Pharmacovigilance Flashcards
The aims of pharmacovigilance includes
A. To improve patient care and safety
B. Cost-effectiveness of drug prescribing
C. Effective communication to the general public
D. AOTA
D
RA 8423 defines counterfeit drug
According to RA 8203, a counterfeit drug means
A. An imported drug that is not registered in the country
B. A medicinal product that has the correct ingredients but insufficient amount
C. A medicine that has the wrong constituents
D. AOTA
D
Optimal Phase II trial for a new analgesic drug for mild pain does NOT include
A. Teratogenicity and mutagenicity studies
B. Placebo
C. Positive control
D. 2000-3000 participants
B
In most cases errors in healthcare is due to the following
A. Willful negligence
B. Systemic flaws
C. Process variation
D. AOTA
C
Codeine, metabolized by CYP 2D6, was given to a patient who did not display therapeutic
effect despite adequate dose. The patient is a…
A. Poor metabolizer
B. Intermediate metabolizer
C. Extensive metabolizer
D. Ultrarapid metabolizer
A
Codeine is a prodrug that must be metabolized to manifest its analgesic effects. The lack of effect
in this patient indicates that his or her CYP 2D6 enzyme is not functioning at normal levels, as in
extensive metabolizers.
The scope of pharmacovigilance covers the following areas of adverse effects of drugs
except?
A. Assessment
B. Prevention
C. Treatment
D. Understanding
C
- Off label drug use can be motivated by:
A. Life threatening medical condition.
B. If pathologic/physiologic function of 2 diseases are similar.
C. Drugs not studied/approved for specific populations
D. All of the above
D
Morbidity and mortality from poisoning cases can provide the following information:
A. Misuse and abuse of drugs
B. Counterfeit drugs
C. Substandard drugs
D. Adverse reactions
A
- Increasing awareness among clinicians on drug safety can be achieved through:
A. Access to reliable information
B. Communication with health professionals
C. Linking clinical findings with health policy
D. All of the above
D
