Drug Safety Flashcards
Unintended, harmful reactions to medicines are among the leading causes of death in many countries
Adverse Drug Reaction
True or False
The majority of adverse drug reactions (ADR) are PREVENTABLE
True
it is the science of collecting, monitoring, researching, assessing, and evaluating the information on the adverse effect of medication.
Pharmacovigilance
It identifies new information about hazards associated with medicines
Pharmacovigilance
An organization that is responsible for evaluating the safety of a drug by looking at the side effects, how it’s manufactured, results of animal testing and clinical trials, and more.
Food and Drug Administration
What republic act represent BFAD
Republic Act 3720
It refers to the degree to which a drug is able to induce maximal effects
efficacy
It is the maximal effect of a drug
Efficacy
It is also known as potency
Effective dose concentration
It is the measure of how much drug is required to elicit effect or a given response
Potency
True or False
The higher the dose required for a given response, the more potent the drug is.
False
Which is more potent for post-operative pain. Morphine or codeine?
Morphine
This represents a decrease response to a drug
Tolerance
If the patient has developed a high tolerance to the drug, what action should be done?
Increase the dose of a drug to achieve the same effect
It is the state resulting from chronic use of drugs that have produced tolerance
Dependence
Abrupt discontinuation of drugs can lead to
Negative physical symptoms of withdrawal
a group of symptoms that occurs upon the abrupt discontinuation or a decrease in dosage of the intake of medications
withdrawal
these are the high points of fluctuations
Peaks
What are the adverse effects of discontinuation of SSRI or SSNRI
Irritability, Agitation, Dizziness, Sensory Disturbance, Anxiety, Confusion, Headache, Lethargy, Emotional, Insomnia, Hypoemia, Tennitus, and seizures
It is the range of drug dosage which can treat the disease effectively while staying within the safety range
Therapeutic Window
these are low points of fluctuation
Troughs
The symptoms of withdrawal are often the?
opposite of the effects achieved by the drug
What are the types of dependence
Physical and Psychological
This is a result when a patient consumes 1 or more of a certain drug for a certain period of time.
Withdrawal
Occurs when a person developed a tolerance to a drug in a certain classification that may result in tolerance to another drug in that same classification
Cross Tolerance
The withdrawal symptoms from one drug in a classification can be relieved by another of the same class
cross dependence
What drugs are given to alcoholics to prevent withdrawal symptoms
Barbiturates and tranquilizers
this is given to heroin users to counteract withdrawal symptoms
Methadone
It is the index of safety between the minimum therapeutic concentration and the minimum toxic concentration of a drug.
Therapeutic Window
It is used to determine the range of plasma levels that is acceptable when designing a dosing regimen.
Therapeutic Window
In the therapeutic window, the minimum effective concentration will usually determine the?
Trough Levels
In the therapeutic window, the minimum toxic concentration determines the?
Peak Plasma Concentration
the toxic concentration theophylline drug is
15mg/L to 20mg/L
The Therapeutic concentration of theophylline drug is
7mg/L to 10mg/L
The therapeutic window for the drug theophylline is fixed in the range
8mg/L to 18mg/L
It is the dosages of medication between the amount that gives an effect and the amount that gives adverse effects than desired effects
Therapeutic Window
It is the ratio of the dose that produces toxicity to the dose that produces a clinically desired or effective response in a population of individuals
Therapeutic Index
It is a measure of drug’s safety
Therapeutic Index
True or False
A drug with a low therapeutic index requires a large increase in dose to achieve toxicity.
False
Drugs with this type of therapeutic index indicate that there is a wide margin between doses that are effective and doses that are toxic
Large therapeutic index
Fetus exposed to thalidomide are born with a condition called
Phocomelia
It is a congenital malformation wherein the hands and feet of the fetus are attached to the abbreviated arms and legs
Phocomelia
This induces or increases the production of P450 enzymes
Vices: Smoking and Drinking
It is the regulatory body that proposes and administers drug regulations
Food and Drug Administration (FDA)
FDA requires the following before human testing is permitted
- Evidence of relative safety derived from acute and subacute toxicity testing in animals
- probable therapeutic action from the pharmacologic profile in animals.
These are not required before human studies are started
Chronic Toxicity Test Results
This animal is used for neurological research
Cats
This animal is used for cardiology, endocrinology, and bone and joint studies
Dogs (Beagle)
This is widely used to develop new medicines and to test the safety of the products
Animal Testing or Animal Experiments
This requires less extensive drug testing
Occasional, non-systemic drug
These drugs require less evidence of safety than do drugs used in less threatening disease
Anti-cancer drugs and AIDS Drugs
These are the set of principles that scientists are encouraged to follow to reduce the impact of research on animals
Reduce, refinement, and replacement
How can we reduce the number of animals being used in the laboratory?
- Improving the experimental techniques
- Improving techniques of data analysis
- Sharing information with other researchers
How can we refine the experiment or the way the animals are cared for?
