02- DDS 6215 Intro to Pharm 2023.pdf

 Pharmacology Introduction Pharmacology Dr. Dan Skaar [email protected] DDS 6215 Agenda and Objectives Course overview Describe drug terminology Understand drug development...

 Pharmacology Introduction Pharmacology Dr. Dan Skaar [email protected] DDS 6215 Agenda and Objectives Course overview Describe drug terminology Understand drug development process Describe evolution of drug regulation Know OTC and generic drug issues  Course Overview Syllabus – Faculty – Exams – Misc. Canvas site Communication  Drug Terminology Pharmacology – pharmaco ~ “drug or medicine” – ology ~ “study” Study of drugs – Drug Chemical compound administered to diagnose, treat or prevent conditions and diseases Alleviate pain and control or improve physiologic or pathologic conditions  Drug Terminology Pharmacokinetics – Body actions on drug Drug changes with time Drug absorption, distribution, metabolism and elimination (ADME) – Influences dosages and dosing intervals Pharmacodynamics – Drug actions on body Biochemical, physiological and behavioral effects of drugs Mechanism of action (MOA)  Drug Nomenclature Chemical name – 2-diethylamino-2,6-acetoxylidide  Drug Nomenclature Generic name – Official and selected by U.S. Adopted Name Council – E.g. lidocaine Brand or trade name – Patent protected – Xylocaine® Drug Development  Drug Regulatory Agencies Food and Drug Administration (FDA) – Prescription drug approval – Manufacturing standards – Physical and chemical standards – Labeling – Sale as prescription or over-the-counter (OTC) drugs – U.S. approval typically more stringent  Drug Regulatory Agencies Drug Enforcement Administration (DEA) – Dept. of Justice – Regulates manufacture and distribution of controlled substances (e.g. opioids) Federal Trade Commission (FTC) – OTC drug advertising  Federal Drug Regulation Food and Drug Act (1904) – Regulate interstate commerce Harrison Narcotic Act (1914) – Federal control over distribution and use of narcotics – Prescribers registration Food, Drug and Cosmetic Act (1938) – Prohibit interstate commerce unless drug safe and effective – Labeling with ingredients – Prohibit false/ misleading claims  Federal Drug Regulation Durham-Humphrey Law (1952) – Clearer distinction between OTC and Rx drugs – Labeled Caution: Federal law prohibits dispensing without prescription” – Prohibit routine prescription refilling Kefauver-Harris Bill (1962) – Demonstrate effectiveness Stricter testing rules Labeling state adverse experiences (AEs), contraindications, and efficacy Report AEs to FDA Controlled Substances Act (1970) – Drug Schedules created Abuse potential and medical use – Current Rx writing requirements established  Misc. Topics Package inserts – Information negotiated between manufacturer and FDA Description Dosage forms Pharmacology Indications and dosing Adverse experiences – Black Box warnings Pregnancy and lactation  Misc. Topics Label and off-label use – Allowed if justified by good medical practices – Example Antibiotics used for oral infections Prescription drug reclassifications – Rx to OTC Ibuprofen and naproxen – Schedule III to II Oxycodone  Misc. Topics Generic drugs – Patent expiration → market as generic drug with another trade name – Demonstrate similar pharmacokinetic and pharmacodynamic profiles Are chemically, biologically and therapeutically “equivalent” – Generic substitution  Misc. Topics Generic and OTC drug safety issues Manufacturing impurities – Generic Rx drugs – OTC drugs Overseas manufacturers – Falsified quality-control data – Carcinogens  Drug Information Resources Published References Online references – Physician’s Desk – Pharmaceutical company Reference (PDR) web sites – Drug Information – Lexi-Comp Handbook for Dentistry – Mosby Dental Drug Health professionals Reference – Pharmacists – Nurses – Physicians  Summary Understand drug terminology Describe drug development process and federal agencies involved Describe evolution of drug regulation Understand generic and OTC drug issues