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Evolution of Medicinal  Drugs Medicinal Origins Legislation & Regulation Drug Testing & Approval
Introduction  *Historical Trends
 
 
Major Areas of Pharmacology <ul><li>Pharmacology  is a science that studies the effects of drugs within a living system. <...
Basic Terminology <ul><li>Adverse Effect </li></ul><ul><li>Agonist </li></ul><ul><li>Antagonist </li></ul><ul><li>Chemical...
Substance Misuse & Abuse Terms <ul><li>Drug Misuse </li></ul><ul><li>Substance Abuse </li></ul><ul><li>Drug Abuse </li></u...
Diagnostic Statistical Manual –IV for Substance Dependence <ul><li>At least three symptoms in 12 months: </li></ul><ul><li...
DSM-IV Criteria for Substance Abuse <ul><li>One or more of the following in 12 months: </li></ul><ul><li>Substance use rep...
Medicines that Changed the World
Medicines that Changed the World <ul><li>Opium </li></ul><ul><ul><li>Sedative/painkiller </li></ul></ul><ul><li>Smallpox v...
Reasons for Medication Use <ul><li>Prevention </li></ul><ul><ul><li>Vaccines </li></ul></ul><ul><ul><li>Antimalaria agents...
Compliance
Reasons for Different Routes of Administration <ul><li>Convenience </li></ul><ul><li>Preferred route is unavailable </li><...
Dosage Routes  Forms <ul><li>Oral (by mouth) </li></ul><ul><ul><li>Swallowed, SL, Buccal </li></ul></ul><ul><li>Parenteral...
Sources & Bodily Effects of Drugs Analgesic Anti-diarrhea Anti-Infective Gastric acid inhibitor Demerol Lomotil Bactrim/Se...
Legend Drugs  Over-the-Counter <ul><li>Prescription ONLY </li></ul><ul><li>Legend Statement </li></ul><ul><ul><li>‘ Federa...
<ul><li>Atomic(molecular) composition </li></ul><ul><li>Chemical Name </li></ul><ul><li>Structural Formula </li></ul><ul><...
 
Drug Legislation & Regulation <ul><li>FDA   Food & Drug  Administration </li></ul><ul><li>FTC  Federal Trade Commission </...
 
Controlled Substances Act <ul><li>Schedule I </li></ul><ul><ul><li>Heroin,THC </li></ul></ul><ul><li>Schedule II </li></ul...
Phases  of Clinical Trials
Drug Testing & Approval Clinical Trials <ul><li>10-15 years from lab to US patients </li></ul><ul><li>Only 1 in 5000 cmpds...
FDA  Phase IV <ul><li>File NDA at FDA </li></ul><ul><li>Review process & approval  (or not) </li></ul><ul><li>Year 1 or mo...
Generic Medications <ul><li>Patent for 17 years on parent compound </li></ul><ul><li>Expires! </li></ul><ul><li>Law suits?...
FDA  Pregnancy Safety Categories <ul><li>Category A  adequate studies indicate no risk to the fetus in the 1 st  trimester...
FDA Pregnancy Safety  cont. <ul><li>Category D  there is evidence of human fetal risk, but the potential benefits from the...
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Evolution of Medications

