Major categories of ADRs related to the immune system include _______________.
A. immunotoxicity
B. autoimmune reactions
C. hypersensitivity or allergic reactions
D. All of the above.
All of the following statements related to autoimmune reactions are correct EXCEPT which one? An autoimmune reaction may _______________.
A. be the specific intent of therapy, e.g., when monoclonal antibodies target specific B cells
B. elicit an antibody response to Rh factors on red blood cells (RBCs) causing hemolytic anemia
C. induce an antibody response to myeloperoxidase or DNA causing a lupus-like syndrome
D. directly cause mast cell degranulation resulting in urticarial lesions
Which of the following statements related to hypersensitivity or allergic reactions is correct?
A. Therapeutic peptides or proteins with molecular weights >600 daltons are recognized by the immune system as foreign substances and can directly trigger allergic reactions.
B. Drugs with molecular weights <600 daltons are too small to act as direct immunogens; however, these drugs may act as haptens.
C. An allergic response is predicated on sensitization, i.e., prior exposure to a drug.
D. All of the above.
Which of the following statements related to Type I or immediate hypersensitivity reactions (anaphylaxis) is correct?
A. Type I reactions are predicated on exposure to an allergen and antigen-specific antibody production dominated by immunoglobulin E (IgE) isotype.
B. Type I reactions are predicated on exposure to an allergen and antigen-specific antibody production dominated by immunoglobulin G (IgG) or M (IgM) isotypes.
C. Type I reactions are predicated on exposure to haptens, which bind to endogenous macromolecules and form hapten-protein complexes.
D. In Type I reactions Langerhans cells phagocytize and process hapten-protein complexes, load them into major histocompatibility complexes, migrate to regional lymph nodes and present them to naïve T-lymphocyte.
Which of the following statements related to Type IV or of delayed T-cell mediated hypersensitivity reactions (anaphylaxis) is correct? Upon re-exposure to a specific antigen, _______________.
A. IgE antibodies bind to mast cells in mucosal and epithelial tissues and trigger degranulation of mast cells resulting in the production and release of histamine, leukotrienes, prostaglandins, and cytokines
B. the antigen binds to the surface of target cells (usually RBCs), the antigen-antibody complexes attract cytotoxic T cells, which release chemical mediators that cause target-cell lysis
C. soluble drug molecules form large insoluble antigen-antibody complexes that are deposited in target tissues (e.g., kidneys, joints and lungs) and initiate complement activation, neutrophil and platelet aggregation, and an intense inflammatory response
D. sensitized T cells in target tissues activate macrophages, which mediate direct cellular damage
Which of the following statements related to idiosyncratic ADRs is correct?
A. Idiosyncratic ADRs are observed in a small number of patients.
B. Factors influencing drug response phenotype include age, gender, underlying disease, and genetic and epigenetic mechanisms.
C. Genetic polymorphism and epigenetic factors have been implicated in both pharmacokinetic and pharmacodynamic variations.
D. All of the above.
All of the following statements related to oncogenic mechanisms of ADRs are correct EXCEPT which one?
A. Primary oncogenic effects can be produced by drugs that damage DNA or by drugs that facilitate proliferation of cells carrying precancerous mutations.
B. Oncogenes are proto-oncogenes, which through amplification or mutation became permanently activated allowing abnormal cells to proliferate.
C. Inactivated tumor suppressor genes slow down cell division, promote the repair of damaged DNA, and initiate apoptosis.
D. Secondary oncogenic effects are related to therapeutic immunosuppression-induced reactivation of latent oncogenic viruses.
Which of the following statements related to teratogenesis is correct?
A. Teratogenesis is the process that results in structural and/or functional defects in a fetus.
B. Exposure to a teratogen during organogenesis, i.e., from day 18 to day 55 results in developmental abnormalities.
C. The period from day 55 through the 3rd trimester is a period of fetal growth, exposure to a teratogen affects organ function.
D. All of the above.
All of the following statements related to rash or pruritus are correct EXCEPT which one?
A. Rash is a specific term and its use is encouraged in describing an ADR characterized by skin eruption.
B. Pruritus may be a symptom of primary skin lesions or less frequently that of a systemic disease.
C. Pruritus may be the result of drug-induced histamine release by mast cells unrelated to the immune system.
D. Pruritus may reflect a bona fide drug-related allergic reaction.
Which of the following ADRs is likely to be unrelated to IgE-induced mast cell degranulation and be described as an anaphylactoid or pseudoallergic reaction?
A. Opioid analgesic-induced central pruritic action and peripheral histamine release.
B. Vancomycin and ciprofloxacin-induced red man syndrome characterized by itching followed by the emergence of a "rash" or hives, i.e., urticaria.
C. Some cases of NSAID-, penicillin-, and antifungal agent-induced itching and urticaria.
D. All of the above.
Which of the following statements related to urticaria is correct?
A. Urticaria is a well-circumscribed erythematous, pruritic plaque on skin associated with the release of histamine and other vasoactive substances from mast cells and basophils resulting in intradermal edema caused by vasodilation.
