Adverse events Flashcards
What is an adverse event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
True or False: All adverse events are caused by the medication.
False
Fill in the blank: An adverse event can occur during ________ of a medical intervention.
any phase
What is the difference between an adverse event and a serious adverse event?
A serious adverse event results in death, a life-threatening condition, hospitalization, disability, or significant medical intervention.
Multiple Choice: Which of the following is NOT considered an adverse event? A) Rash B) Nausea C) Improved health D) Headache
C) Improved health
What does the acronym SAE stand for?
Serious Adverse Event
True or False: Adverse events can be reported by healthcare professionals only.
False
Fill in the blank: Adverse events should be reported to ________ for further investigation.
regulatory authorities
What is the purpose of monitoring adverse events?
To ensure patient safety and assess the risk-benefit profile of a medical product.
Multiple Choice: Which of the following is a common method for reporting adverse events? A) Direct observation B) Patient interviews C) Online databases D) All of the above
D) All of the above
What is the role of pharmacovigilance?
To detect, assess, understand, and prevent adverse effects or any other drug-related problems.
True or False: Adverse events can only occur during clinical trials.
False
Fill in the blank: The ________ is responsible for regulating the safety of medical products in the United States.
FDA (Food and Drug Administration)
What is a common challenge in identifying adverse events?
Attribution of the event to the medical product versus other factors.
Multiple Choice: Which of the following factors can influence the reporting of adverse events? A) Patient demographics B) Severity of the event C) Healthcare provider’s awareness D) All of the above
D) All of the above
What does the term ‘causality assessment’ refer to?
The process of determining whether a reported adverse event was caused by a medical product.
True or False: Only prescription medications can have adverse events.
False
Fill in the blank: The ________ system is a tool used for reporting and monitoring adverse events.
MedWatch
What is the significance of a risk management plan?
To outline strategies to minimize the risks associated with a medical product.
Multiple Choice: Which of the following is a potential outcome of an adverse event? A) Withdrawal of the product B) Label changes C) Increased monitoring D) All of the above
D) All of the above
What is the importance of patient education regarding adverse events?
To empower patients to recognize and report any adverse events they experience.
True or False: Adverse events can have long-term implications for public health.
True
Fill in the blank: An adverse event report may include information about the patient’s ________ and any concomitant medications.
medical history
What is the purpose of a post-marketing surveillance study?
To monitor the safety of a medical product after it has been approved for use.
Multiple Choice: Which organization is responsible for international pharmacovigilance? A) FDA B) WHO C) EMA D) All of the above
D) All of the above
What is the role of healthcare providers in the context of adverse events?
To identify, document, and report adverse events to ensure patient safety.
Why are there an increase in ADRs recently?
There is an increase in medications being prescribed
How many patients are drugs tested in before being approved?
1500
Why is it challenging to identify AEs
It can happen within minutes-weeks making it difficult to pinpoint cause, and sometimes only happens after multiple doses of the same drug
What does the Uppsala Monitoring Center (UMC) do?
They monitor drugs internationally, and screen and analyze adverse reaction data
What is the difference in ADR and ADE?
ADE is a untoward medical occurrence during tx but not necessarily with a causal relationship and a ADR is a unpleasant and unintended effect that occurred at a normal dose with possible causal of the drug
How is a side effect different from an ADR?
it is a unintended effect of the drug occurring at a normal dose related to the drug pharmaceutical effects; like taking aspirin and it is causing gastric irritation.
What is a signal?
reported info on a possible causal relationship between an AE and a drug
what is a SAE/reaction?
any untoward effects that result in death, requires hospitalization, results in significant incapacity or disability, and is life threatening
What are traits of a high risk drug?
Prolonged high doses, narrow therapeutic window, CYP 450 polymorphisms, meds with administration characteristics and drugs requiring monitoring
What are three drugs with a Narrow therapeutic index?
Digoxin, theophylline, and heparin
What are three drugs that are CYP 450 polymorphisms?
Warfarin, codeine, and antidepressants
What administration route is the most high risk?
topical followed by parenteral and oral
What is a Type a reaction?
70-80% of all reactions, a side effect related to a therapeutic effect such as warfarin causing bleeding. It is dose dependent and predictable.
What are Type B reactions?
Allergic or hypersensitivity reactions. Broken up into Types I-IV.
What is a Type 1 reaction, its effects, and how is it mediated?
