Pharmacovigilance principles — Flashcards

Flashcard 1: Phase _____ of clinical trials confirms efficacy compared to the standard of care, as well as adverse effects

Answer: III

Flashcard 2: Most loop diuretics are _____ drugs and thus may cause adverse reactions in allergic patients

Answer: sulfa

Flashcard 3: Phase _____ of clinical trials is the postmarketing surveillance of patients after a treatment is approved

Answer: IV

Flashcard 4: The _____-opioid receptor mediates most of the clinical and adverse effects

Answer: Mu (μ)

Extra: Mu-opioid receptors are the primary mediators of the clinical effects (analgesia) and the majority of adverse effects (respiratory depression, constipation, and euphoria/addiction) associated with opioid drugs.

Flashcard 5: Examples of the beers criteria include drugs that increase the risk of anti_____ activity (antihistamines, GI antispasmodics)

Answer: cholinergic

Flashcard 6: What type of drug interaction is an acute decrease in response to a drug after initial/repeated administration?_____

Answer: Tachyphylactic (e.g. nitrates, niacin, phenylephrine, LSD, MDMA)

Flashcard 7: Sulfonylureas are _____ drugs and thus may cause adverse reactions in allergic patients

Answer: sulfa

Flashcard 8: Beta-blockers may have _____ adverse effects, including seizures, sedation, and sleep alterations.

Answer: CNS

Flashcard 9: thalidomide

Answer: limb defects (flipper limbs)

Flashcard 10: What are the teratogenic effects of warfarin?

Answer: Bone deformities (stippled epiphyses, nasal hypoplasia), fetal hemorrhage, abortion, ophthalmologic abnormalities

Extra: Warfarin inhibits epoxide reductase, interfering with γ-carboxylation of glutamate residues (including Osteocalcin). Exposure during 6-9 weeks gestation leads to Fetal Warfarin Syndrome.