PE 4 Flashcards
What is the role of the United States Food and Drug Administration (FDA) in pharmacoepidemiology?
The FDA has regulatory responsibility for ensuring the safety of all marketed medical products, including pharmaceuticals.
What are serious adverse events (AEs) in the context of the FDA?
Serious AEs are recognized and voluntarily reported by healthcare providers and patients, and mandated reporting by manufacturers.
Define spontaneous reports in pharmacoepidemiology.
Spontaneous reports are unsolicited clinical observations from healthcare professionals or consumers, originating outside of formal studies.
What types of individual spontaneous reports does the FDA receive?
- Adverse drug reactions (ADRs)
- Medication errors
- Product quality problems
What are the requirements of an ideal database in pharmacoepidemiology?
- Easily linked through the patient’s unique identifier
- Regularly updated records
- Verifiable and reliable records
What should a complete database in pharmacoepidemiology include?
- Records from inpatient and outpatient care
- Emergency medical care
- Results of all laboratory and radiological tests
- All prescribed and over-the-counter medications and alternative therapies
What factors must be understood for the implementation of studies through databases?
- Strengths and weaknesses of pharmacoepidemiology study designs
- Data collection procedures
- Enrollment and coverage factors
- Social, cultural, political, and historical settings
True or False: No single database in pharmacoepidemiology is ideal.
True
What are primary data sources in pharmacoepidemiology?
- National surveys
- Registries
What are secondary data sources in pharmacoepidemiology?
- Administrative databases
- Claims databases
- Electronic medical records
What is a national survey in the context of pharmacoepidemiology?
A national survey collects extensive health-related data, such as prevalence of smoking and access to healthcare.
What is a registry in pharmacoepidemiology?
An organized system that collects uniform data to evaluate specified outcomes for a population defined by a particular disease or exposure.
What are the purposes of registries in medicine and public health?
- Describing the natural history of the disease
- Determining clinical efficiency and/or cost-effectiveness
- Assessing medication safety or adverse events
- Measuring or improving quality of care
What are some limitations of using administrative registries for research?
- Data selection and quality issues
- Methodology of data collection predetermined
- Validation studies are essential
What is the primary limitation of secondary data?
The data are not collected for the specific purpose of answering the research question.
Define Electronic Health Record (EHR).
A longitudinal digital record of patient health information generated by one or more encounters in a healthcare setting.
What are the benefits of using Electronic Health Records in pharmacoepidemiology?
- Patient-centric design
- Comprehensive data for tracking health
- Better validity of diagnostic data
What are some significant limitations of automated databases?
- Quality of data input
- Validity of diagnostic information
What is the purpose of data linkage in pharmacoepidemiology?
To identify subjects across databases and consolidate their information.
What is an example of a data linkage study?
A study utilizing the Australian Medicare system linked to the Australian Cancer Database and the National Death Index.
What is the General Practice Research Database (GPRD)?
A database of anonymized longitudinal medical records from primary care in the UK, used extensively in pharmacoepidemiology research.
Fill in the blank: The process of identifying subjects across databases is called _______.
data linkage
What is the significance of training a future workforce in analyzing large electronic databases?
It is critical to harness the potential of healthcare data for studying medication utilization and safety.
What type of data is typically found in claims databases?
Data on prescriptions dispensed and treatment costs justifying expenses with a diagnosis.