B. Chronic urticaria is usually idiopathic or it may be associated with auto-antibodies to IgE receptors causing mast cell degranulation.
C. Acute urticaria most often reflects a hypersensitivity or allergic reaction in which allergen-bound IgE initiates mast cell and basophil degranulation.
D. All of the above.
Which of the following statements related to angioedema is correct?
A. A common feature of pruritus and urticaria is subcutaneous and submucosal angioedema of target tissues.
B. Chronic angioedema is rarely IgE-mediated; it is usually idiopathic and may be caused by the chronic ingestion of certain drugs (e.g., penicillin), preservatives, milk, and food additives; and a few cases are hereditary.
C. Acute angioedema may reflect a localized IgE-mediated reaction, but acute swelling of the extremities, face, lips, tongue, oropharynx, and larynx along with stridor, wheezing, and hypotension are harbingers of systemic anaphylaxis.
D. All of the above.
All of the following statements related to erythema multiforme (EM) is correct EXCEPT which one?
A. EM is an acute T cell-mediated cytolytic reaction.
B. The majority of EM is drug-induced related to NSAIDs, penicillins, anticonvulsants, and sulfonamides.
C. Cutaneous lesions begin as erythematous papules that progress to form the more characteristic iris or target lesions.
D. Hemorrhagic crusting of the lips and vesiculoerosive lesions on unattached oral mucosal tissues are diagnostic.
All of the following statements related to EM, Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) are correct EXCEPT which one?
A. Severity of EM varies from mild (EM minor) to moderate (EM major) to potentially fatal SJS or TEN.
B. The majority of SJS and TEN is a reaction to the herpes simplex virus.
C. Oral features of SJS and TEN are similar to those associated with EM.
D. The major difference between SJS and TEN is the distribution of dermal lesions: SJS affects <10% of the body surface while TEN affects >30%.
Which of the following statements related to lichenoid reactions is correct?
A. Drugs such as NSAID’s and ACE inhibitors can act as haptens and alter the antigenicity of epithelial self-antigens.
B. Oral lichen planus that can be traced to an extrinsic cause is more properly termed a lichenoid reaction.
C. Oral lichenoid lesions most often affect the buccal mucosa, gingivae, and the lateral border of the tongue and may be “reticular," erythematous, or atrophic.
D. All of the above.
Which of the following statements related to arthralgia is correct?
A. Drugs associated with arthralgia include ACE-inhibitors, bisphosphonates, fluoroquinolones, corticosteroids, and vaccines.
B. Only rarely is arthralgia the result of an adverse reaction to a drug.
C. The most common cause of arthralgia is arthritis; other causes include injury and infection.
D. All of the above.
All of the following statements related to Type I hypersensitivity reactions are correct EXCEPT which one?
A. Anaphylaxis occurs within minutes to hours after parenteral or enteral administration of a drug in a previously sensitized patient.
B. The longer the reaction time to an antigen, the more severe the anaphylactic reaction is.
C. Skin-related signs and symptoms of anaphylaxis include erythema, urticaria, and angioedema.
D. Cardiopulmonary effects of anaphylaxis include bronchospasm, hypotension, and shock.
All of the following statements relater either to Type II or Type III hypersensitivity reactions is correct EXCEPT which one?
A. The time required for cytotoxic T cell-mediated target cell lysis or for target cell lysis mediated by the complement system in response to a specific antigen is 1 to 3 weeks.
B. Clinical manifestations of Type II antibody-dependent cytotoxic reactions include hemolytic anemia, neutropenia, and thrombocytopenia.
C. Reactions clinically similar to serum sickness have been noted in association with non-protein drugs such as penicillins, metronidazole, tetracyclines, and NSAIDs.
D. Common symptoms of serum sickness include fever, cutaneous eruptions, arthralgia, nausea, vomiting, diarrhea or abdominal pain, headaches, myalgia, dyspnea and wheezing, and lymphadenopathy.
Which of the following statements related to Type IV hypersensitivity or delayed T cell-mediated reactions is correct?
A. In susceptible patients, cytokines and other mediators of inflammation are released within 2 to 7 days of re-exposure to an allergen.
B. Clinical manifestations include allergic contact dermatitis/mucositis or a drug-induced maculopapular rash.
C. With repeated antigenic challenge, the response becomes more profound and includes fever, malaise, and angioedema in target tissues.
D. All of the above.
All of the following statements related to idiosyncratic ADRs are correct EXCEPT which one?
A. Idiosyncrasy is an unusual reaction of any intensity observed in a small number of the individuals.
B. When a drug produces its usual effect on a person at an unexpectedly high dose, the patient is said to be hyperreactive.
C. Because of genetic polymorphism, up to 10% of patients are poor metabolizers of codeine and do not experience analgesia in response to treatment with codeine.
D. Because of genetic polymorphism, up to 10% of patients are rapid metabolizers of codeine and may experience severe toxicity even with therapeutic doses.
Which of the following statements related to primary oncogenesis-related ADRs is correct?
A. In general, drugs that cause direct damage to DNA and/or that interfere with DNA repair are avoided in clinical practice.
