Introduction to Pharmacology: Drug Regulation and Approval Chapter 1 John Paul Joson MSN CNS

OBJECTIVES What is it? History Classification of Therapeutic Agents as : Drugs Biologics Complementary and Alternative therapies Therapeutic and Pharmacologic Class Chemical vs Generic vs Trade Names Prescription vs OTC

What is it? . . . Pharmacology Pharmakon = ____________________ Logos = ________________________ Application of products to relieve human suffering Focus on patient and to improve quality of life History of pharmacology –oldest form of health care is herbal medicine, plants Modern pharmacology began in 1800’s, chemist testing drugs on animals and selves.

Pharmacology The study of medicine Drug vs. Medicine Therapeutic Adverse Factors Affecting Medication Doses & Responses Age (Peds, Adults, Geriatrics) Sex Body mass Health status Genetics Expansive subject –how drugs administered, where administered, where in body do drugs travel, response produced Need a good foundation in A&P, chemistry, micro, and patho. Drug –chemical agent capable of producing biologic response in body After drug administered it is called a medicine because it is treating something. Desirable/Undesirable

Drug Regulations and Standards 1820 Group of MDs established U.S. Pharmacopeia (drug recipes) 1852 American Pharmaceutical Association, established National Formulary pharmaceutical ingredients 1862 Federal Bureau of Chemistry →Food and Drug Administration Act (FDA) 1902 Biologics Control Act –quality of serums and other blood related products 1906 Pure Food and Drug Act –labeling of medicines, followed in 1912 ensure no false labels 1938 Food, Drug, and Cosmetic Act –drugs must be tested via submission of New Drug Application to FDA prior to marketing 1986 Childhood Vaccine Act 1988 FDA →U.S. Department of Health and Human Services 1994 Dietary Supplement Health and Education Act Few standards or guidelines in place to protect public from misuse of drugs until 19th century. U.S. Pharmacopeia –drug purity, strength, directions for synthesis

Pharmacology Classification of Therapeutics Drug = Desirable vs. Undesirable Medication = Biologics Complementary & Alternatives Drug= chemical agent capable of producing biologic responses Desirable =Therapeutics –prevention of disease and treatment of suffering Undesirable = adverse Biologics –agents naturally produced in animal cells, microorganisms, or by body itself Complementary–natural plant extracts, herbs, vitamins, minerals, dietary supplements (can also include accupuncture, hypnosis)

Therapeutic vs Pharmacological Class Therapeutic = What is used for ? Anticoagulant Antihyperlipidemic Antihypertensive Antidysrhythmic Antianginal Pharmacological = What does it do to the body? Diuretic Calcium channel blocker Angiotensin converting enzyme Vasodilator

Chemical vs Generic vs Trade Name Chemical Name = International Union of Pure and Applied ChemistryN-acetyl-p-aminophenol 2-(4-isobutylphenyl) propanoic acid Generic Name = U.S. Adopted Name Council = usually only one name Acetaminophen Ibuprofen Trade = What everybody knows it as = many names Tylenol, A-mol, Acimol, Activate Advil, Motrin, arthrofen

Pharmacology Prescription Over the counter (OTC) Received written order from person with legal authority to write such a prescription Over the counter (OTC) Do not require physician’s order Legal drugs obtained either by prescription or OTC Advantages and disadvantages to prescription vs. OTC Get thorough assessment from MD and determine specific dx, ordering the proper dose amount, frequency of drug to be dispensed to maximize therapy OTC –if patient does not follow directions of drug can have adverse effect, although OTC are easily obtainable, less expensive, save time with having to make MD appointment, but how do you choose the right one.