chapter 18,19 basic pharmacology quiz/

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Pharmacology
* the study of drugs and their interactions with living organisms
* the study of drug sources, chemical makeup. Preparation and uses of drugs.
pharmacology comes from
the Greek word pharmakon, meaning medicine and the suffix -ology means the study of .
drug
can be any substance, that when administered to a person, produces a change in function.
We commonly mean any MEDICATION that is used for treating disease. ( Key and Lock)
Pharmacodynamics
How drugs produce their effect( actions of drug on the body)
Pharmacokinetics
studies the process of drug absorption, distribution, metabolism and excretion. Based on time and dosage (actions of the body on the drug)
Pharmacotherapeutics
studies the use of drugs in treating disease
Pharmacy
science of preparing and dispensing medicines
Toxicology
study of toxic or poisonous effects of drugs
Clinical Pharmacology
biologic effect a drug has on a patient when used as medicinal treatment. Covers action of a drug over a period of time
medicina
The Latin word for drug is _____ from which we derive medicine
the origins of the three terms pharmacology, medicine, and drugs
Greek, Latin, and Dutch
Medical uses for drugs
* Prevention – vaccines
* Treatment – aspirin, antihistamines
* Diagnose – barium, radiopaque dyes
* Cure – antibiotics
* Maintenance – insulin, vitamins, blood pressure
* Birth Control – (contraception) prevent pregnancy
* Substances body isn’t producing – insulin, Thyroxine
Pharmacology is one of the oldest branches of medicine dating back to the
Egyptians and Sumerians in 2000 B.C.
Drug Sources
Plants
Animals
Mineral
Chemical
Plant drug source
Roots, leaves, seeds
Ex: Purple foxglove – Digitalis – used to tx heart conditions
Animals drug source
Hormones
Ex: Insulin from pigs.
Heparin (anticoagulant) – intestinal lining of pigs and cattle
Minerals drug source
Rocks & crystals
Ex: Iron, Iodine, Calcium & Salt (sodium chloride)
Chemical drug source
Biogenetic – man-made, from a chemist lab
The Food and Drug Act of 1906
• First federal drug law.
• Required accurate labeling
• Passed to protect the public from patent meds.
• Burden of proof still on the government.
• Did not need any approval to market & sell drugs
The Harrison Narcotics Act of 1914
• Identified drugs with potential for abuse and dependence
• Established legal framework for drug control
• Introduced the term narcotic
Food, Drug and Cosmetic Act of 1938
• Result of tragedy – Elixir of Sulfonamide: poisoned over 350 people and many children died. Caused update of 1906 Law
• Food & Drug Administration ( FDA) – to review and evaluate safety of drugs
• Manufactures needed approval
• Burden of proof shifted to drug companies
Durham-Humphrey Amendment – 1951
• Amended 1938 Act
• Defined prescription drugs (legend drugs)
o Drugs that could only be given to patients under the
care of physicians
o Drugs require monitoring by physician to be taken
safely
Kefauver-Harris Amendment – 1962
• Result of thalidomide use in pregnancy for morning sickness – caused limb deformities
• Tightened control on existing drugs & new drugs
• Required manufactures to report adverse side effects from new drugs
The Comprehensive Drug Abuse Prevention & Control Act / The controlled substance Act 1970
• Replaced Harrison Narcotic Act
• DEA was formed : Drug Enforcement Agency
o DEA monitors manufacturing & dispensing of
controlled substances
• Developed five categories / scheduled for controlled substances according to potential for addiction / abuse
• Known as schedule drugs or controlled substances
Orphan Drug Act – 1983 (because of Aids)
• Allow facilitation of new drugs to treat rare disease
• Simplifying process of obtaining FDA approval
• Gives exclusive marketing rights for 7 years
• Incentive credits
Food Allergen Labeling & Consumer Protection Act of 2004
Requires labeling a food if it contains a protein from common allergy-causing foods, such as peanuts, soybeans, cow’s milk, eggs, fish, crustacean shellfish, nuts, and wheat.
