Chapter·PharmacologyDrug interactions and adverse effects

Pharmacovigilance principlesDownloads

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1

A 14-year-old boy is brought to the emergency department because of a 4-hour history of vomiting, lethargy, and confusion. Three days ago, he was treated with an over-the-counter medication for fever and runny nose. He is oriented only to person. His blood pressure is 100/70 mm Hg. Examination shows bilateral optic disc swelling and hepatomegaly. His blood glucose concentration is 65 mg/dL. Toxicology screening for serum acetaminophen is negative. The over-the-counter medication that was most likely used by this patient has which of the following additional effects?

AIncreased partial thromboplastin time

BDecreased uric acid elimination

CDecreased expression of glycoprotein IIb/IIIa

DIrreversible inhibition of ATP synthase

EIrreversible inhibition of cyclooxygenase-1

2

A researcher is trying to determine whether a newly discovered substance X can be useful in promoting wound healing after surgery. She conducts this study by enrolling the next 100 patients that will be undergoing this surgery and separating them into 2 groups. She decides which patient will be in which group by using a random number generator. Subsequently, she prepares 1 set of syringes with the novel substance X and 1 set of syringes with a saline control. Both of these sets of syringes are unlabeled and the substances inside cannot be distinguished. She gives the surgeon performing the surgery 1 of the syringes and does not inform him nor the patient which syringe was used. After the study is complete, she analyzes all the data that was collected and performs statistical analysis. This study most likely provides which level of evidence for use of substance X?

ALevel 3

BLevel 1

CLevel 4

DLevel 5

ELevel 2

3

A pharmaceutical company conducts a randomized clinical trial to demonstrate that their new anticoagulant drug, Aclotsaban, prevents more thrombotic events following total knee arthroplasty than the current standard of care. A significant number of patients are lost to follow-up, and many fail to complete treatment according to the study arm to which they were assigned. Despite these protocol deviations, the results for the patients who completed the course of Aclotsaban are encouraging. Which of the following analytical approaches is most appropriate for the primary analysis to establish the efficacy of Aclotsaban?

AIntention-to-treat analysis

BSub-group analysis

CPer-protocol analysis

DAs-treated analysis

ENon-inferiority analysis

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