Pharmacoepidemiologic Studies
This study design is considered the gold standard for establishing causality
What is a Randomized Controlled Trial (RCT)?
This term refers to patients, caregivers, and the general public who receive information about the risks and safety concerns of medications
What is the receiver?
The FDA patent reporting system
What is MedWatch?
What is consent?
This drug led to the development of stricter drug regulation after causing widespread birth defects
What is Thalidomide?
A p-value less than 0.05 suggests this about the observed results
What is statistically significant?
This term refers to the organization or entity responsible for providing information about the risks and safety concerns of medications to patients, caregivers, and the public
What is the sender?
A global campaign initiative to increase ADR reporting awareness
What is #MedSafetyWeek?
This ethical principle calls for fair representation in clinical trial design
What is equity?
This was introduced to replace the letter-based system for drug risk in pregnancy to improve clarity and detail
What is pregnancy and lactation labeling (PLLR)?
In pharmacoepidemiology, this term refers to new cases of a disease or outcome happen in a group over a specific period.
What is incidence?
Acknowledging uncertainty in drug safety communication is important because it helps build this essential element between healthcare providers, patients, and the public
What is trust?
Concerns raised by patients on social media about changes to this biological process after COVID-19 vaccination became a notable example of patient-led pharmacovigilance
What is menstruation?
This ethical consideration entails using high quality evidence and transparency in research
What is scientific integrity?
The most critical period for embryo-fetal development, when most malformations occur
What is 3rd-8th week of the first trimester?
This type of observational study is most appropriate when researchers want to investigate a group of people over time to see who develops a certain outcome
What is a cohort study?
The primary goal of pharmacovigilance risk communication is to ensure this, allowing healthcare professionals and patients to make safe and effective choices regarding medications
What is informed decision making?
One key benefit of this type of reporting is that it provides more firsthand insight into adverse drug reactions, helping to identify safety issues that might be missed by healthcare professionals
What is direct patient reporting?
One major ethical challenge with using digital technologies in pharmacovigilance is this concern about protecting sensitive information
What is patient data privacy and breaches?
This factor contributes to polypharmacy in older adults, where individuals take multiple medications
An odds ratio (OR) of 1.0 indicates this about the relationship between exposure and outcome
What is no association?
In the case of hydroxychloroquine during the COVID-19 pandemic, this risk communication error occurred
What is premature authorization without sufficient evidence?
This type of surveillance relies on spontaneous reports of adverse drug reactions from healthcare professionals and patients, often leading to underreporting
What is passive surveillance?
Duty to act in patient's best interest
What is fiduciary duty?
This older age-related change in the body can contribute to the buildup of drugs in the system, increasing the risk of adverse effects
What is decreased renal function/excretion?