Enforcement agency, FDA
Patriot Improvement & Re-authorization Act of 2005 (Combat Meth Act)
Restricts the sale of OTC products containing pseudoephedrine and ephedrine. Makes these products available only by purchase through a pharmacy.
Enforcement agency, congress
Controlled Substances
potentially dangerous or habit-forming drugs whose sale and use are strictly regulated by law
Enforcement agency, DEA
*Has 5 schedules – some states have 6 schedules
Drug classifications
classified according to potential for abuse
Schedule I
High potential for abuse – No currently accepted medical use – illegal drugs
• PCP
• Heroin
• LSD
• MARIJUANA
• CRACK
Schedule II
High potential for abuse – Current medical use
• Requires WRITTEN prescription – NO REFILLS
• Severe physical & psychological dependence may result
• Percodan
• Demerol
• Morphine
• Dilaudid
• Cocaine
• Methadone
Schedule III
Moderate potential for abuse – current medical uses
• Can be ordered orally – called into pharmacy. May have 5 refills in 6 months.
• Moderate physical & psychological dependence may result
• Tylenol with Codeine
• Vicodin
• OxyContin
• Lortab
Schedule IV
Less potential for abuse than schedule III – current medical uses
• Can be ordered orally – called into pharmacy. May have 5 refills in 6 months.
• Limited to moderate physical & psychological dependence may result
• Darvon
• Librium
• Valium
• Ambien
• Ativan
Schedule V
Limited potential for abuse – current medical uses
• Lomotil
• Cough syrups with codeine
• Phenergan
In order to prescribe controlled substances
MUST register with DEA and receive DEA certificate number. Some states require registration with state agency as well as at the federal level. Includes:
• Physicians
• Dentists
• Chiropractors
• Podiatrists
• Nurse Practitioners
• Physician Assistants
• Any other healthcare providers that sate licenses allows prescribing of controlled substances
Security & Packaging of controlled substances
• Label & Packaging must show assigned schedule
• Stored separately from other drugs
• Must be kept locked
• Access restricted
• Log for each drug to include wasted drugs / not administered, but disposed – witnessed
OTC Drugs
• Regulated by FDA
• Assisted by OTC Drugs Advisory Committee – established in 1992
• Can be purchased without prescription
• Considered safe used if directions are properly followed
• Prior to 1983 was clear distinction between Rx and OTC drugs
• Many Rx drugs reclassified as OTC drugs
o If indication is similar to use as Rx drug
o Low rate of side effects / toxicity
o Low potential for abuse
o Does not require any special monitoring
o May be half the dose as Rx strength
DRUG NAMES
• Chemical name
• Generic name
• Brand name
Chemical name
*very lengthy
*describes the chemical composition and molecular structure of the drug
Generic name
*typically shorted version of chemical name*the official nonproprietary name assigned by the manufacturer with the approval of the United States Adopted Names (USAN) Council
Brand name
*Name drug company give drug.
*This is registered with the U.S. Patent Office as a registered trade mark
Official name
usually generic name – How drug is listed in National Pharmacopia Forumulary
SPELLING OF DRUG NAMES
• Some generic drugs reflect chemical structure / classification
• Can indicate disease process to be treated
• Part of body being treated
• Simplify generic name while retaining phonetic sound
• Source of Drug
• Action of Drug
• How often drug is to be taken
• Indicate duration of drug action
• Indicate strength of drug
• Indicate amount of active ingredients
• Reflect name of drug manufacture
ORGINS OF NEW DRUGS
Discovered in two ways:
