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49 Cards in this Set
- Front
- Back
- 3rd side (hint)
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Mystical period (before 3000 BC)
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supernatural beliefs explained disease or cure
example:evil spirits or hostile spirits |
unknown and unseen
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Empirical period
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treatment based on observation of a substances effectiveness
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contemporary period
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pharmacy developed into a specialized science
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New Drug Development
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*regulated by FDA
*preclinical development helps identify compounds for safety and efficacy through clinical trials |
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how many phases of Clinical trials?
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4
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clinical trial: Phase 1
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-evaluates tolerance of healthy subject
-drug safety |
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clinical trial: phase 2
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evaluates effectiveness otn small numbers of patients with target disease
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clinical trial: phase 3
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-randomized clinical trials
-large scale evaluation of safety and efficacy based on controlled and uncontrolled trials |
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clinical trial: phase 4
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post marketing survellance of general population
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investigative new drug application
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-IND- first application form thats sponsors must submit to the FDA before the drug may be dispensed to humans
-requires complete description of clinical protocol to be used in testing the drug in human -compounds will not expose human to unprecedented risk esp. during early stage clinical.trials |
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New Drug Development
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Orphan Drug Act of 1983
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provides tax incentives to pharmaceutical companies who develop drugs to treat rare diseases
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New Drug Application
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takes 10 + years for new drug to complete clinical trials and become approved by FDA for public use
-data includes: drug efficacy, toxicity, stability, production and packaging data submitted to the FDA - pending FDA satisfaction for accuracy and completeness of clinical trial 1,2 &3 -manufacturer may market the new drug after NDA is approved |
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Drug Regulation Reform Act (1978)
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Established a more expedient process for release of new drugs to the public
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Food Drug and Cosmestic Act (1938)
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mandated all drugs to be tested for harmful effects and that labels be accurate and complete
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Durham-Humphrey Amendement (1952)
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-distinguished between OTC and prescription drugs
-specified procedure for distribution of precription drugs -permits pharmacist to take telephone orders for noncontrolled drugs and schedule 3 and 4 drugs |
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Kafauver-harris amendment (1962)
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-tightened controls regarding safety and effectiveness of drugs
-made statements about adverse effects and contraindications -introduced drug-testing methods |
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pure food and drug act (1906)
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-restricted manufacture and sale of drugs
-established the National Formulary and the U.S. pharmacopeia as official standards |
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Naming New Drugs
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●chemical name: based on chemical structure (ex: Acetylsalicylic acid)
●Generic name: simplified version of chemical name (ex: Aspirin) ●Brand name: identifies drug as product from a specifi manufacturer (ex: bayer) |
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Schedule 1 (C1)
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●high potential for abuse and no accepted medical use
•approved research protocol only ●prescription cannot be written or cant be filled by pharmacy ▪examples:heroin, LSD, cannabis |
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schedule 2 (C2)
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●may lead to severe dependency and high potential for abuse with accepted medical use
●may result in psychologic or physiologic dependence or both ●written prescription required but federal law permits emergency telephone orders but no telephone renewals ●container must have warning label example: methadone, cocaine, codiene |
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schedule 3 (c3)
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-potential for abuse lower than with drugs schedule 1 &2
-low to moderate physical dependence or high psychological dependence -written or verbal prescription required, prescription expires in 6 months with no more than 5 refills permitted in 6 months & containers must have labels examples: drugs containing limited amounts or that are combined with one or more active controlled ingredients-codiene, hydrocodone, morphine |
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schedule 4 (c4)
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-similar characteristics and requirements as schedule 3
-potential for abuse lower than-schedule 3 -examples: alprazolam, diazepam, oxazepam, lorazepam |
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schedule 5 (C5)
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-may be sold without prescription or require written prescription
-OTC drugs used for relief of cough or diarrhea -purchaser at least 18 and proper ID -max 240ml of C5 containing opium, 120ml or 24 solid dosage units of any other controlled substance can be sold to same person in 24hrs without valid prescription -distrobution by pharmacist only -records of name and address of the person purchasing, name and quantity, date of sale and name or intial of pharmacist |
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6 vital information provided during clinical trails?
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purity
bioavailability potency efficacy safety toxicity |
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what is an orphan drug
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used for diagnosis, prevention, or treatment of diseases that affect less than 20,000 people in the US
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united states pharmacopeia national formulary (USP-NF)
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only official book of drug standards in the US
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medieval stage
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a balance of four body fluids or "humors" were seen as essential requirements for life
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Shirley Amendment
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prohibited drug labels containing false therapeutic claims intended to defraud puschasers
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STEPS
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safety. tolerability.efficacy. price. simplicity of use
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mechanism of action (MOA)
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interaction between a drug and receptor
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half life
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time required for 1/2 of total drug amount to eliminated from the body
t1/2=0.7 × volume/ clearance |
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pharmocodynamics
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how drug affects the body. therapeutic or toxic effects
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affinity
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attraction between drug and receptor
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pharmokinetics
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administration, absorption, distribution and elimination of drug
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biotransformation
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metabolism or degradation of a drug from active to inactive form
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Efficacy
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degree to which a drug is able to induce maximal effects as a results
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up regulation or hypersensitization may lead to an
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exaggerated response if the drug is withdrawn
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CYP34A isoenzymes
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induces and inhibits metabolism of another drug
inhibitor- prevents drugs from degrading inducer- increases clearance of drug in body which might cause drug to be wasted |
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drug antagonist
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midified by concurrent administration of another drug
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4 phases of drug actions
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pharmaceutics
pharmackinetics pharmacodynamics pharmacotherapeutics |
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pharmaceutic phase
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-formulation of drug into suitable dosage form
-administration of drug -disintegration and dissolution of drug - drug enters the body as one form and changes to another in order to be used |
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pharmacokinetic phase
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absorption
distribution biotransformation elimination |
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pharmacodynamic phase
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drug receptor interaction
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pharmacotherapeutic phase
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therapeutic effects
adverse reactions |
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bioequivalence
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absense of significant difference in the rate and extent to which the active ingredient becomes available at site of action when administered at the same dose under similar conditions
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clearance
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removal of a drug from the body and is dependent on the intergrity of glomerular filtration
- most important pharmocokinetic parameter bcos it determines steady rate |
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components of pharmacoeconomic models
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clinical, economic and humanistic outcomes of treatment, quality of life and cost
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pharmacoeconomic desighn
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cost benefit analysis(CBA)
cost effective analysis (CEA) cost utility analysis (CUA) cost minimization analysis cost of illness analyses |
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