INTRODUCTION TO PHARMACOLOGY: DRUG REGULATION & APPROVAL
Chapter 1
INTRODUCTION  Have
you ever stopped to consider the impact YOU will make on the lives of others as a health care worker?
INTRODUCTION  Not
only can you make a tremendous difference in the efficiency of the facility, but you can have a positive impact on your friends and family, as well as the patient or client.
INTRODUCTION  The
purpose of this chapter is to introduce the subject of pharmacology and to emphasize the role of the government in ensuring drugs and natural alternatives are safe and effective for public use.
INTRODUCTION 

May be prescribed for more than one disease and most produce multiple effects in the body. Further complicating the study of pharmacology is the fact that drugs may elicit different responses depending on factors such as sex, age, health status, body mass and genetics.
PHARMACOLOGY
Pharmacology is an expansive and challenging topic Pharmacology is defined as “the study of medicine”. The subject of pharmacology is an expansive topic ranging from a study of how drugs enter and travel throughout the body to the actual responses they produce.
PHARMACOLOGY  To
learn the discipline well, students must master concepts from several interrelated areas including A&P, chemistry and pathophysiology.
PHARMACOLOGY  Over
10,000 brand and generic varieties of drugs with many different names, interactions, side effects, and complicated mechanisms of action are currently available.  Keeping up with the number of drugs is a huge challenge.
PHARMACOLOGY & THERAPEUTICS Health
Care practitioners —prescribe medications (can be physicians, physician’s assistants, dentists, and advanced nurse practitioners) Health Care providers are involved in education, management and /or enforcement of drug issues.
PHARMACOLOGY & THERAPEUTICS Therapeutics—
treatment of disease and suffering. Pharmacotherapeut ics—is the use of medicine to treat diseases.
TRADITIONAL DRUGS, BIOLOGICS, NATURAL ALTERNATIVES Drugs
are any chemical agent that can produce a biological response in the body. Therapeutic Drugs
1. Chemically produced in a laboratory. 2. Biologics—naturally produced in animal cells, microorganisms or the body itself 3. Natural Alternatives—herbs, natural extracts, vitamins, minerals, dietary supplements.
TABLE 1.1
FIGURE 1.1
PRESCRIPTION OR OVER-THECOUNTER Prescription
drugs— need physician’s order
MD has the opportunity to examine the patient and formulate a diagnosis. (yeast) MD can control the specific amount and frequency of the drug. MD can educate on how to use the drug properly and what side effects to expect.
PRESCRIPTION OR OVER-THECOUNTER
OTC drugs—no physician’s order
Depends on margin of safety. If patients do not follow the guidelines, OTC drugs can have serious side effects. (ASA) OTC may react with foods, herbal products, and RX. And other OTC drugs. Self-treatment/diagnosis may allow the disease to progress.
PHARMACEUTICS Definition—
science of preparing and dispensing drugs. Pharmacist— prepares and dispenses drugs and advises clients.
Experts at cataloging s/s, S/E, & drug interactions.
DRUG REGULATIONS (1820-1938) Purpose—protect
public
from drug misuse. Clients could not be assured that available medicines were not a form of quackery.
Rattlesnake oil for rheumatism, epilepsy treatment for spasms, hysteria, and alcoholism, and fat reducers for a slender, healthy figure.
DRUG REGULATIONS (1820-1938) U.S.
Pharmacopeia (USP) (1820)—first comprehensive publication of drug standards. A medical reference summary indicating standards of drug purity, strength, and directions for synthesis. All drug substances and products were covered in the USP
DRUG REGULATIONS (1820-1938) National
Formulary (NF) established by American Pharmaceutical Association (1852)
Included pharmaceutical ingredients.
DRUG REGULATIONS (1820-1938) U.S.
PharmacopeiaNational Formulary (USPNF) formed 1975
Combined the 2
DRUG REGULATIONS (1820-1938) Biologics
Control Act (1902)— standardized the quality of serums and other blood related products. Pure Food and Drug Act (1906)— government controlled the labeling of drugs.
