Pharmacology Ch. 1 - Definitions, Names, Standards, and Information

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Pharmacology

(Greek pharmakon, drugs, and logos, science) deals with the study of drugs and their actions on living organisms

Therapeutic Methods

- Drug therapy: treatment with drugs
- Diet therapy: treatment by diet
- Physiotherapy: treatment with natural physical forces such as water, light, and heat
- Psychological therapy: identification of stressors and methods to reduce or eliminate stress and/or the use of drug

Drugs

(Dutch droog, meaning dry) are chemical substances that have an effect on living organisms

Medicines

Drugs used in the prevention or treatment of disease.

Chemical name

Chemical constitution of the drug and the exact placing of its atoms of molecular groupings

Generic name (nonproprietary name)

Before a drug becomes official. The first letter is not capitalized. Students are strongly encouraged to learn and refer to drugs by their generic name because formularies are maintained by generic name. It's provided by the United States Adopted Names (USAN) council

Official name

Name under which the drug is listed by the U.S. Food and Drug Administration (FDA)

Trademark or brand name or proprietary name

is followed by the symbol ®. This indicates that the name is rergistered and that its use is restricted to the owner of the drug. Most drug companies place their products on the market under trade names instead of official names. The trade names are deliberately made easier to pronounce, spell, and remember. The first letter is capitalized

United States Pharmacopeia (USP)/ National Formulary (NF)

It provide standards for identity, quality, strength, and purity of substances used in the practice of health care. It's enforced by the FDA as the official standards for the naufacture and quality control of medicines and nutritiional supplements produced in the US

Physicians' Desk Reference (PDR)

Published annually by Thomson Reuters. Book is divided into five sections
- Section 1: Manufacturers' Index
- Section 2: Brand and Generic Name Index
- Section 3: Product Category Index
- Section 4: Product Indentification Guide
-Section 5: Product Information Section

Section 1: Manufacturers' Index

Alphabetic listing of each manufacturer whose products are listed in the PDR, their addresses, emergency phone numbers, and a partial list of available products

Section 2: Brand and Generic Name Index

Comprehensive alphabetic listing of the generic and brand name products discussed in the Product Information section of the book

Section 3: Product Category Index

An unlabeled section of white pages containing the definitions of controlled substances categories, Usein-Pregnancy Ratings, FDA telephone directory, poison control centers arranged alphabetically by state and city, drug informationcenters arranged by state and city, list of drugs that may cause photosensitivity arranged alphabetically by generic name, list of drugs that should not be crushed arranged alphabetically by brand name, Patiet Assistance Program, and USP Medication Errors Reporting Form used in association with the Institute for Safe Medication Practices

Section 4: Product Identification Guide

Manufacturers have provided actualsize color pictures of their products. This section is an invaluable aid for product identification

Section 5: Product Information Section

Reprints of the package inserts for the major products of manufacturers, with information on action, uses, administration, dosages, contraindications, composition, patient education, and how each drug is supplied

Health on the Net Foundation (HON)

To ensure accuracy of health informaion found pn a website. Has elaborated the Code of conduct to healp standardize the reliability of medical and health information available on the Internet

Federal Food, Drug, and Cosmetic Act of 1938

Authorized the FDA of the US department of Health and Human Services (HHS) to determine the safety of drugs before marketing and to ensure that certain labeling specifications and standards in advertising are met in the marketing of products

Controlled Substances (1970)

Designed to improve the administration and regulation of manufacturing, distributing, and dispensing of drugs that have been found necessary to be controlled

Drur Enforcement Administration (DEA)

Organized to enforce the Controlle dSubstances Act, gather intelligence, and train and conduct research in the area of dangerous drugs and drug abuse.

