Adverse Drug Events Exam 1 Flashcards
Define adverse drug reactions.
● Any undesirable action
Differentiate between a toxicity reaction and a side effect of a drug.
● Side effect = an undesired effect,
○ many of which can be tolerated
○ generally reversible upon drug discontinuation
○ dose-related
● Toxicity reaction = cell DAMAGE and tissue damage occurs
○ permanent = microscopic, then macroscopic
○ intolerable
Discuss issues associated with polypharmacy & polyherbacy.
● Use of multiple medications in a given patient
○ 5 or more medications
● Includes: excessive/unnecessary medication use
● Generally used to describe management of OLDER adults
● Polyherbacy
Identify the categories of adverse drug effects required by the FDA for listing in drug monographs.
● Adverse effects are categorized according to:
○ a body system
○ an organ system
Categories of Adverse Drug reactions ● Body as a whole ● Cardiovascular system ● Respiratory system ● Digestive system ● Endocrine system ● Reproductive system ● Genitourinary tract ● Skeletal muscle ● Nervous system ● Hematologic ● Special senses ● Hypersensitivities ● Skin
Define and describe drug hypersensitivity reactions.
● Hypersensitivity reactions to drugs in susceptible individuals can lead to classic allergic manifestations such as skin rash, asthmatic syndromes, rhinitis & anaphylaxis
● Person must have previous exposure to a drug to manifest later w/ an allergic reaction
Define drug teratogenicity.
● Ability of drugs or other agents to cause defects in developing embryo
● Pregnant patient may be at risk if medicated w/ any drug early on in pregnancy
● Therapeutic benefit outweighs their risk & can still be prescribed
● For example, thalidomide helps alleviate painful oral ulcers in AIDS pts and is used for multiple myeloma & other blood diseases.
Briefly describe the differences between the FDA pregnancy categories A, B, C, D and X.
● A = Controlled studies in pregnant women failed to demonstrate a risk to fetus.
● B = Animal-reproduction studies have NOT demonstrated a fetal risk.
● C = Studies in ANIMALS have revealed ADVERSE EFFECTS on the fetus, but NO DATA in HUMANS exist.
● D = There is positive evidence of human fetal risk, but the benefits of use in pregnant women may be acceptable.
● X = Studies in animals or humans have demonstrated fetal abnormalities. Contraindicated in women who are or who may become pregnant.
Describe the impact that the drug thalidomide had in medicine during the 1960s.
-The classic example of a teratogenic drug is Thalidomide – sedative used in the 1960s to relieve symptoms of morning sickness. All of the first generation offspring of mothers who took this drug had major limb defects
- Describe modern day uses of thalidomide in medicine and dentistry
● Teratogen – Thalidomide
● Thalidomide shows promise in curing painful mouth& throat ulcers, accompanies AIDS. Used for multiple myeloma & other blood dyscrasias.
Also shows promise in medicine to treat leprosy sores and Reverse “wasting” in AIDS syndrome.
○ Thalidomide – sedative used in the 1960s to relieve symptoms of morning sickness
■ First generation offspring of mothers who took this drug had major limb defects
○ Drugs that are teratogenic may still be approved by the FDA: therapeutic benefit outweighs their risk
Describe the field of pharmacogenetics.
● Studies the genetic variability of drug effects
● Differences in genetic
sequences= polymorphisms
○ Influence drug pharmacokinetics
○ Occur in target genes that mediate the therapeutic effect of drugs (pharmacodynamics)
● Screenings used to prevent drug side effects
Provide examples of how “misspelled genes” affect drug actions.
● “Misspelled” genes that encode differences in drug receptors or CYP metabolizing enzymes can create situations leading to drug adverse reactions or ineffectiveness
○ Albuterol (for asthma) ineffective in dilating smooth muscle in bronchioles
○ Prozac (antidepressant) is metabolized so slowly that it can build to toxic levels
○ Isoniazid (used to treat TB) is metabolized so rapidly that it is ineffective
Explain Biological variation as it relates to effectiveness and safety of dugs.
○ Defined as the range of response per dose
○ An individual may require a higher/lower dose to produce the desired effect
Explain Hypersusceptibility as it relates to effectiveness and safety of drugs
○ A greater-than-normal reaction to a drug
○ Some patients may have a reaction to a drug that is greater than expected
○ eg. A small dose of a tranquilizer would be expected to provide a mild sedation, but in a hypersusceptible patient, it causes major motor incoordination
Explain Drug Idiosyncrasy as it relates to effectiveness and safety of drugs
○ Response of the patient to the drug is qualitatively different from the usual or expected response
○ When some patients are given a hypnotic to sleep, they stay awake all night. Other patients when given a stimulant to overcome sedation will fall asleep. These are unexpected responses
Explain Age as it relates to effectiveness and safety of drugs
○ Pediatrics:
■ Many drugs must be given to children in doses that are similar than the adult dose
■ Children have increased membrane permeability, which allows drugs to be absorbed more quickly & more easily
■ Doses are determined by manufacturer
■ Dosing is based on the weight of the children
