Adverse Effects and Toxicology Practice Test

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• FAEMS reports do not establish which of the following?
• Define torsades de pointes and name two electrolyte disturbances that predispose.
• What are the classic clinical features of salicylate poisoning and its hallmark acid-base disturbance?
• A _______ _______ is an immunologically mediated drug hypersensitivity reaction, which accounts for _____% of all adverse drug reactions.
• What drug was withdrawn from the market in 1997 and why?
• Terfenadine causes _______ _______, leading to __________, by inhibiting Erb channels for ion transport in the heart.
• Which agents can cause oral candidiasis due to Candida overgrowth?
• Which in vitro assay measures metabolic processing by liver enzymes?
• What is the purpose of the Naranjo algorithm in ADR assessment, and what is one possible outcome category?
• NOAEL and LOAEL definitions and their use in risk assessment?
• Which consequence best matches the statement that penicillins are the drug of choice for many indications?
• In LD50 testing, mortality is tracked over how many days?
• Which metabolite is hepatotoxic in acetaminophen overdose?
• Name a common mechanism by which xenobiotics cause hepatotoxicity via oxidative stress.
• Terfenadine is metabolized to ________ by _______.
• Which consequence corresponds to penicillins having a well-established safety profile and being inexpensive?
• What is the standard screening test for lead exposure in children?
• What is whole-bowel irrigation and when is it preferred over activated charcoal?
• If a patient has overdose, who should you call?
• The withdrawal of Terfenadine from the market in 1997 was primarily due to drug interactions that inhibit its metabolism by which enzyme?
• Phase 3 trials are designed to determine whether the drug is safe and effective for the indicated use. Which phase is this?
• Which adverse effect risk increases with higher morphine doses?
• In the PEN-FAST acronym, F stands for how many years the reaction occurred within?
• N-acetylcysteine (NAC) is most effective as an antidote when given within how many hours after overdose?
• Case reports are useful for identifying new or rare adverse effects but are subject to which bias?
• PEN-FAST Risk Groups: 0 points, risk 0.6% = very low risk; 1-2 points, risk 5% = low risk; 3 points, risk 20% = moderate risk; 4-5 points, risk 50% = high risk. Which option lists the correct sequence of risk categories?
• What three types of drugs are associated with gingival hyperplasia?
• LD50 testing involves two species and two routes of administration. How many species and routes are specified?
• A drug with a higher therapeutic index is generally considered safer.
• Indications and contraindications for activated charcoal?
• Which chelating agent is commonly used first-line for severe lead poisoning?
• ______ is a quantitative assessment of the safety of a specific drug.
• Key clues and treatment for digoxin toxicity?
• Toxicology and adverse event data can be used to identify what adverse effects a drug produces.
• Cadmium toxicity is most commonly associated with toxicity in which organ systems?
• NOAEL and LOAEL, and how are they used in risk assessment?
• In risk versus benefit assessment, what is the first factor to consider?
• Carbamazepine is associated with which serious adverse drug reaction?
• Which organ is primarily affected by drug-induced liver injury?
• ___________ is the pharmacokinetics of a drug under conditions that produce toxicity or excessive exposure.
• What is the appropriate initial management for suspected inhalational poisonings in workers?
• The pharmacologic action of a drug can be _______ or _______ target.
• Some patients (1-10%) may have cross-reactivity with ________, which are often avoided in penicillin-allergic patients.
• Terfenadine was developed as a ________ ________.
• Which phase is primarily concerned with establishing safety and efficacy in a broad patient population and is often the pivotal trial for regulatory approval?
• LD50 testing is a type of study characterized as which dosing category?
• Which assay type screens for abuse potential through receptor-ligand interactions?
• Which consequence represents changes to suboptimal broad-spectrum antibiotics?
• How are ethylene glycol and methanol poisoning treated and what lab findings are typical?
• Toxicology data can provide information about drug combinations that should be avoided.
• Mercury toxicity most prominently affects the central nervous system, especially which form?
• Guidelines are implemented to assist providers in taking a drug allergy history and prescribe antibiotics to patients with a penicillin or cephalosporin allergy.
• Name two toxins that commonly cause nephrotoxicity and a basic diagnostic biomarker.
• Which of the following is NOT a consequence of overreporting penicillin allergy?
• In the PEN-FAST acronym, A stands for which reactions?
• A PEN-FAST score less than 3 is associated with which predictive value?
• Which statement about the therapeutic index safety margin is most accurate?
• Which three genetic mutations are associated with malignant hyperthermia?
• Define the dose–response relationship in toxicology.
• Which option correctly lists all categories used by the WHO-UMC causality assessment for ADRs?
• Which type of data becomes most important for detecting rare adverse effects after broad patient use?
• Which of the following is a limitation of FAEMS reporting?
• Which statement best describes the role of poison control centers?