Schedule I Drugs

1. A high potential for abuse
2. No currently accepted medical use in the US
3. A lack of accepted safety for use under medical supervision
Ex: LSD, marigunana, peyote, STP, heroin, hashish

Schedule II Drugs

1. A high potential for abuse
2. A currently accepted medical use in the US
3. An abuse potential that may lead to severe psychological or physical dependence
Ex: Secobarbital, pentobarbital, amphetamines, morphine, meperidine, methadone, Percodan, methylphenidate

Schedule III Drugs

1. A high potential for abuse, but less so than drugs in schedules I and II
2. A currently accepted medical use in the US
3. An abuse potential that may lead to moderate or low physical dependence or high psychological dependence
Ex: empirin with codein, Lortab, Fiorinal, Tylenol with codeine

Schedule IV Drugs

1. A low potential for abuse, compared with those in schedule III
2. A currently acepted medical use in the US
3. An abuse potential that may lead to limited physical or psychological dependence, compared with drugs in schedule III
Ex: phenobarbital, propoxyphene, chloral hydrate, paraldehyde, chlordiazepoxide, diazepam, flurazepam, temazepam

Schedule V Drugs

1. A low potential for abuse, compared with those in schedule IV
2. A currently accepted medical use in the US
3. An abuse potential of limited physical or psychological dependence liability, compared with drugs in schedule IV. Because abuse potential is low, a prescriptiion may not be required
Ex: lomotil, robitussin

Possession of controlled substances

Nurses may give controlled substances only under the direction of a health care practitioner who has been licensed to prescribe or dispense these agents. Nurses may not have controlled substances in their possession unless
1. they are giving them to a patient under a physician's order
2. the nurse is a patient for whom a physician has prescribed schedule drugs
3. the nurse is the official custodian of a limited supply of controlled substances on a ward or department of the hospital.
Controlled substances ordered but not used for patients must be returned to the source from which they are obtained. Violation is punishable by fine, imprisonment, or both

New drug Development

It takes an avereage of 8 to 15 years and up to $1 billion in research and development cose to bring a single new drug to market. The Food, Drug, and Cosmetic Acto f 1938 charged the FDA with the responsibility to regulate new drugs. Rules and regulations evolved by the FDA divide new drug development into four stages:
1. Preclinical reasearch and development
2. Clinical research and development
3. New Drug application review
4. Postmarketing surveillance

Preclinical research

Begins with discovery, synthesis, and purification of the drug. The goal at this stage is to use laboratory studies to determine whether the experimental drug has therapeutic value and whether the drug appears to be safe in animals. Near the end of this phase, the investigator submits an Investigational New Drug (IND) application to the FDA, which describes all studies completed to date and the safety and testing planned for human subject. The FDA must make a decision within 30 days. Range: 1-3 year. Average: 18 months

Clinical research and development stage

Divided into three phases
1. Pharmaceutical phase - from the manufacture of the drug until absorption of the drug takes place in the patient's body. Absorption occurs when the active ingredient of the drug enters the body fluids
2. Pharmacokinetic phase - the movement of the drug's active ingredients from the body fluids into the entire system and to the site where the intended action of the drug takes place
3. Pharmacodynamic phase - the drug's active ingredient interacts with the intended body tissues. The body's cells respond to the action of the drug and change as the drug is metabolized.
Range: 2 - 10 years
Average 5 years

New Drug Application Review

When sufficient data have been collected to demonstrate that the experimental drug is both safe and effective, the investigator submits a New Drug application to the FDA, formally requesting approval to market a new drug for human use.

Postmarketing survellance

Consists of an ongoing review of adverse effects of the new drug, as well as periodic inspections of the manufacturing facilities and products

Current Categories for Drug Use in Pregnancy

A - studies show no risk to fetus
B - studies show an adverse effect but no risk to fetus
C - no adequate information to assess risk to fetus at this time
D - Studies demonstrated risk to fetus
X - studies demonstrated positive fetal abnormalities; contraindicated in pregnancy

Teratogens

Agents, such as chemicals and viruses, that can reach the embryo or fetus during prenatal development and cause harm

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