Pharmacology: Right Ans - The study of chemicals that alter the function of
a living organism
- Drugs: Right Ans - Any chemical that is capable of interacting with a living
organism to produce a biological effect.
- Herbs and supplements: Right Ans - When we get our patient's health
history it is important to ask them if they're currently taking any herbs or
supplements and how much because it can interact with the different
medications that we might put them on.
- Ace Inhibitors (drug class) was originally from Right Ans - the venom of
Brazillian Pit Viper snakes because it helped with hypertension
- Botulinum toxin (better known as botox) was a Right Ans - toxin potent
from spoiled sausages and was used to treat facial wrinkles.
- Warfarin (Cumin) is a Right Ans - blood thinner medication and it
originally came from rat poison.
- Curare: Right Ans - A muscle relaxant that is used in anesthesia that
comes from poisonous dart frogs in South America.
- Federal Pure Food and Drug Act of 1906: Right Ans - This law set
standards for drug quality and purity in addition to strength. It specifically
focused on product labeling and required that any variations from the
standards be placed on the label.
- The Food, Drug and Cosmetic Act of 1938: Right Ans - was the first
legislation to address drug safety. They passed this act because more than 100
people died following the use of a new medication because it had an
automotive freeze in the medication. This Act set standards for how
compounding pharmacies could make medications. The drugs had to be pure
with no additives and undergo testing to ensure that there was no toxicity.
,- Kefauver - Harris Amendment of 1962: Right Ans - This act states that
drugs must be proven to be effective and work properly.
- Controlled Substance Act of 1970: Right Ans - This legislation set rules for
the manufacturer and distribution of drugs considered to have potential for
abuse. One provision of the law defines five categories of controlled
substances, referred to as Schedules I, II, III, IV, and V.
- Orphan Drug Act of 1983: Right Ans - Pharmaceutical companies are
given a tax break if they make medications for rare diseases such as
Hungtington's disease, HIV, AIDS, ALS, and Tourette syndrome
- Experimental Drugs for the Desperately ill of 1992: Right Ans - FDA
regulations were changed to permit accelerated approval of drugs for
acquired immunodeficiency syndrome (AIDS) and cancer. Under these
guidelines, a drug could be approved for marketing before completion of
phase III trials, provided that rigorous follow up studies were performed. The
rationale for this change was that (1) medications are needed, even if their
benefits may be marginal, and (2) the unknown risk associated with early
approval are balanced by the need for more effective drugs.
- The Food and Drug Administration Modernization Act (FDAMA) of 1997:
Right Ans - Manufacturers who plan to stop making a drug must inform
patients at least six months in advance, thereby giving them time to find
another source. This is also when they started doing research on kids and
pregnant woman.
- Best Pharmaceutical for Children Act (BPCA) of 2002 and Pediatric Research
Equity Act (PREA) of 2003 Right Ans - were designed to promote much
needed research on drug efficacy and safety in children. The BPCA offers a 6
month patent extension to manufacturers who evaluate a drug already on the
market for its safety, efficacy, and dosage in children. The PREA gives the FDA
the power, for the first time, to require drug companies to conduct pediatric
clinical trials on new medications that might be used by children.
- FDA Amendments Act (FDAAA) of 2007: Right Ans - The FDAAA expands
the mission of the FDA to include rigorous oversight of drug safety after a
, drug has been approved. Just because a drug is on the market, it can still be
pulled if it doesn't seem to be effective.
- Stages of New Drug Development: Right Ans - First preclinical animal
trials and laboratory studies are done. Every pharmaceutical company test on
animals to determine the lethal dose and potential side effects. The
development and testing of new drugs is an expensive and lengthy process, it
takes 7 - 10 years to approve drugs and around 25 million dollars to get it
approved.
- Drug research stopped: Right Ans - Toxic and unacceptable side effects,
expensive or decreased treatment demand, lack of therapeutic effect, and
small safety margin.
- Phase One: Right Ans - Phase one trials are usually conducted in healthy
volunteers (around 20 - 100 people) However, if a drug is likely to have
severe side effects, as many anticancer drugs do, the trial is done in volunteer
patients who have the disease under consideration. Phase one testing has
three goals: to evaluate drug metabolism (how the drug breaks down in the
system), pharmacokinetics, and biological effects (the effects on humans)
- Phase Two: Right Ans - Phase two trials are usually conducted on a small
group of ill individuals that target a specific disease ex: high blood pressure.
The goal is to determine the therapeutic effects.
- Phase Three: Right Ans - Phase three trials are conducted on a larger
group of ill individuals. The objective is to determine therapeutic effects,
dosage range, safety, and effectiveness. Double blind controlled study 500
people get the drug and 500 people get a placebo. The patients and the
investigators don't know who gets what.
- Phase Four Post Marketing Surveillance: Right Ans - In phase four, the
new drug is released for general use, permitting observations of its effects in a
large population. New side effects may be discovered. Some of the
medications get pulled from the market. A patent is good for 17 years and no
other drug company can make a medication like that.
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