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Evolution of Medications

  1. 1. Evolution of Medicinal Drugs Medicinal Origins Legislation & Regulation Drug Testing & Approval
  2. 2. Introduction *Historical Trends
  3. 5. Major Areas of Pharmacology <ul><li>Pharmacology is a science that studies the effects of drugs within a living system. </li></ul><ul><li>Toxicology concerned with the harmful effects of drugs </li></ul><ul><li>Pharmacy the study of preparing and dispensing medications and a place. </li></ul><ul><li>Pharmacotherapeutics how drugs are used in the treatment of disease. </li></ul><ul><li>Pharmacodynamics </li></ul><ul><li>Pharmacokinetics </li></ul>
  4. 6. Basic Terminology <ul><li>Adverse Effect </li></ul><ul><li>Agonist </li></ul><ul><li>Antagonist </li></ul><ul><li>Chemical Name </li></ul><ul><li>Contraindications </li></ul><ul><li>Dose </li></ul><ul><li>Drug </li></ul><ul><li>Drug indication </li></ul><ul><li>Generic name </li></ul><ul><li>Mechanism of action </li></ul><ul><li>OTC </li></ul><ul><li>Pharmacology </li></ul><ul><li>Receptor </li></ul><ul><li>Side effect </li></ul><ul><li>Site of action </li></ul><ul><li>Trade name </li></ul>
  5. 7. Substance Misuse & Abuse Terms <ul><li>Drug Misuse </li></ul><ul><li>Substance Abuse </li></ul><ul><li>Drug Abuse </li></ul><ul><li>Physical Dependence </li></ul><ul><li>Psychological Dependence </li></ul><ul><li>Addiction </li></ul><ul><li>Illicit Drugs </li></ul>
  6. 8. Diagnostic Statistical Manual –IV for Substance Dependence <ul><li>At least three symptoms in 12 months: </li></ul><ul><li>Tolerance </li></ul><ul><li>Withdrawal </li></ul><ul><li>Use beyond intention </li></ul><ul><li>Inability to reduce usage </li></ul><ul><li>Time-consuming </li></ul><ul><li>Valued activities abandoned or reduced </li></ul><ul><li>Use continues despite problems </li></ul>
  7. 9. DSM-IV Criteria for Substance Abuse <ul><li>One or more of the following in 12 months: </li></ul><ul><li>Substance use repeatedly leads to failure to fulfull home, work, or school responsibilities </li></ul><ul><li>Repeated substance use in physically hazardous situations </li></ul><ul><li>Repeated legal problems for substance use </li></ul><ul><li>Continued use despite resulting, repeated social or interpersonal problems. </li></ul>
  8. 10. Medicines that Changed the World
  9. 11. Medicines that Changed the World <ul><li>Opium </li></ul><ul><ul><li>Sedative/painkiller </li></ul></ul><ul><li>Smallpox vaccine 19 th C </li></ul><ul><ul><li>1798 vax prevent illness </li></ul></ul><ul><li>Salvarsan (arsphenamine) </li></ul><ul><ul><li>1910 20 th cent-cure illness </li></ul></ul><ul><ul><li>Syphillis spirochete </li></ul></ul><ul><li>Insulin </li></ul><ul><ul><li>1920 </li></ul></ul><ul><ul><li>Few other drugs have helped so many so fast! </li></ul></ul><ul><li>Psychopharmacology ’50s </li></ul><ul><ul><li>Drugs can treat mental illness </li></ul></ul><ul><li>Enovid ’60s </li></ul><ul><ul><li>1960 The’PILL’ </li></ul></ul><ul><ul><li>Alter normal physio process </li></ul></ul><ul><li>Thalidomide </li></ul><ul><ul><li>1950’s birth defects </li></ul></ul><ul><ul><li>Prompted radical changes in regulation of medicines </li></ul></ul><ul><ul><li>1990 reemerged (MS, leprosy) </li></ul></ul>
  10. 12. Reasons for Medication Use <ul><li>Prevention </li></ul><ul><ul><li>Vaccines </li></ul></ul><ul><ul><li>Antimalaria agents </li></ul></ul><ul><ul><li>Antibiotic prophylaxis </li></ul></ul><ul><li>Curative </li></ul><ul><ul><li>Antibacterial </li></ul></ul><ul><ul><li>Oncology drugs </li></ul></ul><ul><ul><li>Antifungal </li></ul></ul><ul><li>Control of Disease Process </li></ul><ul><ul><li>Antihypertensives </li></ul></ul><ul><ul><li>Antidiabetics </li></ul></ul><ul><ul><li>Thyroid agents </li></ul></ul><ul><li>Palliation </li></ul><ul><ul><li>Analgesics </li></ul></ul><ul><ul><li>Oncology drugs </li></ul></ul>
  11. 13. Compliance
  12. 14. Reasons for Different Routes of Administration <ul><li>Convenience </li></ul><ul><li>Preferred route is unavailable </li></ul><ul><li>Rapid onset of action is desired </li></ul><ul><li>Target delivery of drug to specific site of action </li></ul><ul><li>Prolong duration of action </li></ul>
  13. 15. Dosage Routes Forms <ul><li>Oral (by mouth) </li></ul><ul><ul><li>Swallowed, SL, Buccal </li></ul></ul><ul><li>Parenteral (injection) </li></ul><ul><ul><li>IV,IM,SQ, ICranial, epidural, Intraperitoneal </li></ul></ul><ul><li>Topical </li></ul><ul><ul><li>Applied to surface of skin or mucous membranes- Transdermal </li></ul></ul><ul><ul><li>Respiratory: inhaled, intra-nasal, smoke, volatile gases </li></ul></ul><ul><li>Tabs, caps, sol, elix, susp, lozenges, ’take a powder!’ </li></ul><ul><li>Solutions & suspensions </li></ul><ul><li>Ung, crm, ltn, otic, opth, inhalants, suppos </li></ul><ul><li>Rectal/vaginal </li></ul><ul><li>Nasogastral </li></ul>