DRUG REGULATIONS (1820-1938)
Sherley Amendment (1912)—prohibited the sale of drugs labeled with false therapeutic claims. Food, Drug and Cosmetic Act (1938)— prevented marketing of drugs without prior testing; companies had to prove safety and efficacy of the drug prior to being sold within the United States.
U.S. DRUG STANDARDS Food and Drug Administration (FDA) (1988) established as agency of the U.S. Department of Health and Human Services. Center for Drug Evaluation and Research (CDER)—branch of FDA—controls whether prescription drugs or OTC drugs are used for therapy based on safety and efficacy. Center for Biologics Evaluation and Research (CBER)—branch of FDA—regulates use of biologics (serums, vaccines, products in the bloodstream)
U.S. DRUG STANDARDS Center
for Food Safety and Applied Nutrition (CFSAN)-- regulates use of herbal products and dietary supplements under the Dietary Supplement Health and Education Act (1994)
FDA oversees administration of herbal products and dietary supplements. Herbal products and dietary supplements may be marketed without FDA approval.
APPROVAL STAGES FOR THERAPEUTIC AND BIOLOGIC DRUGS (SEE FIG. 1.3) There
are four stages:
1. Pre-clinical investigation—basic science research. 2. Clinical investigation—involves three different phases known as clinical phase trials —longest part of the approval processes. Tests performed on volunteers, large groups of clients with selected diseases. New Drug Application (NDA)—submitted to proceed to the next stage
APPROVAL STAGES FOR THERAPEUTIC AND BIOLOGIC DRUGS (SEE FIG. 1.3)
3. Review of New Drug Application (NDA)—
Clinical trial III and animal testing continues.
4. Post-marketing surveillance
Observe for any harmful effects in a larger population
NEW CHALLENGES FOR GOVERNMENTAL AGENCIES TO ENSURE SAFETY OF DRUG A. FDA and regulating agencies criticized for being too slow to approve new life-saving drugs for market. B. Reasons for delay—outdated guidelines, poor communication, not enough staff for workload. C. Prescription Drug User Fee Act (1992)—drug and biologic manufacturers required to provide yearly product user fees. D. Concern now—are drugs being developed faster than risks can be assessed.
CANADA  When
you move to Canada, you can worry about the standards there, no need to confuse you at this point.
NEW CHALLENGES FOR HEALTHCARE PROFESSIONALS 
Prior to the Septemeber 11, 2001, terrorist attacks on the U.S., concern about epidemic diseases was mainly focused on the possible spread of traditional infectious diseases such as influenza, TB, cholera, and HIV.
NEW CHALLENGES FOR HEALTHCARE PROFESSIONALS  Healthcare
providers were also concerned about widespread food poisoning and STDs other than HIV, but because these diseases and conditions produces fewer fatalities, less attention was given to them.
NEW CHALLENGES FOR HEALTHCARE PROFESSIONALS
Now the healthcare community is more aware of the possibility of bioterrorism—the intentional use of infectious biologic agents, chemical substances, or radiation to cause wide-spread harm of illness.
NEW CHALLENGES FOR HEALTHCARE PROFESSIONALS The
goal of a bioterroirst are to create widespread public panic and cause as many casualties as possible. The list of agents that can be used for this purpose is long.
NEW CHALLENGES FOR HEALTHCARE PROFESSIONALS Some
of these agents are easily obtainable and require little or no specialized knowledge to spread. The most worrisome are:
Acutely infectious diseases such as anthrax, smallpox, plague, and hemorrhagic viruses. Incapacitating chemicals such as nerve gas, cyanide, and chlorinated agents Nuclear and radiation emergencies.
NEW CHALLENGES FOR HEALTHCARE PROFESSIONALS Throughout
the text further mention of this will be highlighted. It is important that healthcare professionals are able to identify, isolate, and treat widespread disease caused by bioterrorism.