Chapter 1: Introduction to Pharmacology: Drug Regulation and Approval

1. History of Pharmacology
• History likely began when humans first used plants to relieve symptoms of disease.
• Oldest form of health care –Herbal medicine- has been practiced in virtually ever culture back until antiquity
• Modern pharmacology is though to have begun in the early 1800s when scientist began to isolate active agents morphine, colchicine, curare, cocaine, and other natural products.
• They would study their effects in animals, some early researches even used themselves as test subjects.
• Frederich Serturner who first isolated morphine from opium 1805 injected himself with three friends
• First department of pharmacology was established in Estonia in 1847
• John Jacob Abel Father of American Pharmacology founded the first pharmacology department in US at University of Michigan in 1890
• Now became possible to understand how drugs produced their effect
• Early roots: the application of products to relieve human suffering
2. Pharmacology: The study of Medicines
• Pharmacology- Greek “medicine” “study” ranging from the understanding how drugs are administered, where they travel in the body, and actual response produced.
• More than 10000 brand name drugs, generic drugs, combination are currently available
• Drugs may elicit different responses depending on age, sex, body mass, health status, and genetics.
• Learning the application of existing medicating and staying up with current new drugs is an enormous challenge
• If applied properly drugs can dramatically improve quality of life
• If applied improperly drugs can produce devastating consequences
3. Pharmacology and Therapeutics
• Nurses are most often the health care providers directly involved with patient care and are active in educating, managing, and monitoring the proper use of drugs
• Therapeutics-branch of medicine concerned with the prevention of disease and treatment of suffering
• Pharmacotherapy is the application of drugs for the purpose of disease prevention and the treatment of suffering
4. Classification of Therapeutic Agents as Drugs, Biologics, and Alternative Therapies
• Drug- is a chemical agent capable of producing biological responses within the body. Desirable (therapeutic) or undesirable (adverse)
• After a drug is administered it is called medication
• Biologics are agents naturally produced in animal cells, microorganism, or by body itself. Ex. Hormones, monoclonal antibodies, natural blood products, and components, interferon, and vaccines
• Complementary and alternative therapies involve natural plant extract, herbs, vitamins, minerals, dietary supplements, acupuncture, hypnosis, biofeedback, and massage
5. Prescription and Over the Counter Drugs
• To obtain prescription drugs the person must receive a written order from a person with the legal authority to write such a prescription
• OTC drugs do not require a physicians order. Patients prefer OTC because not require physicians order, obtained more easily, no appointment with physician needed, save time and money
6. Drug Regulations and Standards
• First standard commonly used by pharmacist was formulary- list of drugs and drug recipes
• Pharmacopoeia-medical reference summarizing standards of drug purities, strengths, and direction for synthesis
• Pure Food and Drug Act of 1906 gave government power to control the labeling of medicines
• 1938 Food, Drug, and Cosmetic Act first law preventing the sale of drugs that had not thoroughly tested before marketing
7. The Role of the Food and Drug Administration
• Center for Drug evaluation and Research control over whether prescription drugs and OTC drugs me be used for therapy
8. Stages of Approval fro therapeutic and Biologic Drugs
• Preclinical investigation -involves extensive laboratory research- test on humans, animals to examine drug effeteness at different does
• Clinical investigation –longest part of drug