INTRODUCTION Pharmacology - study of drugs Drug - substance that alters physiologic function in an organism regardless of benefit or harm Pharmacotherapeutics - use of specific drugs to prevent, treat or diagnose disease Toxicology - study of harmful effects of chemicals Pharmacokinetics - absorption, metabolism, distribution. Excretion Pharmacodynamics - mechanisms of action (cellular & systemic effects) Pharmacogenomics - study of how genes affect patient's response to drugs o Personalized medicine Chemical name - refer to the specific structure of compound (long & cumbersome) (acetylsalicylic acid) o We don't like using chemical names because it causes errors and misinterpretation Generic name - derived from chemical name commonly used (aspirin) (ibuprofen) o Most commonly used Generic equivalent - contains essentially identical amounts of active ingredients whose efficacy is supported by blood level data evaluated by FDA (reputation of manufacturer is important) o Same drug Trade name - assigned by pharmaceutical company -> several companies produce same generic drug oEx: ibuprofen (Motrin) (Advil) Therapeutic equivalent - drug product containing different chemical ingredients that have the same pharmacological and/or therapeutic effect o Ex: ibuprofen (Motrin) naprosyn (Aleve) *Different drugs that do the same thing Branded generic -- prescription products that are either novel dosage forms (liquid, tablet, suspension) of off-patent products produced by a manufacturer that is not the originator of the molecule, or a molecular copy of an off patent product with a trade name o Ex: -extended-release oxycodone (OxyContin) : oxycodone is immediate release and OxyContin suspended release and is a branded generic - levothyroxine (Levothroid) :digoxin (Digitek) oral contraceptives pill packs (Errin, Jolivette, Cryselle) o first is the generic name in () is the branded generic o changing the amount, how it's being released, and the amount that's given Biologic -- complex molecule manufactured using living cells to treat chronic inflammatory diseases & cancer Biosimilar -- similar version of originator biologic o Ex: infliximab (Remicade) -- originator Infliximab-dyyb (Inflectra) -- biosimilar Adalimumab (Humira) -- originator Adalimumab-atto (Amjevita) -- biosimilar **biosimilar price is slightly less -- but not as much as we would like - Use a lot more in the EU
Originator drug co.'s don't like biosimilars
Drug approval process Pre-clinical studies - in animals to determine basic pharmacokinetic & pharmacodynamic properties o Animal studies are very important bc it helps figure out .. Clinical studies - in humans o phase I - small number of healthy volunteers (dosing range, kinetic & dynamic properties) - test drugs that don't affect animals but will they affect humans? o phase II - small, select patient population to treat a specific disease (efficacy & adverse effects) o phase III - large group of patients (thousands) for safety & effectiveness o post-marketing surveillance - general population for efficacy & to detect uncommon adverse reactions
Over The Counter (OTC) medications : judged by FDA to be safe for use by the consumer without direct medical supervision
Controlled Substances -- vary by state :Schedule I - highest potential for abuse oEx: heroin, LSD, marijuana Schedule