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91 Cards in this Set

  • Front
  • Back
What 3 things does drug development begin with?
discovery and characteristics of new drug
clinical studies
regulatory approval
process of evaluating drug safety and efficacy as well as adverse effects and interactions caused by drugs
drug development
What are the 7 steps of drug development?
discovery of characteristics of new drug
experimental studies
IND application
clinical studies
submission of NDA
approval of NDA
post marketing
new drug compound synthesized or isolated from natural produce in chemical laboratory; subjected to screening test to determine effect/pharmacological properties of a drug
discovery of characteristics of new drug
What is a case of accidental discovery of some pharmacological effects?
clonidine
pharmacological effects of agent must be investigated in animals prior to use in humans; designed to detect beneficial and harmful cardiovascular, renal, and respiratory effects
experimental studies
What do federal regulations require extensive studies for?
toxicology
teratogenicity
mutagenicity
carcinogenicity
What are experimental studies used to determine?
MOA
Pk
Pd
properties of agent
adverse effects
Who must approve the Investigational New Drug (IND) Application?
FDA
What includes complete description of drug and its properties?
investigational new drug (IND)
What does the IND include?
results of all experimental studies
proposed clinical studies
proposed study sites, investigators, protocols, methods, and analysis
gather information on drug safety, Pk in healthy human subjects (volunteers)
clinical studies (phase 1)
Pk analysis done to determine dosing for next phase
clinical studies (phase 1)
studies performed in human subjects with disease state in which IND is to be used
clinical studies (phase 2)
assess efficacy and safety and help establish dosage ranges for further studies; typically involve small number of patients
clinical studies (phase 2)
involve larger group of subjects and multiple clinical sites and investigators
clincial studies (phase 3)
designed to prevent investigator bias and often double blind and placebo controlled
clincial studies (phase 3)
compare efficacy and safety of new drug with that of other agents
clincial studies (phase 3)
outlines the properties of the drug and reports results of all experimental and clinical studies
new drug application (NDA)
contains proposed labeling of drug, clinical indications, dosing, etc.
new drug application (NDA)
involves gathering and analyzing voluntary reports of adverse effects; submitted by health care practitioners
post-marketing surveillance
federal legislation concerning drug product safety and efficacy in US
Pure Food and Drug Act
passed in response to sale of medications containing toxic and habit-forming ingredients
Pure Food and Drug Act
required accurate labeling of ingredients in drug products
Pure Food and Drug Act
saught to prevent the adulteration of drugs thru substitution of toxic ingredients for labeled ingredients
Pure Food and Drug Act
passed in response to tragic incident involving sulfanilamide and ethylene glycol
Food, Drug, and Cosmetic Act
made strides in requiring evidence of drug safety prior to its marketing
Food, Drug, and Cosmetic Act
FDA established to enforce this act
Food, Drug, and Cosmetic Act
legal authority given to drug product standards
United States Pharmacopeia (USP)
contains information on chemical analysis of drugs and indicates how much variance in content is allowed for each drug product
Food, Drug, and Cosmetic Act
outlines standard for tablet disintegration
United States Pharmacopeia
prohibits distribution of drug products that are adulterated, misbranded (mislabeled) or that do not have an approved NDA
Food, Drug, and Cosmetic Act
not meeting USP standards or not manufactured by "good manufacturing" practices
adulterated products
contain the name, dose, and quantity of ingredients and warnings against unsafe use
drug product labels
prompted by growing problem of heroin abuse
Harrison Narcotic Act
1st major drug abuse legislation in USA
Harrison Narcotic Act
sought to control narcotic use through use of tax stamps
Harrison Narcotic Act
prevented physicians from adminstering drugs to addicts as part of Rx plan
Harrison Narcotic Act
often called the Controlled Substance Act
Comprehensive Drug Abuse Prevention and Control Act
passed in response to prevalent drug abuse in the 1960s in adolescent and young adults
Comprehensive Drug Abuse Prevention and Control Act
included sedatives, stimulants, LSD, marijauna, and other hallucinogens
Comprehensive Drug Abuse Prevention and Control Act
classified abused drugs into 5 schedules based on their potential for abuse
Comprehensive Drug Abuse Prevention and Control Act
high potential for abuse, no legitimate medical use, possession prohibited
Schedule I
high potential for abuse; legitimate medical use; distribution legal, but inventories are controlled, there are record keeping requirements and prescription requirements
Schedule II
lower abuse potential; fewer restrictions on distribution
Schedules III, IV, V
required distributors, practitioners, and medical institutions to register with the DEA
Comprehensive Drug Abuse Prevention and Control Act
DEA is responsible for enforcing act
Comprehensive Drug Abuse Prevention and Control Act
unexpected, unintended effect of a drug that may lead to drug discontinuation, treatment with another drug, hospitalization, etc.
