Drug Definitions, Standards, and Information Sources
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is also referred to as the common name of the drug; may be used in any country and by any manufacturer; first letter is not capitalized; these names are provided by the USAN council.
is the name under which the drug is listed by the U.S. Food and Drug Administration (FDA); FDA is empowered by federal law to name the drugs for human use in the U.S.
A or or is followed by the a symbol; indicates that the name is registered and that its use is restricted to the owner of the drug, who is usually the manufacturer; the first letter is capitalized.
trademark, propriety, or Brand name
is the non-government organization that promotes the public health by establishing state-of-the-art standards to ensure quality of medicines and other health care technologies.
U.S. Pharmacopial Convention
- the primary purpose of this volume is to provide standards for identity, quality, strength, and purity of substances used in the practice of health care; the standards set forth in this are enforced by the FDA as the official standards for the manufacturer and quality control of medicines and nutritional supplements produced in the US.
United States Pharmacopeia (USP)/National Formulary(NP)
published annually and compilation of more than 10,000 drug names.
USP Dictionary of United States Adopted Names (USAN) & Internation Drug Names
- an index of all medicines available in the US; includes a list of common medical abbreviations, tables of weights, measures, and conversion factors, normal lab values, a list of drug names that look and sound alike, oral dosage forms that should not be crushed or chewed, FDA pregnancy categories, a glossary to aid in interpretation of the monographs, a labeler code index to identify drug products, and a list of manufacturers addresses.
American Drug Index
- published by Facts and Comparisons; three-ring, loose-leaf, nearly 800-page binder first published in 1983 and is currently the most comprehensive book available on the subject of drug interactions.
Drug Interaction Facts
- the most comprehensive reference available on the topic of compatibility of injectable drugs.
Handbook on Injectable Drugs
- the most comprehensive text available on OTC medications that can be purchased in the US.
Handbook on NON Prescription Drugs
- has become the scientific gold standard for evidence-based information on herbal medicines and combination products of herbal medicines.
Natural medicines Comprehensive Database
- discusses more than 4000 therapeutic agents; divided into seven color-coded sections for easier access.
Physicians Desk Reference
- authorized the FDA of the 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.
Federal Food, Drug, & Cosmetic Act
- tightened control by restricting the refilling of prescriptions
Durham/Humphrey Amendment of 1952
- was brought about by the thalidomide tragedy; thalidomide was an incompletely tested drug approved for use as a sedative-hypnotic during pregnancy; fetuses exposed to thalidomide were born with serious birth defects; this amendment provides greater control and surveillance of the distribution and clinical testing of investigational drugs and requires that a product be proven both safe and effective before release for sale.
Kefauver-Harris Drug Amendment of 1962
- passed by Congress in 1970; repealed almost 50 other laws written since 1914 that relate to the control of drugs; the Drug Enforcement Administration (DEA) was organized to enforce this act, gather intelligence, and train and conduct research in the area of dangerous drugs and drug abuse; the DEA is a bureau of the Department of Justice; the director of the DEA reports to the Attorney General of the US.
Controlled Substance Act
♦ A high potential for abuse
♦ Not currently accepted for medical use in the US
♦ A lack of accepted safety for use under medical supervision
♦examples: LSD, marijuana, heroin
Schedule I Drugs
♦A high potential for abuse
♦ Currently accepted for medical use in the US
♦An abuse potential that may lead to severe psychological or physical dependence
♦Examples: amphetamines, Morphine, Demerol, Methadone, Methylphenidate
Schedule II Drugs
♦ A high potential for abuse, but less so than drugs in Schedules I and II
♦Currently accepted for medical use in the US
♦An abuse potential that may lead to moderate or low physical dependence or high psychological dependence
♦ examples: Lortab, Tylenol with Codeine
Schedule III Drugs
* a low potential for abuse, compared with those in schedule III
* Currently accepted for medical use in the US
* An abuse potential that may lead to limited physical or psychological dependence, compared with drugs in Schedule III
* Example: Phenobarbital, Valium, Restoril
Schedule IV drugs
*a low potential for abuse, compared with those in Schedule IV
* Currently accepted for medical use in the US
* An abuse potential of limited physical or psychological dependence liability, compared with drugs in Schedule IV. Because abuse potential is low, a prescription may not be required.
* Examples: Lomotil, Robitussin A-C
Schedule V Drugs
, after public hearings, has the authority to reschedule a drug, bring an unscheduled drug under control, or remove controls on scheduled drugs.
The US Attorney General
Every manufacturer, Physician, nurse practitioner, physician assistant, dentist, pharmacy, and hospital that manufactures, prescribes, or dispenses any of the drugs listed in the 5 schedules must register with the DEA.
A health care provider's prescription for substances named in this law must contain the following:
- A. Healthcare Provider's Name
- B. Healthcare Provider's Address
- C. DEA Registration Number
- D Healthcare Provider's Signature
- E. Patient's Name
- F. Patient's Address
- G. Date of Issue
Federal and state laws make the possession of a controlled substance a .
Nurses may give controlled substances only under the direction of a or who has been licensed to prescribe or dispense these agents.
Nurses may not have controlled substances in their possession unless:
- A. they are giving to a patient under physician orders.
- B. The nurse is a patient for whom a physician has wrote the order for.
- C. The nurse is an official custodian of a limited supply of controlled substances on a ward or department of the hospital.
It now takes years and up to in research and development costs to bring a single new drug to market.
8-10 years, $1 billion
is the study of drugs and their actions or effects
- 1.Body System Classifications (cardiovascular, gastrointestinal, etc.)
- 2. Therapeutic use or clinical indications (antacids, antibiotics, etc.)
- 3. Physiological or chemical action (anticholinergics, calcium channel blockers, etc.)
Requires an order by a health professional licensed to prescribe drugs
Over the counter (OTC) drugs sold without a prescription
used for non-therapeutic purposes; obtained illegally
illegal or recreational drugs
which entity is responsible for monitoring drug safety in the US?
U.S. Food and Drug Administration (FDA)
Used to expedite drug development and approval for life-threatening illnesses
chemical substances that have an effect on living organisms
drugs that are used for the prevention or treatment of diseases
- 1. Drug Therapy- treatment with drugs
- 2. Diet Therapy- treatment with diet
- 3. Physiotherapy-treatment with natural physical forces.
- 4. Psychological Therapy- the identification of stressors and methods that can be used to reduce or eliminate stress.
4 stages of regulating new drugs
- 1. Preclinical research- 1-3 years
- 2. Clinical research- 2-10 years
- 3. New Drug Application review (NDA)- 2 months-7 years
- 4. Post marketing surveillance- 2 months - 7 years
an IND may be used for patients who cannot participate in controlled clinical trials and when there is no satisfactory standard therapeutical alternative
Very serious or potentially life threatening problems or were withdrawn from the market because of serious or fatal complications
Black Box Warning
manufacturers have been unable to recover the costs of the research due to the very limited use of the final product.
Which Source of information is best for the nurse to obtain drug information?
Official source for American Drug Standards
- ♦The United States Pharmacopeia (USP)/ National Formulary (NF)
- ♦USP Dictionary of USAN and International Drug Names
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