Outcomes/post marketing

T/F There is an Increase over time in GDP of US being spent on healthcare

T/F There is an Increase over time in GDP of US being spent on healthcare

T

List factors contributing to rising costs of care

•Rising disease incidence and prevalence → Aging population, chronic disease states, improved detection & diagnosis

•Innovation Tech→ Precision medicine, gene therapy, administrative overhead

Define outcomes research

•Seeks to understand end results health care practices and interventions

1)Ability to function

2)Quality of life

3)Mortality

Outcomes research strengths

•captures an intervention's effectiveness

•Patient centered outcomes

•Naturalistic design

Outcomes research limitations

•Limited ability to address confounding variables

•Severity adjustment difficult

•Casuality not establish

•Requires large samples

•Funding challenges

Identify the features of post-marketing surveillance and drug safety reporting

Activities to assess performance of a drug after FDA approval

Studies mainly focus on aspects of safety and effectiveness

Information may come from a variety of sources

May be mandated by the FDA as condition of approval

Benefits of AE reporting databases

inexpensive, monitor/detect AE, establish DDI, long term effects

Limitations of AE reporting databases

underreporting, duplicates, unable to calculate incidence rates, difficult to establish causality

Describe the key components of adverse event analysis

Exposure time to adverse event

Concurrent medications and disease states

Associated laboratory results

Absence of alternative explanations