  14. 16. Sources & Bodily Effects of Drugs Analgesic Anti-diarrhea Anti-Infective Gastric acid inhibitor Demerol Lomotil Bactrim/Septra Prilosec Meperidine Diphenoxylate Co-Trimoxazole Omeprazole Synthetic RBC Stimulant Epogen Erythropoietin Bioengineer Antidiabetic Digestive enzyme Hormone Insulin Pepsin Thyroid,USP Pancreas Cow/Hog Stomach Cow/Hog Thyroid glands Animals Antacid/Laxative Skin Protectant RA/Anti-infective MOM ZnOxide Auranofin/SilverNitr Magnesium Zinc Gold/Silver Minerals Anti Arrthymic Cardiotonic Analges/Antitussive Quinidine Digitalis Morphine Codeine Cinchona Bark Purple Foxglove Poppy (Opium) Plants
  15. 17. Legend Drugs Over-the-Counter <ul><li>Prescription ONLY </li></ul><ul><li>Legend Statement </li></ul><ul><ul><li>‘ Federal law prohibits dispensing of this drug without a prescription’ </li></ul></ul><ul><li>Transfer Warning </li></ul><ul><ul><li>‘ State or federal law prohibits the transfer of this drug to any person other than the person to whom it was prescribed’ </li></ul></ul><ul><li>Prescription is not required </li></ul><ul><ul><li>Safe,effective </li></ul></ul><ul><ul><li>Taken w/o medical supervision </li></ul></ul><ul><ul><li>Dose low (Why?) </li></ul></ul><ul><ul><li>Negligible abuse potential </li></ul></ul><ul><ul><ul><li>Maybe???? </li></ul></ul></ul>
  16. 18. <ul><li>Atomic(molecular) composition </li></ul><ul><li>Chemical Name </li></ul><ul><li>Structural Formula </li></ul><ul><li>Nonproprietary Name (generic) </li></ul><ul><ul><li>Stems & classes </li></ul></ul><ul><ul><ul><li>Therapeutic class </li></ul></ul></ul><ul><ul><ul><li>… pril </li></ul></ul></ul><ul><li>Proprietary Name (brand) </li></ul><ul><li>NDC # </li></ul>Drug Names & Classifications
  17. 20. Drug Legislation & Regulation <ul><li>FDA Food & Drug Administration </li></ul><ul><li>FTC Federal Trade Commission </li></ul><ul><li>DEA Drug Enforcement Agency </li></ul>
  18. 22. Controlled Substances Act <ul><li>Schedule I </li></ul><ul><ul><li>Heroin,THC </li></ul></ul><ul><li>Schedule II </li></ul><ul><ul><li>Methadone </li></ul></ul><ul><li>Schedule III </li></ul><ul><ul><li>Valium, Vicodin </li></ul></ul><ul><li>Schedule IV </li></ul><ul><ul><li>Alprazolam, Darvocet </li></ul></ul><ul><li>Schedule V </li></ul><ul><ul><li>Lomotil </li></ul></ul>
  19. 23. Phases of Clinical Trials
  20. 24. Drug Testing & Approval Clinical Trials <ul><li>10-15 years from lab to US patients </li></ul><ul><li>Only 1 in 5000 cmpds make it to human testing </li></ul><ul><li>Only 1 in 5 tested in humans is approved </li></ul><ul><li>Testing Phases ( double blind, placebo controlled) </li></ul><ul><ul><li>Phase I-lab animals, safety, 6 yr/5000 cmpds </li></ul></ul><ul><ul><li>Phase II-hlthy,(50-100), dose, safe, PK, 2 yr/5cmpd </li></ul></ul><ul><ul><li>Phase III-treat ill(100-500),SE, PD, dose curve, 2yr </li></ul></ul><ul><ul><li>Phase IV-treat ill(1000-5000), LT use, special grps </li></ul></ul>
  21. 25. FDA Phase IV <ul><li>File NDA at FDA </li></ul><ul><li>Review process & approval (or not) </li></ul><ul><li>Year 1 or more </li></ul><ul><li>Post Marketing Surveillance </li></ul><ul><li>Additional testing as required by the FDA </li></ul><ul><li>Continuous monitoring of drug in public use </li></ul>
  22. 26. Generic Medications <ul><li>Patent for 17 years on parent compound </li></ul><ul><li>Expires! </li></ul><ul><li>Law suits? </li></ul><ul><li>Open season for manufacturers to capture the generic market on that particular drug </li></ul>
  23. 27. FDA Pregnancy Safety Categories <ul><li>Category A adequate studies indicate no risk to the fetus in the 1 st trimester & no evidence of risk in later trimesters. </li></ul><ul><li>Category B animal reproduction studies have not demonstrated a risk to fetus, but no well controlled human studies. </li></ul><ul><li>Category C animal studies report adverse effect on fetus, no human studies, benefit/risk. </li></ul>
  24. 28. FDA Pregnancy Safety cont. <ul><li>Category D there is evidence of human fetal risk, but the potential benefits from the use of the drug may be acceptable if safer drugs are not available or ineffective. </li></ul><ul><li>Category X studies in animal or humans demonstrate fetal abnormalities or adverse reaction reports indicating fetal risk. Risk outweighs any benefit. These drugs should not be used in pregnant women. </li></ul>
  25. 29. Summary Slide

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