ADR Quiz Flashcards
Match the responses to the correct statement.
Harms are the opposite of benefits
True
False
Evidence based medicine
Eminence based medicine
True
Match the responses to the correct statement.
Most adverse reactions are caused by exotic medications rather than by anticoagulants or by insulin
True
False
Evidence based medicine
Eminence based medicine
False
Match the responses to the correct statement
Adverse drug reactions do not result in patient harm
True
False
Evidence based medicine
Eminence based medicine
False
Match the responses to the correct statement.
Because I want it.
True
False
Evidence based medicine
Eminence based medicine
Eminence based medicine - making decisions solely based on clinical desire rather than evidence
Which statement is correct?
A) Adverse events are always reported in published trials
B) Spontaneous reporting is the most reliable method for reporting adverse events
C) Adverse events should be reported in the abstract, results, and discussion sections of any paper that claims a benefit to treatment
D) Patients who withdraw from a study because of adverse effects should not be included in the results
C
An INR measured two days after the dose increase was in the desired range. Several days later this patient suffered a serious bleeding event. Why didn’t this lab value predict that the new dose was too high?
A) The INR should only be used to monitor low molecular weight heparins
B) The half life of warfarin is approximately 40 hours. The half life of factor II is 72 hours, and factor X half life is 40 hours. The INR was measured at best after only one half life, probably less than one half life. We were no where near the maximum inhibition of clotting factors. The INR should have been repeated after 5-7 days at the new dose.
C) The INR should have been measured one half hour before, and two hours after the dose increase
D) All of the above
B
In the above case, bleeding resolved after stopping the anticoagulant and initiating a reversal agent (Vitamin K). How likely is it that the described INR event is an adverse drug reaction?
A) Unlikely
B) Possible
C) Probable or definite
D) None of the above
C - I would classify this event as probably since there is no rechallenge. When we rechallenge by prescribing a lower dose if the patient reaches a target response I would classify it as definite.
What type of ADR is this?
A) Pharmacologic
B) Idiosyncratic
C) Allergic
D) None of the above
A - ADR correlates to increases in dosing
You just finished reading a paper about the use of psilocybin in 22 patients to treat depression. Psilocibin was compared to 11 patients that received placebo. This paper found that the incidence of side effects such as nausea, vomiting, constipation, and rash was similar between the treatment and placebo group. The authors concluded that there was no difference in safety between psilocybin and placebo.
Are there any other concerning side effects that the authors should have considered? Is the statement “no difference in safety” correct? What should they have stated.
Other side effects of note are headaches, elevation in heart rate and blood pressure. Mental confusion, agitation, “bad trips”; disassociation, numbness, and weakness.
They did not find no difference in safety, they did not prove there was no difference, only that the difference in GI effects and rash, was not statistically significant. The authors neglected to measure some of the more important adverse effects listed above.
