chapter 1-drug definitions, standards, and information sources

electronic databases

- Cumulative Index of Nursing and Allied Health (CINAHL) - Lexicomp - ePocrates - Daily Med

therapeutic methods

- approaches to treating illnesses - diet therapy - drug therapy - physiotherapy - psychotherapy - therapeutic methods are often used in combination

drug classifications

- body system (e.g., cardiovascular, gastrointestinal) - therapeutic use or clinical indications (e.g., antacids, antibiotics) - physiologic or chemical action (e.g., anticholinergics, calcium channel blockers) - prescription: requires an order by a health professional licensed to prescribe drugs - nonprescription: over the counter (OTC) drugs sold without a prescription - illegal or recreational drugs: used for nontherapeutic purposes; obtained illegally - biosimilar: biologic product that is close in structure/function to an existing approved biologic product (active ingredient is similar to the branded one not identical and can give pt the same therapeutic value at much less cost)

drug name example

- chemical name: (+/-)-2-(p-isobutylphenyl) propionic acid - generic name: ibuprofen - trade name: Motrin, Advil (would also have the trademark symbol after name)

controlled drugs and substances Act (1997)

- establishes requirements for the control and sale of narcotics and substances of abuse in canada - schedules I to VIII

proper name

- nonproprietary or generic name used to describe an official drug in canada

postmarketing surveillance stage

- ongoing review of adverse effects of new drugs

parallel tracking

- used for patients with life-threatening illnesses who cannot participate in controlled trials, when there is no other alternative

which drug schedule indicates drugs with the highest risk for abuse?

schedule I rational: schedule I drugs have the highest potential abuse rate. they are not currently accepted for medical use in the US

Canadian drug legislation

- food and drugs act (1927), Food and Drug Regulations (1953, 1954, 1979): Protect the public in canada through the therapeutic products directorate - national association of pharmacy regulatory authorities (NAPRA) - assigns drugs for four categories - schedule I, II, III and unscheduled

pharmacology

- from Greek words pharmakon (drugs) and logos (science) - physiotherapy uses water, light, and heat - psychotherapy identifies stressors and methods used to reduce them

black box warning

- indicates a very serious life-threating problem - probability of a drug acquiring a new black box warning or being withdrawn from the market within 25 years of being released is 20%

generic name

- legal noncommercial name for a drug - important to know bc formularies use them - not capitalized - true name of the medication

controlled substances

- manufacturers, prescribers, and dispensers must register with the DEA: Requirements must be met to dispense scheduled medications - controlled substances in hospitals: inventory and dispersion control records - possession of controlled substances by individuals: nurses may not have controlled substances in their possession - effectiveness of drug legislation: enforcing laws regarding the proper distribution and use of drugs is dependent on many organizations working together to ensure understanding of reasons for drug legislation

chemical name

- most meaningful to the chemist - chemist understands the exact chemical constitution of the drug and the exact placement of its atoms or molecular groupings

Schedule II Controlled Substances

high potential for abuse-->severe dependence -NARCS: morphine, opium, Dilaudid, Demerol, OxyContin -STIMS: Dexedrine, Adderall, Ritalin -cocaine, amobarbital

official name

listed by the FDA

orphan drugs

medicines developed for rare disorders

how many years on average does it take for a drug to be brought to market from the time of its conception?

- 8-15 years - rationale: this amount of time/money is necessary to adequately test the drug for safety before releasing it to the general population

United States Drug Legislation

- Federal Food, Drug, and Cosmetic Act (1938, 1951, 1962) - controlled substances act (1970)

controlled substances act (1970)

- a federal statute that regulates the manufacture and distribution of the drugs that are capable of causing dependency - defined five classifications or schedules of controlled substances schedule I schedule II schedule III schedule IV schedule V

biologic therapy

- a new class of drugs; has transformed tmt of pts with disorders that attack the body's own organs, tissues, and cells (autoimmune disorders) - biologic agents are large, complex proteins manufactured in a living system

official drug name

- any drug described specifically in the Food and drug regulations; there are some dissimilarities in brand names between Canada and the US

rare diseases and the development of orphan drugs

- national organization for rare disorders estimates that 6000 rare health conditions exist in about 20 million Americans - orphan drug act, 1983: promotes the development of products that demonstrate promise for dx or tmt of rare diseases or conditions (incentive) - ex of rare diseases: cystic fibrosis, Hansen's disease (leopracy), sickle cell anemia, infant botulism

resources for drug information

- official source for american drug standards: the united states pharmacopeia (USP)/National Formulary (NF); USP dictionary of USAN and international drug names - sources for prescription and nonprescription drugs: package inserts, nursing journals, electronic databases

new drug development

- rules and regulations evolved by FDA divide into four stages - preclinical research and development: average time is 18 months - clinical research and development: may require 2 to 10 years; average is 5 years - New Drug Application (NDA) review: Average time is 17 months - Postmarketing surveillance as a whole takes 8-15 years and >$2 billion in research/development cost to bring out a new drug to market

fast tracking

- used to expedite drug development and approval for life-threatening illness - ex: COVID-19

sources of drug information in Canada

-Compendium of Pharmaceuticals and Specialties (CPS) -Patient Self-Care: Helping Patients Make Therapeutic Choices -Compendium of Self-Care Products (CSCP)

schedule III controlled substances

Less potential for abuse than schedule I or II. Narcotic examples: paregoric, APAP & codeine tabs, ASA & codeine tabs Non-narcotic examples: benzphetamine, ketamine, phenobarbital rectal suppositories, stanozolol, testosterone, dronabinol

Schedule IV Controlled Substances

Substances in this schedule have a low potential for abuse relative to substances in Schedule III. Examples of Schedule IV substances include: alprazolam (Xanax), carisoprodol (Soma), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion).

Schedule V Controlled Substances

Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. Examples of Schedule V substances include: cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®), and ezogabine.

Schedule I Controlled Substances

Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ("Ecstasy").

which entity is responsible for monitoring drug safety in the United States?

U.S. Food and Drug Administration (FDA) rationale: FDA is responsible for overseeing drug and cosmetic manufacture and promotion to determine their safety before allowing them to be released to the public

pharmacology deals with the study of _____________ and their actions or effects on the body

drugs

which source of information is best for the nurse to obtain drug information?

electronic databases rationale: all can be sources of drug info, but keeping info current is extremely important. Reliable electronic data bases can provide the most up to date info to healthcare providers, unlike printed resources that are published only periodically

which name(s) of a drug should the nurse use when teaching a patient about a new prescription?

generic and trade names rationale: drug prescriptions may be filled with a trade-name drug or generic equivalent. if the nurse teaches only one name, it may lead to confusion for the patient when he or she receives a drug with a different name

brand or trademark name

registered by manufacturer; capitalized; usually more expensive version of medicine