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Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
Evolution of Medications
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Evolution of Medications

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  • Forms, ordering, disposal, storage
  • Transcript

    • 1. Evolution of Medicinal Drugs Medicinal Origins Legislation & Regulation Drug Testing & Approval
    • 2. Introduction *Historical Trends
    • 3.  
    • 4.  
    • 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>
    • 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>
    • 7. Substance Misuse &amp; 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>
    • 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>
    • 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>
    • 10. Medicines that Changed the World
    • 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>
    • 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>
    • 13. Compliance
    • 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>
    • 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 &amp; 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>
    • 16. Sources &amp; 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
    • 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>
    • 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 &amp; 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 &amp; Classifications
    • 19. &nbsp;
    • 20. Drug Legislation &amp; Regulation <ul><li>FDA Food &amp; Drug Administration </li></ul><ul><li>FTC Federal Trade Commission </li></ul><ul><li>DEA Drug Enforcement Agency </li></ul>
    • 21. &nbsp;
    • 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>
    • 23. Phases of Clinical Trials
    • 24. Drug Testing &amp; 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>
    • 25. FDA Phase IV <ul><li>File NDA at FDA </li></ul><ul><li>Review process &amp; 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>
    • 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>
    • 27. FDA Pregnancy Safety Categories <ul><li>Category A adequate studies indicate no risk to the fetus in the 1 st trimester &amp; 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>
    • 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>
    • 29. Summary Slide

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