1. Totally new chemical substance in environment
2. New chemical derived from molecular manipulation of a chemical already in use.
Researchers are always looking in environment for
basis of new drugs
Some areas for new drug research:
• Soil
• Fungal growths
• Cephalosporin – first isolated near a sewer outlet in Sardina
• Streptomycin – isolated from the stomach of chicken
TESTING OF NEW DRUGS
FDA required drug manufactures to follow guidelines to determine safety & effectiveness
• In Vitro – Latin term for in glass – chemical analysis of drug performed in test tubes
• In Vivo – Latin term for in the living – testing in animals and humans
• Therapeutic Index – margin of safety of dose
• Therapeutic Effect – dosage that produces therapeutic effect – reason drug was prescribed
• Toxic Effect – level of dosage that is determined to be toxic. Can be different between animals and humans
Phases of Testing:
• Animal Phase
• Clinical Trials
o PHASE I
o PHASE II – Experimental
o PHASE III – Double Blind Studies
Animal Phase
precedes human testing
Clinical Trials
testing in humans – Has 3 phases
o PHASE I
o PHASE II – Experimental
o PHASE III – Double Blind Studies
Clinical Trial Phase I
Healthy volunteers
Safe dose range
Side effects
Correct dosage identified
Absorption, metabolism and excretion monitored
Volunteers are monitored
Takes about 1 ½ years
Clinical Trial Phase II
Given to people who have disease drug is to treat
Patients are monitored
Takes about 2 years
Clinical Trial Phase III
Drug studies – often performed in physician’s offices
Given to patients with disease to be treated
Monitored
Performance compared to drugs currently on market
Placebo as well as drug is used
Patients nor physician knows who is actually receiving the drug or placebo
Typically lasts 3 ½ years
Once phase III is complete submission of all documentation on drug is given to FDA for approval of drug. Must include:
•Drug Name
•All label information
•Dosage
•Side effects
•Risks & benefits
•How drug is to be packaged
•Ingredients
Once drug is approved
none of the below can be changed without company submitting new drug application.
•Drug Name
•All label information
•Dosage
•Side effects
•Risks & benefits
•How drug is to be packaged
•Ingredients
DRUG PATENTS
Drug company protected with a 17 year patent on any new drug they develop that is approved by FDA. However part of the 17 years occurs during testing prior to FDA approval.
When the patent expires
any other company may manufacture that drug under the general name or new trade name.
DRUG MANUFACTUREING & QUALITY
•Monitored by FDA
•Generic drugs dosage must contain the same amount of active ingredients as trade name
•Inert Ingredients
•Bioavailability
Bioavailability
can be crucial in drugs with low margin of safety. Some inert ingredients can affect bioavailability of certain drugs.
GENERIC DRUG SUBSTITUTION
• Most states have state Law
• Pharmacists are permitted or MUST substitute a
generic drug for trade name UNLESS
o Physician indicated either “no substitution”
or “dispense as written”
DRUG RECALLS
Performed by FDA for different types of manufacturing defects
• Drug does not remain stable for whole time preceding
expiration date
• Contaminated with particulate matter from
manufacturing process
• Does not contain correct amount of active ingredient
• Causes serious side effects / deaths not revealed
during testing process
• Manufacture MUST notify physicians, pharmacies and
hospitals of recall
o Disposal of drug is responsibility of those notified of
recall
o Many drug manufactures and/or FDA use media (TV,
RADIO, NEWSPAPER) to inform public of recalls
MARKETING & DRUG COSTS
• Totally new marketing approach today – as seen on TV commercials
• Extensive consumer approach
• Insurance companies complains – marketing drives cost of drugs
• Company can charge any price for brand name
• New marketing approach leads consumers looking for “new drugs” when perhaps older drugs are just as effective and cost less
How many drug schedules are there?
5
How many phases of clinical trials are there?
3
endogenous
substances made in the body
exogenous
substances made outside the body
xenobiotics
are exogenous drugs
agonist
is any drug that binds to a receptor and activates a receptor.
specificity
whether agonist or antagonist that must be specific size, ionic charge, and shape to interact with a given receptor
absorbed
a drug must be able to be delivered to site of action
Delivery
a drug must be delivered to site of action
elimimation
drug must be able to be eliminated
“ADME”
Absorption,Delivery, Metabolism, Elimination
PH
Measure of akilinity <7 measure of acidity >7
Affinity
How tightly the receptor binds to the drug
EC/ED 50
half the maximum effect
Potency
the concentration of a drug. dilaudid has more potency then morphine smaller dose to equal more effect
Efficacy
Refers to the effect of the drug more drug more efficacious- morphine stronger
Quantal Dose effect curve
the effect is either achieved or not achieved. either light switch is on or off unlike a dimmer switch.Like a drug used to stop seizure or not no in between.

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