ul></ul>
  79. 79. Drug Legislation and Drug Agencies <ul><li>FDA allows physicians to prescribe some investigational drugs </li></ul><ul><ul><li>life-threatening diseases, no other alternative therapy </li></ul></ul><ul><ul><li>to prescribe </li></ul></ul><ul><ul><ul><li>requires an Emergency Treatment Investigational New Drug (IND) application </li></ul></ul></ul>
  80. 80. Drug Legislation and Drug Agencies <ul><li>Example </li></ul><ul><ul><li>Cardarone </li></ul></ul><ul><ul><ul><li>cardiologists prescribed before it was on the market </li></ul></ul></ul><ul><ul><ul><li>final approval, 1985 </li></ul></ul></ul><ul><ul><ul><li>treats patients with life-threatening cardiac arrhythmias that did not respond to other antiarrhythmic drugs. </li></ul></ul></ul>
  81. 81. Drug Legislation and Drug Agencies <ul><li>HIPAA (Health Insurance Portability and Accountability Act of 1996) </li></ul><ul><ul><li>verifies that health information, including all drug information, is kept secure </li></ul></ul><ul><ul><li>information only released to authorized inquiries </li></ul></ul>
  82. 82. Prescription and over-the-counter (OTC) Drugs <ul><li>The FDA regulates prescription drugs and OTC drugs </li></ul><ul><li>Rx drugs </li></ul><ul><ul><li>defined as those drugs that are not safe to use except under professional medical supervision </li></ul></ul><ul><ul><li>can only be obtained with a prescription by a healthcare provider whose license permits it </li></ul></ul>
  83. 83. Prescription and over-the-counter (OTC) Drugs <ul><li>For many years, distinction was clear between prescription and OTC drugs </li></ul><ul><li>over-the-counter (OTC) drugs </li></ul><ul><ul><li>can be purchased without a prescription </li></ul></ul><ul><ul><li>generally considered safe for consumers to use if </li></ul></ul><ul><ul><ul><li>label directions and warnings are followed </li></ul></ul></ul><ul><ul><ul><li>warnings are heeded </li></ul></ul></ul>
  84. 84. Prescription and over-the-counter (OTC) Drugs <ul><li>Over-the-counter (OTC) drugs </li></ul><ul><ul><li>OTC drug often the same as prescription drug </li></ul></ul><ul><ul><li>1992, the OTC Drugs Advisory Committee was created </li></ul></ul><ul><ul><ul><li>assist the FDA in reviewing drugs </li></ul></ul></ul><ul><ul><ul><li>determining which ones were safe and appropriate for OTC use </li></ul></ul></ul>
  85. 85. <ul><li>Table 1-3 Some prescription drugs that are also OTC drugs </li></ul>
  86. 86. Prescription and over-the-counter Drugs <ul><li>FDA approves a prescription drug being reclassified as an OTC drug if the following criteria are met: </li></ul><ul><ul><li>the indication for the drug’s OTC use is similar to its use as a prescription drug </li></ul></ul><ul><ul><li>the patient can easily diagnose and monitor his or her own condition when using the OTC drug </li></ul></ul>
  87. 87. Prescription and over-the-counter Drugs <ul><li>FDA approves a prescription drug being reclassified as an OTC drug if the following criteria are met: </li></ul><ul><ul><li>the OTC drug has a low rate of side effects/toxicity and a low potential for abuse </li></ul></ul><ul><ul><li>the use of the OTC drug does not require the patient to have any special monitoring or ongoing test. </li></ul></ul>
  88. 88. Focus on Healthcare Issues <ul><li>Supporter of the reclassification of some prescription drugs to an OTC status claim that this will lower drug prices and allow better access to treatment and fewer visits to the doctor. </li></ul>
  89. 89. Focus on Healthcare Issues <ul><li>Opponents to reclassification argue: </li></ul><ul><ul><li>consumers may actually pay more because health insurance plans will not reimburse for OTC drug purchases. </li></ul></ul><ul><ul><li>excessive use of OTC drugs may increase the number of adverse drug-drug interactions, and </li></ul></ul><ul><ul><li>consumers may try to self-medicate serious illnesses instead of visiting their physician for appropriate treatment. </li></ul></ul>
  90. 90. Schedule Drugs <ul><li>Harrison Narcotics Act of 1914 </li></ul><ul><ul><li>Drugs with the potential for abuse and dependence were first regulated </li></ul></ul><ul><ul><li>established the legal framework for controlling these drugs </li></ul></ul><ul><ul><li>introduced the word narcotic </li></ul></ul><ul><ul><li>Act was replaced in 1970 by The Comprehensive Drug Abuse Prevention and Control Act </li></ul></ul>
  91. 91. Schedule Drugs <ul><li>Harrison Narcotics Act of 1914 </li></ul><ul><ul><li>Title II of this Act, The Controlled Substances Act, established the Drug Enforcement Administration (DEA) in 1973 to regulate the manufacturing and dispensing of these drugs </li></ul></ul>
  92. 92. Schedule Drugs <ul><li>Harrison Narcotics Act of 1914 </li></ul><ul><ul><li>divided potentially addictive drugs into five categories or schedules </li></ul></ul><ul><ul><ul><li>based on their potential for physical or psychological dependence </li></ul></ul></ul><ul><ul><ul><li>known as schedule drugs or controlled substances </li></ul></ul></ul><ul><ul><ul><li>labeling and packaging for a controlled substance and all of its advertisements must clearly show the drug’s assigned schedule </li></ul></ul></ul><ul><ul><ul><li>manufacturing, storage, dispensing, and disposal of controlled substances are strictly regulated by both federal and state laws. </li></ul></ul></ul>
