Pharmacovigilance and methods Flashcards
(38 cards)
What is the definition of adverse drug reactions (ADRs)?
ADRs are harmful or unintended responses to medications that can lead to significant health issues and may be preventable.
ADRs remain a leading cause of death in some countries and impose a high financial burden on healthcare systems.
What is pharmacovigilance?
Pharmacovigilance is the systematic and science-based approach to monitoring and assessing the safety of drugs.
The term is derived from the Greek words ‘pharmakon’ (drug) and ‘vigilare’ (to keep watch).
How does the WHO define pharmacovigilance?
The WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug/vaccine related problems.
What are the two phases of the pharmacovigilance framework?
- Pre-Marketing Surveillance
- Post-Marketing Surveillance
What is the focus of post-marketing surveillance?
Post-marketing surveillance focuses on ADRs reported after a drug is approved and marketed.
What is passive surveillance in pharmacovigilance?
Passive surveillance involves spontaneous reports from healthcare professionals or patients regarding ADRs.
What is active surveillance in pharmacovigilance?
Active surveillance is targeted monitoring for specific events or medications to discover the number of ADRs or events.
What tragic event led to improvements in pharmaceutical regulations?
The Sulphanilamide Elixir incident in 1937, which caused poisoning in children, led to improved pharmaceutical regulations.
What was the consequence of the Thalidomide Tragedy in 1961?
It sparked global pharmacovigilance system development and led to the establishment of spontaneous reporting systems.
What is the primary objective of pharmacovigilance systems?
To improve patient care and well-being through safe medication use.
What are the three main groups involved in pharmacovigilance activities?
- Regulatory
- Industry
- Academia
What are descriptive studies in post-marketing studies?
Descriptive studies generate hypotheses and attempt to describe the occurrence of events related to drug toxicity and efficacy.
What is the purpose of spontaneous reporting systems (SRS)?
To collect post-marketing safety data on drugs and facilitate early detection of new, rare, and serious ADRs.
True or False: Over 94% of ADRs remain unreported.
True
What is signal detection in pharmacovigilance?
Signal detection is a critical process for identifying potential safety concerns related to pharmaceutical products.
What are Proportional Reporting Ratios (PRRs)?
PRRs are a method used to compare the frequency of a specific side effect reported for one drug against all other drugs.
What is the Bayesian Confidence Propagation Neural Network (BCPNN)?
BCPNN uses Bayesian statistical methods to highlight dependencies in datasets and identify unexpectedly strong relationships in ADR combinations.
What is the Multi-Item Gamma Poisson Shrinker (MGPS)?
MGPS is a tool used by the FDA to look for patterns in reports about side effects or problems caused by medications.
What are the limitations of data mining in pharmacovigilance?
- Cannot differentiate between known and new associations
- Does not consider clinical information
- Requires manual review by experts
What is intensive monitoring in pharmacovigilance?
Intensive monitoring is a form of active surveillance that collects adverse event reports from prescribers using prescription data.
What are the strengths of intensive monitoring?
- Captures real-world data
- Detects unsuspected ADRs
- Enables risk quantification for specific ADRs
What is the General Practice Research Database (GPRD)?
A UK-based database that collects data from General Practitioners (GPs) covering approximately 3 million patients annually.
What type of data does the GPRD collect?
- Demographics
- Medical diagnoses
- Prescription details
- Vaccinations
- Lab results
What is the percentage of focus on disease epidemiology?
30%