• Idiosyncratic adverse drug reactions are best described as which of the following?
• Which screening tests for mutations in a compound?
• In drug-induced liver injury, cholestatic pattern is associated with which findings and example drug?
• Phase 2 trials evaluate safety and initial efficacy in a larger population with the target disease. Which phase is this?
• Which statement best describes the interpretation of a high therapeutic index in drug safety?
• Which screening tests for whether a compound affects cell viability?
• LD50 is the median lethal dose, the dose at which 50% of treated experimental animals die.
• Which component assesses the extent, routes, duration, and populations exposed to a hazard?
• In the PEN-FAST acronym, what does P stand for?
• ___________ is the pharmacokinetics of a drug under conditions that produce toxicity or excessive exposure.
• What is the standard initial treatment for carbon monoxide poisoning and the diagnostic test?
• Which statement correctly differentiates Type A (augmented) and Type B (bizarre) adverse drug reactions, with an example for each?
• Clinical guidelines provide a standardized method to perform test doses of beta-lactams.
• In acetaminophen overdose, which toxic metabolite causes liver injury when glutathione is depleted, and which antidote replenishes glutathione?
• What term describes the financial burden of drug costs on health and quality of life?
• What is the antidote for cyanide toxicity and its mechanism?
• Name three types of drug interactions that increase the risk of adverse effects.
• Penicillin and abacavir are most associated with which idiosyncratic reaction?
• What does PEN-FAST stand for
• What are common signs of lead poisoning in children and a first-line chelation option?
• Which chart plots acetaminophen concentration versus time to guide N-acetylcysteine therapy in overdose patients, and what is it called?
• In pregnancy, toxicology risk is influenced by placental transfer and fetal susceptibility; what is a key consideration for drug use in pregnancy?
• Rates of which phenomenon cannot be established from FAEMS reports?
• Drug-induced liver injury accounts for 14% of acute liver failure cases excluding acetaminophen.
• FAEMS reports can be filed by which parties?
• Meperidine is metabolized to __________, which has less ______ and is more ______.
• Which component evaluates the relationship between dose and the probability or severity of adverse effects?
• Distinguish inorganic mercury versus organic mercury exposure and their primary toxic effects.
• Which condition is associated with more than 500 medications, increases risk of caries, and disrupts taste?
• FAEMS reports have not been ______.
• What are the three types of drug-drug interactions?
• Phase 1 clinical trials primarily assess safety in a small number of subjects. Which phase is this?
• Enzyme induction is _________ of a toxic _______.
• What is the role of poison control centers?
• Flumazenil is indicated in benzodiazepine overdose with a major precaution. Which statement best reflects this precaution?
• Who should you contact if you suspect a poisoning?
• Which of the following is not a possible Naranjo algorithm outcome?
• In drug-induced liver injury, hepatocellular pattern is most clearly indicated by which finding and which drug is a common example?
• What are the antidotes and mechanism for organophosphate poisoning?
• In toxicology risk assessment, uncertainty analysis serves to evaluate what?
• FAEMS reports are more commonly filed for which type of effects?
• Which component integrates hazard identification, exposure assessment, and dose-response to estimate risk and its significance?
• __________ drug allergy prevalence is variable, ranging from 0.7% to 38.5%.
• What is pharmacovigilance?
• Adverse effects related to which aspect of health are not well documented during the drug approval process and are usually reported in case reports?
• Which action can toxicology and adverse event data be used to perform?
• LD50 is the dose at which 50% of treated animals die. Which of the following statements is true about LD50?
• The antidote for APAP overdose is ______. It is almost ______% effective if given within ______ hours.
• What is the antidotal therapy for digoxin toxicity?
• __________ reactions are rare, not dose-dependent, and can occur at low doses of a drug. This makes them difficult to predict from ______ studies.
• Which drug is commonly implicated in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis?
• Cytochrome _______ is the bad pathway for acetaminophen metabolism, resulting in _______ which is a toxic metabolite.
• In vitro assays typically do not provide information about which of the following?
• Which drug class is a known contributor to medication-related osteonecrosis of the jaw (MRONJ)?
• Which electrolyte abnormality is commonly associated with acute digoxin toxicity?
• What is the name of the public database containing adverse events that have been reported to the FDA?
• Which are the four components of a basic toxicology risk assessment framework?
• Which chelating agent is used specifically for iron poisoning?
• In PEN-FAST scoring for penicillin allergy, what is the negative predictive value when the score is 0?
• Which of the following agents is used for chelation in mild-to-moderate lead poisoning?
• The principle guiding drug use states that the therapeutic benefit should outweigh which of the following?
• Which assays can assess abuse potential?
• Why are spontaneous ADR reports important for patient safety?
• In pregnancy, toxicology risk is influenced by which of the following factors?