  93. 93. <ul><li>Figure 1-9 Controlled substance symbol. The capital C stands for controlled substance. The number written inside (always a Roman numeral) indicates the assigned schedule. It is important to remember that a C with the Roman numeral IV inside it does not mean that the drug is to be given by the intravenous (I.V.) route; it means that the drug is a Schedule IV controlled substance. </li></ul>
  94. 94. Schedule Drugs <ul><li>Schedule I </li></ul><ul><ul><li>extremely high potential for abuse and addiction </li></ul></ul><ul><ul><li>no currently accepted medical use </li></ul></ul><ul><ul><li>not available under any circumstances, even with a prescription </li></ul></ul>
  95. 95. <ul><li>Figure 1-10 Schedule II drug. OxyContin is a prescription drug that is used to treat severe pain. It is also a popular drug of abuse. Because it is a Schedule II drug—see the symbol on the label—it has a high potential for addiction. The drug bottle is sitting on a blue pill-counting tray in the pharmacy. This tray helps the pharmacist accurately count out the exact number of tablets specified in the patient’s prescription. The logo in the center of the tray reminds the pharmacist to “Check, Counsel, Communicate.” Getty Images, Inc. </li></ul>
  96. 96. Schedule Drugs <ul><li>Schedule II </li></ul><ul><ul><li>high potential for abuse and addiction </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul><ul><ul><li>requires an official prescription form </li></ul></ul><ul><ul><li>severe physical and psychological dependence may result </li></ul></ul>
  97. 97. Schedule Drugs <ul><li>Schedule III </li></ul><ul><ul><li>less potential for abuse and addiction than Schedule II drugs </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul><ul><ul><li>moderate physical and psychological dependence may result. </li></ul></ul>
  98. 98. Schedule Drugs <ul><li>Schedule IV </li></ul><ul><ul><li>less potential for abuse and addiction than Schedule III drugs </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul><ul><ul><li>limited-to-moderate physical or psychological dependence may result </li></ul></ul>
  99. 99. Schedule Drugs <ul><li>Schedule V </li></ul><ul><ul><li>limited potential for abuse </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul>
  100. 100. Focus on Healthcare Issues <ul><li>There has been a longstanding debate over whether marijuana (a Schedule I drug) should be legally available to treat patients with certain medical conditions. In 1996, voters in California passed Proposition 215 to allow seriously ill patients to use marijuana if approved by their primary care physician. Eight other states passed similar laws. </li></ul>
  101. 101. Focus on Healthcare Issues <ul><li>However, the federal law that prohibits the manufacturing and distribution of marijuana supersedes individual state laws. In November 2000, the U.S. Supreme Court agreed to hear a case that sought an exemption from the federal law for cases of medical necessity. The American Medical Association (AMA) advised that marijuana did provide medical benefit to patients with certain conditions, and many other groups supported the legalization of marijuana to varying degrees. </li></ul>
  102. 102. Focus on Healthcare Issues <ul><li>In May 2001, however, the Supreme Court issued a decision that federal drug laws that ban the manufacture and distribution of marijuana allow for no exceptions, even for medical necessity. Despite this ruling, many patients do use the marijuana plant to treat themselves. </li></ul>
  103. 103. Focus on Healthcare Issues <ul><li>Of note is that the main active ingredient in marijuana is available as the prescription drug dronabinol (Marinol). It is a Schedule III drug and is used to treat nausea and vomiting caused by chemotherapy and to stimulate the appetite in patients with HIV. </li></ul>
  104. 104. Schedule Drugs <ul><li>To prescribe or dispense scheduled drugs healthcare providers: </li></ul><ul><ul><li>must register with the federal Drug Enforcement Agency </li></ul></ul><ul><ul><li>be issued a DEA certificate and number </li></ul></ul><ul><ul><li>provider’s DEA number must be clearly written on any prescription for a schedule drug </li></ul></ul>
  105. 105. Schedule Drugs <ul><li>Some states require the healthcare provider to also register with the state agency </li></ul>
  106. 106. Orphan Drugs <ul><li>In 1983, The Orphan Drug Act was passed. </li></ul><ul><ul><li>purpose to facilitate the development of new drugs to treat rare diseases. </li></ul></ul><ul><ul><li>drug companies are reluctant to spend large amounts of time and money </li></ul></ul><ul><ul><ul><li>to research and test a drug </li></ul></ul></ul><ul><ul><ul><li>especially if it will have a limited market </li></ul></ul></ul>
  107. 107. Orphan Drugs <ul><li>In 1983, The Orphan Drug Act was passed. </li></ul><ul><ul><li>drugs for rare diseases were not being developed </li></ul></ul><ul><ul><li>The Orphan Drug Act provides special incentives including: </li></ul></ul><ul><ul><ul><li>grants to offset drug development costs </li></ul></ul></ul><ul><ul><ul><li>a tax credit that allows up to 75% deduction of the cost of clinical trials </li></ul></ul></ul><ul><ul><ul><li>streamlined process for obtaining FDA approval </li></ul></ul></ul><ul><ul><ul><li>exclusive marketing rights for seven years </li></ul></ul></ul>