An immediate hypersensitivity reaction with urticaria, rhinorrhea, asthma, gastroenteritis. IgE mediated. Occurs within 1 hour of exposure. Triggered by airborne agents, insect stings, parasitic infection, and food allergies. Treated within IV prednisone or epi or an EPI pen. Could have side effects like asthma, hives, wheezing, eczema.
What is a Type II reaction, its effects, and how is it mediated?
cytotoxic hypersensitivity, like autoimmune hemolytic anemia, drug induced immune thrombocytopenia, hemolytic disease of newborns, Goodpasture syndrome, myasthenia gravis, graves, and Hashimoto’s. and drug induced lupus like skin eruption. IgG and IgM mediated. Usually happens in minutes to hours. leads to cell destruction and sequestration of the spleen.
What drugs can cause a Type II reaction?
beta lactam drugs, levodopa, quinidine, sulfa antibiotics, and some anti-inflammatory drugs.
What are the steps in a Type II reaction?
- drug attaches to platelet and forms an immune complex 2. The immune complex induces formation of antibodies against the hapten portion of the complex 3. the action of the antibodies and complement is to rupture the platelet and cause destruction.
What is a Type III reaction, its effects, and how is it mediated?
An immune complex hypersensitivity, like serum sickness, urticaria, lymphadenopathy, fever, and arthralgias. Mediated to IgG, but have a slower onset than type II, usually take 1-3 weeks after exposure to the drug. Examples are systemic lupus, RA, polyarteritis nodosa, post strep glomerulonephritis and lupus nephritis. You treat with anti-inflammatory agents.
what happens in a type III reaction chain
- formation of antibody antigen complex 2. complexes are despoited in blood vessel walls where they attarct inflammatory cells liek neutrophils. 3. the inflammatory response where enzymes are relaesed from teh neutrophils which cause damages to the endothelial cells lining and blood vessel basement membrane.
What is a Type IV reaction , its effects, and how is it mediated?
Delayed hypersensitivity 24-72 hours later. Caused by T lymphocytes or memory CD4 cells. It includes poison ivy, nickel allergy, contact dermatitis, TB test, fixed drug eruptions, histoplasmosis, leishmaniasis, TB, and leprosy. Treated with corticosteroids and other immunosuppressive agents.
what happens in a type IV reaction chain
inflammatory mediators enhance the activity of macrophages and release more inflammatory mediators. Primarily type 1 cytokines like tumor necrosis factor.
Why are carcinogenic side effects easily missed?
it is a delayed drug reaction and take years to develope.
What are potentially carcinogenic drugs?
Androgens, antineoplastics, Busulfan, corticosteroids, cyclamates, estrogens, griseofulvin, metronidazole, nitrites, nitrofurans, oral contraceptives, and progestins.
What are idiosyncratic causes for ADRS?
decomposition of the drugs, effects of teh additives, or by-product effects. and genetic factors.
What is the most well know teratogenic drug?
Thalidomide
Teratogenesis: what is happening from 0-16 days and what could cause teratogenesis?
fertilization and blastogenesis-> cytotoxic drugs, alcohol,
Teratogenesis: what is happening from 2.5-8 weeks and what could cause teratogenesis?
Embryogenesis-> retinoids, warfarin, antiepileptics
Teratogenesis: what is happening from 8-32 weeks and what could cause teratogenesis?
Fetogenesis-> alcohol, nicotine, ACE-1 inhibitors, steroids
What are category A drugs?
studies in pregnant women showed no increased risk in the 1st trimester and generally considered safe. Examples; levothyroxine, doxylamine, vitamin A,B12, C, D,E and nystatin
What are category B drugs?
Animal studies show no risk to fetus or animal studies show risk, but human studies do not. No evidence in 2nd or 3rd trimester use. Examples are acetaminophen, Zofran, metformin, nitrofurantoin, loratadine, Montelukast cetirizine, diphenhydramine.
What are category C drugs?
Either NO adequate studies have been done in animal or human studies or adverse fetal affects have been shown in animals, but no human data is available. examples: albuterol, Zoloft, fluoroquinolones, sulfonamides, lithium, opioids, pseudoephedrine, ibuprofen, and other NSAIDs
What are category D drugs?
only can be used when benefit outweighs risk in pregnancy. These show evidence of harm but are not well studied. Examples; paxil, dilantin, doxycycline, aminoglycosides, ACE inhibitors, aspirin, NSAIDS (during 3rd trimester)
What are category X Drugs?
Not to be administered in pregnancy- Accutane, warfarin, methotrexate