• DILI is a major cause of drug withdrawals from the market due to rarity and unpredictability.
• The self-reported prevalence of penicillin allergy is about 10%. The actual prevalence of true anaphylaxis is what percent?
• What are common pediatric toxins found in household products, and what safety measure reduces risk?
• The 90-day toxicity test is described as which type of study?
• Which component of risk assessment focuses on identifying hazards and potential adverse effects of a substance or scenario?
• Which type of evidence is most useful for identifying rare adverse effects after widespread drug use?
• Which type of exposure is used to assess carcinogenicity and teratogenicity?
• What term describes the observational and epidemiologic studies that identify rare toxicity after a drug has been used widely?
• Differentiate reversible versus irreversible toxic injury with an example of each.
• In morphine therapy, higher doses are most likely to cause which combination of effects?
• Which statement best describes the primary toxic effects of lead, mercury, and cadmium?
• Which liver enzyme is most specific for hepatocellular injury in many drug-induced liver injury cases?
• Which phase is focused on monitoring long-term safety after a drug has been marketed?
• DILI is a major cause of drug withdrawals due to what characteristics?
• Which of the following is NOT a type of drug-drug interaction?
• In vitro and cell-based assays are typically performed over a range of what?
• Dose-dependent toxicity can be predicted from _______ and _______ studies.
• What is a toxidrome and give two examples?
• APAP overdose is _______ per day. It leads to _______ toxicity due to the production of _________.
• Which screening would be used to detect a compound's effect on ion channel currents relevant to cardiac safety?
• How can you distinguish anticholinergic toxidrome from a sympathomimetic toxidrome clinically?
• In the PEN-FAST acronym, S stands for which term describing severe cutaneous adverse reactions?
• Which of the following is a use of toxicology and adverse event data?
• Enzyme inhibition can be ______, ______, or ______ inhibition.
• APAP overdose mechanism statement.
• What drug should be avoided in patients allergic to penicillin due to cross-reactivity?
• What do LD50 and ED50 represent, and how is the therapeutic index calculated?
• Why is a drug's therapeutic index important for dosing decisions?
• The formula for Therapeutic Index (TI) is _________. A higher TI indicates a _______ drug.
• Toxicology data can identify risk factors that predispose toxicity.
• Which statement best describes the effects of organic mercury exposure?
• Which statement correctly describes the cause of acetaminophen overdose?
• Which of the following is NOT a use of toxicology and adverse event data?
• Meperidine is which type of drug and is used for what kind of management?
• What best defines an adverse drug reaction (ADR)?
• Post-marketing surveillance relies on which types of studies?
• List factors that influence the severity of poisoning on a given exposure.
• 80% of patients with true penicillin allergy no longer react after 10 years, because _____ antibodies dissipate over time.
• Halothane, sevoflurane are associated with which idiosyncratic reaction?
• How does pregnancy alter toxicology risk regarding drug use?
• Typical signs of anticholinergic toxicity and a common treatment approach?
• Carbamazepine is most commonly associated with which idiosyncratic reaction?
• QT prolongation screenings assess the effect on which cardiac process?
• Which scenario is a contraindication to activated charcoal?
• Inorganic mercury exposure primarily affects which organ?
• What are the stages of iron poisoning in a child, and what is a key treatment for toxicity?
• Bromfenac, diclofenac are most commonly linked to which idiosyncratic reaction?
• Which statement correctly identifies the two main patterns of drug-induced liver injury?
• What is malignant hyperthermia?
• Which of the following lists the three mechanisms of toxicity?
• What is the goal of therapeutic drug monitoring (TDM)?
• What tool is used for penicillin allergy risk assessment?
• What is the recommended initial management step and timeframe for N-acetylcysteine administration in acute acetaminophen overdose?
• What is the recommended source for poison information when poisoning is suspected?
• Accumulation of normeperidine can lead to ________. The risk is higher in patients with ________ and ______ ________.
• What is the first-line antidote for opioid overdose and typical route of administration?
• Dose-dependent toxicity can be due to the pharmacologic action of a drug, a pathologic effect of a drug or metabolite, or genotoxicity. Which option best describes this toxicity type?
• Which option correctly lists all categories used by the WHO-UMC causality assessment?
• Which item is NOT listed as a mechanism of toxicity?
• Which of the following correctly lists the triggering agents for malignant hyperthermia?
• In a dose-escalation study, how is the dose administered across groups?
• In a new chemical's toxicology risk assessment, dose-response assessment is used to determine:
• Oxidative stress is defined as which of the following?
• PEN-FAST scoring is used to assess allergy to which antibiotic class?
• What is the purpose of maintaining antidote inventories in hospitals?
• Toxicology is the study of poisoning and the damaging physiologic effects of exposure to xenobiotics.
• What are the core steps in a new chemical toxicology risk assessment?