B. DNA damage and/or interference with DNA repair is the specific intent of cytotoxic alkylating agents used to treat neoplasia and such drugs can cause acute myelocytic leukemia.
C. Tamoxifen, an estrogen receptor antagonist used to treat estrogen-sensitive breast cancer, acting as a partial agonist at estrogen receptors in the uterus can cause endometrial carcinoma.
D. All of the above.
All of the following statements related to teratogenesis-related ADRs are correct EXCEPT which one?
A. A large number of drugs in clinical use have been positively implicated in teratogenesis.
B. Tetracyclines induce enamel hypoplasia, discoloration of teeth, and diminished growth of long bones.
C. Tetracyclines produce higher rates of neuronal-tube defect, cleft palate, and multiple congenital abnormalities such as neuronal-tube defect with cardiovascular malformation.
D. Recent evidence suggests that acetaminophen (APAP) can act as a hormone disrupter such that it interferes with reproductive and thyroid hormone functions essential for normal brain development.
E. Increased risk of attention-deficit/hyperactivity disorder (ADHD)-like behavioral problems or hyperkinetic disorders (HKDs) has been reported among children born to women with a history of frequent APAP use during pregnancy.
All of the following statements related to therapeutic immunosuppression-induced secondary ADRs are correct EXCEPT which one?
A. Bacterial infections often contribute to morbidity and mortality associated with therapeutic immunosuppression.
B. Therapeutic immunosuppression is often complicated by fungal infections such as those associated with the Candida sp.
C. Common viral infections in patients undergoing therapeutic immunosuppression include primary HSV infections.
D. Herpes zoster (HZ) is a common clinical manifestation of immunosuppression-induced reactivation of the latent varicella zoster virus.
Which of the following statements related to therapeutic immunosuppression-induced secondary malignancies is correct?
A. Secondary malignancies related to therapeutic immunosuppression in susceptible individuals include de novo squamous cell carcinoma of the skin.
B. Secondary malignancies related to therapeutic immunosuppression in susceptible individuals include de novo squamous cell carcinoma of the lip.
C. Secondary malignancies related to immunosuppression-induced reactivation of oncogenic viruses include Kaposi sarcoma, lymphoproliferative diseases, Hodgkin's and non-Hodgkin’s lymphomas, and spindle-cell sarcoma.
D. All of the above.
Which of the following statements related to withdrawal syndrome is correct?
A. Withdrawal syndrome is a substance-specific ADR associated with cessation or rapid reduction in the amount of a substance that an individual has been taking for a prolonged period of time and/or in high doses.
B. Withdrawal syndrome can occur with alcohol, tobacco, cocaine, amphetamines, and heroin; and following the long-term use of therapeutic agents such as opioids and benzodiazepines.
C. The signs and symptoms of withdrawal of a drug are opposite to the effects of the acute administration of that drug.
D. All of the above.
All of the following statements related to preventing ADRs are correct EXCEPT which one?
A. Preventing ADRs is a critical part of clinical practice.
B. In the treatment of most oral/odontogenic problems non-pharmacological intervention, i.e., primary dental care is more effective and a safer alternative to pharmacotherapy.
C. When pharmacotherapy is indicated practitioners must embrace “rationalized activism,” i.e., the belief that it is better to over-treat than not to treat at all.
D. Practitioners must also avoid “reflex prescribing,” i.e., catering to the patient’s expectations.
Which of the following statements related to preventing ADRs is correct?
A. Errors in medications, which may lead to ADRs, are related to such factors as progressing age, multiple illnesses, living alone, and poor coping ability of ambulatory patients with their environment.
B. Simple and clear oral instructions on how and when to take a drug should be given and reinforced by clear labeling and written instructions.
C. Patient response to drug therapy should be assessed frequently to confirm efficacy and compliance; and when new signs and symptoms are reported, rule out ADRs.
D. All of the above.
All of the following statements (steps) related to diagnosing ADRs are correct EXCEPT which one?
A. Identify the drug(s) taken by the patient and verify that the onset of signs and symptoms was after the initiation of pharmacological intervention.
B. Determine the time-interval between the initiation of drug therapy and the onset of signs and symptoms.
C. Stop drug therapy and monitor signs and symptoms.
D. Once the ADR is resolved, it is good practice to restart drug therapy to confirm causality.
Which of the following statements related to reporting ADRs is correct?
A. The FDA launched MedWatch, an initiative designed to educate health care professional about the critical importance of being aware of, monitoring for, and reporting ADRs.
B. The reporting clinician is not responsible for proving causality; a suspected association constitutes sufficient reason to report.
C. The FDA holds the identity of the patient in strict confidence; however, unless otherwise indicated on the reporting form, the reporting clinician’s identity may be shared with the manufacturer of the drug.
D. All of the above.
Which of the following statements related to the FDA’s response to reports of ADRs is correct?
A. The FDA may send out "Dear Health Professional" letters and require warning labels and/or changes to the packaging information (package insert).
B. The FDA may request further epidemiological investigations and/or manufacturer-sponsored post-marketing studies and conduct inspections of manufacturers' facilities and/or records.
C. The FDA may require withdrawal of the drug from the market.
D. All of the above.
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