adverse drug reaction (ADR)
results from allergens, responsible for toxicities; range from skin rash to major organ toxicity
hypersensitivity reactions
results from the adverse interaction of antigens/antibodies
allergic reaction
immediate hypersensitivity reaction
Type I Hypersentivity
mediated by immune globulin (IgE) antibodies
Type I Hypersentivity
examples include urticaria, atomic dermatitis, anaphylactic shock
Type I Hypersentivity
mediated by immune complex
Type III Hypersentivity
antigen/antibody deposited in vascular endothelial system causing inflammation, lymph edema, and fever
Type III Hypersentivity
examples include sever drug induced vasculitis-Steven Johnson's syndrome
Type III Hypersentivity
delayed hypersensitivity reaction
Type IV Hypersentivity
mediated by sensitized lymphocytes
Type IV Hypersentivity
examples include ampicillin skin rash occurring with viral mononucleosis
Type IV Hypersentivity
cytolytic reaction mediated by IgG and IgM
Type II Hypersentivity
examples include hemolytic anemia and thrombocytopenia
Type II Hypersenstivity
unexpected reaction caused by genetically determined susceptibility
idiosyncratic reaction
examples include patients with glucose 6phosphate dehydrogenase deficiency-hemolytic reaction from primaquine
idiosyncratic reaction
caused by immunologic mechanism or via direct effect on hepatocytes
hepatotoxicity
may be detected by checking transaminase levels
hepatotoxicity
caused by hypersensitivity mechanism, leading to inflammation, stasis of biliary system
cholestatic
sometimes caused by toxic drug
hepatocellular toxicity
consider alternatives or frequent monitoring when these levels are 2x the upper limit
elevated transaminase levels
discontinue drug when these levels are 3x the upper limit
elevated transaminase levels
removed from market-excessive hepatic failure
rezulin
caused by many drugs, including ATBs
nephrotoxicity
What are 3 forms of renal toxicity?
interstitial nephritis
renal tubular necrosis
crystalluria
precipitation of insoluble drug in renal tubule
crystalluria
decrease clearance, increase plasma levels
nephrotoxicity
less common than renal toxicity; caused by cyclophosphamide hemorrhagic cystitis
bladder toxicity
some drugs cause respiratory depression
pulmonary toxicity
caused by Bleomycin, Amiodarone
pulmonary fibrosis
should have periodic x-rays and gas measurement to detect early signs of fibrosis
pulmonary toxicity
caused by anthracylines, such as doxorubicin (Adriamycin)
cardiotoxicity
HMG reductase inhibitors, such as Lovastatin (Mevacor)
skeletal muscle toxicity
skin rashes may include macular, papular rashes or urticaria (ie., antibiotics)
dermatological toxicity
a change in pharmacological effect of a drug that results when given concurrently with another drug
drug interactions
examples include PCN/Aminoglycosides, Quinolones/Antacids
drug interactions
What are 2 ways in which you might manage drug interactions?
1. space out when you give the drugs
2. decrease dose of one
Adverse Effect: cardiac defects, cleft palate, growth retardation
anticancer agents (antimetabolites)
Adverse Effect: fetal warfarin syndrome
Coumadin
Adverse Effect: cervical adenocarcinoma
Diethylstilbesterol (DES)
Adverse Effect: fetal alcohol syndrome
ethanol
Adverse Effect: fetal hydantoin syndrome, cardiac defects, ear malformations
phenytoin
Adverse Effect: enamel hypoplasia, staining of teeth
tetracycline
Adverse Effect: deafness, heart defects, limb abnormalities
thalidomide