- Using less invasive techniques
- Better medical care
- Better living conditions
what alternative techniques used to replace animal experiments
- Experimenting on cell cultures instead of whole animals
- Using computer models
- studying human volunteers
- Using epidemiological studies
This involves single administration of the agent up to the lethal level in at least two species
Acute Toxicity
This type of testing is required or done for agents that are intended for chronic use
Sub-acute and chronic toxicity
This is a description of all the pharmacologic effects of a drug
Pharmacologic Profile
Effects that pharmacologic profile measures are
Blood pressure gastrointestinal activity respiration renal function endocrine function central nervous system
The induction of generally nonheritable development defects in the fetus by exposure to a drug
Teratogenesis
It is the development stage where the organ of the fetus taken place
Organogenesis
These drugs are known to have teratogenic effects
Thalidomide Ethanol Glucocorticoids Valproic Acid Isotretinoin Warfarin Lithium Androgens
It is a pregnancy category that demonstrates an adequate and well-controlled studies that have failed to demonstrate a risk to the fetus in the first trimester of pregnancy
Category A
Medications that belong to Category A of FDA pregnancy category are
Vitamins and Levothyroxine
In animal reproduction studies have failed to demonstrate a risk to the fetus but there are no test done on pregnant women
Category B
Examples of medications under Category B
Acetaminophen and Amoxicillin
Drugs in this category can be given to the pregnant women if the benefit to the mother outweighs the risks to the fetus
Category C
Examples of medication under category c are
Diltiazem and Spironolactone
There are evidence of human fetal risks based on adverse reaction data but the benefits to the mother may be acceptable despite the risks to the fetus
Category D
Drugs in this category may be used in pregnancy if the benefits to the mother outweighs the risks tot he fetus
Category D
Examples of medications under category D are
Phenytoin and Valproic Acid
A category that demonstrates teratogenic effects both in human and animal experiments
Category X
Examples of medications under category X are
Thalidomide and Warfarin
It is the induction of changes in the genetic material of animals of any age and therefore induction of heritable abnormalities
Mutagenesis
it is the standard in vitro test for mutagenicity
Ames Test
it uses bacteria that naturally depend on specific nutrients in the culture medium.
Ames Test
Loses of natural dependent bacteria during Ames test is an indication of
Mutation
It is an in vivo mutagenicity test carried out in mice.
Dominant Lethal Test
It is a sign of mutation when a male mice exposed to dominant lethal test produces
Abnormalities in subsequent mating (Loss of embryos, deformed fetuses)
Examples of agents that have a carcinogenic effects are
Coal tar, aflatoxin, dimethylnitrosamine and other nitrosamines, urethane, vinyl chlorine, and the polycyclic aromatic hydrocarbons in tabacco smoke (Benzo[a]pyrene)
It is the induction of malignant characteristics in cells
Carcinogenesis
because carcinogenicity is expensive and difficult to study, this test is used to screen chemicals
Ames Test
True or False
There is low degree of correlation between mutagenicity in the Ames Test and carcinogenicity in some animal tests
False. High degree
Examples of carcinogens that have mutagenic effects
Aflatoxin, cancer chemotherapeutic drugs, and other agents that bind to the dna
This requires prior approval from the Investigational New Drug Exemption application which the manufacturer will submit to the FDA
Clinical Trials
It is a legal-defined process of a person being told about key facts involved in a clinical trial before deciding whether or not to participate.
Informed consent
An informed consent includes
purpose, duration, required procedures, risks, potential benefits, and key contacts of the experiment
True or False
The patient can withdraw at any time without penalty
True
It consists of careful evaluation of the dose-response relationship in small number human volunteers
Phase 1 Trial
This phase finds the maximum tolerated dose and it is designed to prevent toxicity
Phase 1 Trial
Approximately how many human healthy volunteers are involved in Phase 1 trial
20-30
It involves evaluation of a drug in a moderate number of patients
Phase 2 trial
This phase goal is to determine whether the agent has the desired therapeutic effect at doses that are tolerated by sick patients
Phase 2 trial
Approximately how many human healthy volunteers are involved in Phase 2 trial
200 to 300 patients
To explore the spectrum of beneficial actions of a new drug and compare it to older therapies and discover toxicities
Phase 3 trial
This represents the post-marketing surveillance phase of evaluation
Phase 4 trial
This phase goal is to detect and report immediately toxicities that occur very infrequently.
Phase 4 trial
In this phase the acute effects of the drug is studied over a broad range of dosage, starting with one the produces new detectable defect progressing to one that produces either major therapeutic response or a very minor toxic effect
Phase 1 Trial
Agents that are exempted during phase 1 trial
Cancer Chemotherapeutic Agents
This phase ha the highest rate of failures
Phase 2 trial
The one administering the drug knows whether it is a placebo or an actual drug but the on receiving it does not.
Single-Blind
Both the one administering and the one receiving do not know whether the drug being administered is a placebo or an actual drug
Double-blinded
Dogs specifically beagles, are used to test for?
endocrinology, cardiology, and bone and joint studies
what animals are usually used in laboratory experiments
Rats, rodents, guinea pigs, rabbits, etc.
Which of the following only needs less extensive drug testing
- Occasional, non-systemic drugs - Chronic systemic administration
Occasional, non-systemic drugs
it is a study that is required for all drugs
Acute toxicity
How long are a test for subacute to be carried out
2-4 weeks
How long are a test for chronic agents to be carried out
6-24 months
