BPS-Pharmacotherapy 試験問題を無料オンラインアクセス

A pharmacotherapy specialist has been asked to provide information on the incidence of a particular side effect for a drug that has now been on the U.S. market for 5 years. The only information available comes from the FDA's MedWatch program. The apparent incidence of a given adverse effect, as determined from the MedWatch database, is likely to be which of the following?

• A.Reliable because the data are accumulated in cooperation with the pharmaceutical industry
• B.Reliable because healthcare institutions such as hospitals are mandated to report all adverse drug events to the FDA
• C.Unreliable because the voluntary nature of reporting makes numerator data questionable
• D.Unreliable because reporting healthcare providers usually fail to establish a temporal relationship

A pharmacotherapy specialist is interpreting a published paper describing a randomized controlled, double-bling study that was conducted to evaluate the effects of antihistamines on the failure rate of treatment of otitis media in children. In the study, 250 children received antihistamines and 264 did not. All children received appropriate antibiotic therapy. Treatment failures occurred in four (1.6%) of the children who received antihistamines and in 13 (4.9%) of those who did not. The difference is statistically significant (p<0.05, chi-square). Which of the following statements about these result is appropriate?

• A.Chi-square is not the appropriate statistical test.
• B.Knowledge of the rate and severity of adverse event in the study is needed to allow a therapeutic decision.
• C.Antihistamines should be administered to all children with otitis media who meet study entry criteria.
• D.The sample size is inadequate to allow clinical conclusions.

A patient with rheumatoid arthritis has been experiencing increased pain over the last 2-3 weeks. The patient's rheumatoid arthritis has previously been controlled with methotrexate and periodic NSAID and steroid use for acute flares. However, currently this regimen is inadequate.
The physician wants to initiate therapy with etanercept.
Which of the following infections should be screened for prior to initiating therapy?

• A.Candida
• B.Tuberculosis
• C.Hepatitis A
• D.Legionella

The pharmacotherapy specialist-directed research team in a large healthcare system plans to submit a comparative effectiveness study proposal in response to the request for proposals released under the Patient Protection and Affordable Care Act. In designing this study, which category of outcomes should be used for the primary endpoint?

• A.Cost savings
• B.Surrogate markers
• C.Cost-effectiveness
• D.Patient-centered health

A physician suspects that a patient's symptoms are related to abrupt discontinuation of a certain drug and asks the pharmacotherapy specialist about common reactions in this type of situation.
A literature search produces one case report of a discontinuation syndrome involving the drug.
What is the most appropriate action to take with regard to the current suspected adverse event?

• A.Report the event to the FDA MedWatch program.
• B.Report the event to the P & T Committee.
• C.Complete a manufacturer's adverse event report.
• D.Write and submit a case report detailing the event.