Introduction to Pharmacoeconomics Part 2 Flashcards
What is the main aim of clinical research?
Determine efficacy
What is the main aim of outcomes research?
Determine effectiveness
What is the main aim of pharmacoeconomics?
Determine efficiency
What is the study design of clinical research?
Randomized clinical trials
What is the study design of outcomes research?
Observational studies and randomized clinical trials
What is the study design of pharmacoeconomics?
Economic analyses based on outcomes and clinical trials
What is the main measure of clinical research?
Efficacy and safety intermediate end points
What is the main measure of outcomes research?
Patient-related outcomes
What is the main measure of phamacoeconomics?
Cost and outcomes
What is the time frame of clinical research?
Short term
Ideal (not actual) clinical practice
What is the time frame of outcomes research?
Long term
Actual clinical practice
What is the time frame of pharmacoeconomics?
Long term
Actual clinical practice
What are some ADVANTAGES of prospective observational analysis?
Flexible
Provider-specific data
Reflects usual care
Offers comparative data
Less $ than RCTs
Prospective (a benefit and drawback!)
What are some DISADVANTAGES of prospective observational analysis?
Expensive
Difficult to control and randomize
Potential for patient selection bias
Small sample size
Difficulty generalizing results to other providers
Longer timeframe
What are some ADVANTAGES of retrospective database analyses?
Has potential for large sample size
Can provide data quickly
Customer specific
Reflects ‘actual care’ or effectiveness
Relatively inexpensive
Shorter timeframe
Data collection is unobtrusive
What are some DISADVANTAGES of retrospective database analyses?
Retrospective
Inconsistent coding
Variations in database quality among managed care plans
Inconsistent access to pharmacy versus medical claims
Inability to randomize patients to treatment
(At the whims of the system)
_______, _______ and ________ of resources is necessary to predict the pharmacoeconomic value?
Identification - identify the resource and any variables
Measurement - count resource in units service required to produce benefit. How are resources measured?
Valuation - market value of goods and services (theoretically the opportunity costs)
What are CLINICAL outcomes in pharmacoeconomics?
Therapeutic outcomes, controllable by a RPh. Use clinical indicators to measure. Death is a clinical outcome too!
What are ECONOMIC outcomes of pharmacoeconomics?
Direct medical resources
Health-related QoL
Patient satisfaction
Reduced hospital stay
When identifying outcomes of interest (economic, clinical, humanistic) we must account for the __________ of all these outcomes
Multidimensionality
What are three possible study designs?
- Experimental
- piggyback RCTs
- Economic clinical trials - Observational designs
- Claims analysis - Simulation designs
- machine learning, computer simulated
+ Combo designs
What may become barriers to the VALIDITY of a study?
Biases!
Internal
Patient selection bias
Crossover bias
Errors in measurement of outcomes
Errors in ascertainment of exposure to technology
External
Differences among people studied versus people with whom the results will be applied
How might we resolve possible ethical issues?
Prospective:
- BEFORE start, ensure all pts are not at risk and have full consent
Retrospective:
- Institutions should be allowed to review study protocol, contact IRB members for clarification
What is involved in conducting a pharmacoeconomic evaluation? Why might one be done?
May be done if:
- Insufficient literature
- Published results cannot be extrapolated to clinical practice,
- Building a model is not appropriate
COSTLY! Save this for only if there’s significant impact
(Retrospective database studies are far more common now
What are 6 steps to conducting pharmacoeconomic research?
- Define the problem
- Define objectives
- Identify alternatives
- Formulate research hypothesis
- Establish a framework
- Conducting pharmacoeconomic research
When creating a research framework for pharmacoeconomics, what considerations should be taken?
- What can be done within the problem/research question identified?
- consider both the processes and outcomes of care
- Consider dependent and independent variables
What four perspectives should the problem/objectives/outcomes of pharmacoeconomic studies be viewed?
Patient
Payer
Provider
Society
When coming up with possible solutions to a pharmacoeconomic problem, why is it important to identify possible alternatives?
Compares options
Would this add new therapy to standard of care?
Do guidelines or systematic reviews exist comparing alternatives?
When establishing a framework, the relationship of information is input -> output. A _____ must be developed based in understanding of care provision, and ______ _______ must always be documented based in care pathway.
A MODEL must be developed for the framework!
Must always describe resource utilization
What is a defined intervention in pharmacoecon research?
Determine parameters specifically!
- what data is being collected?
- Who is collecting this data?
- what model will be used?
Make a timeline!
When collecting data, can we use existing published data or collected data?
Both
What are some resources to be identified when assessing resource utilization?
Salaries/wages
$ savings/losses
Time used
What is a sensitivity analysis?
May replace statistical analysis
Often data is obtained from other studies
- must establish reasonable high and low values for variables
How is pharmacoeconomics used today?
To evaluate the value of pharmacy services
- justify novel services to higher-ups, expand scope of practice
To establish contracts with payers/PCMHs/ACOs
- offer clinical services aimed at improving quality/reducing cost for sellers
Determine cost-effective therapy recommendations for patients or partners
New jobs or opportunities
What is applied pharmacoeconomics?
The practice of pharmacoeconomic principles/methods/theories to assess the value of pharmaceutical products/services in ”the real world”
What are some specific applications of applied pharmacoeconomics?
Formulary Management
Clinical Guidelines
Drug Use Policies
Service or Program Evaluation
Individual Patient Treatment Decisions
What is Formulary Management?
A cost-containment tool used by hospitals/managed care organizations (MCO) that does NOT always represent a list of the least expensive alternatives.
Optimizes therapeutic outcomes balanced with controlling costs!
What are Clinical Guidelines in terms of pharmacoeconomics?
Developing drug use guidelines/policies/protocols in hospitals, influencing/prescribing/promoting the most cost-effective and desirable outcomes.
What are Drug Use Policies?
Policies implemented at institutional/organizational/government level to promote the optimal use of health care products and services
(Pharmacoeconomics should plan a major role in the evaluation of this policy.)
What is a Service (Program) Evaluation?
Principles & methods of pharmacoeconomics are useful in determining the VALUE of an EXISTING pharmacy or medical service, or estimating the POTENTIAL WORTH of implementing a NEW services
Why do this? -> increased competition for resources. Make yourself a necessity!
What are Individual Patient Treatment Decisions?
Pharmacoeconomic studies should evaluate diverse patient groups and include both economic and humanistic outcomes so it is easier to apply to many different individuals
WHOSE approval is needed for human research subjects?
IRB
Study design affects WHAT aspect of the research?
• Cost of the evaluation
• Time required to conduct the evaluation
• Accuracy of the information gained
• Complexity of conducting the evaluation
• Ease of defending the subsequent decisions
